chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EWO151) via an unspecified route in the left arm on 14Apr2021 at 11:30 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications the patient received within 2 weeks of vaccination included insulin and metformin. On 15Apr2021 at 06:00 (reported as18 hours later), the patient had a "gran map seizure" and had to be taken to the hospital via ambulance. The event resulted in visit to emergency room/department or urgent care. The patient was not treated for "gran map seizure". The clinical outcome of "gran map seizure" was unknown. Since the vaccination, the patient has not been tested for COVID-19.
2 weeks history of swelling at the site seen today with a hard red nodule and center ulceration.
No reaction/pt was given Polio inj x 2 on 3/5/14 due to error.
Narrative: COVID infection following COVID vaccine series 02/25, Pfizer, dose #1 03/18, Pfizer, dose #2 10/08, Pfizer, dose #3 12/29 COVID swab, result: detected 12/29 pt cc: cough, congestion, body aches and chills exposure: unknown 12/26 pt admit to ED cc: cough, congestion, body aches and chills dx: COVID viral respiratory illness LOS: 1 day
sore arm; low fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Apr2021 16:00 (Lot number: ER8377) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "low fever".  Additional information: Patient had vaccination at Pharmacy or Drug store, no prior vaccinations (within 4 weeks) were taken. No relevant tests reported. Events resolved in 3-4 days.  Follow-up attempts are completed. No further information is expected.
Generalized muscle pain and tiredness with intermittent cramps in both thigh, started 3 days after injection.  The symptoms has been gradually subsiding, but not completely gone as of 10/02/2023.
Lymph nodes swollen; Headache; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (Lymph nodes swollen) and HEADACHE (Headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0312H) for COVID-19 vaccination.     There was no medical history provided.  The patient's past medical history included No adverse event.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes swollen) and HEADACHE (Headache). At the time of the report, LYMPHADENOPATHY (Lymph nodes swollen) and HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No specific follow-up information recorded.
Patient has a rash on their calves. Its red and raised. Has put Aveeno anti-itch cream and Neosporin and still looks the same
Fatigue, muscle pain, joint pain, chills, fever, sweats. Began 26 hours after vaccine. Worsened over next 72 hours. Unresolved 96 hours after vaccine.
After receiving my shots I started to get brain fog my arms were hurting like somebody was squeezing down on them I had trouble sleeping I would wake up in the middle of the night and be in pain and for the last 6 weeks I have had the pain in my arms all day and all night with no relief there are times I forget what I'm going to say and sometimes even mid-sentence I forget what I'm going to say
MOC reports that there is redness and induration that is increasing around site of Varicella on Right arm.  Redness and swelling 4"X6".  MOC also reports blistering around injection site.  Recommended that pt be assessed by primary MD.
covid test which came back positive; covid test which came back positive; This is a spontaneous report from a Pfizer-sponsored program . A contactable female consumer (patient) of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she received the vaccine and then took Covid test which came back positive (unknown date). The patient would like to know if it is safe for her to get second dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
4 wks after injection 8/17 both of my knees swelled up to size of balloons, I couldn't stand up, bend my knees, extend my knees or put any pressure- level pain at a 10 excruciating- I was tested for blood clots, blood infection, Lyme disease, gout, UTI, Rheumatoid Arthritis, septic, I had 60ml fluid drained from my left knee and it was tested for infection and cultures for 5 days came back clear no infections.  My right knee was drained 20ml and also tested- all clear. I received 2 shots into the knees and received steroids IV every 8 hours- 5 days later I can finally stand walking with a Walker very gingerly. Taking ibuprofen every 8 hours as well.
She had lymphatic ganglion after the first dose; Swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. Other Case identifier(s): US-PFIZER INC-2021498629 (Pfizer).  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 14:00 (Lot number: EW0179) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNOVIAL CYST (non-serious) with onset 03May2021, outcome "not recovered", described as "She had lymphatic ganglion after the first dose"; LYMPHADENOPATHY (non-serious) with onset 03May2021, outcome "recovered" (13May2021), described as "Swollen lymph nodes".  Additional Information: Patient did not visited emergency room or physician office. No prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Patient given second COVID vaccine on 9/30/2022 that was outside of beyond use date vial of 9/27/2022 Parents report no known adverse reactions seen.
started day of (not realized by family until now): mom 'thought she had a stroke' (weakness to 1 side), loss of full bladder control, leg pains, blurry vision (had to get stronger glasses), memory loss. Has been recently hospitalized w/ COVID, and 'possible' stroke.  Family did mention 'blood clots found' and imaging had been done, but no clots seen in the end?? The patient's daughter, can give ALL the details.
