chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It's tender /really painful; really painful; in my left armpit, there's complete swelling of lymph nodes; soreness at the injection site; I felt extremely tired, I could barely keep my eyes open; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (It's tender /really painful), LYMPH NODE PAIN (really painful), LYMPHADENOPATHY (in my left armpit, there's complete swelling of lymph nodes), VACCINATION SITE PAIN (soreness at the injection site) and FATIGUE (I felt extremely tired, I could barely keep my eyes open) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 045A21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). 10-Nov-2021, the patient experienced FATIGUE (I felt extremely tired, I could barely keep my eyes open). On 11-Nov-2021, the patient experienced LYMPH NODE PAIN (It's tender /really painful), LYMPH NODE PAIN (really painful) and LYMPHADENOPATHY (in my left armpit, there's complete swelling of lymph nodes). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, LYMPH NODE PAIN (It's tender /really painful), LYMPH NODE PAIN (really painful), LYMPHADENOPATHY (in my left armpit, there's complete swelling of lymph nodes), VACCINATION SITE PAIN (soreness at the injection site) and FATIGUE (I felt extremely tired, I could barely keep my eyes open) outcome was unknown.            No concomitant medications reported.   This case was linked to MOD-2021-384391, MOD-2021-384392 (Patient Link).
The Physician reports that the pain in his injection site from the Moderna Covid-19 vaccines is more intense than any other vaccine.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (The Physician reports that the pain in his injection site from the Moderna Covid-19 vaccines is more intense than any other vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No medical history was reported.  Previously administered products included for COVID-19 prophylaxis: spikevax (dose 1), spikevax (dose 3) and spikevax (dose 2). Past adverse reactions to the above products included No adverse event with spikevax, spikevax and spikevax. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (The Physician reports that the pain in his injection site from the Moderna Covid-19 vaccines is more intense than any other vaccine.). At the time of the report, VACCINATION SITE PAIN (The Physician reports that the pain in his injection site from the Moderna Covid-19 vaccines is more intense than any other vaccine.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that the pain in the injection site from the Moderna Covid-19 vaccines was more intense than any other vaccine. It was much more sore than when the patient received the flu shot. The patient did not wish to provide any additional information about his previous Moderna Covid-19 vaccine.  No treatment medication was reported.
Information has been received from a medical assistant concerning 38 year old female with no pertinent medical history and no known allergies, who on 12-FEB-2009 was vaccinated with 0.5 ml of a dose of VARIVAX (Oka/Merck) (Lot not reported) subcutaneously. There was no concomitant medication. On 21-FEB-2009 the patient developed swollen lymph nodes in her neck and a Varicella like rash. The patient had the rash on her chest, face and back. On an unspecified date the patient recovered. Additional information has been requested.
Information has been received from a physician concerning a 37 yr old white male with a history of inflammatory bowel disease and inflammatory arthritis who on 14Jun05 was vaccinated SC with a first 0.5ml dose of varicella virus vaccine live. Concomitant medications the same day included a first dose of hep A virus vaccine inactivated (manf unk) and a first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no illness at the time of vaccination. Recently, in approx 2005, the pt developed several dozen lesions. Unspecified medical attention was sought. No product quality complaint was involved. The pt is recovering. Follow up information from the physician indicated that on 04Jul05 the pt began with vesicular skin lesions, LG temp and malaise. He was seen in the office on 06Jul05 and  had several dozen vesicular and papular on trunk. Diagnosis was disseminated zoster. It was noted that the pt was off the leflunomide (Arava) since Feb 2005 and had ana shot. It was also noted that his last etanercept (Enbrel) was 20 days before vaccines. The pt recovered. The physician felt that the disseminated zoster was an other important medical event (OMIC). No additional information was provided.
The shot was on Mon 2/25, by Friday I was very weak and coughing up green sputum. On Sun March 3, I started erupting shingles lesions - look LEVAQUIN for pneumonia.
Patient presented to the clinic w/chest discomfort, nausea, headache, and body aches 2 hrs post vaccination. Patient had elevated BP temporarily.
Hives on cheeks around 5pm that went away; Hives on back of neck the next morning. No treatment was needed for resolution of hives.
