chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; an improperly stored vaccine was administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, allergies and drug reactions were not provided.   On 16-SEP-2022, the patient was vaccinated with improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U039726, expiration date: 15-DEC-2023, (strength, dose, dose number, route and site of vaccination were not provided) for prophylaxis (product storage error). The suspect vaccine underwent temperature excursion of -11.8 Celsius degrees (C) for 1 hour and 45 minutes. The previous temperature excursion was not reported. No additional adverse event (AE) was reported (no adverse event).
Around 18 minutes after my shot I started to experience itchiness on the top of my right hand. I t started with the middle fingers and then it spread to the back of my right hand. The left hand followed suit but just that back of the hand it did not start with my fingers on my left hand.
received vaccine #1 on 12/06/2021 and 2nd on 12/08/2021.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th December 2021).   On 8th December 2021, the patient received the 2nd dose of Shingrix. On 8th December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose early than the recommended time interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Initial report received on 22 February 2007.  This subject was a 15 month-old male who experienced a febrile seizure while enrolled in a study.  The subject received four doses of PENTACEL; last dose prior to the event was administered on 20 February 2007.  The subject experienced a febrile seizure (length of seizure was not reported) around 17:20 p.m. on 21 February 2007, which was one day post-immunization.  The subject was not admitted to the hospital.  Treatments received and diagnostic tests performed were not reported.  The investigator considered the febrile seizure to be an important medical event.  The subject recovered.  Follow-up information received on 26 February 2007.  Twenty-five hours post-immunization, the subject experienced a febrile seizure at home that lasted approximately 30-90 seconds.  He was transported by ambulance to an emergency room for evaluation.  Upon arrival, he was awake, alert, and in no distress.  Temperature in the emergency room was 103.9 degrees Fahrenheit.  He was treated with Motrin and Tylenol and subsequently discharged to home.  No diagnostic testing was performed.  Past medical history was documented on the record as "healthy."  Emergency room diagnoses were febrile seizure and viral illness.  The investigator considered the event to be an important medical event.  The subject recovered from the event and continued in the study trial.  Follow-up information received on 19 August 2008 from the investigator.  The event of fever was removed as a symptom of the febrile seizure as it is implicit in the diagnosis.  The event of febrile seizure was reported by the investigator as related to the study vaccine.   Documents held by sender: emergency room record.
Pts mom states pt screamed for 5 hrs & had a fever of 102 w/in 48 hrs p/inject;
Patient was administered the first dose of  MODERNA COVID - 19  vaccine, , a few minutes later while patient was sitting at post vaccine wait area for observation, patient experienced what may have seemed like SYNCOPE. Patient stated that she felt dizzy and light headed, Pharmacist offered to call ambulance, but patient stated she was ok, patient was given  water to drink and observed for another 45 minutes, patient later left  with a family member saying she was ok. Called patient about 2 hours  later to follow up and per  patient, she was doing ok.
Chills, feeling warm, headache, congestion, tired, achy, nauseous, loss of appetite. All symptoms except for slight congestion gone within 48 hours of shot.
