chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Weight, Weight increased
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "had breathing issues" (unspecified if ongoing), notes: Dates for had breathing issues: (From: Unspecified To: Unspecified). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: ACUTE RESPIRATORY FAILURE (hospitalization) with onset 25Jan2022, outcome "unknown", described as "acute respiratory failure"; PNEUMONIA (medically significant) with onset 23Dec2021, outcome "recovered with sequelae" (03Jan2022), described as "Pneumonia"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "could not get out of bed"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "stated that she has put on some weight since all of this started happening"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "hands are doing these twitchy things"; NEUROLOGICAL SYMPTOM (non-serious), outcome "unknown", described as "something neurological going on". The patient was hospitalized for acute respiratory failure (start date: 25Jan2022, discharge date: 31Jan2022, hospitalization duration: 6 day(s)). The events "acute respiratory failure" and "pneumonia" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: oxygen saturation: (23Jan2022) low; weight: (unspecified date) put on. Therapeutic measures were taken as a result of pneumonia. On 23Dec2021, patient was started on oxygen. She saw her doctor on 03Jan2022 and was put on antibiotics and steroids due to pneumonia. She went back home and had been off work the entire time. On 25Jan2022 that she went to the ER and was told that she was in respiratory failure. Her health dropped off so much she could not get out of bed and had to have her son come dress her. She does not know if the oxygen will permanent. She was hospitalized for acute respiratory failure and was diagnosed with pneumonia on 23Dec2021 but was not hospitalized and only went to the ER. She had breathing issues that started earlier on from that date. She did not recover from pneumonia and her condition was getting worst so she called her doctor back and asked for some more steroids and antibiotics. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: autoimmune issues; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 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: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune issues". The event "autoimmune issues" was evaluated at the physician office visit. Clinical course: The patient got the first vaccine and was suddenly having all these mysterious like autoimmune issues which resulted to a need to go to the doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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: U
Vaccine: COVID19
Symptoms: Nerve injury, Neuropathy peripheral
Clinical narrative: neuropathy in hands and feet; I have been left with severe nerve damage in torso; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date Apr2021 (Lot number: 53x42-EJ4MB) as dose 1, single and administration date Apr2021 (Lot number: 53x42-EJ4MB) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy in hands and feet"; NERVE INJURY (medically significant), outcome "unknown", described as "I have been left with severe nerve damage in torso". It was stated that the patient had been seriously injured by the Covid 19 vaccine. The patient received 2 doses in April of last year from lot number reported as 53x42-EJ4MB. The patient had been left with severe nerve damage in torso and neuropathy in hands and feet. The patient stated that this was unacceptable and tragic. The patient had spent thousands of dollars trying to get help to no avail.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Insomnia, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: neuropathy type pain; cold sensation; pain and tingling on legs; pain and tingling on legs; unable to sleep; This is a spontaneous report received from a contactable reporter (Physician) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy type pain"; FEELING COLD (non-serious), outcome "unknown", described as "cold sensation"; PARAESTHESIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "pain and tingling on legs"; INSOMNIA (non-serious), outcome "unknown", described as "unable to sleep". The events were evaluated at the physician office visit. Course of events: The patient got a cold sensation neuropathy type thing, pain and tingling on legs and being unable to sleep. Patient has been to 5 doctors about a side effect she had after the vaccine. The patient has been to a neurologist and rheumatologist about the neuropathy in her legs and they both feel it is from the vaccine. It has been 3 months for the patient and she has had lots of tingling and pain in her legs and can't sleep because of it. This all started right after the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dysarthria, Thrombosis, Tinnitus
Clinical narrative: blood clots; there are day where he is slurring; he heard loud popping in his head. it was so loud thought something hit the building; His stomach is tight from top to bottom; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022SA029849.  A 56 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; enoxaparin sodium (LOVENOX [ENOXAPARIN SODIUM]) (Batch/Lot number: unknown) for thrombosis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots"; DYSARTHRIA (non-serious), outcome "unknown", described as "there are day where he is slurring"; TINNITUS (non-serious), outcome "unknown", described as "he heard loud popping in his head. it was so loud thought something hit the building"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "His stomach is tight from top to bottom". The action taken for enoxaparin sodium was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Biopsy, Pruritus, Urticaria
