chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature  rose to 102.1, with swelling and pain of right upper arm where vaccine had been administered.  Had to leave work at about 8:30 PM, returned home and was administered Tylenol (2), cold compress on area of arm as described.  Temperature started to decline about two or three hours later.  By next morning, temperature was back to normal and  right arm had also returned to normal
developed swelling of R ankle; pain of R ankle; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had no past medical history. No history of injury. Concomitant medications included cetirizine hydrochloride (ZYRTEC) for an unknown indication on an unknown date. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 (as reported), 5 days after vaccination (31Mar2021), the patient developed swelling and pain of right (R) ankle. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of swelling and pain of R ankle included treatment with ibuprofen, immobilization and muscle relaxants. The clinical outcome of the event developed swelling and pain of right (R) ankle was not resolved.  No follow-up attempts are needed. No further information is expected.
Started have extreme joint pain.  Went to a rheumatologist and was diagnosed with spondyloarthritis.  His joints are very enflamed.
left side of the face felt numb; teeth tingling; mouth tingling; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (left side of the face felt numb), DENTAL PARAESTHESIA (teeth tingling) and PARAESTHESIA ORAL (mouth tingling) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HYPOAESTHESIA (left side of the face felt numb), DENTAL PARAESTHESIA (teeth tingling) and PARAESTHESIA ORAL (mouth tingling). On 26-Feb-2021, HYPOAESTHESIA (left side of the face felt numb), DENTAL PARAESTHESIA (teeth tingling) and PARAESTHESIA ORAL (mouth tingling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Patient was given Moderna on 08/25/21 and second dose of Pfizer was given on 9/22/21.
Information has been received from a registered nurse concerning a 56 year old female who had chickenpox as a child, who on 27-MAR-2007 was vaccinated with 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot# 656078/0169U) instead  of zoster vaccine live (MSD). The patient came in without a written order by her physician and the patient may have incorrectly told another nurse on the day of vaccination which vaccine she was to receive. The nurse believed that since the patient had chickenpox as a child, the patient was supposed to get zoster vaccine live (MSD). The nurse is waiting for a call back from the patient's physician to confirm whether varicella vaccine live (Oka/Merck) or zoster vaccine was supposed to be given. The nurse will call back with additional information. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is expected.
Dizzy; Chills; Decreased appetite/loss of appetite; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2023, the patient received the 2nd dose of Shingrix (intramuscular). On 10th February 2023, 1 days after receiving Shingrix, the patient experienced dizziness, chills and decreased appetite. On an unknown date, the outcome of the dizziness, chills and decreased appetite were unknown.   It was unknown if the reporter considered the dizziness, chills and decreased appetite to be related to Shingrix.     Additional Information: GSK receipt date: 10-FEB-2023 Reporter's comment: The case was self reported by the patient. The patient received dose of Shingrix in the series yesterday (the day before reporting), and today (on the day of reporting) began feeling dizzy, with chills and decreased appetite. The patient asked if her symptoms were normal side effect of the Shingrix vaccine.  Read from package insert, gave medical disclaimer, referred to healthcare professional. The reporter consented to follow up.
Received Flu vaccine on site at place of employment (10/30/13 at 6 AM) 9 AM - onset of coughing and couldn't seem to stop. Shortly after chest felt tight and started getting stringy, yellowish-white drainage in both eyes. Thought might have rash on chest, but this wasn't clear. Denied difficulty swallowing or swelling of tongue. Still under Dr's care on prednisone and albuterol inhaler.
Developed hives at the injection site within 24 hrs, started small then increased in size and amount. Went to urgent care on 7/12/23 and was given a steroid, which is helping the itching.  Mother indicated that child was given Benadryl when areas began to appear.
HORRIBLE SIDE EFFECTS; OFF LABEL USE; VACCINE ADMINISTERED TO CHILD; This spontaneous report received from a consumer via a company representative concerned a child of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced horrible side effects that had to be corrected by surgery, off label use, and vaccine administered to child. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the horrible side effects, off label use and vaccine administered to child was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20211031658-covid-19 vaccine ad26.cov2.s- Horrible side effects that had to be corrected by surgery. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Patient reported that after ~30 minutes after receiving vaccine she reported that her fingers and both her arms were tingling going up towards her shoulders. Patient also c/o her heart racing. Patient's VS were stable, HR: 80, BP: 136/70. EMS was called @ 1139 am: at which time patient reported that her symptoms had not worsen but that she was not improving. Patient was given 25 mg 1 tablet of Benadryl PO, patient denied any sob or chest pain. When EMS arrived, @ ~ 1145 am: patient was assessed and BP was still the same, however patient c/o dizziness when standing and then sitting down as well as nausea.
This is a spontaneous report from a contactable consumer. A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date: unknown), on an unspecified date, single dose,  for COVID-19 immunization. The patient's  medical history and concomitant medications not reported. On an unknown date, patient wanted to know if coughing up from the lungs was natural. It started with a  runny nose and injection site irritation. "Was that common? Should I get the second one or was that going to put me in the hospital?" The outcome of event: unknown. Sender's comment: Reporter type could not be probed as consumer hung up the call abruptly, hence reporter type captured as consumer or non-healthcare professional by default. Follow-up (Oct 4, 2021): This is a spontaneous follow-up report. Phone answered by the consumer who stated she does not want to be contacted any further.
