chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever (101.7 at highest); headache; entire body muscle aches and pain; arthritis pain in shoulders, wrists, and fingers; pounding heart; intense pain at injection site; large, swollen gland in left armpit (side of injection); pain at site of previous shingles infection (left back, same side as injection); tightness in lungs; exhaustion - all started and continued through the first night after the shot. Took Tylenol ~12 hrs after shot to reduce fever and heart pounding. All symptoms lasted throughout the entire next day.  Forty-eight hours after shot, most symptoms subsided except for tiredness and headache, swollen gland, pain and swelling at the injection site.  Seventy-two hours after shot, a large cold sore appeared on my lip. Headache is gone, but pain and swelling at the injection site and swollen gland persist.
MMR vaccine was given on 9/28/06. On 10/3/06 child vomits before bedtime. On 10/6/2006 child vomits again. From 10/4 to 10/6 child complains of pain around her neck before bedtime, grabs the area around her neck - reaction to the mumps portion? Mother had mumps at 6 years old. Mother also had rubella and measels as a child/teenager.
Residual neuralgia; 2nd shot Sep2021, Shingles in Aug2022/Vaccination failure; Shingles involved his eye, positive eye test for HZ; Awful case of shingles in Aug2022; Has seen a pain/facial pain management expert; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer (was pre-existing and he was in remission when the Shingrix doses were administered).   In September 2021, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). In August 2022, between 10 and 12 months after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and pain. On an unknown date, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were recovering/resolving and the outcome of the pain and post herpetic neuralgia were not recovered/not resolved.   The reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, pain and post herpetic neuralgia to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 15-FEB-2023 Reporter's comment:  The reporter was the patient.  The patient reported that he had Shingrix shot number 2 in September 2021. He did not know the exact month that he had Shingrix shot number 1 but thight it was a month (or two) prior to shot number 2.  Both shots were given intramuscularly in unspecified arm.  The reporter provided the phone number of the pharmacy where the shots were administered.  The pharmacy should have the exact dates (and lot numbers) on file.  The patient did not have access to this information at the time of the call.  The reporter a provided his primary care physician's (PCP) contact information and gave consent for GSK to follow up with his PCP as the Shingrix dates of administration and lot number data might have been forwarded to the PCP from the pharmacy.  The patient developed an awful case of shingles in August 2022.  The shingles involved his eye.  He had seen several doctors regarding this including an eye doctor, a pain management expert, and a facial pain management specialist. One of his doctors Oncologist suspected it was shingles and administered a test where he, put some kind of a strip on eye and that test came back positive for herpes zoster.  The reporter said that the shingles was not completely resolved.  He said it was a lot better, about 90 percent better but he still was residual neuralgia.  The reporter was consented to follow up.
employee complained of pain and tingling going down to fingers in same arm day after injection. Continued with pain and moved to not able to move arm. Saw Worker comp provider was placed on NSAIDs without relief. was placed out of work and sent for physical therapy.
Pt recv vax on 12/17/98; on same day pt exp red/ itchy rash on trunk & legs w/ itchy scalp; tx=Benadryl, Zantac, Hydrocortisone cream
pt recv vax 13NOV97 & 23NOV97 pt devel several chickenpox like lesions;
Soreness in arm at injection site after about 3-4 hours.  Approx 12 hours later, chills, aches and extreme fatigue.
Dermatomyositis diagnosed 5/11/2010. Leg pain and walking difficulties began on day of immunization, worsened(?) at two weeks and continued until diagnosis (central greater than periferal); elevated CPK, characturistic rash, classic case per Rheumatology. Treated with prednisone and IVIG is much improved.