Clinical narrative: Hives; itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Feb2021 (Lot number: EM9810) at the age of 72 years as dose 2, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administration date 04Feb2021 (Batch/Lot number: unknown). Relevant medical history included: "Verbatim: Colitis" (unspecified if ongoing), notes: Diagnosed 15 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EL3249), administration date: 14Jan2021, when the patient was 72 years old, for Covid-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "not recovered", described as "Hives"; PRURITUS (non-serious), outcome "not recovered", described as "itching". The events "hives" and "itching" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Concomitant Products: everything that she has been taking she has been on for years. Caller adds that when she talked to my doctor about it, he told her it wasn't a side effect and asked if she was still itching. Which she states she is still itching, but the Budinsoid helped her colitis. She has big red welts and confirms those are the hives. Nothing has changed. Patient was not administered any Prior Vaccinations    No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood testosterone, Blood testosterone decreased
Clinical narrative: testosterone levels dropped after vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Lot number: ER8736) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/lot number: ER8734, after the first shot, he just thought he was tired), administration date: 06Apr2021, for COVID-19 immunization, reaction(s): "tired". The following information was reported: BLOOD TESTOSTERONE DECREASED (non-serious), outcome "unknown", described as "testosterone levels dropped after vaccines". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: States prior to getting the Pfizer Covid vaccines, he had blood tests done, states his testosterone levels were normal, states after he had the vaccines there was a severe drop in his testosterone levels. States prior to the shots his level was about 650 and after it dropped to 157.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; 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 61 year-old male 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: DIZZINESS (non-serious), outcome "unknown", described as "Dizzy".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "Pulmonary embolism".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: Sore arm; body aches; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Apr2021 15:30 (Lot number: EW0162) at the age of 50 years as dose 2, single and intramuscular, administered in arm left, administration date 27Mar2021 15:30 (Lot number: ER8733) as dose1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE taken for hypertension (ongoing); OLMESARTAN taken for hypertension (ongoing); ALPRAZOLAM taken for anxiety (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Sore arm"; PAIN (non-serious), outcome "unknown", described as "body aches"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  Additional information: The first 2 shots He got from Pfizer, he just had a few side effects, sore arm and body aches, and tiredness, they all went away after a few days. The booster he bet at (pharmacy name), had a much shorter expiration date then first two shots, She didn't know it this means anything or not. He also gave blood from the same arm that he got the booster shot in the same day. All he knew, he had the same reaction , few body aches next day and sore any different was that he had pain in that arms veins since shot, that had not gone away . It was like either his muscles or nerves on veins +arteries hurt. They feel thick mostly in that arm, but also in other arm as well as lees behind knees down calves it was like my nerves, veins, or muscles are enflamed and irritated. He told his doctor, he did nothing that is why he was asking you could this be the side effect from booster. He have had this pain since shot.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation delayed, Oligomenorrhoea, SARS-CoV-2 test
Clinical narrative: delayed menstrual cycle >14 days for two cycles; very heavy bleeding and lasting for >1 week (both cycles); delayed menstrual cycle >14 days for two cycles; very heavy bleeding and lasting for >1 week (both cycles); delayed menstrual cycle >14 days for two cycles; very heavy bleeding and lasting for >1 week (both cycles); This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Dec2021 (Lot number: FJ1620) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, single, Previous dose lot number=EW0158, Previous dose vaccine location=Left arm), administration date: 21May2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, single, Previous dose lot number=EW0158, Previous dose vaccine location=Left arm), administration date: 30Apr2021, when the patient was 43 years old, for COVID-19 immunization.  The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUATION DELAYED (non-serious), OLIGOMENORRHOEA (non-serious) all with onset 19Jan2022, outcome "recovered" and all described as "delayed menstrual cycle >14 days for two cycles; very heavy bleeding and lasting for >1 week (both cycles)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstruation delayed, oligomenorrhoea.  Additional information: No other vaccine were received in four weeks. No other medications were received in two weeks. No covid prior vaccination. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Sep2021 (Lot number: EW8177) as dose 1, single and administration date 03Nov2021 (Lot number: FF8841) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (unspecified if ongoing), notes: medical history of underlying vertigo problem. The patient's concomitant medications were not reported.  