chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable physician via Pfizer sponsored program.     A 60-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation Solution for injection, Lot Number unknown, Expiry date: 31Jul2021) via an unspecified route of administration on 20Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 20Apr2021 patient Stated that hives experienced almost immediately after receiving the first dose Pfizer Covid Vaccine. Outcome of the event was recovered.  Follow-up attempts are needed. Further information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, urticaria cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: had a problem with bleeding; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE Dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a problem with bleeding after getting her vaccine on an unspecified date. The outcome of the event was unknown. Information on lot/batch number has been requested.  Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE Question: The caller stated her husband has an aneurysm in his head and has not received the vaccine but she asked if there is any danger in him getting the vaccine? She stated he cannot take aspirin or baby aspirin because of the risk of bleeding. She wanted to know if it is safe to get the vaccine for someone with an aneurysm.  She stated she got the vaccine and had a problem with bleeding when she got it.   DSU- the caller just reported this with an agent; Reference #BWXAH3NP; e-transmitting potential duplicate AE details Response: Read from the PI section 4. Explained that there is no data or information that specifically addresses the safety of the vaccine for someone with an aneurysm. Referred to HCP for further discussion.  LAB-1457-7.0 Revised: 06 April 2021
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Tested positive (for COVID-19) on a Rapid Test performed today; Congested/congestion; This is a spontaneous report from a non-contactable consumer (patient's mother). A female patient of unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiry date: unknown), via an unspecified route of 27Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Question asked if the Pfizer COVID-19 vaccine, received by her daughter on 27Apr2021 (first dose) can change her rapid test to positive for COVID-19. It is reported that the patient woke up yesterday (May2021) (8 days after first shot) very congested and tested positive (for COVID-19) on a Rapid Test performed today (06May2021), the only symptom her daughter had congestion. The patient underwent lab tests and procedures which included on 06May2021 Rapid test for COVID-19 result positive and PCR Test today and will get back the results in a few days, to know for sure. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Off label use, SARS-CoV-2 test
Clinical narrative: first dose on 16Mar2021/did not do the second dose of vaccine yet; tested positive for covid; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported herself that on an unspecified age she received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Mar2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive for COVID on 21Mar2021, first dose on 16Mar2021/did not do the second dose of vaccine yet on an unspecified date. Patient was supposed to take her second dose 06Apr but was in quarantine until 08Apr2021 then tested negative for COVID. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on Apr2021, SARS-CoV-2 test: positive on 21Mar2021. The outcome of event tested positive for COVID was recovered on 08Apr2021 and for other event outcome was unknown. The patient asked if she should get the second vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated
Clinical narrative: patient states that 2 weeks ago she developed a flare; This is a spontaneous report from two contactable Other healthcare professionals (HCPs) via Pfizer-sponsored program Optum Xeljanz Program.   A 61-year-old female patient received tofacitinib citrate (XELJANZ, 5 mg), via an unspecified route of administration from 20Apr2021 at 5 mg unknown frequency for an unspecified indication and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 20Apr2021 (at 61 years) at single dose for covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient stated that 2 weeks prior, in Apr2021, she developed a flare but believed it was related to getting vaccinated for Covid. The final outcome of the event was unknown.  Tofacitinib was prescribed until 08May2021, however action taken for tofacitinib citrate in response to the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Skin discolouration
Clinical narrative: Doesn't feel good; feels bad; Found some black spots on her leg and her arm after taking this dose, this morning; This is spontaneous report received from a contactable consumer (patient husband).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02May2021 (Batch/Lot Number: EW0176) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0153) on unspecified date as single dose. The patient experienced doesn't feel good; feels bad (feeling abnormal) (non-serious) and found some black spots on her leg and her arm after taking this dose, this morning (skin disorder) (non-serious) on 02May2021 with outcome of unknown. The patient had the second dose on 02May2021 in the morning and then she did not feel good, and she found something, and she found some black spots on her leg and her arm after taking this dose, this morning.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Neck mass, Neck pain
