chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme shoulder pain and lack of ability to rotate shoulder. Flu shot was given very high up on the arm near shoulder. Physical therapy and cortisone shots to no avail. Told tear in rotator. Considered surgery and set a date for it, but needed to cancel. 11 months after pain began, I woke up one day and it was gone. The reason I am writing this now, is that no one believed that the flu shot caused my problems. I read a story this week in the newspaper which mirrored all my problems. So I am reporting this because I do not want to see people suffer because shots are being administered improperly.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 19-AUG-2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 17-APR-2013, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient was prescribed nortriptyline, prednisone, and hydrocodone for management of her painful symptoms and chronic pain. On or about 06-MAY-2016, the patient sought subsequent treatment by another physician. She was prescribed hydrocodone and gabapentin for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA292656 (same reporter). This case involves a 69 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ042AB, expiration date: 19-May-2019, dose, via intramuscular route and in left deltoid) on 18-Oct-2018. The patient's medical history and concomitant medications were not reported. No other vaccine was administered. It was an actual medication error due to incorrect product storage (administered prior to realizing a one day shipping excursion had occurred with the product, Delayed Transit Vaccine Stability, no reaction reported). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
Shortly after I took the booster shot I felt weak. I thought it was like the other shots and I would feel bad for maybe a day or so but my health never came back. Big drop off in energy level shortness of breath and fatigue.
Pt recvd vax & following 2nd dose pt c/o pruritis, swelling & redness in area of circular bandaid;
Might be 11 years of age. Doing well. No issues per mom. Vital records has her as 11 years of age.  Mom says he is 12 years of age. Mom seemed eager to get child vaccinated. Unsure of birth date or age. Noticed after vaccinated, when documenting in the KS Immunization Registry that vital records has the date of birth as 1 year later. Vital records =  Mom reports =
Felt like my heart was racing.  The highest my  heart rate went up to while in the waiting area was 138bpm.  I did not immediately notify anyone as I was not aware a fast heartbeat was considered an allergic reaction.  The fast heartbeat resolved, but my heartbeat continued to be elevated about 10-20bpm from my usual baselines for 2 days post vaccine.  I also developed the following side effects; headache, fatigue, muscle/joint pain, chills, swelling of lymph nodes on right arm, pain on right arm/joints, and mild tingling/numbness of right arm; all side effects resolved by day 3 post vaccine.
After receiving Gardesil vaccine started experiencing headache,depression, insomnia, suicidal ideation, acute psychosis and is now still hospitalized for further treatment and worsening symptoms.
Patient describes right shoulder soreness/ pain beginning a couple hours after the injection. Shoulder pain increased and made his "shoulder feel like it might pop out of the shoulder joint." He states that his shoulder feels "loose."
This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Felt tingling going through her neck), PYREXIA (Fever) and CHILLS (Chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced PARAESTHESIA (Felt tingling going through her neck). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Felt tingling going through her neck) outcome was unknown and PYREXIA (Fever) and CHILLS (Chills) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. This case was linked to MOD-2022-454758, MOD-2022-454759 (Patient Link).
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-SEP-2015, the patient was vaccinated with the improperly stored VAQTA (lot number L009445 and expiration date 01-JUN-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chills; very itchy episode; Runny nose; This is a spontaneous report from a contactable consumer, the patient via PPDi. An 82-year-old male patient received first dose of BNT162B2 (BioNTech COVID 19 vaccine, solution for injection, lot number: caller could not locate the lot number, NDC number: Unknown, Expiry Date: Unknown) on 11Mar2021 at 13:00 as a single dose for COVID-19 immunization. Patient took the second dose on 01Apr2021 at 1pm (unknown NDC number, for lot number and expiry date: caller could not locate the information).  Caller stated both doses were received in the left arm. Patient had no family and medical history. Patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. Patient did not receive any prior vaccination (within 4 weeks). relevant to AE(s). There were no AE(s) following prior vaccinations. For concomitant products caller stated "no" because he took his regular medication from his primary care doctor. Caller clarified that the antibody test was given at the church and he was given the number to find out results of the COVID-19 antibody test, which was 2 weeks before the first dose. Caller stated the antibody test was not Pfizer. He got a telephone number (Withheld) that he called which was who told him the results for not being exposed to the virus. Caller stated he was not exposed to the virus and decided to follow up to get the Pfizer vaccine and he received the first dose on 11Mar2021 and the second dose on 01Apr2021. Caller stated he was calling about the BioNTech COVID-19 vaccine. Caller stated he took the shot at Church. The runny nose started a day or two before the first shot, he clarified it was around 10Mar2021 this started, which was still ongoing. Caller stated he was experiencing a very itchy episode right after the first shot of the COVID 19 vaccine which was on 11Mar2021. Caller stated those are the two items he was complaining about. Caller stated chills started in between the two doses. Caller stated it is not going on now but sometimes early in the morning when he woke up and until he got the temperature up in his apartment, he experienced chills. Caller stated if the heat was on, he does not noticed chills but if the heat was not on, he does notice it. The temperature is in the high number and he had a little chill right now while speaking. Caller stated the outcome is the same. Patient took one except for Tylenol. He has taken a couple of Tylenols, he clarified he had just been taking tablets of Tylenol for chills. Outcome of the events very itchy episode was not recovered while that of chills and was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1), for Covid-19 immunisation.  