chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu; Initial information received on 06-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demographics who had flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient had a serious event flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   No lab data reported.  Action taken: not applicable.  An unknown corrective treatment was received for the event (Flu).  Outcome was Unknown for the event flu.  Seriousness Criteria: The patient was hospitalized for this event.; Sender's Comments: Sanofi company comment dated 12-Dec-2022: This case involves a patient of unknown demographics who had flu after receiving vaccine INFLUENZA VACCINE. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Pt reports developed mid back pain, worse when lying down, pain in left shoulder and left upper arm. Ribs hurt when takes deep breath. No apparent fever, has redness or swelling at site. Had been playing basketball few days before symptoms occurred.
Dad felt fine the day of the shot and had a normal morning the next day.  However, while he was playing tennis on the 27th, he started to feel odd and went home.  While in the bathroom, his legs gave way and he fell to the floor.  He remained there, unable to move his arms or legs, for several hours.  He managed to push his way to the staircase on his back and eventually was able to turn over and crawl up the stairs.  He finally made it to a telephone at 5:30pm.  Dad refused any medical care, so I called him every hour until 11pm.  He was able to make it up to his bedroom and woke up the next day feeling better.  By Friday, he was completely back to normal.  Still, the partial paralysis was terrifying.
Following anthrax vaccination, member states she had 5 menstration flows in a 6 week period.  This reaction has never happened to her prior to vaccination or since.
Patient received the Hepatitis B Vaccine after showing non-immunity to a post-series antibody. Titer was required for schooling purposes. Patient called the triage RN on 5/23/19 with complaints of right sided pain. Pain to the right upper arm and shoulder, right hip, and right knee. Triage advised patient to come to the clinic for evaluation which was completed. Patient reported to the MD that she had right upper arm and shoulder, right hip, and right knee pain. Arm and shoulder pain woke her up from sleep the evening after the vaccine, discomfort making it difficult to fall asleep. Difficulty using her right arm. Did try ibuprofen and Tylenol but was unsure of dosing at the time of appointment. Right thigh had mild discomfort, most achiness in joints. Patient did report subjective breathlessness the evening of 5/22, though also reported she was objectively breathing "fine". Denied fever, chills, rash, dizziness, parenthesis, difficulty with swallowing or breathing except as mentioned. Patient was advised to follow up in 5 days if no improvement or as needed. Was advised when to report to ED/UC.
Information has been received from a  Registered Nurse concerning a female who in October 2008 was vaccinated with a first dose of GARDASIL, single dose vial, in physician's office.  The patient experienced abdominal pain within 24 hours of receiving her first dose of GARDASIL.  Unspecified medical attention was sought.  At the time of reporting, the patient's outcome was unspecified.  Additional information has been requested.
Bell's palsy; postherpetic neuralgia; vision problems; hearing problems; balance problems; Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 67-year-old patient of an unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 04-OCT-2012, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiration date were not specified), at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by a providers for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster, postherpetic neuralgia, vision problems, hearing problems, balance problems and Bell's palsy. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of Bell's palsy was determined to be medically significant.
Information was received from pharmacist (also reported as a physician) regarding a patient (demographics unknown), who on 15-OCT-2013, was vaccinated with ZOSTAVAX lot # J006155. It was reported that the patient received ZOSTAVAX which had been exposed to 26 C for 24 hours. No adverse symptoms reported. Additional information has been requested.
Moderna COVID-19 vaccine EUA Sore arm at injection site for 2 days.   22hrs after the vaccine, (approximately 1:30 pm on 7/21/21) severe onset migraine, severe sweating, rapid heart rate, nausea, high BP 151/119.   The pain was the worst I?ve ever experienced.   I had to call 911 for ambulance and went to the ER .  I had bloodwork and cat scan done. White blood count was slightly elevated.  Cat scan was normal.  Was released from ER at 7 pm.  I then had severe headaches and rapid heart rate that lasted for 4 days.   I thought I was gonna die.
