chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Generalized nerve pain; Relapse of  fibromyalgia; relapse of fibromyalgia; This is a spontaneous report from a contactable consumer, the patient. A 50-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 left arm on 02Apr2021 at 19:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 07:30 the patient experienced generalized nerve pain and relapse of fibromyalgia. The events did not result in doctor or other healthcare professional office/clinic, 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 events generalized nerve pain and relapse of fibromyalgia were not resolved at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Covid19 breakthrough.  1st vaccine received on 03/04/2021.  74 y/o PMHx of sacral ducubitus ulcer, HTN, CHF, HLD, Prostate CA, Afib, Pacermaker, DM type 2, Covid PNA presents to ED with c/o increasing SOB, low O2sats, fevers, and severe buttock pain.  Pt states was diagnosed with Covid19 2 weeks ago and was doing well on his usual 2L NC until yesterday when O2 sats dropped and oxygen increased to 5L NC.  Pt febrile.  CXR no acute findings.  Started on IV Abx.
Immediately after receiving vaccination I saw a red mark with tiny raised red dots on it approx. 5 inches down from the injection site.  I told the nurse and she had doctor look at it and he said not to worry about it.  However, as the day went on my entire left arm turned red.  I went to my primary care doctor the next day and he told me to ice it and put lotion on it.  The redness is going away 3 days later however I can still feel the dots under the skin . They are not painful.
CHIEF COMPLAINT:   pt c/o general weakness and diarhrea for last week. denies any fever.   HISTORY OF PRESENT ILLNESS:     89-year-old female with history of hypertension, normally able to fully care for self, comes to the ER for evaluation of generalized weakness, diarrhea nausea vomiting and fatigue.  No history of renal injury in her lifetime.  Patient has been vaccinated against COVID-19.  Mild abdominal pain.  Patient says that she has felt so weak at home due to the diarrhea that she has been unable to do that today.
No immediate sequelae but did have erythematous patch on anterior thigh approx. 6x8cm in size.
Given DTap/Hib/IPV and HebB/Hib- no sx
PATIENT CALLED IN PHARMACY ON 09/15/21 AND COMPLAINED THAT SHE HAS SORE THROAT,COUGH,AND CHEST PAIN AFTER GETTING COVID-19 PFIZER AND FLUARIX SHOTS ON 09/14/21. I TOLD PATIENT TO GO TO CLINIC.
Chills and headache. BP 107/67, 96 OSat, supine positioning. Resolved.
Case number PHEH2013US008455 is an initial spontaneous report received from a nurse on 11 Apr 2013 with a follow-up received on 29 May 2013: This report refers to a 6-month-old female patient. Her medical history and concomitant medications were not reported. It was reported that she was inadvertently vaccinated 0.5 ml intramuscular dose of MENVEO (batch number: A11076, expiry date: Apr 2014) on 10 Apr 2013. On the same day she was also vaccinated with PEDIARIX (other manufacturer, batch number: unknown) at 0.5 ml into the left thigh, along with PREVNAR 13 (other manufacturer, batch number: unknown) at 0.5ml in to the right thigh and with rotavirus (other manufacturer, batch number: unknown) at 2ml orally. After vaccinations, her mother brought her back to the clinic on 12 Apr 2013, for a follow-up checkup and reported some irritability and sleepiness. The events subsided on an unknown date. Mother was instructed to bring the patient back to the clinic if there was any change in patient's mental status, abnormal behavior, irritability and fever. Follow-up received from the physician on 29 May 2013: Updated patient demographics, co-suspect vaccinations, event (irritability and sleepiness) and outcome.
Within 72 hrs urticarial periorbital edema morbilliform rash myalgias.
18Mar I had a POSITIVE PCR test for Covid 19; 18Mar I had a POSITIVE PCR test for Covid 19; This is a spontaneous report from a contactable consumer (patient), received Pfizer-sponsored program. A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in right arm on 24Feb2021 17:45 (Lot number and expiration date was not reported) at single dose, first dose via an unspecified route of administration, administered in Left arm on 03Feb2021 17:00 (Lot number and expiration date was not reported) at single dose for Covid-19 immunization. The patient's medical history included obese and high blood pressure. The patient's concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), and metoprolol. On 18Mar2021, the patient had a positive PCR test for Covid-19.  The patient did not received treatment for the events. There is a high likelihood it will be the (Country Name) Variant from (Name). The patient caught it from a (Country Name) whose roommates friends had just come back from that region. The patient underwent lab tests and procedures which includes PCR test for Covid 19: positive on 18Mar2021 . The outcome of the events was unknown.  Information on the lot/batch number has been requested.
