chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: fainting; POTS; Dysautonomia; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient (non-pregnant at time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in the left arm on 20Mar2021 (Lot number: EP7534) as single dose for COVID-19 immunisation. Medical history included hypertension and depression, allergies to penicillin. Concomitant medications included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), labetalol. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in the left arm on 02Mar2021 (Lot number: EN6205) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Occurred on 29Mar2021, patient experienced dysautonomia: fainting and POTS. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The outcome of events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Headache, SARS-CoV-2 test
Clinical narrative: Headache; positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Apr2021 (Batch/Lot Number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that: "I got the vaccine on Sunday afternoon and I got the COVID test yesterday at the school and I got positive result". The patient experienced headache on 28Apr2021.  The patient underwent lab tests and procedures which included COVID-19 test: positive on Apr2021.  The patient outcome of headache was recovering and unknown for the other events.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Thrombosis
Clinical narrative: blood clot; heart attack; This is a spontaneous report from a contactable consumer. This consumer reported for his father.   A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose  for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced blood clot  and had an heart attack  on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: her sugar numbers are high; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0175), via an unspecified route of administration on 27Apr2021 as 1st dose, single for COVID-19 immunization. Medical history included diabetes (she is a diabetic), IUD (intrauterine contraception, 10 year IUD). The patient's concomitant medications were not reported. She got the first dose of the Pfizer covid 19 vaccine yesterday (27Apr2021). She has 10 year IUD in her, states it is not a hormonal one and she is asking if her IUD could affect anything. Reports her sugar numbers are high, she is a diabetic. She is wondering if the vaccine could affect her sugar. The outcome of the event was unknown.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia oral, Paraesthesia oral, Pruritus, Rash
Clinical narrative: Itching; Tongue is numb and tingling; Tongue is numb and tingling; allergic reaction; at the injection site she broke out; rashes on both arms/saw other red dots appear; Rash; This is a spontaneous report from a contactable consumer.A 18-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Apr2021 18:00 (Batch/Lot Number: EW0153; Expiration Date: Jul2021) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced rash on 27Apr2021, itching on 28Apr2021, tongue is numb and tingling on 27Apr2021, allergic reaction on 27Apr2021, she thought it was acne at first, but at the injection site she broke out on 27Apr2021, rashes on both arms/saw other red dots appear on 27Apr2021. Clarified allergic reaction as: She thought it was acne at first, but at the injection site she broke out. She has rashes on both arms. Rash seems to be spreading. Really started to show on day two and day three. Hasn't taken anything for it. She tends to break out on her arms, that's just her own body, but she saw other red dots appear that hadn't been there on her arms. She was itching last night and that was new. Is not itching as of now. She went to the hospital and was told to take Benadryl. Clarified she went to the vaccination facility, which was the hospital, and she was asked what was going on. She was not a patient of the ER and was not admitted to the hospital. Forgot to mention her tongue has been numb and tingling for a couple of days. First noticed it when she had something cold, but has persisted even without drinking something cold. Started Tuesday, 27Apr2021, night. Wondering if that is a side effect. Read in the pamphlet it is part of an allergic reaction. Read that rash is a part of a severe reaction.Outcome of all events was not recovered.  Therapeutic measures were taken as a result of all events.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Itching; Tongue is numb and tingling; Tongue is numb and tingling; allergic reaction; at the injection site she broke out; rashes on both arms/saw other red dots appear; Rash; This is a spontaneous report from a contactable consumer.A 18-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Apr2021 18:00 (Batch/Lot Number: EW0153; Expiration Date: Jul2021) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced rash on 27Apr2021, itching on 28Apr2021, tongue is numb and tingling on 27Apr2021, allergic reaction on 27Apr2021, she thought it was acne at first, but at the injection site she broke out on 27Apr2021, rashes on both arms/saw other red dots appear on 27Apr2021. Clarified allergic reaction as: She thought it was acne at first, but at the injection site she broke out. She has rashes on both arms. Rash seems to be spreading. Really started to show on day two and day three. Hasn't taken anything for it. She tends to break out on her arms, that's just her own body, but she saw other red dots appear that hadn't been there on her arms. She was itching last night and that was new. Is not itching as of now. She went to the hospital and was told to take Benadryl. Clarified she went to the vaccination facility, which was the hospital, and she was asked what was going on. She was not a patient of the ER and was not admitted to the hospital. Forgot to mention her tongue has been numb and tingling for a couple of days. First noticed it when she had something cold, but has persisted even without drinking something cold. Started Tuesday, 27Apr2021, night. Wondering if that is a side effect. Read in the pamphlet it is part of an allergic reaction. Read that rash is a part of a severe reaction.Outcome of all events was not recovered.  Therapeutic measures were taken as a result of all events.