7 th cranial nerve affecting the right side of her pallet; Herpes zoster on lip; has a pustule on lip; This case was reported by a nurse via call center representative and described the occurrence of herpes zoster infection neurological in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Shingles thrice). Previously administered products included Shingles vaccine.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than 2 months after receiving Shingrix, the patient experienced herpes zoster infection neurological (serious criteria GSK medically significant), herpes zoster and lip pustule. On an unknown date, the outcome of the herpes zoster infection neurological was unknown and the outcome of the herpes zoster and lip pustule were not recovered/not resolved.   It was unknown if the reporter considered the herpes zoster infection neurological, herpes zoster and lip pustule to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter was a retired nurse practitioner and stated a history of shingles on three separate occasions prior to receiving Shingrix and stated previously receiving shingles vaccine in the past.  The 1st dose of Shingrix was administered approximately 2 months ago and scheduled to receive second dose of Shingrix tomorrow that would be day after date of reporting since tomorrow would make 2 months and a day since receiving the first dose of Shingrix.  Approximately 4 days ago, reporter stated breaking out with shingles on her 7th cranial nerve affecting the right side of her pallet and her lip.  Reporter described current outbreak as the mildest of all previous outbreaks and that it feels like outbreak wants to progress but it was not. Reporter stated that the outbreak runs across top of pallet and had a pustule on lip.  Reporter had bloodwork drawn to measure IgG and IgM to determine if immune system was impaired in any way.  Shingles outbreak unresolved but getting better.  Reporter was comfortable forwarding lab work to Safety. The reporter consented to follow up.
Swollen injection site, muscle aches, fever (104), fatigue, mild nausea, swollen taste buds
Within 24 hours severe fatigue (could not get up), dizziness, headache, confusion, cold but no fever.
tested positive; tested positive; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 17Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 02Oct2021 as dose 3 booster, single (Lot number: FF2589), in left arm and on 23Apr2022 as dose 4 booster, single (Lot number: FK9895) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 21Jun2022, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) positive; (22Jun2022) positive; (09Jul2022) positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course included Anti-viral details: Product-COVID 19 Treatment, Brand-Paxlovid, treatment start date-22Jun2022, treatment stop date-26Jun2022 for treatment of COVID-19. Patient had Paxlovid rebound. Ongoing fatigue and cough prompted another Covid test. Originally tested positive on 21Jun, 22Jun. Test had faint line on 29Jun. No further tests until 09Jul and tested positive.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Nausea, hot flashes, cough, SOB and pain to left lung. These symptoms started approx. 10 minutes after vaccination and progressed over the next 5 hours going from mild to severe. Patient took 50 mg. of Benadryl at 6pm and rested for 2 hours. She states that she felt 80 % better upon waking and was completely well the following day.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 10:30 as dose 5 (booster), single (Lot number: 59267-0304-01) at the age of 75 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "Known allergy: Shellfish" (unspecified if ongoing); "low thyroid" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19.
Initial case was received from a consumer on 08 February 2013. A 64-year-old female patient received an injection of ADACEL, sanofi pasteur Ltd., (lot number, route, site, side and dose in series not reported) on 28 January 2013. The next morning on 29 January 2013, the patient woke up with aching in her neck, spine and diaphragm and could not turn her head side to side. Injection site was still very sore. The following day, she experienced low grade fever, and weakness. She visited her doctor. According to the report, the patient describes Arthus reaction per her doctor. On 08 February 2013, the date of report, the patient stated she had low grade fever and neck pain, but had good energy. The patient had a past medical history of arthus reaction and "tons" of allergies to unspecified: drugs, foods, pets and hay fever. She had no illness at time of vaccination. She had received a shingles vaccine on an unspecified date four or five weeks prior to vaccination. Concomitant medications were not reported. Laboratory or diagnostic testing and treatments were not reported. The patient's outcome was reported as not recovered (also reported as recovered, date not specified). Documents held by sender: None.
Patient called about 6:30 complaining of red eyes, with a mucus discharge. Questioning if it could be related to flu vaccine.
violently sick throwing up/vomiting; I was vomiting and chills; violently sick throwing up/vomiting; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 19Jul2022 at 13:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "coronary artery disease" (unspecified if ongoing), notes: I have coronary artery disease. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization, reaction(s): "vomiting"; Bnt162b2 (Dose 3 Booster, I was vomiting and chills), for Covid-19 immunization, reaction(s): "chills", "vomiting". The following information was reported: VOMITING (non-serious) with onset 19Jul2022 at 23:00, outcome "unknown", ILLNESS (non-serious), outcome "unknown" and all described as "violently sick throwing up/vomiting"; CHILLS (non-serious), outcome "unknown", described as "I was vomiting and chills". Additional information: the reporter stated she was violently sick throwing up. She was up all night and vomiting with the vaccine, every time I take it, this is what happens. The reporter stated the first time she didn't vomit, the second dose she was vomiting up a storm, the first and second booster she was vomiting and chills.  The reporter just received the last booster yesterday, she was okay in the beginning and started vomiting about. She received the vaccine at 1:30pm and started vomiting at 11PM and it lasted all night until about 8 or 9AM , she was up every hour on the hour vomiting.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient stated had hives, redness, fever, itching, swelling in left arm from shoulder to elbow.  The symptoms lasted for 3 weeks.  She is fine now and just "stuck it out".