The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizziness".  Additional information: The patient who has a medical history of underlying vertigo problem and is calling about the gray and purple cap Pfizer Covid-19 vaccine. She received the first dose on 22SEP2021 (LotEW8177-did not come up in the system per Pfizer  and the second dose on 03NOV2021 (LotFF8841-purple cap formulation. She reported that she had complaints of dizziness after receiving both doses of the Pfizer Covid-19 vaccine but stated that she has "dizzy problems anyway". She asked if the potassium chloride or tromethamine in the Pfizer Covid-19 vaccines causes dizziness. She asked which of the Pfizer Covid-19 vaccines (gray and purple caps) does not have tromethamine and asked if the gray cap Pfizer Covid-19 vaccine is the one with potassium chloride.   No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Alanine aminotransferase, Aspartate aminotransferase, Basophil count, Blood albumin
Clinical narrative: stomach pain; swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Feb2022 (Lot number: FL8094) at the age of 10 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergy" (unspecified if ongoing), notes: Verbatim: Seasonal allergy. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 24Jan2022, when the patient was 10 years old, for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 14Feb2022, outcome "not recovered", described as "stomach pain"; LYMPHADENOPATHY (non-serious) with onset 14Feb2022, outcome "not recovered", described as "swollen lymph nodes". The events "stomach pain" and "swollen lymph nodes" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Follow-Up (22Mar2022): Follow-up attempts are completed. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin, Blood calcium, Blood chloride, Blood creatinine, Blood phosphorus
Clinical narrative: stomach pain; swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Feb2022 (Lot number: FL8094) at the age of 10 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergy" (unspecified if ongoing), notes: Verbatim: Seasonal allergy. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 24Jan2022, when the patient was 10 years old, for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 14Feb2022, outcome "not recovered", described as "stomach pain"; LYMPHADENOPATHY (non-serious) with onset 14Feb2022, outcome "not recovered", described as "swollen lymph nodes". The events "stomach pain" and "swollen lymph nodes" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Follow-Up (22Mar2022): Follow-up attempts are completed. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Blood potassium, Blood sodium, Blood test, Blood urea, C-reactive protein
Clinical narrative: stomach pain; swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Feb2022 (Lot number: FL8094) at the age of 10 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergy" (unspecified if ongoing), notes: Verbatim: Seasonal allergy. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 24Jan2022, when the patient was 10 years old, for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 14Feb2022, outcome "not recovered", described as "stomach pain"; LYMPHADENOPATHY (non-serious) with onset 14Feb2022, outcome "not recovered", described as "swollen lymph nodes". The events "stomach pain" and "swollen lymph nodes" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Follow-Up (22Mar2022): Follow-up attempts are completed. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Haematocrit, Haemoglobin, Investigation, Lymphadenopathy, Lymphocyte count
Clinical narrative: stomach pain; swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Feb2022 (Lot number: FL8094) at the age of 10 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergy" (unspecified if ongoing), notes: Verbatim: Seasonal allergy. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 24Jan2022, when the patient was 10 years old, for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 14Feb2022, outcome "not recovered", described as "stomach pain"; LYMPHADENOPATHY (non-serious) with onset 14Feb2022, outcome "not recovered", described as "swollen lymph nodes". The events "stomach pain" and "swollen lymph nodes" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Follow-Up (22Mar2022): Follow-up attempts are completed. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte count
Clinical narrative: stomach pain; swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Feb2022 (Lot number: FL8094) at the age of 10 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergy" (unspecified if ongoing), notes: Verbatim: Seasonal allergy. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 24Jan2022, when the patient was 10 years old, for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 14Feb2022, outcome "not recovered", described as "stomach pain"; LYMPHADENOPATHY (non-serious) with onset 14Feb2022, outcome "not recovered", described as "swollen lymph nodes". The events "stomach pain" and "swollen lymph nodes" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Follow-Up (22Mar2022): Follow-up attempts are completed. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Nicotine test, Platelet count, Protein total, Red blood cell count, Red cell distribution width increased
