chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received the vaccine approximately 12:22 PM on Saturday, April 10, 2021.  At approximately 6:55 pm that same day (Saturday, April 10, 2021) my husband collapsed in our living room.  I called 911 and the operator talked me through how to do chest compression CPR on my husband until the paramedics arrived.  My husband was then taken by ambulance to hospital where doctor performed an emergency procedure wherein he removed the blood clot in one of my husband's stints (he has three) that he had put in in 2017. Doctor was able to eventually stabilize my husband's heart.  My husband spent 5 days in the hospital as a result of this.
Large local reaction to vaccine, presume pertussis component. Right armpit is very sore, difficult to move without pain.
The pt experienced pain in her shoulder beginning 1 to 2 hours, post vax. The pt has had continuing discomfort with difficulty in raising arm, lifting, etc. Presently, she is under the care of a physician. She takes ibuprofen 800mg 4 x/day, stretching, ie.
Weakness, headache, muscle aches, fever (high 102.6), nausea, sore, swollen, red arm (approx diam 2" x 3") - could barely move arm - incredibly painful - doctor prescribed CLARITIN, ALEVE, DOXYCYCLINE. No fever-improving, arm still swollen, red and painful.
pt recv vax & exp high pitched crying & fussiness;pt had fever on/off;had leukocytosis & improved p/ATB;MD has had mult environmental allergies develop including allergies against several fruits & latex in balloons;
This is a spontaneous report from a contactable consumer (Practice manager) reported same events for 2 twins patients. This is the 2nd of 2 reports. A 19-year-old female patient of an unspecified ethnicity received TRUMENBA via an unspecified route of administration at 0.5ml, single on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On 15May2017 the patient passed out as soon as she was administered, fainted, had reactions on her arms very painful, sore and swollen on 15May2017 with outcome of recovered, The outcome of the events was recovered. The same events occurred to her twin sister.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017252009 same reporter/drug/event, different patient.
Fever, chills, exhaustion for 24 hours. Runny nose for 3 months. Loss of taste & loss of smell for 5 months.
approx 5-10min p/vax pt felt nauseated, dizzy, lost hearing in lt ear;pt eyes became fixed & dilated & began to have sz, LOC for about 1min;regained consciousness & began vomiting;
Pt reported itching starting on 11/19/20, then on 11/20 reported 3-4, 2-3 mm areas of swelling and 1, 30 mm area of redness and swelling. No other symptoms
Rash developed on forearm the day after the vaccine . on April 7th left palm started peeling .Rash has not gone away.
Received vaccines on 4-27-07 - varicella, Menactra, Tdap, Hep A, HPV. Dx with Sinusitis and migraine Type headache on 5-1-07. Returned to the office on 5-2-07 with probable migraine Dx.
Within 4 hours of receiving vaccine in left arm, received rash (red, macular, lacy) which was itching and extended to rest of her body lasting 3-4 days.
Urticaria trunk and upper legs, approx 20% of body, treated with hydroxyzine and prednisolone.
Information has been received from a nurse practitioner concerning a 20 year old female with no pertinent medical history and no allergies who on 26-DEC-2007 was vaccinated with the first dose of GARDASIL vaccine (lot# 655327/1287U) 0.5mL IM. On 10-MAR-2008, the patient was vaccinated with the second dose of GARASIL vaccine (lot# 0151X) 0.5mL IM. Concomitant therapy included minocycline (manufacturer unknown). The patient was on minocycline for about a year and this was recently discontinued because of the liver test: In June 2008, the patient had elevated liver enzymes. The patient had no symptoms but the liver function test was done because patient was worried family history of diseases. The patient sought medical attention. Additional information has been requested.  10/08/08 This is in follow-up to report(s) previously submitted on 7/15/2008. Initial and follow-up information has been received from a nurse practitioner concerning a 21 year old female with family history of antiphospholipid antibody syndrome and no allergies who on 26-DEC-2007 was vaccinated with the first dose of GARDASIL (lot# 655327/1287U) 0.5ml IM in the left deltoid. On 10-MAR-2008, the patient was vaccinated with the second dose of GARDASIL (lot# 0151X) 0.5ml IM in the right deltoid. On 27-JUN-2008 the patient was vaccinated with the third dose of GARDASIL (lot# 0250X) IM in the left deltoid. Concomitant therapy included minocycline. It was reported that the patient was seen in the office on 27-JUN-2008 for her third dose of HPV vaccine and the patient stated she had had joint pain for 3 months. In June 2008 she was taken to a rheumatologist who drew liver enzymes and "they were elevated". The patient had no symptoms but the liver function test was done because patient was worried family history of diseases. The patient was on minocycline for about a year and this was recently discontinued because of the liver test. The patient stated her levels were returning to normal, and subsequently, she was vaccinated with her third dose. There was no illness at time of vaccination. The outcome of the patient's arthralgia was unknown. Additional information has been requested.
