chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Slightly swollen throat; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EN53118), via an unspecified route of administration, administered in arm left on 05Feb2021 08:00 as 1st dose, single for COVID-19 immunization, (age at 70-year-old). Medical history included Gout, High Cholestrol & Enlarged Prostrate, food allergy (some Fish (not iodine). The patient previously took keflex and experienced drug allergies. The patient's concomitant medications was not reported. No other vaccine in four weeks. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 05Feb2021 08:30, the patient experienced slightly swollen throat. Treatment medication included OTC Benadryl for the event. Outcome of the event was reported as recovered.    Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Muscular weakness, SARS-CoV-2 test, Sleep disorder
Clinical narrative: feeling weak muscles; chills; sleep disturbance; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient) reported for himself. An elderly male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: LL9262; Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 01Feb2021 at 14:00 pm (age at vaccination was unknown) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. 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. The patient received his 1st dose and after three days on 04Feb2021, the patient experienced feeling weak muscles, chills and sleep disturbance and stated that he did not know where to go after his symptoms appear. No treatment was received for the adverse event. Post the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included SARS-COV-2 test (Nasal Swab) which was negative on 19Jan2021. The outcome of the events was resolving.  Follow-up attempts completed. No further information expected.  Follow-up#01 (04Feb2021) and Follow-up#02 (14MAY2021): New information received from a contactable consumer (patient) reported for himself included: Updated the age group (Elderly), vaccination details (administration date: 01Feb2021 and administration time: 14:00 pm), facility type vaccine (Doctor's office/urgent care), added new events (feeling weak muscles and sleep disturbance), outcome of the events (resolving), treatment details (no), laboratory tests (SARS-COV-2 test (Nasal Swab) and details about follow-up attempts (Follow-up attempts completed. No further information expected).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling and Soreness of Left arm; Swelling and Soreness of Left arm; This is a spontaneous report from a contactable consumer. A 26-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 (Batch/Lot Number: EL9263) as single dose for COVID-19 immunisation. The patient medical history was not reported. Allergies were unknown. There were no concomitant medications. The patient did not have any other vaccine in four weeks and any other medications in two weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. On 23Jan2021, the patient experienced swelling and soreness of left arm. The patient received no treatment for AE. Outcome of the events was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: her shoulder hurts again (48 hours after the second dose); This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was not reported), dose 2 via an unspecified route of administration on 06Feb2021, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was not reported), administered on an unknown date, as single dose for COVID-19 immunisation and experienced shoulder was sore at the injection site. The patient previously took flu shot on an unspecified date for immunization and She had the same reaction to the flu shot. However when she went to sleep the pain was still bothering her so she called (Specialty Pharmacy name) and they told her it was okay to take Advil 24 hours after the vaccine, she took 2 Advil, after a couple of days the pain disappeared. When she received the second dose of the vaccine, the nurse told her that she should not have taken Advil. She would like to know if she should not have taken it because she reduces the effectiveness of the vaccine. After 48 hours of the second dose on 08Feb2021, the patient shoulder hurts again. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: On my shoulder there is a large bump; circle around it; It's reddish and inflamed; itchy/The middle is solid, itchy around; Next morning developed a bump on her shoulder. It is red, swollen, and itchy; It's warm to the touch; This is a spontaneous report from a contactable consumer or other non health care professional (patient herself). A female patient (Age: 77 units: Unspecified) received bnt162b2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Feb2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that, she had her first dose of the Pfizer vaccine on (Saturday) 06Feb2021 afternoon in her shoulder. She had an interesting reaction that appeared, next morning 07Feb2021 developed a large bump on her shoulder, circle around it. It was pretty reddish/red, inflamed, hot, swollen, and itchy. It was a little bigger, about 2.5 inches to 3 inches in diameter. It was at injection site. The middle was solid, itchy around. It was warm to the touch. It was around 2.5-4 inches. She wanted to know if the needle went in all the way. She didn't feel the vaccine, but she was pretty tough. She wanted to know if it was normal for people to get the rash and bump and asked for the second dose any contraindications on taking it. Investigation Assessment was not Provided. The outcome of the events was unknown.  