Clinical narrative: a knot underneath my  collar bone and in the muscle of my neck; was throbbing all day; I was unable to go to sleep; This is a spontaneous report from a contactable female consumer (patient).  A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration in left arm on 28Apr2021 (Batch/Lot Number: ER, unknow what that is U, V, 0175) as single dose at an unspecified age for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: ER8729) as single dose at an unspecified age for COVID-19 immunisation.  The patient experienced a knot underneath her collar bone and in the muscle of my neck, it was throbbing all day, she was unable to go to sleep on an unspecified date. The outcome of events was unknown.   Reporter seriousness for events was unspecified.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Swelling face
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A 58-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Apr2021 16:45 (Batch/Lot Number: EN0161) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took lisinopril and experienced allergy. After getting shot about 1/2 hr later tongue on right side started going numb and right side of face started to swell on 16Apr2021 17:30. Therapeutic measures were taken included steriods and antihistamine. Patient visited doctor or other healthcare professional office/clinic visit for events. Outcome of events was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Influenza like illness, Nasopharyngitis
Clinical narrative: fainting; Severe stomach-flue like symptoms with diarrhea; Severe stomach-flue like symptoms with diarrhea; Aches/Body aches in core; Head-cold like symptoms with sinus pain; Head-cold like symptoms with sinus pain; fatigue; Wooziness; Body aches in core and legs; This is a spontaneous report received from a non-contactable consumer (patient). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route of administration on 29Apr2021 (at age of 30 years old) as single dose for COVID-19 immunization. Medical history included known allergies: Sulfa drugs. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No COVID prior vaccination. No COVID tested post vaccination. The patient experienced Severe stomach-flue like symptoms with diarrhea, fainting, aches. Head-cold like symptoms with sinus pain, fatigue, wooziness. Body aches in core and legs. All events on 30Apr2021. No treatment received for all events. The outcome of the events was recovered in 2021.  No follow-up attempts are Possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Sinus pain, Syncope
Clinical narrative: fainting; Severe stomach-flue like symptoms with diarrhea; Severe stomach-flue like symptoms with diarrhea; Aches/Body aches in core; Head-cold like symptoms with sinus pain; Head-cold like symptoms with sinus pain; fatigue; Wooziness; Body aches in core and legs; This is a spontaneous report received from a non-contactable consumer (patient). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route of administration on 29Apr2021 (at age of 30 years old) as single dose for COVID-19 immunization. Medical history included known allergies: Sulfa drugs. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No COVID prior vaccination. No COVID tested post vaccination. The patient experienced Severe stomach-flue like symptoms with diarrhea, fainting, aches. Head-cold like symptoms with sinus pain, fatigue, wooziness. Body aches in core and legs. All events on 30Apr2021. No treatment received for all events. The outcome of the events was recovered in 2021.  No follow-up attempts are Possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Biliary colic, Breast mass, Cholecystitis
Clinical narrative: Inflammed gallbladder; Large mass in left breast; Inflammed gallbladder - severe pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received her first single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration in left arm on 11Apr2021 09:00 (lot number ER8737) at the age of 35-year-old for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. On 14Apr2021 12:00 AM, the patient experienced large mass in left breast, Inflammed gallbladder - severe pain. The patient did not receive any treatment for the events. The patient had not recovered from the events at the time of reporting. The patient considered the events were non-serious. Follow-up attempts are needed. Further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Herpes simplex
Clinical narrative: Several hours after getting my shot I developed a rapid onset, severe Herpes outbreak; Several hours after getting my shot I developed a rapid onset, severe Herpes outbreak; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient (not Pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 07Apr2021 16:00 (Lot Number: en6201, at age of 67 years old) as single dose for COVID-19 immunisation. The patient medical history include: Herpes Simplex 2 for several decades. Concomitant medications included simvastatin and valacyclovir (reported as valcyclovir) for Herpes Simplex. The patient previously took morphine and experienced Allergies, tetracycline and experienced Allergies. The patient had Herpes Simplex 2 for several decades. It was well controlled with a low daily dose of valcyclovir. Several hours after getting shot the patient developed a rapid onset, severe Herpes outbreak on 07Apr2021 08:00 PM (reported as 07Mar2021). The patient took the "outbreak dose" of Valcyclovir, but it didn't calm the sx. The outbreak lasted for about a week. It's the worst case the patient ever had, both in severity and duration. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on unknown date.
