chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WEIRD FEELING IN LEFT LEG MUSCLE; REDNESS BETWEEN ONE EYEBROW  TO THE OTHER; NUMBNESS IN THE LEFT LEG; FEEL DIFFERENT WHEN EYE MOVES, ONE EYE  WORSE THAN THE OTHER; SWELLING AROUND RIGHT EYE; POSSIBLE MILD SWELLING OF RIGHT EAR/EAR FELT A LITTLE DIFFERENT; GOT SCARED; SWELLING INCREASED FROM EYEBROW TO THE CORNER OF NOSE; MILDLY BLURRY EYE; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On NOV-2021, the patient experienced swelling around right eye. On NOV-2021, the patient experienced possible mild swelling of right ear/ear felt a little different. On NOV-2021, the patient experienced got scared. On NOV-2021, the patient experienced swelling increased from eyebrow to the corner of nose. On NOV-2021, the patient experienced mildly blurry eye. On NOV-2021, the patient experienced feel different when eye moves, one eye worse than the other. On 08-NOV-2021, the patient experienced weird feeling in left leg muscle. On 08-NOV-2021, the patient experienced redness between one eyebrow to the other. On 08-NOV-2021, the patient experienced numbness in the left leg. On 09-NOV-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in the left leg, weird feeling in left leg muscle, swelling around right eye, possible mild swelling of right ear/ear felt a little different, got scared, swelling increased from eyebrow to the corner of nose, mildly blurry eye, redness between one eyebrow to the other, and feel different when eye moves, one eye worse than the other. This report was non-serious.
Having menstrual period occurring less than 21 days apart for my last two cycles, one being less than 14 days, usually I am very consistent between. Also having longer duration of bleeding of 7 days compared to 4 that I had consistently experienced before.  I do not take any birth control or changed anything else in my life or life style.
received Moderna COVID-19 vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received Moderna COVID-19 vaccine while pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 13-Oct-2020 and the estimated date of delivery was 27-Jul-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received Moderna COVID-19 vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (received Moderna COVID-19 vaccine while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Narrative: Patient with breakthrough covid infection. 1 dose of moderna prior to infection, 1 dose post infection. Treated with monoclonal antibodies.
Left arm and shoulder pain, weakness, decreased range of motion started evening of vaccination. Tried acetaminophen, ibuprofen, stretches, PT referral placed a little over 1 month after pain started. Symptoms have continued and not resolved.
Mild sore throat - all 42 hours Mild congestion - First 24 hours Mild fatigue - all 42 hours All abruptly disappeared during lunch on the 31st (it was a good lunch)
Patient presented to ED three post vaccine with increasing redness/swelling at the injection site.  No issues identified. Patient received Doxycycline and Benadryl prescriptions.
A post I made where someone suggested I report this.   I know I was all for the vaccine but lemme share my experience: I got my second Vaccine June 4th.  Felt like dog. Exactly 7 days after (typical incubation period)  not only did I get the worst cold I've ever had I couldn't read, couldn't speak clearly and couldn't think. Just now at 5pm did I regain my ability to communicate fully.  This could have been from MS and the temperature change, the neurological part at least.  But I really do wanna warn people that something isn't legit with this vaccine.  I called the clinic several times and was blown off.  This isnt a normal or average reaction.  Please make your choices with caution.  Every case is different but this was my reaction.
no adverse effect. but patient was given a dose that was past the discard after date. the vaccine was stored in the fridge with a discard after date of 7/13/23 but administered on 8/4/23. it was discovered today on 8/10/23 that the box of moderna doses of that batch were not discarded.
No additional adverse effect reported; patient received improperly stored MMR II; This spontaneous report was received from a nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 29-JUN-2020, the patient was vaccinated with dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot# S004119, expiration date: 11-FEB-2021, albumin status has been verified as recombinant human albumin (rHA) for prophylaxis (strength, dose, frequency, route of administration were not reported), which was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion above 47 degrees Fahrenheit (F) (55.5 F) for 6 hours and 30 minutes. Data logger was involved. There were no previous excursions reported. No adverse event was reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with antiviral Paxlovid from 20Jan2023 to 25Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events  DRUG INEFFECTIVE, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
bad headache, fever, fatigue, body ached, hips hurt (hard to lay down or sitting) for about a day.
This spontaneous report was received from a pharmacist via company representative refers to a 52 year old female patient. Approximately on 30-AUG-2013 (reported as approximately 2 weeks ago on a Friday), the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date was not reported and route was subcutaneous). Approximately on 02-SEP-2013 (reported as on following Monday), the patient experienced rash and swelling in her lymph nodes, the pharmacy called the patient to follow up with her experience on the following Wednesday at which time the patient explained that she was showing some improvement in her symptoms specifically that the pain in her lymph nodes had improved however they were still swollen. The patient sought medical attention. Additional information is not expected.
pt recv vax 7JAN99 & devel fever to 10JAN99 (<48hr later) w/associated sz x1;seen in ER w/ bilat OM dx;
few minutes after she was vaccinated, she fainted on the floor.  she sat down on the chair for a little while, felt better, and went home.  we offered to call ambulance, she refused.  follow up calls were made, but no answer by patient.
chills; fever; runny nose; This is a spontaneous report from a contactable consumer from the Pfizer-sponsored program. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 03Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose last 03Feb2021, then the next day 04Feb2021, she experienced chills, fever and runny nose. They gave her decongestant because of the runny nose. The reporter was asking if it's the side effect of the first dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Fatigue, temperature of 101.7, chills, can't get warm, nauseous,  body aches, pain in left arm, swelling of lymph nodes on left neck,  increased asthma symptoms, lack of appetite.