States left work at 6:45PM and went to mall to return some items.  Was standing in line at one of stores and felt something in the back of her throat that felt like the size of a "golf ball".  Began coughing and wheezing but states no trouble breathing.  Noticed a red rash on her chest when she came home.  No reactions at injection stie.  Some redness from bandaid noted.  Called her FMD at 9:20PM and he advised her to take Benadryl 50 mg. by mouth and if experiences any problems in one hour to go to ER.  States she did look at throat and did not see any swelling of her uvula.  States she fell asleep.  Awoke in AM with hoarse throat and feeling sluggish.
TEMPERATURE EXCURSION EXPOSURE; This spontaneous report received from a pharmacist concerned a 30 year old female. The patient's height, and weight were not reported. The patient does not have any allergies. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced temperature excursion exposure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion exposure was not reported. This report was non-serious.
Information has been received from a licensed practical nurse concerning a 22 year old female with no concomitant medications or pertinent medical history, who on 09-MAY-2008 was vaccinated with the first dose of GARDASIL, 0.5ml, IM, (Lot # 659182/1757U).  Later that same day she developed diarrhea, was afebrile and had no nausea or vomiting.  The patient sought medical attention over the phone and was advised by the doctor to take IMODIUM as needed.  As of the date of the report (12-MAY-2008), she continued with diarrhea, and had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Information has been received from a registered nurse (RN) concerning a 9-month-old white female with no medical history who on 19-DEC-2006 (Lot #654664/0726F), 19-FEB-2007 (Lot #655406/1114F) and 19-APR-2007 (Lot #655485/1033F) was vaccinated PO with the first, second and third doses, respectively, of Rotateq. There was no illness at the time of vaccination. The RN reported that on 26-JUL-2007, the patient developed diarrhea. On 29-JUL-2007, the patient was taken to the Emergency Room (ER). The patient tested positive for rotavirus. A stool leukocyte smear showed no polymorphonuclear cells, a stool culture revealed no Salmonella, Shigella or Campylobacter and a C. diff toxin assay was non-reactive for toxin A or B. The patient was placed on Isomil DF formula and a diarrhea diet. On 01-AUG-2007, the patient's stools were noted to be normal. No further information is available.
Pt erroneously received expired Pfizer dose on 12/1/21. Staff contacted Pfizer to inquire if lot of vaccines were still viable at time of vaccination. Following discussion with Mfr,  pt did not need to be revaccinated as Pfizer Mfr had stability data to support this excursion for 1 day post expiry from manufacturing
Pt awoke that evening with fever, chills and sweating. Also, noted extreme pain in shoulder joint (L). It was too painful to move arm at all. Saw a physician on 2/12/2000 and was prescribed Motrin 800mg and Lortab 7.5. This did not help. Saw physician on 2/14/2000 and was prescribed indomethacin 25mg and took x-rays. Still no better, pain has also moved to neck, back and shoulders. No redness or fever. Dull ongoing headache in temples. Very dizzy and lightheaded on the evening of 2/10/2000.  Follow up 06/05/2000: "Patient did not recover from adverse event.  Recovering from surgery of left shoulder (AC Joint) due to staph infection/osteomyelitis of left clavicle bone in shoulder-part of clavicle was removed due to infection."
almost died; Initial information was received on 14-Dec-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves an unknown age female patient who had almost died (ill-defined disorder) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious almost died (ill-defined disorder) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "my sister in law almost die after that"  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.   It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
it causes me to itch; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (it causes me to itch) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 17-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PRURITUS (it causes me to itch). At the time of the report, PRURITUS (it causes me to itch) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Dosage text for suspect drug was reported as unknown. Patient took the mRNA LNPS B series on the 17th of November. The treatment medication was not reported by reporter.   This case was linked to MOD-2021-077905 (Patient Link).
Presented as a pulled muscle in the left chest/lung area.  No SOB, just pain and tightness in the chest.  Began after the second vaccine and occurred on and off for about 2-3 weeks.
Patient started having increases in blood pressure, heart rate, and respiratory rate. Patient also started having a fever with all symptoms starting around 2:30 pm on the day of vaccine administration. Stated that he had to go to hospital and is feeling better now.
I exp hives all over my body went to ER was observed and given medications the symptoms lasted 12 hours.
Patient began to feel dizzy and lightheaded after vaccine was given. Patient was helped to cot to lay down and began to feel better.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Severe
Patient stood to leave after the vaccinations, and reported feeling shaky, dizzy, and his hands were tingling.  We took his blood pressure and it was 82/48, then 5 minutes later it was 84/56, and 15 minutes later it was 103/68.  We offered him some water at his request and he felt much better after waiting for 15 minutes.  He never lost consciousness.
