chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain
Clinical narrative: OVERALL ACHING; Leg cramps  for 3 weeks.; This is a spontaneous report from a contactable Non health care professional, the patient. An 82-year-old non pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA vaccine, Lot/Batch no: Illegible, Dose number:2) via unspecified route of administration in the left arm on 23FEB2021 at 14 hrs 15 min as the second dose for Covid-19 immunization. Patient had taken BNT162B2(PFIZER-BIONTECH COVID-19 mRNA vaccine, Lot/Batch no: EL3247, Dose number:1) on the left arm on 02Feb2021 at 14 hrs 15 min as the first dose for covid -19 immunization. Medical history included CABG 2011, hiatal hernia, low iron and allergy to artificial sweeteners. Concomitant medication(s) included Iron and Calcium within 2 weeks of vaccination. The patient previously took Levaquin and experienced allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and neither tested positive since the vaccination. The patient experienced Leg cramps and overall aching on 24Feb2021 and continued for 3 weeks. The patient aching was so bad and she went to primary care office. Therapeutic measures were taken as a result of leg cramps and overall aching and included treatment with Celebrex for 2 weeks with no relief in pain. The patient has still not recovered from leg cramps and overall aching. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable female consumer (Patient) reported that:  A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 08Feb2021, 4 days after the vaccination the patient had tested positive for Covid-19 along with her husband who had scratchy throat and assumed that was from allergies. Patient wanted to know about 2nd shot of vaccination. The outcome of the event was unknown.  No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Pain in extremity
Clinical narrative: sore arm; fatigue; general malaise; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL-3247), via an unspecified route of administration on 15Mar2021 at 14:00 (at the age of 52-year-old), as 2nd dose, single, in left arm for COVID-19 immunization at Workplace Clinic. The patient's medical history included atrial fibrillation. Patient had no known allergies. Concomitant medications received within 2 weeks of vaccination included Famotidine, low dose aspirin, 1000 IU vitamin D. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL-3247), via an unspecified route of administration on 22Feb2021 at 14:45, as single dose in left arm for COVID-19 immunization. On 15Mar2021 at 15:00, the patient experienced sore arm 1 hr after injection to 24 hours; fatigue within 3-4 hours; fatigue and general malaise at 6-24 hours; muscle aches from 6-24 hrs after vaccination. There was no treatment received for the adverse events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Itching; hives; Rash; This is a spontaneous report from a contactable consumer or other non hcp.   A 64-years-old non-pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6207; Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 09Mar2021 13:30 as 1st dose, single for COVID-19 immunization. Medical history included rheumatoid arthritis from 1999 to an unknown date, hypertension from 2001 to an unknown date, blood cholesterol increased from 2002 to an unknown date, sleep apnea syndrome from an unknown date. Concomitant medications included folic acid, methotrexate sodium, tofacitinib citrate, metoprolol tartrate taken for an unspecified indication, start and stop date were not reported. Caller says they have not had any other recent vaccinations or started any new medications. Caller says she hasn't had any vaccinations for a year and the last one was for shingles  a year ago.The patient previously took Vicodin, valtaran, ciprofloxacin, actemra and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Mar2021 16:00, after first dose on Tuesday March 9th, and 2-3 days later she started itching and breaking out in a rash that is not better and is still spreading. She says that everything she can find on the internet says that the rash is mostly from Moderna. She says that she would like to know if others have reported having issues with this, or if this is something she should be worried about. Caller says that the itching started a little at first, and then the rash took off by Friday. She says it was mostly around her neck, but the last couple days it has gone down onto her torso and her arms. She says she has been treating it with Benadryl and Hydrocortisone cream. She says she is going to her doctor tomorrow to see if she can get some sort of shot or something. She says that the hydrocortisone cream is Ultra Moisturizing Hydrocortisone Cream with EXP Oct 2022 and LOT 0LT0491. She says that there is a barcode on the tube but there are no numbers on it below there. She says that she threw away the outer package. She says that she used it twice yesterday and once today, she really only uses it when it starts to itch really bad. She says when she called her doctor Sunday he said to take two Benadryl 25mg tabs, so take 50mg every 6 hours by mouth  Therapeutic measures were taken with steroid pack. The clinical outcome of the events was recovering.     Information on Lot/Batch number was available. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Enlargement of lymph node; This is a spontaneous report received from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 16:00 (age at vaccination 37-years-old) as a single first dose for COVID-19 immunisation.  Medical history and Concomitant medications were not reported. Allergies to medications, food, or other products reported as None. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 15Mar2021 at 12:00, the patient experienced enlargement of lymph node, one pea-sized swollen lymph node appeared on left clavicle (same arm where shot was given) and another nodule appeared on 16Mar2021.The patient did not receive any treatment for the event. The clinical outcome of the enlargement of lymph node was recovering. No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Fatigue, Throat tightness, Vertigo
