chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; achy; Allergic reaction; face swelling; Hives; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 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 immunization. The patient medical history included UTI from an unknown date. Concomitant medications were not reported. The patient previously received Cipro for UTI and she never had a problem with Cipro previously. The patient experienced fever, achy, allergic reaction, face swelling, hives on an unspecified date. The caller had the first Pfizer Covid-19 vaccine. She had the Pfizer covid shot and had been normal. She felt a little fever and was achy, but nothing major. About a week out, all of a sudden she got an allergic reaction. They weren't sure, but she had taken Cipro for a UTI. She never had a problem with Cipro previously. However, she had face swelling and hives. She had to stop taking the Cipro. She received a shot of steroids because the Benadryl was not working. The Benadryl was not working for an allergic reaction that occurred. The outcome of the events was unknown.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Pt. woke up following morning 12/29/10, injection site red, swollen, hot, itching at the site, 12/30/10 pt. seen by Dr. for this. Started on Cephalexin. Pt. instructed to notify us to complete VAERS spoke with pt Monday 1/3/10 looking much better, clearing up.
Developed redness swelling at injection site, first noted by mom one day after vaccination.    4 X 5 inch area.
macular pruritic rash around the site of injection; macular pruritic rash around the site of injection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (macular pruritic rash around the site of injection) and VACCINATION SITE PRURITUS (macular pruritic rash around the site of injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (macular pruritic rash around the site of injection) and VACCINATION SITE PRURITUS (macular pruritic rash around the site of injection). At the time of the report, VACCINATION SITE RASH (macular pruritic rash around the site of injection) and VACCINATION SITE PRURITUS (macular pruritic rash around the site of injection) outcome was unknown.        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.   Concomitant medication was not reported. Treatment medication was not reported. It was reported that the events were allergic reactions to Moderna.
Information has been received from a pharmacist concerning a 42 year old female patient with chronic shoulder pain, asthma and unspecified allergies and no illness at the time of vaccination who on 29-DEC-2008 was vaccinated with ZOSTAVAX (Merck) (lot # 662857/1560X) SQ. Concomitant therapy included VICODIN. On 30-DEC-2008 the patient developed a red rash at the injection site of the right arm and a fever. The patient had sought unspecified medical attention. The symptoms resolved on 01-JAN-2009 without treatment. This is one of several reports from the same source. Additional information has been requested.
Dizziness, HA noc 12/31 - continued HA, dizz with PAIN, SWELLING, Warm itching local site 1/1.
Patient administered vaccine after the manufacture's date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) in a 75-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) outcome was unknown.        For mRNA-1273 (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was unknown.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter's address updated.
Post vax, this pt developed an injection site reaction characterized by red, hard, hot "knots" described as the size of "tennis balls."
This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, (dosing details and route of administration unknown) (lot # L037554 with expiry date 25-DEC-2017; lot # M037770 with expiry date 01-JUN-2019; lot # M035486 with expiry date 05-JUN-2019; lot # M040412 with expiry date 30-JUN-2019) for prophylaxis. Medical assistant did not know which of the vaccine lot numbers were administered. The administered doses of GARDASIL 9 experienced a temperature excursion of 47 degree Fahrenheit (F) to 77 degree Fahrenheit(F) for a time frame of 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. No additional information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001442: Original Case: 1706USA001442.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 22-year-old male. Neither medical history nor concomitant medication were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There were no adverse events associated with this medication error; therefore, the treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flue season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Flu-like episode. Vomiting, watery diarrhea. Forehead pain [different than usual], extreme chills, no fever. Neck extremely sore. [Sore due to gardening the day before plus vomiting 6 times]. Upset stomach tasting like eggs. The extreme chills is unusual for me. Every other time in my entire life after I have thrown up, I have run a fever/had hot flashes. Not this time. I also have apx. 2 inch bruise on my left arm. I do not normally bruise after injections. Maybe a small bruise, but not one of this size.
Within two (2) days (on 3/19/22) of Pfizer COVID-19 vaccine administration (3/17/22), I experienced extreme swelling of my lymph nodes in both armpits - right greater than left.  Within one (1) week (3/24/22) of my vaccine administration, I started to experience right thigh pain like a pulled muscle, although I had not had any physical activity or injury.  The pain advanced with a "tearing" feeling which required pain medicine and rest off of the leg.  Two days later, I experienced the same onset in the left thigh, which progressed to a "tearing" feeling in the leg.  I was limping and felt uncoordinated in walking.  I notified my physician of the original lymph node swelling on 3/21/22 and was advised to observe as I should expect swelling for approximately 1 month and report if swelling had not resolved by then.  I reported the leg pain to my physician on 3/28/22.  I am awaiting her response.