1st dose 20-oct-2022, 2nd dose 29-nov-2022, 3rd 23-feb-2023; 1st dose 20-oct-2022, 2nd dose 29-nov-2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 23-FEB-2023, the patient received the 3rd dose of Twinrix. On 29-NOV-2022, the patient received the 2nd dose of Twinrix. On 29-NOV-2022, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 20-oct-2022, 2nd dose 29-nov-2022). On 23-FEB-2023, the patient experienced drug dose administration interval too short (Verbatim: 1st dose 20-oct-2022, 2nd dose 29-nov-2022, 3rd 23-feb-2023). The outcome of the drug dose administration interval too long and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Mar-2023 A pharmacist reported that the vaccines were given at the reporting clinic. The reporter did not had the lot or expiry date at the time of report. The late 2nd dose was discovered during the escalated call to another agent. No symptom were reported. The reporter consented to follow-up via email. The patient received 2nd dose of Twinrix later than the recommended interval and 3rd dose of Twinrix earlier than the recommended interval, which led to lengthening of vaccine schedule and shortening of vaccine schedule. The facility type was captured as clinic as in reported information it was reported that the patient got the vaccines at the reporting clinic and for the same query was raised.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 as dose 5 (booster), single (Lot number: GJ6742) at the age of 60 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "mild allergy-related asthma" (unspecified if ongoing), notes: mild allergy-related asthma treated with Zyrtec-D. The patient's concomitant medications were not reported. Past drug history included: Zyrtec-d for mild allergy-related asthma. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Sep2023) Negative, notes: Tested negative on 19Sep and 20Sep on home test; (20Sep2023) Negative, notes: Tested negative on 19Sep and 20Sep on home test; (21Sep2023) Positive, notes: Tested positive on 21Sep; (28Sep2023) Negative, notes: 28Sep tested negative on home test and again on 30Sep; (30Sep2023) Negative, notes: 28Sep tested negative on home test and again on 30Sep. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 21Sep2023 till 26Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300317391 same reporter/patient, different drug/AE;
The morning after my second dose of Pfizer?s Covid-19 vaccine, I woke up feeling freezing (at 9:00 am) and suspected I had a fever.  After waking up again later (around 12:30 pm), I took my temperature and found that I have a fever of 101°F.  I still have a fever and chills (2:50 pm).  I have not taken any medication to treat the fever yet and plan to just take it easy.  If I begin to feel worse, I might take an ibuprofen.  After getting the vaccine, my left shoulder was sore, and is still sore, but it?s my understanding that this is normal, and just as my arm was sore with the first vaccine, it may be 2 days before my arm feels better.  I am not concerned about the soreness of my arm.
I received the vaccine on 3/31/2021 at 9:30 in the morning. My arm was sore a few hours later but not bad. By 8pm I had chills and my arm hurt when I moved my fingers. I took Tylenol at 10pm and chills went away until 3am. Took more Tylenol at 4am and had sweats. Woke up feeling very achy and chills. Took more Tylenol at 10am and felt better. Arm was still very sore. Chills, aches, arm pain, and headache at 3pm. Took Tylenol at 4pm and started to feel better. No more bad chills or aches but headaches every morning since then
Severe muscle aches, headache, unable to get out of bed - aches started a few hours after injection.  By the next morning the patient could not even get out of bed even while on tylenol.  Very sick.  Couldn't eat or sit up. 21 hours later - on Tylenol and Advil - can sit up for a few minutes
Morning after arm pain with significant armpit swelling. Full upper body rash appeared 7/15 followed by SOB, throat tightness/coughing, fatigue, vision blur left side, cold feet/hands, chest pain, sleep disruptions (waking up gasping for air), digestive issues, unwanted weight loss* (20+ lbs.). This has continued off and on for many months and is ongoing still. I waited to report since symptoms continued and evolved somewhat. I still can't exercise heavily (yoga/slow walks okay) without all the symptoms flaring back up again. *Weight loss/digestive issues feels like post-infectious IBS flareup (which I had not experienced since initial diagnosis/onset in 2018).