Clinical narrative: Diarrhea; Throat constriction; Worsened breathing; Fatigue; Vertigo/Head spinning; This is a spontaneous report from a contactable consumer. A 19-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 16Mar2021 at 14:30 as 1ST DOSE, SINGLE for COVID-19 immunization. The patient was sometimes allergic for some types of fruit (edema of mouth, pustules in mouth). The patient did not receive any other vaccine in four weeks. The patient's medical history included phenylketonuria, thyroid gland disease, Crohn's disease. The patient's concomitant medication included zirtec, magnesium, acylpirin. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. On the same day of COVID vaccination with in one minute, the patient felt throat constriction, worsened breathing, feeling of vertigo. The patient administered double dose of antiallergic drug Zyrtec and the symptoms re-solved. Only fatigue and mild vertigo were persisted. The next day after vaccination, the patient experienced diarrhea, and persisted till the day of reporting, and only mild form. The patient felt head spinning was still present. The patient received home treatment and patient was ready for possible adverse events, therefore the medication was available immediately. The outcome of the event diarrhea was not recovered and rest all other events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Red Hives; Swelling of arms and legs; Itching; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Mar2021 14:15 (Batch/Lot Number: 8733; Expiration Date: unknown) as 1ST DOSE, SINGLE for covid-19 immunisation administered in Hospital. The medical history included blood disorder, Penicillin, sulfa and gluten allergies. Concomitant medications included warfarin sodium (COUMADIN), escitalopram oxalate (LEXAPRO), levothyroxine sodium (SYNTHROID) and trazodone were received within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had known allergies to Penicillin and sulfa gluten. The patient reported, red hives, swelling of arms and legs and itching on 27Mar2021. He had two Benadryl as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Rhinitis allergic
Clinical narrative: He asked if he could take Flonase or OTC nasal spray for his allergy; This is a spontaneous report was received from Pfizer sponsored program. A contactable male consumer (patient) reported for himself that: A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/ Lot number and expiry date were not reported) via an unspecified route of administration on 01Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had previously received first dose of vaccine on 05Feb2021. In Mar2021, patient had nasal allergy and asked if he could take fluticasone propionate (FLONASE) or OTC nasal spray for his allergy. The outcome of event was unknown.  Information about batch/lot number has been requested.  Follow-up attempts completed. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: I was exposed to a person that tested positive for Covid 19 on March 17th.  I had my second vaccination on March 19th. I tested positive for Covid19 using a rapid test on March 27th.; I was exposed to a person that tested positive for Covid 19 on March 17th.  I had my second vaccination on March 19th. I tested positive for Covid19 using a rapid test on March 27th.; I was exposed to a person that tested positive for Covid 19 on March 17th.  I had my second vaccination on March 19th. I tested positive for Covid19 using a rapid test on March 27th.; This is a spontaneous report from contactable consumer female (patient) reported for herself. A 59-years-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: E11283 or EI13S3 or E112S3, Expiration date: 01Apr2021), via an unspecified route of administration in left arm on 2Feb2021 08:45 AM at first dose, single for covid-19 immunisation. patient received second dose of bnt162b2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on 19March2021 at second dose, single for covid-19 immunisation. Patient had allergies to medications, food, or other products include Shrimp and Crab. Patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient received any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered at Hospital. Patient was exposed to a person that tested positive for Covid 19 on March 17th. she had second vaccination on March 19th. she tested positive for Covid19 using a rapid test on March 27th and event start date on 28Mar2021. Patient did not receive any treatment for the adverse event. patient underwent lab tests and procedures which included Nasal swab sars-cov-2 test: positive on 28March2021. The outcome of event was unknown.  No follow-up attempts are needed:  information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia, Pharyngeal swelling, Swelling face, Swollen tongue
