chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: who's the only one that got real sick/he bounced back; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A male patient in his 70's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "who's the only one that got real sick is [Patient Name]" (unspecified if ongoing), notes: Before vaccine available for young, healthy guys, whole family got sick. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "who's the only one that got real sick/he bounced back".  Additional information: The other patient experienced unexpected therapeutic benefit from COVID vaccine. Well last year right before the vaccine became available for the young, healthy guys the whole family got sick, the babies, his daughter, his wife, and himself. And who was only one that got real sick. But after six months, he decided let try something else, cause we had no treatment. He got the vaccine and in two more months he bounced back. So he was fired and quit his old job, told his boss to go to a different place.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain
Clinical narrative: stomach was dust a little sore; All around sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2022 (Lot number: 330308D) as dose 1, single for covid-19 immunisation. Relevant medical history included: "paralyzed left diaphragm", start date: 2013 (ongoing), notes: Illness/AE: paralyzed left diaphragm, Stop date: Non repair above, Pertinent details: Last surgery. Family history included: "sleep apnea" (unspecified if ongoing), notes: Dad passed from sleep apnea; "Alzheimer" (unspecified if ongoing), notes: Mom was Alzheimer, dementia insomnia; "dementia" (unspecified if ongoing), notes: Mom was Alzheimer, dementia insomnia; "insomnia" (unspecified if ongoing), notes: Mom was Alzheimer, dementia insomnia. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach was dust a little sore"; PAIN (non-serious) with onset 06Jan2022, outcome "unknown", described as "All around sore". Therapeutic measures were not taken as a result of pain.  Additional Information: The patient stated that just got the first pfizer vaccine. The patient had been procrastinating. The patient felt ok often, stomach was dust a little sore. Patient took second dose on 28Jan2022 in left arm with lot number: 330308D. Prior vaccination was none.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Endometriosis, Menstrual disorder, Stress, Ultrasound scan
Clinical narrative: ovary pain; an inconsistent cycle; stress; endometrioma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jun2021 (Lot number: EW0221) at the age of 31 years as dose 2, single and administered in arm left, administration date 29Apr2021 (Lot number: EY4825) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: other medical history: migraine. Concomitant medication(s) included: ZINC; VIT C. The following information was reported: ADNEXA UTERI PAIN (non-serious) with onset 2021, outcome "recovered" (Oct2021), described as "ovary pain"; MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "recovered" (Oct2021), described as "an inconsistent cycle"; STRESS (non-serious) with onset 2021, outcome "recovered" (Oct2021), described as "stress"; ENDOMETRIOSIS (non-serious) with onset 2021, outcome "recovered" (Oct2021), described as "endometrioma". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of adnexa uteri pain, menstrual disorder, stress, endometriosis.  Additional Information: Patient did not experience covid prior to vaccination. Patient received supplements only (zinc, vit c, vit b, prenatal, et). After the first 2 shots, patient experienced ovary pain and an inconsistent cycle. Patient attributed that to stress and maybe a normal reaction to the vaccine at first, but after 2 or so months, the pain and inconsistent cycles persisted so her doctor gave her an ultrasound where they discovered an endometrioma. Patient took some supplements (serrapeptase, DIM, NAC) and did acupuncture and 3 months later, the follow up ultrasound showed that the endometrioma was no longer there. This was end of October. Patient didn't feel anymore discomfort and had a regular cycle in November and December until the booster.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyslexia
Clinical narrative: New onset of occasional dyslexia- transcribing numbers and letters from hearing to typing from seeing to speaking from seeing to typing from seeing to writing.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19Dec2021 (Lot number: PF2587) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unknown if ongoing). Concomitant medication(s) included: ZYRTEC-D. Vaccination history included: Bnt162b2 (previous dose product: COVID 19, previous dose lot number: PFIZER ER8737, previous dose administration date: 06Apr2021 , previous dose dose number: 2), administration date: 06Apr2021, when the patient was 41 years old, for COVID-19 Immunization; Bnt162b2 (Previous dose product: COVID 19, previous dose lot number: PFIZER EN6204, previous dose administration date: 06Mar2021 , previous dose dose number: 1), administration date: 06Mar2021, when the patient was 41 years old, for COVID-19 Immunization. The following information was reported: DYSLEXIA (non-serious) with onset 2021, outcome "not recovered", described as "New onset of occasional dyslexia- transcribing numbers and letters from hearing to typing from seeing to speaking from seeing to typing from seeing to writing.". Therapeutic measures were not taken as a result of dyslexia. No follow-up attempts are possible. No further information is expected. Additional Information: The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with covid prior vaccination. The patient was not tested with post vaccination. The patient reported that new onset of occasional dyslexia transcribing numbers and letters from hearing to typing from seeing to speaking from seeing to typing from seeing to writing. The patient other medical history was reported as none.  