Sex: U
Vaccine: COVID19
Symptoms: Electrocardiogram, Palpitations
Clinical narrative: transient, but consistent, heart palpitations; This is a spontaneous report from a contactable consumer. A patient (doctor) of unspecified age and gender received the second dose of BNT162B2 (Pfizer/BioNtech covid-19 vaccine details, lot number: ER8729), via an unspecified route of administration in left arm on 26Apr2021 17:00 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included mirtazapine 15 mg as sleep aid. The patient previously received the first dose of BNT162B2 (lot number: ER8734) on 05Apr2021 in left arm for COVID-19 immunisation. Patient had been out of work for a week following his second dose of the Pfizer vaccine due to transient, but consistent, heart palpitations from 27Apr2021 19:00, which ultimately brought him into the ER to take his own electrocardiogram (EKG). Event resulted in: Emergency room/department urgent care. No treatment was received. Outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Burn oral cavity, Glossodynia, Swollen tongue
Clinical narrative: Sensation of having a lightly burned tongue, mid tongue to tip; Sensitive tastebuds; the feeling that the tongue is slightly swollen; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown as did not look) via an unspecified route of administration, first dose administered in Left arm on 31Mar2021 at 10:30 (at the age of 26-year-old) at single dose, second dose administered in Left arm on 28Apr2021 at 10:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medication included progesterone (PROGESTIN) and birth control. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sensation of having a lightly burned tongue, mid tongue to tip. Sensitive tastebuds, sometimes the feeling that the tongue is slightly swollen. No loss of taste. Happened several days after first vaccine in Apr2021 and lasted about a week. Happens again, 2-3 days after the second on 30Apr2021. No hospitalization prolonged involved. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered in Apr2021 for about a week, then reoccurred on 30Apr2021 with outcome of recovering.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Maternal exposure during pregnancy, Off label use, Premature rupture of membranes
Clinical narrative: Water breaking day of shot with no contractions until castor oil at 36 hour mark; Pregnancy at time of Vaccination: Yes; first dose on 16Apr2021, second dose on 30Apr2021; first dose on 16Apr2021, second dose on 30Apr2021; This is a spontaneous report received from a contactable healthcare professional (patient). A 35-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in right arm on 30Apr2021 08:45 (Batch/Lot Number: EW0164) as single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing , seasonal allergy from an unknown date and unknown if ongoing. She received the first dose of BNT162b2 (lot number: ER8729) on 16Apr2021. Concomitant medication(s) included levoglutamide, polaprezinc (ENDOZIN) taken for an unspecified indication, start and stop date were not reported; urtica dioica leaf (NETTLE LEAF) taken for an unspecified indication, start and stop date were not reported; and  "designs for health prenatal pro p". No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was pregnant at time of vaccination. The date of last menstrual period was 03Aug2020, due date was 09May2021. Gestation period was 38 weeks at the time of the second dose of the vaccine. The patient experienced water breaking day of shot (on 30Apr2021 19:15) with no contractions until castor oil at 36 hour mark. The outcome was reported as recovering.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb immobilisation, Muscle twitching, Neck pain, Pain in extremity
Clinical narrative: inability to move my arm; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; This is a spontaneous report from a contactable consumer who reported for herself. A 47-year-old non-pregnant female patient received her first single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration in left arm on 11Apr2021 16:30 (lot number EW0153) at age of 47-year-old for COVID-19 immunization. The patient's medical history was not reported. The patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received Vicodin. The patient experienced "severe pain up to my neck and down my arm (just on the left/injection side) then tingling and numbness, then inability to move my arm with twitching muscles (neck pain)" on 13Apr2021 19:00, "I thought I was having a heart attack or a stroke" on 13Apr2021 19:00. On 13Apr2021 19:00, severe pain up to patient's neck and down her arm (just on the left/injection side). Then tingling and numbness, then inability to move her arm with twitching muscles. She thought she was having a heart attack or a stroke. It lasted for about a minute then it subsided. It happened again 20 minutes later and again the next day. No lasting effects that she noticed and had not returned. The patient did not receive treatment for the events. The events resolved