Description of complaint: Had a bump that was itchy and red after COVID-19 Vaccine. Concerned needle didn't go in deep enough. Caller declined to complete report. Full details not obtained. Product strength and count size dispensed and Additional lot numbers Not provided. sample of the product available to be returned, if requested as Not provided. Packaging sealed and intact was Not provided. From mail trail received in response to query sent regarding confirmation correct PRD involved in this report: Query: Please help to confirm correct PRD of attached report since "09Feb2021" provided in the source, but SRD is 08Feb2021in the processed ICSR screen. (Screen shot attached). Response: PRD is 08Feb2021(see below). Nurse is currently sending dates over to hospital format. If you have any questions around this, please contact your BT support or digital team for further information.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea after receiving vaccine; This is a spontaneous report from a non-contactable consumer or Non-healthcare Professional reporting for a patient. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea after receiving vaccine. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Incision site pain
Clinical narrative: Incision site pain; Joint Pains; Fatigue/Tiredness; This is a spontaneous report from a non-contactable physician. A 38-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: 59267-1000-1 and Expiration date: unknown), via an intramuscular route, in left arm on 04Feb2021 at 08:30 as dose 1, single for covid-19 immunisation. Medical history included migraine headaches from an unknown date and covid-19 from an unknown date and unknown. The patient's concomitant medications were not reported. Patient has no known allergies. Patient did not receive any other vaccine in four weeks. On 04Feb2021 at 14:00, the patient experienced incision site pain for 24-48 hours, joint pains and fatigue/tiredness. Patient was not tested covid positive post vaccination. No treatment was received for events. Outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia, Paraesthesia
Clinical narrative: Event: numbness in left arm was reported as worsened; feeling tingling and numbness in my left arm; feeling tingling and numbness in my left arm; This is a spontaneous report from a contactable consumer (reporting on herself). A 23-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot number and Expiry date was not reported) via an unspecified route of administration in Arm Left on 02Feb2021 as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient got her Pfizer shot on 02Feb2021 (last Tuesday) in her left arm. 4-5 days later, on 07Feb2021 patient feeling tingling and numbness in her left arm. Is this a normal side effect. Patient dose not see it listed in the Pfizer vaccine information. Numbness in left arm. Event: numbness in left arm was reported as worsened. She was experiencing numbness in her arm that she got the injection in. She has not received treatment or seen a doctor. She was a medical sales rep, and she got it be-cause they fit patients for power wheel chairs. She was in and out of nursing homes and rehabs.  The outcome of the feeling tingling and numbness in my left arm was not recovered and for event numbness in left arm was reported as worsened was unknown.  Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin burning sensation, Skin exfoliation
Clinical narrative: Feeling burn and itching behind the ears and under the back hair line; I have redness around those areas and a bit peeling; I have redness around those areas and a bit peeling; This is a spontaneous report from a contactable consumer (patient herself). A 23-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 06Feb2021 at 18:15 (Batch/Lot number was not reported) (at the age of 23-year-old) as single for covid-19 immunisation. The vaccine facility type was others. The patient medical history and concomitant medication were not reported. Patient received birth control was received within 2 weeks of vaccination. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Feb2021, the patient stated that "feeling burn and itching behind the ears and under the back hair line and had redness around those areas and a bit peeling". The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events was unknown. Post vaccination, the patient was not tested with COVID-19. The outcome of the events was resolving.  Information about batch/lot number has been requested.  Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on both legs above the ankle and spreading upward; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 73-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 05Feb2021 at 14:00 (Batch/Lot Number: EL9261, Expiry date was not reported) as single dose covid-19 immunisation. Medical history included diabetes mellitus and adverse reaction to narcotic pain relievers. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number and Expiry date was not reported) as single dose covid-19 immunisation. The patient did not experience covid prior to vaccination and covid was not tested after vaccination. On 05Feb2021, at 12:00 AM, the patient experienced rash on both legs above the ankle and spreading upward. There was no treatment received for the reported event. Outcome of the event was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Neck pain, Pain in extremity