Fever; Chills; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration as single dose and had previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration as single dose for covid-19 immunization. Patient medical history and concomitant medications were not provided. On an unknown date, during the night after the second dose of Covid-19 vaccine, the patient experienced fever and chills. The outcome of the events fever and chills was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Jan 25- chills, fever, headache  Jan. 27- obtained rapid and PCR COVID SWABS- which resulted negative  Jan 30- started antibiotics from primary doctors with no relief of fevers. Jan 31 - Brought to ER And was admitted for observation . Multi Covid  testing negative. Cat scan showed pneumonia picture. SARS COVID IGG was negative, but antibody for vaccine was positive
Initial and follow up information has been received from a 67 year old male consumer, who in September 2004, was vaccinated with PNEUMOVAX 23.  The patient reported that he developed a fever of 102 to 105 degrees for over a year after the administration of PNEUMOVAX 23 (onset not specified).  The Lot # was not provided.  It was reported that two months prior to vaccination the patient had chemotherapy and after the administration of PNEUMOVAX 23 he had chemotherapy and radiotherapy.  The patient reported that he was hospitalized for almost 3 months (dates not specified).  Follow up information from the consumer indicated that he had been diagnosed with a "rare strain of infection."  He recovered in mid-2006.  No further details were provided.  Additional information has been requested.
Uncontrollable shaking; rise in blood pressure; hives; (stomach, back, face, injection site) high heart rate; swelling in face and neck; shortness of breath.
Vaccination was requested and administered on 11/9/2021. Patient reported cramping and heavy bleeding on 11/12/2021, and was transported to ED. Gestation 13 weeks 5 days. EDD 5/2022. OB history:  9 pregnancies, 2 live births, hx of pre-eclampsia and gestational diabetes.
Pt received 1st dose of Hep-B. Mother called 30 minutes later, stating the infant had foaming of the mouth, milk on the nostrils and blue color. She blew into infant's face and she recovered. Mother brought baby to office. Physical exam was wnl. Milk on both nostrils. Pt was referred to ER and was admitted to the hospital for sepsis work-up and observation.
On 01/13/2022 at the clinic, Patient,  age 11, was given a dose of Pfizer purple cap indicated for persons 12 and older. Patient, age 11, should have received Pfizer orange cap indicated for persons 5 to 11 years of age.
PT BEGAN GETTING HIVES ON BODY 10-2-20 AND WAS COMPLETELY COVERED BY MORNING OF 10-3-20. PT CONTACTED HER PCP AND WAS TOLD TO TAKE ZYRTEC AND PEPCID. RASH BEGAN TO LESSEN IN SEVERITY. ON 10-4-20 RASH WAS GONE. PT CONTACTED PHARMACY ON ADVICE OF HER PHYSICIAN TO NOTIFY PHARMACY OF RASH.
Patient presented to the ER with progressively worsening cough and SOB. Patient was diagnosed with acute respiratory failure with hypoxia secondary to Covid-19. Patient received IV steroids, remdesivir, 1 dose of tocilizumab, antibiotics. Patient was weaned down to 2L of oxygen by time of discharge. Patient was discharged home with home oxygen.
