chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm for 1st 24 hours it subsided. then had a low grade 99.9-100.4 temperature and body aches for next 48 hours.
This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018) (dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) (60.33 °F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Erythematous, discrete, papular areas along hairline, in scalp, neck, axillae and inguinal areas as well as trunk and extremities.
Worse arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Worse arm sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Worse arm sore). At the time of the report, PAIN IN EXTREMITY (Worse arm sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-054215 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054215:Husband Case
Symptomatic Thrombocytopenia c/w ITP with platelet count <5k occurring 7 days after vaccine.  Treated with Dexamethasone 40mg PO daily x 4 days with improvement and normalization of platelet count a week later
Narrative: PRINICIPAL DIAGNOSIS (Reason for admission after study): 1). Typical Migraines characterized by headache, visual impairment, paresthesia of the right face and hand 2). COVID-19 w/Viral Pneumonia 3). Neutropenia 4). Possible TIA 5). Hyperlipidemia the patient is a 40 y/o male with a PMH of CAD and sarcoidosis who presented to ED complaining of neurological changes. The patient states that when he woke up this morning he noted blurry vision, right-sided facial numbness, confusion, and slurred speech. He states that when he went to work he had difficulty spelling and speaking. The patient states that his last known normal was at approximately 12:30AM this morning. He denies overt weakness, ataxia, and coordination difficulties. He states he has been vaccinated against COVID-19. Upon arrival in the ED the patient was found to be COVID-19 positive. CTA of head and neck showed No significant cervical or intracranial vascular disease and biapical parenchymal opacities concerning for pneumonia. WBC was 2.7. presented with blurry vision, right-sided facial numbness, confusion, and slurred speech after waking up. His head/neck CTA was unremarkable except for lungs, apical opacities c/w pneumonia. He is COVID-19 (+) which he is asymptomatic after getting his COVID vaccination. He was seen by Neurology today and he feels his symptoms are c/w Typical Migraines. He admits to being back to baseline except for slight slurred speech. He will be d/c'ed home with home quarantine x 10 days per guidelines. ASSESSMENT/RECOMMENDATIONS: Patient had one of his typical migraines characterized by headache, visual impairment, paresthesia of the right face and hand; all of the symptoms have resolved at this stage. He takes Topiramate 100 mg prn for acute headache, which can cause transient difficulty with attention/focusing, and for word finding. TIA would be less likely for the given presentation. Discussed at length with him. He has been advised against taking Topiramate on prn basis, the medicine is for migraine prophylaxis, either he should take it daily or avoid using it. If he decides to take it every day, then it should be started at 25 mg qhs and gradually increased to 100 mg daily over the span of few weeks. ASSESSMENT/PLAN: COVID-19 Pneumonia Neutropenia - Imaging showed biapical parenchymal opacities concerning for pneumonia - The patient does not require supplemental oxygen - Discussed risks and benefits of convalescent plasma and remdesivir; the patient declines both of these therapies - COVID severity is currently mild; consider dexamethasone if condition worsens - Albuterol PRN Possible TIA Possible neurologic sequalea of viral infection - CTA of head and neck showed no significant cervical or intracranial vascular disease Hx of sarcoidosis Hx of CAD Hx of systolic heart failure last ECHO, 5/1/19-EF 30-35%, -pacemaker placement - Continue atorvastatin 40mg daily - Continue sotalol 40mg BID Hyperlipidemia: -Chol/LDL 200/128 - Restart Atorvastatin 40mg qhs, possible noncompliant
More or less, like a little bit towards the bottom of kidney, it hurts in that area. She states it's muscular maybe but its on the right side.; little bit of flu-like symptoms; in the bed the whole week; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 (Lot number: EW0182, Expiration Date: 31Jul2021) at the age of 70 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE: 1, Lot Number: ER8727, Expiry Date: 31Jul2021, She mentions it's kind of small on her vaccine card but she sees the following: Pfizer CV vaccine 0.3mL/mg BUD 8 hours at RT. The caller mentions the expiration is so small, Anatomical Location: Left arm), administration date: 23Mar2021, when the patient was 70 years old, for COVID-19 immunization, reaction(s): "she had no problem"; Flu vaccines (she all the vaccines required such as shingles, flu, that has been during the year and nothing to do with the Pfizer.). The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Apr2021, outcome "unknown", described as "little bit of flu-like symptoms"; BEDRIDDEN (non-serious) with onset Apr2021, outcome "unknown", described as "in the bed the whole week"; MYALGIA (non-serious), outcome "unknown", described as "More or less, like a little bit towards the bottom of kidney, it hurts in that area. She states it's muscular maybe but its on the right side.".  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
My menstrual cycles have been off, sometimes i get a period after 16 days, it's coming early one month, then late the next.My periods have always been a 28 day cycle, since the vaccine, I have darker blood, lighter sometimes than normal. Example July 2021- 15 day cycle,  June 32 day cycle. Should I be worried about this?