Initial and follow up information has been received from a registered nurse concerning a 21 year old female with no drug allergies, who on 17-MAY-2007 was vaccinated intramuscularly in the left deltoid with a first dose of Gardasil (Lot# 657622/0388U). Subsequently, the patient developed a rash from her shoulders to her neck (previously reported as shoulders to her face.) The patient notified the physician's office when she went there for the second dose of GARDASIL. The second dose was never given to the patient. At the time of the report, the patient's outcome was unknown. Additional information has been requested. The patient recovered on an unspecified date. Additional information is not expected.
Painful upper arm near injection site after second dose. Pain not subsiding 4 days after. Injection site feels tender and slightly swollen. Also had 101.7 degree fever, fatigue and overall body aches approximately 12 hours after second dose. Fever, fatigue and aches subsided after approximately 12 hours.
PUFFY RED FACE. SKIN PEELING. FEVER. MIRGRIANE. CHILLS. ACHES.
after receiving my vaccines I've become fatigued again; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Jan2021 09:00 (Lot number: EK9231) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Probably had chronic fatigue" (unspecified if ongoing), notes: verbatim: Probably had chronic fatigue but undiagnosed. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "after receiving my vaccines I've become fatigued again".  Additional information: Facility where the most recent COVID-19 vaccine was administered: Hospital. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:No known allergies: No allergies. Device Date : 04Aug2021  No follow-up attempts are possible. No further information is expected.
Left hand tingle- instantly after shot Right hand tingle- 2 min after shot Difficulty breathing/shortness of breath- 2 min after shot Nausea- 2 min after shot  Pharmacist suggested going across the street to an urgent care clinic. Patient wanted to wait before taking this step. These symptoms dissipated after approx. 30 mins.  Right side of face numb 15 hours after shot.  This symptom dissipated approx. 2 hours later.   Mild fever (99.5 degrees F) 27 hours after shot.  This symptom dissipated approx. 5 hours later.  Other "expected" symptoms like sore neck, muscle fatigue, feeling tired/weak, headache, and left arm soreness at injection site persist.
devel rash around site of vax;whelped areas;no drainage;temp 99;
DRs office reported to us 11/29/22 that pt had Bell's Palsy symptoms and a local reaction underneath the area she received the shingrix
Progressive, muscle pain that worsens with physical activity and is not relieved by OTC ibuprofen.
Pt. developed neurologic symptoms, including (R) hand tremor and dizziness/"spaciness" which was episodic.
Took flu shot in left arm, have been having pain for over a month, hurts to sleep or raise arm with constant pain. Haven't had any treatment due to medical cost, I do work at same facility that gave shot, shot didn't hurt when given, however started hurting several hours alter and hasn't got better.
Extreme pain during injection followed immediately by severe swelling and increased warmth at site. 1-2 hours later had generalized body aches. Symptoms worse the next day, with low-grade fever and stiff neck. Second day stiff neck gone, swelling better, still some body aches.
afebrile sz the morning p/DTP given, lasting 30-45sec, post-ictal state afterwards; No signif local rxn or fever noted;  ER visit had 2nd sz;
Pain in the tonsils tiredness headache and dizziness and itchy nose and watery eyes.
pain in my left arm going down the entire arm into my hand; pain in my neck; pain in my back; pain up my shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my left arm going down the entire arm into my hand), NECK PAIN (pain in my neck), BACK PAIN (pain in my back) and ARTHRALGIA (pain up my shoulder) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in my left arm going down the entire arm into my hand), NECK PAIN (pain in my neck), BACK PAIN (pain in my back) and ARTHRALGIA (pain up my shoulder). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in my left arm going down the entire arm into my hand), NECK PAIN (pain in my neck), BACK PAIN (pain in my back) and ARTHRALGIA (pain up my shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment included heat and cold packs.
Headache; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date as single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient stated that she had second shot already today but have a headache and she was wondering if she could take Advil. The outcome of the event was unknown.   Follow up attempts are needed; Information on lot number/batch number has been requested.
No symptoms....Son who is three months received the Flu Mist vaccine along with the reagular three month shots.  It has been a week he seems fine but still want to report it does not happen again.
Based on additional information received on 14-Jan-2019, this case becomes medically confirmed. (Nurse reported). Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from a non-health professional. This case involves a 4 months old male patient who received an expired dose of vaccine PENTACEL (batch number: C5449AA, expiry date: 7-Dec-2018), dose, dose in series, route and site of administration were not reported) on 10-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to expired vaccine administered. It was not reported if any adverse event was experienced or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. Follow up information received on 14-Jan-2019 from a nurse. Case becomes medically confirmed. Patient demographics, suspect vaccine administered date, batch number was updated. List of documents held by sender- none.
