chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel dizzy; Difficult to swallow; swollen throat; Rapid heart rate; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 06Apr2021 at 13:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, penicillin allergy, fruit allergy (kiwi and watermelon), drug allergy (sulfate antibiotics) and allergy to nuts (pistachios). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and mometasone furoate (FLONASE) and multivitamin (MANUFACTURER UNKNOWN) taken for unknown indication from unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other medications in four weeks of COVID vaccine. On 06Apr2021 at 13:30, within 15 minutes the patient started to feel dizzy, difficult to swallow, swollen throat and rapid heart rate (tachycardia). The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures taken included allegra for the reported adverse events. The clinical outcome of the events difficult to swallow, swollen throat, rapid heart rate and feel dizzy were resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Event verbatim typo error was correctly changed from Difficult to sallow' and was updated to Difficult to swallow'.
Patient described a metallic taste within a minute after administering the vaccines. Shingrix was given first followed by Pfizer Bivalent. 2:24pm Then he said he was getting very sweaty.  We applied ice packs to his neck and wrists immediately. 2:32pm BP check 164/101 pulse 85, 2:36pm BP check 177/107 pulse 82, 2:38pm taste resolved, 2:41 BP check 158/98 pulse 83. He did not have a headache, nausea, nor dizziness. He described it as a flushing type feeling. He stood up and was fine to walk - no dizziness. Checked in with pt at 7:15pm - he stated he was feeling fine after he got home.
The COVID19 booster shot was given approximately 3 months too early. The dose was 0.3mL.
Intradermal injection; Dose repeated; 1'' from original administration site; Dose repeated; 1'' from original administration site; Case reference number US-BN-2022-003337 is a spontaneous case initially received on 14-Sep-2022 from health care professional via Communication (reference number: USBAV22-1395) and concerns a 24-year-old male patient.  The patient's relevant medical history and concomitant medications were not not provided.  On 06-Sep-2022, the patient was vaccinated with a first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number FDP00005), at an unknown dose, intradermally (explicitly coded as 'intradermal injection'), in left arm, for an unknown indication.   As reported, no wheal formed with initial administration and the dose was repeated with the same lot 1 inch from original administration site (explicitly coded as 'Inappropriate schedule of vaccine administered' and 'Lack of administration site rotation').   At the time of this report, it was unknown if patient experienced any adverse event.  No further information received.  Additional information received on 15-Sep-2022 included local case ID.  Additional information received on 19-Sep-2022 included report of this case.; Reporter's Comments: A 24-year-old male patient was vaccinated with first dose of Jynneos vaccine intradermally. As reported, that initial attempt did not result in a wheel and the dose was repeted with the same lot 1 inch from original administration site (explicitly coded as 'Inappropriate schedule of vaccine administered' and 'Lack of administration site rotation'). No associated adverse events have been reported. Intradermal injection, lack of administration site rotation and inappropriate schedule of vaccine administered are not related to Jynneos, but to a human factor.; Sender's Comments: A 24-year-old male patient was vaccinated with first dose of Jynneos vaccine intradermally. As reported, that initial attempt did not result in a wheel and the dose was repeted with the same lot 1 inch from original administration site (explicitly coded as 'Inappropriate schedule of vaccine administered' and 'Lack of administration site rotation'). No associated adverse events have been reported. Intradermal injection, lack of administration site rotation and inappropriate schedule of vaccine administered are not related to Jynneos, but to a human factor.
No adverse event reported.  Mis-matched vaccine was given.   Dose#1-5/22/21-Pfizer-ER8736-Right Deltoid Dose#2-6/22/21-Moderna-041C21A-Left Deltoid  Patient was notified of the mis-matched dose and informed that no additional doses would be needed.  Patient having no symptoms and told to be seen by a medical professional if symptoms develop.   Patient agreed.    Documentation placed into the local reporting database.
Her  side effects as of yesterday are flu like symptoms, fever of 101; lots of body aches; flu like symptoms; This is a spontaneous report from a Pfizer-sponsored program Support. A non-contactable consumer reported that a female patient of an unspecified age received BNT162B2 (BNT162B2, solution for injection, (Batch/Lot number and expiration date: was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (BNT162B2, solution for injection, (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date the patient experienced her side effects as of yesterday are flu like symptoms, fever of 101, lots of body aches and flu like symptoms. The patient underwent lab tests and procedures which included body temperature: 101. Events were reported as non- serious. The event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Developed low grade fever (99.3F), fatigue, aches, headache around 6pm on 01/13/2020.  Treated with OTC Aleve. All resolved within 12 hours except the fatigue. Also noticed painful axillary lymph node swelling on 01/13/2020 upon waking at 6:30am. Treating with OTC Aleve.