Clinical narrative: Sore arm; headache; sore neck muscles; intense fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 73-years-old non-pregnant female patient received 1st Dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) administered Arm Left on 04Feb2021 at 15:00 as SINGLE DOSE for an unspecified indication. Medical history included hypersensitivity to penicillin. The patient's concomitant medications were not reported. The patient did not have Covid prior to vaccination nor the patient was tested for Covid post vaccination. The patient experienced sore arm, headache, sore neck muscles, and intense fatigue on 05Feb2021 at 01:00 am. The patient did not receive any treatment for the events. The outcome of the events was resolved.  Follow-up attempts completed. No further information expected.  Information about Lot/Batch is requested.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Fever, temp 100; Body aches; This is a spontaneous report from a non-contactable consumer. This consumer reported for a patient. A patient of unspecified age and gender received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 07Feb2021 as dose 1, single for covid-19 immunisation at Pharmacy. The patient medical history and concomitant medications were not reported. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient been tested for COVID-19. On 08Feb2021, the reporter stated that a coworker of hers was experiencing symptoms after receiving a first dose of the covid vaccine, administered 07Feb2021. The patient had a fever, Temp 100, and body aches. The patient underwent lab tests and procedures which included body temperature: 100 on 08Feb2021. The outcome of the events was unknown.  No follow up attempts are possible. Information on the lot/batch number could not be requested. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site pain
Clinical narrative: feel arm pain on the injection site; This is a spontaneous report from a  female patient of an unspecified age received first dose of BNT162B2 (BNT162B2, PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in arm on an unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient got the first dose and feel arm pain on the injection site. The outcome of the event was unknown.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms; aches and pains; fatigue; chills; headache; This is a spontaneous report from a contactable Other HCP. A 37-year-old non pregnant female patient received BNT162B2 (BNT162B2, Solution for injection, Batch number and Expiry date were not reported) intramuscularly in the right arm on 05Feb2021 10:00 as SECOND DOSE, SINGLE for covid-19 immunisation. The patient medical history included allergy-induced asthma; uterine fibroids; fibrocystic breast disease; chronic sinus issues; migraines; associated with pregnancy (2017-18): pre-eclampsia and postpartum anxiety disorder; and allergy to Amoxicillin, Penicillin, CT Scan Reaction dye, Allium family when raw (onions/garlic and all relatives), dust, mold and cat dander. Concomitant medications included Amfetamine aspartate, Amfetamine sulfate, Dexamfetamine saccharate, Dexamfetamine sulfate (ADDERALL XR and ADDERALL QR), Fluticasone Furoate (FLONASE SENSIMIST); Hydroxyzine, ibuprofen and Olly women's multivitamin. Historical vaccine included first dose of BNT162b2 (BNT162B2, Solution for injection, Lot number was not reported), intramuscularly in the left arm on 11Jan2021 10:00 as FIRST DOSE, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was clinic/facility. On 05Feb2021 at 10:00 PM (beginning at 12 hours after vaccine), the patient experienced 48 hours of flu-like symptoms including aches and pains, fatigue, chills and headache. No treatment was received for the events. The outcome of the events was recovered.  Information on lot/batch number has been requested.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: Sciaitic nerve is acting up and wants to take ibuprofen to help.; This spontaneous report from a contactable consumer via Pfizer-sponsored program.   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date 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 experienced Sciatica nerve was acting up and wants to take ibuprofen to help on an unspecified date. Patient clarified has not taken ibuprofen or anything for nerve pain and has been many years since Sciatica nerve has acted up. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Neck pain
