chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 19-JUN-2012, patient received improperly stored (Oka/Merck) VARIVAX dose 1, from batch/lot # 671861-1907AA (expiry date, dose units, rout and anatomical location were not specified) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested
Raised Red hive/lump size of a silver dollar that lasted for 6 days and includes flu/bronchitis type symptoms.  After the 6 days the Bronchitis type symptoms still persist to the present day  and are on going!!!
This spontaneous report refers to an approximately 19 year old female patient. On 22-MAR-2010 the patient was vaccinated with VARIVAX (Merck), subcutaneous. Lot number 1296Y was reported. Concomitant therapies included IBUPROFEN. On 03-JAN-2014, the patient experienced shingles and red rash on her mid thoracic area to right coastal margin on the abdomen, no vesicles and red bumps or erythematous papules were reported. On 03-JAN-2014, patient went to the emergency room at hospital in regards to this reaction but was not admitted. Patient was prescribed Famciclovir (manufacturer unknown) and hydrocodone (manufacturer unknown) and was also prescribed gabapentin (manufacturer unknown). The outcome of red rash on her mid thoracic area to right coastal margin on the abdomen was reported as not recovered, she was still experiencing these symptoms. The relation between the events and the VARIVAX (Merck) was unknown. Additional information has been requested.
PATIENT HAD WHAT APPEARED TO BE AN INJECTION SITE REACTION. PATIENT DESCRIBED RED RASH, SORENESS, STIFFNESS, AND WARMTH LOCALIZED TO AREA AROUND INJECTION IN LEFT ARM.
Moderna booster.  No reactions to first two doses.  This time extreme chills, fever, ears ringing,  head pounding, extreme fatigue, flu like symptoms, aches, plus very sore injection site
cough; congestion; sinus pressure; fatigue; headache; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 17 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Unable to locate or read the details,, prev dose dose number=2}]), for Covid-19 immunization; Bnt162b2 ({prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False, prev dose lot unknown=True, prev dose lot unknown reason=Unable to locate or read the details,, prev dose dose number=1}]), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 21May2022, outcome "recovered", described as "body ache"; NASAL CONGESTION (non-serious) with onset 21May2022, outcome "recovered", described as "congestion"; COUGH (non-serious) with onset 21May2022, outcome "recovered"; FATIGUE (non-serious) with onset 21May2022, outcome "recovered"; HEADACHE (non-serious) with onset 21May2022, outcome "recovered"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 21May2022, outcome "recovered", described as "sinus pressure". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of cough, nasal congestion, paranasal sinus discomfort, fatigue, headache, pain. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200792447 Same patient and drug, different event separated in time.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 05-Apr-2022; Expired vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 05-Apr-2022) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 05-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 05-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that thought that the vaccine expired in Jun-2022, however it was expired in 01-Apr-2022.  No treatment information was reported.
?COVID? arm. Red, raised itchy lump at injection site showed up one week after injection.
Patient reported that after getting the vaccine and sitting in the post-vaccination area for 15 minutes as instructed, starting feeling dizzy and a headache at the back of her head almost immediately after. When reported to me, I went to the patient and she was feeling faint and was drinking water thinking it may be due to dehydration. I asked if she was feeling any other symptoms, she denied any and reported no trouble breathing or chest tightness. I took her blood pressure which came to be 143/98 and she stated that was high for her as she is always 120/80. I asked her questions regarding her PMH and she said she has hypothyroidism, IBS, and may have rheumatoid arthritis but it waiting on her tests with her physician. I kept her talking to assess for any changes but she was not improving, so I called EMS. Patient also stated she had a large meal before coming and she mentioned having a dish that had gluten in it even though she had a gluten allergy. When EMS arrived, they did a check-up and when escorting her to the ambulance truck patient was not able to take more than a few steps and needed to sit so they took her in a stretcher.
I got a rash; I was allergic to Propylene glycol; nausea; and I would be like fatigued; 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), in Nov2021 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; Lot number: Unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: Unknown), for Covid-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "I got a rash"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "I was allergic to Propylene glycol"; NAUSEA (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "and I would be like fatigued".  Additional information: Patient so far received the Pfizer vaccine and had two boosters. Patient went in on that day to get another booster, it had been a while, the last one patient had in Nov2021. Patient was due so, went in and told them that the patient allergic to Propylene glycol. Patient took propylene glycol in medication not knowing and got a rash, nausea and would be like fatigued. When patient first had the first shot, the first Pfizer shot, patient was fine. patient did not have any kind of symptoms at all and the second one.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Upon awakening had stomach ache. When I stood noticed I was light headed at 6 a.m.  Went into work starting feeling fatigue, body aches, headache. By 10a.m. my voice was weak, very light headed , and fatigued. Went home. At noon fever began 100. By 3 p.m. fever was 103. Began taking Tylenol. Fever would drop but come back. By 6 P.M. the chills were bad. 8P.M. Covered with 6 blankets and a heating pad. Fever 102. Sometime during night I soaked bed clothes and sheets. Slept and upon waking at 7: 00 a.m today fever is gone. I feel ok still little appetite. Lasted total of 36 hours. I had Covid 10 weeks ago prior to first dose of vaccine.
