chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Terrible headache could not even move my head for whole day; Muscle ache; Site pain; Fever 101 and up; This is a spontaneous report received from a non-contactable nurse (Patient). A 36-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, intramuscular, administered in Arm Left on 04Feb2021 18:00 (at the age of 36-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 05Feb2021, the patient experienced terrible headache could not even move my head for whole day, muscle ache, site pain and fever 101 and up. The patient underwent lab tests and procedures which included body temperature: 101 and up on 05Feb2021. Patient received Tylenol as a therapeutic measure to treat adverse events. The events were recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
This spontaneous report as received from a other health professional refers to a female patient of unknown age. On 2002 the patient was vaccinated with M-M-R II for prophylaxis. On 19-JUL-2017 the patient experienced rubella antibody negative. The outcome of rubella antibody negative is unknown.
Fatigue, malaise, joint aches, muscle aches, headaches, neck aches, overall symptoms seemingly similar to fibromyalgia which were not being experienced before the flu vaccine was administered. (Flublok was administered even though I was out of the realm of the approved age range of 18-49). This vaccine was administered per employment requirements, if I had not had the vaccine I would have been suspended, ultimately terminated "fired" from my workplace.
Patient reporred feeing dizzy after receiving dose. Bp 121/79 pulse 96 temp 97. Reported feeling better after giving water and monitoring for 15 minutes
On 1/7/01, the child presented at this physician's office with a temperature of 103 and a papillary rash on arms, legs, and slightly on the trunk. Additional information was received stating that while the child was in the office he required two breathing treatments for his asthma and was found to have infiltrates in his lungs. The child has since been dx with pneumonia and a bacterial infection in the blood.
This spontaneous report as received from a registered nurse refers a female patient of unknown age. There was no information about the patient's concurrent conditions, medical history, any known allergies, reactions or concomitant medications. On 10-APR-2017, the patient was vaccinated with an expired dose of PROQUAD (lot # L039269; expiration date 05-APR-2017), intramuscularly, for prophylaxis (dose and frequency not reported) reconstituted with sterile diluent injection (DILUENT MRK) (unknown lot # and unknown expiration date). No adverse effects were reported. No further information was available. No product quality complaint was involved. Additional information has been requested.
I went to the Hospital on 12/21/2021. I stayed 5 nights because I had a kidney removed and on the 12/24/2021 is when I  felt like my heart was pounding and raising my pulse which was 152, I was having a low grade fever, elevated my red cell count.
cough; runny nose; over the counter COVID test came back positive; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 19Aug2021 (Batch/Lot Number: FC3181; Expiration Date: 31Oct2021) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included cold (She wonders if she may have gotten the COVID vaccine too soon after having a cold and that's why she thinks that the test may can come out with a false positive after her COVID vaccine). Concomitant medication(s) included budesonide (RHINOCORT [BUDESONIDE]) taken for an unspecified indication, start and stop date were not reported. The patient experienced over the counter covid test came back positive on 21Aug2021 with cough, runny nose on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 21Aug2021 (She says, what if the positive result is from the COVID vaccine since it is an antigen that she is getting and the test tests for antigens). The outcome of events was unknown.  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot FC3181 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FC3181, fill lot EY0567, and the formulated drug product lot FE3195. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.   No follow-up attempts are needed. No further information is expected.
heart rate of 105; Blood pressure of 156/70; fever; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (heart rate of 105), HYPERTENSION (Blood pressure of 156/70) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced TACHYCARDIA (heart rate of 105), HYPERTENSION (Blood pressure of 156/70) and PYREXIA (fever). At the time of the report, TACHYCARDIA (heart rate of 105), HYPERTENSION (Blood pressure of 156/70) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Sep-2021, Blood pressure measurement: 156/70 (High) 156/70. On 21-Sep-2021, Heart rate: 105 (High) 105.         Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Patient presented to ED with generalized weakness and fatigue in setting of COVID-19 diagnosis one day prior.  Patient was confused on presentation.  Patient admitted and treated with convalescent plasma, remdesivir, steroids, and antibiotics.  Patient improved and was discharged to home with new home oxygen.