Vac. expiration date 06/13/21 Vac. administered 06/14/21
Patient complained of lips and tongue tingling; denied any shortness of breath; Benadryl (5cc) administered.  Advised to go home and go to bed.    After reaction started, she admitted that she has this happen after any type of vaccine received.  Did not advise of this when completing questionnaire - only acknowledged allergy to statin.
Redness, soreness at the site of the smallpox vaccine scar. Smallpox was administered in childhood in the country. COVID vaccine injection site is about two inches away from the smallpox scar.
Pt developed urticaria and angioedema and was given Benadryl and prednisone.
This case was reported by a non-health professional via sales rep and described the occurrence of pruritus in a patient who received FLULAVAL QUADRIVALENT 2018-2019 season for prophylaxis. On 1st October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. In October 2018, less than a week after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced pruritus, swelling and erythema. On an unknown date, the outcome of the pruritus, swelling and erythema were unknown. It was unknown if the reporter considered the pruritus, swelling and erythema to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The reporter was the Corporate Negotiator of the pharmacy. The age at vaccination was not applicable for this report. The patient demographic details were unknown. The reporter stated that they began giving flu vaccine a day before reporting and since then they had several staff members who had reactions such as redness, swelling and itching. All other information regarding vaccination was unknown. The reporter agreed to be followed up.
Expired vaccine administered to 30 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 30 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 30 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 30 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  Reporter stated that the Vials were refrigerated until the day of administration and unused portions discarded within 12 hours.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Contains Non significant information.
Pharmacy gave her double dose for her 2nd booster, Instead of giving her 0.25mL, they gave her 0.5mL for her 2nd booster dose.; Was drenched; Woke up at 3am with no energy, Had no energy for 3 days; Tiredness; Must have broke out into fever per patient; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Was drenched), ASTHENIA (Woke up at 3am with no energy, Had no energy for 3 days), FATIGUE (Tiredness), PYREXIA (Must have broke out into fever per patient) and ACCIDENTAL OVERDOSE (Pharmacy gave her double dose for her 2nd booster, Instead of giving her 0.25mL, they gave her 0.5mL for her 2nd booster dose.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 039F21A, 031A21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Pharmacy gave her double dose for her 2nd booster, Instead of giving her 0.25mL, they gave her 0.5mL for her 2nd booster dose.). In April 2022, the patient experienced HYPERHIDROSIS (Was drenched), ASTHENIA (Woke up at 3am with no energy, Had no energy for 3 days), FATIGUE (Tiredness) and PYREXIA (Must have broke out into fever per patient). In April 2022, ASTHENIA (Woke up at 3am with no energy, Had no energy for 3 days) had resolved. At the time of the report, HYPERHIDROSIS (Was drenched), FATIGUE (Tiredness), PYREXIA (Must have broke out into fever per patient) and ACCIDENTAL OVERDOSE (Pharmacy gave her double dose for her 2nd booster, Instead of giving her 0.25mL, they gave her 0.5mL for her 2nd booster dose.) outcome was unknown.            No concomitant information was provided. The patient stated that the immune system of patient was good. No treatment information was provided.
Waking up swollen in the morning. Felt swollen and went to take a shower then noticed golf balls sized masses under armpits. Took Tylenol and and drank lots of fluids, then it resolved in about 3 days.
developed urticaria and the local site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site urticaria. On an unknown date, the outcome of the injection site urticaria was unknown.   It was unknown if the reporter considered the injection site urticaria to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: Pharmacist reported on behalf of a staff member at the hospital where he worked.  The patient received Shingrix vaccine at the hospital and developed urticaria at the local site of injection.  Pharmacist did not had any additional information and any patient demographic information. Pharmacist enquired if the 2nd dose of Shingrix could be given and what the effectiveness was after 1 dose of Shingrix. The representative spoke from content and package insert(PI) and gave medical disclaimer and referred to health care professional (HCP).  Reporter was also given medical information telephone number for future reference and warm transferred call to Medical Information (MI). The consent obtained to contact pharmacist for follow-up.
This spontaneous report as received from a physician refers to a patient of unknown age (gender not reported). On 19-OCT-2012, the patient was inadvertently administered an expired dose of ZOSTAVAX, lot number 671596/1056AA, exp. date 02-OCT-2012 (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Pt reported itching at injection site the day after receiving the vaccination, did not initially notice a rash.  Later that day he noticed an erythematous, micropapular, pruritic, blotchy rash in the flexural creases of bilateral elbows.  Rash then spread to bilateral groin region and behind posterior aspect of left knee.  Pt denies a history of eczema or psoriasis.  No new hygiene products correlating with onset of rash.  No other vaccinations around time of COVID-19 vaccination.  No anaphylactic reaction.  Has never had a reaction to any other vaccine in the past.
pt recvd vax & appeared to go into shock, color very pale, lethargic & appeared not to be breathing for approx 1 min, apical pulse 120/min; hypotonic state for approx 10-15 mins; crying;  dx pertussis reaction;
Red, swollen, warm to touch rt deltoid; swollen into shoulder area; reaction 24 hrs p/inject given; 3AUG92 swelling dec;
Red, itchy rash that was warm to the touch around site of injection that started 7 days after the injection and lasted for 5 days.