Clinical narrative: stomach pain; swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Feb2022 (Lot number: FL8094) at the age of 10 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergy" (unspecified if ongoing), notes: Verbatim: Seasonal allergy. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 24Jan2022, when the patient was 10 years old, for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 14Feb2022, outcome "not recovered", described as "stomach pain"; LYMPHADENOPATHY (non-serious) with onset 14Feb2022, outcome "not recovered", described as "swollen lymph nodes". The events "stomach pain" and "swollen lymph nodes" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Follow-Up (22Mar2022): Follow-up attempts are completed. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan, White blood cell count
Clinical narrative: stomach pain; swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Feb2022 (Lot number: FL8094) at the age of 10 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergy" (unspecified if ongoing), notes: Verbatim: Seasonal allergy. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 24Jan2022, when the patient was 10 years old, for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 14Feb2022, outcome "not recovered", described as "stomach pain"; LYMPHADENOPATHY (non-serious) with onset 14Feb2022, outcome "not recovered", described as "swollen lymph nodes". The events "stomach pain" and "swollen lymph nodes" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Follow-Up (22Mar2022): Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: I have a itching red rash all over; I have a itching red rash all over; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Feb2021 (Lot number: EN6200) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. The patient's concomitant medications were not reported. Past drug history included: Nope just the covid vaccine, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Dose Number: 1, Lot No: EN5318, Location of injection: m Left), administration date: 27Jan2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious), RASH ERYTHEMATOUS (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "I have a itching red rash all over". The event "i have a itching red rash all over" and "i have a itching red rash all over" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pruritus, rash erythematous.  Additional information: Patient had a itching red rash all over that does not go away or heal and have see several doctors and dermatologists, nothing helps and treatment medication included prescription meds, cream and pills. Patient had not received other vaccine in four weeks. Patient had received blood pressure medications in two weeks. Patient had no covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: COVID vaccine made her lose her hair; 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: ALOPECIA (non-serious), outcome "unknown", described as "COVID vaccine made her lose her hair". Therapeutic measures were taken as a result of alopecia.  Additional information: Reporter just spoke with a nurse in this department. She was going in circles here. She gave her information and some phone numbers. This was where she started. She needs help receiving Xeljanz to make her hair grow because the COVID vaccine caused her to lose her hair. She just spoke with (Name withheld). She doesn't want to do another report. She has probably done this a few times now. Anyway, she is trying to get Xeljanz, but they told her she exceeds the financial limit. That was a problem for her. She has been speaking with people since the fall. All they tell her is she makes too much. She will have to buy it out of pocket. She thinks Pfizer should help her pay for this because Pfizer caused this. Reporter doesn't want to do another report. She wants to get over to Xeljanz support. . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; fever; body ache; loss of taste; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2022 16:00 (Batch/Lot number: unknown) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "high blood pressure" (unspecified if ongoing), notes: other medical history: high blood pressure. Concomitant medication(s) included: TRELEGY; SINGULAIR; LISINOPRIL; APPLE CIDER. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 03Sep2021, when the patient was 26 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Vaccine Administration Time: 05:00 PM), administration date: 13Aug2021, when the patient was 26 years old, for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 19Mar2022 12:00, outcome "not recovered", described as "Chills"; PYREXIA (non-serious) with onset 19Mar2022 12:00, outcome "not recovered", described as "fever"; PAIN (non-serious) with onset 19Mar2022 12:00, outcome "not recovered", described as "body ache"; AGEUSIA (non-serious) with onset 19Mar2022 12:00, outcome "not recovered", described as "loss of taste"; HEADACHE (non-serious) with onset 19Mar2022 12:00, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of chills, pyrexia, pain, ageusia, headache.  Additional information: patient did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not had been tested for COVID-19. Patient had known allergies.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feels tired but not bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date 16Mar2022 (Batch/Lot number: unknown) as dose 4, (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose: 1), for COVID-19 Immunization; Moderna (Dose: 2), for COVID-19 Immunization; Moderna (Dose: 3), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 18Mar2022, outcome "unknown", described as "Feels tired but not bad". Therapeutic measures were not taken as a result of fatigue.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2022 15:00 (Batch/Lot number: unknown) at the age of 14 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE., Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 03Jun2021, when the patient was 13 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE., Location of injection: Left Leg , Vaccine Administration Time: 03:00 PM), administration date: 14May2021, when the patient was 13 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 18Mar2022 12:00, outcome "not recovered", described as "Swollen lymph nodes". Therapeutic measures were not taken as a result of lymphadenopathy.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Urticaria