was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; Vomiting; Nausea; Chills; Tiredness; Jaw pain; stress on my heart; shortness of breath; no energy; This is a spontaneous report from a contactable consumer (patient). A 79-years-old patient of an unspecified gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number AN5318) , via an unspecified route of administration on 26Jan2021 at single dose for covid-19 immunisation .  The patient previously took the first dose bnt162b2 on 05Jan2021for covid-19 immunization at 79-years-old, then experienced headache, chills, jaw pain, tiredness, nausea, vomiting. The patient medical history was not reported.  The patient's concomitant medications were not reported.  In 2021, the patient have had both the shots of the vaccine (COVID Vaccine) and was still having a lot of symptoms that should not be having like headache, chills, jaw pain, tiredness, nausea, vomiting and patient have had both of them (Both shots) and patient also have been in the hospital with this. The patient had bad jaw pain. The patient had the first shot on 05Jan2021 and had the problems since then and then got the second shot on 26Jan2021 and it got worse. The patient had chills and shortness of breath and after the second shot, the patient landed in the hospital. The physician did several tests. The patient was bleeding, stool was black from blood, and patient was vomiting blood. The patient had stress on heart and did not have a heart attack but had stress on heart. The patient had no energy and cannot breath and it is just that have not energy. The outcome of events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021214946 same patient/drug/event, different dose
I felt like I had the flu, I couldn't breathe, my chest was heavy, I was coughing. I tested for COVID-19 with a home test that came back negative. I asked my husband to take me to the emergency room. Once we got to the emergency room, they retested me for COVID-19, RSV, Influenza A and B, the only test to come back positive was Influenza A. I was prescribed steroids, a Z-pack and benzonatate. I saw my primary care physician in a week. I was not feeling well I was advised that it was from no longer taking the steroids.
Horrible dizziness Intense fatigue Brain fog - to the point of slurring words All lasted several weeks, then the dizziness turned to vertigo, the intenseness of the fatigue, and the brain fog VERY SLOWLY lifted over the past two months.
Low degree fever, body aches lasted 36 hours sweat and nausea occasionally within the first 36 hours Arm sour 48 hours All gone on it own without treatment
+ 1.5 X 3 cm area of erythema / tiny blisters/ mildly raised on R anterior thigh.
The patient is a 82y.o.  male admitted at a local Hospital since 10/7/2022  8:38 PM with the diagnoses of Hypernatremia.  Patient has a history of dementia and has been living at a assisted living facility.  And has been exhibiting aggressive behaviors on and off.  He has been refusing his psychotropic medications.  The patient was in the process of being transferred to a Geri psych unit however being admitted to our medical floor for treatment of dehydration.  Patient has a bed waiting at another Hospital    Patient continues to be confused.  He is unable to have a logical conversation.
Post vax, the pt developed an injection site reaction characterized by a large area of redness and itching. She recovered.
Information has been received from a registered nurse concerning a patient "greater than 32 weeks of age", who on an unknown date was vaccinated with the third dose of ROTATEQ vaccine. No adverse effect was reported. Additional information has been requested.
Baby went pale and limp, was unresponsive for about 30 seconds, very fussy.
Case number PHEH2014US021232, is an initial spontaneous report from a consumer received on 20 Oct 2014. This report refers to a female patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with influenza vaccine (unknown manufacturer, batch number: not reported) on an unknown date (years ago). On an unknown date after vaccination, she experienced Guillain-Barre syndrome. It was reported that the patient cannot get the vaccine now. The outcome of the event was unknown. Seriousness and causality was not reported. Seriousness assessment of the event Guillain-Barre syndrome was based on NVD key events.
The pt experienced a fever, seizures lasting 2-3 minutes. This developed within 24 hours post vax.
This spontaneous report as received from a registered nurse (R.N.) refers to an unspecified number of patients of unspecified age and gender. No medical history and concurrent conditions were reported. Since 09-JUN-2015 (exact dates unspecified), the patients received doses of improperly stored, oral, ROTATEQ suspension 2 (lot number, dose, frequency, route and site of administration was not reported). No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was filed. No further information was provided. This is one of the 4 reports of the same reporter. Additional information has been requested.
