chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site of vaccination developed cellulitis tx with keflex x 24 hrs. Pt returned with 20 cm x 8.5 cm bullous reaction bilaterally on dorsal aspect of forearm. Smpox site 2.5 - 3 cm. Pt afebrile.
father states about 2hr p/vax pt vomited then immed turned white then green & went limp for a period less than 1min duration;pt was real quiet & showed slow responsiveness;temp was nl;breast fed nl ;30min later appeared tired;no MD eval
This case was reported by a physician and described the occurrence of local reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Flu vaccine, GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received unspecified dose of Flu vaccine (unknown).  At an unspecified time after vaccination with Flu vaccine, the subject experienced local reaction.  At the time of reporting the outcome of the event was unspecified.
dose 1 given 2/24/2021 Pfizer, LOT # n/a pt hospitalized for covid 19, was discharged home
rash on legs started afternoon of injection got worse over week 1am on October 17, developed into hives all over body.  gave him Benadryl and put benadryl directly on rash. eventually he slept again. slowly diminished over the course of 7-14 days. within a week, the soles of his feet were cracked and bleeding and skin peeling In January 2021, he was diagnosed with insufficient pancreas.
Information has been received from a 61 year old physician with no allergies and hypertension who on 02-MAR-2007 was vaccinated IM with a dose of Zostavax. Concomitant therapy included amlodipine besylate (+) benazepril hydrochloride (LOTREL). Two days after vaccination, on 04-MAR-2007, the patient developed a serpiginous, erythematous rash that covered about two square inches of the dorsolateral area of his right hand. He "believed that it was serum sickness." He also had some arthralgia. He has been treating it was oral non-steroidal anti-inflammatory drugs and acetaminophen. His symptoms were improving but were not completely resolved. No medical attention was sought and no diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested. 06/22/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Additional information has been received from the physician who reported that no diagnosis was available and he had only had observation. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-DEC-2013, the patient was inoculated with ZOSTAVAX at the pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 09-MAY-2014, the patient was treated by the physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
Received injection 1/8/2021 at 6:00 pm.  12 hours after injection experienced very sore arm, temp that peaked 101, aches and chills.  Symptoms lasted about 15 hours.  Upon waking on 1/10/2021 no fever, aches or chills.  Sore arm continues.
The day after her vaccine, her (R) arm got swollen and warm and painful; it was worse the next day and better today.
Information has been received from a registered nurse concerning a patient who on 15-OCT-1999 was vaccinated with a dose of Varivax. Subsequently, on 08-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Within about 5 minutes of getting the HPV vaccine and PPD placement patient felt hot and started sweating. He was standing at a desk and fainted. He was observed for about 40 minutes and improved.
Sore arm; MIld fatigue; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (MIld fatigue) and HEADACHE (Mild headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided). Concomitant products included VITAMIN D NOS for Immunization.    On 07-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (MIld fatigue) and HEADACHE (Mild headache). On 08-Jan-2021, PAIN IN EXTREMITY (Sore arm), FATIGUE (MIld fatigue) and HEADACHE (Mild headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender'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.
This particular LOT recalled by Pfizer due to short dating. Product was unknowingly administered after the updated expiration date
He woke up with nasal congestion and running nose. The next day develop a cough and not feeling like himself. He was tired and whiny so, we told at home COVID-19 test. I wasn't sure if it was accurate so, we went to the doctor for another testing and it came back negative. The doctor said he just a viral infection and he took ROBITUSSIN and ibuprofen. The symptoms lasted for 5 days.
Headache, NauseaVomiting, chills, Arm Hot and Painful Narrative: missed work due to symptoms
Client recieved Varicella vaccine on 04/26/08 @2:00pm. On 04/27/08 client woke up with a slight red rash under left eye and mother applied Benadryl cream to area. By the pm of 04/27/08 the rash had spread to right side of face and by 04/28/08 the rash and swelling became apparent at injection site. Client back in clinic today 04/29/08 with increased swelling and redness to face accompanied with extreme itching. Client has been taking Benadryl by mouth since yesterday without any improvement.
