chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects were reported.; Patient received improperly stored PNEUMOVAX 23.; This spontaneous report was received from a Vaccine coordinator referring to a patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 12-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, route, dose, frequency, and anatomical location were unknown) with lot # R033079 and expiration date 06-JUN-2020 for prophylaxis.      The administered dose of vaccine experienced the temperature excursion of minimum 32°F degrees Fahrenheit for and unknown time frame, and had no previous temperature excursion nor a digital data logger involved. No adverse events were reported.; Sender's Comments:  US-009507513-1910USA002523:
Badly swollen right tonsil the day after receiving a flu shot in the left shoulder.  Started late that evening with continued tonsil swelling and sore throat the next day (10/02/1010) as well. No other symptoms other than minor bruising-type pain at the site of injection so far.
Four hours after receiving immunizations, child had seizure. Admitted to hospital and transferred. Complaints of blisters on left leg, fever 103.7. EEG and MRI negative per mom. Child had 3 more seizures. No previous history of seizure. Discharge Summary received on 2/02/2005 states pt experienced diarrhea, sleepiness and dehydration.
Rash on left arm on the 9th day after vaccine. It cleared after 2 days. On April 10, woke up with severe dizziness. Here I am on 4/19 and still experiencing dizziness. I feel like I have a daily hangover.
advised her not to get no second dose during the pandemic; This case was reported by a consumer via call center representative and described the occurrence of off label use in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose Intramuscularly on an unknown date in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not applicable for this report. The reporter reported that her health care professional advised her not to get second dose during the pandemic, which led to off label use by the health care professional.
swelling down to the elbow; injection site redness; This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th March 2020, 8 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site erythema. The patient was treated with steroids nos (Steroids) and antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In the first of March 2020, the patient received the first Shingrix shot in unspecified arm at a pharmacy and presented to her primary care health provider with injection site redness and swelling down to the elbow.  The physician treated with unspecified oral steroids and antibiotics.  The event resolved within 5-7 days from the onset. The Shingrix administered in pharmacy the physician did not had the lot and exp date of the vaccine.
This case meets vaccine breakthrough criteria review.  SxS include SOB, N/V, weakness, headache, chills, body aches,.
erythema, warmth, swelling and tenderness of right upper extremity at the site of pneumonia vaccine. On exam today: It is around 4 inches in size and is spreading medially    was seen in the office today by provider; cellulitis  prescribed Keflex 500mg twice daily for 5 days follow up at visit in 1-1/2 week for reeval
1st vaccine 2/6/21; developed altered speech, drooling, nausea, vomiting 2/17/21; seen at ED 2/18/21 and admitted to hospital for stroke symptoms
Information has been received as part of a business agreement (claim number 30120503005-0001), concerning a patient who on an unknown date, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot# not reported). Subsequently the patient experienced shingles outbreak. It was unknown if the patient sought medical attention. At the time of reporting, the outcome was unknown. This was originally reported by a consumer. Follow up information was received from a patient who was not referred to by a physician and "did this on their own". Additional information is not expected.
Zero reaction noted. Gave child hep B to a 61 year old female 6/8/02. Caught the mistake and gave proper adult hep B. to patient.
Temp. 105, febrile seizure, lethargic. Began to lose acquired skills within 3 months of vaccination. Per 60 day follow up: Patient has not recovered, severe Autism-manifested after vaccination. Diagnosed as late-onset. Severe behavior social, cognitive deterioration. Also exhibits severe sensory deficts, started shortly after and continue to accelerate w/ age. He was normal in behavior & milestones. He began to deteriorate shortly after his vaccine (105 degree temp/3days). I received the same vaccine & had reaction as well (muscle atropy @ injection site), tremors in same arm ever since. Follow-up: Patient regressed in the months following the vaccine. He still functions below the level he did when he received vaccine.
pt c/o of rush feeling-pt was put in position feet up;arm started to devel a rash, w/swelling & a feeling of warmth-MD was notified;ordered DPH;pt was monitored for over 45min;arm looked better p/s felt OK;
she got the flu after a flu shot/ suspected vaccination failure; flu after a flu shot; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 77-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced vaccination failure (Verbatim: she got the flu after a flu shot/ suspected vaccination failure) (serious criteria GSK medically significant) and influenza (Verbatim: husband got the flu after a flu shot).  The outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine.     It was unknown if the company considered the vaccination failure and influenza to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 05-OCT-2023 The reporter stated that she got the flu after a flu shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter did not consent to follow-up. The case is linked with US2023137025, by same reporter.; Sender's Comments:  US-GSK-US2023137025:Same reporter
04/20/2012 Client noticed a reaction that was red in color, tender and hard to the touch, slightly raised, and about 1.5 inches in diameter. Client was told that the redness, tenderness & swelling was not unusual reactions to the ZOSTAVAX vaccine and was recommended to see PCP if she is still concerned about the reaction.
