chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: has broken out with herpes on the back of her leg and it is currently red and blistery; has broken out with herpes on the back of her leg and it is currently red and blistery; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. Medical history includes shingles break out. The patient's concomitant medications were not reported. The patient previously took valaciclovir hydrochloride (VALTREX S) from an unspecified date to unspecified date in 2021 at three times a day for shingles break out. The patient inquired if there is an interaction between the Covid vaccine and Valtrex. The patient reported that before she received her first vaccine dose, she experienced a shingles breakout and was taking Valtrex 3 times per day. She mentioned that she received her first vaccine dose on 08Apr2021 and now, she is experiencing herpes breakout on her leg and needs another prescription for Valtrex. She inquired if this would interact with the vaccine as her second vaccine dose is scheduled for 29Apr2021. The patient further mentioned that she had to postpone the first dose of the Pfizer COVID vaccine because of shingles. She stated that she was taking Valtrex three times a day and that the Valtrex package said do not take with any vaccine or immunization so she rescheduled the first dose of the Pfizer COVID vaccine because Valtrex should not be taken with a vaccine. She waited a week after completing the Valtrex and got the first Pfizer COVID vaccine on 08Apr2021. She reported that she has broken out with herpes on the back of her leg and it is currently red and blistery on Apr2021. She added that she has had this before and she guesses she needs to talk to her dermatologist, but figures Pfizer know more about the interactions than the dermatologist does. She further added that usually when she has a herpes breakout that the dermatologist either does a cortisone shot into the breakout or she takes Valtrex, but she saw that it is not good to mix the Valtrex with immunizations. She mentioned that this current breakout is not related to the Pfizer COVID vaccine and she declines to complete the report. The adverse events were considered as non-serious. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the events of shingles and condition aggrevated.  The reported events likely represent intercurrent medical conditions.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Scab
Clinical narrative: unusual crusty thing on her arm as a side effect; red spot; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation and tocilizumab (ACTEMRA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing (RA for several years). On an unspecified date, the patient experienced unusual crusty thing on her arm as a side effect on an unspecified date and red spot. The action taken in response to the events for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Axillary pain, Chest discomfort, Conjunctivitis, Dizziness
Clinical narrative: fumbling over words; metallic taste; dizziness; daily headaches; Sore arm; Sore armpit on arm of injection site; Waves of feeling like my body was giving up; Fever; Spontaneous conjunctivitis; Skin soreness; Chest tightness; Itchiness; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- EW0153), via an unspecified route of administration, left arm on 09Apr2021 at 09:45 (at the age of 42-years old) at a single dose for COVID-19 immunization. Medical history included allergy to peppers and COVID-19. The patient's concomitant medications included NSAIDs. No other vaccine was given in four weeks. It was unknown if the patient was pregnant. On 09Apr2021 at 16:45, the patient experienced sore arm, sore armpit on arm of injection site, waves of feeling like my body was giving up, fever, spontaneous conjunctivitis, skin soreness, chest tightness and itchiness and on 10Apr2021 at 09:30, the patient experienced fumbling over words, metallic taste, dizziness and daily headaches on 10Apr2021 at 09:30. The patient did not receive any treatment for the events. Since vaccination, the patient has not been tested for COVID-19 The outcome of the events sore arm, sore armpit on arm of injection site, waves of feeling like my body was giving up, fever, spontaneous conjunctivitis, skin soreness, chest tightness and itchiness was recovering; and the outcome of the events fumbling over words, metallic taste, dizziness and daily headaches was not recovered.  No follow up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling abnormal, Headache, Pain in extremity, Pain of skin