sore arm/arms were quite sore; injection site pain; extreme fatigue/exhaustion; a little headache; chills; muscle pains which makes them a little achy overall; feel like they have Covid all over again; achy; feel lousy; sleepy all afternoon and stated that she sat down and just passed out, caller clarified that she went to sleep/very drowsy; issues with breathing and shortness of breath; This is a spontaneous report from a contactable consumer (patient herself) via Medical information team. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248) intramuscularly on 28Jan2021 at single dose in left arm for COVID-19 immunization. Medical history included Covid (she had Covid already). Concomitant medication was none. Patient received the 1st dose of the vaccine yesterday afternoon. Today patient experienced a sore arm, injection site pain, extreme fatigue, a little headache, chills, and muscle pains which makes them a little achy overall on 29Jan2021. she received the vaccine yesterday and stated that she felt like she has Covid all over again on 29Jan2021. She stated that she had Covid already and stated that they have chills and are achy in 2021. Caller said that she was also having issues with breathing and shortness of breath in 2021. Caller said that she was also having that Covid exhaustion. Their arms were quite sore too from the shot, but she did not expect to feel lousy in 2021. patient have been sleepy all afternoon and stated that she sat down and just passed out, caller clarified that she went to sleep in 2021. Yesterday they were ok, but she felt sleepy. She started feeling very drowsy after the shot and they were fine all night. Caller said that since they have slept all afternoon they have perked up a little bit. She does not feel the chills anymore, she turned the furnace up a little bit. Achy: She said that it has improved as her back does not hurt as badly. patient said that this was her first dose of the Covid-19 vaccine. The outcome of event chills was recovered on 29Jan2021, for fatigue, COVID-19 and ache was recovering and for other events was unknown.  No follow-up attempts are possible. No further information is expected.
Injection was above the deltoid into the joint, burning occurred at time of injection and continued to increase throughout the day. Over the next several days and weeks there is continued aching in the joint and difficulty in moving the R arm above the shoulder level.
Left tricep, induration quater size, flare baseball size, mild pain, length x4 days, no TX.
Whole body itching / rash. Warmer areas, and areas itched would flare up more. Tried limited Benadryl due to drowsiness. Also body lotions that only gave temporary relief. Visited a center five days after symptoms appeared and reviewed the issue. Instructed to try sensitive skin products (Soaps, Lotions, etc.), and Claritin instead of Benadryl. Took 1 Claritin and started having relief from symptoms within a couple of hours. Currently of day two of Claritin and the issues are staying in check.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates the patients were vaccinated with VARIVAX (Merck) (lot # L019124 and expiry date 27-MAY-2017) (dosage, strength and route were not reported) that was improperly stored. Additional doses of VARIVAX (Merck) (lot # L019124 and expiry date 27-MAY-2017) were administered to an unspecified number of patients on 16-SEP-2015. At the time of the report, no adverse effect was reported. Additional information has been requested.
Subsequent to receiving varicella virus vaccine live the pt developed a rash described as a few spots that lasted for 5 days. It was described as a mild illness with no other symptoms present. The physician reported that the rash was a post vax rash.
Immediate pain on the left side of my neck, still experiencing this almost 2 weeks later. Left jaw issues: tightness/ sore/unable to open completely. Mild headache daily, relieved with ibuprofen. Elevated heart rate for 12 days now. Fatigue by mid day. Joint pain. All these are new and ongoing symptoms for a young, healthy individual with no past medical issues.  Nauseas and dizzy for 3 days post shot. Nickel size lump at injection site for 3 days.
Subsequent to receiving one dose of varicella virus vaccine live, the pt experienced a fever of 102 F with generalized rash. The rashes were widely spread on her legs, stomach, waist and face. The rash on her face had white blisters.
does not feel well after getting the shot; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (does not feel well after getting the shot) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received 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 MALAISE (does not feel well after getting the shot). At the time of the report, MALAISE (does not feel well after getting the shot) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. This report was about COVID-19 treatment. Patient did receive the vaccine. Patient received other medications in 2 weeks. Patient received treatment for COVID-19 as Paxlovid from 27May2022 to 31May2022  No follow up attempts are possible. No further information is expected.
Seizure  4/12/2021 go to ER, stayed in hospital 4 days
Aches,chills,slept for 18 hours. Very uncomfortable. Shot sight red and about the size of a baseball. Site felt hot, hard and itched for one week. Took ADVIL (2 doses).