Patient woke up and had a headache on 12/1, and described his eyes as sore, but not photo sensitive.  He then broke out in a rash he described as fluid filled pox on face, then back, and rest of body, which were very itchy.  Fever over 100 degrees began the next day on 12/2.  The pox rash has now scabbed over.  Mother is a nurse and felt outbreak resembled a case of chicken pox.
symptom onset 5/14/2021 body aches, headache, sore throat, nasal congestion, lost smell
Lethargic for a week, fever lasting three days (99 degrees - 102 degrees), dizziness and trouble walking for a week, irritable for a week, loss of appetite for two weeks.
Patient presented to emergency department on 11/22/2021 with shortness of breath, worsening over the past 5 days and fluid retention. Patient was found to be COVID-19 positive and admitted for further management. She was treated with dexamethasone and continued her home dose of 4L oxygen. Patient left against medical advice on 11/25/2021.
Pt started with redness/swelling of leg after flu vaccine. worsened -per parent pt  with significant swelling of leg. Symptoms  improved with Benadryl + Motrin. Mom  reports redness after flu vaccine last year but  not to this extent recommend Allergic evaluation.
I could immediately feel pain at the site of injection and then my arm went numb within minutes. I was told that it was normal and that it would go away. It did not go away, it only got worse  and I continue to be treated by my GP and a neurologist to this day.
Information has been received from a licensed practical nurse concerning an 18 year old female patient with no pertinent medical history and no known drug allergies who on 5-MAR-2009 was vaccinated with the third dose of GARDASIL (lot # not provided). Concomitant therapy included YAZ. On 6-MAR-2009 the patient experienced a fever of 99.8 F to 101F, achiness and headache. No lab diagnostics studies were performed. The patient was treated with MOTRIN. At the time of reporting, the patient was recovering. The patient sought medical attention via an office visit. Additional information has been requested.
1ST DOSE MODERNA GIVEN ON 7/29/2021 2ND DOSE PFIZER GIVEN ON 8/26/21
Patient given nasal mist instead of injectable vaccine.   No adverse reactions per patient. Patient should have received .5cc H1N1 injection not nasal mist.
Chills, sweats, fever for 2 days Excruciating headache for 3 days Nausea, severe for 3 days Nausea, moderate to light for 4 more days  Weakness 5 days Dizzy, foggy condition for 5 days  These symptoms were  simultaneous for close to a week Not inclined to get booster in 12 months
This is a spontaneous report from a contactable consumer. A 66-year-old female patient received PREVNAR 13, via an unspecified route of administration at the left upper arm, on 08Jan2019 at a single dose for immunization. Medical history included thyroid disorder. Concomitant medication included ARMOUR THYROID for thyroid. The patient reported on 16Jan2019 when she woke up, the injection site was very red, hot, itchy, and a little sore. The patient also reported that she felt the itching was getting worse. The pharmacist told her to take 2 ibuprofen and put ice on the area. Patient also mentioned that she will take an antihistamine, though she hasn't yet. The patient has not yet recovered from the events at the time of report. Information on batch number has been requested.
tiredness; This case was reported by a consumer and described the occurrence of tiredness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In August 2021, the patient received the 2nd dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself/herself The age at vaccination was not reported. The patient got the second Shingrix vaccine on Friday afternoon and experienced tiredness. The patient asked how long it would last.
HER SITE INJECTION IS RED AND SWOLLEN AND SHE CAN BARELY MOVE HER ARM.  IT HURTS ALL THE WAY UNDER HER ARMPIT.  I ADVISED HER TO TAKE SOME BENADRYL AND APPLY HYRDROCORTISONE CRM TO THE SITE.