PATIENT RECIVED THE DATP, IPV, PREVNAR, ROTATEG #1,AND HEPB AT 7 WEEKS OLD. AFTER THE VACCINA  TION SHE WAS SLEEPY FOR 7 DAYS. HER APPOTITE WAS NOT CHANGED BUT I HAD TO WAKE HER UP FOR HER BOTTLE. AFTER EXACTLY 7 DAYS SHE CAME BACK TO NORMAL R0UTINE. I THINK SHE HADE A ABNORMAL REACTION THAT CALLED "MARKED INCREASE IN SLEEPING TIME"
Swelling in left arm through forearm, pain and tenderness as well as warm to touch. patient had no other complaints, no redness. Onset 9/26/16 in am Pt came in 9/30/16 approx 9:30am. MD office notified and Pt was prescribed MEDROL dosepak.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 09:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 49 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25May2022 as dose 4 (booster), single (Lot number: FM9992), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing), notes: both genetic: good diet and lifestyle, BMI 20. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body mass index: 20; Daily tests: antigen band is much stronger than in the original; SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies. Patient took Paxlovid (Lot number: GF4023) from 07Apr2023 to 11Apr2023 for treatment of COVID-19.  Based on investigation result conclusion: This is a daily notification generated from the RA system. As part of the simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the One and Done business process according to in PQS Q1215 and/or Q1252. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9694. The final scope was determined to be the associated lot(s) of the reported lot FM9992. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300161782 same reporter/patient, different product/event.;US-PFIZER INC-202300161869 Pfizer (Invalid);
Approximately 12/14 or 12/15/03 onset numbness of right side (arm and leg). Numbness in R arm gradually resolved. Numbness extended to L leg. Pt experienced sensory changes including dragging leg. Increased weakness. MRI showed inflammation of spinal cord. Hospitalized and treated with steroids. Discharged home. Rested at home while strength returned. Improved; returned to work then 1/15/04 developed unsteady gait and readmitted to hospital on 1/16/04. Medical record states urinary retention. msv
Patient was inadvertently given Proquad (MMR and Varicella) as opposed to MMR  and a separate Varivax (varicella) vaccine.
Patient 5 years of age received Boostrix; Patient received  Boostrix instead of Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th August 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 19th August 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a medical assistant. The patient (5 years of age) received a dose of Boostrix when Kinrix was intended to be given, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
Information has been received from a nurse concerning her 22 year old daughter with a history of crohn's disease who on 30-JAN-2008 was vaccinated with the first dose of GARDASIL (lot number not reported). Concomitant therapy included PENTASA. Subsequently the patient experienced vomiting and nausea. It was reported that the vomiting has resolved but the daughter is still nauseated. No further information is available.
Fever 101.4, severe shivering, nausea, few palpitations. Improved with Acetaminophen and aleve. Temp this am 100.3
Dizziness; Nausea/gets lot of nauseous; Weakness/she feels like weak; Vomiting; Her muscle still sore; fever; Feeling unwell; This is a spontaneous report from a contactable consumer who reported for her/his mother. A 49-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arrm on 30Apr2021 17:30 (Batch/Lot number was not reported) as single dose (at 49 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 30Apr2021, the patient experienced dizziness, nausea/gets lot of nauseous, weakness/she feels like weak, vomiting, her muscle still sore, fever, feeling unwell. Dizziness, nausea, weakness, vomiting, myalgia were worsened. The outcome of all events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt received both vaccines around 11am on 10/1/18. Around 2pm she felt chills, sleepy, achy, temp of 101, dizzy, sweaty, and a little nauseous. As of 10/4/18 Patient is feeling much better.
at first I felt foggy like a haze feel... left the store a few hours later and the next day my eyes felt like they were burning sensation. It felt like when you spray bleach and the fumes get in your eyes thats what I felt. now comes and goes
Extreme fatigue, soreness at the injection site. Went to hospital one month after the shot for heart palpitations
rash on body trunk that spread to arms, pubic area and neck; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of an unknown age received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced rash on body trunk that spread to arms, pubic area and neck. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with triamcinolone. The clinical outcome of the event rash on body trunk that spread to arms, pubic area and neck was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient went to the emergency department on 04/15/2021 due to symptoms of possible stroke. She was dx with Bell's Palsy. She went back to the emergency department on  04/17/2021 due to worsening symptoms. She notified our office on 04/19/2021 of adverse reaction. We asked her to contact her primary care physician for treatment.
ADMINISTRATION ERROR; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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 not reported, batch number was not reported and has been requested.) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 07-APR-2021, the subject experienced administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration error was not reported. This report was non-serious.
3 weeks after the second vaccine, constant menstrual bleeding occurred for 15.5 weeks.  Three years into having the mirena IUD where menstruation is light to non existent, a low dose hormone pill was used to stop the bleeding.  An ultrasound was performed to rule out IUD issues or endometriosis.  After ruling out other issues, the hormone pill was stopped and bleeding with golf ball sized clots resumed.  I had to be within 30 seconds of a restroom at all times because clots do not absorb into pads and golf ball sized clots don't stay inside a tampon.  15 weeks of large golf ball sized clotting continued.  A low dose pill slowed then stopped the period.  After consulting with GP, he assured me the vaccine was not causing anything like that, so I got the booster in anticipation of an upcoming international trip.  3 weeks after the booster, menstruation occurred despite being on the pill.  Doubling up on the pill stopped the menstruation after a week. Don't ignore me.