Sex: M
Vaccine: COVID19
Symptoms: Epilepsy, Seizure
Clinical narrative: had two seizures on the same day; epilepsy; This is a spontaneous report received from a non-contactable consumer reported for a 20-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient had epilepsy. He had two seizures this week on the same day and he had not had a seizure in 1.5 years. The outcome of the events was unknown.  Information on the lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Pneumonia, Sputum discoloured
Clinical narrative: pneumonia; a hard time breathing; coughing up dark yellow phlegm; coughing up dark yellow phlegm; This is a spontaneous report from a contactable consumer (patient's sister). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medication included tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from Oct2020 to an unspecified date, at 11 mg for an unspecified indication. On an unspecified date the patient experienced pneumonia, had a hard time breathing and coughing up dark yellow phlegm and was admitted to the hospital. The patient was treated with antibiotics for pneumonia. The outcome of the events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, Pharyngeal abscess
Clinical narrative: abscess on her pharynx; sore throat; This is a spontaneous report received from a contactable consumer (patient herself).  A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: solution for injection; Lot number and Expiration date: UNKNOWN),  via an unspecified route of administration on 18Apr2021, as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported.   Patient reported that a week later on 27Apr2021, she got a sore throat. Caller reported that she went to the doctor on 30Apr2021 and was tested negative for covid but was diagnosed with an abscess on her pharynx. Patient described it as a pouch full of puss. Patient reported that she was prescribed an antibiotic and steroids as treatment for events. Patient stated that her throat does not hurt anymore. Patient reported that she will go to an ENT on Friday to make sure it was completely gone. Patient asked if was is safe to take the second dose even if she was taking antibiotics and steroids. Patient stated her last dose of the steroid was today and she would only be on the antibiotic on Sunday. Patient inquired would there be a problem, and response was given. Drug Interactions. Patient also inquired if she can wait more than three weeks apart. The outcome of the events was resolved for sore throat and unknown for abscess on pharynx.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Diagnosed with UTI and was under the medication of antibiotics; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program, COVAX Support. A female patient of unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 11Mar2021 (also reported as 12Mar2021) (at an unspecified age) at 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had her first dose on 11Mar2021 and was scheduled to return on 01Apr2021. However, she was not able to receive the second dose because she was diagnosed with UTI (urinary tract infection) on an unspecified date in 2021 and was under the medication of antibiotics. The patient also mentioned that on 04Apr2021, she had a surgery on wrist that caused her to delay the second dose again. On 03May2021, the patient reported that it has been six weeks since she had her first Pfizer COVID vaccine, it was on 12Mar2021 (pending clarification). The patient has been unable to get the second shot due to health issues. The patient then asked if she needs to start over with the first shot again or if she can just arrange for the second shot. Outcome of the event was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a non-contactable consumer (Pfizer employee). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at 2nd dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. After the patient got her 2nd Pfizer vaccine for Covid, she got shingles, and she thought they were related. Outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid and is in the hospital; tested positive for covid and is in the hospital; This is a spontaneous report received from a contactable consumer (Patient husband) via Medical Information Team. A 61-Year-old female patient received first dose of BNT162B2 (Pfizer- Biontech COVID-19 Vaccine, solution for injection, Lot number: unknown) via an unspecified route of administration on 15Apr2021 (at the age of 61-years-old), as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient tested positive for COVID and was in the hospital. The patient under lab test that included: SARS-CoV-2 test: Positive on an unspecified date. The patient was due for the second dose on 06May2021. The outcome of the events was unknown.    Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nephrolithiasis
