chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received TRUMENBA, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness on the application site on an unspecified date. The outcome of the event was unknown. Information on the batch number has been requested.
Moderna vaccine #1 given 3/11/21 2d later admitted Hospital Severe functional decline in rehabilitation that never improved to the point that patient was walking and smiling to requiring two person transfer within overhead lift system and needing extensive assist patient Recovered faster to her baseline from actually having Covid infection when was an ICU three months prior than she recovered from having that vaccine. Biological sister had the vaccine same manufacture the same day and was hospitalized the day before patient was. I've had elevated D dimer is both had shortness of breath both had wheezing and both individuals were patients of facility-which facility decline to attribute any possible changes in their baseline to the vaccine and/or minimized it and both individuals whom both had to go to a nursing home because they were too high needs to return to their group home setting safely. There were multiple abnormal lab values for inflammatory markers and elevated D dimer's that were actually high which was similar when the person had Covid infection three months prior-and their body acted as if they were reinfected with it or it got activated again and they did not recover as quickly as they did with the actual infection. This reaction was very minimized is any correlation to the vaccine and it was not communicated to the nursing home of this possible correlation and it wasn't documented on their dismissal summary on their records when they were sent to the nursing home and we did make sure that new team was aware of it. Both ladies were biologically related and had intellectual disabilities. Similar symptoms within 24 hours requiring both to be hospitalized and both had the Moderno vaccine the same exact day.
Chills, fatigue, body aches, headaches for first 24 hrs (similar to previous doses of pfizer- stayed earlier but slightly less severe as previous doses).  After 24 hrs this symptoms resolved but now hot flashes sporadically throughout day and night. Possibly decreasing in frequency now.
This is an initial spontaneous report by a contactable nurse. This nurse reported a currently 5-year-old female child who was previously administered four doses of PREVNAR on unknown dates, site and time of administration. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day were unknown. Vaccines taken within the last four weeks were unknown. On an unknown date it was reported that PREVNAR did not work, which she explained as it was not effective. It was unknown if the patient had any siblings. Relevant lab data was unknown. At the time of the report the clinical outcome of the above event was unknown. Follow-up (06Dec2011): Follow-up attempts completed. No further information expected.
Patient stated that she was very fatigued, went to bed at 8:00 PM on the 17th, slept most of the 18th, and 4 hour nap on the 19th. Upper left arm is red, swollen and warm to touch.
Staff member received her 2nd dose on Mon 2/8 at 8am. She woke up on Tues 2/9 with a pounding headache / migraine that would not go away. She went to her MD office on Wed 2/10. As of Thurs 2/11, the migraine still persisted.  Her MD has decided to keep her out of work until Mon 2/15.  She does not have a history of migraines.
Redness, itching, swelling, and mild pain at the injection site that didn't appear until 9 days after the injection.  Redness and swelling was about 2 inches in diameter. Symptoms improved with topical analgesic and resolved within 2 days.
4-19-19 Had Shingrix #2 @ 9AM. Then between 7-8 PM chills, increased fever nausea felt like going to pass out face edematous flushed felt "like run over by truck " the whole next day". Took OTC. meds. Thrus "felt entirely different no SX".
Since receiving my first Moderna vaccination, I have been itchy all over my body.  I do not have a rash and my skin is not dry, it's just itchy.  I have taking Benedryl and applying Cortisone cream to help with this.  I am scheduled to get my second vaccine in 2 days.  Should I proceed with this?
Pt received tetanus injection on 04/07/03. He presented today with erythema, bruising, tenderness on left deltoid about size of softball. Referred to MD for follow-up treatment and recommendations.
She got a rash in the arm where she was injected. She went to her doctor where she was treated for the rash. The rash disappears and comes back again.
Mom called - took child to patient to doctor and the doctor told her to call health department to report adverse reaction. Mom states child's right arm began to swell and get red after a bath about 20 hours after immunizations. Mom states it is the child's right arm - "the one with 2 vaccines." Our records indicate DTaP, IPV given on left arm. States it is swollen from shoulder to elbow doctor put her Cephalexin and told the mom it was an "allergic reaction". Mom is using ice pack, Tylenol, Ibuprofen. Denies fever or other s/s.
Seen 12/31/03 at our office with attenuated varicella. Pruritic, vesicular rash on pink base of face, scalp, trunk, extremities.
