chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Joints hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: ARTHRALGIA (non-serious), outcome "unknown", described as "Joints hurt".  Additional information: The patient reported that his joints hurted now after activities and he felt 95 after receiving Covid vaccine. It was worse after part 2 also.  The lot number for bnt162b2 was not provided and will be requested during follow up.
DOSE INJECTED WAS STRONGER THAN 30MCG/0.3ML . THE VIAL OF PFIZER VACCINE WAS DILUTED IMPROPERLY USING ONLY 1.2ML OF SALINE, INSTEAD 1.8ML, SO THE RESULTING SOLUTION WAS MORE CONCENTRATED. THE PATIENT GOT A 0.3ML DOSE, BUT IT CONTAINED ABOUT 30% MORE ANTIGEN (ABOUT 38.5MCG DOSE).  PATIENT WAS CONTACTED AND TO DATE HAS HAD NO ADVERSE REACTIONS OTHER THAN A SORE ARM. REPORT OF EVENT WAS ALSO FAXED TO PATIENT'S DOCTOR FOR INCLUSION IN CHART.
This spontaneous report as received from a pharmacist via a company representative refers to two patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the doses of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On unknown dates, the patients experienced shingles. The outcome of shingles was unknown. The relatedness between shingles and ZOSTAVAX was not provided. Additional information has been requested.
Anthrax Vaccine started on April 3, 2000. Vaccine discontinued due to adverse reaction. (Joint Pain/Fever). Developed Ulcerative Colitis with symptoms noted as early as January 6, 2001. Also developed Obstructive Sleep Apnea, and Sleep onset Insomnia.  11/06/2008 MR received from GI consultant. Pt presented with bloody, mucusy stools up to 15xday. Placed on Prednisone with improvement. Dx:  Ulcerative colitis.  11/12/08 Records received from pt with vax info (no lot#s). Pt first presented 4/22/2001 with c/o 2 week hx of abdominal cramps and bleeding from the rectum.  PE (+) for abd tenderness. Assessment:  Internal hemorrhoids. Seen again 1/15/02 with c/o 8 mon intermittant hx of rectal bleeding. Guaiac (+) stool. Sent for GI consult. DX: IBS/ Proctitis. 4/30/08 OV for aphthous oral ulcers. Tinea cruis. RLL pneumonia 10/8/2002. In June 2006 presented with c/o snoring/gasping as well as difficulty falling and staying asleep. Dx with Sleep Disorder/ Primary Snoring vs Obstructive sleep apnea.. Snoring. Fattly Liver.
Patient complained of a salty taste in her mouth after the vaccination.  She has not been relieved from the salty taste.  Patient stated that she experienced a salty taste after the flu vaccine last year, which lasted about 8 months.
Sudden, unexpected hearing loss and tinnitus in right ear. No symptoms preceded this event it just happened suddenly. Called primary care physician, they recommended going to urgent care because no appointments available. Was seen on 7/20/21 and was prescribed 60 mg of prednisone (20 mg 3x a day) for 10 days with a follow up appointment with ENT. Appointment with ENT was on 7/29/21 and was preceded by hearing test that determined both eardrums were not ruptured and hearing loss at 8000Hz was noticed in right ear. Physical exam noted nothing significant so it was determined that tinnitus was nerve related. No further medications were prescribed and future treatment is follow up hearing test and exam on 8/26/21. Tinnitus is still ongoing at the time of reporting with symptoms unchanged since initial event.
patient came back to pharmacy about 2 to 3 hours after the vaccine, bp was high and wouldnt even register in the left arm.  as I was talking to her, and she answered back her speech slurred mid sentence.  we called 911, er dr seemed to think it was a panic attack and unrelated to the vaccine
Dob 9-16-10 dod 11-15-10 received ENGERIX B 9/18/10.
Pt here for 15 month check and well at time. Rash began 11/17/2005  on face, by noon rash head, neck, tummy. Seen and diagnoses as varicella at 6pm 11/17/2005. Fever to 104 on 11/22. No known exposure to disease. Pt was ill for 10 days with fever for 7 days.
Woke up with fever and chills approximately 14 hours later,  nausea and vomiting, blacked out.  Continued to have fevers for 2 days after along with massive headache and joint pain.  They should really put a warning that you will not be able to function the day following the shot.  I am reporting to further this push to have a warning for the shot.