Follow-Up (18Jan2022): Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: For the first two doses I had a sore arm, which I expected; 1st dose administration date 16Jun2021 2nd dose administration date 11Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 14:00 (Lot number: FE3380) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; FLUOXETINE. Vaccination history included: Bnt162b2 (prev dose administration time=08:45, AM, prev dose dose number=1,, prev dose vaccine location=Left, arm, prev dose lot number=FA1027), administration date: 16Jun2021, when the patient was 28 years old, for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 11Aug2021 14:00, outcome "unknown", described as "1st dose administration date 16Jun2021 2nd dose administration date 11Aug2021"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "For the first two doses I had a sore arm, which I expected". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: No other vaccine in four weeks. Other medications in two weeks included Lamotrigine, Fluoxetine, Birth control. For the first two doses she had a sore arm, which she expected. However about 16 hours after her booster she also had chest pain and heart palpitations, which I have never had from a vaccine before.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug interaction
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INTERACTION (non-serious), outcome "unknown", described as "Two days after the vaccination, I lost the effect of the steroid". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: She reported stomach upset with the first dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "She reported stomach upset with the first dose".  Additional information: The patient had pre-existing medical issues with her back and shoulders. Her stomach was upset after getting the first dose of Covid vaccine and mentions with the second dose she had less of reaction but did not specify.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: throughout the day the pain does not go away with medication; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Dec2021 16:30 (Lot number: 331308a) at the age of 37 years as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ew982, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 17May2021, when the patient was 37 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: en9581, Location of injection: Arm Left, Vaccine Administration Time: 04:00 AM), administration date: 26Apr2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 30Dec2021 17:00, outcome "not recovered", described as "throughout the day the pain does not go away with medication"; HEADACHE (non-serious) with onset 30Dec2021 17:00, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of pain, headache.  Additional information: The patient reported that after 5 days that she took the third dose of the covid-19 vaccine, and so far, she had a lot of headache, throughout the day the pain does not go away with medication, she never had a headache in her life, she was very worried. She reported "arm", which is "Privacy" in Privacy.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot, Hypoaesthesia, Inappropriate schedule of product administration, Paraesthesia
Clinical narrative: Tingling and numbness on right hand; Tingling and numbness on right hand; warm sensation on inner side of right leg near foot.; warm sensation on inner side of right leg near foot.; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 05Jan2022 13:15 (Lot number: FJ8757) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (ongoing); "PUD" (ongoing); "Insomnia" (ongoing); "Constipation" (ongoing); "GERD" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); SPIRONOLACTONE (ongoing); TRELEGY; OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2590, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 27Oct2021, when the patient was 34 years old, for Covid-19 Immunization, reaction(s): "Covid-19". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Jan2022, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 07Jan2022 12:00, outcome "not recovered" and all described as "Tingling and numbness on right hand"; BURNING SENSATION (non-serious), FEELING HOT (non-serious) all with onset 07Jan2022 12:00, outcome "not recovered" and all described as "warm sensation on inner side of right leg near foot.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia, burning sensation, feeling hot.  Additional Information: It was unknown if the patient received any other vaccine in four weeks. The patient did not have covid prior vaccination and the patient was tested for COVID post vaccination. There were no known allergies. There were no relevant test done for thromboembolic events with thrombocytopenia   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200047545 Same reporter/patient/drug, different dose/events