Suddenly sick; Sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US285221_OS (Novartis).  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Kidney Disease Stage 3B" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "unknown", described as "Sore throat"; MALAISE (non-serious) with onset 2022, outcome "unknown", described as "Suddenly sick".  Additional information: Patient had all Covid vaccines, including the 5th booster. Patient received 5th booster on 14Nov2022, and then took monthly injection on 30Nov and was suddenly sick. The next day, patient developed a sore throat and on 03Dec2022 tested positive for Covid. Patient Covid was fairly bad with a high fever. On Covid Day 4, Patient received a half-dose of Paxlovid, as the patient also has Kidney Disease Stage 3B. Patient started feeling better on Covid Day 10 and tested negative on Day 11 and Day 12. On Day 13 patient began to feel badly again and tested positive for Covid.  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.
Approx 15 min post vaccination with booster dose of Pfizer after a J&J primary series, the patient states that he was begining to feel flushed and clammy. I immediately obtained vitals which were BP 148/98, respirations were 16, O2 sat 98, and HR 68.  Patient explains that the blood pressure reading was high for him. Due to the known risk he has related to multiple allergies, I gave 2 benadryl 25mg PO and did a repeat BP. BP 2nd reading was 146/96. Patient was sent to the local ER to be evaluated just to be safe.
patient reported feeling heart racing.  Patient did experience heart rate above 100  with elevated BP of 155/91.   Patient was observed Additional 15 minutes until BP and HR was stable  (BP 132/80 and HR 85).
My menstrual period after the second dose disappeared the first dose was on April 13 and the second on May 4 , I have 4 months that I have not had menstruation.
The 14 yo male patient came into the immunization clinic for his first HBV.  Up to this time the patient has had no problems with his routine childhood immunizations. After the HBV was given, the patient sat down stating he was feeling funny.  His eyes rolled back and he then became listless. At this time he was supported and moved to the floor.  His coat was removed. His airway was protected. He then had a loss of conscousness and began making snorting noises from his throat. At the same time his arms stiffened and curled toward his chest, appearing decordicate.  This stiffening lasted approximately 3 minutes.  The LOC lasted approximately 4-5 minutes. An ammonia ampule was used to try and wake him. Upon wakening, he was very pale, warm and diaphoretic.  He remained supine on the floor for approximately another 10-15 minutes.  During this time a sucker was given and then later some water.  The patient came into immunization clinic during the lunch hour and had not eaten.  The RN advised the mother to call the family physician and update him to the events of the day regarding the immunization and request quidelines for additional HBV.  The RN advised the mother that it would be inappropriate for the health department to proceed with #2 and #3 HBV.  It would be more appropriate for the child to get the vaccine from his PCP. He was then assisted into the car by his mother.
This spontaneous report was received from a Company Representative, who reported on behalf of Medical Assistant refers to patients of various ages, (3 yr old, 12 month old, and an 8 year old, and 2 other age unknown,) gender unknown who received VARIVAX. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX lot # J008170, expiration date 20-JUL-2015, subcutaneous Chicken Pox vaccine. On an unknown date, the patients experienced chickenpox described as spots and fever and with a diagnoses of chickenpox after administration of the Chickenpox vaccine. The outcome of chickenpox described as spots and fever was reported as Not Recovered/Not Resolved. No further information was provided. Follow up information: Representative received a second call from the Medical Assistant. A fourth patient 8 years old, presented to office today with, "a few spots" and no fever. Patient was diagnosed with Chicken Pox. he clarified that this patient had received two separate VARIVAX injections on unspecified dates. He indicated that he believed VARIVAX may have had same expiration date of previously reported patients. No further information was provided.
Fever of 99.8, arm pain, muscle aches, chills. Time course 18 hours. No treatment needed.