Clinical narrative: neck pain radiating to my shoulder blade; she felt uncomfortable near my neck on the evening of getting vaccine; This is a spontaneous report received from a contactable consumer (patient). A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm left on 07Feb2021 at 09:30 as single dose (age at vaccination was 38 years) for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hypothyroid (take daily Synthroid tablets in the morning). Concomitant medications included levothyroxine sodium (SYNTHYROID) taken for hypothyroidism, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient had no COVID prior vaccination. The patient felt uncomfortable near her neck on the evening of getting vaccine on 07Feb2021 and experienced neck pain radiating to her shoulder blade on 08Feb2021 around 19:30. The clinical course of event was reported as: she took the vaccine on 07Feb2021 at 9:30 and on 08Feb2021 around 19:30, she started a neck pain radiating to her shoulder blade. Note that she received the shot on her left arm and the radiating pain was from her neck (right side of her neck near throat) to her right shoulder. She never had this type of pain until now. If she took a deep breath, she felt intense pain radiating from her neck to shoulder blade. She did not do anything unusual and spent her usual workday (work from home) as normal. She even took a short nap early evening too. Yesterday (as reported) she just stayed home and relaxed after getting vaccine. After getting the vaccine, she felt uncomfortable near her neck on the evening of getting vaccine (07Feb2021). She did not know if she could conclude that this was an adverse effect to the vaccine or not but as a precaution, she was reporting it. If the pain intensifies, she will visit an urgent care tomorrow (09Feb2021). The patient was not COVID tested post vaccination. No treatment received for the reported events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Pain in extremity, Tenderness
Clinical narrative: a patient who received the 2 doses of the vaccine 4 days apart; a patient who received the 2 doses of the vaccine 4 days apart; Usual side effect of arm soreness, tenderness; Usual side effect of arm soreness, tenderness; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, NDC number, Expiry Date of Pfizer COVID-19 Vaccine: unknown), via an unspecified route of administration, administered in arm on 29Jan2021 13:30 (Batch/Lot number was not reported) as 1st dose, 30 ug, single, [30mcg injection to unknown arm] and received BNT162B2 via an unspecified route of administration on 02Feb2021 09:45 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient age at time of vaccination was 35 years. Medical history included ongoing depression and anxiety and looks like the patient has been getting treatment for depression and anxiety, further details unknown. Family history reported as none. Concomitant medications were not reported. HCP said that the patient had who received the 2 doses of the vaccine 4 days apart on 02Feb2021 and experienced usual side effect of arm soreness, tenderness on an unspecified date in 2021. The adverse events do not require a visit to emergency room and physician office and not hospitalized. No relevant tests performed. Prior vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. The report assessed as non-serious. Outcome of the events arm soreness, tenderness was recovered on an unspecified date in 2021. Relatedness of the events was reported as unrelated.  Information about lot/batch number has been requested.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Hot and sweaty within 3 minutes; Hot and sweaty within 3 minutes; SOB; nausea; tired; headache; muscle pain/weakness; muscle pain/weakness; dizziness; fever; high BP and HR; high BP and HR; throat swelled up; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 05Feb2021 at 12:30 PM as SINGLE DOSE for covid-19 immunisation. Medical history was reported as very healthy, no medical problems, MDD. The patient had no known allergies. The patient received other medication in two weeks. The patient did not receive any other vaccines within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Feb2021 at 12:45 PM, patient experienced hot and sweaty within 3 minutes, SOB, nausea, tired, headache, muscle pain/weakness, dizziness, fever, high BP and HR, throat swelled up. The events resulted in: Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement: high, heart rate: high. The patient received treatment due to the events with exam, muscle relaxers, pain meds, Zofran. The outcome of all events was recovered with sequel on an unspecified date in 2021.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Heart rate, Heart rate increased, Hyperhidrosis
