chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 09-NOV-2012 10:06, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Hearing loss (right ear) Non stop Loud Ringing in ear (right ear)  Migraine due to ear pain.  Pain in left chest when breathing.
Within 15 minutes: Headache and sensory distortion in face.  Cognitive fog. Next couple days, then resolving: Sore right arm, torso rash.  Days 3 to present, variable intensity: MS, fibro, & RD flare, possibly IBC.  See #12 for sx.  Unusual intensity: hand inflammation, gingivitis (at 5 wks) & cold sore (at 2.5 months) attacks w/ entire face swelling, urinary & bowel accidents, digestive slow-down & pain, food intolerances, MS spasticity.  At 4.5 months, flare still continuing, decide LDN dose may now be too high and start titrating down from 2.5 mg, to 2.0 mg, etc, until 12/31, take last LDN.  During and after, continuing sx reflect withdrawal/immune adjustment.  See p 2.   Item 18:  Note: My sister's MS and Crohn's both flared after 2 Pfizer shots in March, and she has not recovered yet either.  She takes no DMD's, only drugs for sx.   So neither of us are "immune suppressed;" if anything, we are hyper-immune.  She doesn't think she had COVID.
Pt recvd 3rd doses Hep B vax 1APR91 & on 4APR91 exp back pain, stiffness & swelling of the hands & feet & fatigue; On 5APR91 devel t102.4; Later that day pt presented to ER t101.3; lab eval revealed nl UA, WBC count 6200, 2 atypical lympho
Quarter size, hard, swollen area on upper left thigh states temperature to area is same to surrounding skin-warm. States no change in behavior noted other than increased drowsiness.
INJECTION SITE DISCOMFORT; SHARP SHOOTING PAIN IN LEFT ARM; This spontaneous report received from a consumer concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced injection site discomfort. On APR-2021, the subject experienced sharp shooting pain in left arm. Treatment medications included: diphenhydramine hydrochloride/naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp shooting pain in left arm, and the outcome of injection site discomfort was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored M-M-R II (strength, dosing details, anatomical locations, lot # and expiration date were unknown). No patients reported adverse effects. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
swelling of feet, face/foot numbness, asthma, vomiting, sneezing, headache, coughing, chest pain and tightness, veins swelling and electric shock waves through arm
Pt recv'd Anthrax vax on 11/6/99; pt exp site tenderness on 11/7/99. On 11/8/99, site welted. Hot to touch and aching.
Oct 6 she woke up with pain when she moved her arm over her head or behind her. She is currently seeing her ortho MD and getting an MRI.
No adverse effects were reported; the patient, was inadvertently administered an expired dose of MMR II; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided.   On 06-MAY-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # N013869, expiration date 05-MAY-2019; strength and dose were not reported) subcutaneously for prophylaxis (expired product administered). No adverse events were reported.
22 y/o Pt reported to the clinic three hours post vaccine reporting that they felt like someone was choking them. Pt received Benadryl and Epi and was transported.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 13 months old child patient and unknown gender. On 29-AUG-2014 the patient was vaccinated with a dose M-M-R II (lot H020255, expiration date not reported) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 6 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Discomfort on left, including  arm, shoulder, back, neck,  under arm and  breast.  Became more noticeable  8-11 days post vaccine.  Today is day 11 and it feels like it is radiating out more.  Mild neurologic feeling pain in areas noted above.  Still have reddened area on arm at vaccine site as well, which feels warm.   I am not alarmed at any of this, but am reporting so that more data is available.  I have read that other women have reported similar reactions.
TIA stroke.  Admitted to hospital overnight.  CT and MRI. EKG (2) Prescribed Rosuvastatin, aspirin  Also had secondary finding of mass on pituitary gland
Skin rash. Hydroxyzine 25 mg QID, Fluocinonide BID, Pramoxine Prn.
Had sore throat the next morning, with headache, and by evening changed to cold. Felt feverish and had muscle aches and body pain. After 2 days developed cough. Still monitoring as of today Oct 19 2021. Gave tylenol for 2 days.
