chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe autism symptoms; Very aggressive behaviors - Hitting friends and teachers; Not eating well; Delusional like behaviors; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 15:30 (Batch/Lot number: unknown) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "delayed speech" (unspecified if ongoing); "known allergies: some nuts" (unspecified if ongoing); "known allergies: dairy" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: AUTISM SPECTRUM DISORDER (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Severe autism symptoms"; AGGRESSION (non-serious) with onset 22Nov2021, outcome "not recovered", described as "Very aggressive behaviors - Hitting friends and teachers"; EATING DISORDER SYMPTOM (non-serious) with onset 22Nov2021, outcome "not recovered", described as "Not eating well"; DELUSIONAL DISORDER, UNSPECIFIED TYPE (non-serious) with onset 22Nov2021, outcome "not recovered", described as "Delusional like behaviors". The events "severe autism symptoms", "very aggressive behaviors - hitting friends and teachers", "not eating well" and "delusional like behaviors" were evaluated at the physician office visit. Therapeutic measures were taken as a result of autism spectrum disorder, aggression, eating disorder symptom, delusional disorder, unspecified type included: Speech and occupational therapy. Clinical course: No other vaccine in four weeks. No other medications in two weeks: No. No covid tested post vaccination: No.  The lot number for bnt162b2 was not provided and will be requested during follow up.
patient received Pfizer (age 5 to <12, orange cap) 8 days beyond it's expiration date. We are still waiting to hear back from Pfizer about whether dose needs to be repeated. patient's father was informed of error
Itchy around the injection site; Red arm around injection site; Swollen around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy around the injection site), INJECTION SITE ERYTHEMA (Red arm around injection site) and INJECTION SITE SWELLING (Swollen around the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itchy around the injection site), INJECTION SITE ERYTHEMA (Red arm around injection site) and INJECTION SITE SWELLING (Swollen around the injection site). At the time of the report, INJECTION SITE PRURITUS (Itchy around the injection site), INJECTION SITE ERYTHEMA (Red arm around injection site) and INJECTION SITE SWELLING (Swollen around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
50 cent piece size welp, redness tender to touch. Motrin as directed and warm pack to injection site.
I received my 2nd Moderna vaccine on 2/6/2021.  My arm hurt from the injection, but nothing unusual.  On 2/8/2021, around 9:00 pm, I noticed that my arm was more sore and there was an area of redness the size of my hand on my upper arm.  Site is warm to the touch and firm when compared to the rest of my arm.
Several weeks after the 2nd vaccine, I started having slight nose bleeds, this lasted for 2 weeks then stopped. After that I noticed my arms, fingers tingling like when they go to sleep. this was happening throughout the day getting worse. I took my BP and the Diastolic number was in the 60's sometimes 50's. I stopped taking my BP medication (been 2 weeks now) and the tingling has stopped, but my Diastolic # is till low, in the 60s. I have an appointment this Thursday, May 6 with the above doctor for a checkup and will make her aware of this reaction. I will see my cardiologist in June, who is the one who placed me on BP medication in 2014 and will ask him what to do.
Painful raised/swollen skin on bicep.  Burning,, itchy rash that spread over the next day but stayed localized to my upper arm.  Extreme muscle weakness in left arm.
Overall aches and pains; Sweating; Dizziness; Lethargic; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0171) via an unspecified route of administration in the arm left on 29Apr2021 at 12:45 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The medical history were reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0153) via an unspecified route of administration in the left arm on 08Apr2021 at 12:45 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 02:00, the patient experienced overall aches and pains, sweating, dizziness and lethargic. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events overall aches and pains, sweating, dizziness and lethargic was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
12/23- began to experience intermittent right lower quadrant pain in the morning, fever of 100.4 F in the evening which subsided with ibuprofen.  12/24- no fever noted but intermittent right lower quadrant pain continued, seen at the Health Clinic, sent to Hospital ER for CT scan, diagnosed with appendicitis, appendectomy performed.
This is a spontaneous report from a contactable physician communicated to a sales representative. A female patient of an unspecified age and ethnicity received PREVNAR13 on arm at 0.5 ml single dose. The patient medical history and concomitant medications were not reported. The patient experienced redness and swelling in arm where vaccine was given occurring 3 days post injection. The outcome of the events was unknown. Follow-up (09NOV2010) Follow-up attempts completed. No further information expected.
Patient has red, warm, swollen area to right upper arm. Area was outlined to see if swelling or redness increased. Patient's parent told that if symptoms got worse to follow up with ED.
30 minutes after vaccine administration, resident presented with slurred speech and abnormal vital signs including a spike in blood pressure.  Resident was sent out to hospital Emergency.
Started as chills, I felt very cold and could not get warm, then I spiked a mild fever. I took ibuprofen and it seemed to help and I was able to go back to sleep. Body aches started yesterday and continue to today.
pain on her left ankle; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain on her left ankle) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, CHLORTHALIDONE and SIMVASTATINE for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain on her left ankle). At the time of the report, ARTHRALGIA (pain on her left ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment to the events not provided   This case was linked to MOD-2021-078049 (Patient Link).
11JUN97 fever 102 -103;13JUN97 1AM seen by MD dx ear infect placed on augmentin-had one dose episode of rapid breathing, lips bluish, shaking 630PM, fever 104 tub bath, motrin, APAP;rash appeared 14JUN97 630AM;
This spontaneous case reported by a consumer, describes the occurrence of swelling, pain in extremity (stabbing pain near the elbow), severe headache, arthralgia (pain in the shoulder) and pyrexia (low-grade fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19  vaccine) for COVID-19 immunization. No medical history provided. Concomitant products included gabapentin for an unknown indication. On Apr 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 22, 2021, patient experienced severe headache and  arthralgia (pain in the shoulder). On an unknown date, patient experienced swelling, pain in extremity (stabbing pain near the elbow) and pyrexia (low-grade fever). At the time of the report, swelling, pain in extremity (stabbing pain near the elbow), severe headache and pyrexia (low-grade fever) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. Treatment: Tylenol.
pt became very irritable w/nonstop crying p/3hr receiving vax; had a total of 4 hr of nonstop crying & was very irritable-pt remained alert, & had no vomiting;
Pt appt made for Novavax, but was administered Moderna (Ped). Based on data it was determined the pt was underdosed and pt was given a dose of Novavax.
Arm soreness on day 1, Chills, fever and worsening arm soreness on day 2. Diarrhea and redness, bruising, swelling, and pain on day 3 and 4. An area of about 5 square inches total was swollen and painful. Swelling is somewhat reduced on day 5, but it is still very painful.
Approximately 12 hours after 2nd injection patient reports:   Severe injection site pain (lasting 8 Months) Nausea ( lasted approx. 15 hours) Vertigo (still dealing with off and on since vaccine) Intense muscles aches ( lasted approx. 15 hours)
Severe body aches, nausea, dizziness, headaches, rash/skin reaction on back for 3-5 days Pain, hardness and scabbing at injection site. Bump still present 4/14/21
pt recv vax 1JUL96 & woke up the next morning 14JUL96 w/gen pruritus & swelling lt eye;seen in local hosp & given oral ATB;
I woke up next day w/ splitting headache, aches & pains all over my body, dizzy & weak with hot & cold flashes. This lasted 6 days. Dr said take 2 TYLENOL every 4 hrs until you feel better. I was weak & dizzy for 2 weeks after that, but finally got to feeling better. It left me so weak.