on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had her second dose on 02May2021. Information about batch no/lot no has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: inability to move my arm; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; This is a spontaneous report from a contactable consumer who reported for herself. A 47-year-old non-pregnant female patient received her first single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration in left arm on 11Apr2021 16:30 (lot number EW0153) at age of 47-year-old for COVID-19 immunization. The patient's medical history was not reported. The patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received Vicodin. The patient experienced "severe pain up to my neck and down my arm (just on the left/injection side) then tingling and numbness, then inability to move my arm with twitching muscles (neck pain)" on 13Apr2021 19:00, "I thought I was having a heart attack or a stroke" on 13Apr2021 19:00. On 13Apr2021 19:00, severe pain up to patient's neck and down her arm (just on the left/injection side). Then tingling and numbness, then inability to move her arm with twitching muscles. She thought she was having a heart attack or a stroke. It lasted for about a minute then it subsided. It happened again 20 minutes later and again the next day. No lasting effects that she noticed and had not returned. The patient did not receive treatment for the events. The events resolved on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had her second dose on 02May2021. Information about batch no/lot no has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Hypoaesthesia, Nervousness, Palpitations
Clinical narrative: Numb left ear and parts of left side of face; Heart Pressure; Irregular heart palpitations; very scary; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 51-year-old female patient received first dose of BNT162B2 (Lot Number: ER8731) via an unspecified route of administration, administered in left arm on 07Apr2021 at 14:00 at age of 51-year-old as single dose, and received second dose of BNT162B2 (Lot Number: EWO167) via an unspecified route of administration, administered in left arm on 28Apr2021 at 14:00 at age of 51-year-old as single dose for covid-19 immunisation. Medical history was not reported. Facility where the most recent COVID-19 vaccine was administered reported as Public Health Clinic facility. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 28Apr2021 at 16: 00, patient experienced heart pressure, irregular heart palpitations - almost went to emergency room a few times. Patient was very scary, had numb left ear and parts of left side of face. No Hospitalization Prolonged. No treatments were received for events heart pressure, very scary and numb left ear and parts of left side of face. The outcome of events was recovered with sequelae.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Thrombosis
Clinical narrative: week later diagnosed with blood clot in right leg; 102 degree fever; This is a spontaneous report from a contactable consumer (patient). This 55-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, dose 2 via an unspecified route of administration, administered in left arm on 24Apr2021 15:30 (Batch/Lot Number: EW0161) (age at vaccination: 55 years) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant. The patient had received first dose of BNT162b2 on 03Apr2021 (Batch/lot number: ER8733) for COVID-19 immunisation and experienced headache, joint pain and muscle aches. Prior to vaccination, the patient was not diagnosed with COVID-19. She had not been tested for COVID-19 since the vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included zolpidem tartrate (AMBIEN) taken for an unspecified indication, start and stop date were not reported. Week later after the second dose, the patient was diagnosed with blood clot in right leg on 27Apr2021 and developed 102 degree fever on 27Apr2021. The patient received treatment (unspecified) for the events. The events resulted in emergency room/department or urgent care. The events were not resolved.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac disorder, Discomfort, Headache, Syncope
Clinical narrative: Faint; Heart problem; Whole left side just had pressure, pressure from all around my left breast and my back, down my arm, my ear; Headache; Don't really have the energy; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 27Apr2021 (Lot Number: ER8736) as single dose for COVID-19 immunisation. Medical history included thyroid, COVID (patent was almost 100 percent sure that she had COVID before but she did not know for sure because she had not been tested for antibodies). Concomitant medication included levothyroxine sodium (LEVOTHYROXINE NA) taken for thyroid. The patient stated she got the Pfizer shot on the 27Apr2021 and she had a reaction to it, heart problem and she really did not think that she might have had, she was almost 100 percent sure that she had COVID before but she did not know for sure because she had not been tested for antibodies. But she just really had a terrible effect and she did not know what was the next step. She meant her whole heart, she fainted, her whole left side just had pressure, pressure from all around her left breast and her back, down her arm, her ear. She had a headache and she gave it a couple days and she was feeling better today (03May2021) but she did not really have the energy. No treatment received. Due date for the next shot is 18May2021. Height and weight were reported as 5 (feet) 3 (inches), and 135 (pounds) (That's just an estimate per patient). Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable consumer (patient's daughter) reported for 70-year-old patient that: A 70-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and expiration date were unknown), via unspecified route, on 14Apr2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was tested positive the week after, they are now getting out from the disease, The reporter would like to know the appropriate amount of time when to receive the second dose. The Customer and/or medical inquiry forwarded or referred to MI. The outcome of the event was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I received Pfizer vaccine 1st shot January 31st, February 2nd I tested positive for Covid; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 31Jan2021 as 1st dose, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 02Feb2021, the patient was tested positive for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 02Feb2021. The clinical outcome of the events was unknown.     Follow-up#1 (05May2021): This is a follow-up spontaneous report from a contactable consumer. This contactable female consumer (patient) reported for herself: no new significant information has been received.   Follow-up#2 (04May2021): This is a follow-up spontaneous report from a contactable consumer. This female contactable consumer (patient) reported for herself: no new significant information has been received.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I developed a skin rash starting on my lower legs, then spread throughout the body.  It spread to my arms, back, stomach, face and both ear lobes.; This is a spontaneous report from a contactable consumer. A 41-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 24Mar2021 at 16:45 (Batch/Lot Number: ER8732) as SINGLE DOSE for covid-19 immunization. Medical history included seasonal allergy, and latex sensitivity. Concomitant medication included ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in right arm on 14Apr2021 at 11:45 (Batch/Lot number: EW0161) for COVID-19 immunization. On 17Apr2021 at 11:00, the patient developed a skin rash starting on lower legs, then spread throughout the body.  It spread to arms, back, stomach, face and both ear lobes. The patient received topical steroid cream and antihistamine as treatment for the event. The outcome of the event was not recovered. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: wants to know if she tested positive for covid can she get the vaccine?/Unsure if this was between doses or before getting the first dose; wants to know if she tested positive for covid can she get the vaccine?/Unsure if this was between doses or before getting the first dose; This is a spontaneous report from a contactable consumer, the patient. A patient of an unspecified gender and age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient wanted to know if she tested positive for COVID, could she get the vaccine. It was unknown if this was between doses or before getting the first dose. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: she was fully vaccinated with the Pfizer COVID vaccine at the end of FEB2021 and she still got COVID; she was fully vaccinated with the Pfizer COVID vaccine at the end of FEB2021 and she still got COVID; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL8982) on 21Jan2021 (afternoon), and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9867) on 12Feb2021 (morning), both via an unspecified route of administration, administered in left arm, as single dose for COVID-19 immunization. The patient medical history was none. Concomitant medications were not reported. Patient did not receive any other vaccine four weeks prior the vaccination. On 03May2021, patient had two instant tests prior to the full one that were positive for COVID-19. On 04May2021, the patient has done three tests and COVID-19 was confirmed. Patient stated that she was fully vaccinated with the Pfizer COVID vaccine at the end of FEB2021 and she still got COVID. The patient underwent lab tests which included two times instant SARS-CoV-2 test on 03May2021 and full one for SARS-CoV-2 test on 04May2021, all the tests with Positive results, also patient described that NYU did some unspecified extensive test. Patient had the full test because her doctor was so shocked that she tested Positive, and doctor wanted to let Pfizer know. Patient thought that it was going to protect her from getting COVID. Patient has gone all of the time and never got COVID and then she gets the COVID vaccines and gets freaking COVID. Patient thinks that she has no predisposing factors for getting COVID but that the only thing that she was worrying about was that she lives in an apartment building and they had parties going on in her building and was trying to track that down. Patient did not go to the party though, but she wonders if COVID can be in the air in the building. Patient only concern was that this COVID vaccine was a bummer, got vaccinated and then got COVID. The outcome of the events was unknown.   Follow up attempts are needed. Further information has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Pyrexia, SARS-CoV-2 test, Vaccination site discomfort