This case was reported by a pharmacist via call center representative and described the occurrence of cough in a 62-year-old male patient who received SHINGRIX (batch number MG42F, expiry date 21st May 2021) for prophylaxis. On 16th January 2019, the patient received SHINGRIX. On 17th January 2019, 1 days after receiving SHINGRIX, the patient experienced cough, cold and tiredness. On an unknown date, the outcome of the cough, cold and tiredness were not recovered/not resolved. It was unknown if the reporter considered the cough, cold and tiredness to be related to SHINGRIX. Additional details were provided as follows: The next day of vaccination, the patient began to feel like he had a cough and cold post vaccination. The patient was also feeling exhausted and tired. The reporter consented to follow up.
Shoulder pain and hives and "heat bumps" developed around 24 hours after vaccination. Benadryl helped tp resolve the hive and "heat bumps, " but the shoulder pain persisted. I called the patient to follow up on 04/14/2021 and she stated  her hives and heat bumps have resolved but her shoulder pain is still persisting even after seeing a doctor and being prescribed ibuprofen. She also stated she was prescribed a patch as well but was unsure of what kind.
fever, nauseous, redness itch lower injection area, fatigue, headache, urinated 10 times that evening, tired, chills, itching, swollen arm
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 17-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ(lot # R002805, expiration date: 23-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
obtained flu like s/s beginning 8 days p/vax;had temp fluctuations (hot & cold), mental slowness, weakness, fatigue, lack of energy, cough, some muscle aches, some joint pain;
low grade temp, mild swelling, gen pain in lt leg x 2wks;25OCT96 tx @ ER w/t102, croupy cough, cont & c/o pain;28OCT96 refused to walk-screaming w/pain, bed wetting;seen by MD;lost control of arms & hands as well as legs;dx GBS;
12/02 Diahrrea started 4 1/2 hrs. after H1N1; 12/3 fever next day- Doesn't know how high but high enough -She gave her Tylenol. Sudsided after 2 days. Diahrrea continues; cough; severe yesterday- Bad enough daycare would not take her today.
patient experienced abdominal rash the morning following vaccination.  She took Zyrtec, but rash got worse for the following 7 days.  She applied aloe vera gel and hydrocortisone cream and rash is slowly resolving
Pt has continuous glucose monitor and she noticed the glucose reading was rising steadily. She took extra injections of insulin, which would lower it slightly, but then it would go back up. Her glucose level got to 400 around 3:30 pm. She experienced issues with this for two weeks. She also had periods of abdominal pain, nausea, palpitations, and weakness.
This is a spontaneous report from a contactable consumer who reported for her son. A male patient of an unspecified age and ethnicity received, on 29Apr2016, the third dose of TRUMENBA at 0.5 ml, single dose. Relevant medical history and concomitant medications were unknown. The patient previously received the first dose of TRUMENBA on 18Dec2015 and the second dose on 18Feb2016, both at 0.5 ml, single dose. After the third shot, which was given by mistake 2 months after second dose, he felt warm. Clinical outcome was unknown at time of this report. Follow-up (24JUL2016): Follow-up attempts are completed. No further information is expected.
No adverse events; patient received an expired dose; This spontaneous report as received from a physician, concerning to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 14-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at 0.5 milliliter dose, which had a lot # R018136 with expiration date in 10-JUL-2020 (expired product administered) (route of administration was not provided) for prophylaxis.  At the time of this report the patient had not had adverse events. No PQC was reported.
Within 10min after vaccination, developed chest tightness, wheezing, eye watering, redness/hives all over. EMS was called.  He received 2 epinephrine shots and antihistamines.  He was taken to ER where he was treated with more meds (type?), and monitored for about 4 hours before being released, feeling completely recovered.  Presumed anaphylactic reaction was followed-up in Allergy Clinic on 11 July 2019.  Because patient had no prior episodes, and regularly ate eggs and gelatin (YF-Vax excipients) with no problems, Allergist opted against extensive testing.  Because YF-Vax not indicated for repeat dosing, patient was allowed to return to work without limitations.