On 1/26/21 the patient called to report that on 1/23/21 she woke up and noticed a very large red area on her arm where she received the vaccination, it was warm to the touch and sore. She denies muscle pain and is able to move her arm without pain. She states over the next few days following 1/23/21 the redness increased and continued to be warm to the touch. Patient did call and discuss with her physician.
injection site at the right arm turned red and painful with some raised bumps 6 hours after receiving the vaccine
Headache beginning two to three hours after the injection. Generalized malaise approximately 9 pm.  Awoke from sleep at 1 AM with severe chills and tremors lasting until 3 AM.  Temperature of 103. Back to sleep and awoke at 4:30 with severe headache and N/V.  Temperature 100.8. Muscle aches, headache extreme tiredness throughout the day on the 25th.  Chills again around 11:00, temp 100.1.  Generalized malaise, stomach cramping and headache lasted throughout the day.  Awoke on the 26th at approximately 2am  with night sweats. Went back to sleep and awoke at 8am on the 26ths with wet blankets and pajamas.  Felt better after showering. Still had a headache but didn?t really hurt unless sneezing or coughing.  Well enough to go to church.  After returning had diarrhea a couple of times. Now only a lingering heaviness in center of my chest and need to cough that I have had since a week before my Covid diagnoses in November
POOR QUALITY DRUG ADMINISTERED; THE VACCINE WAS OUT AND THEN PUT IN THE FRIDGE AND THEN OUT AGAIN "BEYOND THE 2 HOUR MARK" / INCORRECT STORAGE OF DRUG; This spontaneous report received from a health care professional concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 21-SEP-2021) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-AUG-2021, the patient experienced poor quality drug administered. On 30-AUG-2021, the patient experienced the vaccine was out and then put in the fridge and then out again "beyond the 2 hour mark" / incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality drug administered and the vaccine was out and then put in the fridge and then out again "beyond the 2 hour mark" / incorrect storage of drug was not reported. This report was non-serious.
Tested positive for COVID-19; Tested positive for COVID-19 on September 7th; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Tested positive for COVID-19 on September 7th) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Overweight and Smoker (former smoker). Concurrent medical conditions included Hypertension.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Tested positive for COVID-19 on September 7th). At the time of the report, COVID-19 (Tested positive for COVID-19) had not resolved and DRUG INEFFECTIVE (Tested positive for COVID-19 on September 7th) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, SARS-CoV-2 test: positive (Positive) positive.         Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.; Sender's Comments: This case concerns a 55-year-old female patient, former smoker, overweight and hypertensive, who experienced the unexpected event of COVID-19, vaccination failure was considered as an additional event. The event occurred approximately 4 months after the second dose of Spikevax. The event was considered related to the product per the reporter's assessment. The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report.
At about 15 minutes post vaccination individual experienced a feeling tongue was swollen. Initial vital signs stable and she self-reported to vaccination staff.  Provider was called, and 0.3 mg Epinephrine via Epi pen was given. On-base emergency response  EMTs and command post activated.  Symptoms were slight hoarseness, salivating, difficulty pronouncing words, and flushed.  She felt her cheeks were  starting to swell.  After the one dose epinephrine she felt swelling start to resolve and symptoms improving. She was transported via EMS to hospital where she  reports back to us IV hydration and is anticipating release with a clear airway and normal vital signs.
Patient is complaining of still having arm pain and a bruise in her arm - now 2 weeks later after the immunization. She may not be able to visually see herself what the arm looks like but did report this reaction over the phone.
Pt's sister noticed pt had swelling & redness on arm at administration site but pt is not experiencing any pain or discomfort so had no idea when it started! Arm was very swollen and red; circular, large red area around site of injection; PT DOES NOT KNOW WHEN SX'S BEGAN...I FILLED IN BOXES ABOVE B/C I HAD TO.
I;30 am--chills, fever, severe headache, body / joint aches.... 5:30 am-added nausea to above  continued all of 3/24--fever broke 3/25 @4:00am , then other gone with tiredness for rest of day 3/26--okay-back to normal, just little tired
2 days after vaccination pt. reported redness,swelling,& pain in right arm.Pt. stated tx w/ Keflex by MD.
Information has been received from a registered nurse concerning a 19 year old female with no allergies or medical history who on 18-APR-1987 and 14-MAY-1997 was vaccinated with a first and second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live.  Concomitant vaccines on 14-MAY-1997 included a dose of hepatitis B virus vaccine rHBsAg (yeast).
Increase in volume of existing tinnitus. This started soon after the shot and has continued for 16 days and counting.
pt exp behavioral changes, (violent behavior) & complex partial szs; since we did not know was having szs @ first not sure onset; 2 wks p/that had status epileptic sz devel emotion problems, ADHD & learning disabled; hospitalized x 7 days;
PAIN AND SWELLING TO RIGHT UPPER ARM 10-12 HOURS AFTER VACCINATION. PATIENT REPORTED TO ER 48 HOURS AFTER RECEIVING VACCINE WITH COMPLATINT OF SWELLING AND TENDERNESS. DX WITH CELLULITUS TO RIGHT UPPER ARM. TREATED WITH NAFCILLIN 1 GM IV;TORADOL 30MG IV; ANCEF 1 GM IV AND TYLENOL 1 GM PO.
Pt recv vax on 10/13/97; on 11/1/97 pt exp spots on right foot &ankle, lower leg, left ankle, thighs; dx=Schonlein-Henoch purpura