Clinical narrative: Broke out an allergic reaction with hives; Broke out an allergic reaction with hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): A male 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: URTICARIA (non-serious), DRUG HYPERSENSITIVITY (non-serious), outcome "unknown" and all described as "Broke out an allergic reaction with hives". The event "broke out an allergic reaction with hives" and "broke out an allergic reaction with hives" was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria, drug hypersensitivity.  Additional Information: coronavirus Pfizer vaccine received by one of our associates during the normal course of business. Members mother reports withheld is allergic to the Coronavirus Pfizer Vaccine son is broken out into an allergic reaction with hives that is why has gotten Dupixent.  Was aware did not want to speak with Registered Pharmacist.  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: Fever; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s).  A 25 year-old 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: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown", described as "Chills".  Additional information: Event: Fever and chills with first dose similar to when I got the covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): CMOD22-01342 (MODERNA).  A 89-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 1, lot number is unknown, expiration date is not provided, left arm shoulder deltoid muscle as an Intramuscular injection), administration date: 29Dec2020, for COVID-19 immunization, reaction(s): "feeling tired after receiving the first dose"; Moderna covid-19 vaccine (Dose 2, lot number is unknown, expiration date is not known, Intramuscular injection), administration date: 22Jan2021, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of covid-19. The clinical course reports as the reporter reports that her husband also had his Moderna primary shot series and a Pfizer booster dose. The reporter husband tested positive for Covid-19 in either Dec2021 or Jan2022. The reporter husband received his first Moderna Covid-19 vaccine on 29Dec2020 lot number is unknown expiration date is not provided. The patient received his first Moderna Covid-19 vaccine in his left arm shoulder deltoid muscle as an Intramuscular injection. The patient reports feeling tired after receiving the first dose of the Moderna Covid-19 vaccine. Reporter does not remember which arm that he received the Moderna Covid-19 vaccine in. Patient received the vaccine as an Intramuscular injection. The patient had no Adverse Reactions or side effects after the second Moderna Covid-19 vaccine. The patient received his booster dose in his left arm shoulder deltoid muscle. The patient reports no Adverse reactions or side effects to the booster dose. The patient tested positive for Covid-19 in Dec2021 or Jan2022. The patient was given two medications at the hospital for Covid-19. Ibuprofen and Acetaminophen.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Drug ineffective, Suspected COVID-19
Clinical narrative: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2022 18:00 (Lot number: KF9895) at the age of 18 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "PNC" (unspecified if ongoing), notes: known allergies: PNC, Sulfa drugs; "Sulfa drugs" (unspecified if ongoing), notes: known allergies: PNC, Sulfa drugs; "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: PROPRANOLOL; KLONOPIN; EFFEXOR. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Prior to vaccination, was the patient diagnosed with COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: blood test: (19Mar2022) negative. Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity, Pruritus, Rash, Somnolence
Clinical narrative: Right arm pain; Weakness; Sleepiness; Rash and itchiness on thighs; Rash and itchiness on thighs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Lot number: FM0698) 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: PAIN IN EXTREMITY (non-serious) with onset 13Mar2022, outcome "unknown", described as "Right arm pain"; ASTHENIA (non-serious) with onset 13Mar2022, outcome "unknown", described as "Weakness"; SOMNOLENCE (non-serious) with onset 13Mar2022, outcome "unknown", described as "Sleepiness"; RASH (non-serious), PRURITUS (non-serious) all with onset 13Mar2022, outcome "unknown" and all described as "Rash and itchiness on thighs". The events "right arm pain", "weakness", "sleepiness", "rash and itchiness on thighs" and "rash and itchiness on thighs" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of pain in extremity, asthenia, somnolence, rash, pruritus.  Additional information:  The reporter was reported about her vaccination  and did not had Seriousness criteria-Results in death , Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. The patient had Covid (12Y UP) VAC-Gray. The brand name was unknown lot and Administration time=05:15 PM. The patient did not had receive any other vaccines within 4 weeks prior to the COVID vaccine. The reporter Reported Event were Right arm pain, weakness, sleepiness. Rash and itchiness on thighs. The adverse event result in any of the following and Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19 with Paxlovid.  The lot number for bnt162b2 was not provided and will be requested during follow up.