Clinical narrative: kidney stones; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that, A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2 solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant was not reported. On an unspecified date the patient experienced kidney stones with outcome of unknown.  Follow up attempts needed. Further information is expected
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in arm left on 21Jan2021 (Batch/Lot Number: EL3302) at the age of 34-year-old as single dose, 2nd dose via an unspecified route of administration, administered in arm left on 10Feb2021 12:00 (Batch/Lot Number: EM9810) at the age of 34-year-old as single dose for COVID-19 immunization. Relevant medical history and relevant past drug history was none. The patient was not pregnant. Concomitant medications included escitalopram oxalate (LEXAPRO); ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE); probiotics; paracetamol (TYLENOL). 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. Reported event was tested positive for COVID on 03May2021. Treatment received for the adverse event was medicines and rest. The patient underwent lab tests and procedures which included Lumiradx Sars-Cov-2 AG: positive on 03May2021 (Nasal Swab). The outcome of event was recovering.   Follow-up attempts are needed. Further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Diarrhoea, Inappropriate schedule of product administration
Clinical narrative: dvt; diarrhea; okay for him to get the second dose outside of the recommended 3 weeks ( 6 weeks and 2 days ).; This is a spontaneous report from a contactable consumer. This male consumer reported for himself. A 63-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Mar2021 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date patient experienced side effects such as diarrhea and DVT on their left leg. As second dose scheduled on 06May2021 wanted to know if it is okay for him to get the second dose outside of the recommended 3 weeks (6 weeks and 2 days). He would like to know if Diarrhea and Blood Clots are side effects of the vaccine as he is currently experiencing these adverse events. The Outcome of the events were unknown. Follow-up (05May2021): This is a Follow-up spontaneous report from a Pfizer-sponsored program. This contactable male consumer reported side effect from the first dose, second dose scheduled on 06May2021. Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: Yes: Customer and/or medical inquiry forwarded or referred to MI. Information about lot/ batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Glaucoma, Lacrimation increased, Ocular hyperaemia, Vision blurred
Clinical narrative: Tendency to glaucoma; She had an episode were her eyes swelled up really bad; Eyes were red and wet; Blurry vision; Eyes were red and wet; This is a spontaneous report from a contactable consumer (patient herself). A 25-year-old female patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot/Batch number: not reported) via an unknown route of administration on 10Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. In 2021, the patient experienced tendency to glaucoma, she had an episode were her eyes swelled up really bad, eyes were red and wet, blurry vision. The outcome of the events was unknown. It was reported that the patient was supposed to receive the second dose yesterday and she had to reschedule because of events. The patient questioned if there are reports of deaths after getting the vaccine.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Magnetic resonance imaging
Clinical narrative: my facial paralysis significantly worsened; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 26Apr2021 (Lot Number: EW0170) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications included unspecified products within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The patient previously received BNT162B2 lot EW0150 on 05Apr2021 14:00 at left arm for Covid-19 Immunization, 9 days later, on 14Apr2021, woke up with severe facial paralysis and MRI result determined it was Bells Palsy. He received 2nd vaccination on 26Apr2021, the following day on 27Apr2021 his facial paralysis significantly worsened. He cannot close his eye all the way, he cannot keep saliva in his mouth, his speech was impaired, it's difficult to eat and frankly he's mortified to go out in public and terrified that he might have to live this way for a while. The patient received Prednisone as treatment. The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the event was not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Subclavian vein thrombosis, Ultrasound Doppler