48 hours after flu shot patient experienced arthritis-like joint pains - "doubled", fatigue, "bones aching" requiring laying down. Patient instructed to try TYLENOL. On Wednesday patient with urging admitted the symptoms were subsiding. She was angry and irate.
This spontaneous report was received from a licensed practical nurse refers to patients of unknown age and gender. Approximately on an unknown date in 2012 the patient was vaccinated with a dose of RECOMBIVAX HB (lot#, expiration date and route not reported). Improperly stored RECOMBIVAX HB had been administered to an unknown number of patients. The dates RECOMBIVAX HB were improperly stored were between 30-JUN-2012 to 24-JUL-2012 (exact dates of administration were unspecified). No adverse event reported. The office did not wish follow-up for a safety report. No other information to report. This is one of the several reports from the same source. Additional information is not expected.
Initial report received from a healthcare professional on 15 September 2014. A 74-year-old male patient, whose medical history and concomitant medication were not reported, received an intramuscular dose of FLUZONE HD (batch number, site and dose in series not reported) on an unspecified date. On an unspecified date 9 day after vaccination the patient had experienced severe weakness and decreased appetite for 2-3 days. Corrective treatment and laboratory investigations were reported as unknown. At the time of this report, the outcome of the events was reported as recovered. List of documents held by sender: none. Follow up information received from a physician on 27 April 2015. Patient's age at the time of event was 73-year-old, previously it was reported as 74-year-old. It was reported that, patient pre-existing, physician-diagnosed allergies, birth defects, medical condition were asthma and bronchitis (chronic) and other medication was valsartan. Patient had no vaccine within 4 weeks of vaccination, and corrective treatment and laboratory investigations were reported as none. List of document held by sender: none.
tingling in her throat; "funny sensation" in throat; woozy; pain in back; pain in lung when breathing; pain in lung when breathing; body inflammation on CAT scan; sore arm/body ache; headache; Her arm was also sore at the site of the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHARYNGEAL PARAESTHESIA (tingling in her throat), OROPHARYNGEAL DISCOMFORT ("funny sensation" in throat), DIZZINESS (woozy), BACK PAIN (pain in back) and PULMONARY PAIN (pain in lung when breathing) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included NORETHINDRONE ACETATE, MULTI VITAMINS & MINERALS and PRO BIOTIC BLEND for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PHARYNGEAL PARAESTHESIA (tingling in her throat), OROPHARYNGEAL DISCOMFORT ("funny sensation" in throat), DIZZINESS (woozy), BACK PAIN (pain in back), PULMONARY PAIN (pain in lung when breathing), DYSPNOEA (pain in lung when breathing), INFLAMMATION (body inflammation on CAT scan), MYALGIA (sore arm/body ache), HEADACHE (headache) and VACCINATION SITE PAIN (Her arm was also sore at the site of the injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Inflammation, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Inflammation, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Inflammation, at an unspecified dose and frequency. At the time of the report, PHARYNGEAL PARAESTHESIA (tingling in her throat), OROPHARYNGEAL DISCOMFORT ("funny sensation" in throat), DIZZINESS (woozy), BACK PAIN (pain in back), PULMONARY PAIN (pain in lung when breathing), DYSPNOEA (pain in lung when breathing), INFLAMMATION (body inflammation on CAT scan), MYALGIA (sore arm/body ache), HEADACHE (headache) and VACCINATION SITE PAIN (Her arm was also sore at the site of the injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: elevated (High) Test for blood clot was elevated. On an unknown date, Computerised tomogram: inflammation (abnormal) Inflammation all over the body.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date, prior to mRNA-1273, antibody test was positive.   This case was linked to US-MODERNATX, INC.-MOD-2021-085271 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-085271:Case for husband
Fever of 100.3 F, Severe Low Back Pain, Swollen/Sore Left Arm
Had a headache from 12-17-08 time given till Dec 28, 2008 almost (2 wks) also hoarseness same time.  Everything is ok now.