SIRVA. Unable to move arm for months. Shooting pain in arm. Saw a chiropractor, PT, received MRI to confirm SIRVA.
allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction". The event "allergic reaction" was evaluated at the physician office visit.  Additional information: The reporter stated that her fiance (patient) who had his first dose of the Pfizer Biontech COVID-19 vaccine on Aug2021. He had a slight reaction and was advised not to get the second dose. However, after going to multiple doctors and getting multiple tests it has been deemed that the vaccine was not the cause of the allergic reaction and was able to proceed with the second dose. The reporter asked if he needs to restart the whole series over again or is he able to get his second dose this far out.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
swelling at the injection point; welt at the injection point; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2023, the patient received the 1st dose of Shingrix. On 28th January 2023, 2 days after receiving Shingrix, the patient experienced injection site swelling and injection site wheal. On an unknown date, the outcome of the injection site swelling and injection site wheal were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site wheal to be related to Shingrix.  Additional Information: GSK Receipt Date: 28-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the Shingrix dose on Thursday.  On the day of reporting, the patient had swelling and a welt at the injection point.  The reporter wanted to know how long should this last. Additional Supportive Information: The follow up would not possible as no contact details were available.
About 15 minutes after 1st vaccine pt felt swelling, itching of throat given Benadryl and symptoms resolved.   1330- Pt given vaccine 2nd done in first aid area.  Pt lying on stretcher. 1346- Pt feeling lightheaded Allergies: Flu shot, jalapenos, rosemary, eggs Denies medical history and medications. 1345- Benadryl 25mg PO- water given 1400- Water helped, no dizziness, no complaints of itching or swelling. Pt dangled, no dizziness, standing- standing dizziness but subsided.  30 min obs- pt feel ok to go.
Patient received 2 shots (PNEUMOVAX 23 and FLUAD) on Sunday 10/15/17. Both shots administered into the left deltoid. On Tuesday she developed a painful rash below injection site. Went into an clinic. Patient diagnosed cellulitis and prescribed Cephalexin 500mg. Shots received at 11:35AM 10/15/17. Called pt 10/18 9:20AM feeling better.
Headache, ErythemaMultiform, Fatigue, pain at injection site Narrative:
Nauseated not; Wretching; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2020, the patient received the 2nd dose of Shingrix. On 17th October 2020, less than a day after receiving Shingrix, the patient experienced nausea and retching. On an unknown date, the outcome of the nausea and retching were not recovered/not resolved.   It was unknown if the reporter considered the nausea and retching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had got second Shingrix vaccination on the morning of reporting date and was nauseated and wretched then.
Rash on his neck and down his chest, reported joint aches, headache, loss of appetite and lethargy since 5/16/2017.
Fever, Diarrhea, NauseaVomiting, Fatigue Narrative:
At 09:45 Rash to lower and upper ext. Given BENADRYL 12.5 mg = 5mL oral, recovered rash went away 25 min after BENADRYL given.
Injection site itching; Injection site redness; Injection site swelling; Injection site rash; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE RASH (Injection site rash) in a 70-year-old female patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE RASH (Injection site rash). At the time of the report, VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE RASH (Injection site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   .Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-025324 (Patient Link).; Reporter's Comments: .Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
appendicitis; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced appendicitis on an unspecified date. As reported, the reporter stated that 'I have never been to the hospital for medical issues. I had 2 friends call me to let me know of same experience of appendectomy within 2 weeks of 2nd vaccine'. Therapeutic measures were taken as a result of appendicitis. The outcome of the event was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100963151
No additional AE reported; Medical assistant student calling with question about adult vaccination with MMR II and VARIVAX states an adult patient was recently vaccinated with MMR II. Because there is no adult dosing schedule in the MMR II prescribing information, AE is being; This spontaneous report was received from a medical assistant student and refers to a 44-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 16-NOV-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, lot #U039908, expiration date: 16-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided) reconstituted with a sterile diluent (Inappropriate age at vaccine administration).
This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site was really hot for few days), VACCINATION COMPLICATION (other general side effects), CHILLS (Chills) and PYREXIA (Fever) 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 11-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (Injection site was really hot for few days), VACCINATION COMPLICATION (other general side effects), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, INJECTION SITE WARMTH (Injection site was really hot for few days), VACCINATION COMPLICATION (other general side effects), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient's concomitant medication was not reported. No treatment information was provided by the reporter.
