chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Progressive soreness in L.shoulder area/frozen shoulder; The range in my L arm, trying to lift, is noticeably restricted- by severe pain?; Sore arm/L arm sore; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 09:00 (Lot number: FF8829) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Spinal stenosis" (ongoing), notes: Onset date: 5 Years ago, Pertinent details: Micro Discectomy 2017, 2021; "radiculopathy" (unspecified if ongoing); "Lumbar stenosis" (unspecified if ongoing); "Neuropathic pain" (unspecified if ongoing). Family history included: "HTN" (ongoing), notes: Onset date: Years ago, both parents; "Hypercholestemia" (ongoing), notes: Onset date: Years ago, both parents; "Myocardial infarction" (unspecified if ongoing), notes: Both parents CAD. Concomitant medication(s) included: INFLUENZA, administration date 16Sep2021; CYMBALTA taken for neuralgia, spinal stenosis (ongoing); GABANTIN taken for neuralgia, lumbar spinal stenosis (ongoing); DILTIAZEM taken for hypertension (ongoing); CALCIUM; ASPIRINE 325 MG. Past drug history included: Thimerosal preservative, reaction(s): "Frozen shoulder"; Sulfa, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FJ1685, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 18Dec2020, when the patient was 75 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL32489, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 08Jan2021, when the patient was 75 years old, for Covid-19 immunization; Influenza shot (I had a frozen shoulder many years ago when Influenza shots contained Thimerosol preservative), for Immunization, reaction(s): "frozen shoulder". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Sep2021, outcome "not recovered", described as "Sore arm/L arm sore"; ARTHRALGIA (non-serious) with onset 30Sep2021, outcome "not recovered", described as "Progressive soreness in L.shoulder area/frozen shoulder"; MOVEMENT DISORDER (non-serious) with onset 30Sep2021, outcome "not recovered", described as "The range in my L arm, trying to lift, is noticeably restricted- by severe pain?". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, movement disorder. Additional information: Prior to vaccination, the patient was not diagnosed with COVID19. Since the vaccination, the patient had not been tested for COVID-19. Hospitalization was not prolonged. Within 48 hours after receiving 3rd (booster) vaccine in left arm, patient experienced events. patient had similar experience years ago 2/2 preservative in Flu shot. Patient have learned Pfizer covid vaccine also contains preservative (different ones). Patient wonder if current soreness is reaction to that.  Follow-up attempts are completed. No further information is expected.
vial that had been punctured 1-2 days before; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial that had been punctured 1-2 days before) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 04-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial that had been punctured 1-2 days before). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial that had been punctured 1-2 days before) 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 treatment reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Non-significant follow up: Source Document attached
noticed a sensation of a film over my eves.  L eye is fine (11/6) but R eye feels like there's a contact lens in my eye.  seems to be resolving.  No treatment.  Is wondering if this is a potential side effect
Still have pain in my arm at the point where the vaccine was given; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party (BIONTECH SE). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, 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: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Still have pain in my arm at the point where the vaccine was given". The event "still have pain in my arm at the point where the vaccine was given" required physician office visit.  Additional information: The patient was vaccinated two doses in 2021. She still had pain in her arm at the point where the vaccine was given. When she went to the doctor, they did not know why and there was no solution.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  BNT162b2 is under agreement with BIONTECH SE.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300104500 same patient, drug, event, different dose;
CANCER; This spontaneous report received from a consumer via a company representative via media concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case.  On an unspecified date, the patient experienced cancer (new cancer diagnosis). It was reported that "anyone with a brain, didn't get the vax. I begged my hubs not to get it and now has a new cancer diagnosis". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cancer was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221223430.; Sender's Comments: V0: 20221223452-cancer. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Agency Causality is considered indeterminate. The company causality is considered unassessable.
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 25-FEB-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 2.5 ml, five dose vial, (lot number J004332, with an expiration date of 26-SEP-2014) (route and anatomical location of administration were not reported) that was improperly stored. The lowest temperature excursion was of 32 degree Fahrenheit (F) (0 Celsius) for a total of 72 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
pt recvd vax;pt unable to suck,difficult feeding;infant v;seen by MD 18oct where pt became pale,LOC;to hosp x 2 days;EEG neg,as of 12oct occasional difficulty sucking;
PATIENT REPORTS 60 TO 64 HOURS AFTER VACCINATION HE DEVELOPED A RASH FROM FEET TO NECK ALL OVER BODY. FACE WAS NOT INVOLVED. NO ITCHING; JUST REDNESS. HE TOOK ONE DOSE OF CHLOR-TRIMETON AND RASH RESOLVED WITH TIME. **THIS WAS THE BOOSTER DOSE TO PRIMARY SERIES WITH ONE SHOT OF J&J**
pt presented to ER w/refusal to walk, ataxia, devel sz;required intubation during hosp;CT scan cerebral edema, herniation, death;
After pt properly screened and identified, at 1120 AM anthrax #2 was administered IM to the left deltoid.  Within 20 seconds the patient began to feel "funny", pt was offered to lay down and help was called. Within 5 seconds:  Pt inspirations were prolonged, strained (stridorous), with intermittent gasping.  Simultaneously pt color went from pink to red then bluish purple and stopped breathing and lost conciousness; pt upper extremity musculature became rigid and exhibited rythmic jerking motions as observed with seizure activity lasting approximately 15 seconds accompanied by observation of pt eyes rolled back into head while open with only the whites visible. (Epipen administered immediately by LPN when pt was moved to the floor in a lying position 0.5 ml to the left thigh LOT 8EM563 Exp March 2010).  Pt respirations observed to improve to slightly labored approximately 30-45 seconds after administration of EPI.  Pt observed to have marked palor and be diaphoretic.  At approximately 11:22:34 pt transported via gurney to MAC-D by 2 doctors and 2 nurses.  Pt had emesis x 1.