Clinical narrative: Acute Deep Vein Thrombosis of the Right Subclavian Vein; Swelling of his right arm; This is a spontaneous report received from a contactable Physician. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via intramuscular, administered in right arm on 14Feb2021 (Lot Number: el9269) at single dose for COVID-19 immunization in workplace clinic. Medical history included hypertension, hyperlipidemia, lyme, osteoarthritis. There was no known allergies. Concomitant medications included lisinopril; pravastatin; pantoprazole sodium sesquihydrate (PROTONIX). It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 via intramuscular, administered in left arm on 24Jan2021 (Lot Number: en5318) at single dose for COVID-19 immunization. The patient evaluated in the emergency room on 18Mar2021 for swelling of his right arm.  Patient had a venous doppler right ext, which showed acute deep vein thrombosis of the right subclavian vein. The events result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, and serious for life threatening illness. Treatment for the events included rivaroxaban (XARELTO) and referral to hematologist. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.; Sender's Comments: Based on the information currently available, causality between reported events Subclavian vein thrombosis and Peripheral swelling and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Erythema, Rash, Urticaria
Clinical narrative: Hashimoto's Thyroiditis; patchy redness on my cheek; rash; welts; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), via an unspecified route of administration on an unspecified date as 1st dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced after the first dose on the 3rd day, she had patchy redness on cheek, then had a rash on her face from earlobe to the other earlobe. It started out as red spots that it's so bad that it welts together. It went down on her neck and she had one spot that stayed on her face and one spot on chest and a rash on face. After the 1st dose, she went to a dermatologist and he put to patient on a topical steroid cream and steroid tablet for 5 days. After she had the 2nd vaccine, she didn't have an outbreak until 2 weeks after because she still had that steroid in her system, she believes. The patient had a sore in mouth after the 2nd outbreak. It was also on lips during 2nd one. The patient stated that her lips were really dry, so it was possibly her body just being run down. About 5-6 days ago, she had a rash, but it has appeared only on my lips. Each time she got this outbreak, she had chills for 4 hours and a low-grade fever. Now it's on her lips and on the outer rim of my lips. She will go to the dermatologist. She also had Hashimoto's Thyroiditis, which reduces her immune system. She has been to urgent care, to HCP, and she stated that it was her 3rd trip to the dermatologist. The outcome of the events was reported as an unknown.   Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Headache
Clinical narrative: brain bleeds; headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single (at the age of 55-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she had brain bleeds on an unspecified date. She had had no headache. The patient stated that she had one (referring to headache) after the vaccine that lasted for three days. She was going to get the second vaccine on 04May2021. The patient did not know if this triggered another bleed. The patient stated that the doctor has not ordered a scan to check if she has had another bleed. The patient did not know if she should get the second dose or not, and wanted to know if it was safe to get the second dose or if it was related to vaccine. The outcome of event headache was recovered, and of the other event was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Dysgeusia, Systemic lupus erythematosus
Clinical narrative: angioedema, Not just with the pfizer with other things; lupus flare; smelled the metal I taste; This is a spontaneous report from a contactable nurse (reported herself). A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. She had unspecified allergies. The patient medical history and concomitant medications were not reported. The patient experienced angioedema not just with the Pfizer with other things, lupus flare and smelled the metal she tastes on an unspecified date. The patient stated that she had angioedema, not just with the Pfizer with other things (Unspecified Medication), that she probably need to hold up and take the injection and she was trying to make sure when she could receive. It was reported that she was just trying to find out if she was qualified to get the injection because she had angioedema. Patient reported that she has a lot of health issues. She has high dose of metal that she smelled (looked at the ingredients: Mercury) and two hospitalizations with severe reactions. The report was not related to the study program. The outcome of the events was unknown.  Information about lot/ batch number has been requested. ; Sender's Comments: Based on the limited information currently available the causal association between the reported events angioedema, lupus flare and smelled the metal she tastes and the usage of the vaccine cannot be excluded and meaningfully assessed. The case will be reassessed once the information regarding the date of vaccination and event onset, medical history and concomitant medications are reported. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Confusional state, Thrombosis