Clinical narrative: Hot and sweaty within 3 minutes; Hot and sweaty within 3 minutes; SOB; nausea; tired; headache; muscle pain/weakness; muscle pain/weakness; dizziness; fever; high BP and HR; high BP and HR; throat swelled up; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 05Feb2021 at 12:30 PM as SINGLE DOSE for covid-19 immunisation. Medical history was reported as very healthy, no medical problems, MDD. The patient had no known allergies. The patient received other medication in two weeks. The patient did not receive any other vaccines within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Feb2021 at 12:45 PM, patient experienced hot and sweaty within 3 minutes, SOB, nausea, tired, headache, muscle pain/weakness, dizziness, fever, high BP and HR, throat swelled up. The events resulted in: Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement: high, heart rate: high. The patient received treatment due to the events with exam, muscle relaxers, pain meds, Zofran. The outcome of all events was recovered with sequel on an unspecified date in 2021.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Nausea, Pharyngeal swelling, Pyrexia
Clinical narrative: Hot and sweaty within 3 minutes; Hot and sweaty within 3 minutes; SOB; nausea; tired; headache; muscle pain/weakness; muscle pain/weakness; dizziness; fever; high BP and HR; high BP and HR; throat swelled up; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 05Feb2021 at 12:30 PM as SINGLE DOSE for covid-19 immunisation. Medical history was reported as very healthy, no medical problems, MDD. The patient had no known allergies. The patient received other medication in two weeks. The patient did not receive any other vaccines within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Feb2021 at 12:45 PM, patient experienced hot and sweaty within 3 minutes, SOB, nausea, tired, headache, muscle pain/weakness, dizziness, fever, high BP and HR, throat swelled up. The events resulted in: Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement: high, heart rate: high. The patient received treatment due to the events with exam, muscle relaxers, pain meds, Zofran. The outcome of all events was recovered with sequel on an unspecified date in 2021.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Migraine, Oropharyngeal pain
Clinical narrative: Slight cough; Chills; body aches; fatigue; migraine; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3247) via an unspecified route of administration in left arm on 01Feb2021 at 12:30 as 1st dose, single for COVID-19 immunization. Medical history included recurring sinusitis, recurring migraines, hypothyroid, anxiety. Patient had allergies with Codiene, Dillauded. Concomitant medications included thyroid (ARMOUR THYROID), guaifenesin, pseudoephedrine hydrochloride (MUCINEX D), levocetirizine dihydrochloride (XYZAL), ibuprofen, ergocalciferol (VIT D). Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. Patient was not pregnant. On 06Feb2021 at 04:30 PM, patient experienced slight cough, chills, body aches, fatigue, migraine, sore throat. No treatment was received for the adverse events. Patient had not been tested covid post vaccination. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Slight cough; Chills; body aches; fatigue; migraine; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3247) via an unspecified route of administration in left arm on 01Feb2021 at 12:30 as 1st dose, single for COVID-19 immunization. Medical history included recurring sinusitis, recurring migraines, hypothyroid, anxiety. Patient had allergies with Codiene, Dillauded. Concomitant medications included thyroid (ARMOUR THYROID), guaifenesin, pseudoephedrine hydrochloride (MUCINEX D), levocetirizine dihydrochloride (XYZAL), ibuprofen, ergocalciferol (VIT D). Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. Patient was not pregnant. On 06Feb2021 at 04:30 PM, patient experienced slight cough, chills, body aches, fatigue, migraine, sore throat. No treatment was received for the adverse events. Patient had not been tested covid post vaccination. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Soreness of the arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male patient (husband) who had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reported two AE for her and her husband. Reporter mentioned that her husband experienced soreness of the arm. The outcome of the event was unknown.  This follow-up was being submitted to notify that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts had been completed and no further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Therapeutic response unexpected
Clinical narrative: Got a good nights sleep which she usually does not get; feeling tired; dizzy; This is a spontaneous report received from a contactable consumer, the patient via Pfizer sponsored program Pfizer first connect. A female patient of an unspecified age received first dose of BNT162B2 (COMIRNAT PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262, NDC number and Expiry Date: unknown) via an unspecified route of administration on 25Jan2021 as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was feeling tired and dizzy after the first shot. Patient got a good night sleep which she usually did not get. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: she was 80 years old and has heart issues; This is a spontaneous report from a non-contactable female consumer(patient).  A 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: Unknown) via unknown route on 28Jan2021 as 1st dose, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient reported that she was 80 years old and has heart issues. Patient was watching the today show and they are telling viewers that you can wait 3-6 weeks to get the 2nd dose on an unspecified date. Patient stated that she would contact the local health department in (State name) and see if they will allow her to get the 2nd dose there and go from there. She wanted to know what happens if the health department tells her no and she cannot get the 2nd dose until end of Feb. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Mobility decreased, Neck pain
Clinical narrative: had a temperature of 100.4; pain in his shoulders and neck/has joint pain across his neck; he has joint pain across his shoulders and neck and that he cannot turn his head/ pain in his shoulders and neck; he has joint pain across his shoulders and neck and that he cannot turn his head; This is a spontaneous report from a contactable consumer. This 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on 05Feb2021 (at age 78-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, Caller stated that he had his first Pfizer shot Friday 05Feb2021. Stated that he had a temperature of 100.4 that went back to normal. Stated that he had pain in shoulders and neck since he got the shot. Clarified that it was for Pfizer Covid 19 shot. Stated that it may be normal or if others felt this way. Clarified that he had joint pain across his shoulders and neck and that he couldn't't turn his head. Wanted to know if this was serious. Patient underwent lab test includes body temperature for which result 100.4 was reported. The outcome of event was resolved for body temperature increased, whereas unknown for all other events.  Information on lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Pain
Clinical narrative: Chronic pain; lot of health issues; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect.   A contactable female patient with (unspecified age and unit) reported that she received first dose of  bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 22Jan2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient just read from the fact sheet not to take pain medicines. On an unspecified date, the patient experienced a lot of health issues and chronic pain. Patient had taken tylenol and motrin for pain relievers 2 nights ago as treatment. She was asking if there was any timeframe where she can take the pain reliever safely. Cold transfer to  due to longer wait time (19 calls ahead). The outcome of the events lot of health issues and chronic pain was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Daughter had covid vaccine. She had bad reaction.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (Covid-19 Vaccine, Solution for injection) via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No patient identifiers were provided but the reporter had first-hand knowledge of the patient and was reporting on a specific patient. Daughter had Covid vaccine. She had bad reaction. Outcome of the event was unknown.  Information on lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Neck pain, Pain
Clinical narrative: sore reaction; neck pain; dizziness; nauseous that went away again after a few days; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 18Jan2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient stated that she received her 1st shot of our vaccine last 18Jan2021 and had a sore reaction that went away after a few days. Then on the 15th day, she had neck pain, dizziness and nauseous that went away again after a few days. She was asking if this was normal. 2nd vaccine was scheduled 08Feb2021. The outcome of the events neck pain and dizziness was unknown and recovered on an unspecified date for other events.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose decreased, Blood test, Fatigue, Pruritus
Clinical narrative: itching; Rash; fatigue; joint pain; low blood sugar; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809/Expiry date: unknown), via an unspecified route of administration on 04Feb2021 at 11:00 AM in the left arm (at the age of 78-years-old) as single dose for COVID-19 immunization. The patient medical history included ongoing diabetes from 2000 and hysterectomy in the year 2000. The patient had received some other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No pre-disposing factors was reported. Follow up received on 21Apr2021, it was confirmed that on 27Feb2021 at 10:00, the patient experienced rash, fatigue, joint pain and low blood sugar (previously reported as, 05Feb2021, 12:00 AM, the patient experienced rash, fatigue, joint pain, and low blood sugar. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient was given advice and reassurance for the treatment of the adverse event). The patient had received treatment for rash. No treatment medication for received for events fatigue, joint pain, and low blood sugar. The patient was not hospitalized as a resulted of these events. Patient reported that the Doctor suggested taking benadryl for itching due to rash. The patient reported that she required a virtual visit to Physician office. It was unknown if the patient had any primary infection site. No culture was performed. The patient reported that she was fine now at the time of reporting. The clinical outcome for the event itching was unknown and the outcome of other events had recovered.  