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tingling and numbness on right hand; Tingling and numbness on right hand; warm sensation on inner side of right leg near foot.; warm sensation on inner side of right leg near foot.; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 05Jan2022 13:15 (Lot number: FJ8757) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (ongoing); "PUD" (ongoing); "Insomnia" (ongoing); "Constipation" (ongoing); "GERD" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); SPIRONOLACTONE (ongoing); TRELEGY; OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2590, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 27Oct2021, when the patient was 34 years old, for Covid-19 Immunization, reaction(s): "Covid-19". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Jan2022, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 07Jan2022 12:00, outcome "not recovered" and all described as "Tingling and numbness on right hand"; BURNING SENSATION (non-serious), FEELING HOT (non-serious) all with onset 07Jan2022 12:00, outcome "not recovered" and all described as "warm sensation on inner side of right leg near foot.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia, burning sensation, feeling hot.  Additional Information: It was unknown if the patient received any other vaccine in four weeks. The patient did not have covid prior vaccination and the patient was tested for COVID post vaccination. There were no known allergies. There were no relevant test done for thromboembolic events with thrombocytopenia   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200047545 Same reporter/patient/drug, different dose/events
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product preparation error
Clinical narrative: one dose of undiluted vaccine, 0.2ml, was administered; one dose of undiluted vaccine, 0.2ml, was administered; Arm pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Jan2022 (Lot number: FL0007, Expiration Date: 21Feb2022) as dose number unknown, 0.2 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 08Jan2022, outcome "unknown" and all described as "one dose of undiluted vaccine, 0.2ml, was administered"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "Arm pain".  Additional information: it was reported that an event in which the vaccine was administered undiluted and was looking for recommendations and guidelines in that situation. Reporter clarifies that one dose of undiluted vaccine, 0.2ml, was administered 3 times, to 3 different patients. Reporter reported that he has spoken to the patients parents.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling in both arms n hands, entire arms fall asleep; numbness and tingling in both arms n hands, entire arms fall asleep; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Nov2021 17:30 (Lot number: FH8020) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ulcerative Colitis" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: LIADIA; VYVANSE. The following information was reported: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 05Nov2021, outcome "unknown" and all described as "numbness and tingling in both arms n hands, entire arms fall asleep".  Additional information: The patient received second dose of BNT162B2 (lot number: 33025BD) via unspecified route on 04Jan2022 18:30 on arm right for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. On 02Nov received 1st of Pfizer, 3 days following patient had numbness and tingling in both arms and hands, entire arms fell asleep and currently waiting to see a neurologist. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Just received 2nd dose of Pfizer on 04Jan2022 and day 6 she was having chest tightness, shortness of breath, rapid heartbeat. Waiting to see a doctor today 11Jan2022. Currently waiting for treatment. Since the vaccination, the patient had not been tested for COVID-19. Known allergies: Not that patient was aware of.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: Felt sluggish; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 08Mar2021 15:00 (Lot number: EN6199) as dose 2, single for covid-19 immunisation. Relevant medical history included: "HTN" (ongoing); "hypothyroid" (ongoing); "hypokalemia" (unspecified if ongoing). Concomitant medication(s) included: HCTZ taken for hypertension (ongoing); LISINOPRIL taken for hypertension (ongoing); LEVOTHYROXINE taken for hypothyroidism (ongoing); METOPROLOL taken for hypertension (ongoing); KCL taken for hypokalaemia (ongoing). Vaccination history included: Bnt162b2 (Dose: 01, Time: 02:30 PM, Anatomical location: Right Deltoid, Route of administration: Intramuscular, Lot Number; EN6201), administration date: 15Feb2021, for COVID-19 immunization. The following information was reported: SLUGGISHNESS (non-serious) with onset 09Mar2021, outcome "unknown", described as "Felt sluggish".  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: For the first two doses I had a sore arm, which I expected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Jul2021 08:45 (Lot number: FA1027) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "other medical history: IBS" (unspecified if ongoing), notes: other medical history: IBS; "Birth control" (unspecified if ongoing), notes: other medications in two weeks: Yes (Birth control). Concomitant medication(s) included: LAMOTRIGINE; FLUOXETINE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "For the first two doses I had a sore arm, which I expected". No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Rash