Hospital Course:  Patient is a 80 y.o. female patient with history of essential hypertension diabetes mellitus coronary artery disease presented with nausea vomiting and diarrhea Discharge Diagnoses: AKI; prerenal Improved Mostly secondary to decreased oral intake and persistent nausea vomiting and diarrhea Avoid nephrotoxic medications Encouraged PO intake     Acute Gastroenteritis Improved Continue supportive care   Covid-19 Virus Infection Date of onset of symptoms: 2 weeks ago and tested positive around thanksgiving period Symptoms present on admission: Nausea vomiting diarrhea Date of covid positive test: Around thanksgiving Vaccination status: vaccinated Imaging: CTA Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: not indicated Consultants following: None Anticipated special isolation end date: Does not need isolation since patient tested positive more than 2 weeks ago and patient has been afebrile for >24 hrs   Diabetes mellitus Type 2 not long-term insulin use Last A1c 8.310 2622 Continue ISS Likely needs to be taken off Glimepiride due if renal function does not improve.    Anxiety and depression Resume Prozac and Atarax  Chronic HFrEF Stress-induced cardiomyopathy Last echo 10/31/2022 ejection fraction of 45% +/-5 Monitor intake and output with gentle IV hydration Trend troponins Resume GDMT as tolerated   Paroxysmal A. fib on anticoagulation Continue Eliquis and metoprolol
Pt recvd 1st dose of Hep B vax JUL92 & approx AUG92 devel acute bronchitis which progressed to asthma; pt was hospitalized for 3 days & tx w/Ventolin;
about 5 minutes after vaccine was administered patient said she felt the room spinning and was dizzy she walked to over to the immunization room and vomited. We gave patient water and had her lie down for a few minutes and then she felt better. Took her bp 120/78 hr 81 .  Patient felt back to normal a few minutes later.
severe pain in her right arm\got worse; Pain radiates down to the butt cheek\got worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in her right arm\got worse) and PAIN (Pain radiates down to the butt cheek\got worse) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for Pain.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (severe pain in her right arm\got worse) and PAIN (Pain radiates down to the butt cheek\got worse). At the time of the report, PAIN IN EXTREMITY (severe pain in her right arm\got worse) and PAIN (Pain radiates down to the butt cheek\got worse) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant list is provided. No treatment is provided.
Adverse reaction to vaccine. Headache, nausea, diarrhea, arm felt heavy and hot, red and swollen. Went to ER - BP was low, IV given and released. Ibuprofen for 3 days, give 3 every 6 hours and take it easy.
One week of moderate soreness, as warned. Then, about three weeks later, return of upper arm soreness, together wtih migrating (temporary and changing from day to day) impaired muscular movements. As full range of motion returned in each instance after 1-2 days, conclude temporary nerve inflammation/block (perhaps due to intense immune reaction to target in vivo viral proteins still being expressed on nerve cell surfaces?).
TIREDNESS AFTER VACCINE; This spontaneous report received from a consumer concerned a male 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced tiredness after vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tiredness after vaccine was not reported. This report was non-serious.