Day 2 arm aches. On Monday the 19th HA, Backache and increase in O2 needs cannot keep O2 above 77% without oxygen  being administered, .overnight O2 dipped to 55%. However is also on new meds from her pulmonologist which may be a factor.
Patient day after vaccine w/ intermittent chest pain x3 days. Presented to the ED found to have troponin elevation with high suspicion for myocarditis. Workup pending cardiac MRI at this time.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "BPH" (unspecified if ongoing); "Chronic back pain" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: Rebound Rapid covid test after negative test after treatment with paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound Rapid covid test after negative test after treatment with paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
9-year-old patient received an adult dose of Pfizer vaccine for their 2nd dose in COVID-19 vaccine series.
Patient stated the evening of her immunization she was 'itchy all over.' She took a benadryl and was better. On 6-9-17, she called and stated she had a silver dollar sized bump at the injection site and there was warmth and redness over the area that was the size of her hand. She was not concerend, would take an anti-inflammatory and use ice.
Joint ache and tiredness on the next day after vaccination; Joint ache and tiredness on the next day after vaccination; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-years-old female patient (not pregnant) received BNT162B2 (lot number: EK5730) first dose on 18Dec2020 12:45 PM intramuscularly on Left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No Known allergies to medications, food, or other products. Facility type vaccine was Hospital. Other medications in two weeks was No. Patient experienced Joint ache and tiredness on the next day after vaccination (19Dec2020). Patient had no covid prior vaccination. Patient had covid tested post vaccination on 21Dec2020, Nasal Swab, the result was negative. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the events. The outcome of the events was recovering. The seriousness was reported as no.
Within one hour of getting first dose of vaccine PT sts she experienced a headache and sore throat, a few hours later, vomiting, and diarrhea began.  on 20DEC20 PT sts headache continued and vomiting began.  Diarrhea and vomiting continued intermittently over following 48 hrs.  Pt went home 20DEC20 from work and was able to resume regular duties the next day with intermittent diarrhea.
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain in arm, swelling arm and fever. On an unknown date, the outcome of the pain in arm, swelling arm and fever were unknown. It was unknown if the reporter considered the pain in arm, swelling arm and fever to be related to BEXSERO.   Additional details were provided as follows:  The age at vaccination was not reported. The doctor stated that he gave his son the dose of Bexsero and experienced a sore arm for 3 days, also had swelling, and fever of 99.9 degree units.      Lab Comments: On an unknown date patient body temperature were recorded to be 99.9 units.
Myalgia Injection site pain, Chills Narrative:  Other Relevant History:
This spontaneous report as received from a healthcare professional refers to a 16 day old patient of unknown gender. The patient's medical history was not specified. On an unknown date, a 16 day old instead of 1 month old patient was vaccinated with the second dose of RECOMBIVAX HB (lot #, route and site of administration were not reported). No adverse effect was reported. Additional information has been requested.
Information has been received from a pharmacy intern concerning a female patient of unknown age. The patient lived with a smoker for 30 years. The patient's medical history included reaction/allergy to soy products, feathers, latex, TYLENOL, morphine, codeine and sulfa drugs. Pharmacy intern reported that on an unspecified date, the patient received 1 dose of ZOSTAVAX (indication, strength, dose, route, injection site, lot number and expiration date, were not provided). Other suspect therapies included sterile diluent. Concomitant therapies included tramadol. On an unspecified date after receiving ZOSTAVAX, the patient received "a flu shot" (manufacturer unspecified). On an unspecified date, the patient developed "respiratory problems" and "a cough". On an unspecified date the patient then went to the doctor and was prescribed a prednisone taper as a treatment for the events. No lab diagnostic tests were performed. The outcome of cough and respiratory disorder was reported as not recovered/not resolved. The causal relationship between the events and therapy with ZOSTAVAX was not reported. Respiratory disorder and cough were considered to be potentially life threatening and potentially disabling, by the reporter.
This is a spontaneous report from a contactable consumer (mother) reported for her son. A 16-year-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient developed pain at the injection site and down to his elbow, he had pain in his arm/with moving his arm, pain that was radiated down his arm to his elbow and the pain was also in his shoulder, he was also very tired. The outcome of the events was unknown. Reporter mentioned that she wanted to know if Tylenol could be taken with TRUMENBA because her son had a lot of pain in the arm.