ITCHING ON ARM; SOME REACTION; RASH ON ARM; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) on 14-MAY-2021 was received on 14-MAY-2021 and concerned a 69 year old male. The patient's weight was 106.59 kilograms, and height was 185 centimeters. The patient's pre-existing medical conditions included the patient did not had any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced itching on arm. On MAY-2021, the subject experienced some reaction. On MAY-2021, the subject experienced rash on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching on arm, rash on arm, and some reaction. This report was non-serious.
her tremor got worse.; This is a spontaneous report from a contactable consumer (patient) and physician via medical information team. A 71-year-old female patient received second dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via unspecified route of administration on 21Mar2021 as a single dose for covid-19 immunization. The patients medical history included essential tremor from Jan2020 to Jan2020. Patient had brain surgery in Jan2020 to improve the tremor and did fine until she got the first dose of the Pfizer Covid 19 vaccine on 28Feb2021. Concomitant medications were not reported. The patient previously received first dose of  as a single dose on 28Feb2021 for COVID-19 immunization. Patient states a few days later her tremor got worse on an unknown date in 2021. Patients Neurologist said it was possible it was due to the vaccine and that it might happen again after the second dose. She received the second dose of the vaccine on 21Mar2021 and she states the tremor got worse again and has not gotten better. The Neurologist said it should go back to baseline but they didn't know how long it would take. Stated that the PI for the vaccine contains no information about tremor being reported as a side effect. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Got the shot around 10 a.m. arm was sore all day. That night I was very tired. Fell asleep early around 9 p.m. woke up around 3 a.m. with a high fever of 103.6 went back to sleep. Woke up on and off all day with high fever, body aches, head aches. And I'm finally feeling better today.
PT CAME IN FOR TWO VACCINES, FLU AND COVID.  SHE REQUESTED BOTH SHOTS IN HER LEFT ARM.  I GAVE HER THE FLU SHOT FIRST, NO PROBLEM.  THEN I GAVE HER THE COVID VACCINE.  AS I WAS APPLYING A BANDAGE, SHE LET GO OF THE PAPERS IN HER HAND AND BEGAN TO SLUMP IN HER CHAIR.  I HELD SO SHE WOULD NOT FALL OUT OF HER CHAIR.  SHE CAME TO IN ABOUT 30 SECONDS TO 1 MINUTE.  SHE FAINTED.  WHEN SHE CAME TO, I HAD HER REMAIN SITTING IN THE CHAIR FOR ABOUT 5 MORE MINUTES JUST TO BE ABSOLUTELY SURE SHE WAS FEELING OKAY.  SHE SAID SHE WAS  FEELING OKAY.  THEN SHE WAS ABLE TO STAND UP AND MOVE TO THE NEXT ROOM (WAITING ROOM) WHERE SHE WAITED ANOTHER 15 MINUTES.
This spontaneous report was received from a Licensed Practical Nurse concerning to an 18 years old patient of unknown gender who recently received two concomitant doses of RECOMBIVAX HB (dose, route and lot number not reported) at one time, when he or she should only had received one. It was unknown where in the series of dosing the patient was supposed to be. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. The outcome of the event was unknown. The event was not related to RECOMBIVAX HB. Additional information has been requested.
11/17/18, started around 2 a.m. and lasted till 2 p.m. on 11/17/18. Chills, fever of 103 orally, malaise, fatigue, reoccurring dreams each time I fell asleep of file cards with dead baby names, and names of immunizations. Blisters on outer lower lip started on 11/19/18.