dose 1 on 21Mar2021 and dose 2 on 4Apr2021; I have bodyaches; Chills; headache; am sleeping anywhere from 18 to 20 hours a day with no energy; "I can hardly get out of bed".; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 04Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 21Mar2021, for covid-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Apr2021, outcome "unknown", described as "dose 1 on 21Mar2021 and dose 2 on 4Apr2021"; PAIN (non-serious) with onset 04Apr2021, outcome "not recovered", described as "I have bodyaches"; CHILLS (non-serious) with onset 04Apr2021, outcome "not recovered", described as "Chills"; HEADACHE (non-serious) with onset 04Apr2021, outcome "not recovered", described as "headache"; ASTHENIA (non-serious) with onset 04Apr2021, outcome "not recovered", described as "am sleeping anywhere from 18 to 20 hours a day with no energy"; MOBILITY DECREASED (non-serious) with onset Apr2021, outcome "unknown", described as ""I can hardly get out of bed".".  Additional information: Patient was given the Pfizer covid shot at Pharmacy on 3/21. She had no reactions after the first shot. She was then scheduled by Pharmacy for my 2nd shot on 4/4. exactly two weeks later. Since the evening of the fourth and even up until today she had body aches, chills, headaches and am sleeping anywhere from 18 to 20 hours a day with no energy. She was quite concerned since Pharmacy did not follow correct protocol and now for a week and a half she could hardly get out of bed. She went to her PCP.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt vax in jan1980 & on 10/1/96 pt devel pneumonia; was treated by MD & devel asthma; addl information requested;
Patient reports of chills & night sweat the day of vaccination, followed by fever, body ache and a slight cough. Pt says he is feeling better now but has a residual cough.
had a bad nerves on my right arm; had tight right upper shoulder; headache; chill; very tired for 3 days then four days I felt great; This case was reported by a consumer via media and described the occurrence of peripheral neuropathy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), stiffness shoulder, headache, chills and tiredness. On an unknown date, the outcome of the peripheral neuropathy was unknown and the outcome of the stiffness shoulder, headache, chills and tiredness were recovered/resolved.   It was unknown if the reporter considered the peripheral neuropathy, stiffness shoulder, headache, chills and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter. The age at vaccination was not reported. The patient received Shingrix and had a bad nerve on right arm, tight right upper shoulder, headache, chill and was very tired for 3 days then four days felt great.  The reporter mentioned that after second dose of shingles vaccine the patient felt strong fine.
Allergies; Really bad body aches; Sick; Caller has been exposed to another person that tested positive for COVID/she does not know if her symptoms are COVID; Diarrhea; Low grade fever; Really bad headache/headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), DIARRHOEA (Diarrhea), HYPERSENSITIVITY (Allergies), MYALGIA (Really bad body aches) and PYREXIA (Low grade fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 17B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MAGNESIUM CITRATE for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Low grade fever) and HEADACHE (Really bad headache/headache). On an unknown date, the patient experienced ILLNESS (Sick), HYPERSENSITIVITY (Allergies), MYALGIA (Really bad body aches) and EXPOSURE TO SARS-COV-2 (Caller has been exposed to another person that tested positive for COVID/she does not know if her symptoms are COVID). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (Sick), HYPERSENSITIVITY (Allergies), MYALGIA (Really bad body aches) and EXPOSURE TO SARS-COV-2 (Caller has been exposed to another person that tested positive for COVID/she does not know if her symptoms are COVID) outcome was unknown and DIARRHOEA (Diarrhea), PYREXIA (Low grade fever) and HEADACHE (Really bad headache/headache) had not resolved.            No concomitant medications reported.
received expired TYPHIM VI  vaccination with no reported adverse event; Initial information was received on 08-Oct-2021 regarding an unsolicited valid non-serious case from a physician via consumer/non-health care processional (Reference number- 00805095).  This case is linked to 2021SA336821 (same reporter).  This case involves a two-year-old male patient who was vaccinated with an expired dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (expired product administered).  Medical history, past medical treatment, vaccination and family history were not provided.   Patient had no other vaccines.  On 30-Sep-2021, the patient received a 0.5 ml first dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot number and expiry date: not reported) (Frequency: Once) via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "Doctor states that two patients received expired TYPHIM VI vaccinations in his practice 9 days ago. Doctor states that the date was approximately 30SEP2021. Doctor states that neither of these patients experienced any adverse events and that he was calling to find out if Sanofi had any safety or efficacy data related to expired products. Doctor also asked if the patients should be re-vaccinated"  Doctor states that specific information regarding lot number of TYPHIM VI and date of birth (DOB) of patients is not available at this time. Doctor states that he may be contacted in the future at the phone number provided if this information is required.  At the time of reporting, no adverse event was reported.  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 the 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.  There will be no information available on the batch number for this case.