Uticaria, global and is still recurring  Requires Zyrtec over the counter
This spontaneous report as received from a physician refers to a female patient in her 60's. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed shingles and post herpetic neuralgia after receiving the vaccine. It was unspecified if the patient sought medical attention. No treatment information was reported. The outcome of shingles and post herpetic neuralgia was unknown. The relatedness for shingles and post herpetic neuralgia was not provided for ZOSTAVAX. Additional information has been requested.
Injection site urticaria. a physician reported that a child received an injection of Prevnar and subsequently developed a red welt at the injection site. Additional information received from the physician on 5/22/01 indicated that the child was a 2 yr old male. He recovered.
Pain in the arm; Itchiness; Very dizzy; Nauseated; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), PRURITUS (Itchiness), DIZZINESS (Very dizzy), NAUSEA (Nauseated) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No relevant medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN and METFORMIN HYDROCHLORIDE (GLUMETZA) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm), PRURITUS (Itchiness), DIZZINESS (Very dizzy), NAUSEA (Nauseated) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain in the arm) and PRURITUS (Itchiness) had resolved and DIZZINESS (Very dizzy), NAUSEA (Nauseated) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
vomiting; achy; sick; felt bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 01Apr2021 12:15 (Batch/Lot number: unknown) at the age of 68 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: VOMITING (non-serious), outcome "unknown", described as "vomiting"; PAIN (non-serious), outcome "unknown", described as "achy"; ILLNESS (non-serious), outcome "unknown", described as "sick"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt bad".  Additional information: Reporter reports her son was sick and he had to take off work. She reports he got sick vomiting at work and the next day he didn't go because he felt bad. He got sick at work, she's not sure of the exact date, maybe over the past weekend. He was also achy. She reports he feels ok now. Onset of AE was one week after receiving the Covid 19 vaccine. No prior vaccinations within 4 weeks and no AE(s) following prior vaccinations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed erythema, swelling warmth and pain on the left triceps area where Pneumococcal vaccine was given earlier in the day. 48 hours after the vaccination the erythema, swelling, warmth began expanding rapidly, went below the elbow. I was hospitalized and given IV Vancomycin.
(R) arm swelling, erythematous, tenderness around circumference of (R) upper arm.
I wake up around 1 AM with severe dizziness or Vertigo and a little nausea. Then, I walked downstairs and fell on the floor. Then, I walked upstairs and fell on the floor again. I had cold sweat. I called the nurse line and talked to them for about 15 minutes. Then, the symptoms passed.
Pfizer was administered at 07/30/2021 at 10:49 AM. At 10:52, patient began feeling lightheaded and dizzy. Vitals were taken 10:52 AM : Spo2: 98% Pulse: 58 BP 90/62 . Patient was assessed by Dr. and provided Gatorade for hydration and had patient inhale amonia inhalant as needed. Per Dr. monitored patient for 30 additional minutes. After 30 Minutes vials taken again at 11:30 AM  BP: 110/72 Spo2: 100%   Pulse :72, per Dr. advised patient to hydrate and advised to eat something since patient did not have breakfeast. Notified if symptoms persist may go to nearest emergency for further evaluation. Patient verbalized understanding and agreed.
Mid morning the next day started feeling pain in my left testical. Not a constant pain but enough to know it?s not normal.
Patient presents with numbness of tip of right thumb, extending into CMC joint.  Numbness is strongest felt at distal site of thumb joint. As it radiates towards right wrist, it begins to  lessen in severity. Patient is a healthcare provider as well. She did experience needlestick injury to this thumb resulting in keflex antibiotic for treatment, however problem ongoing prior to injury. She is concerned regarding this symptom as several staff members in her office are experiencing the same, as well as her father in law. Problem ongoing for the past three weeks. Patient was vaccinated five weeks prior to R thumb numbness.
Redness all over skin including huge patches of redness and raised hives from her neck down to her toes.
This spontaneous report was received from a medical assistant concerning a 8 months old patient. On 06-SEP-2012, the 8 months old patient was vaccinated with a dose of 0.5 milliliter VAQTA (25 U) (dose, route and lot number unspecified). No concomitant medications were reported. No symptoms were reported. Additional information has been requested.
Fever - 102 to: 103 degree F, nausea, vomiting, threw up yellow bite, dizzy - couldn't function for 2 days.
Chickenpox dx. on 7-21-07; rash began 2 days prior 7-19-07; fever 101.5 on 11-19-07; small raised bumps, no vesicles, on face, buttocks, and trunk.