felt like he had the flu; felt sick; Headache; fever; Aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like he had the flu), ILLNESS (felt sick), HEADACHE (Headache), PYREXIA (fever) and MYALGIA (Aches) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medication history was reported by the provider.  Concomitant products included CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE (CORICIDIN HBP COUGH & COLD), PARACETAMOL (TYLENOL) and NAPROXEN SODIUM (ALEVE) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like he had the flu), ILLNESS (felt sick), HEADACHE (Headache), PYREXIA (fever) and MYALGIA (Aches). On 13-Feb-2021, INFLUENZA LIKE ILLNESS (felt like he had the flu), ILLNESS (felt sick), PYREXIA (fever) and MYALGIA (Aches) had resolved. At the time of the report, HEADACHE (Headache) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment medications were reported.   This case was linked to MOD-2021-232713 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Added demographic details- age, gender and Date of birth
Patient reports about 4 hours after the shot he had stomach cramping and diarrhea.  He reports at about 12 hours after the shot, he developed a fever to 101.5, body aches, chills, headaches, no dizziness or difficulty breathing.  He reports the cramps worsened.  He reports the diarrhea has been present for about 48 hours with loose stools 2-3 times an hour and the cramps have been present the whole time.  No fevers this morning.  He reports the cramps and the diarrhea is finally starting to improve - He has not been eating due to the diarrhea
This spontaneous report was received from a pharmacist and refers to a 66 year old female patient. The patient's concurrent conditions included diabetes and blood pressure high. The patient had no drug reactions nor allergies. On 10-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX injection, lot # M035693 with expiration date on 07-NOV-2017 (dose and route of administration were not reported). Concomitant therapies included sitagliptin phosphate (JANUVIA), glipizide (reported as glypizide) and metformin. On an unknown date in MAY 2017,, the patient experienced redness, a lump itchiness and bruising at the injection site. The patient sought medical attention by calling the pharmacy, however she did not receive any treatment for the events. No laboratory test diagnostic was performed. The outcome of the events was not reported. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
She started having delusions and hallucinations, body tremors like epileptic seizure, she was falling down and using the bathroom on herself, her walk was a shuffled gate, she didn't remember almost 3 months in hospital, coma for 5 days and had a mini stroke. Her psych doctor thought maybe the vaccine could have triggered this type of reaction. She gained consciousness and was sent to a rehab nursing home where she's learning to walk to feed herself and getting stronger now that she's home. There's a long road to recovery.
COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot; COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot; COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot; COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot; COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot), VACCINATION SITE ERYTHEMA (COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot), VACCINATION SITE PRURITUS (COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot), VACCINATION SITE PAIN (COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot) and VACCINATION SITE WARMTH (COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot), VACCINATION SITE ERYTHEMA (COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot), VACCINATION SITE PRURITUS (COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot), VACCINATION SITE PAIN (COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot) and VACCINATION SITE WARMTH (COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot). At the time of the report, VACCINATION SITE REACTION (COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot), VACCINATION SITE ERYTHEMA (COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot), VACCINATION SITE PRURITUS (COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot), VACCINATION SITE PAIN (COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot) and VACCINATION SITE WARMTH (COVID arm: the entire top area of her arm down to her elbow was red, itchy, sore and hot) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   This case was linked to MOD-2021-076607 (E2B Linked Report).; Sender's Comments:  MOD-2021-076607:Second dose case
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: COVID 19 Treatment (Paxlovid). Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Treatment start date: 09Dec2022, treatment stop date: 13Dec2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt was admitted on 08/18/2021 Hypotension r/t dehydration and had diffuse body pain, one week of diarreah and fatigue. Pt received Ive fluids. No need for O2 or steroids.
Patient was administered Tdap vaccine in (L) deltoid with no complication. Then given HPV #1 into Rt. deltoid, pt. let out a cry due to burning sensation when administered. She immediately tilted to left side of table and fell off exam table. I was at right side, mom was sitting across room. Patient passed out about 10-15 secs. became pale.
