chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received SHINGRIX (batch number A4X57, expiry date 13th July 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX. On 27th June 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced injection site cyst and wrong injection technique. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injection site cyst and wrong injection technique were unknown. It was unknown if the reporter considered the pain in arm and injection site cyst to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 65 or 64 years old. The patient believed that, the SHINGRIX vaccine was given too deep into the deltoid which caused it to pool behind the muscle forming a liquid filled cyst, which led to wrong injection technique. At the time of this report, 3 weeks after receiving SHINGRIX, the patient still had pain in injected arm during strenuous exercise such as weight lifting at the gym.
he no longer had depression; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "severe depression", "colds"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "severe depression", "colds". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "he no longer had depression".  Additional Information: Is The Reporter A Healthcare Professional (HCP)? No; Occupation/Specialty: Unknown, Is the reporter contact information available to you or a sub-contracted party? Unknown, Is The Reporter The Prescribing HCP? No, Name: Unknown, Address: Unknown, Occupation/Specialty: Unknown, Suspect Product(s): (provide Name/Indication/Dosage/Start and Stop date where possible):  Pfizer Covid-19 Vaccine, Start Date: Unknown, Stop Date: Unknown, Verbatim And Event Description: Patient Had Severe Depression And Only Had Colds After The First 2 Doses, When He Had The 3rd Dose Wanted To Inform And Thank Pfizer. This call was from sponsored program line Swap to Covid, Caller hangs up, Submitted AE form. Medical Information Were any medical questions addressed by this program forwarded/referred to Medical Information? (Live Operators Only): NO: Customer and/or medical inquiry was NOT forwarded or referred to MI.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm hurts like shot in muscle. I am left handed, it hurts to write, hook my bra, hook passenger seat belt, can't read over to right shoulder. It hurts all the time if I'm using left arm. Hurts most when arm is drawn back and any pressure applied. Can still find shot site, tired of it hurting.
Woke up with fever, chills, body aches, and overall feeling of malaise.
Developed a pink rash that covers my arms, upper back and chest, as well as my thighs. Visited dr and she said it was not scabies or shingles. She said there is no drainage, no fluid. Itches. Taking BENADRYL & oatmeal soaks. Prescribed steroid and ointment to manage symptoms. Rash is not showing improvement.
Information has been received from news article via an unspecified reporter in a website referring to 140 patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with GARDASIL (strength, dose, dose#, route and lot# unknown). On unknown dates the patients died. It was unknown if autopsy was done. The cause was death was unknown. The reporter considered death to be associated with GARDASIL. This is one of several reports received from the same source. Additional information is not expected since there was no contact details provided.
patient reported positive experience with the vaccine, ie, felt like getting a vitamin B12 shot, felt better after shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, omi ba.4-5, as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Unknown manufacturer), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "patient reported positive experience with the vaccine, ie, felt like getting a vitamin B12 shot, felt better after shot".  Additional information: Patient had received more than 3 dose.  Follow-up attempts are completed. No further information is expected.
This case was reported by a physician via sales rep and described the occurrence of diarrhea in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced diarrhea and vomiting. On an unknown date, the outcome of the diarrhea and vomiting were unknown. It was unknown if the reporter considered the diarrhea and vomiting to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by GlaxoSmithKline representative to Medical Information on behalf of the physician. The patient experienced diarrhea and nausea. The physician did not want to be contacted. No additional information was provided. This case had been linked with US2017130641, reported by same reporter.