Received SPV 6th of March. On 15 Mar he started having chest pain and SOB, could not exercise or run. States he has never had a problem before with running or exercise, has no cardiac history and is essentially healthy. Went to ED, had nml cxr and ekg. At ED he denied SOB, reported dull constant left side chest pain, worsened with exertion. Pt left ED before work up completed. Is working and is pain free.
Pt. had large area of (R) arm (deltoid) swelling and erythema. Hot and painful to the touch. Pt. went to urgent care given MEDROL Dose pack; KEFLEX 500 mg qid x 10 d.
Pt had diarrhea approx 10 days prior to clinc visit but diarrhea ceased day of immun then restarted 4MAY91; t101R 3MAY91pm & 4MAY91; Afebrile 5MAY91; Taken to ER tx Pedialyte & soy based formula
PRODUCT STORAGE ERROR; VACCINE WAS ADMINISTERED TO PATIENT WITHOUT BEING STORED AT RECOMMENDED STORAGE CONDITIONS OF 2 TO 8 CELSIUS; This spontaneous report received from a health care professional concerned a 34 year old male. 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, and batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 25-APR-2022 for prophylactic vaccination. Age at time of vaccination 34 years old. No concomitant medications were reported. On 25-APR-2022, the patient experienced vaccine was administered to patient without being stored at recommended storage conditions of 2 to 8 celsius. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and vaccine was administered to patient without being stored at recommended storage conditions of 2 to 8 celsius was not reported. This report was non-serious. This case, from the same reporter is linked to 20220505340, 20220505192, 20220505373, 20220505044, 20220504995, 20220505593 and 20220505824.
About 7 hours after receiving the vaccine (2nd dose), I broke out into a cold sweat/fever - alternating. Had body aches, as well. Had I not taken ibuprofen or Tylenol throughout the day I probably would?ve had a 103-104 fever. I did have a 101-102 fever throughout almost the entire day, even with the medicine. In the afternoon my head was pounding from migraine symptoms so I did take my rizatriptan. Around 7pm last night I experienced some chest tightness as well, which was the scariest part. As I?m writing I still have a fever of over 100 (I am currently 43 hours post vaxx).  I also have a slight rash at the site of the vaccination and some swelling under my armpit on that side. For reference, I?m a distance runner, in considerably good shape for my age group, and I drank almost 6 liters of water yesterday.
Pityriasis rubra pilaris; This is a literature report.   A 54-year-old woman with a history of melanoma on her small finger presented with a 4-month history of a widespread, pruritic rash. The rash was initially localized to her trunk but gradually expanded to cover the majority of her body. It first appeared 2 weeks after she received the Pfizer-BioNTech COVID-19 booster vaccine. She had previously received the Janssen COVID-19 vaccine 6 months prior, with no rash eruption. Examination showed multiple large, orange-red plaques covering 70% to 80% of the body surface area, including the back chest, abdomen, and extremities, with multiple islands of sparing. Additionally, she had hyperlinear palms with waxy, orange hyperkeratosis on her hands and feet. She had previously been treated with topical triamcinolone and clobetasol, oral prednisone, and dupilumab with no significant improvement. A punch biopsy was performed on one of the lesions bn the upper back prior to her referral to our clinic. The biopsy revealed hyperkeratosis, including broad areas of parakeratosis, overlying the epidermis showing patchy hypogranulosis, moderate acanthosis, and mild spongiosis. Focal exocytosis of small cytologically bland, mature-appearing lymphocytes was also noted. No interface vacuolar changes were identified. The dermal portion of the biopsy contained a perivascular lymphocytic infiltrate; however, no atypical lymphocytes were identified. Overall the biopsy was consistent with psoriasiform spongiotic dermatitis. The initial differential diagnosis included psoriasis and PRP. Atopic dermatitis was less likely given the lack of improvement with oral steroids and dupilumab. At the time of her initial presentation, the physical examination appeared most consistent with type PRP. Given her history of melanoma, the plan was to treat her with a more targeted biologic medication to minimize her risk of immunosuppression. As such, she was initially treated with ixekizumab injections at an initial dose of 160 mg and 80 mg every 2 weeks thereafter. Complete blood count, complete metabolic panel, and quantiferon gold were unremarkable. Additionally, HIV, hepatitis B, and hepatitis C serologies were negative. After 2 months of treatment with ixekizumab there was near-complete resolution of her rash. Only mild, thin erythematous plaques remained On small areas of the bilateral flanks buttocks, and lateral aspect of the thighs.; Sender's Comments: Based on the temporal relationship, the reasonable possibility of an association between "Pityriasis rubra pilaris" and BNT162B2 cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
8:00pm 4/19: - Body Aches (back, neck) - Headache 10:00pm 4/19: - Body Aches - Headache - Chills - Unable to sleep due to pain 5:00am 4/20: - Body Aches - Headache - Fever (101.9 degrees F) - Able to sleep after taking acetaminophen   Fever subsided after ~4 hours  Body aches continued throughout day, all symptoms gone next day
Approximately 10 hours after receiving the vaccine, I experienced chills, fever of 99F, mild headache, body aches and fatigue.  That evening I experienced more chills and a fever of 100F.  This lasted for about 8 hours.