Swelling redness at sight and swelling in finger and hand redness at various areas on arm, fever > 101, pain cellulitis. IV antibiotics given at hospital (ER).
watery eyes; tightness in jaw; rash on her neck and chest; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a nurse and describes the occurrence of LACRIMATION INCREASED (watery eyes), MUSCLE TIGHTNESS (tightness in jaw) and RASH (rash on her neck and chest) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20a) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced LACRIMATION INCREASED (watery eyes), MUSCLE TIGHTNESS (tightness in jaw) and RASH (rash on her neck and chest). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form. At the time of the report, LACRIMATION INCREASED (watery eyes), MUSCLE TIGHTNESS (tightness in jaw) and RASH (rash on her neck and chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient called nurse to report she began having adverse events within 1 hour after receiving first dose of vaccination. Patient was due for her second dose tomorrow and nurse was questioning whether to give the patient her second dose. No concomitant medication were reported  No concomitant medication use was provided by the reporter.  Treatment of events was with diphenhydramine (Benadryl ). Nurse reporter was unsure of how long the symptoms lasted.   This case was linked to MOD-2021-040823 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up document received on 04-MAY-2021 contains no newinformation
Periodic, pinpoint, sharp headaches above right eye. Originally attributed them to my new Fitbit and stopped wearing it at night when my arm could end up near my head.  I get one every few days. I have a high threshold of pain and they are unbearable. They last about 15 minutes.
High fever, rapid heartbeat, uncontrollable shaking, chills, extremely painful body aches, dizziness, blurred vision, dilated pupils, difficulty breathing, migraine, pain level of 10 on a scale of 1-10.
Rash (not itchy) over entire torso (not neck, head, or limbs). Chills. Mild fever.
Pt received TD booster as routine shot on 4/13/01. On 5/24/01, she noticed an electrical "zinging or zapping" sensation going down her arms. This comes and goes. Starting 5/26/01, she noticed more itching and cramping in her (B) arms and hands. I spoke with doctor on 5/25/01 and he recommended conservative therapy and monitoring of symptoms. Pt to call me if symptoms do not resolve in 2 weeks.
Same day: fever, cough, shortness of breath, "sinus" - still continuing through today 10/15/20-diarrhea
Narrative: 72 yo male patient w/hx of Pulmonary Fibrosis, COPD, CAD, Esophageal CA w/mets to lungs presents to the ED with shortness of breath. Ongoing since seen on 6/1/21. States he can't his breath. + pain with deep respiration. Diagnosed with Covid Pneumonia, admitted to hospital for supportive treatment. Positive COVID 19 test after having completed vaccination series with Pfizer Covid-19 vaccine (#1 on 1/19/21, #2 on 2/9/21. Treated with dexamethasone and other supportive care (O2, inhalers, etc.) Patient's SOB improved, however he is near end-stage with metastatic cancer and plan is to discharge home with hospice care.
Eight days post vax, she had 3 seizures not associated with fever, requiring ER visit and hospitalization. She had only had a day of vomiting with 6-8 episodes of watery diarrhea, 2 days prior to admission. On the morning of 3/4/00, she was sitting on the floor with her dad, when she developed a blank stare, her eyes deviated to the right, and she slumped back and to the right onto a floor pillow. He went to pick her up to go call 911 and she was very stiff, lasting about 2 minutes and she was sleepy afterward. In ER, after her LP, she had another seizure witnessed by the MD which was described as tonic-clonic and lasting about 2 minutes. She was post, so not very cooperative. She was started on maintenance IV fluids. She was started on Dilantin and her acidosis improved with IV and oral rehydration. Was seen by neurology and will follow up in 1 month.