Stated approx. 2 hrs after receiving vaccines. Had a profuse nose bleed. Went to ER she stated her BP was 195/105 and they couldn't stop the bleeding so they had to pack the nares.
stopped my Shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "stopped my Shingles"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "stopped my Shingles"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, guessing the 3rd booster is not as strong.), for Covid-19 immunization, reaction(s): "Even after I got shingrix shots my shingles were still coming monthly", "So I am guessing the 3rd booster is not as strong", "all COVID 19 shorts and the two booster also stopped my Shingles. This third booster did not, I broke back out a week after 3rd booster.". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "stopped my Shingles". Additional information: Patient stated that the patient wanted to share that all COVID 19 shots and the two booster also stopped Shingles. Patient known that Pfizer shots for COVID were not for Shingles, but it was an added benefit. Even after patient got shingrix shots, shingles would still come monthly.  Follow-up attempts are completed. No further information is expected.
COVID TURNED INTO PNEUMONIA; This spontaneous report received from a patient via a company representative via social media (J and J Corporate) concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with additional information on 27-DEC-2022. The patient's weight was 115 (unspecified unit) and height was 170.18 centimeters. The patient's pre-existing medical conditions included: Patient ate healthy and take care of him/herself. No obesity or other risk factors. The patient was previously received with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced covid which turned into pneumonia (Dose number in series 2). It was reported as "my friends don't have any of those factors and still have had it bad. I've had the vaccines and had a severe case of Covid and it turned into pneumonia. I'm 5'7 and weigh 115. I eat healthy and take care of myself. No obesity or other risk factorssave it!! " The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid turned into pneumonia was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221257349. This report was associated with product quality complaint: 90000264778.; Sender's Comments: V0: 20221257371- covid turned into pneumonia. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.
11/13 reddened area. 11/15 5cmx4cm reddened area, nausea. Arm hurts and feels tingly and itching.
Incident:   DOH in (Privacy) informed DOH on site that client "may have" received another Pfizer covid 19 vaccine today at Store/Pharmacy as there was another record of Pfizer Covid 19 vaccine  in the Immunization Information System with today's date (12/04/21) entered by Store/Pharmacy.  Followed-up with client (7:04 PM) to inform her of our findings, client does not speak the language and her son whom also accompanied her to site translated for her, son states client did go to Store/Pharmacy today and received Flu and shingles vaccine but to their knowledge she did not receive another covid 19 vaccine at Store/Pharmacy. Son states mom is doing well and currently not experiencing any side effects. Update (8:00 PM) Son confirmed  after speaking with his brother (client's other son whom accompanied her to Store/Pharmacy for flu and shingles vaccine) that client did receive another covid 19 vaccine at Store/Pharmacy. DOH medical team advised client to follow-up with healthcare provider if client experiences reactions other than expected side effects.
Pt came into the office on 2/29/00 with rash for 2 days. At peak of rash pt had 191 lesions over entire body including scalp. Treated with Benadryl and instructed on signs of infection.
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant medication and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 from lot # M037770 with expiry: 01-JUN-2019. No adverse effects reported. The vaccine was exposed to a temperature of 35 degree Fahrenheit for 20 minutes. It also had 3 previous temperature excursion of 35 degree Fahrenheit for 20 minutes each. The temperature excursion was detected by digital data logger. This is one of the three reports received from the reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA007096: US-009507513-1707USA007097.
Started having slight headache with slight nausea while at work; Work in the Emergency Room, Left work at 0200, by 0600 woke up with severe vomiting which persisted until 1200.  Took phenergan at home to calm vomiting.  By 2200, 10/19/2009, severe vomiting subsided, still sligtly nauseated but able to take fluids.  No fever during this time.  Moderate headache during this time persisted about the same time.  10/20/09 symptoms subsided.
Large local rxn characterized by redness & swelling inner aspect upper arm to & including 1" below elbow; Also fever & nausea; Seen by MD;
? Dialysis Access     PT missed dialysis due to unsteady gait. PT has left arm swelling and is vomiting        HPI:   This is a 65y.o. male with significant past medical history of HTN, T2DM, CVA, COPD, ESRD on hemodialysis, DVT, MI, and PVD that presented to the hospital with chief complaint of missed hemodialysis. Patient reportedly tested positive for COVID-19 on 1/5/22. He has since missed 3 of his hemodialysis sessions secondary to inability to tolerate, weakness, fatigue, and shortness. For the past two weeks he has had decreased mentation. He was brought to the ED for further evaluation and management.   In the ED, patient normotensive, afebrile, stable SPO2 on room air. Cr 12.99, K 5.0, Na 137, Hb 12.4. Ammonia 43. CXR with bibasilar airspace opacities. He has been admitted for further evaluation and management with ID and nephrology consultations.   Patient seen and examined only by the attending physician; NP only responsible for chart review in an effort to limit exposure given the patient's COVID positive status.