Information has been received from a health professional concerning a 72 year old female with penicillin allergy, sulfonamide allergy and dexamethasone allergy who on 10/19/05 was vaccinated with Pneumococcal 23v polysaccharide vaccine (lot 650649/0790P). On 10/19/05, the pt experienced raised red hot area at the injection site. Unspecified antibiotics were started on 10/21/05. Additional information has been requested.
Pt. states that after receiving the 2nd dose of Moderna 04/25/2021, started experiencing symptoms 04/26/2021 of blotchy "bubbles" blister-like rash appearing on the right abdomen lasting 48hrs. No noted Primary visit/communications. Symptoms had subsided 48hrs later.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
SKULL ACHE (INTERMITTENTLY DIRECTLY ON THE TOP OF HEAD); This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's past medical history included front subdural hematoma, and concurrent conditions included bees allergy, horse allergy, alcohol user (15 drinks per week), and cigarette smoker (quarter of pack per day since 17 years), and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with tramadol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced skull ache (intermittently directly on the top of head). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skull ache (intermittently directly on the top of head). This report was non-serious.
Projectile vomiting, w/in a few hrs; t99.6; had n/v 6 days prior to vax, diarrhea 24 hrs prior to vax;
sick; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 17Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
First dose: March 25, 2021 On April 9 I  began to have dizziness and feeling as if the room was spinning. I also had a feeling of tiredness and upset stomach. No vomiting and no fever. I had all of the classic symptoms of Benign Paroxysmal Positional Vertigo. By April  13, I had only a slight feeling of light-headiness and by April 15, I felt fine.  I have never had vertigo before.   Second dose: April 16 As of April 17 I have swollen lymph nodes under my left arm toward my left breast. The area is tender but is mostly felt during movement. I will be applying warm compresses to see if that makes a difference.
Information has been received from a licensed practical nurse concerning a 23 month old female with no pertinent medical history or drug reactions/allergies who on 21-MAY-2009 was vaccinated with ROTATEQ (lot # 663846/0067Y, expiration date 12-APR-2009). Concomitant therapy PENTACEL and PREVNAR. The patient was vaccinated with ROTARIX on 09-JUL-2009. On 08-FEB-2011 the patient experienced vomiting, diarrhea (that was yellow and foul smelling) and fever of 101 F. No treatment was given. This patient had been exposed for an entire week to another patient that had rotavirus (WAES # 1102USA00878). The patient was recovering at the time of this report. The patient had rotavirus screen done, result not provided. The patient sought unspecified medical attention. Follow up information has been received from a licensed practical nurse. The patient with no drug allergies or pertinent medical history was vaccinated with the first dose of ROTATEQ (lot # 63846/0067Y). There was no illness at the time of vaccination. The patient was vaccinated with the second dose of ROTARIX (lot number A41FA859A) on 09-JUL-2009. It was reported that on 08-FEB-2011 at 05:30 the patient experienced vomiting and yellow diarrhea. The same day, at 14:40 the patient presented temperature and loose stools with foul odor. The licensed practical nurse reported that the patient was exposed to rotavirus at the daycare. On 12-FEB-2011 the patient recovered from temperature and diarrhea. On 14-FEB-2011 the patient recovered from vomiting and yellow diarrhea (also reported as 12-FEB-2011). The patient required a doctor visit (also reported as no medical attention required). No further information is expected.
1/15/22 Pt tested positive for COVID at SNF; pt brought to ED via EMS with c/o increasing dyspnea over past 12-24 hrs; in A Fib with RVR, treated with improvement in HR; on BiPAP; given decadron, remdesivir, Baricitinib; DNR; hematochezia with worsening anemia; PRBCs transfused; pt found to be minimally responsive on 1/18/22; RRT initiated; respirations slowed, heart bradycardic which led to asystole; pt expired in the hospital
Redness and swelling at injection site; feeling of nausea; fatigue; very limited movement of arm that was injected - scale of 1-10 (10 = worse) the pain is 10 from neck to finger tips of arm that was injected.
no sense of smell and taste; Bad headache; dry eyes; no sense of smell and taste; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient herself) reported that she received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot number/Expiration date: unknown) via an unspecified route of administration on 13Mar2021 as single dose for covid-19 immunization. Patient medical history and concomitant medication were not reported. On an unspecified date, after her first vaccination caller got exposed to Covid positive person and experienced with no sense of smell and taste, Bad headache, and very dry eyes. No lab data was recorded. Caller questioned whether she could take second dose if it was ok. Outcome of the event was unknown.  No follow-up attempts are possible, Information about lot/batch number cannot be obtained.