Clinical narrative: break out in a rash on her forearm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Dec2021 17:40 (Batch/Lot number: unknown) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "bee sting", start date: Jul2021 (unspecified if ongoing), notes: she had a prior bee sting this summer in Jul2021. There were no concomitant medications. The following information was reported: RASH (non-serious), outcome "unknown", described as "break out in a rash on her forearm". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (08Feb2022): 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 completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Multiple allergies, Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: I began to suffer all over my body, from allergic reactions to everything. Allergies to metals, plastics, wood, fabrics, dust on surfaces.; They appear as welts, itchiness, lumps on the welts; They appear as welts, itchiness, lumps on the welts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 10:00 (Lot number: Ew0158) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MULTIPLE ALLERGIES (non-serious) with onset 17Apr2021, outcome "not recovered", described as "I began to suffer all over my body, from allergic reactions to everything. Allergies to metals, plastics, wood, fabrics, dust on surfaces."; URTICARIA (non-serious), PRURITUS (non-serious) all with onset 17Apr2021, outcome "not recovered" and all described as "They appear as welts, itchiness, lumps on the welts". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of multiple allergies, urticaria, pruritus. Additional information; Dose received: 3 Most recent dose details: Product COVID 19,  Brand Pfizer and Lot Number Fh8030 along with Administration date 21Nov2021, time 01:00 PM, Vaccine location (was not provided). Previous dose details: dose number 2, Previous dose product COVID 19, Previous dose brand Pfizer and lot Number Ew0179 along with administration date 01May2021, time 10:00 AM, Vaccine location(was not provided). Additional information (dose 2, dose 3) amended in narrative. , No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Endocrine disorder
Clinical narrative: a great deal of hair loss; COVID-19 (mRNA) vaccine interfere with the Endocrine System; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Mar2021 (Lot number: ER8727) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot EN6205, Anatomical site: Right arm, Route of administration: Intramuscular), administration date: 09Mar2021, for COVID-19 Immunization. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "a great deal of hair loss"; ENDOCRINE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "COVID-19 (mRNA) vaccine interfere with the Endocrine System". The event "a great deal of hair loss" was evaluated at the physician office visit. Therapeutic measures were taken as a result of alopecia.  Additional information: Patient had no other vaccines within 4 weeks prior to vaccination. Patient had PRP treatment for the hair loss .Patient had no relevant tests and patient had no concomitant therapy.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypersensitivity, Hypoaesthesia, Pain in extremity
Clinical narrative: immediate burning painful feeling in arm, brief and mild; burning and numbness in the arm between the shoulder and her elbow; burning and numbness in the arm between the shoulder and her elbow; allergic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 16May2021 (Lot number: EN0185) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16May2021, outcome "recovered" (16May2021), described as "immediate burning painful feeling in arm, brief and mild"; HYPOAESTHESIA (non-serious), BURNING SENSATION (non-serious) all with onset 16May2021, outcome "recovered" (16May2021) and all described as "burning and numbness in the arm between the shoulder and her elbow"; HYPERSENSITIVITY (non-serious) with onset May2021, outcome "unknown", described as "allergic reaction". Therapeutic measures were not taken as a result of pain in extremity, hypoaesthesia, burning sensation.  Additional information:Caller received a callback from Colleague (Name withheld), INT #. Saying she had additional information for her. During transfer, Caller mentioned that her daughter received primary first and second dose in may and june of the Adult Pfizer covid 19vaccine. After the first dose, she experienced a bit of burning and numb sensation in the arm where she received the vaccin, between her shoulder and elbow, and for the next dose a month later, she experienced a much stronger, but similar sensation. It started immediately after the administration of the vaccin. 30 minutes after, when she got home, it got worse, and it got briefly to her head. It was frightening and she was crying. Her heart was pounding, then the burning sensation numbness came all through her arms, fingers and other parts of her body. 40 minutes after the dose it started to subside and patient wasn't taken to ER. weigts 109 pounds, heights 5. 6 Caller wanted to know if her 13 years old can take the booster. She also read that this kind of symptoms happen to people who react to ingredients of the vaccine. She wanted to talk to staff to receive the additional information she found on this questions. Potential EA duplicated. Transmitted to safety. No visit to Emergency Room and Physician Office. No Prior Vaccinations (within 4 weeks).