Pt. states that after receiving the 3rd dose Booster of Moderna 08/30/2021, started experiencing symptoms 08/31/2021 of pain at the injection, redness, and fever. Exhibited muscle aches first, chills, nausea, dizziness, and rash. No noted Primary visit. Flu shot received at the same time.
Shooting, aching pain on left-side where shot was given. Pain started at jawline, extended halfway down left-side of back and chest. Continued into badly swollen shoulder, down left arm to elbow. Pain intense in collarbone, shoulder bone and elbow. Pain medicine doesn't work.
10 hours post vaccination, swelling to left eye. No redness at injection site, no cough, no SOB. Treated with BENADRYL.
achy; sweaty; tired; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), HYPERHIDROSIS (sweaty), FATIGUE (tired), PYREXIA (fever) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     The patient's past medical history included Pertussis in 2007 and Pertussis (bronchioles was effected) in 2012. Previously administered products included for Product used for unknown indication: Pfizer on 01-Mar-2021 and Pfizer on 21-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Cough.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achy), HYPERHIDROSIS (sweaty), FATIGUE (tired), PYREXIA (fever) and HEADACHE (headache). At the time of the report, PAIN (achy), HYPERHIDROSIS (sweaty), FATIGUE (tired), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
Positive covid-19 test on March 18, 2021 after fully vaccinated for over one month Patient completely asymptomatic, tested for friend visit
Patient was taking a shower when his spouse noticed that he had a rash on his chest and left arm.  Next morning patient woke up with rash on chest, both arms, back, neck, and upper legs.  Rash is itchy with pustules.
Severe joint and muscle pain throughout body. Fever of 101. Sore throat, earaches, headaches. All of these lasted for approximately 26 hours.
Fever, body aches, nausea, chills, arm pain, headache dizziness, lethargy
5-10  minutes after vaccine administration patient had a 1-2 minute tonic seizure with loss of posture, urinary incontinence.  Both arms tonic flexed elbows, clenched inverted hands.  Lowered to the floor.  Post-ictal for 20-30 minutes, briefly fell asleep.  Vomited x 2 after seizure was over.  No memory of seizure.  Spontaneous resolution of seizure.
Patient developed vomiting and diarrhea at age 7 mo, on 1/11/15, was taken to ER on 1/12/15, bloody stool developed and he was transferred to hospital and was diagnosed with ileocolic intussusception, had surgery for this.
a few days after she rcvd her shot she fell down and part of her body locked itself and she had seizure like symptoms
Pt received PNEUMOVAX vaccine 10/2/13. She developed diffuse redness and swelling of (L) arm the next day. Redness started 4 inches below immunization site and extended 12 inches down (L) arm and redness was 4" wide. Seen in office 10/4/13 and was given prednisone 40 mg BID.
arm is very sore where I got the shot; Chills; Fever; Headache; Neck is sore; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2019, the patient received Shingrix. In November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, chills, fever, headache and neck pain. On an unknown date, the outcome of the injection site pain, headache and neck pain were not recovered/not resolved and the outcome of the chills and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, chills, fever, headache and neck pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had chills, fever and neck was sore. The patient arm was very sore where received the vaccine. The reporter asked how long did side effects last. The reporter asked was there anything else can assist. The reporter was day 3 since fever and chills were gone but headache, sore neck was still hurting.
rash on neck & chest on 27APR95 w/fever 102.6 (ear);28APR95 blotches of rash;29APR95 head to toe rash;cough & runny nose started 24APR95;sensitive eyes 27APR95;Koplik spots per MD 29APR95;appear very sick starting 27APR95;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-OCT-2015, the patient was vaccinated with the involved in the temperature excursion dose of VAQTA (lot # L018499, expiration date 25-FEB-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented to clinic for booster following receipt of J&J for primary series. Full-dose Moderna was administered by mistake. Patient was notified about dosing error via phone. No questions or concerns.
UNSURE WHICH VACCINATION CAUSED REDNESS AND SWELLING WITH CELLULITIS WAS GIVEN BOTH MMR AND DTAP ON THURSDAY AND RED AREA NOTED IN LT THIGH AREA.