Clinical narrative: Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; This is a spontaneous report received from a contactable female consumer (patient). A 50-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN6207, Expiration date was not reported), via an unspecified route of administration on 27Mar2021 09:00 first dose single for covid-19 immunisation. Medical history included fatty liver, diverticulitis, migraine and cigarette smoke. The patient concomitant medications were not reported. The patient previously took sulfonamide (Sulfa / FQ drugs) allergy to sulphonaminde and histamine allergy to histamine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination of antioxidant Green Tea and Liver Cleanse Tea and Vitamin C. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient experienced Tingling and Swelling of lower face, lips, tongue, throat on 28Mar2021 02:30 AM. Patient visited the emergency room. As per the reporter seriousness criteria for the events swelling of lower face, lips, tongue, throat was medically significant. Patient received treatment of Benadryl-self-administered prior to ER. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021430745 similar report from same reporter
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Occupational exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: Came in contact with someone with covid on Saturday and now caller has covid; Came in contact with someone with covid on Saturday and now caller has covid; Came in contact with someone with covid on Saturday and now caller has covid; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced came in contact with someone with covid on saturday and now caller has covid on Mar2021. Reporter stated that received first covid vaccine 2 weeks ago and came in contact with someone with covid on Saturday and now caller has covid. Caller would like to know if he can still get the second covid vaccine or will he have to start completely over. Transferred due to getting covid after getting the first covid vaccine. Due to their being a few callers ahead asked to see if the caller would mind waiting in the waiting que and the next available medical professional would be happy to answer your question. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in Mar2021. The seriousness of the events drug ineffective, COVID-19 was reported as serious (medically significant). The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Back disorder, Herpes zoster
Clinical narrative: he was scheduled to have a back surgery a week before the 2nd dose and had surgery; shingles; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient stated, "I received the first dose of the Pfizer vaccine on 16Feb2021 and the second dose was due on 09Mar2021. One week before my second dose I had my surgery and the following week I got shingles. I have fully recovered from the shingles. When can I receive my second dose?" The patient was supposed to get the 2nd dose on 09Mar2021, however, he was scheduled to have a back surgery a week before the 2nd dose; thus, he wasn't able to get it. Then he returned to the facility on 16Mar2021, but they did not allow him to be vaccinated because he contracted shingles and was advised to delay the 2nd dose. Now, the patient wants to know how long he should wait to get his 2nd dose. The outcome of shingles was recovered on unspecified date and unknown outcome for the other event.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: My eyes started to get swelled up; This is a spontaneous report from a contactable other HCP (patient). A 34-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN6199, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 11Mar2021 16:15 as first dose single for covid-19 immunisation. Medical history included anaemia, high cholesterol (Under control) and Known allergies: aspirin. Concomitant medications included ascorbic acid (VITAMIN-C) and cholecalciferol (CALCIFEROL) both are taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccine in four weeks. On 11th March 2021 (The day patient received vaccine first dose) around 7:15pm, patient eyes started to get swelled up. Patient took Benadryl. Swelling decreased during the night. Then, in the morning, patient woke up with her eyes swollen again. patient took Benadryl once more. Around noon, swelling dismissed. As per the reporter seriousness criteria for the event reported as medically significant. The outcome of the event was recovered on an unspecified date in Mar2021.   Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: As there is limited information in the case provided, the causal association between the event eye swelling and the suspect drug BNT162B2 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 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.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a Spontaneous report based on the information received by Pfizer from AbbVie (Manufacturer Control No: 20K-163-3609696-00) from a contactable consumer. This consumer reported events with both dose of vaccine. This case refers to first dose. A 72-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 21Jan2021 (Batch/Lot Number: EL8982) as single dose for covid-19 immunisation.  