HYPOTENSION 4/12/2023 BLADDER CANCER, INVASIVE, UNSPECIFIED SITE  HYPOTENSION 4/12/2023 ATHEROSCLEROSIS OF AORTA  HYPOTENSION 4/12/2023 SMALL BOWEL OBSTRUCTION
Moderate redness, swelling, and pain at the injection site for the first 2-3 days that resolved (along with mild fever and myalgias).  Then 1 week later, on 1/15 I woke up with a very large red, hot, itchy patch on my left biceps around my injection site.  It is not as bright now, but still very large (larger than my palm) and intermittently itchy.  It will be 2 weeks from my injection tomorrow.  I am concerned about whether or not to get the second dose as I am afraid this was some sort of allergic reaction and I read that many people experience more significant adverse reactions to the second dose.  I did check in with a health care provider at my clinic and she only suggested ice and Tylenol, which provided relief of itchiness, but no improvement.  I also notified Moderna.  No one seems to know for sure if I should receive the second dose.
pt recvd vax; red  bumpy rash all over body; lips really swollen, T 101 started 2 days ago; swelling getting worse; advised to call PMD;23jan red bumps,redness presists, itchy going away; T 99 friday evening; much improved;
Patient began feeling dizzy and nauseous about an hour after the vaccine was administered. She reported left arm pain at the injection site with pain traveling from deltoid to her elbow. She has no redness or swelling at the injection site.
Patient has a history of vagal reactions following vaccinations. She experienced some dizziness following this vaccination.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 07-MAY-2016, the patient was inadvertently vaccinated with improperly stored PEDVAXHIB (lot # L042835 and expiration date 19-AUG-2018, dose and route of administration were not reported). Concomitant therapy was not reported. The temperature of excursion was 31.5F and the time frame was 11 hours. There was no previous temperature excursion and the call was because of the data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Heart palpitations. Still occurring. Itchy skin rash all around my torso. Still occurring. General confusion. Still occurring.
12/9/2022 I started having what felt like a sinus infection. I had a headache, congestion, weakness, sore throat and a little bit of fever. I was fatigued and slept a lot. It continued to get worse. I tested negative for COVID with an at home test three times. I called the doctor and had an appointment on 12/13/22. She diagnosed me with sinusitis and gave me a prescription for azithromycin for 5 days. This is the fourth day, and I am finally feeling better and starting to feel like myself again.
Upper right arm discomfort upon palpation and upon extension, especially at inner and back of upper right arm. Patient also reports "lumpy" sensation.
No adverse event/no signs or symptoms/no actual medical issue. Defective BD Safety Glide Needle 25G X1. When vaccinating the patient, all the contents of the flu vaccine fell out of the needle onto the floor, none went into the patient.  Due to verifying this, patient did receive a vaccine today using a different(non-defective) needle. Patient okay and no issues. Patient content with his vaccine admin. Just wanted to report situation.
The patient did not have a reaction to Moderna. This event was a vaccine administration error.  The recipient is 12 years old and intended to receive Moderna.  This event happened at a community vaccination clinic where all three covid vaccinations were being administered.  The error was made by an EMT by human error who had been administered hundreds of vaccines weekly since January.
Swelling began apx 16 hrs later in left breast area, beginning to show in right breast, now concerned for swelling to continue and/or lymphadema; lymphadema; Anatomical Location- Left leg; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection and Lot Number: EP7533), via an unspecified route of administration, in Leg Left on 02Apr2021 12:45 (at the age of 55-years-old) as dose 1, single for COVID-19 immunization. Medical history included breast cancer (Still receiving treatment, Double mastectomy 02Jun for breast cancer, incl lymph node removal right side. Expanders placed during surgery for implants at later date) and known allergies: Penicillin. Concomitant medications included gabapentin, trazodone, celecoxib (CELEXA) and ergocalciferol (ERGOCALCIFEROL). The patient experienced swelling began apx 16 hrs later in left breast area, beginning to show in right breast, now concerned for swelling to continue and/or lymphadema on 03Apr2021 07:00, anatomical location- left leg on 02Apr2021 and lymphadema on 03Apr2021 07:00. Prior and Since the vaccination, was the patient diagnosed with COVID-19 reported as no. For breast swelling and Lymphedema emergency room visit reported as yes and the treatment were reported as unknown. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
About 25 hours after vaccination, pt returned to pharmacy w/ localized rxn. (Redness, mild site swelling, pain & itch). