chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Office practice was to draw up all doses from vial in the morning. They did not routinely do a double check and discarded vial. They used bivalent NDC, lot and expiration that was on a sticky note to enter all data into EMR. At some point they realized that some days they had pulled monovalent and administered instead of the intended bivalent booster. It is impossible to know which vaccine the patient received
Fatigue, headache, upset stomach and ended up sinus issues. Sleeping a lot more than usual
Student had 2nd dose of Hep B left upper arm at 11:45am at clinic on 04/19/2018. Student states while driving home from school on 04/19/2018 about 4pm began to experience pain in her neck and pain while swallowing. Was seen in ER of hospital treated with and released.
Initial unsolicited report received from a nurse on 22 December 2014. It pertains to one of three patients from the same facility who experienced similar events after receiving ADACEL; the other two reports are captured in case numbers 2014SA145943 and 2014SA177586. A 40-year-old patient, with no past medical history, received a left deltoid intramuscular injection of ADACEL (lot number U4874AA) on 09 October 2014. One day post-vaccination, the patient experienced arm swelling, soreness, and pain, and was seen by a physician on 14 October 2014. The patient was diagnosed with cellulitis and treated with BACTRIM. The patient underwent testing (CBC, CMP, lipids, TSH, Hemoglobin) but results were not reported. The event resolved on an unspecified date, and the patient did not return for follow-up. Documents held by sender: None.
Child received third dose of Pfizer vaccine and Seasonal Flu vaccine on 9/30 at 5:30PM. On 10/4 at 12:30PM, child presented with a mild rash on torso and legs. Pediatrician diagnosed with viral exanthem on 10/4. Rash worsened and spread to face and arms by 10/5. Rash cleared by 10/8/2022.
fever; chills; headache; tired; feeling not good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (lot number: EL1283) second dose on 11Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history was not reported. Concomitant medications included cyanocobalamin (B12). The patient previously received BNT162B2 (lot number: EK7530) first dose on 21Dec2020 (age 49-year-old) at single dose for COVID-19 immunisation and experienced dry cough on 23Dec2020 and tested positive on 28Dec2020 after receiving the first dose. She received the second dose on 11Jan2021. She started having fever, chills and a headache. The headaches come and go in waves. She was tired and took a nap and woke feeling not good. She is now taking B12 and it is helping her. The outcome of the events was unknown.
This case was reported by a pharmacist via call center representative and described the occurrence of nausea in an elderly male patient who received SHINGRIX (batch number 4492P, expiry date unknown) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced nausea. On an unknown date, the outcome of the nausea was recovered/resolved. It was unknown if the reporter considered the nausea to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The reporter did not have expiration date of vaccine. The patient experienced nausea lasting 6 weeks after dose of SHINGRIX and did not intend on completing the series due to this adverse event. The reporter consented to follow up.
10-15 minutes post immunization the patient complained of dizziness at the reception desk where she briefly lost consciousness falling into her mothers arms. Observed 15 mins.
tested positive for covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for covid) 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 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
I initially experienced arm redness and soreness.  Then headache and fatigue set in and increased on Day 4.  Ran fever of 100.5 on 9/30.  Experienced painful urination/back pain on Day 5.  Contacted PCP after doing AZO urine test that was positive for leuckocytes and neutrophils.  Sent photo of result and had an on-line appointment with PCP.  Started CIPRO on day 5--500 mg/BID.  Began feeling better after 4 doses of antibiotic.  I have had recurring UTI's over the past couple of years and think it was probably coincidence that this one occured after receiving the vaccine.  My arm redness and soreness got better after 5 days.
Shingles after 1st dose; Neuralgia pain; This case was reported by a physician via call center representative and described the occurrence of shingles in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix. On 3rd February 2020, 116 days after receiving Shingrix, the patient experienced shingles and neuralgia. On an unknown date, the outcome of the shingles and neuralgia were unknown.   It was unknown if the reporter considered the shingles and neuralgia to be related to Shingrix.  Additional information was received as follows: The patient received Shingrix and experienced shingles and also had neuralgia pain. The reporter consented for follow up.
Regis complained of still having arm/shoulder pain from last years flu shot. Regis stated the pain occurs in the same spot periodically and began after receiving his flu shot last year.
Acute immune thrombocytopenia. Presented with diffuse ecchymotic and petechial lesions and recent history of epistaxis, with exam on admission notable for slight mucosal bleeding. Found to be profoundly thrombocytopenic (plt count 0 on 1/22/22) with all other cell counts appropriate on CBC, presentation most likely consistent with ITP. No recent h/o viral infection, but could be secondary to covid vaccine on 1/14. Due to presence of mucosal bleeding, patient received 1x dose of IVIG on 1/22. Subsequently showed good response in Platelets uptrending from 0 -- > 6 (1/23) -- > 17 (1/24) prior to discharge. Bleeding symptoms and signs on exam improved. Discharged in stable condition on 1/24/2022 after reviewing need for activity restrictions until Plt count improves > 50-100. Will have outpatient Hematology f/up in next 2-3 weeks and will repeat Plt count at that time.
pain below the shoulder blade bone; has difficulty of breathing/Shortness of Breath in Upper Chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 72 years as dose 1, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: She had Asthma before but this feels different. There were no concomitant medications. The following information was reported: MUSCULOSKELETAL PAIN (non-serious), outcome "unknown", described as "pain below the shoulder blade bone"; DYSPNOEA (non-serious) with onset Mar2021, outcome "not recovered", described as "has difficulty of breathing/Shortness of Breath in Upper Chest". Therapeutic measures were taken as a result of dyspnea.  Additional information: Reporter was a 72 year old female stating that she received her first dose of Pfizer BioNtech Covid vaccine on Feb2021 and second dose Mar2021. She has completed all kinds of breathing tests and heart test and was trying to find out what was happening to her. When doing Physical activity, she experiences pain below the shoulder blade bone and has difficulty of breathing and these symptoms appeared just about the same time as she received the shots. and she would like to know if this side effect has been reported? she would like to keep this information confidential. She has had Asthma before but this feels different. Reporter was stated that she was calling about the Shot, the Covid Shot; clarified the Pfizer Covid 19 Vaccine. Reporter was stated she has reported different things and they send her a survey every so often. Reporter was stated what she wanted to know was, this problem started happening after those shots, the Shortness of Breath in her upper chest, and she keeps telling her doctors that it was the shot that did it. Reporter was stated the shortness of breath in her upper chest started after her second dose. Reporter was states she was going through treatment, they think it was Asthma, but she has had that all her life, and the shortness of breath just started happening after the shots.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Awakened with headache, ear pain, red-swollen hive-like area at injection site, nausea, and burning pain at injection site.  Took Benadryl. Still "not feeling well" on 02/08/15. Took Benadryl as needed.  Reported reaction to Employee Health Nurse on 02/10/15.
had COVID; had COVID; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization), COVID-19 (hospitalization), outcome "not recovered" and all described as "had COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid). The patient had COVID and had all of her shots (Pfizer COVID-19 Vaccine), so it did not work for her at least may the final strand.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported event Bacterial enteritis.Case will be reviewed on receipt of FU information.
developed small rash saturday morning given benadryl. alleviated returned in the afternoon second dose of benadryl given , she continued to have  itchiness and her face began to swell.  was given pepcid, benadryl, prednisone at home, attempted to go to out pt clinic they instructed to go to facility.  Facility evaluated her provided with iv forms of benadryl, pepcid, and decadron, itchiness not relieved given vistaril and fentanyl discharged from facility with decadron for 3 days and vistaril.  she continues to have hives but they moved down to bilateral arms, provided with anti itch creams and dombeoro soaks.  also ice packs to swollen areas.
hip pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 02Feb2021 as SINGLE DOSE for covid-19 immunization.  Medical history and concomitant medications were not reported. On an unspecified date, patient experienced hip pain. It was reported that, she had her first dose of Pfizer's COVID vaccine today on 02Feb2021, upon follow-up (02Feb2021) reported that she hasn't experienced any side effects but wants to know if she can take Cortisone for hip pain. She will have the second dose on 23Feb2021. Upon follow-up (05Feb2021), her doctor reported her as she "needs a new hip." Patient was scheduled for surgery on 25Feb2021, and patient would like to know if it is going to effect the vaccine for her to have surgery so soon after receiving the second dose of the Pfizer COVID-19 vaccine. It was reported that, patient is scheduled to have hip surgery after receiving both doses of the Pfizer COVID-19 vaccine. The outcome for the event was unknown.  Information on the lot/batch number has been requested.