Medical history included cataract from 2011 to 2020 , upper limb fracture from 03Jan2011 to 16Feb2011 , upper limb fracture from 03Jan2011 to 16Feb2011 , cardiac failure congestive from 2017 and ongoing , pneumonia from 2017 to 2017 , ongoing constipation , coeliac disease from 2008 to an unknown date , lumbar spinal stenosis from 2017 to an unknown date , weight increased from 2020 to an unknown date , joint range of motion decreased from an unknown date and unknown if ongoing, crohn's disease. Concomitant medication(s) included adalimumab (HUMIRA), subcutaneous from 2006 (Batch/Lot Number: 1132579) and ongoing, at 40 mg, weekly (Humira 40 mg/0.4 ml/40 mg,1 in 1 wk), subcutaneous from an unspecified date (Batch/Lot Number: 1135601) to an unspecified date, at unspecified dose, subcutaneous from an unspecified date (Batch/Lot Number: 1137002) to an unspecified date, at unspecified dose for crohn's disease, amlodipine (AMLODIPINE) taken for blood pressure abnormal, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for blood cholesterol increased, start and stop date were not reported; calcium (CALCIUM) taken for osteoporosis, start and stop date were not reported; carvedilol (CARVEDILOL) taken for cardiac failure congestive, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for depression, start and stop date were not reported; hydrocortisone (HYDROCORTISONE) taken for adrenal insufficiency, start and stop date were not reported; furosemide (LASIX [FUROSEMIDE]) taken for cardiac failure congestive, start and stop date were not reported; lisinopril (LISINOPRIL) taken for blood pressure abnormal, start and stop date were not reported; mirtazapine (MIRTAZAPINE) taken for depression, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for gastrooesophageal reflux disease, start and stop date were not reported; tramadol (TRAMADOL) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for vitamin d deficiency, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for depression, start and stop date were not reported.  The patient experienced arm soreness on 21Jan2021 with outcome of recovered on 23Jan2021.    No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021287078 same patient/ vaccine, different dose/ AE
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Herpes zoster, Hypoaesthesia, Paraesthesia
Clinical narrative: shingles; Rash; pain/pain in the right quadrant of her chest; Numbness and tingling; Numbness and tingling; Skin very sensitive; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 64-years-old via an unspecified route of administration, administered in arm left on 13Mar2021 10:00 (Batch/Lot Number: EN6200) as 1st dose, single. Medical history included ongoing Grave's disease and ongoing hypothyroid (about 4 years ago, still have it), was under a lot of stress and immune system was way way down in 2012. Concomitant medication included levothyroxine taken for thyroid from an unspecified start date and ongoing. The patient previously received a flu shot in 2012 and experienced flu symptoms. The patient received pneumonia shot and flu shot on an unspecified date (reported as in the fall). The patient reported she had the first dose of the vaccine on 13Mar2021 and came down with pain on the 23Mar2021; she started to experience a lot of pain. She had pain in the right quadrant of her chest. It was like a stabbing pain with a lot of tenderness and numbness to the touch of her skin. It was very sensitive. The skin was very sensitive on 23Mar2021. It may be an odd coincidence, she doesn't know.  One is closely associated with the other.  She went into the doctor and got a Cortisone shot. She got the Cortisone shot because there was no breakout at the time. She had done some yardwork on Monday and thought it may be just a pulled muscle. On Saturday (27Mar2021) she noticed the rash, it broke out and she had about 6 spots on her back. Sunday she had a couple small ones underneath her right breast. On Monday, 29Mar2021, she went back into the doctor and found out that she had Shingles; she was diagnosed with shingles and is on an antiviral medication, Valacyclovir. The actual infective site on her back has gone down some. The patient also experienced numbing and tingling on 23Mar2021. The tingling is not to the amount it was. The patient underwent lab tests and procedures which included blood test: fine on an unspecified date. Therapeutic measures were taken as a result of pain/ pain in the right quadrant of her chest which included cortisone shot, Gabapentin 100mg (can take up to 3 before bedtime, but actually she has just been taking Ibuprofen) and for shingles, valacyclovir. The outcome of rash was unknown, the patient did not recover from shingles and was recovering from the other events. The next dose of the vaccine is due Saturday. Her dosage for the antiviral doesn't expire until Sunday. She asks if she should get the next course of the vaccine or delay.  No Follow-up attempts completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin sensitisation