Nausea, vomitting, headache, pain, 100.3 fever, pain at injection site
She was walking and just collapsed, eyes rolled back and strange breathing for a few minutes, then stopped breathing, CRP given but she died.
The patient presented to ED on 4/13/2022 with aphasia. At 10 AM the family noted an abrupt change in the patient, with expressive aphasia/word salad.  The family also reported patient was seemingly unstable when walking, leaning to the left. The patient was observed for malaise, cough, difficulty speaking, and hypotension. He was hospitalized for a similar but more severe episode after a COVID booster in October 2021.  A stroke was ruled out and he was observed overnight. He was hypotensive but responded promptly to IVF.  He has had a mild cough and pneumonia was clinically ruled out. On the day of discharge, he was ambulating without difficulty independently.
On 10JUL91 pt seen by MD extreme fatigue, h/a & heart problem (PACS); from 3JUL to 7JUL had very sore painful swollen lt deltoid;
This vaccine was used after BUD. Parent  did not report any adverse reaction  after receiving this vaccine.
On 6/14/01 the patient developed vomiting, low grade fever, joint ache and fatigue. She later developed diarrhea. On 6/15/01 she had no vomiting but still had diarrhea, fatigue and joint pain.
About 8-10 minutes after injection, he was talking with a colleague in the observation area and  became dizzy and sat down. Then got "really hot", then everything went black". Next thing he remembers is  2 colleagues assisting him to ambulate to ambulance. States his vitals were fine in the ambulance and at the hospital. IVF were given en route to hospital. Reports he "never eats breakfast".  He was observed for ~ 2 hours at the hospital and released.
On 10/11/21,  Nurse inadvertently retrieved an undiluted vial of COVID-19 vaccine from the shelf of the vaccine room. The undiluted vial of COVID-19 vaccine was sitting out to thaw to room temperature for the appropriate time period before dilution. The nurse then drew up 0.3mL of the undiluted vial of COVID-19 vaccine and administered it to Shayla Chavis at 4:12pm in her left deltoid intramuscularly. was given 800mg of ibuprofen at 4:41pm, observed for 30 minutes. left the office in stable condition.    At 8:00pm, CPNP called to see how she was doing. She stated she was doing fine, and was instructed to call with any concerns. was advised to keep hydrated and take 800mg ibuprofen every 8 hours as needed.   On 10/12/21 at 8:48am, Clinical Manager called to see how she was doing  - complains of sore L arm, sensitive to touch, and also hot to the touch. she feeling tired but with no fever.    On 10/14/21 at 8:29am, Clinical Manager spoke again. she states she has had a migraine x2 days/"head feels dizzy", has taken ibuprofen and acetaminophen but headache has not improved.   states speech is not right - she feels like she is talking very fast.  Also, she states that she had a fever yesterday of 102.3F.  has tried to get in touch with her physician but unable to get in touch or get a response.  Clinical Manager discussed these symptoms with a Pediatrics provider and  advised to go to ER. Relayed advice to mom and mom agrees to be evaluated by ER.
Complaint of severe headache which subside 2 days after vaccination (2/24/03).
negative reactions to PNEUMOCOCCAL 23-VALENT VACCINE; This spontaneous report was received from a physician and refers to a 69-year-old male patient. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (exact dose, site and route of administration, lot# and expiration date were not reported) for prophylaxis. On 16-FEB-2009, the patient had negative reaction to the vaccine. The outcome of adverse event was unknown. The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was related.; Sender's Comments:  US-009507513-1801USA008915: US-009507513-2003USA002315:
an expired Daptacel was given to a patient; Initial information received on 29-Apr-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of an unknown age and gender who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect  DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel] lot not reported; expiry date: 24-Apr-2019 via unknown route in unknown administration site. (Information on the batch number was requested)  It was an actual medication error case due to expired vaccine used.   It was not reported whether the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 08-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M025870 and expiration date 18-MAY-2018. (Dose and route of administration were not reported). It was stated that the temperature excursion was 6 degrees C (Celsius degrees), the time frame was 1 hour and there were not previous temperature excursions. It was stated that the alert of the temperature excursion was not because of a data logger. There was not a product quality complaint (PQC) involved. This is one of two reports from the same reporter. Additional information has been requested.