chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 09 December 2011 from the Investigator under the reference number M5A16. A case of pertussis disease in a 4-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject's vaccine history included 4 doses of TRIPEDIA; lot number U1813BA received on 27 March 2007, lot U1813BA received on number 01 June 2007, lot U1813BA received on number 07 August 2007 and lot U2397AA received on 06 October 2008 (route and site of administration not reported). The subject developed cold-like symptoms on 15 August 2011, approximately 3 years after the last dose. On 17 August 2011, the subject developed a paroxysmal cough, but no whoop or posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 22 August 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin for 5 days starting on 23 August 2011. The subject was not hospitalized. At the time of final contact on 20 September 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 37 days. The outcome was reported as not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Information has been received from a physician concerning a 9 yr old female who in May 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine. On 02Jun04 titers were taken and for 14 of the 23 valents the results were negative for seroconversion. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Infant pale following administration of PENTACEL, PREVNAR, RECOMBIVAX, and ROTATEQ. O2 sat, BP, P, R all normal Blood sugar normal. Symptoms gradually resolved over a 30 minute time period.
Child's grandmother called and stated he had a lump the size of a golf ball in the area of the shot on the left arm. Nurse instructed her to give Benadryl and nurse then reported to childs Pediatrician.
Administration: 5:00 PM. nausea Vertigo 7:00 PM.
Significant body rash from second vax; Very itchy all over tat night particularly if I have any insect bite; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Significant body rash from second vax) and PRURITUS (Very itchy all over tat night particularly if I have any insect bite) 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.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 RASH (Significant body rash from second vax) and PRURITUS (Very itchy all over tat night particularly if I have any insect bite). At the time of the report, RASH (Significant body rash from second vax) and PRURITUS (Very itchy all over tat night particularly if I have any insect bite) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.
S&S: SOB, edema to lips, wheezes, tachypnea. Treatment: OTC PO Benadryl 50 mg @ 1124; Epi-Pen .3mg RLE @ 1126.  Outcome: + improvement-transferred to EMS- Hospital.
Developed 2-3 cm local reaction at injection site following day.  The rash at side that continued over the body.  Tried Benadryl, was given Prednisone at doc. visit.
Fever102.8, chills, sweats, clamminess, body aches, joint pain, uncontrollable shaking. Began 6 hours after vaccine administered. Tylenol taken to bring fever down. Still has symptoms today although tge fever is lower.
After waiting by the pharmacy for approximately 15 minutes the patient and her sister (who also got the vaccine) went shopping in the store. After a few minutes she started coughing and having difficulty breathing and felt as if her throat was starting to close up. Her sister urged her to come back to the pharmacy. We had her come sit in the counseling room and have her tell us what was happening. Since her chest and throat felt tight and she she was having breathing issues we gave her a dose of epinephrine and called 911. She did state her breathing got easier after the epipen was administered. At no time did she lose consciousness or the ability to speak. She did go with EMS to the ER for observation.
reaction because of the polyethylene glycol in the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction because of the polyethylene glycol in the Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction because of the polyethylene glycol in the Moderna COVID-19 vaccine). At the time of the report, VACCINATION COMPLICATION (reaction because of the polyethylene glycol in the Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication is not provided.  Reporter declined for followup
Post vax, had 4 days of inconsolable crying, decreased intake, minimal sleep and unresponsive to acetaminophen. No fever and normal physical exam on 12/22/00; leg not swollen or tender.
Shingles inj given 10/3/17. Rx next AM red, swollen, tender, warm to touch, and itching.
Fussy for 3 days after shots given. Sleep disruption. Perceived leg pain; no swelling.
"horrible side effects that feels like I am have COVID all over again" -- very dizzy, terrible headache, left side of throat sore, temp of 100.2, chills, night sweats, can barely stand
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other=Moderna, Vaccine brand: Pfizer / BioNTech; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Feb2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hx of stroke" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; MAGNESIUM GLYCINATE; B12 [CYANOCOBALAMIN] sublingual; RIBOFLAVIN; TYLENOL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Oct2022 at 14:00, outcome "unknown", described as "Vaccine brand other=Moderna, Vaccine brand: Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 09Dec2022 to 14Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case, a possible causal association between the reported events and the suspect drug cannot be excluded.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 16-DEC-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, albumin status: recombinant human albumin (rHA)). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742.