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Shortness of breath; chest pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; CHEST PAIN (non-serious), outcome "unknown", described as "chest pain".  Additional information: Shortness of breath and chest pain after Pfizer vaccine. Was not sure that was just what the oxygen oximeter done. Patient went to a cardiologist so that patient could get more answers.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: The reporter advised that the patient had an allergic reaction to the Covid.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): NUS2022US006703 (Novartis).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "The reporter advised that the patient had an allergic reaction to the Covid.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Illness, Influenza, Pyrexia
Clinical narrative: sick; flu; unable to get out of bed; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; INFLUENZA (non-serious), outcome "unknown", described as "flu"; BEDRIDDEN (non-serious), outcome "unknown", described as "unable to get out of bed"; PYREXIA (non-serious), outcome "unknown", described as "fever". The events "sick" and "flu" were evaluated at the emergency room visit.  Additional Information: Patient reported being sick for the past 5-6 days with the flu. He is due for his second Pfizer Covid19 vaccine today and would like to know how to proceed. Should he get his dose? Patient stated he had presented to the ER for his flu symptoms, and "been exposed to the elements" and has been sick since then. He is currently unable to get out of bed. He is unable to go in to receive his dose, today as he is sick in bed and does not feel he is able to drive. The patient indicated his illness was the flu, but it occurred in between his 2 Covid vaccine doses. The patient did not say whether he was covid-tested or not. Explained that "fever" is listed something to discuss with HCP in "CONS-what should I mention to vaccination provider before getting the vaccine. The patient sick with the flu and unable to make his appointment for his second Pfizer Covid19 vaccine, today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: rigors; fevers; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4467433.  A 44 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "NSAID allergy" (unspecified if ongoing), notes: Patient concurrent condition included: NSAID allergy; "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "rigors"; PYREXIA (non-serious), outcome "unknown", described as "fevers".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). A 9 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 31Dec2021 (Lot number: FK5618) at the age of 9 years as dose 1 (tris), single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 02Jan2022, outcome "recovered", described as "rash/come and go rash"; HYPERSENSITIVITY (non-serious), outcome "un-known", described as "having allergic reaction"; URTICARIA (non-serious) with onset 02Feb2022, outcome "recovered", described as "Had hives all over body"; PRURITUS (non-serious), outcome "not recovered", described as "very itchy". The events "rash/come and go rash" and "had hives all over body" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, urticaria, pruritus. Additional information: Nurse stated, they did not put one on the like we got the COVID record card from the patient they did not put expiration date. For NDC and UPC numbers Nurse stated, I do not, we just Location pediatrician so, we just have the vaccination record card we are not sure which, they got their vaccine from a different clinic. Vaccination facility type was Other. Vaccine did not administer at military Facility. Prior vaccination before four weeks, the patient has not received any vaccine prior vaccination before four weeks. There is not anything to help when problem. Father of child reported to clinic that patient having an allergic reaction, had hives all over body was given Benadryl. Advised to follow up if symptoms not improving. 03Jan2022 MOC calls 18Jan2022 stating rash had returned and similar to rash on 03Jan2022 offered patient Benadryl. Patient came into clinic for appointment on 19Jan2022. Examined by Physician, 09-Year-old female with rash that started after the Covid vaccine. The rash comes and goes. Very itchy, raised. Then disappears and shows up somewhere else. Benadryl helps, then comes back when it wears off. The reporter does not know the vaccination time, but the date was 31Dec2021. Adverse event Required visit to Physician Office. Given Benadryl for active rash Claritin or Zyrtec once daily. Relevant test was reported as None. Specific Relevant Test for Thromboembolic Events with Thrombocytopenia was None. No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Investigation
