chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had the same side effect from the Moderna COVID19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had the same side effect from the Moderna COVID19 vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had the same side effect from the Moderna COVID19 vaccine). At the time of the report, VACCINATION COMPLICATION (Had the same side effect from the Moderna COVID19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-265628 (Patient Link).   Reporter did not allow further contact
Patient developed headache within 24 hours of the vaccination.  The headache has persisted.  She then developed a mild erythema, mild edema, and pruritus of the palms of both hands 3 days after the vaccination.  Also has pruritus of both feet but no erythema.  No vesicles, ulcerations, or papules have developed.
Patient told me on 9/20/21 that she had redness around both shots, and then on the following day from getting the shot (9/16/21) she passed out while eating breakfast. The redness is now gone on her arm, and she seemed ok when she was here at the pharmacy.
sharp joint pain, swelling in knees and ankles, new pain in all joints including thumb sheath.  also swelling.    additional pain in neck, lower spine upper arms and legs. I thought it would go away but it seems to be getting worse.   additional inflamation also in knuckles of hands.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The health care professional (HCP) reported quite a few people had experienced flu like symptoms after SHINGRIX vaccine. This adverse event was captured during re-listening to the call, HCP did not provide additional details or number of patients. This case is linked with case US2018169157, reported by the same reporter.
Experienced pain at site of injection (left arm) immediately (as expected) but *pain continued at chronic low level for months* (not very impairing). Approx. 1 month ago, pain level increased quite a bit and extended throughout arm, radiating from site of injection. Became increasingly difficult to raise arm laterally and to put arm behind me (e.g., to put on coat). Pain has reduced somewhat in last week or so, but still impairs everyday activity.
2 hours after shot, he was short of breath - he said he need some oxygen - went to hospital - said pulse rate was too low 33-34. Was in hospital 3 days and pulse didn't go up. 6/19/09 Death certificate received. Cause of Death: Urosepsis-secondasry COD Dehydration, dementia, renal failure.
Information has been received from a pharmacist concerning a 54 year old male with a history of pneumonia (twice) and no drug reactions (allergies who on 10-DEC-2007 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot# unknown) IM (lot# 658449/0989U) IM. Concomitant therapy included influenza virus vaccine (unspecified) and (therapy unspecified) (ANAFRIL). On "11-OCT-2007" after being administered his first dose of pneumococcal 23v polysaccharide vaccine the patient developed fever and chills. The patient's arm was also sore and swollen. Medical attention was sought. The patient is currently taking ibuprofen hcl (ADVIL). At the time of reporting it was unknown if the patient had recovered. No further information was available. Additional information has been requested.
Severe headache; dull intractable headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jul2022 at 17:00 as dose 4 (booster), single (Lot number: FP7135) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "chronic migraine" (unspecified if ongoing). Concomitant medication(s) included: TECFIDERA; UBRELVY; ZOLOFT; BLISOVI FE 1/20; SEROQUEL. Vaccination history included: Covid-19 vaccine (Primary immunization series complete. , MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE , MANUFACTURER UNKNOWN), for Covid-19 immunization.  The following information was reported: HEADACHE (non-serious) with onset 05Jul2022, outcome "not recovered", described as "Severe headache"; HEADACHE (non-serious) with onset 05Jul2022, outcome "not recovered", described as "dull intractable headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, headache.  Additional Information: No other vaccine in four weeks. No COVID prior to the vaccination. No known allergies. Severe headache starting on 05Jul (four days post-vaccination). Since then, dull intractable headache most days for the last two weeks. Migraine abortives don't seem to help. OTC painkillers help temporarily. Prednisone seems to help temporarily. COVID test post vaccination: COVID test type post vaccination: Nasal Swab on 07Jul2022, COVID test result : Negative.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a registered pharmacist refers to a 83 year old male patient with allergic to vancomycin. The patient's medical history included heart condition. On 02-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000495, 14-APR-2014), 0.65 ml, subcutaneous. Concomitant therapies included fluticasone propionate, ADVAIR and SPIRIVA. On 02-MAY-2013, "within an hour" after vaccination, the patient experienced "raised spots on her face and experienced chills". No treatment was given. No lab was performed. The reporter called patient during the time of call and the patient's daughter reported that the patient's symptoms were "subsiding". The patient did not seek medical attention. The outcome of chills and raised spots on her face was reported as recovering/resolving. Additional information has been requested.