Clinical narrative: fumbling over words; metallic taste; dizziness; daily headaches; Sore arm; Sore armpit on arm of injection site; Waves of feeling like my body was giving up; Fever; Spontaneous conjunctivitis; Skin soreness; Chest tightness; Itchiness; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- EW0153), via an unspecified route of administration, left arm on 09Apr2021 at 09:45 (at the age of 42-years old) at a single dose for COVID-19 immunization. Medical history included allergy to peppers and COVID-19. The patient's concomitant medications included NSAIDs. No other vaccine was given in four weeks. It was unknown if the patient was pregnant. On 09Apr2021 at 16:45, the patient experienced sore arm, sore armpit on arm of injection site, waves of feeling like my body was giving up, fever, spontaneous conjunctivitis, skin soreness, chest tightness and itchiness and on 10Apr2021 at 09:30, the patient experienced fumbling over words, metallic taste, dizziness and daily headaches on 10Apr2021 at 09:30. The patient did not receive any treatment for the events. Since vaccination, the patient has not been tested for COVID-19 The outcome of the events sore arm, sore armpit on arm of injection site, waves of feeling like my body was giving up, fever, spontaneous conjunctivitis, skin soreness, chest tightness and itchiness was recovering; and the outcome of the events fumbling over words, metallic taste, dizziness and daily headaches was not recovered.  No follow up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: fumbling over words; metallic taste; dizziness; daily headaches; Sore arm; Sore armpit on arm of injection site; Waves of feeling like my body was giving up; Fever; Spontaneous conjunctivitis; Skin soreness; Chest tightness; Itchiness; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- EW0153), via an unspecified route of administration, left arm on 09Apr2021 at 09:45 (at the age of 42-years old) at a single dose for COVID-19 immunization. Medical history included allergy to peppers and COVID-19. The patient's concomitant medications included NSAIDs. No other vaccine was given in four weeks. It was unknown if the patient was pregnant. On 09Apr2021 at 16:45, the patient experienced sore arm, sore armpit on arm of injection site, waves of feeling like my body was giving up, fever, spontaneous conjunctivitis, skin soreness, chest tightness and itchiness and on 10Apr2021 at 09:30, the patient experienced fumbling over words, metallic taste, dizziness and daily headaches on 10Apr2021 at 09:30. The patient did not receive any treatment for the events. Since vaccination, the patient has not been tested for COVID-19 The outcome of the events sore arm, sore armpit on arm of injection site, waves of feeling like my body was giving up, fever, spontaneous conjunctivitis, skin soreness, chest tightness and itchiness was recovering; and the outcome of the events fumbling over words, metallic taste, dizziness and daily headaches was not recovered.  No follow up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Felt stinging in my right arm soon after vaccine injection; Felt slight sting in my neck and something minor by my ear; Woke up with a very groggy feeling; couldn't look at self in the mirror and focus; arm was minorly sore; congestion in my head; fogginess; swollen lymph node behind my right ear; minor ache in right side of head/mild aching; sinus pressure in front of face now-near eyes and nose/sinus pressure; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 53-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8737) via an unspecified route of administration in the right arm on 31Mar2021 at 15:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies, asthma as a child and some sinus infection history which was reported as not usual, all from unknown dates and unknown if ongoing. The patient had no allergies to medications, foods or other product. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. Concomitant medications included Proflora women's Probiotic, Prebiotic, and cranberry, all from unknown dates for unknown indications. The patient reported that on 01Apr2021 at 08:00 she felt stinging in her right arm soon after vaccine injection and slight stinging in her neck and something minor by her ear. She reported the next day she woke up with a very groggy feeling and couldn't look at herself in the mirror and focus. She reported that on day 1 her arm was minorly sore, but this went away after day 2; she felt congestion in her head, fogginess, and swollen lymph node behind her right ear for 7 days. The reporter stated, "was thinking did the vaccine travel up to my head? Did I have a sinus infection?" The patient made appointments with an ear, nose, and throat doctor and a neurologist. The patient reported she improved slowly over 7 days and by day 8 still minor ache in the right side of head, ear node better. She reported day 9 sinus pressure in front of face now-near eyes and nose; day 10 mostly better in head but still some aching and sinus pressure, grogginess gone. No treatment was received for the events. The events required a physician office visit. The clinical outcomes of felt stinging in her right arm soon after vaccination, felt sting in her neck and something minor by her ear, woke up with a very groggy feeling, couldn't look at self in mirror and focus, swollen lymph node behind her right ear, arm was minorly sore, congestion in her head, fogginess, minor ache in right side of head/mild aching, and sinus pressure were recovered with sequel in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Somnolence, Upper respiratory tract congestion, Vaccination site pain, Vision blurred