Complained of Left arm tingling, and chest pressure 3:06 p.m. while under observation. PA assessed lungs and VS. Lungs clear. SpO2 98% on Room Air. 911 called at 3:14pm B/P 154/98 Pulse 88. At 3:20pm B/P 163/111 Pulse 88 spO2 98% Room Air 3:21pm Nitro 0.4 mg given x 1. 3:24 pm Paramedics arrived, shortly after administered Nitro paste patch due to Left arm tingling and chest pressure.
Receuved Varicella vaccine on 06-04-2008 at approximately 3:00 P.M.  On 06-08-2008 developed a red spot at injection site.  Redness at injection site grew in size over a period of four days until it reached 2.5 cm long and .5 cm wide.  Developed fever on 06-12-2008 100.4 actual axillary temp.  After Tylenol actual axillary temp dropped to 99.6.  On 06-13 and 06-14-2008, actual axillary temp was 102.8 without Tylenol and after med dropped to 101.4, actual axillary temperature.  Actual axillary temp on 06-15-2008, without Tylenol was 101.8 and after Tylenol dropped to 100.4.  On 06-16-2008, actual axillary temp. without Tylenol was 101.2 and after Tylenol dropped to 99.4.  On 06-17-2008 had normal temperature all day.  On 06-18-2008 had actual axillary temp. of 99.4, Mother gave a dose of Tylenol. Mother reports around the 13th or 14th of June she noticed that after child got up from napping, her skin was mottled a reddish purple color where she had lain on wrinkled bedding.  After child was up and about for a while skin color returned to normal.
Resident of a local Nursing home. Public health nurse on site to adminster COVID vaccines. Resident  received 0.3 cc of Pfizer vaccine IM Left deltoid. Upon record review. Pt noted to have previously received 2 dose series of Moderna on 01/14/2021 and 02/10/2021. Booster dose 0.25 cc of Moderna on 10/29/2021.  No booster was needed at this time. Nursing home staff made aware. Nursing home medical staff notified. Resident to be monitored for 72 hours. At time of report no adverse effects noted.
Had hives all over her body, difficulty breathing, neck swelling and not able to swallow, rapid heartrate  Went to ER and then saw an allergist at a later time.   on a lot of new medications because of this
dizzinesss 30 minutes felt ok afterwards red blotchy shoulder where injection was for 2 days
Raised rash on arms, facial flush, sweating, c/o feeling hot and prickly, doses of epinephrine
fever; tired; some appetite loss; chills; This spontaneous case was reported by an other caregiver and describes the occurrence of CHILLS (chills), PYREXIA (fever), FATIGUE (tired) and DECREASED APPETITE (some appetite loss) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event on 09-Mar-2021.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 16-Mar-2021, the patient experienced PYREXIA (fever), FATIGUE (tired) and DECREASED APPETITE (some appetite loss). At the time of the report, CHILLS (chills) had resolved and PYREXIA (fever), FATIGUE (tired) and DECREASED APPETITE (some appetite loss) had not resolved.            No concomitant medications were provided.  No treatments were provided. Reporter waiting on call back from HCP.   Reporter did not allow further contact
I had chest pain and abdominal pain. I just did not feel normal. I went to the ER about this. They did EKG. They gave me GI medicine and referred me to a GI specialist. The GI specialist did not find anything abnormal. I have never had stomach issues like that before.
Later in the day the patient noticed she had a large rash (about 6" diameter) around the injection site, as well as a raised "welt" that is hard to the touch, pain and itching at injection site; had a fever (101, same day only), chills, general malaise and fatigue, headache for the last 4 days; patient said rash and swelling is getting better, peaked about 24-36 hours after administration. 11/12 is the first day she has not been tired.
Chills; Fever; Aches; Lethargic; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 10Apr2021 at 11:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), biotin (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 20Mar2021 at 11:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient previously also received sulfur (MANUFACTURER UNKNOWN), for unknown indication from an unknown date and experienced drug allergy. On 11Apr2021 at 00:30, the patient experienced chills, fever, aches, and was lethargic for about 18 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events chills, fever, aches and lethargic was recovered on 11Apr2021 at 18:30. No follow-up attempts are needed. No further information is expected.