Pt recvd Hep B vax on 27APR92 & on the evening of vax pt exp severe abdo cramps, vomiting, sore arm @ the inject site; pt recovered; No further details were provided;
underarm swelled; felt pain in the arm; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer-sponsored program. A male patient (husband) of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  It was reported that the patient received the first dose of the vaccine on 25Feb2021 (Thursday). After receiving the vaccine on 25Feb2021, the patient felt pain in the arm. The following day on 26Feb2021, the patient's underarm swelled. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
ordered a 15 month old to have DTap and ActHIB separately but the person gave the child, Pentacel and Acthib( another brand) today, with no reported adverse event; Initial information received on 02-Mar-2022 regarding an unsolicited valid  non-serious case received from a nurse practitioner.  This case involves a 15 months old male patient for whom nurse practitioner ordered to have dtap and acthib separately but the person gave the child diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] and HIB vaccine CONJ (TET TOX) [Acthib] (another brand) today, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevenar 13) and HIB vaccine CONJ (TET TOX) (Acthib) for Immunisation.  On 02-Mar-2022, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine, suspension for injection (lot U7013AA, expiration date: 10-Sep-2022) unknown strength via intramuscular route in the right thigh for immunization and on same day nurse practitioner reported that she ordered to have dtap and acthib separately but the person gave the child, pentacel and acthib( another brand) today, with no reported adverse event (wrong product administered). The caller asked what to do.  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 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.
Narrative: COVID infections following completion of COVID vaccine series 03/08/21 COVID vaccine dose #1 03/27/21 COVID vaccine dose #2 07/21/21 Pt  reports to ED stating exposure to COVID three days ago and now presents with  sore throat, mild dry cough but otherwise feels fine; denies N/V/D; COVID POSITIVE 07/25/21 Pt reports cough, runny nose, headache 07/26/21 Pt reports minimal cough, insomnia, but is improving 07/28/21 Pt reports mild runny nose, denies other symptoms 07/29/21 Pt reports no symptoms, quarantine ended
This spontaneous report as received from a female consumer via company representative who refers to her niece. On an unknown date the patient was vaccinated with GARDASIL (route, dose, number of doses, lot# not reported). As was reported that on an unknown date the patient died from complications while using GARDASIL. No more information were provided. Additional information has been requested.
27SEP91 pt felt hot to touch & c/o h/a; given APAP, but felt hotter; pt vomited, then wouldn't drink fluid; mom put pt in tub of water to bring down fever; 28SEP91 pt still had fever & pulse was rapid; pt given supp for nausea;
Arm  was really sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm  was really sore at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm  was really sore at the injection site). At the time of the report, VACCINATION SITE PAIN (Arm  was really sore at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
itcy rash; red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itcy rash) and RASH ERYTHEMATOUS (red rash) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history information provided by the reporter.  Concomitant products included METOPROLOL, AMLODIPINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced RASH PRURITIC (itcy rash) and RASH ERYTHEMATOUS (red rash). At the time of the report, RASH PRURITIC (itcy rash) and RASH ERYTHEMATOUS (red rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that the rash is red and looks like a donut with circle in the middle. No treatment details reported.    Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: NNI
Fever, rash, ankle and knee swelling. Our pediatrician says it?s serum syndrome.
menstrual cycle started 6 days early on 4/25, normally am very regular and track it
1/2 hour after receiving intranasal live attenuated 2009 H1N1 vaccine sudden sneezing fit. Prior to going to bed felt "itchiness" above upper lips. When awake @ 0200 - lip swollen and itchy. At 0830 swelling between nose and upper lip decreasing.
05/222/2021, a few hours after receiving the vaccine, the decedent started to experience shortness of breath.  On 05/25/2021, the decedent went to the Medical Center, where he was diagnosed with pneumonia.
I got the flu shot at facility, agency came on site to give flu shot for employees. Right after I got flu shot in my right arm, felt obvious pain compared with previous years (I had flu shot for over ten years), after 7 days the pain didn't get any relief, two weeks later, the pain spread from shot spot to whole shoulder, up and low arm, right chest and back, now 40 days passed, I still had pain in my right side, saw my family doctor, he said I had inflammation obviously, prescribed two medicines for me, said if still not good after these medication, I need to see a specialist.
Pfizer on 2/11 and 3/12. Positive on 10/27
started to have hives, pain in feet, hands, bones, itching.  took Benadryl, not effective, was started on Famotidine and Zyrtec which controlled hives, came back if missed a dose, started ASA bid  on day #10 for pain, was started on oral Pred taper day #15 for persistent symptoms (60mg x 2 day to taper ever 2 days), these symptoms consistent with serum sickness.
0917 am anxiety, n/v, dizziness, feeling faint, hypertension
About 20-22 hrs after booster, neck and shoulder of the same side as shot became so stiff and sore I could not straighten my head without excruciating pain accompanied by severe nausea. This lasted until the following afternoon of 12/23.  Ran fever and had chills as well as very fatigued through 12/25.
