chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer reporting for herself. A female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of the event and included bed rest, some antibiotics and other stuff. The information on the lot number has been requested.
A report has been received from a Health Professional concerning a 61 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 01-Oct-2013. The reporter stated they administered FLUMIST QUADRIVALENT to a 61 yo on 01-Oct-2013. The outcome of the event of administered FLUMIST QUADRIVALENT to a 61 yo is unknown. The report was considered to non-serious.
No adverse event.  Just administered the liquid vial portion of the Menveo, did not reconstitute with the powder vial of the vaccine.
pt devel wheezing & difficulty breathing same noc following vax; taken to ER;
real strong reaction to first dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (real strong reaction to first dose) 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 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 ADVERSE REACTION (real strong reaction to first dose). At the time of the report, ADVERSE REACTION (real strong reaction to first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment was not reported by the reporter.
Pt called clinic on 2-12-19 after having flu vaccine on 2-8-19 stated "started having sx of H/A, dizziness and SOB the next AM". Instructed to see Dr. Also stated "have heart valve issue". Will call pt back after sees Dr. this AM. No answer when called back x 2.
In the weeks following, I have had occasional unexplained tiredness, blocked ears and tinnitus.  The blocked ear last 2 days and the tinnitus seems to have gotten worse.   I have no idea if these symptoms are related to the the vaccine but thought I should let you know.
PATIENT'S FAMILY IS REPORTING THE PATIENT IS CURRENTLY BEDBOUND AND MISSING WORK DUE TO EXTREME SWELLING AT THE INJECTION SITE. THE ARM IS REPORTEDLY RED, TENDER, AND SWOLLEN. PATIENT WAS SEEN BY A LOCAL CLINIC ON 9/25/2020. PATIENT'S REPRESENTATIVES WERE ADVISED TO MONITOR SWELLING BY DEMARCATING THE AREA WITH A MARKER, AND TO SEEK ADDITIONAL TREATMENT IF CONDITION PERSISTS OR GROWS.
I woke up about 4am on the 8th  I had fever and chills and shaky, temp was 100.5 nauseous, weak, dizzy, I called into work, I assumed the shot was working. I called my physician to let her know I was having a reaction, I diarrhea for 3 days . I just took some tylenol and after the 3 days I started feeling better
Pt recvd Engerix-B 22AUG90, 25SEP90, & 25FEB91, & 22APR91 & 12JUN91 HBSAB was neg; 14JUN91 recvd 1 dose of Engerix-B & 15JAN92 HBSAB still neg; pt exp no adverse effects x/non response;
On 4/26/2000, pt developed intussusception, non-reducible by barium enema. Was reduced in surgery. Bowel intact and no illness or stomach flu.
2nd dose in series: vomiting, bilateral leg pain, stomach discomfort, metal-taste described in mouth after vomiting. These same Sx occurred after 1st dose of vaccine, but mom attributed to viral illness coexisting at time of immunization.
Shot hurt when first injected, extreme pain for the next few weeks. Four months later I still have pain in my arm, have started physical therapy to see if it will help with pain.
Chills; Flu like symptoms; Might have had diarrhea; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient friend's wife) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus. The patient's concomitant medications were not reported. Patient was sick for a few hours after the second dose. He got it at the same time same place. He had chills, flu like symptoms, and he might have had diarrhea. He got flu like symptoms, reporter was not sure exactly what they were. Patient had chills and some more symptoms. He had the shot in the afternoon and his symptoms were over with by 23:00 or 00:00 that evening. Those symptoms are gone. The outcome of events was recovered.  No follow-up attempts are possible, information about batch number cannot be obtained.
relaxed in bed that whole day; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An elderly female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: FEELING OF RELAXATION (non-serious), outcome "unknown", described as "relaxed in bed that whole day".  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-202101393021
Pt. had facial swelling, and difficulty breathing the night he received the vaccine.  Difficulty breathing resolved by morning and facial swelling resolved the next day.  Patient also had redness, pain, and swelling at injection site. Patient never sought treatment for reaction and feels it has completely resolved
arm hurt, wasn't as bad; flu like symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date date, refer link  case US2022AMR046919).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced pain in arm and influenza-like symptoms. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were unknown.   It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR046919  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient experienced pain in arm after receiving 2nd dose of Shingles vaccine, but was not bad as 1st dose. The patient did have flu like symptoms the next day. No other information was provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR046919:Same patient, different dose
Area of injection was swollen,painful, and warm. Pt. was taking Mobic and adding Advil 600mg for 3 doses.