Information on the lot/batch number has been requested.  Follow up(21Apr2021): This is a follow up-spontaneous report from a contactable consumer received in response to Non-HCP letter via follow-up letter which included: Added patient's age at vaccination, medical history, suspect drug details (Lot number, Time of vaccination), updated event details (onset date and outcome), clinical course and narrative updated accordingly. Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: itching; Rash; fatigue; joint pain; low blood sugar; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809/Expiry date: unknown), via an unspecified route of administration on 04Feb2021 at 11:00 AM in the left arm (at the age of 78-years-old) as single dose for COVID-19 immunization. The patient medical history included ongoing diabetes from 2000 and hysterectomy in the year 2000. The patient had received some other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No pre-disposing factors was reported. Follow up received on 21Apr2021, it was confirmed that on 27Feb2021 at 10:00, the patient experienced rash, fatigue, joint pain and low blood sugar (previously reported as, 05Feb2021, 12:00 AM, the patient experienced rash, fatigue, joint pain, and low blood sugar. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient was given advice and reassurance for the treatment of the adverse event). The patient had received treatment for rash. No treatment medication for received for events fatigue, joint pain, and low blood sugar. The patient was not hospitalized as a resulted of these events. Patient reported that the Doctor suggested taking benadryl for itching due to rash. The patient reported that she required a virtual visit to Physician office. It was unknown if the patient had any primary infection site. No culture was performed. The patient reported that she was fine now at the time of reporting. The clinical outcome for the event itching was unknown and the outcome of other events had recovered.  Information on the lot/batch number has been requested.  Follow up(21Apr2021): This is a follow up-spontaneous report from a contactable consumer received in response to Non-HCP letter via follow-up letter which included: Added patient's age at vaccination, medical history, suspect drug details (Lot number, Time of vaccination), updated event details (onset date and outcome), clinical course and narrative updated accordingly. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity
Clinical narrative: effects on her bowel movements.; This is a spontaneous report received from contactable consumer (reporting on herself) via a Pfizer-sponsored program. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and Expire Date was not reported) via unspecified route of administration on an unspecified date as un-known, single for Covid-19 immunization. Medical history and concomitant medications were not reported. Patient received COVID vaccine and has inquired about its effects on her bowel movements. The outcome of event was unknown.   Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: skin growth; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient).  A male patient an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, Formulation: Solution for injection, Lot Number was not reported), dose 1 via an unspecified route of administration on an unspecified date as  single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had skin growth. The patient reported as his doctor prescribed him a Fluorouracil Cream for skin growth. The outcome of event was unknown.  Information about Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Said can feel a migraine coming on; I was getting migraine headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient herself) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: not reported) via an unspecified route of administration on 03Feb2021 as 1st dose, single dose for COVID-19 immunization. Medical history included migraine; she suffered from migraines, clarified had migraines before getting COVID vaccine from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that, she received first dose of COVID vaccine yesterday and said that she could feel a migraine coming on. She was getting migraine headache on unspecified date in Feb2021. She don't want to take anything but sometimes it escalates. She wanted to know if she could take something. Therapeutic measures were taken as a result of migraine coming on and headache as currently, she was on Imitrex or the generic Sumatriptan 50 mg and she enquired would that effect it or not. The outcome of events was unknown.  Limited information was available over the call.  Information on lot and Batch number has been requested.  Follow-up attempts are completed. No further information is expected.