Clinical narrative: Felt stinging in my right arm soon after vaccine injection; Felt slight sting in my neck and something minor by my ear; Woke up with a very groggy feeling; couldn't look at self in the mirror and focus; arm was minorly sore; congestion in my head; fogginess; swollen lymph node behind my right ear; minor ache in right side of head/mild aching; sinus pressure in front of face now-near eyes and nose/sinus pressure; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 53-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8737) via an unspecified route of administration in the right arm on 31Mar2021 at 15:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies, asthma as a child and some sinus infection history which was reported as not usual, all from unknown dates and unknown if ongoing. The patient had no allergies to medications, foods or other product. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. Concomitant medications included Proflora women's Probiotic, Prebiotic, and cranberry, all from unknown dates for unknown indications. The patient reported that on 01Apr2021 at 08:00 she felt stinging in her right arm soon after vaccine injection and slight stinging in her neck and something minor by her ear. She reported the next day she woke up with a very groggy feeling and couldn't look at herself in the mirror and focus. She reported that on day 1 her arm was minorly sore, but this went away after day 2; she felt congestion in her head, fogginess, and swollen lymph node behind her right ear for 7 days. The reporter stated, "was thinking did the vaccine travel up to my head? Did I have a sinus infection?" The patient made appointments with an ear, nose, and throat doctor and a neurologist. The patient reported she improved slowly over 7 days and by day 8 still minor ache in the right side of head, ear node better. She reported day 9 sinus pressure in front of face now-near eyes and nose; day 10 mostly better in head but still some aching and sinus pressure, grogginess gone. No treatment was received for the events. The events required a physician office visit. The clinical outcomes of felt stinging in her right arm soon after vaccination, felt sting in her neck and something minor by her ear, woke up with a very groggy feeling, couldn't look at self in mirror and focus, swollen lymph node behind her right ear, arm was minorly sore, congestion in her head, fogginess, minor ache in right side of head/mild aching, and sinus pressure were recovered with sequel in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: single supraclavicular swelling appearing 24 hours after ipsilateral intramuscular vaccine administration; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) intramuscularly in the right arm on 05Apr2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food or other product, had not been diagnosed with COVID-19 prior to vaccination and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included lamotrigine from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number unknown) on 15Mar2021 at 12:00 (at the age of 48-years-old) for COVID-19 immunisation. On 06Apr2021 the patient experienced single supraclavicular swelling which appeared 24 hours after ipsilateral intramuscular vaccine administration. No treatment was received for the events. The clinical outcome of single supraclavicular swelling appearing 24 hours after ipsilateral intramuscular vaccine administration was reported as not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Pain
Clinical narrative: Body aches; Chills; Headache; Fatigue; Malaise; This is a spontaneous report from a non-contactable nurse (patient). This 24-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 09Apr2021 at 09:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient had no concomitant medications and had not received any other vaccines in the four weeks prior to vaccination. On 09Apr2021 at 23:00 the patient experienced body aches, chills, headache, fatigue and malaise. No treatment was provided for the events. The clinical outcomes of body aches, chills, headache, fatigue, and malaise were recovering. It was also reported the patient had not been tested for COVID-19 post-vaccination.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 102.4 fever; This is a spontaneous report received from a non-contactable consumer (patient). This non-pregnant 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 06Apr2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing, and penicillin allergy from an unknown date an unknown if ongoing. Concomitant medications included meloxicam from an unknown date for an unknown indication, and levothyroxine sodium (SYNTHROID) from an unknown date for an unknown indication. The patient had not received any other vaccines in the four weeks prior to the COVID vaccination. On 06Apr2021 the patient experienced 102.4 fever, further reported as higher than when she had COVID. No treatment was received for the event. The clinical outcome of 102.4 fever was recovered on an unspecified date in Apr2021. It was also reported that since vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Muscular weakness
Clinical narrative: muscle weakness; joint pain; This is a spontaneous report from a contactable physician. A 60-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration in Mar2021 at single dose for COVID-19 immunization. The patient's medical history included G71.19 and concomitant medications included diclofenamide (KEVEYIS). It was unknown if the patient was diagnosed with COVID-19 and did receive any vaccines within four weeks prior to vaccination. The patient experienced muscle weakness and joint pain since receiving the vaccine, on an unspecified date in Mar2021. It was unknown if patient has been tested for COVID-19 since the vaccination and received any treatment for the event. Outcome of the event was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Affect lability, Anxiety, Crying, Disturbance in attention