The following information was reported: BACK PAIN (non-serious) with onset 24Mar2021, outcome "unknown", described as "back pain". Additional information: The patient was asking if she could take Tylenol for her back pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CONFUSION, HOARSE VOICE, SWELLING, ITCHING ALL OVER BODY. WENT TO ER AND DETERMINED TO BE ALLERGIC REACTION TO MODERNA VACCINE
23 y/o male with no PMH c/o dizziness ~10 min post pfizer vaccine 1st dose assoc with blurry vision. Pt was assessed by clinical leads/EMS. Pt never LOC, was attached to monitor, VS monitor, placed on stretcher, given H2O x 5 (250mL) + ice packs + cookies. Pt reported complete resolution of symptoms within ~4min. 3 lead showed irregular sinus arrythmia w/ peaked T waves. Pt was started on 20g IV on left hand 1L NS bolus with no change in EKG. Based on clinical judgement EKG changes dont appear to be a vaccine related adverse RXN, most likely a benign finding or electrolyte abnormality. Pt was advised to go to ER for further evaluation and management, pt agreed to transport to ER. Pt was advised to drink water and ea
Redness and soreness around injection site, swelling in the surrounding area,  redness beyond that spreading down the arms. Occurred within 12 hours. Still red, itchy, and sore but has subsided significantly.
Fever, chills, soreness subsided after 48 hrs Redness & heat on arm below injection still going
58 year old male administered Flumist live virus vaccine that should not be given to individuals older than 50. Pt educated on influenza symptoms and instructed to report for medical care immediately if symptoms present. Pt stated he is very healthy and will comply.
No side effects reported; HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 28-JUN-2023, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally, lot number W026137 with expiration date 05-FEB-2024 (dose was not reported); and with a dose of toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(VAXELIS), lot number U7374BA with expiration date 06-MAY-2025 (dose and anatomical location were not reported); both vaccines for prophylaxis who were exposed to temperature excursion (product storage error). The vaccines were exposed to 8.74 degrees Celsius for 35 minutes. No previous temperature excursion was reported. No side effects were reported.
Experienced a fever; Severe redness and swelling of her upper arm; Severe redness and swelling of her upper arm; This is a spontaneous report from contactable physician via Pfizer sales representative.  A female patient in her 20s received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , on an unspecified date at single dose for immunisation. Medical history included asthma. The patient's concomitant medications were not reported.  On an unknown date the patient experienced fever and severe redness and swelling of her upper arm, that lasted for a few days after vaccination. The outcome of the events was recovered on an unknown date.Information on the batch number has been requested
This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohns disease.  The patient was previously treated with covid-19 vaccine ad26. cov2. s  (suspension for injection, intramuscular, batch number was not reported) for prophylactic vaccination. (Dose number in series 1)   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 2). Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. No concomitant medications were reported.   On an unspecified date, the patient experienced hemorrhoids, diarrhea, and fever (Dose number in series 2). Laboratory data (dates unspecified) included: Magnesium (NR: not provided) low, Potassium (NR: not provided) low, and Vitamin B12 (NR: not provided) decreased. Treatment medications (dates unspecified) included: zopiclone.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported.  The patient recovered from fever, and was recovering from hemorrhoids, and diarrhea.  This report was non-serious.
Information has been received from an RN concerning an 11 year old white female who on 1/25/99, was vaccinated with Hep-B vaccine and on 1/26/99, she was seen at a physician's office with a swollen, painful right deltoid. The pt also experienced itching at the injection site on 1/29/99. The area was red and warm to the touch. The area of swelling on the right upper arm was 6cm X 4cm. This was also noted as a "questionable infection". The pt recovered within 48-72 hours of symptom onset. The pt has not continued the vaccination series. No further information is available.
baby patient who received Havrix second dose 4 months apart the first dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 1-year-old female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (1st dose received on 2nd May 2022).   On 21st September 2022, the patient received the 2nd dose of Havrix. On 21st September 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.    Additional Information: GSK receipt date: 12-OCT-2022 Reporters comment: The baby 1 year 5 month old patient who received Havrix second dose 4 months apart the first dose. HCp was looking for information about how to proceed.  The reporter did not consent to follow-up. Additional Supportive information: The patient received 1st dose on 02nd May 2022 and 2nd dose on 22nd September 2022 which led to shortening of vaccinations schedule.