Information has been received from a nurse practitioner concerning a 23 year old female patient. There were no pertinent medical history or drug reactions/allergies. On 16-OCT-1992, 09-DEC-1992 and 15-JUN-1993, the patient was vaccinated with the first, second and third doses of RECOMBIVAX HB, lot numbers reported as 102482 (1st dose) with expiration date June 1995, 106182 (expiration date unspecified) (2nd dose) and 1023B2 (expiration date unspecified) (3rd dose), 0.5 mL, intramuscularly, respectively (inappropriate schedules of vaccine administration). On 01-APR-2016, the patient was seen by the nurse practitioner and had titers drawn which showed her titers were low for Hepatitis B. On 04 APR-2016, the patient was seen by the nurse practitioner again and was mistakenly administered a 0.5 mL dose of RECOMBIVAX HB (lot # L025738 and expiration date 14-AUG-2017) instead of a 1.0 mL dose as indicated (underdose). The nurse practitioner stated this dose of RECOMBIVAX HB was given since the patient had "low titers". No treatment was given for the event. The outcome of the event was unknown. The reporter did not provide the causality assessment. Additional information has been requested.
No additional AEs; Expired Sterile Diluent was administered on 1/30/2023; Expired Sterile Diluent was administered on 1/30/2023; This spontaneous report has been received from a pharmacist, concerning a 25-year-old female patient.  The patient's medical history, concurrent conditions, concomitant therapies, and historical drugs were not reported.  On 30-JAN-2023, the patient received an expired sterile diluent (MERCK STERILE DILUENT) (lot number T014588 was verified to be valid for sterile diluent [MERCK STERILE DILUENT], expiration date reported and confirmed as 25-NOV-2022) (Expired product administered), and also received measles, mumps, and rubella virus vaccine live (M-M-R II) (not expired and stored properly) (doses and routes of administration were not provided) (Product preparation error).  No additional adverse events (AEs) were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA008360:
Information has been received from a medical assistant concerning a 16-year-old female with no medical history or allergies who on 25-MAR-2009 was vaccinated with the first dose of GARDASIL (lot# 660557/0072X) 0.5ml IM into the left deltoid. Concomitant therapy included MOTRIN. A minute after the vaccination, the patient developed dizziness and convulsion. The patient stayed at the office and was observed. The patient recovered in seconds. Upon internal review, convulsion was considered to be an other important medical event. Additional information has been requested.
Pt experienced redness and swelling in arm from shoulder to elbow. 3 days post vax, swelling is down to 5 x 7cm. Pt also feels tired. (Swelling was hot and itchy.)
Trauma in left knee; Groin Pain; joint tenderness/Elbow Pain/ both shoulder /Hip Pain started to become sore/painful (3 - 5 out of 10); This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (Trauma in left knee), GROIN PAIN (Groin Pain) and ARTHRALGIA (joint tenderness/Elbow Pain/ both shoulder /Hip Pain started to become sore/painful (3 - 5 out of 10)) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Back pain. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, CANNABIS for Chronic back pain, ATORVASTATIN and METFORMIN for Type 2 diabetes mellitus.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced JOINT INJURY (Trauma in left knee), GROIN PAIN (Groin Pain) and ARTHRALGIA (joint tenderness/Elbow Pain/ both shoulder /Hip Pain started to become sore/painful (3 - 5 out of 10)). On 23-Apr-2021, ARTHRALGIA (joint tenderness/Elbow Pain/ both shoulder /Hip Pain started to become sore/painful (3 - 5 out of 10)) had resolved. At the time of the report, JOINT INJURY (Trauma in left knee) outcome was unknown and GROIN PAIN (Groin Pain) was resolving.            No treatment information were provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-227257 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Patient demographics, medical history , concomitant medications and new events were added.
Headache started 11/6/2009. Headache continued. 11/8/2009 Parents took child to Hospital. Child saw Neurologist. Could not determine if Headache was from vaccine or related to viral illness the week before.
Chills, body aches, right flank/abdominal pain, GI upset, Headache that has lasted multiple days. Still currently have a waxing and waning headache.
bodyache; FEVER; chills; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (bodyache), PYREXIA (FEVER), CHILLS (chills) and HEADACHE (Head ache) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Calf pain.   On 02-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 02-Feb-2021, the patient experienced MYALGIA (bodyache), PYREXIA (FEVER), CHILLS (chills) and HEADACHE (Head ache). At the time of the report, MYALGIA (bodyache), PYREXIA (FEVER), CHILLS (chills) and HEADACHE (Head ache) had not resolved.            No concomitant medications reported by investigator No treatment medications provided by the reporter.