Clinical narrative: Patient reported clot developed in calf 1 week following first dose; Confusion; This is a spontaneous report from a contactable consumer (reporting for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization; and sarilumab (KEVZARA), via an unspecified route of administration from 05Mar2021 (Batch/Lot number was not reported) at an unknown dose and frequency for an unspecified indication. The patient medical history was not reported. Concomitant medication included enoxaparin sodium (LOVENOX [ENOXAPARIN SODIUM]) taken for an unspecified indication, start and stop date were not reported. In Mar2021, the patient reported that clot developed in calf 1 week following first dose of Pfizer covid-19 vaccine. Also, with a lot of confusion. She stated that she was driving and got lost in her 1 stoplight/1-mile small town. The outcome of the events was unknown. The action taken in response to the event for sarilumab was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got COVID after the 1st shot; got COVID after the 1st shot; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the third of three reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient got COVID after the 1st shot. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021503608 same reporter/vaccine, similar events, different patient.; PFIZER INC-2021503619 same reporter/vaccine, similar events, different patient.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint stiffness
Clinical narrative: Unable to fully extent her arm past the 90° angle/her arm is very stiff, she can rotate it, but can't extend it; This is a spontaneous report received from a contactable consumer (Patient, reported for herself). A 19-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date was unknown), dose 2 via an unspecified route of administration, in arm left on 29Apr2021 15:00 (at the age of 19-year-old) as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated she just knows her family has a history of high blood pressure, but she is in perfect health. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date was unknown), via an unspecified route of administration, in arm left on an unspecified date 09:00 (at the age of 19-year-old) as single for COVID-19 immunization. The patient did not get any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not report any side effects prior vaccination. The patient did not administer additional vaccines on same date of vaccination. The patient experienced unable to fully extent her arm past the 90 degree angle/her arm is very stiff, she can rotate it, but she cannot extend it on 30Apr2021.  The patient caller reported being unable to fully extent her arm past the 90 degree angle after getting the second dose of the Pfizer-BIONTECH COVID-19 vaccine.  She explained the affected arm is where she received the vaccine. She asked if her symptom was reported as a side effects from the vaccine, and how to treat it. Patient stated that she visited an emergency room on Saturday and they gave her FLEXERIL, a muscle relaxant, and it has not really done much. Caller stated FLEXERIL is 5 mg twice a day by mouth. Patient stated she took FLEXERIL and she is been taking Aleve too but it is the Aleve for back and muscle, she thought it is 50mg or something around that. Seriousness of the event was reported as serious, medically significant. The outcome of event was not recovered.  Information on lot/ batch number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Unable to fully extent her arm past the 90° angle/her arm is very stiff, she can rotate it, but can't extend it; This is a spontaneous report received from a contactable consumer (Patient, reported for herself). A 19-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date was unknown), dose 2 via an unspecified route of administration, in arm left on 29Apr2021 15:00 (at the age of 19-year-old) as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated she just knows her family has a history of high blood pressure, but she is in perfect health. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date was unknown), via an unspecified route of administration, in arm left on an unspecified date 09:00 (at the age of 19-year-old) as single for COVID-19 immunization. The patient did not get any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not report any side effects prior vaccination. The patient did not administer additional vaccines on same date of vaccination. The patient experienced unable to fully extent her arm past the 90 degree angle/her arm is very stiff, she can rotate it, but she cannot extend it on 30Apr2021.  