Dizziness, Arthralgia, low grade fever Narrative: missed work after second dose due to above symptoms
Case number PHEH2013US009894 is an initial spontaneous report received from a registered nurse on 30 Apr 2013. This report refers to an adult patient (over 55-year-old) of unspecified gender. The reporter stated that the patient was vaccinated with a dose of MENVEO (batch number: not reported) on an unspecified date. No adverse reaction was reported following this administration error. The reporter refused to provide additional information.
The following day my heart rate went to 140?s I fell as if I was going to faint, that day after 20 minutes it went into the 110.  Even sitting it would not go lower than 100.  8 days after that I was sitting and my HR went up to 130?s. I called 911, I was not sure what was happening. I went to the ER . I was treated for low potassium and suggest to follow up with primary care.  My PCP repeated the bloodwork and things were coming down.  My red blood count is low and have a follow up blood test. I am to follow up with a cardiologist in July of 2022.
Muscle weakness and easy injury, extreme nerve pain in upper body, especially around the spinal cord. Extreme fatigue, fog.
has been worn out; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program Pfizer First Connect. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number/Expiration Date: unavailable after follow-up), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she got vaccinated on Friday and she has been worn out since then, she was wondering if she should get the second shot if this would be the result she gets. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Severe headache Severe chills Nausea Stomach cramps Fatigue Body muscle aches
I woke up in the middle of the night at 2AM with a sore throat for 4-5hours. Had a PCR test and rapid test done at work. Tests both came back positive. I stayed home for 5 days then went back to work.
vomited for 6 straight days every time she tried to eat; This is a spontaneous report from a contactable consumer or other non-HCP (parent reported for daughter). A 14-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 13Sep2021 as dose 1, single (at the age of 14-years-old) for COVID-19 immunization. Vaccination Facility type was reported as Pharmacy or Drug Store. The patient did not receive any other vaccine in four weeks. The patient had not been tested for covid post vaccination. Medical history included COVID-19 and known allergies were reported as unknown. Concomitant medication included sertraline hydrochloride (ZOLOFT). On an unspecified date in 2021, the patient experienced vomited for 6 straight days every time she tried to eat. The patient only stopped after taking Zofran and she took it for a week. Patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 05Oct2021 as dose 2, single for COVID-19 immunization. The outcome of the event was resolved on an unspecified date in 2021.  The lot number for the vaccine, BNT162B2, was not provided and would be requested during follow up.
did not developed antibody titers against the virus; The patient is 32 years old; The patient is 32 years old; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 32-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunosuppression.   On an unknown date, the patient received the 1st dose of Shingrix. On 3rd December 2019, the patient received the 2nd dose of Shingrix. On 3rd December 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced therapy non-responder and inappropriate age at vaccine administration. On an unknown date, the outcome of the therapy non-responder, inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose of Shingrix. The pharmacist reported a patient, who completed the vaccination schedule of Shingrix, did not developed antibody titers against the virus. The patient received the second dose of Shingrix on 3rd December 2019. After that, she went to the doctor and performed some studies that shown she had no titers for Herpes Zoster Virus. The patient was 32 years old.      Lab Comments: Lab test performed on an unknown date.
Patient started getting electrical zingers across her shoulder, clavicle and neck later in the afternoon, occurring every 15 minutes.
Pt was brought to me in the hallway. I looked at his (L) arm which had a band aide covering the injection spot. There was a 2 cm x 1 cm extension of redness off to the 1900 position - no vesicles, no streaking, no open sites.
Low fever (100 F), pain at injection site, nausea and dizziness.  It lasted about 12 hours. I took a Tylenol when nausea subsided (in the afternoon).
No further adverse events; Caller is nurse reporting administered dose of expired VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #T017682, expiration date: 21-MAY-2022, administered for prophylaxis (strength, exact dose and route of administration were not provided) (expired product administered).  No further adverse events provided.
Complained of left upper extremity pain, redness and swelling.  Limited range of motion.  Sought medical care with her PCM and received Medrol Pak 4 mg, advised to use warm compression and rest.  Returned to provider with slow relief from symptoms and was given another Medrol pac to.
The vaccine had to be given lower than deltoid region due to patient clothing. The next morning she experienced redness/heat on side of her arm and a small nodule. It did not hurt. It looked similar to a rash. It did not itch.
improperly stored dose of PROQUAD was administered to a patient; no additional adverse effects reported; This spontaneous report as received from an office manager and refers to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 25-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S031705 and expiration date 06-APR-2021 for prophylaxis (dose, strength, route of administration and frequency were not reported).  On an unknown date, the vaccine had a temperature excursion of 22.3F for 4 hours and 25 minutes; previous temperature excursion was reported at 8.6F for 1 hour an 51 minutes. Digital data logger was involved.