1/23/12 Febrile seizure - evaluated ER no labs or x-rays done. Temp 103.7 in ER.
Pt states 7 days post vaccine she noted redness, itching from injection site down to elbow, pt described as "flat red ithcy rash". Itchiness is relieved with OTC antihistamines, however 15 days post vaccine arm is still very red and itchy.
RPR positive; This spontaneous case was reported by a consumer and describes the occurrence of TREPONEMA TEST POSITIVE (RPR positive) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A, 032B21A and 067F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced TREPONEMA TEST POSITIVE (RPR positive). At the time of the report, TREPONEMA TEST POSITIVE (RPR positive) outcome was unknown.            No concomitant medications was provided by the reporter.  No treatment was provided by the reporter.
Redness at site of injection on left deltoid, extending to elbow. Hot to touch. No rash/difficulty breathing. Enc. Children's Benadryl. Enc to see MD if problems persist/worsen.
pt recv vax 18NOV96 & site of inj rt deltoid immed became red w/ 1/2" area of swelling;area was red & site cont to swell over next few hr;arm painful & swelling to axilla area;
Pt returned to clinic 2 days after Pneumovax given IM to rt. deltoid. Pt presented with 6-4 inch tender warm erythema of right arm distal to injection site. Temperature of 98.3. Seen by doctor in clinic that day  for r/o cellulitis and treated with Cephalexin for 5 days, elevation and ice. Pt to call clinic 2 days later to check improvement. Patient had a pneumovax 10 years prior with no reaction. No more pneumo vax for pt in the future.
Patient had COVID-19 in November of 2020 and "never quite felt right" afterwards. But no real breathing issues that he noticed, though does not exercise. Most active thing he does is walk around and water plants at work. He developed heart failure symptoms starting 4 days after his 2nd Moderna shot in August of 2021.  He was treated for pneumonia at Urgent Treatment Center twice, in September and October, without relief of symptoms. His symptoms worsened until he presented to Hospital with overt orthopnea, PND and 20 lb weight gain  on November 16, 2021. He has not had fever or other infectious symptoms recently. No recent travel history, works growing marijuana but does not ingest it regularly, average etoh use (10 beers per week), no other illicits, no other concerning exposures, no other vitamins, no recent sick contacts.  Echo revealed severe LV systolic dysfunction, EF 20%.   Now undergoing treatment for acute HF and will follow-up with me as outpatient.
PATIENT REPORTED ON 11-17-20 ON 11-15-20 IN EVENING AFTER VACCINE: FEVER 102* , CHILLS AND SORENESS UNDER THE ARM. AS OF TODAY TEMPERATURE AT 98* BUT STILL HAS SORENESS UNDER THE ARM.
Incorrect vaccine given.  Pt received Kinrix when she should have received Infanrix.
Rectal bleeding abdominal pain R55 - Syncope and collapse K92.2 - Lower GI bleeding
Fever Lasted 3 days, peaking at 103F on second day Used ibuprofen for 2 1/2 days Spotted rash Started 5/11/11 Still has it on hairline, chest, arms and back Called doctor 5/12/11, said normal
This spontaneous report was received from a physician via company representative refers to a 17 year old female patient. The patient's medical history and concurrent conditions were not reported. The patient was given a shot of GARDASIL 9 and also given a second shot of MENVEO (reported as "MENZEO") concomitantly. After a minute, the patient "became dizzy and lightheaded". The physician asked the patient lay down, which helped her to feel better (recovering). Causality was not provided. Product quality complaint (PQC) was not involved. No additional adverse events have been reported. No further information has been provided. Additional information is not expected since there was no consent to contact the reporter.
My first covid vaccine the next day I had headache, very bad body aches, I could not lift my right arm, fever, chills, sweating,fatigue, weak, nausea which lasted 2 days. The second dose I received on 12/28/21 immediately my left arm hurt, I bled from the injection site,  around 7 I got a headache. The next day at 5am I had very bad body aches, left arm hurt so bad could not use it and had a bruise, nausea, headache, loss of appetite, weak, fatigue.  Today I still feel nausea, little headache, some body aches and left arm is still hurts when I move and lift it, I feel weak and fatigued like I can sleep all day.