The patient caller reported being unable to fully extent her arm past the 90 degree angle after getting the second dose of the Pfizer-BIONTECH COVID-19 vaccine.  She explained the affected arm is where she received the vaccine. She asked if her symptom was reported as a side effects from the vaccine, and how to treat it. Patient stated that she visited an emergency room on Saturday and they gave her FLEXERIL, a muscle relaxant, and it has not really done much. Caller stated FLEXERIL is 5 mg twice a day by mouth. Patient stated she took FLEXERIL and she is been taking Aleve too but it is the Aleve for back and muscle, she thought it is 50mg or something around that. Seriousness of the event was reported as serious, medically significant. The outcome of event was not recovered.  Information on lot/ batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), 1st dose via an unspecified route of administration, administered in arm left on 28Jan2021 as a single dose, 2nd dose via an unspecified route of administration, administered in arm left on 17Feb2021 as a single dose; both at age of 23 years old for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient contracted COVID-19 after being fully vaccinated on 01May2021. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. And the patient had no COVID-19 prior vaccination. The report was reported as non-serious. The patient underwent lab tests and procedures which included PCR test: positive (nasal swab) on 04May2021. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypersomnia
Clinical narrative: Patient is feeling weak; All she wants to do is to sleep; This is a spontaneous report from a contactable consumer reported a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 15Apr2021 as 1ST DOSE SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  Patient was feeling weak and all she wanted to do was to sleep and she did not know when she going out of the hospital. Patient was scheduled for the 2nd dose on 06May2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Electrocardiogram, Feeling abnormal, Heart rate increased
Clinical narrative: chest pain; pulse started racing; dizzy and light headed; significant allergic reaction to the vaccine/Respiratory tract oedema /Flushing/urticaria/swollen tongue/Pharyngeal swelling/Dizziness; mental fog; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 12Apr2021 14:45 (Batch/Lot Number: Er8737) as 2nd dose, single for covid-19 immunisation. The first dose was received on 22Mar2021 14:45 (lot number: En6208) on the left arm. Medical history included polycystic ovaries, thyroid and serious food allergies. Concomitant medications included levothyroxine sodium (TIROSINT) taken for an unspecified indication, start and stop date were not reported. Approximately 10 minutes after shot on 22Apr2021 15:00 (2nd dose only) patient was flushed, pulse started racing, and hives appeared all over her chest. Over the next hour hives worsened, heart rate stayed fast, had swelling in tongue and throat, and became dizzy and light headed. Patient's husband wanted to take her to ER, but patient was stupidly resistant. She took a large dose of Benadryl. As the swelling in her airway lessened and the mental fog passed it became more obvious that patient had been having a significant allergic reaction to the vaccine. She was instructed to wait at the pharmacy she received the shot at for only 5 minutes because she had not had an adverse reaction to the 1st dose. She was alone when the reaction began. Patient took a 2nd dose of Benedryl before bed. The next day on 23Apr2021, chest pain began again and patient did go to the ER. The doctor believed symptoms on day 1 were an allergic reaction to vaccine and on day 2 were a strong immune response to the vaccine. They did an EKG and monitored the patient. She reported she was okay at the time of report. Patient received treatment for the events. Outcome was recovered. Patient was not diagnosed with COVID prior to vaccination and had not been tested post-vaccination  Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: chest pain; pulse started racing; dizzy and light headed; significant allergic reaction to the vaccine/Respiratory tract oedema /Flushing/urticaria/swollen tongue/Pharyngeal swelling/Dizziness; mental fog; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 12Apr2021 14:45 (Batch/Lot Number: Er8737) as 2nd dose, single for covid-19 immunisation. The first dose was received on 22Mar2021 14:45 (lot number: En6208) on the left arm. Medical history included polycystic ovaries, thyroid and serious food allergies. Concomitant medications included levothyroxine sodium (TIROSINT) taken for an unspecified indication, start and stop date were not reported. Approximately 10 minutes after shot on 22Apr2021 15:00 (2nd dose only) patient was flushed, pulse started racing, and hives appeared