This study case was received from the investigator in a trial on 05 July 2013. A 20 year-old male subject with a past medical history of shortness of breath was found to have acute pericarditis unspecified 11 days after the subject had received the following vaccines on 08 July 2009: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM VI (lot number, route and site of administration not reported), and Anthrax I (manufacturer, lot number, route and site of administration not reported). Troponin I, ECG, echocardiogram, Lumbar puncture and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Patient's date of birth in our EHR was incorrect.  At the time of check-in, the information was verified and confirmed by the patient's parent.  In the exam room, the provider discussed that "at age 9, the patient can have the vaccine HPV" and the mother confirmed and agreed at that time to administer the vaccine.  The vaccine was administered along with the flu vaccine that requires a consent form to be signed, and on that consent form the mother had written the patient's date of birth which put the child under the age of which we would suggest the HPV vaccine.  The front desk person was asked to verify the date of birth again and the parent said the one on her form was the accurate year.  The correction was made in her chart at that point, but the vaccine was already administered.
Patient started to report feeling dizzy and light-headed about 10 minutes following the vaccination and tried to stand up when he nearly fainted. Patient was caught and gently lowered to the ground and then placed in a chair. About 20 minutes after vaccination EMT services arrived and checked patient vitals and found no irregularities. Patient was starting to feel better and around 30 minutes after vaccination the patient felt back to normal.
severe swelling, erythema, lymphadenopathy;rt deltoid site of inj of pneumococcal vax & flu vax w/fever & pain;
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021 at 11:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 11:51 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 37.37.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 08-Feb-2021, Excursion time was 10 AM, temperature was 29, Excursion time was 11 AM, temperature was 35, total doses given for the day was 30, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 02-Feb-2021, vial was moved to clinic on 08-Feb-2021. 03 vials were sent to clinic. Vaccine BUD date was 04-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Initial report received from a consumer (The patient) on 13 June 2013. A 45-year-old female patient had received an intramuscular first dose of ADACEL vaccine (batch number- unknown) in left deltoid on an unspecified date in 2010. The patient's medical history and concomitant medications were not reported. Three day after vaccination, It was reported that the patient's left arm was swollen with swollen with redness, pain and itchy at injection site. Laboratory investigations and corrective treatment was not reported. At the time of this report, outcome was recovered on an unspecified date. List of documents held by sender: none.
muscle weakness(generalized)  1/7/2021; This is a spontaneous report received from contactable other healthcare professional. This other healthcare professional reported different events with each dose of the same product; this case refers to dose 1. An 88-year-old elderly female received the first dose of intramuscular BNT162b2 (solution for injection; Lot EJI685 expiry information not provided) as a single dose in the right arm on 05Jan2021 at 14:30 (at 88-years-old) for COVID-19 immunization. History of previous allergies included codeine phosphate, morphine, HCL, peanuts, sulfites, and pethidine hydrochloride (DEMEROL). There were no concomitant medications reported. The patient did not receive any recent vaccines for any other conditions prior to the event; the patient did not receive any recent vaccines for SARS CoV-2 other than Pfizer BioNTech COVID-19 vaccine prior to the event; and the patient did not receive any recent vaccines around the time of Pfizer BioNTech COVID-19 vaccine. On 07Jan2021 the patient experienced muscle weakness(generalized). The outcome of the event muscle weakness(generalized) was unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021423227 PFIZER (Same reporter/patient/product, different dose/event)
Itchy, red welt on left arm at the injection site, about 2 inches in diameter.
Soreness and hard lump (approx 2.5cm diameter) at injection site two days after vaccination. Child was unusually fussy and would not sleep well. Treated with infant ibuprofen for pain relief. Third day after vaccination the child became letharhic and developed a 104F fever with head scanning thermometer, followed by a runny nose and very exaggerated muscle twitches (flailing arms, jerking body movements) in her sleep. Treated with ibuprofen as needed, which reduced fever and improved energy levels. Fever was ongoing for 4 days at the time of this report.
POST VACCINE PT STARTED TO EXPERIENCE HEADACHES. PT TRANSFERRED TO MED OBS VIA WC. PT REPORTS FEELING BETTER AFTER LYING DOWN AND DRINKING APPLE JUICE AND EATING GOLD FISH. VSS EXCEPT ELEVATED BP, HAS HISTORY OF. INSTRUCTED TO MONITOR ONCE HOME WITH AUTOMATIC BP CUFF. REPORTS BP INCREASES WITH HEADACHE. STATES WILL TAKE TYLENOL AND WILL SEEK FURTHER EVAL/TREATMENT IF WORSENS/PERSISTS. 1603 SITTING BP 161/106, HR 74, SPO2 97% 1610 STANDING BP 154/103, HR 80, SPO2 100%
Initial report received on 18/Aug/2006 from a nurse.  A 29-year-old male patient with no current illnesses had a received a dose of Tripedia, lot number U1857CC, in the right deltoid, on 14/Aug/2006 at 07:30 am.  The route of administration was not reported.  The manufacturer dose not recommend Tripedia in this age group.  Within hours of the immunization the patient experienced fever (Temperature unknown), chills, headache, muscle aches, and was unable to lift his right arm due to injection site pain and soreness.  The patient required medical evaluation but the treatment provided was not reported.  The recovery status of the patient was reported as recovered. The reporter for this case is the same as for case 2006-02200.