Information has been received from a physician concerning a male patient who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # not provided). The physician reported that the patient developed shingles in their mouth after the vaccine. Subsequently the patient experienced shingles in mouth after vaccination. The patient sought unspecific medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a physician concerning a male patient who was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not provided).  The physician reported that the patient developed shingles in their mouth after the vaccine.  Subsequently the patient experienced shingles in mouth after vaccination.  The patient sought unspecific medical attention.  Follow up information was received from an other health professional concerning the 75 year old male who on 28-FEB-2008 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot number 658082/0744U).  In July 2008, the patient developed shingles in the back area below shoulder.  The patient gave history but was not evaluated for shingles in reporter's office.  Rash occurred at the site of injection or elsewhere within 42 days of the vaccination.  The patient was not exposed to chickenpox or herpes zoster prior to acquiring herpes zoster.  No photo was taken.  The patient was recovered.  It was also reported that the patient's vaccination history included: a dose of FLUZONE on 22-OCT-2008 given intramuscularly in the right deltoid; a dose of PNEUMOVAX 23 on 13-OCT-1998, and intramuscularly in the right deltoid on 22-OCT-2008; a dose of DECAVAC given on 25-JAN-2008.  No further information is available.
Chest congestion; Injection site was now red and warm; njection site was now warm; Flu-like symptoms; Head cold; Runny nose; Fever; Little red spots on his back; head congestion; arm was a little sore; This case was reported by a consumer via call center representative and described the occurrence of lower respiratory tract congestion in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 12 days after receiving Shingrix, the patient experienced lower respiratory tract congestion, injection site erythema, injection site warmth, influenza-like symptoms, head cold, runny nose, fever, red spotty rash, head discomfort and pain in arm. The patient was treated with guaifenesin (Mucinex) and paracetamol (Tylenol). On an unknown date, the outcome of the lower respiratory tract congestion, influenza-like symptoms, head cold, runny nose and fever were recovered/resolved and the outcome of the injection site erythema, injection site warmth and pain in arm were unknown and the outcome of the red spotty rash was recovering/resolving and the outcome of the head discomfort was not recovered/not resolved.   It was unknown if the reporter considered the lower respiratory tract congestion, head cold, runny nose, fever, red spotty rash, head discomfort and pain in arm to be related to Shingrix. The reporter considered the injection site erythema, injection site warmth and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comment: The case was reported by the patient. He stated that, he got the Shingrix shot (on an unspecified date).  He did not specify if it was Shingrix shot 1 or Shingrix shot 2.  Where he received the shot (in the arm), it was a little sore, no big deal. About 12 days later, he developed flu-like symptoms including head-cold, chest congestion, fever, and runny nose.  At the time, he did not associate these events with Shingrix.  He took total 4 covid tests and all were negative.  After the symptoms persisted, he called his primary care doctor who advised him to take Mucinex and Tylenol.  About 5 days of having the flu-like symptoms, he looked at the mirror and saw that the injection site was now red and warm (previously it was not).  He called the place where he got the injection and they told him to come in so they could look at it.  While there he described his flu-like symptoms and the doctor there indicated that he thought that all his symptoms (flu-like symptoms and injection site redness/warmth) were due to the Shingrix vaccine.  The flu-like symptoms had resolved except for he still had some head congestion but he did not know if that was due to allergies. He also mentioned that, he experienced little red spots on his back but most of it was pretty much gone at the time of reporting. He did not have the lot number of the suspect vaccine.  He did not have/would not provide the phone number of where he received the vaccination.  Additional Supportive Information: The follow up would not possible as no contact details were available.
According to hospital records, patient presented to the ER in full cardiac arrest with ongoing CPR in progress.