Clinical narrative: Emotional lability; weepy; anxious; unfocused; This is a spontaneous report received from a non-contactable consumer (patient). A 37-year-old-female patient received dose 1 of BNT162B2 (PFIZER-NIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 08Apr2021 at 17:15 (at the age of 37-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine the patient was not diagnosed with COVID-19. Concomitant medications included nebivolol (BYSTOLIC; 10 mg) and amfetamine aspartate, amfestamine sulfate, dexamfetamine saccarate, dexamfetamine sulfate (ADDERALL; 10 mg) from unspecified dates for unspecified indications. The patient did not have any allergies to medications, food, or other products. On 09Apr2021 at 20:00 the patient experienced emotional lability the day following the vaccine. It was similar to the feeling of no sleep and too much coffee- weepy, anxious, and unfocused. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of emotional lability, weepy, anxious, and unfocused were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: My menstrual cycle started early and has not stopped/a similar side effect; My menstrual cycle started early and has not stopped/a similar side effect; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 3 patients (herself, sister, and friend). This is the second of three reports for the consumer's sister. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced similar side effect to the reporting consumer. The reporting consumer described that the week after her second vaccine shot she had experienced her menstrual cycle started early and had not stopped with 12 days of menstrual bleeding as of 10Apr2021. The consumer stated her sister and friend had a similar side effect. The outcome of similar side effect was unknown. The consumer stated they thought it was a side effect of the "COVID-19 cmvacvine."  No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392948 same reporter/drug/event, different patient.;US-PFIZER INC-2021407010 same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: My menstrual cycle started early and has not stopped/a similar side effect; My menstrual cycle started early and has not stopped/a similar side effect; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 3 patients (herself, sister, and friend). This is the second of three reports for the consumer's friend. An adult female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced similar side effect to the reporting consumer. The reporting consumer described that the week after her second vaccine shot she had experienced her menstrual cycle started early and had not stopped with 12 days of menstrual bleeding as of 10Apr2021. The consumer stated her sister and friend had a similar side effect. The outcome of similar side effect was unknown. The consumer stated they thought it was a side effect of the "COVID-19 cmvacvine."  No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021407009 same reporter/drug/event, different patient.;US-PFIZER INC-2021392948 same reporter/drug/event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Feeling abnormal, Insomnia, Pain in extremity
Clinical narrative: Last night I took a Tylenol PM to help me sleep; low energy; just little joint (in the feet and arm) problems; I just feel a little different; My arm hurt more than the first shot; This is a spontaneous report received from a contactable consumer (patient). A 60-year-old male patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 09Apr2021 at 08:00 as a single dose for COVID-19 immunization. Medical history included a rotator cuff injury. The patient had never had a flu shot and had been healthy overall. Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on 19Mar2021 for COVID-19 immunization and experienced arm hurt. On 09Apr2021, the patient experienced "I took a TYLENOL PM to help me sleep." On an unspecified date in Apr2021 after dose 2 of BNT162B2 the patient experienced arm hurt more than the first shot, low energy, just little joint (in the feet and arm) problems. He didn't feel tired. He just felt a little different. The patient was treated with diphenhydramine hydrochloride, paracetamol (TYLENOL PM) on 09Apr2021 to help him sleep. The outcomes of arm hurt more than the first shot, low energy, and just little joint problems were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392759 same reporter/patient, different vaccine dose with different AE;US-PFIZER INC-2021407626 same reporter/drug, different patient/AE;US-PFIZER INC-2021407624 same reporter, different patient/AE
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Iritis