Information had been received from a pharmacist who reported that on 10-NOV-2014 a male received both ZOSTAVAX and PREVNAR (manufactured unspecified). The manufacturers of PREVNAR indicated to the pharmacist that it is "probably not appropriate to give these 2 vaccines together". No known adverse effects. All of the data here was confirmed with the pharmacist. No further information provided. Additional information has been requested.
Post vax, he experienced extreme fatigue, couldn't walk or get off couch X 6 hours. Mother also noticed him to be "slobbering/drooling". No seizure activity, no fevers. Mom did not report this to anyone (did not contact our 24 hour service) until sibling came for well child visit (2 month later) and described above to me (primary care practitioner)
This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. 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 not reported, batch number: Unknown) dose was not reported, 1 total administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-NOV-2021, the patient became ill first (covid-19 infection). On 11-NOV-2021, the patient tested positive for Covid (confirmed clinical vaccination failure). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On an unspecified date, the patient experienced side effects for several weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 infection, confirmed clinical vaccination failure and side effects for several weeks was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority number: 90000202098.; Sender's Comments: V0; 20211130145-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Pt developed zoster outbreak in T11 dermatome on the right, symptoms began within 48 h of vaccine dose.
Had vaccine 10/28, 3:15pm. On 10/29/02 late in day noticed site hot and tender, no redness or fever. Also had pain into neck and numbness in right arm. Saw MD who prescribed antibiotic - Amoxiclau 875mg BID and Meclizine 12.5mg TIO. Began to feel better after 2 doses of antibiotic. 11/1/02 stated everything "ok".
Given .5mL of a .25mL dose of the covid vaccine for ages 6m-11y.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported different events for two patients (brother and sister). This is the first of two reports. A male patient of an unspecified age (but older than 5-year-old) and ethnicity received TRUMENBA, intramuscular on an unspecified date at 0.5 ml single. Medical history and concomitant medications were not reported. The patient experienced aches and pains and nausea on an unspecified date with outcome of unknown. The reporter assessed aches and pains as related to TRUMENBA. Follow-up (08OCT2015): Follow-up attempts are completed. No further information is expected.
Pain in left arm after shot. During the night I got a sharp pain in my hip that went away with Advil. But the next day I got pain in my left calf that lasted 1 month, got better for 3 weeks and has returned. I cannot stretch or even bend down without an increase in pain.
Pain on the outer left labia, worsend in hrs., lasted most of the night. Felt like a shock on top of a deep bruise. Body tensed w/ea. shock. Next day notice of outbreak of HSV Type 1 inner left labia. Cld gyno. did not return call. Treated myself and saw dr. 12/19/12 as prev. scheduled. Test proved type 1. Nvr had before. One sex partner in life, celebate since 1992, ex hus. was faithful.
Administration of an expired dose of Twinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 74-year-old female patient who received HAB (Twinrix) (batch number X239D, expiry date 07-AUG-2022) for prophylaxis.   On 06-JUL-2023, the patient received Twinrix. On 06-JUL-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Administration of an expired dose of Twinrix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JUL-2023 The reporter was a medical assistant. The reporter asked for information regarding the administration of an expired Twinrix dose to a patient. The healthcare professional asked how to proceed with this patient. The reporter consented to follow up. The patient received expired dose of Twinrix, which led to expired vaccine used.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Feb-2022; Covid-19 vaccine that were given beyond the 30 day use by date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Feb-2022) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022 at 8:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Feb-2022 at 8:59 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 11-Feb-2022, the patient took the booster dose of the vaccine. No concomitant drug information was provided. The 30 days Expiry date vaccine went into 2 to 8 °C thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg date of 04-Apr-2022  No treatment drug information was received.   This case was linked to MOD-2022-542869 (Patient Link).
Tiredness (lasted until about 36 hours after vaccination)  Headache (lasted until about 36 hours after vaccination)  Sore arm (lasted 3-4 days after vaccination)