I started by the site swelling, and got fatigued. The next day I was weak, headache, the swelling was very red, hard about the size of a pop can. 5 inches outside the site I got an infection, the skin was red.
headache; nausea; liver enzymes became elevated 20 times what was normal (liver enzymes was 208 and ALT 165); liver enzymes became elevated 20 times what was normal (liver enzymes was 208 and ALT 165); This is a spontaneous report from a contactable consumer (the patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EW0172), via an unspecified route of administration in the left arm on 29Apr2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. There was no medical history or concomitant medications. The patient received the second dose of her Pfizer COVID vaccine on 29Apr2021 and reported headache and nausea (unspecified date). She also stated that her blood test done on 03May2021, showed her liver enzymes became elevated 20 times what was normal (liver enzymes was 208 and ALT (alanine aminotransferase) 165). She had the same bloodwork done on 15Apr2021, and everything was normal. She asked if these side effects were normal and how long should they last for? The outcome of headache and nausea was unknown. The outcome of other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Headache, Myalgia, Arthralgia, Fever, fatigue Narrative:  states, "started with sore arm at midnight after being vaccinated progressing to worse symptoms" c/o symptoms 1/12-1/5 later resolving.
Pneumonia; Post herpetic neuralgia; Herpes zoster; Information has been received regarding a case in litigation, referring to a female pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 15-APR-2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as "shortly after", the pt suffered from a productive cough, shortness of breath and generalized joint pain and was diagnosed with pneumonia. The pt also experienced skin severe pain along with rash/lesions and was diagnosed with herpes zoster and post herpetic neuralgia. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not presented prior to vaccination. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Furthermore, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the outcome of pneumonia, herpes zoster and post herpetic neuralgia was reported as not recovered. The lawyer considered pneumonia, post herpetic neuralgia and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event pneumonia was determined to be medically significant. Additionally, the events were determined to be serious due to disability.
Breakthrough case admission after 2 vaccines Pfizer 4/9/21 Lot# ER8734;  Pfizer 1/14/22 Lot# FJ6369
BP 132/80 HR 82 RR 18 O2 99% Developed Hives 5-7 minutes after injection.  No respiratory distress.  Given 50 mg of PO Benadryl and hives lessened. No worsening of symptoms.  Has a history of hypersensitivity reactions.  Released after 1 hr with strict instructions to self monitor.
Patient complaining of left shoulder pain after TDAP injection DOS: 3/2/15, initially pain at site then after a week developed periodic pain in different areas on left arm. It varies in location, sometimes in triceps sometimes in hand, sometimes in bicep with w/radiation to hand.
Rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over body) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RASH (Rash all over body). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (Rash all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Fever, chills, body aches and vivid nightmares causing me to wake up crying about a half dozen times.
Initial report received from a healthcare professional on 04 September 2012. A female patient whose age, medical history and concomitant medications were not reported; had received intradermal FLUZONE ID (lot number was not provided) in arm on 24 August 2012. On 24 August 2012, the patient developed 2x2" swollen, hard, red lump at the injection site, hot to touch, muscle weakness in injection site arm. The patient also had difficulty sleeping due to pain in her arm which continued for 11 days with itching and peeling. Details of lab tests were not reported. The patient was prescribed "BENEDRYL". The patient's outcome was recovered on unspecified date. Documents held by sender: None.
My arm started getting red and itchy on the second day.  I had a red circle a little bigger than a silver dollar that was hot, hard and stinging and itchy for about 3 weeks after the injection.  Today my arm is better but it is still not completely gone.  My arm still itches and burns at the injection site.  I did not run a fever or feel really bad.   I don't know if this event was related to the vaccine or not but about 3 days after getting the vaccine, my tongue started burning like when you eat to many nuts or salty snacks and it was only on the left side of my tongue.  My left check also was itchy.  That resolved after about a week.  I have had in the past a similar situation that I have called burning tongue/
Sore arm and mild body aches on 1/6/21 Moderate body aches on 1/7/21 Rash on back of arms, lower back, thighs 1/8/21 Felt 100% back to normal 1/9/21
Reconstituted a dose of Menveo with sterile water instead of the provided diluent; Reconstituted a dose of Menveo with sterile water instead of the provided diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA936A, expiry date 31-MAY-2024) for prophylaxis.   On 14-JUN-2023, the patient received the 1st dose of Menveo. On 14-JUN-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted a dose of Menveo with sterile water instead of the provided diluent) and inappropriate dose of vaccine administered (Verbatim: Reconstituted a dose of Menveo with sterile water instead of the provided diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter was a medical assistant. The reporter reported that the nurse accidentally reconstituted a dose of Menveo vaccine with sterile water instead of the provided diluent  The reporter wanted to know how to proceed. The vaccine administration facility was the same as primary reporter. Menveo reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did consent to follow up.
Eruption of rash on neck and chest approximately 36 hours after injection. Diagnosed by dermatologist, Dr. to be shingles. After one week, rash appears to be resolving.