Clinical narrative: shingles; Rash; pain/pain in the right quadrant of her chest; Numbness and tingling; Numbness and tingling; Skin very sensitive; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 64-years-old via an unspecified route of administration, administered in arm left on 13Mar2021 10:00 (Batch/Lot Number: EN6200) as 1st dose, single. Medical history included ongoing Grave's disease and ongoing hypothyroid (about 4 years ago, still have it), was under a lot of stress and immune system was way way down in 2012. Concomitant medication included levothyroxine taken for thyroid from an unspecified start date and ongoing. The patient previously received a flu shot in 2012 and experienced flu symptoms. The patient received pneumonia shot and flu shot on an unspecified date (reported as in the fall). The patient reported she had the first dose of the vaccine on 13Mar2021 and came down with pain on the 23Mar2021; she started to experience a lot of pain. She had pain in the right quadrant of her chest. It was like a stabbing pain with a lot of tenderness and numbness to the touch of her skin. It was very sensitive. The skin was very sensitive on 23Mar2021. It may be an odd coincidence, she doesn't know.  One is closely associated with the other.  She went into the doctor and got a Cortisone shot. She got the Cortisone shot because there was no breakout at the time. She had done some yardwork on Monday and thought it may be just a pulled muscle. On Saturday (27Mar2021) she noticed the rash, it broke out and she had about 6 spots on her back. Sunday she had a couple small ones underneath her right breast. On Monday, 29Mar2021, she went back into the doctor and found out that she had Shingles; she was diagnosed with shingles and is on an antiviral medication, Valacyclovir. The actual infective site on her back has gone down some. The patient also experienced numbing and tingling on 23Mar2021. The tingling is not to the amount it was. The patient underwent lab tests and procedures which included blood test: fine on an unspecified date. Therapeutic measures were taken as a result of pain/ pain in the right quadrant of her chest which included cortisone shot, Gabapentin 100mg (can take up to 3 before bedtime, but actually she has just been taking Ibuprofen) and for shingles, valacyclovir. The outcome of rash was unknown, the patient did not recover from shingles and was recovering from the other events. The next dose of the vaccine is due Saturday. Her dosage for the antiviral doesn't expire until Sunday. She asks if she should get the next course of the vaccine or delay.  No Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Five days later I got Covid, confirmed by test; Five days later I got Covid, confirmed by test; This is a spontaneous report received from contactable consumer via Pfizer sponsored program. An unspecified aged male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 12Mar2021 at 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Patient took the first dose of the Pfizer COVID vaccine on 12Mar2021. Five days later he got COVID, confirmed by test. He was symptomatic for 7 days. His next dose is scheduled for 02Apr2021. Should he postpone it and for how long. The outcome of events was unknown.  Lot/Batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 34-years-old male consumer received first dose of bnt162b2 (BNT162B2, solution for injection) (Batch/Lot number - EP7534; Expiration date: Unknown) via unspecified route of administration in left arm on 22Mar2021 at 08:15 AM (at the age of 34-year-old) as SINGLE DOSE for COVID-19 immunization. The medical history of the patient was not reported. The concomitant medication included Nasacort, Equate Allergy Relief (generic to Zyrtec). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Nasacort, Equate Allergy Relief (generic to Zyrtec) within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, Prior to vaccination. Patient has been tested for COVID-19, Since the vaccination. On 28Mar2021, patient experienced cold like symptoms, cough, fever chills. On 29Mar2021, patient had positive nasal swab test. Patient did not receive any treatment for the adverse event. Patient received positive COVID-19 test on 31Mar2021. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Herpes zoster
Clinical narrative: shingles; body is shutting down; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunisation and has had hives ever since. They have put her on steroids and that didn't help. They told her she had shingles, but the patient's parents don't believe it was shingles. She has had hives since she got the first shot and then they give her the second shot and that is when they thought it was shingles. The reported also stated, "the doctors don't know how to help her. They keep passing her off. No one is helping her. Her body is shutting down. She is not anaphylactic but can it turn anaphylactic. I need to know what Pfizer wants us to treat her with. You have to know how to treat your side effects. No one cares. I can't get her into the allergist office. All you care about is distributing these vaccines but you don't care anything about what is happening to the people taking them". The outcome of the events was unknown.   