1st dose approx. 30 days prior; fainted, was found unresponsive / reaction to vaccine; vomited; fever of 104; sweating; chills; nausea; diarrhea; abdominal pain; back pain; This case was reported by a consumer and described the occurrence of faint in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 9th November 2019, the patient received Shingrix. On 9th November 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. In November 2019, the patient experienced faint (serious criteria GSK medically significant), vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain. On an unknown date, the outcome of the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR171834   Additional Information: GSK receipt date: 17-Nov-2022 Reporter's comment:  The patient received the second dose of Shingrix vaccine. About 12 hours post injection, the patient was fainted and vomited. The patient was found unresponsive in a restaurant bathroom. The patient was taken at home and having fever of 104 and symptoms of sweating, chills, nausea, diarrhea, abdominal pain and back pain through the night. The patient also stated that she received 1st dose approximately 30 days prior did not lead any adverse reaction The patients one of friend had recently reported the same adverse reaction following Shingrix dosing. The reporter did not agree to follow up from GlaxoSmithKline. Additional supportive information: The patient received the 2nd dose approximately 30 days prior to 1st dose of Shingrix, which led to shortening of vaccinations schedule. This case had been linked with US2022AMR171834 same reporter, different patient.; Sender's Comments:  US-GSK-US2022AMR171834:same reporter ,different patient US-GSK-US2022AMR171947:same reporter
6 year old received Varivax at age 16 mo. Developed herpes-zoster (shingles) in right L-5 dermatome Nov 2005. No history of natural chicken pox infection.
Report 2001009563-1 described numb fingers (right hand) in a 41 year old female who received Lyme disease vaccine recombinant OspA (Lymerix) for the prevention of Lyme Disease. This report was received from the vaccinee and has not been verified by a physician or other health care professional. The vaccinee has seasonal allergies. Her medical history included crushed vertebrae (cervical spine). She took Hydrocodone and Zolpidem Hemitartrate (Ambien) prn. On 04/13/01, the vaccinee received her first left deltoid dose of Lymerix, twenty minutes post-vaccination, she experienced fever, chills, numb fingers (right hand), and weakness. As of 04/13/01, the outcome of the events was resolved. The adverse event of "numb fingers" does not meet ICM serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter. Follow up states the patient also experienced a headache and light headedness.
About 12 hours the vaccine I had severe pain in my shoulder as well as limited mobility.  The pain is so intense I can?t lay on my right arm or put any pressure on it. I also can?t lift my arm very high.It has continued without relief. I was applying for job and not able to attend the physical practice test because of the limited mobility  and pain in shoulder. I have no prior shoulder injuries.
Information has been received from a physician assistant, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female with high risk papilloma viral infection diagnosed on 16-AUG-2010 and no drug reactions or allergies who was vaccinated IM with the first, second and third 0.5ml dose of GARDASIL (lot# not reported) on 29-MAR-2010, 02-JUN-2010 and 23-SEP-2010 respectively.  Concomitant therapy included prenatal vitamins (unspecified).  It was reported that the patient was administered her third dose of GARDASIL on 23-SEP-2010 and was subsequently determined to be pregnant on 13-OCT-2010.  A pregnancy test in the office on 23-SEP-2010 was negative but a urine pregnancy test in the office on 13-OCT-2010 was positive.  Her last menstrual period was 31-AUG-2010 and her estimated delivery date was 07-JUN-2011.  A prenatal ultrasound would be scheduled for next week.  No problems reported.  The patient sought medical attention.  Follow up information received indicating the patient had ultrasound on 09-NOV-2010 which showed 8 weeks and 2 days pregnancy, early dating.  The patient had irregular menses.  The patient's last menstrual period was 31-AUG-2010, estimated delivery date was 19-JUN-2011.  The patient had no previous pregnancies.  Follow-up information was received from a outcome pregnancy questionnaire which reported that the patient had prenatal vitamins daily from 21-OCT-2010 to 01-DEC-2010 for pregnancy.  The patient had IUFD (intra uterine fetal demise) and on 01-DEC-2010 sonogram showed missed abortion at approximately 9.5 weeks (also reported on 06-DEC-2010, at 12 weeks and 1 day).  Upon internal review, spontaneous abortion was considered to be an other important medical event.  Additional information is not expected.