Clinical narrative: After the second dose I started to have sporadically. I thought that was some allergies. I went to the doctor, did some exams and everything is normal.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 14:00 (Lot number: EN6203) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Surgical menopause and hypercholesterolemia" (unspecified if ongoing); "Surgical menopause and hypercholesterolemia" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid19 vaccine (DOSE 1, SINGLE, Batch/Lot No: EL9261, Location of injection: Arm Left), administration date: 22Jan2021, for COVID-19 IMMUNIZATION. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "After the second dose I started to have sporadically. I thought that was some allergies. I went to the doctor, did some exams and everything is normal.". The event "after the second dose i started to have sporadically. I thought that was some allergies. i went to the doctor, did some exams and everything is normal." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypersensitivity.  Additional information: After the second dose I started to had sporadically. I thought that was some allergies. I went to the doctor, did some exams and everything was normal. 4 days after the third dose , I have strong hives in my entire body: legs, arms, belly and back. The hives didn't go way. I search and I found person with the same hives due vaccine allergies. The events result in doctor or other healthcare professional office/clinic visit. The events treatment was Zyrtec. The patient had not received any other vaccine prior to the COVID vaccine. The patient had not been tested since the vaccination. The patient had no known allergies. Follow-up attempts are completed. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Overdose, Poor quality product administered, Product preparation error, Pyrexia
Clinical narrative: patient was given an undiluted dose; patient was given an undiluted dose; patient was given an undiluted dose; She is having the chest pain; fever; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2022 (Lot number: FL8094) at the age of 10 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 20Jan2022, outcome "unknown" and all described as "patient was given an undiluted dose"; CHEST PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "She is having the chest pain"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "fever".  Additional information: Patient was given an undiluted dose of the Pfizer-Biontech Covid19 vaccine for pediatrics (orange cap). Caller stated that patient has been experiencing fever since then.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Right arm swelling and itching; Right arm swelling and itching; Hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): LRN4531462.  A 59-year-old female patient received bnt162b2 (BNT162B2), administration date 20May2021 (Batch/Lot number: unknown) at the age of 58 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Back surgery" (unspecified if ongoing); "COVID with pneumonia" (unspecified if ongoing); "A-fib" (unspecified if ongoing); "Fluid around heart" (unspecified if ongoing), notes: Fluid around heart; "C-section" (unspecified if ongoing); "Cabbage allergy" (unspecified if ongoing), notes: cabbage allergy; "Antibiotic allergy" (unspecified if ongoing); "Crawfish allergy" (unspecified if ongoing), notes: Crawfish allergy. Concomitant medication(s) included: XOLAIR. The following information was reported: PERIPHERAL SWELLING (non-serious), PRURITUS (non-serious) all with onset 10Jun2021, outcome "recovered", and all described as "Right arm swelling and itching"; URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "Hives".  Additional Information: Patient's concurrent condition included: Hives. On 20May2021, patient started therapy with Pfizer Covid Vaccine. We have no further information regarding the reported event(s) described above. Any additional material information received will be forwarded to you in accordance with RA's policies and procedures.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Laboratory test, Lymph node pain, Lymphadenopathy, Swelling
Clinical narrative: experienced random uncomfortableness; swollen lymph nodes under my arms; The swelling continued and only started subsiding until after the Booster; lymph node pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 54 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Jan2022 17:00 (Lot number: FL3198) as dose 3 (booster), single, administered in arm left, administration date 25Apr2021 (Lot number: EW0170) as dose 2, single and administered in arm left, administration date 02Apr2021 (Lot number: EW0151) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HP" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension, start date: 2015 (ongoing); SIMVASTATIN taken for blood cholesterol, start date: 2020 (ongoing). The following information was reported: DISCOMFORT (non-serious) with onset Apr2021, outcome "recovered", described as "experienced random uncomfortableness"; LYMPHADENOPATHY (non-serious) with onset Apr2021, outcome "unknown", described as "swollen lymph nodes under my arms"; SWELLING (non-serious) with onset Apr2021, outcome "recovering", described as "The swelling continued and only started subsiding until after the Booster"; LYMPH NODE PAIN (non-serious) with onset Apr2021, outcome "recovering", described as "lymph node pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that patient had both of COVID vaccines back in April and have experienced random uncomfortableness from time to time because of swollen lymph nodes under my arms. Patient had ultrasounds that have confirmed the swelling and will be going for an MRI in a few weeks. Patient reluctant to go for my booster. Specific Relevant Test for Thromboembolic Events with Thrombocytopenia was Unknown. Patient experienced lymph node pain after my first vaccine in April, the swelling continued and only started subsiding until after the Booster in Jan2022. At First, after the booster the swelling was worse for the first week, now the Discomfort is minimal, almost gone.  No follow-up attempts are possible. No further information is expected.  Follow-Up (23Feb2022): Follow-up attempts are completed. No further information is expected.