No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: a lump came out close to my neck, lymph node type; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EP6955, Expiration date was not reported), via an unspecified route of administration, in left arm on 09Mar2021 10:15 (age at the vaccination 41-years) as first dose single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included potassium citrate taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccine in four weeks. Patient received within 2 weeks of vaccination: Anticoncep, bifllex, wate way. It was reported that 10 days after first dose, a lump came out close to my neck, lymph node type on 19Mar2021 03:00 PM. Patient did not receive treatment for the event. The outcome of the event was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Broke out all over with rash started with underarms then moved/broke out in a mid rash but it was head to toe; Itching; Arm soreness; Fatigue; Mild fever; Achiness; This is a spontaneous report received from a contactable consumer reported for herself. A 56-year-old female patient (non-pregnant) received first dose bnt162b2 (Bnt162b2, Solution for injection, Lot number: EN6207, Expiration date was not reported) via unspecified route of administration in left arm on 18Mar2021 at 3:45 PM at first dose single for covid-19 immunisation. The patient relevant medical history included Hashimoto thyroid disorder. The patient has allergy to amoxicillin or benzonatate and broke out with hives while taking both. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines 4 weeks prior to administration of COVID vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID), spironolactone, calcium and ergocalciferol (VIT D) and Krill. Since the vaccination, the patient has not been tested for COVID-19. On 19Mar2021, the very next day after vaccination, the patient experienced fatigue, mild fever, arm soreness, achiness and then the next day was fine. Then a week later on 25Mar2021 13:15 she broke out in a mild rash, she literally started breaking out on the inside of her arms, it went from head to toe and moved all over body. The itchiness lasted for 4 days but was better each day. She said the rash/itchiness is similar when she had an allergic reaction to amoxicillin. The patient was confused about taking the second dose of vaccination due to reaction after first dose. She spoke to her doctor about it, and he suggested not to take the second dose of the vaccine but her son's pediatrician suggested to contact Pfizer for the same. The events rash all over and itchiness were considered as medically significant. Patient received the treatment of Claritin for the adverse events of Itching and rash all over. The outcome of the events fatigue, mild fever, arm soreness and achiness were recovered on 20Mar2021, Itching was recovered on 29Mar2021 and rash all over was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out all over with rash started with underarms then moved/broke out in a mid rash but it was head to toe; Itching; Arm soreness; Fatigue; Mild fever; Achiness; This is a spontaneous report received from a contactable consumer reported for herself. A 56-year-old female patient (non-pregnant) received first dose bnt162b2 (Bnt162b2, Solution for injection, Lot number: EN6207, Expiration date was not reported) via unspecified route of administration in left arm on 18Mar2021 at 3:45 PM at first dose single for covid-19 immunisation. The patient relevant medical history included Hashimoto thyroid disorder. The patient has allergy to amoxicillin or benzonatate and broke out with hives while taking both. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines 4 weeks prior to administration of COVID vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID), spironolactone, calcium and ergocalciferol (VIT D) and Krill. Since the vaccination, the patient has not been tested for COVID-19. On 19Mar2021, the very next day after vaccination, the patient experienced fatigue, mild fever, arm soreness, achiness and then the next day was fine. Then a week later on 25Mar2021 13:15 she broke out in a mild rash, she literally started breaking out on the inside of her arms, it went from head to toe and moved all over body. The itchiness lasted for 4 days but was better each day. She said the rash/itchiness is similar when she had an allergic reaction to amoxicillin. The patient was confused about taking the second dose of vaccination due to reaction after first dose. She spoke to her doctor about it, and he suggested not to take the second dose of the vaccine but her son's pediatrician suggested to contact Pfizer for the same. The events rash all over and itchiness were considered as medically significant. Patient received the treatment of Claritin for the adverse events of Itching and rash all over. The outcome of the events fatigue, mild fever, arm soreness and achiness were recovered on 20Mar2021, Itching was recovered on 29Mar2021 and rash all over was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vomiting
Clinical narrative: throwing up; legs went limp; This is a spontaneous report from a contactable consumer (patient) via Pfizer Oncology Together. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient was in the hospital for 4 days from Covid vaccine and was in rehab. Was throwing up, legs went limp, and had a bad reaction. Stretching her last bottle of Inlyta to hold her over until approval and another bottle arrives. The outcome of events was unknown.   