SWOLLEN TESTICLES TO 3 TIMES THEIR NORMAL SIZE; SWEATS; CHILLS OR TEETH CHATTERING; FEVER; This spontaneous report received from a health care professional concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included the patient did not have known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 05-MAY-2021 11:38 for prophylactic vaccination. Concomitant medications included testosterone. On 05-MAY-2021, the subject experienced sweats. On 05-MAY-2021, the subject experienced chills or teeth chattering. On 05-MAY-2021, the subject experienced fever. On 06-MAY-2021, the subject experienced swollen testicles to 3 times their normal size. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills or teeth chattering, fever, sweats, and swollen testicles to 3 times their normal size. This report was non-serious.
About 7-10 minutes after vaccine administration, Pt. got up to make second dose appointment.  When he returned to his chair, he felt light-headed, dizzy, disoriented, sweaty, nauseous, and started dry-heaving.  Pt.'s blood pressure was normal.  I monitored the PT.'s blood pressure, put an ice pack on his neck, gave him saltines.  Pt. started to feel better after about 15 minutes or so.  Pt.'s Mom was with him and drove him home.  Pt. stated when he was little he would faint from hypotensive events from sitting to standing. I called PT.'s MD this morning and they were going to follow-up with PT. today.  I followed-up with PT. last night and PT. was doing well.
Chills, felt sick, fatigue-started evening of vaccine, continued x 2 days. 1 week later, lips swollen and tingling, has persisted since then.
Flu like symptoms lasting over 2 days now. Dizzy, tired, aches, headache, fever. Second morning felt better, but getting worse as day went on.
arm was sore; This is a spontaneous report from a contactable consumer (patient) received via regulatory authority. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number unknown), via an unspecified route of administration, administered in the right arm on 21Apr2021, at 16:30 (at the age of 41 years old) as dose 1, single for COVID-19 immunisation. Medical history included known allergies: cillin based medicine. She was not pregnant at the time of report. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine and other medications within two weeks of vaccination. The patient reported that her arm was sore after shot 1. The pain subsided and then came back. It was reported that the onset of the event was on 19May2021, at 16:45. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. The patient has not recovered from the event at the time of report. She also received the second dose of BNT162B2 on 21Apr2021 (as reported; being clarified) (at the age of 41 years old) for COVID-19 immunisation.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100911353 same patient, drug, and event; different dose
Transverse Myelitis worsened; Transverse Myelitis worsened; I could not walk; trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunisation. Medical history was not provided. Patient was not pregnant, was not pregnant at time of vaccination. Concomitant medications included other medications in two weeks. No other vaccine in four weeks. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) at the age of 39-years, via an unspecified route of administration in right arm on 19Mar2021 14:00 at single dose for COVID-19 immunisation and experienced transverse myelitis; received zaleplon (SONATA) and experienced allergies. Less than 24 hours after receiving the second vaccination, the transverse myelitis worsened and patient could not walk and was beginning to have trouble breathing. Patient went to emergency room and was admitted and treated there for the following week for the condition transverse myelitis. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Days hospitalisation: 7. Patient received treatment for the events included among other meds, 5 day course of IV steroids . No covid prior vaccination, patient underwent covid test (Nasal Swab) post vaccination on 10Apr2021, covid test result was Negative. Outcome of the events was not recovered.  Information about lot/batch number has been requested.
Arm got very sore, red and very hot to the touch  about 2 inches below the injection site. Her husband called the doctor office and left a message and then to the pharmacy. The RPh on duty advised the patient to take Benadryl and two Ibuprofen 200mg on Monday evening. The patient went to the doctor Tuesday morning and got a prescription for Keflex 500mg ( four times daily for 5 days).
Large local reaction with redness, swelling right arm, elbow to shoulder with some redness spreading to R anterior chest wall. Tactile fever.
Injection site reaction: Redness, swelling, pain and tenderness on injection site next morning. Second day now and the redness has increased. Told by provider these are expected symptoms.