chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; year later got shingles on neck and side of head; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received the vaccine and about a year later got shingles on neck and side of head, that was gone in two weeks. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule and laboratory confirmation for shingles were unknown.
After administering the shot  I was explaining  to wait for 15 minutes, as we were speaking patient stated he was feeling light headed then he slumped forward and became unresponsive for a few seconds during that period he urinated on the chair and floor I  had a customer get the pharmacist and the patients wife came to him. The patient remained shaky, as we retrieved a towel and some water for him. The patient remained sitting and resting for about 20 mins during this time we offered to call 911 to which the patients wife stated that something similar to this happened before and declined the call to 911.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media through company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose not reported, start therapy date were not reported for prophylactic vaccination. It was unknown if the patient experienced any adverse events following vaccination with covid-19 vaccine (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 01-FEB-2022, the patient stated she got new form of covid and was sick (suspected covid-19 infection, and suspected clinical vaccination failure) (all events with dose number in series 2). It was reported that "well I had all three. Yes, I felt sick after the 3rd one but it went away after 3 days, that was last year. The new form of covid got me 4 days ago. I am sick but not dying". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000216413.; Sender's Comments: V0: 20220217928-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
On 7/4/21, my lips started swelling around 7:30pm. I did an online visit with a doctor who told me to try Benadryl and Pepcid. I went to bed and slept really well. When I woke up I noticed it was still swollen and my tongue was now also swelling. I then headed to the ER. The ER put me on an IV for steroid and more Benadryl & Pepcid. The ER also prescribed an oral steroid and said continue taking the Benadryl & Pepcid.
fever 102, vomiting, diarrhea, painful, red, swollen arm;
No period after both shots; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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. On an unknown date, the patient experienced no period after both shots. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event no period after both shots was unknown at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Inappropriate schedule of vaccine administered; Inappropriate schedule of vaccine administered; This spontaneous report has been received from an other health care professional (HCP) via medical records from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (RA# 2112USA008168), concerning a 3-month-old female patient (pt).  On 02-FEB-1996, pt was vaccinated with a first dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (dose, units, route of administration, lot#, and expiration date were not reported) for prophylaxis. On 10-APR-1996, pt was vaccinated with a second dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (dose, units, route of administration, lot#, and expiration date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered). On 02-OCT-1996, pt was vaccinated with a third dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (dose, units, route of administration, lot#, and expiration date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered).
This spontaneous case was initially received on 13-Oct-2015. The case report was received from a Non Health Professional and concerns a male patient. Weight: not provided, Height: not provided. Concurrent medical conditions (s), medical and drug history: At the time of the event the patient concomitantly suffered from beginning stages of osteoarthritis. The patient has a medical history of Heavy metal (arsenic) poisoning years ago and Lost 23% lung capacity (reason unknown to his doctors). the patient was very careful what he consumed. He only ate natural foods with on preservatives and they are labeled non-GMO. He was not allowed to drink alcohol. When he consumed alcohol, he got rib cage pain. It had taken him a long time to recover from the heavy metal poisoning. At the time of reporting, he was on drugs to help his liver and oxygen at night. For concomitant medication and therapy dates. CREON (6 tablets a day orally depending on diet) for the liver, TMG; trimethylgycine) for the liver, milk thistle for the liver, acetylcysteine, unspecified oral inhaler, and unspecified nasal inhaler. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA at pharmacy for the prevention of influenza on 09-Oct-2015, Batch no; either U55106 or U58908, Route of administration: Intramuscular: Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 09-Oct-2015, after starting/ treatment with AFLURIA, the patient experienced pains under my rib cage/pain under right rib cage feels swollen to the touch/right rib cage pain (non serious, outcome: Not Recovered/Not Resolved). His neck also felt stiff (non serious, outcome: Not Recovered/Not Resolved). He compared his AFLURIA rib cage pain as similar to his alcohol pain. Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Td was administered subcutaneously. Area of mild erythema and warmth at injection site. Resolving without progression.
head pain on the right near ear and on top of head; This is a spontaneous report received from a contactable consumer, the patient. A 66-year-old elderly male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via unspecified route of administration in the right arm on 13Mar2021 at 18:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. No medical history was reported. The patient was allergic to eggs. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of COVID vaccine. On 15Mar2021 at 18:00, 48 hours after the first shot piercing the patient experienced head pain on the right near ear and on top of head which was sore to touch. The patient did not receive any treatment for the adverse event. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event headache was not recovered at the time of report.   No follow-up attempts possible. No further information expected.
keep getting sick over and over again after getting these shots; keep getting sick over and over again after getting these shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (176890).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: ILLNESS (non-serious), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "keep getting sick over and over again after getting these shots".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300001876 Same reporter/drug/events, different patient.;
I CALLED THIS PATIENT AND HE SAID HE FELT NAUSEOUS LAST NIGHT. HE SAID IT MAY HAVE BEEN DUE TO WHAT HE ATE. BUT OTHER THAN THAT, JUST A SORE ARM TODAY.