That evening - severe bloody nose - fever of 104 as measured by home thermometer.  Fever, nose bleeds, lethargic behavior for subsequent days.  June 17th (5th day) morning - unable to stand (bare weight) on legs.   In months following, recurrent inability to stand/walk.  Approximately six months following, neurological symptoms including chorea, head bobbing, dysphagia, ataxia.
The patient came in for the first mono-valent Pfizer Covid-19 but was given the Pediatric Pfizer Update booster instead 3 weeks ago.  The patient came in to get the second primary dose that was when we recognized the mistake.  We will give the patient the mono-valent Pfizer as a second primary dose.
Mom phoned to advise that rash of small red dots on child's wrists appeared 1/24/08 and continued to progress to full body rash over next 2 days, then redness, swelling of hands.  Seen by private MD 1/30 advised measles.  By 2/7 rash faded, hands and feet peeling with cracked skin.  On 2/8 second rash, blistery with fluid filled areas appeared, crusted & scabbed in 1-2 days.  No fever reported through all rashes.  Not seen by MD after 2nd rash developed.
chills; fever; fatigue; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. After first dose of covid-19 vaccine, experienced chills, fever, and fatigue for approximately 6 hours. Outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Complained of feeling foggy and a weird taste in her mouth after getting the first dose of the vaccine.  transferred to ED via wheelchair.
pt recv vax 6OCT95 & devel a fever, chills & inflamed lymph glands in axilla & breast on the side where the inj given;tx was hot compresses & sx subsided;
PINKISH RED SKIN; DRY TONGUE; DRY THROAT; BURNING ITCHY SENSATION AROUND JAW , NECK AND EYE; EARS PAIN; HOT ITCHY EARS/NECK/BACK/ARM; INJECTION SITE PAIN; INJECTION SITE SORE  AND BLED; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included ldl high, and other pre-existing medical conditions included the patient does not have any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and diphenhydramine hydrochloride.  On 31-MAR-2021, the subject experienced injection site sore and bled. On 31-MAR-2021, the subject experienced injection site pain. On 13-APR-2021, the subject experienced ears pain. On 13-APR-2021, the subject experienced hot itchy ears/neck/back/arm. On 13-APR-2021, the subject experienced burning itchy sensation around jaw, neck and eye. On 14-APR-2021, the subject experienced pinkish red skin. On 14-APR-2021, the subject experienced dry tongue. On 14-APR-2021, the subject experienced dry throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site pain, injection site sore and bled, ears pain, pinkish red skin, burning itchy sensation around jaw , neck and eye, dry tongue, and dry throat, and had not recovered from hot itchy ears/neck/back/arm. This report was non-serious.
Within 15 minutes, headache, shivering, muscle and joint pain.  Within an hour, hives outbreak, severe immobilizing joint pain and vertigo with vomiting.   Feet and ankles and right knee, plus hands, were visibly swollen.  Unable to get out of bed for 48 hours until found by neighbor and was able to get Benadryl and a cane.   Hives and vertigo improved after 300mg of Benadryl.   Joint pain slowly subsided but right ankle is still 6 out of 10 for pain today, 20 days later.  Still having difficulty walking.