Pt with dizziness and chest pain that started about 10 minutes after getting  the Moderna Covid19 vacccine. No shortness of breath, no rash, no fever, no  swelling, no weakness.  Feels pain in center of chest and on L side.  Pt also has  been  having stress with work.  Pain started in the R side of the chest and  migrated to the L side. It improved with Nitro and Aspirin but pt states he still  feels, "fussy."  He has no symptoms of allergic reaction or anaphylaxis.  Pt has no known hx of cardiac dz, nonmoker, nondrinker. His Mom has a cardiac  murmur but no other known history of heart disease.
Rash developed all over my body; very itchy; Spot rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 (Lot number: EW0173) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (ongoing). Concomitant medication(s) included: METFORMIN; CREON; JARDIANCE; GLIMEPIRIDE. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot No: EW0162, Location of injection: Arm Left), administration date: 13Apr2021, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 10May2021, outcome "not recovered", described as "Rash developed all over my body"; PRURITUS (non-serious) with onset 10May2021, outcome "not recovered", described as "very itchy"; RASH MACULAR (non-serious) with onset 10May2021, outcome "not recovered", described as "Spot rash". The events "rash developed all over my body", "very itchy" and "spot rash" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, pruritus, rash macular.  Additional information: It was reported that the rash developed all over his body. Spot rash, very itchy. It continues to form. The dermatologist prescribed something to help that costs a lot and at best only seems to pause the effect. The patient received treatment (Enstilar topical application) for the events. He claims other patients who received Pfizer shot reported the same. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
facial pain; a golf ball size lump on the left side of the face near the jaw line; the patient developed  fever; This spontaneous report has been received from a pharmacist concerning to a 3-year-old male patient.  The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On 14-AUG-2019, the patient received a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneously (anatomical location, lot# and expiration date were not reported) to prevent measles, mumps and rubella (prophylaxis).  On 25-AUG-2019, the patient developed a fever (pyrexia) (the temperature was unknown), facial pain and a golf ball sized lump on the left side of the face near the jaw line (mandibular mass). The patient sought medical attention; the patient's family called the pharmacist and went to see a physician. An unspecified blood tests were performed; however, the results were unknown. No treatment was given for the events. At the reporting time, the patient had not recovered from the events of pyrexia, facial pain and mandibular mass.  The causal relationship between the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and the events was unknown.
Pt was out on a boat and became dizzy and felt like his head wasn't clear per dad. Father reported to me that his friends on the boat that he was difficult to arouse and "out of it". Dad went to pick pt up at dock and pt vomited 6 times, was dizzy and had a headache. Dad took pt home. Pt is sleeping.
no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 01-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Donor reported severe nausea uncontrolled by anti-nausea medications given by personal physician.  Donor then went to Emergency Room when nausea medications were noneffective. Nausea persisted for longer than 24 hours.
Autistic symptoms.  Treatment is ot, pt, and speech. 4/14/08-records received-Developmental evaluation at 9 months of age-2/26/02 cognitive skills at 3 1/2 to 5 months. Self-help skills 5-8 months level. Communication skills-5 1/2 to 6 1/2 level. Early childhood intervention program evaluation 3/7/02-does not interact with toys, not sitting, arching back to avoid sitting, not crawling or moving forward. Frequent otitis media. Office note 12/20/02-hypotonia of unknown etiology.  11/26/02-Has not met developmental milestones, delayed by about 9 months. Delay began at 6 months of age. 11/22/02-Neurology visit-impression unexplained developmental delay with hypotonia. 1/24/07-Unexplained static encephalopathy with nocturnal seizures and some autistic features. No social interaction with peers.
a severe allergic reaction to a Pneumococcal 23 causing "two autoimmunes"./Highly allergic to the Pneumococcal-23; a severe allergic reaction to a Pneumococcal 23 causing "two autoimmunes"./Highly allergic to the Pneumococcal-23; This spontaneous report was received from a  female patient of unknown age referring to herself. Information about medical history, concurrent conditions and concomitant therapies was not provided.      In 2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis.         On an unknown date, the patient experienced highly allergic to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) causing "two autoimmunes" which was severe. The outcome of the events was unknown. The causality assessment was related.  Upon internal review, event autoimmune was determined to be medically significant.