Clinical narrative: little fever; coughing; headache; he felt pressure at the injection site; injection part hurt for a good 24 to 36 hours; This is a spontaneous report from a contactable consumer (patient).   A 74-years-old male patient received second dose of PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6203 and expiry date: Jun2021) via an unspecified route of administration, in the right arm, on 19Feb2021 at 16:00 - 17:00 (at the age of 74-years-old) as a single dose for covid-19 immunisation. Patient's medical history included overweight, blood pressure, thyroid and diabetes. Concomitant medication was not reported. He reports he does not exercise. Patient did not receive other vaccine in four weeks of vaccination and no adverse effect, prior vaccination. No additional vaccines were administered. Patient had previously received first dose of vaccine on 18Jan2021 (Batch/lot number: EL3246and expiry date: Apr2021) in right arm and from 01Feb2021. On 01Feb2021, COVID-19 virus test was perform and result was positive. He started having symptoms on 01Feb2021, experienced cough, headache, sinus issues, tiredness and weak and had no fever. He was tested for the Covid 19 virus on 03Feb2021 with the swab in his nose and he received his positive results in the afternoon on 04Feb2021. His symptoms only lasted until about 05Feb2021, except for the tiredness. He was tired and weak for about 6 weeks. On 19Feb2021, patient experienced little fever, coughing, headache, injection part hurt for a good 24 to 36 hours and pressure at the injection site. Reporter seriousness for all events was unspecified. The outcome of event fever, coughing and headache was resolved on 20Feb2021 and for other events was unknown. He has routine blood work done every 6 months and was healthy.   No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little fever; coughing; headache; he felt pressure at the injection site; injection part hurt for a good 24 to 36 hours; This is a spontaneous report from a contactable consumer (patient).   A 74-years-old male patient received second dose of PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6203 and expiry date: Jun2021) via an unspecified route of administration, in the right arm, on 19Feb2021 at 16:00 - 17:00 (at the age of 74-years-old) as a single dose for covid-19 immunisation. Patient's medical history included overweight, blood pressure, thyroid and diabetes. Concomitant medication was not reported. He reports he does not exercise. Patient did not receive other vaccine in four weeks of vaccination and no adverse effect, prior vaccination. No additional vaccines were administered. Patient had previously received first dose of vaccine on 18Jan2021 (Batch/lot number: EL3246and expiry date: Apr2021) in right arm and from 01Feb2021. On 01Feb2021, COVID-19 virus test was perform and result was positive. He started having symptoms on 01Feb2021, experienced cough, headache, sinus issues, tiredness and weak and had no fever. He was tested for the Covid 19 virus on 03Feb2021 with the swab in his nose and he received his positive results in the afternoon on 04Feb2021. His symptoms only lasted until about 05Feb2021, except for the tiredness. He was tired and weak for about 6 weeks. On 19Feb2021, patient experienced little fever, coughing, headache, injection part hurt for a good 24 to 36 hours and pressure at the injection site. Reporter seriousness for all events was unspecified. The outcome of event fever, coughing and headache was resolved on 20Feb2021 and for other events was unknown. He has routine blood work done every 6 months and was healthy.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Dizziness, Dysphagia, Ear pain