Clinical narrative: I have another episode of Iritis, more painful this time.; I have another episode of Iritis, more painful this time.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 via an unspecified route of administration in the left arm on 09Apr2021 11:00 (Batch/Lot Number: ER8731) as a single dose for covid-19 immunization. Medical history included HLA-b27 positive, iritis and allergies to some processed flours allergy. The patient has not been diagnosed with Covid-19 prior to vaccination. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 59-year-old in the left arm on 19Mar2021 11:15 AM (lot number: EN6204) for COVID-19 Immunization but had iritis flared up. Concomitant medications included brimonidine tartrate (BRIMONIDINE TARTRATE) taken for an unspecified indication, start and stop date were not reported. The patient received the most recent vaccine from the public clinic/administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. As reported after first COVID shot, the patient had iritis flared up and had another episode of Iritis on 10Apr2021 06:30 AM which was more painful this time. The patient has not been tested for COVID-19 since vaccination. The adverse event did not received treatment and was considered as non-serious. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Loss of personal independence in daily activities, Lymphadenopathy, Maternal exposure during pregnancy, Pain
Clinical narrative: pregnant at the time of vaccination; Swollen lymph nodes/ painful swollen lumps; Shingles/ pustules on my head and neck; The pain progressed over the course of a week before it became unbearable; prevented her from daily activities including work; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8737) via an unspecified route of administration, administered on the left arm on 29Mar2021 19:00 as 1st dose, single for COVID-19 immunization. Medical history included dermatomyositis, antisynthetase syndrome and Sjogrens syndrome. Concomitant medications included metformin; insulin glargine (BASAGLAR); hydroxychloroquine and levothyroxine sodium (LEVOTHYROX). The patient previously took azathioprine and experienced allergy. Patient was pregnant at the time of vaccination. Within hours, patient developed painful swollen lumps and pustules on my head and neck, later diagnosed as swollen lymph nodes and shingles on 30Mar2021 04:00. The pain progressed over the course of a week before it became unbearable and patient was treated at ED and given antiviral for shingles. She is on DAY 16 and the pain from the swollen lymph nodes still prevented her from daily activities including work. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Treatment received for the events in the ED included morphine drip and acyclovir RX. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19: Nasal Swab test: negative on 06Apr2021. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The mother reported she became pregnant while taking bnt162b2. The mother was 24 Weeks pregnant at the onset of the event. The mother was due to deliver on 17Jul2021. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: pregnant at the time of vaccination; Swollen lymph nodes/ painful swollen lumps; Shingles/ pustules on my head and neck; The pain progressed over the course of a week before it became unbearable; prevented her from daily activities including work; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8737) via an unspecified route of administration, administered on the left arm on 29Mar2021 19:00 as 1st dose, single for COVID-19 immunization. Medical history included dermatomyositis, antisynthetase syndrome and Sjogrens syndrome. Concomitant medications included metformin; insulin glargine (BASAGLAR); hydroxychloroquine and levothyroxine sodium (LEVOTHYROX). The patient previously took azathioprine and experienced allergy. Patient was pregnant at the time of vaccination. Within hours, patient developed painful swollen lumps and pustules on my head and neck, later diagnosed as swollen lymph nodes and shingles on 30Mar2021 04:00. The pain progressed over the course of a week before it became unbearable and patient was treated at ED and given antiviral for shingles. She is on DAY 16 and the pain from the swollen lymph nodes still prevented her from daily activities including work. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Treatment received for the events in the ED included morphine drip and acyclovir RX. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19: Nasal Swab test: negative on 06Apr2021. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The mother reported she became pregnant while taking bnt162b2. The mother was 24 Weeks pregnant at the onset of the event. The mother was due to deliver on 17Jul2021. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: vaccination dose on 3-26-2021. Patient reports less joint pain; This is a spontaneous report received from other health care professional (clinician). This Other Health care professional reported for a 64-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number unknown, Expiry date: unknown), via an unspecified route of administration on 26Mar2021 at a single dose for COVID-19 immunization. Patient's physician had put Xeljanz on hold since 11Apr2021, due to elevated cholesterol, blood pressure, HA's. Patient reported less joint pain since off of Xeljanz, but she cannot be sure if her COVID vaccine had anything to do with her present s/e's.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Chills, Depressed mood, Ear discomfort