Hives all over body, chest super painful having a hard time breathing, sharp pains when I took deep breaths
Patient received the vaccination on Friday and by Sunday patient developed tingling of the mouth and slurred speech. EMS brought patient to hospital for a possible TIA. Hospitalist did a CT and MRI. The conclusion was negative for TIA. Not sure of Bell's Palsy diagnosis.
4 year old patient was administered the product ADACEL instead of DAPTACEL with no reported adverse event; 4 year old patient was administered the product ADACEL with no reported adverse event; Initial information received on 05-Apr-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 4 years old and unknown gender patient who was administered the product diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] instead of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the 4 year old patient was administered of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (dose, strength,lot number and expiry date not reported) via unknown route in unknown administration site for Immunization instead of Daptacel with no reported adverse event (product administered to patient of inappropriate age) (wrong product administered) (latency; on same day).  It was stated it was given in the ED for purpose of Tetanus prophylaxis  Action taken : not applicable.  Outcome :  Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
left eye blurred vision, facial drooping, continuous watery eye.  ED test:  CT, MRI, Labs, Urine, EKG
12 hours after the 2nd dose I was sicker than ever before in my life.  Shortly after, I had a sharp pain at injection site for months and now I have pain in a 3 x 5 inch area around injection  site mostly when I lie down
Began 4/7/21 am started with rash on bilat arms; caller states it resembles "measles" 4/13-Caller reports she has been using hydrocortisone cream as well as TAO on bilat arms with some relief noted; Recommend oral antihistamines (zyrtec, claritin, or benadryl) if she can tolerate. Pt agreeable 4/15-f/u call made; caller reports rash still the same; has appt with PCP next week
Has had severe nose bleeding since covid shot.  Hemophilia center asked caregiver to ask to report as possible vaccine side effect
Could not lift my arm up severe pain   Fever/ chills Severe body aches Headache Diarrhea  No energy / Feel horrible
- Delayed menstrual cycle (normally about 35 days, became 58 days and slightly heavier - abnormal heart flutter/palpitations starting on July 7 (disappeared after 1 day) and then elevated heart rate for a week  - pulsatile tinnitus developed 3 weeks later, feel pressure in ears and head
Large red blotch in a circle around injection site. Pink, itchy, a little swollen.
pt recv vax  11SEP96 & that same day pt exp muscle spasms in back & stomach, pressure in chest & vomiting & presented to ER;dx was not made, but pt was treated w/muscle relaxer & something for indigestion;
I experienced a very sore arm for about a week but no redness or rash. It was 24 hours after the vaccine where the symptoms really arose. I had a fever of about 100.3 for about 2 days after the vaccine. Took medicine for the fever but didn't seem to help. I was very fatigued and wiped out, had the chills and a slight cough as well. I called the doctor and they said to monitor it, and notified me to go to the ER if the temp did not go down. The fever broke Monday evening (~99). It took about 3 more days for the fever to completely resolve. During this time, I was still very achy and fatigued, and wanted to sleep. These symptoms lasted for a total of 5 days where they eased up with each consecutive day.
Heart palpitations; PVC and PAC and was symptom free but they seemed to restart after my second vaccine; PVC and PAC and was symptom free but they seemed to restart after my second vaccine; This is a spontaneous report from a contactable consumer (patient herself). A 54-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 23Mar2021 10:00 (age at vaccination: 54 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication(s) included trazodone 50mg. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration, administered in left arm on 01Mar2021 09:15 as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021, the patient experienced heart palpitations, pvc and pac and was symptom free but they seemed to restart after my second vaccine. The events led the patient to visit Doctor or other healthcare professional office/clinic. It was unknown if any treatment was received for the adverse event. The patient was not diagnosed with covid-19 prior to vaccination nor was tested for covid-19 since the vaccination. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.