This spontaneous report as received from a medicine assistant refers to a patient of unknown age. The patient was vaccinated with 0.65 ml VARIVAX (Merck) (lot number unknown) subcutaneously on 16-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 16-JUL-2012 the patient was inadvertently administered VARIVAX instead of ZOSTAVAX. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
child received Immunization (6wks) sched. on 7/24/03 P.M. in the evening had 20 min. episode of unconsolable crying & apnic episode of 30 sec. brought to E.R., admitted overnight for observation, then discharged
started acting strange, paranoid; started acting strange, paranoid; she forgets things; dementia; This is a spontaneous report from a contactable consumer (patient's daughter)   An 82-year-old female patient received the 1st dose bnt162b2 (BNT162B2) at single dose in arm on 22Jan2021 for Covid-19 immunisation, administered a Clinic. Medical history included macular degeneration from Aug2020 and treated with Saffron and Eylea. The concomitant medications included: Saffron, an herb, started a few weeks before the vaccine was administered for macular degeneration, Eylea shot for the macular degeneration and she got a shot within a few weeks of getting one of the vaccines but this is not a new medication for her. No additional vaccines administered on same date of BNT162B2. No prior vaccinations within 4 weeks. The patient experienced dementia in Jan2021, started acting strange, paranoid on 24Jan2021, she forgets things in Jan2021. The events did not require a visit to Emergency Room or Physician Office. Course of events: About 2 days after the 1st shot she started acting strange, paranoid. Her mom lives with her daughter, son in law, and 21-year-old grandson. She though they were stealing from her, her daughter and grandson. Reporter explained she knew this sounded like classic dementia and she forgot things like everyone does but this was uncharacteristic and she was fine up until 3 days after the shot. They have called her primary care doctor who has done blood test looking for a UTI or infection and that came back good. The doctor also did a CT scan and it came back good. Caller explains that the event was about the same since it started. The outcome of dementia was unknown, of started acting strange, paranoid was not recovered. The patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose in arm on 12Feb2021 for Covid-19 immunisation, administered a Clinic.  Information on the lot/batch number has been requested.
Fever of 101,  severe chills and severe fatigue. Lasted 24 hours from start, moderate headaches and body aches  for about 6 hours. No after effects beyond 36 hours after injection
Right thoracic rash (herpes zoster) appeared about 1 month ago and child has had stomach ache for past 2 weeks. Valtrex 1 gram, 1/2 tab, 2x/day for 8 days. Started 04/28
Racket Ball that day, didn't use left arm, but started to feel feverish that day hr 20 min able to exercise, went away and then 5 days later noticed stiffness and pain whenever lifted arm. Today feels the same 15 days later.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 01-JUL-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot # I002422, expiration date 23-APR-2016 (strength, dose and route of administration and anatomical location were not provided). No adverse effects were reported. Additional information had been requested.
Moderna Booster Vaccine given instead of Moderna Bivalent Booster that the patient asked to receive.
swelling 1" diameter w/sl redness but no tenderness or dec range of movement;
Experiencing Chills, Headache, Nausea she feels the symptoms of having a fever; Experiencing Chills, Headache, Nausea she feels the symptoms of having a fever; Experiencing Chills, Headache, Nausea she feels the symptoms of having a fever; Experiencing Chills, Headache, Nausea she feels the symptoms of having a fever; This is a spontaneous report from a contactable consumer (patient) received via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on 30Jan2021 as 1 ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had experienced chills, headache, nausea she felt the symptoms of having a fever, but her temperature was normal. The outcome of the events was unknown.   Information on Lot/Batch number has been requested.  Follow-up attempts completed. No further information expected.
About a week after the second shot felt sick to my stomach and thought I would vomit but came out as a belch instead. Ever since I am belching constantly. No other dietary or medical changes in years. Six months later (late August) I had massive diarrhea and some vomiting for three to four days making it utterly impossible to keep anything down. Couldn't have been a stomach bug as people I had shared food and even a bottle of water with were fine. At that point the frequency and severity of belching has been steadily increasing and now with reflux almost daily. GI specialist prescribed omeprazole which made all symptoms worse. Two visits to chiropractor had no affect. Did probiotics for a month and a half which had brief improvement but now no effect.
My son went into the military. He was forced to take the shots or face prison. Within 12 hours he came down with the flu. While in formation he asked the 60 other inductees which had received the flu from the shots and by a raise of hands more than half had come down with the flu. Some has since been hospitalized and have not returned. It's been 2 weeks.
Flu shot 9/21/17 - had pain up (L) arm to shoulder area that night. Throbbing pain. Has taken TYLENOL for pain relief.
Presented to PER, 1 day after discharged from hospital for asthma exacerbation and receiving a flu shot for the first time. Mom noticed rash to both arms and stomach at home on 02/02/05. Came to pediatric emergency room with rash and hives to body. Given Benadryl, no fever reported.