(L) deltoid warm to touch, painful. 2 3/4"x4" erythema and induration. Patient took Tylenol 325 mg po once that evening. After showing to LPN - advised to ice, continue monitoring and Tylenol PRN.
Wheezing, difficulty breathing, hoarse cough, itching in ears. No treatment; waited for reaction to pass.
She began with headache, fever and vomiting which then progressed and included BL gastrocnemius pain, making it difficult for her to walk.  Patient went to ED, was given IVF and, by today, symptoms resolved.
Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022; No Adverse Event; Patient administered vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022).    No concomitant medications was provided by the reporter. The vial did not undergo the temperature excursion. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. the vial was initially stored in the refrigerator on 08-jul-2022 was vaccine was administered since 07-aug-2022 to 11-Aug-2022 No treatment medications was provided by the reporter.
Information has been received from a 75 year old female with no allergies and unremarkable medical history who on 30-OCT-2005 was vaccinated with pneumococcal 23v polysaccharide vaccine, in her left arm.  Concomitant medication included phenytoin (DILANTIN) and atorvastatin calcium (LIPITOR).  On 30-OCT-2005 the patient experienced swelling of elbow, rash 3 inches below and 6 inches above elbow, redness, and warm to touch in area of injection.  At the time of the report she was still experiencing most of the events.  The patient "felt rash had improved slightly today".  There were no relevant diagnostic tests or laboratory data.  The patient was considered to be recovered.  No additional information is expected.
This is a 70y.o. female who presents to ER due to altered mental status and difficulty with word finding. The family found the patient is dysarthric and aphasic and she was brought to the emergency department via EMS. Overnight her speech has improved. A CT of the brain with stroke protocol was consistent with early/subacute ischemia involving the left insular cortex?left MCA distribution. She was initially normal sinus rhythm overnight went into atrial fibrillation. Additionally, she tested positive for COVID-19 on 10 4 urgent care. She is vaccinated ×2 with the Pfizer vaccine, and had been in the process of getting set up for posterior she tested positive. She did receive monoclonal antibody treatment.   This morning the patient denies any new complaints. Her breathing is at baseline. She reports that her speech is approximately 80% better.   Cardiology and neurology on consult   I spoke with the patient's daughter who assisted with additional history
No additional AE reported; Customer reporting administration of improperly stored ROTATEQ; This spontaneous report was received from an office manager, concerning an approximately 4 months old female patient. The patient's concurrent condition, concomitant medications and drug allergies were not reported, she presented for a physical examination without any concerns (well child visit). The patient had eczema at the time of vaccination (illness at vaccination).   On 06-APR-2021 (also reported as 27-APR-2021), the patient was vaccinated with the first dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally at the dose of 2 milliliter for prophylaxis, lot number 1742460 has been verified to be a valid lot number, expiration date reported and validated as 16-NOV-2021 (product storage error), however, the temperature was not reported.   It was stated that the patient did not received any treatment, it was confirmed that the operator was trained, and it was used according to the instruction leaflet. Previous temperature excursions were reported as yes, and digital data logger was involved. No adverse events were reported, nor product quality complain.  This is one of the several reports received from the same source.; Sender's Comments:  US-009507513-2105USA001739: US-009507513-2106USA002133: US-009507513-2106USA001659:
Fever (~100.5), chills, and nausea starting around 9PM day of vaccination. No treatment, just went to bed.  2:30 AM woke with continued fever (~101.6), chills, and nausea with one round of vomiting.  Again no treatment, just went back to bed. 5:30AM woke with fever (~101.5), chills, and nausea again, no vomiting, no treatment. 9:30AM woke with no nausea just fever (~100.5) and headache, took Tylenol.  Rested most of the day and took Tylenol again in afternoon which kept temp under 100.  Next morning no fever or headache.
Reports itching and redness with tenderness that PM of vaccinations. In AM of next day child complained of itching at site and mother noted small, raised bumps (blister-like). Today bumps noted about 15mm long and 5mm wide across injection site. Bumps appear and feel like poison ivy bumps but mother denies any exposure to such. Red, indurated area around injection site about 8cm in size.