Dizziness, Headache, NauseaVomiting, fatigue Narrative:
Initial unsolicited report received from nurse on 05 Jan 2018. This case involves 52 years old female patient who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (batch number: UI852AB and expiry date was not reported) intramuscularly in deltoid once, on 15 Nov 2017. The patient's medical history and concomitant medication were not reported. On an unspecified date, 10 minutes post vaccination patient had developed right eye swelling and redness to right cheek along with tingling sensation around her mouth. Laboratory investigation was not reported. Patient was treated by the school nurse with 50 mg of oral DIPHENHYDRAMINE HYDROCHLORIDE (Benadryl) and was being evaluated by her pvt physician that day. On an unspecified date, patient was recovered from events. List of documents held by sender: none.
Moderate swelling & redness at site of vaccination (DTAP vaccine given in left arm).
Confusion at times; Forgets her words in the middle of the sentence; Soreness in right arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness in right arm), CONFUSIONAL STATE (Confusion at times) and MEMORY IMPAIRMENT (Forgets her words in the middle of the sentence) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 009C21A) for COVID-19 vaccination.     No relevant past medical history was provided.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced MYALGIA (Soreness in right arm), CONFUSIONAL STATE (Confusion at times) and MEMORY IMPAIRMENT (Forgets her words in the middle of the sentence). On 13-Apr-2021, MYALGIA (Soreness in right arm), CONFUSIONAL STATE (Confusion at times) and MEMORY IMPAIRMENT (Forgets her words in the middle of the sentence) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Patient's daughter called on behalf of her mother(patient) who has been experiencing some side effects of the Moderna COVID-19 Vaccinations.  Patient had some soreness in arms, appears confused at times, and stops in the middle of her sentence and forgets what she is saying. Patient received the first dose of the Moderna COVID-19 Vaccination in the right arm muscle; with unknown Expiration date.  Patient experiences some soreness in her right arm, confusion at times, and forgets her words in the middle of her sentences, however it all resolved the next day, 13Apr2021.   The second dose of the Moderna COVID-19 Vaccine was given on 11May2021, in her left arm muscle; Lot number:  009C21A; unknown Expiration date.  Patient experience soreness in her left arm and is more confused this time and forgets more and stops in the middle of her sentence when she is saying something and has not gone away.  Daughter is bringing her mother (patient) to her health care provider today, 12May2021.  Daughter's mother (patient) was present while daughter was speaking to Agent and gave consent for follow up with patient's health care provider and Safety.  Preferred communication is phone number
MILD HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. 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: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for pain in back (sciatica). On 06-MAR-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild headache on 07-MAR-2021. This report was non-serious.
Information has been received from a 56 year old female with allergies to different forms of "neomycins" and osteoporosis who on 17-APR-2007 was vaccinated SC on right arm with 0.65 ml dose of Zostavax. Concomitant therapy included simvastatin (MSD) and risedronate sodium (ACTONEL). On 17-APR-2007 the patient developed swollen, hot and red area at injection site. By 19-APR-2007, patient's upper arm had a hematoma "size of a softball". Patient's physician presented prescribed phenhydramine hydrochloride (BENADRYL). At the time of report, the patient was recovering and the hematoma was the "size of dime" with red area at injection site. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested. Additional information from the consumer indicated one day after vaccination, her arm became inflammed, swollen, itchy and very painfu;/ She went to the doctor and had to ice the area and took BENADRYL to stop the itching and swelling. Subsequently she recovered.
Around 6pm I felt fatigued and tired. I went to bed around 8pm. I could not sleep. Had injection site pain on right arm. Tossed and turned. Had a headache. Became fevered and chilled. Had temperature of 100.1 at 2am on 1/4/2021. Temperature decrease back to 98.3 in the morning hours. Remained fatigue and chilled throughout rest of the day. Minor headache.
Fatigue, dizziness, tight chest, nausea, diarrhea,  and headache on 05/12/2021. Fatigue, dizziness, nausea, diarrhea, and headache on 05/13/2021.
pt recvd vax; dec range of motion at hip; no pain, no swelling or redness at site; improving by 15nov; mom unable to change diaper easily;
Upon admission, patient reported erythema and warm to touch at the pneumococcal vaccine injection site. She received the vaccine as an outpatient.
About 3 weeks post vaccination, 08/24/2021- I had really severe arthritis flare up on all my joints, head to toe and high blood pressure. I went to the doctor twice-they discontinued lisinopril and chlorthalidone 25 mg and replaced it with lisinopril hctz 20/12.5 mg and meloxicam 15 mg and amlodipine besylate 10 mg. My arthritis is still very bad, and my blood pressure is still high.