SUSPECTED CLINICAL VACCINATION FAILURE; BACK PAIN; SUSPECTED COVID-19 INFECTION; SINUS; This spontaneous report received from a patient concerned a 61 year old female. Initial information was processed along with additional information received on 03-AUG-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies, drug abuse or illicit drug usage. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the patient started feeling or having sinus, sore throat, chills and fever. The patient also had a headache that was really bad and was having body aches. The patient stated that the symptoms are like waves they come and go and also back hurts really bad. The patient had Tylenol and Advil for symptoms. The patient had contacted the physician and planned to receive infusion as patient was asthmatic. The patient was tested positive for covid-19 and test type was nasal instant test. The patient believed that it was the delta one. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sinus, suspected covid-19 infection, suspected clinical vaccination failure and back pain was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000188105.; Sender's Comments: V0:20210803371-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
cold sore/sore; lip started to feel uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included imiquimod (Imiquimod Cream) cream for product used for unknown indication.   On 15th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Imiquimod Cream at an unknown dose and frequency. In September 2020, between 1 and 3 weeks after receiving Shingrix, the patient experienced cold sores and lip discomfort. The action taken with Imiquimod Cream was unknown. On an unknown date, the outcome of the cold sores was not recovered/not resolved and the outcome of the lip discomfort was unknown.   It was unknown if the reporter considered the cold sores and lip discomfort to be related to Shingrix.  Additional details were reported as follows: The patient developed what she thinks might be a cold sure approximately a week and a half ago from  the reporting day. The patient described it as the lip started to feel uncomfortable. The patient was was using a Imiqmod cream on her face following the vaccine and was not certain if that might have caused the sore. It was unknown if the reporter considered the cold sores and lip discomfort to be related to imiquimod. The reporter consented to follow up.
Information has been received from a physician concerning a patient "over the age of 60" who on an unspecified date was vaccinated SC with a dose of Zostavax. Within five days of being vaccinated, the patient developed shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
THE PATIENT INDICATED THAT SHE EXPERIENCED SEVERE PAIN IN HER LEFT ARM THE EVENING AFTER RECEIVING THE SHINGRIX VACCINE. SHE WAS TAKEN TO THE HOSPITAL AFTER BECOMING DIZZY LATER THAT NIGHT. SHE WAS ADMITTED TO THE HOSPITAL AND IS STILL BEING TREATED AT THE HOSPITAL. THE PATIENT INDICATED A POSSIBLE INJECTION SITE INJURY.
About 3PM shot given (on 2/21/2012). About 8PM - Adverse event headache, eyes swell, aches, stuffy nose, dizzy, tight throat, chills.
No adverse effects reported; Patient received unspecified dose of RECOMBIVAX that was improperly stored.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions and allergies were not reported.  On 18-MAR-2019, the patient was vaccinated with an improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot number: R012001, expiration date: 06-NOV-2020), intramuscular for prophylaxis. Administered vaccine was stored in a temperature of 50.1 degrees Fahrenheit (F) for 1 hour and 55 minutes, and below 36 degrees F for 290 minutes. There was a previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Atrial fibrillation; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient came down with A-fib (atrial fibrillation) a week after receiving the vaccine. The patient had the vaccination a week prior to going into the hospital. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Intermittent shooting pains in left arm shoulder to wrist. Continued for 2 months, ongoing although less frequent. TYLENOL, ALEVE Rx.
COVID LIKE SYMPTOMS, RUNNY NOSE, LOSS OF TASE AND SMELL, SHORTNESS OF BREATH, NAUSEA/VOMITING, STOMACH HURTS
Fatigue      x3 days. generalized weakness     Patient presents via EMS with complaints of syncope with collapse. Patient states that for the last 3 days he has been feeling fatigued and has been diaphoretic and not feeling well. Patient states this morning he did have a syncopal episode. Patient denies falling or hitting his head. Patient denies chest pain, shortness of breath, or abdominal pain. Patient denies any sick contacts at home. No current nausea or vomiting. No other complaints.         Review of Systems  Constitutional: Positive for chills, diaphoresis and fatigue. Negative for fever.  HENT: Negative for congestion, ear pain and sore throat.   Eyes: Negative for discharge and redness.  Respiratory: Negative for cough, shortness of breath and wheezing.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Negative for abdominal pain, constipation, diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria and frequency.  Musculoskeletal: Negative for back pain and myalgias.  Skin: Negative for rash.  Neurological: Negative for dizziness, seizures and headaches.
she has arm pain after receiving covid vaccine; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient called because she has arm pain after receiving covid vaccine and she wanted to know if she can take tylenol for the pain. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Rash Narrative:  Developed ~ 1x3in ovoid rash over injection site 1-2 days afterwards. Area took another 2 days to resolve. Described as warm, erythematous, and associated with minimal induration. No associated pruritis. Low dose hydrocortisone was applied to area. No other therapies tried or adverse effects reported.
3/26/2021   Ms. was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  TINGLING TO TONGUE AND LIPS, SHE REPORTS THIS HAPPENED WITH 1ST DOSE AND PREMEDICATED HERSELF WITH BENADRYL 25 MG .   Assessment : Time of assessment 1215PM. Alert and oriented.   Actions taken:  VAERS form obtained and completed.       Medications administered: Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 1215. Administered by RN.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/26/2021 11:58 AM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc
I've lost about 50% of my sense of touch or feeling in my hands within 2 weeks of vaccination March and it has not returned.