Received her second dose on February 5th. When in the lab on February 8th, displayed a red, swollen, warm area the size of a large baking potato on her left arm. She has been taking ibuprofen consistently. She reports her arm as painful.  She was instructed to ice twice today and take diphenhydramine after work.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided. On 13-OCT-2021 the patient was vaccinated with a Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-RVAXPRO) however reporter was unsure about which lot number administered to patient (Lot T000890 with expiration date reported 08-JAN-2022 and Lot T010650 with expiration date reported 26-MAR-2022 (dose, strength, frequency, route of administration and anatomical location were not provided) for prophylaxis, which was improperly stored (product storage error). The temperature of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-RVAXPRO) was stored had been above was 46F (49.6F) for 2 hours 21 minutes for lot T000890 and was 46F (56.1F) for 3 hours 33 minutes for Lot T010650. No additional adverse effect was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2112USA000033: US-009507513-2112USA000050: US-009507513-2112USA000051.
Sore arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concomitant products included DILTIAZEM HYDROCHLORIDE (CARDIZEM CD) for an unknown indication.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment details were not provided.
Lump at shot site,  Red and very swollen.  This was from 1st shot.  Then 2nd shot on March 9, had a severe headache right away and during night fron 4-7am high temperature and chills, followed by nausea/diaria, body aches and extreme dry mouth.  For 2 weeks aafter had extreme dehydration with fever everynight with body weakness.  It has left me with kidney damage and extreme dehydration.
Patient had swelling, itching and soreness in L arm  after vaccination.  no swelling of throat, fever, vomiting, other rash, diarrhea, shortness of breath.Patient is doing well after a dose of benadryl
10/27/03 Pt c/o blisters and itching of scalp for 2 days. Rash moved to neck and forehead, rash and swelling. Next AM hives over body, lips swollen, joint swelling and pain. Impression: Possible adverse flu vaccine reaction. Symptoms resolved as of 11/10/2003.
12 HR EPISODE OF ATRIAL FIBRILATION, CONFIRMED BY NURSE. RAPID HEARTBEAT, AGITATION, ANXIETY, SYMPTOMS LASTED APPROX 2 HRS. CONFIRMED AS A 12 HR EPISODE OF AFIB BY NURSE FROM REMOTE PACEMAKER READ OUT ON OCT 10,2022, FROM 5:30 PM ON OCT 8 TO 5:30 AM ON OCT 9.
Fever, chills , headache- day after vaccine  2 weeks later - lymp node swelling underarm righthand
This time I went to the dermatologist rather than urgent care. So when I went to the dermatologist, they thought it was Lupus, but tested and it was not that. They gave me steroids for 4 weeks and they gave me a topical cream to help with the pain and a medication the doctor compared to Benadryl. I did go to a follow up visit with this same doctor. This treatment helped some, but my skin is not right,  I now have very sensitive skin to everything, for example items I have always used cause issues for my skin, I can not use the sun screen I have always used. I have to use sun screen that is completely mineral based. Other products that I have used for a while that I never had a reaction to I have had problems. I need to use very basic products that I put on my skin otherwise I break out.
This spontaneous prospective pregnancy report was received from a physician referring to a female patient of unknown age. Concurrent conditions and medical history of the patient were not reported. On 14-DEC-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K009198, expiry date 27-SEP-2015) (dose, route unspecified) (Expired vaccine used). The last menstrual period (LMP) was 02-JUN-2015 and expected delivery of date (EDD) was 08-MAR-2016. The patient was in 30 weeks gestation at the time of ZOSTAVAX administration (Drug exposure during pregnancy, third trimester) (Product used in unapproved population). The pregnancy outcome was unknown. No adverse effects have been reported. Additional information has been requested.
After second vaccine had body aches and joint pain. Three week later had swollen feet and high heart rate.
Injection site warm to touch, edema noted, red band around arm toward axilla, swollen lymph node (left axillary area). C/o pain, onset, 10/25/99 pm., c/o clammy skin & chills on 10/26/99 and c/o sore throat on 10/27/99.