Metallic taste in mouth beginning the evening of the vaccine. The metallic taste has persisted for over a week now and causes me to be nauseous whenever eating.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly dose of ROTATEQ (lot # N030174 exp date 13-JUN-2019 (also reported as 30-JUN-2019)) (dose not reported) orally. There was a data logger issue. The temperature of excursion was 47 °F to 77 °F (47.3 °F) for a time frame of 5 minutes. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1809USA009046: US-009507513-1809USA009096:  US-009507513-1809USA009098: US-009507513-1809USA009099:
c/o weird taste in mouth, warm, rash on chest and right deltoid around injection site only, pt given benadryl 25mg , water, and ice pack, waited 30 minutes, rash subsided and pt feeling ok
Information has been received from a physician concerning a 10 year old male with no medical history or allergies who on 05-AUG-2010 was vaccinated with the first dose of GARDASIL (lot# not reported), 0.5 mL. Concomitant therapy included Tdap (manufacturer unspecified) and MENACTRA. The patient waited around for about 10 minutes and started complaining of dizziness and then experienced syncope. "Pretty quickly after the episode", the patient recovered from dizziness and syncope. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Hives around injection site and left abdomen; Lightheaded, heart racing, slight fever 101-102, and nauseated
Pneumococcal (Left arm)Influenza (Right arm) 05 Nov 2003 Received vaccinations on this date.  No complaints.    07 Nov 2003 Presented to VHC for evaluation.  Reports left arm sore from pneumococcal vaccination.  Concerned regarding the red ring surround site.  Last received the pneumococcal vaccination 5 years previously at the age of 65 after having had pneumonia.  No problems noted after that vaccination.  Feels fine except for tender, red arm. Denies fever, chills, chest pain, or shortness of breath.  Assessment:  1. Arthus reaction to Pneumococcal vaccination.  Plan/ Recommendations:  1.  Discussed etiology of arthus reaction.  The redness does not indicate a bacterial infection, and no antibiotics are needed. 2. Meds:  Kenalog 0.1% cream apply tid x 5 days. 3. May use Tylenol or Motrin (with food) for comfort. 4. Heating pad for 20 minutes four to five times a day to affected area for comfort. 5. If any signs of infection develop, such as drainage, red streaking, fever, or chills, call or return to our office or the ER. 6. Current guidelines recommend the pneumococcal vaccination as a one-time dose with a one-time revaccination booster 5 years after the first dose for high risk people and those >= 65 if the first dose was given prior to age 65.  As this was her second dose, she does not require any further boosters at this time.  ***However, should immunization guidelines change with a recommendation for further pneumococcal boosters, it is strongly recommend that patient have pneumococcal titers drawn prior to receipt of further vaccination to assess for residual immunity.  We also recommend evaluation by a provider with expertise in adverse vaccine management if further pneumococcal vaccinations are needed.
This is in follow-up to report (s) previously submitted on 7/16/2007. Information has been received from a physician concerning a 19 year old female patient with no known allergies who on 19-JUN-2007, was vaccinated with a first dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). On the 20-JUN-2007 at approximately 08:00,  she developed a rash on both arms, neck and chest and redness on the injection site forearm. By the next day, the redness developed into a clustered pin-pricked - but not raised - red, itchy rash.  It was reported that the patient did not have a fever. Unspecified medical attention was sought. On 25-JUN-2007, the patient had recovered from fash on both arms, neck and chest and did not recover from redness on injection site forearm and itchy rash. No product quality complaint was involved. Additional information is not expected.
rash, red, blister type, started with one or two spots then spread in patches oi arms, neck, buttocks, Fatigue, muscle aches one or two days- not bad per pt, 09/29 could nt sleep , like restless leg syndrome, with cramping per patient, no fever, no nausea/ vomiting or diarrhea,
Fever 104 and vomiting since 4PM on 10/6/04 (day of vaccination)
HA, dry cough x 3-5 days; tested positive for COVID (exposure happened on same day as vaccine) Narrative:
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 16-JUL-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J000495 and expiry date: 14-APR-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.