I don't know the details of the vaccine. I started feeling chills and shivering. That got worse as the night wore on. I took some tylenol. When I woke up about 6AM I was much improved but not 100%.
No adverse effect reported; patient received improperly stored VARIVAX; Information has been received from a pharmacist referring to a 54 years old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported.  On 01-APR-2019, the patient received improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number R024023 and expiration date 22-AUG-2020; route of administration was not reported) for prophylaxis (incorrect product storage). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effect was reported.   The temperature excursion was from 15 Fahrenheit scale to 46 Fahrenheit scale for 744 hours. There was no previous temperature excursion. Data logger was not involved.  This is one of two linked cases received from the same reporter.; Sender's Comments:  US-009507513-1904USA006161:
I contracted COVID-19 on 05/18/2022 with symptoms of fever, cough, congestion, difficulty breathing, fatigue, rash on my face and chest, and joint pain. I was not prescribed any medications. I was ill for 16 to 17 days before my symptoms resolved. I am still experiencing fatigue and difficulty breathing.
slight cough day of shot & next day- fever- no temp taken- cough became phlegmy- vomiting & diarrhea 09-01-08 to 09-06-08-loss of appetite 08-14-08 to 09-05-08-fever 08-27-08 to 08-28-08- coughs day and night- client never went to MD- still has not gone to MD- I encouraged client's mother to go to MD
Sxs: Injection Site had edema and erythema present. Swelling was about an inch in diameter. Monitored Pt for about 20 - 30 minutes and the swelling and erythema started to go down. Instructed patient that if they had any other symptoms or if swelling came back or got worse to contact employee for instruction. If started experiencing shortness of breath, instructed to call 911.
24 hours later lost all feeling in both arms and both legs. This sensation lasted 12 hours and than I was ok.
11-7-17 10:30 pm itching, rash, all over body.
chills; a fever of 101; arm was swollen; arm was itchy; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (a fever of 101), PERIPHERAL SWELLING (arm was swollen) and PRURITUS (arm was itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 CHILLS (chills), PYREXIA (a fever of 101), PERIPHERAL SWELLING (arm was swollen) and PRURITUS (arm was itchy). At the time of the report, CHILLS (chills), PYREXIA (a fever of 101), PERIPHERAL SWELLING (arm was swollen) and PRURITUS (arm was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Caller reports her husband received the wrong booster dose and received a half dose instead of the full dose.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Caller reports her husband received the wrong booster dose and received a half dose instead of the full dose.) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asplenia and Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Caller reports her husband received the wrong booster dose and received a half dose instead of the full dose.). At the time of the report, ACCIDENTAL UNDERDOSE (Caller reports her husband received the wrong booster dose and received a half dose instead of the full dose.) outcome was unknown.            No concomitant medication information was provided.  It was reported that the patient received wrong booster dose and received a half dose instead of the full dose.  No treatment medication were provided.   This case was linked to MOD-2022-570971 (Patient Link).
Moderna COVID-19 vaccine was administered after the beyond use date; 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 (Moderna COVID-19 vaccine was administered after the beyond use date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided
shortly after vaccination pt. became dizzy, tunnel vision, muffled and layed on floor with legs in air and sent to observation with no injury.  Vitals: B/P 119/76 P, 85, resp. 18, O2 @08:30 a.m    At 08:40 vitals were  b/p 108/73, pulse 73, resp..18. Pt. reported feeling ok, discharged in wheelchair at 08:50.
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX. On 17th May 2018, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The event redness at injection site lasted for 7 days after vaccine administered. No other details were provided.
Patient had "hot" feeling and dizzy. HR 170 - no medication administered. Patient observed for longer time with noted improvement prior to leaving clinic.
On June 5 I broke out in painful rashes on my back shoulder (left). It then spread to the front of my shoulder (left) The doctor diagnosed me with Shingles. I prescribed Valacyclovir for 7 days and pain medication. As of today the rash is almost gone. I still have some areas that is scabbing over.
Vasovagal Rx to needle and drop of blood after vaccination. Pt felt faint after seeing a drop of blood on his arm. He and his wife sat in the immunization room with his feet elevated. We took BP and he said it was at his baseline. He left, felt nauseous.