Clinical narrative: noticed change in swallowing; Yellow coat on tongue; noticed stomach gurgling and gas bubble pressure in chest; Dizzy; Head pain left side. Symptoms gone after eating; pain in shoulder and neck; pain in shoulder and neck; Pain left ear & base of neck btwn shoulders; This is a spontaneous report from a contactable consumer (patient).    A 54-years-old female (54 years age at vaccination) patient received first dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EUBK7), via an unspecified route of administration, administered in left arm on 07May2021 at 10:15 as single dose for COVID-19 immunisation. The patient's medical history included tonsillar abscess (she was recently there for an event of tonsillar abscess) and food allergy (Soy causes bumps on forehead). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medication included 4mg nicotine gum (taken before two weeks of vaccination for an unspecified indication). After vaccination, at 10:15 (07May2021), the patient experienced pain in left ear and base of neck between shoulders (for 30 mins). She felt dizzy and head pain on left side at 11:00. Symptoms went off after eating. She noticed change in swallowing at 15:30. The patient noticed stomach gurgling and gas bubble pressure in chest. There was no pain of any kind and felt like gas. She assumed the cause might be due to recent weight gain. The patient experienced slightly difficult to swallow at 18:00. She checked for it, and no swelling was there, but found yellow coat on tongue. She googled and concluded it as typical vax symptoms. The patient was advised by a nurse (on phone) to go to urgent care to get checked. In urgent care at 18:30, the nurse did not look at her throat, despite she informed the nurse, that she was recently there for an event of tonsillar abscess. The nurse's notes incorrectly stated chest pain. The patient's underwent lab tests which reported all vitals as normal, EKG was normal, and BP was reported as 139/77. The patient was advised to go to the ER, because COVID was "too new" for them to know what was going on or how to treat. They never explained what they thought was wrong. The patient went home at 19:00. Therapeutic measures included Pepto Bismal and gargled with salt water and symptoms went off. The outcome of all the events was reported as recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Flatulence, Headache, Neck pain, Tongue coated
Clinical narrative: noticed change in swallowing; Yellow coat on tongue; noticed stomach gurgling and gas bubble pressure in chest; Dizzy; Head pain left side. Symptoms gone after eating; pain in shoulder and neck; pain in shoulder and neck; Pain left ear & base of neck btwn shoulders; This is a spontaneous report from a contactable consumer (patient).    A 54-years-old female (54 years age at vaccination) patient received first dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EUBK7), via an unspecified route of administration, administered in left arm on 07May2021 at 10:15 as single dose for COVID-19 immunisation. The patient's medical history included tonsillar abscess (she was recently there for an event of tonsillar abscess) and food allergy (Soy causes bumps on forehead). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medication included 4mg nicotine gum (taken before two weeks of vaccination for an unspecified indication). After vaccination, at 10:15 (07May2021), the patient experienced pain in left ear and base of neck between shoulders (for 30 mins). She felt dizzy and head pain on left side at 11:00. Symptoms went off after eating. She noticed change in swallowing at 15:30. The patient noticed stomach gurgling and gas bubble pressure in chest. There was no pain of any kind and felt like gas. She assumed the cause might be due to recent weight gain. The patient experienced slightly difficult to swallow at 18:00. She checked for it, and no swelling was there, but found yellow coat on tongue. She googled and concluded it as typical vax symptoms. The patient was advised by a nurse (on phone) to go to urgent care to get checked. In urgent care at 18:30, the nurse did not look at her throat, despite she informed the nurse, that she was recently there for an event of tonsillar abscess. The nurse's notes incorrectly stated chest pain. The patient's underwent lab tests which reported all vitals as normal, EKG was normal, and BP was reported as 139/77. The patient was advised to go to the ER, because COVID was "too new" for them to know what was going on or how to treat. They never explained what they thought was wrong. The patient went home at 19:00. Therapeutic measures included Pepto Bismal and gargled with salt water and symptoms went off. The outcome of all the events was reported as recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she tested positive for COVID; This is a spontaneous report from a contactable consumer (patient's daughter).  A 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: Unknown) via unspecified route of administration on 20Jan2021 (at the age of 80-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of the Pfizer COVID-19 vaccine on 20Jan2021 and was infected the same day. On 25Jan2021 Monday, the patient was tested positive. She started having symptoms on the 24Jan2021. Because of her age, she was taken to doctor and on 27Jan2021, she got antibody infusion for COVID. The patient was then told to wait 90 days because she had antibodies, and on 29Apr2021 she received her second COVID shot, it was Pfizer as well. The clinical outcome of the event was unknown.  Follow up (07May2021): This follow-up is being submitted to notify new information: Event onset date and lab data was added.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.