INAPPROPRIATE SCHEDULED OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a pharmacist concerned an elderly of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have an autoimmune disease or any other notable diseases. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021, and dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested (for second dose). No concomitant medications were reported. On 06-MAY-2021, the patient experienced inappropriate scheduled of vaccine administered, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate scheduled of vaccine administered and off label use was not reported. This report was non-serious.
Child was running a fever and had to be picked up from daycare. I gave her 5ml of children's Advil (fever reducer) around 12:30 PM. About 8:30 PM child had febrile seizure and was taken to the emergency room. Child received a dose of Tylenol. Attending nurse practitioner diagnosed febrile fever and pneumonitis.
(Completed FLUMADINE 9-19-12). 9-27-12 noticed apx. 2 inch oval below injection site; red & hot to the touch & painful; states had confirmed flu 2 wks prior.
Fever starting at 100 increasing to 102.5, general muscle,pain general weakness, some delirum
Pediatric patient (17 years old) received adult dose of Havrix. Follow-up with patient the following clinic day, patient reported soreness at injection site, denied any other signs/symptoms of adverse reaction or complication.
Information has been received from a registered nurse (R.N.) concerning her daughter now 18 year old, with drug hypersensitivity to PHENERGAN who on 01-JAN-1996 and 01-JUN-1998 was vaccinated with the first and second dose of VARIVAX (Merck) (LOT# not reported), respectively. On unspecified dates, after vaccination, the patient has initially symptoms of tiredness, terrible itching of the arms and legs and gradually weight loss. One day, the patient come home and was discovered there was a lump on the node that was very puffy on the right side of neck. The lump on the neck almost covered the front of the lung. In July 2008, at age of 17 year old, the patient was diagnosed with stage 3 Hodgkin's lymphoma. The patient was hospitalized and underwent chemotherapy and radiation. Labs/diagnostics were reported which included: white blood cell count with differential, "autoimmune antibodies", "chem 20", computed axial tomography, positron emission tomography, lymphatic structure biopsy, bone biopsy and bone marrow biopsy, but no outcomes were provided. The patient completed therapy in mid December 2008 and was in remission at the time of the report. Stage 3 Hodgkin's lymphoma was considered to be immediately life-threatening, disabling and was considered to be an other important medical event. Additional information has been requested.
Child woke up next day to a rash all over face, trunk, arms, hands, and some on legs. Child went to primary care physician and was prescribed benadryl and was told that child had a reaction to some component of the shots.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU) (dose and route of administration were unknown) either with lot number M041086 with expiration date of 03-JAN-2018 or lot number N020942 with expiration date of 26-OCT-2018 for prophylaxis, which were reconstituted with properly stored sterile diluent and stored in a temperature range from 15 Fahrenheit (°F) to 46°F (32 °F) for 13 hours and 45 minutes. The temperature excursion was not detected by a data logger. There was a previous temperature excursion from 15°F to 46°F  (23 °F) for 5 hours and 16 minutes. No adverse effects reported.
first night high fever 103, bad chills, muscle pain.  Next night tinnitus.  I have existing tinnitus that is not that noticable.  This increased the volume 3 times.  lost weight, 3 pounds not since injection.  stomach pain 3rd night.
Patients spouse reported started feeling weak about 2 hours after vaccination. Then around October 20th patient complained of burning of feet. She was taken to MD office then later admitted in hospital. Pt had muscle weakness and paralysis.
Information was received from a licensed vocational nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, the patients were administered improperly stored doses of ROTATEQ (lot# L042215, expired on 02-JUN-2017; lot# L048854, expired on 31-AUG-2017 (dose unknown) orally. The vaccines were exposed under 48 Fahrenheit degree (F) for undetermined time frame and was back in range. There was no previous temperature excursion. Digital data logger was involved. No adverse events was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had vaccine as described below, 2 hours later developed generalized hives, particularly on left side of body. These came and went over the next 4 days with no other symptoms. He is fine since.
Parent states son's left arm become red & swollen about 2 days after shots. She put "a hot pad on the arm for quite awhile". - Recommended Ibuprofen & cool, not hot compressions prn.