On Tuesday, 12/28/21, I received my Pfizer booster shot in my left arm at Urgent Care. The next day, I noticed a swollen lymph node in my left underarm pit as a reaction to the shot. I called the Urgent Care , and spoke to someone who took the information down and said that a doctor would return my call but he/she never responded. Today, I noticed redness around where the shot was administered and sent an e-mail to the urgent care informing them of my adverse reaction to the booster shot.  As of yet, I have not received a response.
unable to feed himself; confused; unsteady gate; urinary incontinence; could not remember wife's phone number; flush; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confused), FLUSHING (flush), GAIT DISTURBANCE (unsteady gate), URINARY INCONTINENCE (urinary incontinence) and MEMORY IMPAIRMENT (could not remember wife's phone number) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced FLUSHING (flush). On 23-Apr-2021, the patient experienced CONFUSIONAL STATE (confused), GAIT DISTURBANCE (unsteady gate), URINARY INCONTINENCE (urinary incontinence) and MEMORY IMPAIRMENT (could not remember wife's phone number). On 25-Apr-2021, the patient experienced FEEDING DISORDER (unable to feed himself). At the time of the report, CONFUSIONAL STATE (confused), FLUSHING (flush), GAIT DISTURBANCE (unsteady gate), URINARY INCONTINENCE (urinary incontinence), MEMORY IMPAIRMENT (could not remember wife's phone number) and FEEDING DISORDER (unable to feed himself) outcome was unknown. Not Provided      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.   No concomitant medication details were provided. No treatment medication details were provided.
1 year old received Kinrix on June 29th 2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 29-JUN-2023, the patient received Kinrix. On 29-JUN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 1 year old received Kinrix on June 29th 2023). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-Jul-2023 The reporter consented to follow-up. The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration.
I am have some swelling like near my armpit on my left side; it look like a little bit of soreness their too; Anatomical site of injection: Consumer stated, "Left shoulder."; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 30Sep2021 (Lot number: FF2589) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D3; N-ACETYLCYSTEINE. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization.  The following information was reported: SWELLING (non-serious), outcome "unknown", described as "I am have some swelling like near my armpit on my left side"; AXILLARY PAIN (non-serious), outcome "unknown", described as "it look like a little bit of soreness their too"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Anatomical site of injection: Consumer stated, "Left shoulder."". Therapeutic measures were not taken as a result of swelling, axillary pain, incorrect route of product administration.  Follow-up attempts are completed. No further information is expected.
RECEIVED BOTH DOSES OF PFIZER COVID-19 ON 01/27/21 & 02/17/21 REPORTED TO ED ON 02/21/21  WITH COMPLAINTS OF CHEST PAIN AT 25 WKS PREGNANT. DAIGNOSED WITH ACUTE CHEST PAIN, ACUTE PULMONARY EDEMA, AND DYSPNEA ON EXERTION.  ADMITTED TO HOSPITAL ON 02/21/21.
Resident received vaccine without event as noted above.   Family contacted EMS Ambulance Service on 7/20/2021  because patient was unresponsive.  EMS arrived @ 0440 &  documented no respirations or heartbeat.   EMS worked on patient 50  minutes.  Got ROSC about 10 minutes PTA.  Patient intubated.  Arrived to ER @ 0630.  Lost  pulse on arrival to ER local Hospital. Full ACLS Protocol.   Defibrillations performed.  Hyperkalemic;  Chest X-ray confirmed left lower lobe Pneumonia.   Sepsis WBC  20.8.  Differential Diagnosis: Altered Mental Status, sepsis, flu.   Epi Infusion. Levenox.  Pronounced death @ 1648
Mother reported bilateral shoulder pain then severe migraine in "back of head" Sxs started about 2 hours after vaccines given (menactra and bexsero).  Vomited "violently" at 0300 and 0400. pale and felt faint.  This am developed t 102, felt somewhat better with 400 mg ibuprofen. Also noted tingling/pain in back "like when she had hand/foot/mouth few months ago.  Examined pt during brother's visit and she looked pale and like she didn't feel well. Able to cooperate and engaged in nl conversation.  BP-108/76 HR-93 Nl PE with DTRs 2+ BUE and BLE. CV nl, pulm nl, OP nl, No nuchal rigidity, neg tenderness with leg raise; nl gait, but appears mildly weak.  Likely side effect from vaccine; advised to take ibuprofen q 6-8 hours and Imitrex if "full migraine" returns