RDT and hives happened and nurse reported to provider to give 1 1/2 tsp of Benadryl observed x50 min then treated with 20mg per mouth Prednisone, 5mg Zyrtec.
pt developed golf ball size swelling on left arm immediately following covid vaccine dose 1 administration. pt had minor bleeding after needle removed from pt, then blood pooled in the surrounding area to a golf ball sized lump. applied pressure to stop the bleeding, monitored swelling and provided pt with ice pack to reduce swelling. swelling decreased significantly during 30 minutes post administration. followed up with pt via telephone 2 hours post administration - pt said that swelling continues to reduce. no pain.
Local reaction to Pneumovax swelling, pain and increased warmth. Medrol dose pak given-ice.
A nonserious report of expired dose of vaccine administered has been received from a physician concerning a two-and-a-half year old female patient. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on an unknown date. The FluMist had expired on an unknown date. The reporter indicated that no adverse events have occurred since the time of the report. Rechallenge is not applicable to this adverse event. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Patient died on 6/24/2022 On June 24th, she was noted to become hypothermic.  She said that she was not feeling well, but did not give any focal symptoms.  She suddenly decompensated from a clinical standpoint and Code Blue was called.  She was found unresponsive, apneic, and pulseless.  CPR was performed.  Return of spontaneous circulation was achieved after 4 minutes.  She was given IV fluid and pressors were started.  She then went into another PEA arrest.  Return of spontaneous circulation was again achieved after about 4 minutes.  She did require intubation.  Workup revealed a market increase in her white blood cell count as well as drop in her hematocrit.  No obvious GI bleeding was noted.  There was also no obvious abdominal stigmata of intraabdominal bleeding.  Family requested DNR status.  She was given IV fluids and empiric antibiotics.  Stress dose steroids were added.  She was maintained on mechanical ventilatory support.
Diagnosed with Pericarditis Symptoms: Chest Pain, Abdominal Pain/Swelling, indigestion, Shortness of Breath Treatment: Ongoing as of 10/19/21, follow up Echocardiogram scheduled for 11/03/21
sore throat; cough; This is a spontaneous report from a contactable Consumer. A 49-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 25Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included mild covid-19. The patient's concomitant medications were not reported. On 01Mar2021 05:00, the patient experienced sore throat and cough. Patient reported to someone before speaking to you. She told me her name but patient forgot. They took all of the information from patient, she asked patient for the card that they gave her, but patient don't have it, it is in the car and her husband has it. Patient got the Pfizer shot on Thursday 25Feb2021. As of yesterday at 5am, she have had a sore throat, went away after couple of hours, have cough, no fever, no nausea, only have a cough. Patient asked whether these adverse effects from the vaccine because she usually baby sit her grandbaby, because she was not sure if it is a side effect or a cold. Maybe she caught it again, she had covid before, it wasn't like this, it was very mild. Upon follow-up on (02Mar2021), Patient reports that she took the Pfizer Inc, BioNTech COVID shot on Thursday, and now she had a really bad cough. Caller reports that she had no fever, no body aches, no nausea, so she was wondering if the cough could be a side effect of the vaccine. Coughing started yesterday early morning about 5am 01Mar2021. Patient had no other vaccines on the same day as her COVID vaccine. The outcome of sore throat was recovered and the outcome of cough was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recvd vax; t of 100+ w/ local rxn of swelling & redness; 24may93 f/u: recovered;
possible Atrial Fibrillation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (prev dose product=COVID 19,, prev dose brand=Moderna,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose dose number=2,), for COVID-19 immunization; Moderna (prev dose product=COVID 19,, prev dose brand=Moderna,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose dose number=1), for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "possible Atrial Fibrillation". The event "possible atrial fibrillation" required physician office visit. It was unknown if therapeutic measures were taken as a result of atrial fibrillation.  Clinical Course: The patient had received the Moderna COVID vaccine initially and then received the Pfizer vaccine as a booster. subsequent to receiving the Pfizer booster, patients apple watch detected possible Atrial Fibrillation. Patient went to see his cardiologist who confirmed he has Atrial Fibrillation but was not concerned as he was generally healthy. Doctor or other healthcare professional office/clinic visit.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.