patient had received his vaccine and was still sitting at the vaccinators table, stood up to leave and became very dizzy and unsteady. Per the vaccinator she had him sit down on the ground. Patient was give water, BP was taken and WNL.  Refused further intervention. Remained sitting for about15 minutes at the vaccinators table as well as in the waiting area for 30 more minutes and resolved. Encouraged the patient to let us know for the second vaccine and we will let him lie down for the second vaccine
Dizzy, lightheaded, shakey, nausea ; no screen time; no television; still get episodes until this day
sleepy; lazy; Both were left arm injections and she had right arm pain; She has a bad shoulder/This pain was different; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL1283 and expiry date was not reported), intramuscularly, in Arm Left, on 03Mar2021 at 09:00, as a single dose for COVID-19 immunization at hospital (Age at vaccination: 69 years). The patient medical history included heart palpitation (She is taking medication for heart palpitation when she gets stressed out. Her heart palpitation does go up. Since she has taken this medication, it has been under control and she is good and she is a healthy person generally), magnifying glass (she stated she cannot even see without her prescription glasses. They cannot get it right. She has magnifying glass. She needed before she got both doses. It was pre-existing). The patient weight was weight is 145-150 lb. Historical vaccine included first dose of dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6201 and expiry date was not reported), intramuscularly, in Arm Left, on 10Feb2021 at 08:35 am, as a single dose for COVID-19 immunization at hospital After first vaccination, she felt tired and lazy around 12:00. They got home and had lunch and she was feeling lazy, so she layed on floor and fell asleep for a few hours. It continued for a couple of days and then she was total 4-5 days, was still feeling lazy and had no energy. Nothing hurt. She then stated that the opposite arm hurt from injection. She got injection in left arm and her right arm was sore around 10:30 and it hurt at home before 12:00. She got shot on left arm both times. Both have improved. Her arm was fine after that. No additional Vaccines administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccine in four weeks. The patient received second injection on 03Mar2021, at 09:00, she still felt very lazy. She made an appointment to see her primary doctor. She said she had other issues going on anyway that she wanted to see her doctor for. No further details provided. Her husband brings her a little breakfast and she stayed in bed to checked messages. By the time she comes downstairs, she feels sleepy. She ate and then cannot keep eyes open. That started 03Mar2021. It has been just persisting. She just feels like you are wasting time by sleeping. She said nothing is hurting, then stated that her arm hurt both times in the opposite arm. Both were left arm injections and she had right arm pain. She has a bad shoulder. This pain was different. It came a couple of times a day for 2 days and after that it was normal. It can be frustrating because you want to go out and you feel sleepy. No ER or physician office required. Outcome of the event sleepy was unknown; event lazy was not recovered; events both were left arm injections and she had right arm pain was recovering and other event recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
had a reaction and am still suffering from aching joints /elbow joints have pain; The arm by afternoon was red in a big circle to the elbow.; injection was given in the back of the arm /shot being given in soft tissue instead of the muscle; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (in childhood, had severe chicken pox) and shingles (patient's grandmother, mother, and one daughter all had shingles.The patient's daughter for 2nd time.).   In November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a day after receiving Shingrix, the patient experienced erythema of extremities and intramuscular formulation administered by other route. On an unknown date, the patient experienced joint pain. On an unknown date, the outcome of the joint pain and erythema of extremities were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the joint pain and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine in unknown arm. The patient experienced aching joints. By afternoon the patient was experienced red in a big circle to the elbow, which was lasted days were not recovered. due to joint pains the patient unable to lift even a cup of coffee. The patient asked that the shot being given in soft tissue instead of muscle made a difference, which led to Intramuscular formulation administered by other route. The patient also asked about having the 2nd dose.
High blood pressure; Low blood pressure reading sometime; When i got the second shot i had after reactions to it; Erractic heart beat; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (When i got the second shot i had after reactions to it), HEART RATE IRREGULAR (Erractic heart beat), HYPERTENSION (High blood pressure) and HYPOTENSION (Low blood pressure reading sometime) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 019B21A) for COVID-19 vaccination. The patient's past medical history included Parathyroid gland excision (Removed it 5 years back.). Concurrent medical conditions included Drug allergy (Statins Hmg Coa Reductase inhibitors), Drug allergy (Doxycycline), Drug allergy (Levothyroxine (Synthroid)), Drug allergy (Ibuprofen) and Hypercholesterolemia (Patient was told this was genetic by the endocrinologist.) since 1985. Concomitant products included FISH OIL for High cholesterol, MULTIVITAMIN [VITAMINS NOS], CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) and CALCIUM for an unknown indication.   On 28-Apr-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021 at 9:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2012 at 6:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE IRREGULAR (Erractic heart beat). On 29-May-2019, the patient experienced VACCINATION COMPLICATION (When I got the second shot I had after reactions to it). On 29-May-2021 at 6:00 AM, the patient experienced HYPERTENSION (High blood pressure) and HYPOTENSION (Low blood pressure reading sometime). At the time of the report, VACCINATION COMPLICATION (When i got the second shot i had after reactions to it), HEART RATE IRREGULAR (Erractic heart beat), HYPERTENSION (High blood pressure) and HYPOTENSION (Low blood pressure reading sometime) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2021, Heart rate: low (Low) Low.         Treatment information was not provided.   This case was linked to MOD-2021-122775 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Patient demographics updated, medical history added, and dose 2 information updated. Dose 2 events added. On 08-Jul-2021: Follow up received contains No new information. On 06-Aug-2021: Follow up received contains no new information.