Clinical narrative: feel "down" and weak; feel "down" and weak; her eyes, ears and head felt like they were "burning"; her eyes, ears and head felt like they were "burning"; her eyes, ears and head felt like they were "burning"; headache; chills; body aches; a little bit of fever; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Lot Number: ER8729), dose 1 via an unspecified route of administration, administered in Arm Left on 11Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She received the first dose of the Pfizer Covid 19 vaccine on Sunday (11Apr2021) and was having some reactions. Monday (12Apr2021), she reported having a headache, chills, body aches, a little bit of fever and she couldn't work. Tuesday (13Apr2021), she felt better in the afternoon. Wednesday (14Apr2021), her eyes, ears and head felt like they were "burning".  Today (15Apr2021), she felt "down" and weak. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Headache, Pain, Pyrexia
Clinical narrative: feel "down" and weak; feel "down" and weak; her eyes, ears and head felt like they were "burning"; her eyes, ears and head felt like they were "burning"; her eyes, ears and head felt like they were "burning"; headache; chills; body aches; a little bit of fever; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Lot Number: ER8729), dose 1 via an unspecified route of administration, administered in Arm Left on 11Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She received the first dose of the Pfizer Covid 19 vaccine on Sunday (11Apr2021) and was having some reactions. Monday (12Apr2021), she reported having a headache, chills, body aches, a little bit of fever and she couldn't work. Tuesday (13Apr2021), she felt better in the afternoon. Wednesday (14Apr2021), her eyes, ears and head felt like they were "burning".  Today (15Apr2021), she felt "down" and weak. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye irritation, Eyelid disorder, Feeling abnormal, Headache
Clinical narrative: sleepy; she still feels bad; chills; fever; shaking like a leaf; a little cough/she is swallowing phlegm; muscles are aching all over/aches in her knees but mostly the shoulders and lower arms; headache; she has a pain that goes down the right side of her headache to her shoulder, arm and back; eyes are burning all the time noting it is hard to open her right eye; eyes are burning all the time noting it is hard to open her right eye; This is a spontaneous report from a non-contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She had the second dose of BNT162B2 on 16Mar2021. Patient was still getting symptoms she did not like. Caller stated her symptoms started four days after the vaccine (20Mar2021) and had continued for four weeks. Caller stated she was sleepy as she could possibly be. Caller stated she had chills, fever, shaking like a leaf and a little cough. Caller stated that her muscles were aching all over. She ached in her knees but mostly the shoulders and lower arms. She had a headache at the back of her head on the top. She had a pain that goes down the right side of her headache to her shoulder, arm and back. Her eyes were burning all the time noting it was hard to open her right eye. She was swallowing phlegm. She still felt bad. Caller asked if it is normal to feel this way after four weeks and how long should it be. Outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021426400 same reporter/drug, different patient/AE
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Productive cough, Pyrexia, Somnolence
Clinical narrative: sleepy; she still feels bad; chills; fever; shaking like a leaf; a little cough/she is swallowing phlegm; muscles are aching all over/aches in her knees but mostly the shoulders and lower arms; headache; she has a pain that goes down the right side of her headache to her shoulder, arm and back; eyes are burning all the time noting it is hard to open her right eye; eyes are burning all the time noting it is hard to open her right eye; This is a spontaneous report from a non-contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She had the second dose of BNT162B2 on 16Mar2021. Patient was still getting symptoms she did not like. Caller stated her symptoms started four days after the vaccine (20Mar2021) and had continued for four weeks. Caller stated she was sleepy as she could possibly be. Caller stated she had chills, fever, shaking like a leaf and a little cough. Caller stated that her muscles were aching all over. She ached in her knees but mostly the shoulders and lower arms. She had a headache at the back of her head on the top. She had a pain that goes down the right side of her headache to her shoulder, arm and back. Her eyes were burning all the time noting it was hard to open her right eye. She was swallowing phlegm. She still felt bad. Caller asked if it is normal to feel this way after four weeks and how long should it be. Outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021426400 same reporter/drug, different patient/AE