6 Panic Attacks; Nerve system unbalanced; Cannot sleep at night; little pinch nerve/shocks all over the body; This spontaneous case was reported by a consumer and describes the occurrence of ELECTRIC SHOCK SENSATION (little pinch nerve/shocks all over the body), INSOMNIA (Cannot sleep at night), PANIC ATTACK (6 Panic Attacks) and NERVOUS SYSTEM DISORDER (Nerve system unbalanced) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 02-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced ELECTRIC SHOCK SENSATION (little pinch nerve/shocks all over the body). On 08-Mar-2021, the patient experienced INSOMNIA (Cannot sleep at night). On an unknown date, the patient experienced PANIC ATTACK (6 Panic Attacks) and NERVOUS SYSTEM DISORDER (Nerve system unbalanced). At the time of the report, ELECTRIC SHOCK SENSATION (little pinch nerve/shocks all over the body) and INSOMNIA (Cannot sleep at night) had not resolved and PANIC ATTACK (6 Panic Attacks) and NERVOUS SYSTEM DISORDER (Nerve system unbalanced) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   The patient visited doctor's office and emergency room on 10-Mar-2021 and 31-Mar-2021. Patient said that the frequency of the event paresthesia has dropped. Patient felt her nervous system was unbalanced after vaccine and don't want to take second shot.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: updated HCP information, allergy, patient race, ethnicity and  added two events and changed event start date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Diarrhea after 1st day x 1 day. Flu like symptoms - feverish, localize redness and swelling lt delt. soreness after 4 days. Ibuprof warm compress prn.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2020, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset Jan2020, outcome "recovered" (2020) and all described as "I have been fully vaccinated, I got Covid"; SLEEP DISORDER (non-serious), outcome "unknown", described as "I'm also having trouble sleeping"; ASTHENIA (non-serious), outcome "unknown", described as "I just don't have the kind of "energy" I had before/debilitating". It was reported that, a potential AE has been reported to the Pfizer Clinical Trials Contact Center. Stated that, the patient was over 60-years-old. Stated that, although the patient had been fully vaccinated, the patient got Covid before anyone knew what it was. Stated that, the patient had experienced a very bad case of Covid on an unspecified date in Jan2020. It was debilitating. Stated that, the patient had recovered but the patient just didn't had the kind of energy that the patient had before. Stated that, the patient was very active for the patient age. Stated that, the patient work out 3-4 times a week but it's been a struggle lately. Stated that, the patient also having trouble sleeping. Withheld. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Serotonin syndrome, withdrawal of SSRI, addition of lower dose different SSRI, slow recovery
Within a few minutes, my mouth began to produce excessive amounts of saliva w/a metallic test, followed by hives and severe tightening of the chest. went home sick from work and ended going to the emergency department w/increased severe chest pains.
couldnt move; symptoms were "just really bad!"; sight headache that gradually worsened; chills; muscles aches; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (couldnt move), ADVERSE EVENT (symptoms were "just really bad!"), HEADACHE (sight headache that gradually worsened), CHILLS (chills) and MYALGIA (muscles aches) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced HYPOKINESIA (couldnt move), ADVERSE EVENT (symptoms were "just really bad!"), HEADACHE (sight headache that gradually worsened), CHILLS (chills), MYALGIA (muscles aches), PYREXIA (fever) and HEADACHE (headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPOKINESIA (couldnt move), ADVERSE EVENT (symptoms were "just really bad!"), HEADACHE (sight headache that gradually worsened), CHILLS (chills), MYALGIA (muscles aches), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.
Patient presented to office approximately 24 hours after IM injection of annual flu vaccine. No fever or resp distress. Injection site with approx. 7x6cm erythematous area below injection site, mildly warm to touch, nonfluctuant, not raised, mild tenderness to touch. No bogginess.
pt recv vax 21MAY97 & w/in 1hr exp blurred vision;
Vomiting, dizziness, flushing/sweating. BP 134/82; HR 85, SpO2 98%, Temp 97.3. Pt reported feeling dizzy while in observation. Pt was brought in to observation area. Pt felt dizzy, and nauseous began vomiting. Provider was called to assess pt; Pt reported feeling slightly better but still felt dizzy.
the dose was administered unknowingly following a cold temperature excursion/No AE; Based on information received on 11-OCT-2019, the report previously considered as non-valid became valid: patient identifier reported.  Based on additional information received on 11-OCT-2019, this case became medically confirmed.  Initial information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff)/non-hcp.  This case involves a 2 months old male patient who received 0.5 mL dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ101AAA via intramuscular route in the anterolateral thigh On 26-Jul-2019, following a cold temperature excursion.  It was as actual medication error due to incorrect product storage.  The dose was administered unknowingly following a cold temperature excursion and patient was revaccinated as recommended by manufacturer.   No adverse reaction reported by the patients family.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Follow-up information was received on 11-OCT-2019 regarding an unsolicited valid non-serious case received from a physician (naturopathic doctor).  The report previously considered as non-valid became valid and case became medically confirmed.  Patient details, lot number, vaccination details and event verbatim updated in field and narrative.
arm was sore; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient (reporter's husband) of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm was sore on an unspecified date in Jan2021. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Fever to 103 after shots - febrile seizure x1 - seen in ER, temp down with TYLENOL - resolved in 24 hours.
Chest pain; Pain in neck and shoulder; High Temp 103 F; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PAIN (Pain in neck and shoulder) and PYREXIA (High Temp 103 F) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced CHEST PAIN (Chest pain), PAIN (Pain in neck and shoulder) and PYREXIA (High Temp 103 F). On 31-Jan-2021, CHEST PAIN (Chest pain), PAIN (Pain in neck and shoulder) and PYREXIA (High Temp 103 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 103 f (High) High Temp 103 F.         No concomitant medicines were reported. No treatment information were reported.  Action taken with the drug in response to events was not applicable.
visual disturbance-everything was glowing, nausea, dizziness, fainted 2x, vomited 6x, profuse sweating, urinary incontinence, unresponsive.   was transported by rescue to emergency dept. was given pill for nausea, iv, and ekg en route.  was given 2nd iv fluids, comprehensive bloodwork, chest xray, cat scan of brain.   symptoms resolved after 5 hours