Patient received Fluad on 10/11/2023 and accidentally received again today (11/7/2023)
C/O inflammation and swelling up to 2 cm at site of injection(R deltoid) with pain in arm with movement. Area warm to touch. These signs presented upon waking up morning after the injection. Parent using ice pack, Ibuprofen, and Benadryl as treatment. Mother reported signs 8-2-18 at 1400.  Mother called again 8-3-18 at 1400 to report arm no longer painful, but inflammation site increased to 3 cm, warm to touch. Denies nausea, syncopal episode, limited mobility/ROM of R arm. Child performing normal ADL.
itchy at the injection site; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A child 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: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "itchy at the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever 101.4; Injection sight pain; Headache; This is a spontaneous report from a contactable consumer (patient). A 50-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: el3247, patient was 50-year and not pregnant at th time of vaccination), via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 04:45 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Penicillin allergy, covid-19 prior vaccination. Concomitant medication(s) included naproxen sodium (ALEVE); ibuprofen (ADVIL [IBUPROFEN]); acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID; CAFFEINE; PARACETAMOL]) all taken within two weeks of vaccination. No other vaccine received in four weeks. No covid tested post vaccination. On 26Feb2021 at 11:00, the patient experienced fever 101.4, injection sight pain, headache. No treatment received for events. The patient underwent lab tests and procedures which included body temperature resulted as 101.4 on 26Feb2021. The outcomes of reported events were not recovered.  No follow up attempts are possible. No further information is expected.
pt recv vax & 1 wk later exp soreness, redness throat, fever, aches all over body;
Severe arm pain at injection site for 3 solid days.  Still have temporary arm pain for 3-4 hours every day. More so if I?m using my arm for sanding or scrubbing type activities
Expired product administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired product administered) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered). On 04-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired product administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported. The treatment information was not provided.; Sender's Comments: This report refers to a case of medication error, administration of expired Covid 19/mRNA-1273 vaccine with lot number/batch number 015M20A with no known associated adverse event.
life threatening blood clots/blood clots to brain and clots in neck; life threatening blood clots/blood clots to brain and clots in neck; This is a spontaneous report from a contactable consumer. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Feb2021 (Lot number was not reported) at the age of 38-year-old as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported.  It is reported the caller reports he has a couple of family members who had the Covid vaccine back in Feb2021. They suspect they are experiencing a side effect of the life-threatening blood clots on Feb2021. They have never had issues until they had the vaccine. He found out that the day after the vaccine, his sister-in-law, blood clots, life threatening blood clots to brain and clots in neck started, but it hasn't been confirmed but the doctors say there is a high suspicion and likelihood there is blood clotting. She just got the x-ray from emergency room 2 days ago and went back yesterday and they are still waiting for the results. Caller unsure if patient had both shots. Know she got a Pfizer Covid shot and the day after the blood clots started. Event caused patient visit physician office and emergency room. The patient underwent lab tests and procedures which included x-ray: still awaiting results on Feb2021.
We noticed my mother's foot was swollen, after alerting her nurse practicioner they ordered a scan to be done on my mother. It confirmed that she had a blood clot between her groin and below her knee. They prescribed eloquis.
had not received second dose, first dose over 2 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No specific patient or vaccine information were shared by reporter. The reporter consented to follow up.
Right after the Vaccine I started experiencing facial burning and instantly broke out in hives. Prior to the vaccine I was given allergy medication which did not work for me. This lasted for about 10 days. Visited Urgent Care and was prescribed Benadryl as needed and cold showers for relief. They referred me to an Allergist for additional testing.
Urticarial rash starting about 6 hours after vaccination, treated with antihistamine and steroid. Mom also notes a mild fever the morning of 8/17/2021.
I talked to my allergist about my shortness of breath with my first dose. He told me to take medications prior to the second dose to reduce my symptoms for the second dose. I got my shot around 9:25am and around 9:40am or so I had shortness of breath and had to take my emergency inhaler. My throat felt itchy for at least 30 minute after.
Patient called to report that her face got red and swollen within 45 minutes of vaccine and she had a rash on her face and she had a little bit of throat swelling and was speaking like a frog and it was hard to swallow. She said within 3 days her legs started to go numb and especially her thigh muscles and her veins in her left foot were engorged. She said she went to the ER and they rxed 40mg prednisone for 4 days and her papers from the ER read "allergy."  When I spoke to her for the second time and advised her she does not qualify for a second moderna vaccine, patient said that when she went to the ER she went for abdominal swelling, leg swelling, leg numbness, and swelling of the left ankle and foot. I confirmed with her that her symptoms have all improved and she said "yes, tremendously." She said she spoke to her PCP and at least one additional doctor yesterday.
TOOK TWO DOSES IN A ROW; This spontaneous case report was received from a nurse (PVX2019-550) on 28-Feb-2019. The report describes a female consumer who "took two doses in a row". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took the first dose of Vivotif on 27-Feb-2019 and today she took another dose.  The action taken with Vivotif with respect to the event "took two doses in a row" was not applicable.  The clinical outcome of the event "took two doses in a row" was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Patient experience diarrhea and broke out in a rash. Patient also had blisters on his skin.