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: sleepy; she still feels bad; chills; fever; shaking like a leaf; a little cough/she is swallowing phlegm; muscles are aching all over/aches in her knees but mostly the shoulders and lower arms; headache; she has a pain that goes down the right side of her headache to her shoulder, arm and back; eyes are burning all the time noting it is hard to open her right eye; eyes are burning all the time noting it is hard to open her right eye; This is a spontaneous report from a non-contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She had the second dose of BNT162B2 on 16Mar2021. Patient was still getting symptoms she did not like. Caller stated her symptoms started four days after the vaccine (20Mar2021) and had continued for four weeks. Caller stated she was sleepy as she could possibly be. Caller stated she had chills, fever, shaking like a leaf and a little cough. Caller stated that her muscles were aching all over. She ached in her knees but mostly the shoulders and lower arms. She had a headache at the back of her head on the top. She had a pain that goes down the right side of her headache to her shoulder, arm and back. Her eyes were burning all the time noting it was hard to open her right eye. She was swallowing phlegm. She still felt bad. Caller asked if it is normal to feel this way after four weeks and how long should it be. Outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021426400 same reporter/drug, different patient/AE
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose, and the second dose via an unspecified route of administration on 08Apr2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date with outcome of resolved. On 01Apr2021, Pfizer and BioNTech announced an updated topline analysis up to 6 months following second dose of a COVID-19 Vaccine Study. Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates Pfizer-BioNTech COVID-19 Vaccine (BNT162B2) is effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to 6 months after the second dose of Vaccine was 100% effective in preventing severe disease as defined by the Centers for Disease Control and Prevention (CDC) and 95.3% effective in preventing severe disease as defined by the Food and Drug Administration (FDA) o Vaccine was 100% effective in preventing COVID-19 cases, where the B.1.351 lineage is prevalent of Vaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second dose of Pfizer and BioNTech plan to share these results with worldwide regulatory agencies soon.  The press release is available release: Please note that the "Pfizer-BioNTech COVID-19 Vaccine - Antibody Persistence and Duration of Immunity" SRD has been updated to include the Press Release information. Patient was so thrilled and very happy to receive the vaccine and she did not experience anything other than a sore arm that lasted for a day or 2 after both doses. She was asking if she would not anymore have side effects since a week had passed after getting vaccinated. Patient was asking for her relative and her senior citizen father. She mentioned that her relative received his 1st dose today but was scheduled to take his 2nd dose on 05May2021. Counting the 21 days, it should be 6May2021. She mentioned that the person from the vaccination facility might have started the count of the 21 days and erroneously gave him 20 days after the 1st dose. For her father, she was asking if it would be okay for him to get the 2nd dose 22 days after. His 2nd dose was scheduled at 21 days after the 1st dose but was scheduled on a Sunday, attributing to many people at the drive thru in which they waited for 2 hours the last time they were there.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion
Clinical narrative: Right ankle pain; bruise; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 13Apr2021 09:15 (Batch/Lot Number: EW0162), at same age, as single dose for covid-19 immunisation. Medical history included Non-Hodgkin's lymphoma 9 years ago, prediabetes, and chronic migraines. Concomitant medications included metformin; simvastatin; and levothyroxine sodium (LEVOTHYROXIN). The patient experienced right ankle pain, and bruise on 14Apr2021 09:45. No treatment was received. No covid prior vaccination. No covid test post vaccination. No known allergies. Patient is not pregnant at time of vaccination. The outcomes of events were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Product substitution error, SARS-CoV-2 antibody test
Clinical narrative: I'm Nervous; First dose Moderna, second dose Pfizer Vaccine; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 2 intramuscular, administered in left arm near shoulder on 17Feb2021 16:00 (Batch/Lot Number: EL9266) as single dose for didn't want to get the virus; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), dose 1 via an unspecified route of administration in left arm near shoulder on 28Jan2021 (Batch/Lot Number: EL9269), at unspecified dose for didn't want to get the virus. Medical history includes cholesterol and thyroid. Concomitant medication included simvastatin taken for cholesterol from 2011; levothyroxine taken for thyroid from 2011. Patient had pneumonia vaccine about 5 years ago (2016) and arm swelled up for almost 6 months and was red, never received second pneumonia vaccine. She is not pregnant at vaccination time. The patient was nervous. Patient went to the doctor for a physical. She received first dose Moderna Vaccine and the second dose Pfizer Covid Vaccine. She didn't' know she received the Pfizer Covid Vaccine until she waited the first 15 minutes after the Pfizer Covid dose two was administered. Patient went to get a physical, took a blood test to see if had antibodies, there are none. She just found out there are no antibodies and stated she was nervous. Patient surprised got two different vaccinations. The outcomes of events were unknown.   No follow-up attempts are needed. No further information is expected.