This case was reported by a nurse via sales rep and described the occurrence of myalgia of lower extremities in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a day after receiving BEXSERO,  the patient experienced myalgia of lower extremities. On an unknown date, the outcome of the myalgia of the lower extremities was recovered/resolved. It was unknown if the reporter considered the myalgia of lower extremities to be related to BEXSERO. Additional details were provide as follows: The age at vaccination was not reported. The patient received a dose of BEXSERO  and experienced painful myalgia in legs, which lasted for a couple of days. The clinic was going to call back with more details.
Hands turned red/ Purple No difficulty breathing or other reverse reactions all other Vitals were WNL.  Pt states that Redness resolved 2/10/2021 and she feels fine and out walking. She has scheduled an appointment with her Primary Care doctor.
after 15 min - fatigue, nausea. P.S. I walked ~9km to home. Thought it will help.  At home - 3 hours after - temperature 37.5, strong nausea, strong chills (cold feet, cold hands).  5 hours after - insomnia, fatigue, chills. 10 hours after - vomiting. Sleep 2-3 hours. 15 hours after - chills, fatigue. Sleep more 6 hours. 24 hours - fatigue. (no chills, no temperature) Headache.  30 hours - headache, slight insomnia, fatigue 40 hours - no headache, fatigue.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-DEC-2015 at 15:43, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.8 and 5.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a registered nurse referring to multiple patients (age and gender unknown). The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were administered improperly stored doses of ROTATEQ (lot # M019691 with expiration date of 02-NOV-2017, lot # M031802 with expiration date of 09-NOV-2017, dose unknown) orally. The vaccines were exposed to 55 Fahrenheit (F) for 24 hours, 49 F for 24 hours, and 49.6 F for 24 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Day 1 after vaccine Sight Bright red, hard and sore.  Day 4 sight looks normal but nauseated until  Day 6
This spontaneous report as received from a male patient of unknown age, regarding himself. No medical history and current conditions were reported. On an unknown date in 2012 (reported as 2-3 years ago) the patient was vaccinated with ZOSTAVAX, 1 vaccine (dose, route and lot number was unknown). No concomitant medications were reported. On an unknown date in February 2015 the patient thinks he has shingles after receiving ZOSTAVAX (2 or 3 years ago) and also experienced itchiness with a small rash on his back and severe pain on his left side. It was reported that the rash never developed into blisters and also reported that unspecified pain medications does not really help. No product quality complaint was involved. The outcome of the events shingles, itchiness with a small rash on his back and severe pain on his left side was unknown. The reporter causality was not provided. Additional information has been requested.
Child developed large area of induration, inflammation, erythema and tenderness of left anterior thigh within 24 hours of immunization with DTap.
experiencing redness and mild pain on my entire arm of the injection site.; Mild pain on entire arm of the injection site.; Lymph node under arm was sore and hurts to the touch.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO167) via an unspecified route of administration in the left arm on 06May2021 at 11:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, potassium low, anemia and allergy to sulfa medications. 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. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and potassium (MANUFACTURER UNKNOWN) all from unknown date for unknown indication and unknown if ongoing. On 09May2021 at 07:00, the patient experienced redness, mild pain on entire arm of the injection site and lymph node under arm was sore and hurt to the touch. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events the patient experienced redness, mild pain on entire arm of the injection site, lymph node under arm was sore and hurts to the touch was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
No adverse events reported as of yet. Patient misled our staff and received a 3rd Moderna vaccination. He only revealed this after the dose was already given.  He stated that he would not need his "second" appointment as this was actually his 3rd shot.  He was concerned about the Delta variant and wanted a "booster".  He received his first 2 vaccines.
Breakthrough case admission after 4 vaccines ; Moderna 3/2/21 Lot# 025A21A;  Moderna 3/30/21 Lot# 028A21A;  Moderna 9/1/21 Lot# 058E21A;  Moderna 3/9/22 Lot# 026L21B
Pt began feeling ill the evening of her 2nd Moderna COVID vaccination 4/27 in which she had c/o fever, body chills, n/v in which she was unable to eat/drink, dizziness, generalized weakness and achiness. In the ED, she was found to be dehydrated with an AKI and hypotensive. Head CT showed a likely new evolving lacunar infarct in the right external capsule. Treated with 2L of fluids, low dose levophed and abx. Blood cultures were negative. Neurologist added aspirin to her regimen.
Red, itchy bumps (about 5-6) about 4 x 4 patch on right lower back. Cleared up in about 10 days after using CALADRYL and taking VALTREX.
Initially, extreme fatigue, followed by muscle soreness and fever (102.4) and continued fatigue/soreness. Lasted for more than 36 hours and disappeared as suddenly as it arrived.
Received VARIVAX right arm. Immediately had a distinct hive (s) pt had no respiratory distress. Pt given BENADRYL.
Headache began 32 hours after the 1st dose. Followed by muscle aches and pain and malaise over the next 48 hours. Then fever (Temp 102 oral) and shaking chills. At this point I sought help.