THE INJECTION WAS BELOW THE STANDARD IM DELTOID AREA, APPROXIMATELY MIDWAY IN ARM (APPROXIMATELY 2 INCHES BELOW THE LOWER DEFINITION OF DELTOID); This spontaneous report received from a health care professional concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 at deltoid area approximately midway in arm (approximately 2 inches below the lower definition of deltoid) for prophylactic vaccination. The batch number was not reported and has been requested.   Concomitant medications included guselkumab for psoriasis. On 31-MAR-2021, the subject experienced the injection was below the standard im deltoid area, approximately midway in arm (approximately 2 inches below the lower definition of deltoid). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection was below the standard im deltoid area, approximately midway in arm (approximately 2 inches below the lower definition of deltoid) was not reported. This report was non-serious.
On 5/15/01 patient developed pain in shoulder and feeling of heaviness in entire right arm. On 5/16/01, the pain continued in the shoulder and extended to neck and right occiput and trapezius was tender. She began having nausea and gagging. On 5/17 the nausea was resolving, but the pain continued in neck. She was treated with ibuprofen and heat. On 5/18 she had resolution of her symptoms.
This spontaneous report was received from a nurse practitioner referring to a 12 month old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 09-OCT-2018 the patient was vaccinated with an expired dose of PROQUAD for prophylaxis (therapy type: rHA, lot # N010866, expiration date 01-OCT-2018; strength, frequency and route were not reported) with MERCK STERILE DILUENT. No adverse effect were reported.
he violently threw up/vomiting; lost control of all of his extremities; acute pancreatitis; had no strength; affected his memory; barely moving; balance was horrible/his whole balance everything was off; lost his appetite right away; not eat; This is a spontaneous report from a contactable consumer reporting for the husband. A 76-year-old male patient received the first dose of bnt162b2 (Batch/lot number: EL3302), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunisation. Medical history included Allergy from an unknown date, blood pressure abnormal from an unknown date, ongoing kidney patient and was on dialysis three times a week. Concomitant medication included insulin aspart (NOVOLOG), insulin glargine, vitamin b complex (SUPER B COMPLEX), acetylsalicylic acid (BABY ASPIRIN), vitamin d3, ascorbic acid, biotin, folic acid, mecobalamin, nicotinic acid, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine (DIALYVITE), atorvastatin, cetirizine for Allergy, fish oil, docusate, amlodipine besilate for Blood pressure and other medications as the patient was kidney patient. For Concomitant medication amlodipine besilate, the consumer stated, Right now at this time he was not supposed to take them on his dialysis days. So, he took one tablet on Saturday & Sunday, Tuesday & Thursday. The patient had his first shot of the Pfizer on 21Jan2021, he lost his appetite right away and wasn't eating. And then on 29Jan2021 he took 2 bites of a meal, and had extremely volatile vomiting and lost control of all of his extremities. He violently threw up on the 29Jan2021 and from that's when on he had no appetite, she couldn't get him to eat anything. Her daughter had to help her pick him up of the floor, the Friday night 24 hours it was just horrible. The consumer stated, Saturday morning (30Jan2021) he had gotten use of extremities back but barely moving and still very, his whole balance everything was off. He was able stand up and use the restroom by himself. This had all affected his memory, he couldn't do his medications alone anymore and he couldn't take care of himself. And then on the 12Feb2021 the consumer took him over to the hospital because after when he vomited on the 29Jan2021 he lost all use of his extremities. They diagnosed him with acute pancreatitis, but he still, he was in the hospital from Friday 12Feb2021 and they released him on the 17Feb2021. And he still had no strength. His balance was horrible. It was affecting, whatever it was affecting his memory. The consumer stated they had no idea why he came down with acute pancreatitis and he never had any pain with it. They said they were amazed that he was not in severe pain, never any pain. The outcome of events had no strength and balance was horrible was not recovered. The outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187441 Same reporter/patient/product, Different dose/AE
Patient got cellulitis at injection site. Given cephalexin 500 mg for ten days as treatment.