all over her chest. Over the next hour hives worsened, heart rate stayed fast, had swelling in tongue and throat, and became dizzy and light headed. Patient's husband wanted to take her to ER, but patient was stupidly resistant. She took a large dose of Benadryl. As the swelling in her airway lessened and the mental fog passed it became more obvious that patient had been having a significant allergic reaction to the vaccine. She was instructed to wait at the pharmacy she received the shot at for only 5 minutes because she had not had an adverse reaction to the 1st dose. She was alone when the reaction began. Patient took a 2nd dose of Benedryl before bed. The next day on 23Apr2021, chest pain began again and patient did go to the ER. The doctor believed symptoms on day 1 were an allergic reaction to vaccine and on day 2 were a strong immune response to the vaccine. They did an EKG and monitored the patient. She reported she was okay at the time of report. Patient received treatment for the events. Outcome was recovered. Patient was not diagnosed with COVID prior to vaccination and had not been tested post-vaccination  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Headache, Hypertension
Clinical narrative: something sitting on my chest; I had a headache but it got worse and worse; blood pressure was 160/80; This is a spontaneous report from a non-contactable consumer (patient) via information team. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration in Apr2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. About 24 hours after the vaccination, the patient had a headache but it got worse and worse and 28 hours after that the patient's blood pressure was160/80. Over the course, the blood pressure had run high 132/72, 152/75, 135/70. On, 05May2021, the blood pressure came down to 110/62 which is the closest to her consistent 90/60. The patient also reported 'something sitting on chest'. The outcome of the event headache and chest discomfort was unknown. The outcome of the event high blood pressure was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Dizziness, Dysarthria, Pharyngeal swelling
Clinical narrative: delirium; swelling inside of throat; dizziness; slurred speech; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EWO150), via an unspecified route of administration, administered in arm left on 07Apr2021 at 16:00 (at the age of 56-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included myocarditis from COVID, elevated BP and allergies to IV contrast dye for CT scans, all from an unknown date and unknown if ongoing. Concomitant medications included other medications (unspecified). The patient previously took cipro and experienced allergies. For both shots, the patient experienced swelling inside of throat, dizziness, slurred speech and delirium on 07Apr2021 at 16:45. There was no treatment received for the events. The outcome of the events was recovered on an unspecified date.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: After the 1st shot, my right great toe had sudden onset of chronic neuropathy with sensation as if a cord is tied tightly around it and that sensation has not gone away and has stayed constant; This is a spontaneous report from a contactable consumer. A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Apr2021 13:30 (Batch/Lot number was not reported) as 1st dose, single (at the age of 35 years) for covid-19 immunization. The patient's medical history included Lymes disease (prior TBI, Lymes disease at 12 yrs old and treated with amoxicillan and tested negative for Lymes in 2019) and ganglion cysts (since 2018 in hands). Concomitant medications included indomethacin; diphenhydramine hydrochloride (BENADRYL); and fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. The patient previously took hydrocortisone  and had allergies (as an adolescent, had inflammatory response to hydrocortisone topical cream). The patient experienced after the 1st shot, her right great toe had sudden onset of chronic neuropathy with sensation as if a cord is tied tightly around it and that sensation has not gone away and has stayed constant on 01May2021 16:00. Patient was not treated for the event. It was reported that the event was mild and further reported as, after the 1st shot, her right great toe had sudden onset of chronic neuropathy with sensation as if a cord is tied tightly around it and that sensation has not gone away and has stayed constant. Shr never had this condition prior. After the second shot same evening, her left ankle was swollen without pain, which was not a normal condition for her and she did not recall any recent bumps or twists which would have caused it. Patient would seek treatment if conditions worsen and/or after the weekend. The patient diagnosed with COVID-19 prior to vaccination. Patient was tested for COVID-19 since the vaccination. The outcome of the event was not recovered.