Patient is a 93 y.o. female patient of a MD with history of hypertension, glaucoma, CHF presented to a local Hospital with SOB, low HR. Found to have covid infection.   Sinus bradycardia HR 30s to 40s initially, received 2 doses of atropine Likely 2/2 combination of long acting BB and acute covid infection Discontinued home Toprol XL permanently Echo with EF 62%, RVSP 48 mmHg Patient asymptomatic, HR improved Cardiology followed in the hospital and signed off   Acute Respiratory Failure with Hypoxia, resolved Patient has oxygen at baseline and uses PRN rarely Etiology:Thought to be secondary to COVID Pneumonia May also have CHF Exacerbation contributing See management of COVID and CHF e Initially required supplemental oxygen.  Weaned down to RA prior to discharge.  No O2 requirement at discharge  Covid-19 Virus Infection Date of onset of symptoms: 3/21/2023 Symptoms present on admission: Cough, SOB, fatigue Date of covid positive test: 3/21/2023  Vaccination status: vaccinated Imaging: Increased opacity left costophrenic angle may be atelectasis or developing pneumonia ar pleural effusion Oxygen requirements  1L>RA Medical therapy: Completed Paxlovid.  Steroids on taper Anticipated special isolation end date: 3/31/2023 Had significant cough for which Tessalon Perles as needed and breathing treatments were utilized in the hospital   Acute Exacerbation of HFpEF Etiology: May be due to underlying COVID Patient showing signs of CHF by LE Edema, Pulmonary edema, SOB, elevated BNP Echo with EF 62%, RVSP 48 mmHg Home Rx: Lasix 20 mg daily.  Started IV diuresis with 40 mg BID, transitioned to oral Lasix. Low-salt diet, daily weights, strict I's/O Cardiology followed in the hospital DC home on Lasix 40 mg daily  Elevated Troponin  Serial troponin 39> 35.  Not consistent with ACS. Echo with no wall motion abnormalities. No further work-up indicated   HTN Accelerated BP Home Rx: Norvasc, Losartan Held and discontinued Toprol XL due to bradycardia Home Rx: Norvasc 2.5 mg daily, increased to to 10 mg daily. Continued home losartan 50 mg daily Started PO hydralazine low dose and increased to 25 mg TID and DC'd on that dose  Glaucoma Continue Home: Xalatan, Cosopt   Obesity BMI 37.11   Gait weakness Patient is from independent living.  At her baseline she is able to transfer to wheelchair without difficulty. PT/OT followed with daily evaluations.  They recommended two-person assist Daughter arranged for 2 caregivers x24 hours. Daughter also arranged hospital bed. Arrangement of caregiver and hospital bed delayed discharge
Vaccine administered by medical assistant and exited patient before entire dose given, about quarter sized amount of vaccine spilt onto patient. Vaccine was initially administered medial to vastus lateralis muscle, then after vaccine exited patient, it was was re-administered without changing needle into area medial to vastus lateralis muscle.
Patient received 4 vaccines (smallpox, typhoid, anthrax, and Hepatitis B) and experienced vasovagal-like response w/ decreased alertness, diaphoresis, transient left arm weakness, and not his usual self.  L. arm weakness persisted for about 10 minutes, but slow mentation continued even after pt consumed a can of orange juice and rested.  Vital signs and oxygen sats wnl w/ exception of HR of 52.  Pt had no problems breathing and responded to questions. Pt was transferred to SMC for further evaluation.