No adverse reaction: error-pt is 16yo and was given a full dose (0.5ml) of Moderna instead of Pfizer. Pt's mom has been contacted and plan is to vaccinate dose #2 with Pfizer 0.3ml
Had onset of fever (102 degree F), rash, dry heaves, sick to stomach and knot where immunization was given. Took BENADRYL on 11/10 for rash and it helped. Starting to feel better as of 11/10/17.
Body aches, joint pain, shaking, chills, cough, fatigue, shortness of breath on exertion
Patient reports feeling exhausted and very cold. She does not have a fever. Injection site is also very tender and sore.
Itching in left arm, upper shoulder, right arm; painful tiny pin  prick sensations; Rash; Unable to sleep; painful tiny pin  prick sensations; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 43SG5, expiry date 13th October 2023) for prophylaxis.   On 14th October 2022, the patient received the 1st dose of Shingrix .5 ml. On 16th October 2022, 2 days after receiving Shingrix, the patient experienced pruritus, pain, rash, sleeplessness and paresthesia. On an unknown date, the outcome of the pruritus, pain, rash, sleeplessness and paresthesia were recovered/resolved.   It was unknown if the reporter considered the pruritus, pain, rash, sleeplessness and paresthesia to be related to Shingrix.     Additional Information: GSK Receipt Date: 12 DEC 2022 Reporter's comment: Pharmacist reported a patient received her first dose of  SHINGRIX vaccine on 14th October 2022.  The patient was scheduled to receive her second dose of SHINGRIX on 10th December 2022. The pharmacist held off on administering the second dose because the patient described adverse effects from the first dose.  Two days after receiving the dose of SHINGRIX, the patient experienced itching in the left arm (vaccinated arm), then it moved across the upper shoulder to the other arm.  She also experienced painful, tiny pin prick sensations, a rash, and she was unable to sleep.  The reporter stated the patient experienced these events up until 1 week prior to her scheduled 2nd vaccination date.
Entire body pain (muscle ache); This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 03Jun2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and hypertension. Patient had no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), amlodipine besilate (AMLODIPINE), ibuprofen (MOTRIN) and glycopyrronium bromide, formoterol fumarate, budesonide (BREZTRI) on an unknown dates for unknown indications and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Jun2021 at 18:00, the patient experienced entire body pain (muscle ache). No therapeutics were taken as a result of the reported event. The clinical outcome of the event entire body pain (muscle ache) was not resolved at the time of reporting. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 24Jun2021 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unspecified date, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. On an unspecified date, the patient experienced an injury (NOS). The outcome of the event was not reported. Additional information has been requested.
product lot number issue; no symptoms or additional adverse effects reported; second dose in GARDASIL 9 immunization series was administered to patient past its expiration date; This spontaneous report has been received from a medical assistant regarding a 21-years-old patient of unknown gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.    On an unknown date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, lot # and expiration date were not reported) as prophylaxis. On 24-JUL-2020, the patient was vaccinated in the immunization series with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter once (reporter reported of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) with Lot # N026814 which was not valid for of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). However, lot # N026814 is valid for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), expiration date 15-JUL-2020) past its expiration date. No symptoms or additional adverse effects reported.
Irritable, not sleeping, low grade fever, rash. Have Tylenol as instructed by doctor. By Monday he was covered in a severe rash and brought him back to the doctor. They ruled out allergic reaction. Dr referred to a dermatologist who said it's a vaccine injury "Gianotti Crosti".
One day after receiving the PNEUMOVAX he experienced pain in his left shoulder which increased over the next 24hr. and he had mild swelling in lymph nodes in (L) axillary area. He also noticed a red path 4" x 6" in (L) triceps area. By the 3rd day post vaccination the red area was swollen, warm, very tender, and had spread below his elbow. It has gradually improved since. Extended armpit to 2" below elbow.
3 days after the vaccine booster in my Left arm, I woke with sudden Rt sided hearing loss.  Had audiogram done and compared to prior  done 3 years ago, with noted significant 30 dB low freq HL.  Also, significant increased tinnitus on the Rt.  Feeling of ear fullness on the Right.
myalgia; malaise; arm pain that lasted 24 hours; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, myalgia and malaise. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the myalgia and malaise were unknown.   It was unknown if the reporter considered the pain in arm, myalgia and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received both doses of Shingrix. He did not had any reactions with 1st dose. With 2nd dose, he reports, myalgia, malaise, arm pain that lasted 24 hours. He said it did not interfere with daily activities.
This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. Approximately on April 2015, the patient received first dose of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 12-JUN-2017, the patient received second dose of RECOMBIVAX HB lot# M027339, expiration date 31-MAY-2017 (dose and route of administration were not reported). No adverse effects reported. Additional information has been requested.