Fever 102.5, body temp drop before fever to 97. Excessive crying 2+ hours after vaccines. Fever with acetaminophen 99. Decreased appetite.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild.
Case number PHEH2016US008633, is a spontaneous report initially received from a nurse on 05 Apr 2016. This report refers to a 17 years old female patient. Medical history and concomitant medication were not reported. The patient (under the age of 18) was vaccinated with FLUCELVAX (batch number: 174087A) on 10 Oct 2015, intramuscularly instead of FLUARIX (batch number: 9JX2N, expiration date: 16 Jun 3016) as the patient was supposed to receive FLUARIX. No adverse event was reported following this mal administration. Follow up report received from a nurse via fax on 22 Jun 2016: Added co suspect vaccine (FLUARIX, batch number and expiry date), event wrong drug administered and deleted the event inappropriate age at the time of vaccination.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Lot number: EK5730), on 02Feb2021 as dose 2, single (Lot number: EN5315), in left arm, on 01Dec2021 as dose 3 (booster), single (Lot number: 3303050), in left arm and on 22Jul2022 as dose 4 (booster), single (Lot number: FP7135), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos disease" (unspecified if ongoing); "Granuloma Annulare" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: Rebound of COVID infection. Positive test and symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19 (treatment with PAXLOVID).; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drugs BNT162B2 and BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded. The case will be reassessed once new information is available.
received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 30-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  Date of refrigeration of vial is 07-MAY-2021.
Localized swelling to an area of 10 x 7cm on the right lateral thigh. Erythematous. Warm to palpation. Swollen. No breathing difficulties. Treatment recommended Benadryl, cold compresses, Tylenol for fever or discomfort. Recheck in two days on Monday.
This case was reported by a pharmacist via call center representative and described the occurrence of joint infection in a adult female patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced joint infection (serious criteria GSK medically significant). On an unknown date, the outcome of the joint infection was unknown. It was unknown if the reporter considered the joint infection to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. In 2015, the patient received the BOOSTRIX. The patient reported as result of the vaccine being administered intramuscular, she developed an infection in her shoulder. The pharmacist wanted information about the BOOSTRIX vaccine. The patient was transferred to medical information (MI).
FLUZONE QIV HIGH DOSE was administered to a 20 year old patient today with no reported adverse event; Initial information received on 05-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 20 years old female patient to whom INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Oct-2022, the patient received 0.7 ml dose, once (1x) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE ( lot UJ917AD, exp date: 30-Jun-2023) via intramuscular route in the left deltoid for immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Approximately 5 hours after vaccination pt experienced Double vision, Dizziness, Nausea, Headache and "Racing Heart". Pt called Health Dept and was referred to PMD. Pt states PMD diagnosed "viral syndrome" and prescribed Naproxen.
Felt like she was drowning; Fever; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Felt like she was drowning), PYREXIA (Fever) and MYALGIA (Sore arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt like she was drowning), PYREXIA (Fever) and MYALGIA (Sore arm). At the time of the report, FEELING ABNORMAL (Felt like she was drowning), PYREXIA (Fever) and MYALGIA (Sore arm) outcome was unknown.        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 concomitant medications were reported. Treatment information was not provided by the reporter.
He got the vaccine on a Friday, and felt sore after. On Monday he still felt pain on his back, but thought it was because of the vaccine.  He also felt warm and itchy on his back and under arm as well. It started as a small patch that looked like a rash, and was very painful and itchy. By the end of the week he decided to go to the doctor because he couldn?t take the pin anymore and it was spreading and blistering.  He was given Ibuprofen, and acyclovir ointment. The second visit on April 5th they gave him Gabapentin 100 mg.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), HEADACHE (Severe headache) and FATIGUE (Tired) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN (Achy), HEADACHE (Severe headache) and FATIGUE (Tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Achy), HEADACHE (Severe headache) and FATIGUE (Tired) outcome was unknown.        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 concomitant medications were reported.