Information about lot/batch number had been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for the Covid-19; tested positive for the Covid-19; This is a spontaneous report from a Pfizer-Sponsored program, . A contactable consumer (patient's wife) reported that 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, via an unspecified route of administration on 13Mar2021 (Batch/Lot number not reported) (at the age of 64-year-old) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient tested positive for the Covid-19 virus and he now in the hospital. The patient's second dose would be on Saturday, 03Apr2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: Shingles; sore arm; This is a spontaneous report from a contactable consumer (patient's daughter). An 88-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (at the age of 88-years-old), administered in Arm Left on 16Mar2021 11:45 (Lot Number: EN6208) as 1st dose, single for COVID-19 immunisation. Medical history included ongoing hypertension about 20 years ago, ongoing arthritis about 20 years, ongoing hypercholesterolaemia about 20 years, pneumonia. Unspecified concomitant medications were taken ("he has been taking the same medications for many years and doesn't find his medications relevant. He isn't taking any new supplements or anything like that"). The patient previously has had the pneumonia vaccine and the flu vaccine with no problems. The patient experienced sore arm on 16Mar2021 and shingles on 02Apr2021. The patient received his first Pfizer Covid 19 vaccine on 16Mar2021. The patient had a sore arm beginning the evening of 16Mar2021 after he received his Covid 19 vaccine. Patient's daughter had asked the patient when his arm wasn't sore anymore and he said 2-3 days after the COVID 19 vaccine. The shingles started on Friday, 02Apr2021 (2.5 weeks after the vaccine) and is showing a sciatic distribution. Caller reports the shingles is worsening. He's getting new patches in his lumbar region, left buttock, left back and upper thigh. He was diagnosed with Shingles on 04Apr2021 by his primary care doctor. He has been prescribed Valtrex today for 7 days (1 gram three times daily) which will put him finishing the Valtrex on 11Apr2021. He has not started taking it. Her father's second Covid 19 vaccine is scheduled for 13Apr2021. She is asking if it's ok that her father take the Valtrex and should he push back getting his second Covid 19 vaccine a week or so. The events did not require a visit to the emergency room or physician office. Therapeutic measures were taken as a result of shingles. The outcome of the event sore arm was recovered on an unspecified date in Mar2021 while for shingles was not recovered. The events were considered as non-serious. No prior vaccinations within 4 weeks, no adverse events following prior vaccinations.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Magnetic resonance imaging, Pain in extremity, Pyrexia, Rotator cuff syndrome
Clinical narrative: torn rotator cuff; can't raise her arm or hold it straight out/she can't raise on own; it really hurts; mild fever; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Apr2021 08:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. There were no medical history and concomitant medications. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 (batch/lot: ER8733 also reported as "EN6204") in the left arm for COVID-19 immunisation and experienced arm soreness. The patient received second dose of the Pfizer BioNTech Covid 19 vaccine yesterday (05Apr2021) at 8AM. At 10:30 PM, torn rotator cuff in the arm, and no problems with it since the diagnosis. She only received an injection and some exercises for it. This morning, she can't raise her arm or hold it straight out, she has a mild fever on 05Apr2021. The patient wanted to know if there has been reports of having flare ups of a rotator cuff with receiving the vaccine. She can't move arm up to raise it above her head, has to have other arm help her raise it up, she can't raise on own; it really hurts - the left arm which was reported as worsened. She is not concerned about her temperature; she figures a lot of people run a temperature. She has a torn rotator cuff on her left arm that it was given in and she didn't think about it. Now she can't move her arm up to raise it above her head, she has to have the other arm help her raise it up. The patient stated that she is sure it is from the shot. She is concerned and wanted to know if this is going to subside. She tore the rotator cuff, had an MRI, got a shot and had physical therapy and she never had anymore trouble with it, so she didn't do anything about it. Her arm is killing her, and she can't raise her arm. The patient stated that it is hard to get up and it is hard working with one arm.  The patient clarified that this is after her second vaccine. Her arm was sore after the shot but the pain and couldn't raise it really kicked in around 10:30 P.M. She has a call into her primary care to see if anything needs to be done. They are thinking this will subside over a couple of days, but it is a little scary to not be able to raise her arm, that is why she is wanting to find out everything she could. She took Tylenol because the doctor's office said she could and wanted to know if that is correct that she could have Tylenol. The outcome of the event pain in arm was not recovered while the other events was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Fatigue
Clinical narrative: FATIGUE; Pain in hip; This is a spontaneous report reported from a contactable female reporter based on information received by Pfizer from Abbvie (manufacturer control number: 21K-163-3831799-00).  A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose, dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg for hidradenitis. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced fatigue and pain in hip on an unspecified date with outcome of not recovered.  The action taken in response to the event(s) for bnt162b2 was not applicable , for adalimumab was dose increased.  No follow-up attempts are needed. No further information is expected.