This case is linked with case# 2013-06246 and case# 2013-06247 (reported by the same reporter) Initial misuse report received from a healthcare professional on 24 April 2013. An adolescent patient was given DAPTACEL instead of ADACEL. (No more information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Rash on trunk and legs not going away; Rash on trunk , arms, and legs not going away.; Papular; Rash on trunk , arms, and legs not going away. Papular, itches, and burns; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 24Dec2020 at 00:00 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known drug allergies (NKDA). Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. On 15Mar2021 at 00:00, the patient experienced rash on trunk, arms and legs and was not going away. The rash was papular, itched and burned. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of the events and included treatment with Me from dose pack (as reported). Since the vaccination, the patient had been tested for COVID-19. On 29Mar2021, the patient underwent COVID-19 virus test (via nasal swab) and the result was negative. The clinical outcome of the events rash on trunk, arms and legs; papular, itches and burns was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Second shot was worse than first and took longer to go away.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE and LEVOTHYROXINE for an unknown indication.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION COMPLICATION. At the time of the report, VACCINATION COMPLICATION had resolved.        No treatment medications were reported.   This case was linked to MOD-2021-403775 (Patient Link).
3 days following vax pt returned 30JUN95 to clinic because arm was reddened, warm, tender & swollen @ inj site;tx symptomatically ice, ibuprofen w/warm moist compresses p/2 days;
This case was reported by a pharmacist and described the occurrence of fever blisters in the mouth in an adult female subject who was vaccinated with FLUARIX. There were no concurrent medications. On 01 November 2008 the subject received a dose of FLUARIX at 0.5 ml. On 01 November 2008, less than one day after vaccination with FLUARIX, the subject developed fever blisters in her mouth. The event resolved. The pharmacist considered the events unrelated to vaccination with FLUARIX.
Erythema, mild swelling of left upper arm with a 3" slightly raised area inferior to injection site which appeared 7 days after vaccination. C/o muscle soreness at site, pain on forward movement of neck and dizziness. Tx; meclizine, ibuprofen.
sinus headache; loss of energy. (Just felt very tired very fast); loss of energy. (Just felt very tired very fast); I felt like I was getting a sinus infection with pressure in my head; I felt like I was getting a sinus infection with pressure in my head; My nose was runny; just started feeling bad; Not sure if the headache woke me up or I just woke up; This is a spontaneous report from a contactable consumer. This 50-year-old male consumer (patient) reported.   A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6199), dose 2 via an unspecified route of administration, administered in Arm Left on 10Mar2021 09:45 (age at the time of vaccination was 50-year-old) as dose 2, single for COVID-19 immunization. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing, blood cholesterol abnormal from an unknown date and unknown if ongoing. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. No known allergies were reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: 9581), dose 1 via an unspecified route of administration, administered in Arm Left on 17Feb2021 09:30 as dose 1, single for COVID-19 immunization and left arm was sore about 2.5 hours the shot. It had felt like a had a Techna shot. The soreness went away 5-6 hours after the shot. It was reported that after the second shot, three hours later the patient was working outside in the yard and had a noticeable loss of energy on 10Mar2021 23:30. (Just felt very tired very fast).The patient felt like he was getting a sinus infection with pressure in his head and his nose was runny and just started feeling bad on 10Mar2021. As the evening progressed at about 7:30 pm- 8 pm he went to bed and feel asleep very fast. He woke up at 11:30 pm with a what felt like a sinus headache on 10Mar2021. He was able to fall asleep again and awoke at 04:30 am with a pounding headache not sure if the headache woke him up or he just woke up on an unspecified date in Mar2021. Treatment medication included Naproxen 250 mg for the event sinus headache and event not sure if the headache woke me up or I just woke up. Outcome of all the events was reported as recovering at this time of the report.   No follow-up attempts are possible. No further information is expected.
Pt recvd 3 dose series of Engerix-B & HBSAB test was negative p/3rd dose; pt has not yet received booster;
Very shortly after booster, injection site was itchy & slightly pink. Now a bit over 24 hours later there is pink welt the size of a half dollar if not bigger. Still itchy. This did not occur with my first two shots. Everything I am reading online says arm rashes occur 2-12 days after but this happened almost immediately.
I am having a tinnitus on my left ear after my first covid 19 vaccine shot and seems to get worse after a second shot.
Fever, chills, nausea, bodyaches, headache, fatigue.  my arm at the injection site is extremely painful.