One week after the 1st Moderna shot, I noticed a small red mark on my upper left arm where I got the shot, about the size of my pinky. The next day, it had grown. It continued to get larger and while the edges were fairly distinct at the beginning, as it grew, the edges got more and more faded. It was warm to the touch and a little bit itchy at times. I took antihistamines for a few days and also used a benadryl gel topically on my arm. After about 5-6 days, it had faded completely. It did not hurt, and I felt fine the whole time, just had a hive. At its largest, it covered most of my outside upper arm.
nausea  vomiting and painful flush feeling in chest and extremes.  improved after vomiting but  nausea and flush feeling persisted for 3 hours
Hospitalization for Covid exacerbation on dates 6/27/22- 7/6/22. Treated with dexamethasone, ascorbic acid 1000mg daily, zinc sulfate 50mg daily
burning pain on thigh; Burning pain on left side of the body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (burning pain on thigh) and PAIN (Burning pain on left side of the body) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (burning pain on thigh) and PAIN (Burning pain on left side of the body). The patient was treated with ENOXOLONE, GLYCOL SALICYLATE, LEVOMENTHOL, TOCOPHERYL ACETATE (SALONPAS 30) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (burning pain on thigh) and PAIN (Burning pain on left side of the body) outcome was unknown.            No Concomitant medications was reported
PT HAD YELLOW FEVER VACCINE LT UPPER ARM ON 6/6/13. WAS HAVING A REACTION AT INJECTION SITE ON 6/7/13. HIVES APPEARED ON LT ARM IN AM ON 6/8/13 AND HIVES APPEARED ON RT ARM. PT GIVEN BENADRYL.
Information has been received from a physician and the office manager concerning a 19 week old female patient who on 17-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of (PREVNAR) by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Patient received TDAP injection on left deltoid on 10/14/10 and came back to flu clinic 10 days later to show reaction to vaccination. TDAP site noted marked redness around injections site. Patient stated that 2 days after vaccination upper arm was very red, swollen, also with itchiness around and below injection site. Patient did seek medical attention when symptoms initially started. According to pt. symptoms were better when she came to the flu clinic to complain.
Information had been received on 10-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a patient of unknown age and gender was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 16-JAN-2013 at a family health facility/physician's office, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 16-MAY-2016, the patient was at the family health facility/physician's office for a painful rash that was diagnosed as shingles. On or about 25-MAY-2016, the patient was treated at the same facility for a worsening residual condition of postherpetic neuralgia. On or about 05-AUG-2016, the patient was treated again at this facility for continued and painful postherpetic neuralgia. The patient was prescribed "FAMIR" (It is unclear if this is FAMVIR), NEURONTIN, STADOL, PHENERGAN, and TORADOL injections for management of these painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Pain; Dry mouth; Chills; Body aches; Headache; fever was 103F; Feeling a bit nauseated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), DRY MOUTH (Dry mouth), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), ATENOLOL, PRAVASTATIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN (Pain), DRY MOUTH (Dry mouth), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache), PYREXIA (fever was 103F) and NAUSEA (Feeling a bit nauseated). At the time of the report, PAIN (Pain), DRY MOUTH (Dry mouth), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache), PYREXIA (fever was 103F) and NAUSEA (Feeling a bit nauseated) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Body temperature: 103 (High) 103.         On an unknown date, patient's temperature was reported as 99.3.  No corrective treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: Added vaccine's dosage detailsand patient's lab data.
The pt experienced a few pox on abdomen, back and behind right ears. Treated with Benadryl for 24 hours.
Rash appeared on Sat. Diagnosed as shingles on Tues morning. Flu like symptoms, no fever no chills. Treatment: rx Valtrex 1000, 1 ev 8 hrs for 7 days.
Menstral cycle changes heavier and more frequent.; Menstral cycle changes. heavier, and more frequent.; Menstral cycle changes.; This is a spontaneous report from a contactable nurse, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 21Dec2020 at 15:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The medical history included asthma, hypothyroid and allergy to tree nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included venlafaxine hydrochloride (EFFEXOR), fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride(ZYRTEC) and levothyroxine sodium (SYNTHROID), all from unknown dates for unknown indications and unknown if ongoing. On an unknown date in Feb2021, the patient's menstral cycle changed, became heavier and more frequent. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstral cycle changed, heavier and more frequent were resolved with sequelae on an unknown date in 2021.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
On unspecified dates, the subject received the 1st and 2nd injections of Hep-B vaccine (mfr unk). Subsequent to the 2nd injection of Hep-B, the subject experienced an exacerbation of multiple sclerosis. The Hep-B immunization series was discontinued. Additional info was received from the spouse on 11/8/02. He stated that he considered the exacerbation of multiple sclerosis to have resulted in "severe or permanent disability". He considered the event to be possibly related to "Hep-B and Hep-C vaccination". As of 11/8/02, the exacerbation of MS had "improved".