Got a fever at 1am, followed by little vomit of mucus. At 4:30am, had a febrile seizure that caused her to stop breathing and turn blue for 1 and a 1/2 minutes. Transported to hospital for treatment. Monitored a skin rash and skin discoloration - was blueish/purple on limbs and had a red raised rash on legs - especially knees.
Sick; Initial information received on 04-Nov-2021 regarding an unsolicited valid social media non-serious case received from a consumer/non-health care professional.  This case involves adult patient (unknown age and gender) who had sick (illness) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "the only times I got sick is when I got the flu shot Never again for me".  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Systemic: Headache-Mild, Additional Details: Went to MD about headaches that appeared after vaccine. Has had CT scan 09/22/2021. Awaiting results. May not be related.
Information has been received from a health professional concerning a 13 year old who on 08/15/2001 was vaccinated with a dose of varicella virus vaccine live. On 08/29/2001 , the child broke out with 20-30 lesions. No other information was provided. Additional information has been requested.
Wednesday, April 7, 2021 about 11 am I noticed my arm was red at the ejection site. I also started noticing it get bigger, redder, hot to the touch (about 100°) and very swollen. It's extremely itchy also.
2 min. after vax with dizzyness, mild tachycardia and hypertension.  Taken to ED. Observed x 2 hours, improved, D/C.
pt recvd vax; ran fever that apap did not bring down; devel hard knot on leg; sxs sarted next day after vax; to MD 2 days after immun;
Given flu shot at approx 3:30 PM on 10/26/07. By 7:30 PM felt " different". Within 10 minutes in bed with chills and oncontrollable shaking, aches, muscle cramps. This lasted for 5 hours. Next day muscle weakness and still feeling out of sorts. Feeling better by Sunday 10/28.
unable to talk w/mom; according to pt my arm got really red & sore & swelled up big; pt indicated entire lt upper arm & to below lt elbow; pt did not go to MD or take any med for it;
HEAT RASH ON CHEST STOMACH AND BACK; UPPER TORSO BROKEN OUT IN A RASH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown) dose was not reported, administered on 27-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-OCT-2021, the patient experienced heat rash on chest stomach and back. On 29-OCT-2021, the patient experienced upper torso broken out in a rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the upper torso broken out in a rash and heat rash on chest stomach and back was not reported. This report was non-serious.
Pt given RECOMBIVAX HB instead of Hep A. Discovered when putting in NCIR. Medication Error.
I developed cold symptoms on June 26th, I was on vacation with a number of relative.  In hindsight, I think all 11 of us contracted COVID-19. It last about a week, I believe on the 1st of July I developed fatigue and kept napping and also developed diarrhea. The diarrhea went on for 6/7 days even after we returned from vacation. The tiredness was gone, the cold symptoms were gone but the diarrhea remained. I spoke with Doctor office and they took some culture that revealed Campylobacter, so unknown if it was related to COVID-19. Doctor prescribed an antibiotic, and that cleared it up. I also seem to have an upper respiratory cough that I cannot get rid of that seems to come and go.
pt recvd flu vax & exp raised area around inject site 1st 24 hrs p/inject & c/o itching, generalized rash w/in raised area @ inject site;
experiencing itchiness; the skins of the patient's hands has broken up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (experiencing itchiness) and SKIN DISORDER (the skins of the patient's hands has broken up) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history      ). Concomitant products included Blood pressure tablets for Blood pressure, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PRURITUS (experiencing itchiness) and SKIN DISORDER (the skins of the patient's hands has broken up). At the time of the report, PRURITUS (experiencing itchiness) and SKIN DISORDER (the skins of the patient's hands has broken up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included hand lotion.
14 Jun 06: Cardiology clinic - vaccinated 1 Jun with onset of headache on 10 Jun he reported increasing headache associated with fever, shakes, chills. On 12 Jun he reported onset of episodic resting sharp chest pains. He was treated with antibiotic and NSAIDS. Subsequent CK, CKMB, and Tnl were positive and patient was instructed to drive to the emergency department. With the exception of a minor headache the patient is now asymptomatic. ECG over the past 2 days demonstrate diffuse 0.5-1 mm ST elevation with T-wave inversions. There are not any appreciable PR depressions. The patinet denies travel or sick contacts. Flu-like symtoms <96 hours Start: 06/11/06 Comment: headache/fever/chills. Chest pain, sub-sternal Start: 06/12/2006.  04/23/2007 MR received for 2 OVs on 6/15/2006 for F/u for c/o 2 day hx of headache, fever chills and new onset of episodic resting sharp chest pain. A/P:  Acute Myopericarditis:  Temporally related to the vaccinia virus/small pox vaccination. F/U 7/10/2006 Asymptomatic. Per annual follow up: Pt lost to F/U.
This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates in 2015, the unspecified number of patients were vaccinated with doses of LIQUID PEDVAXHIB, (strength, dose, frequency, route and anatomical location were not reported) (lot # reported as K015462, expiration date 10-JUL-2017) which were improperly exposed to 47 Fahrenheit temperature for 11 hours since an unspecified date in March 2015. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.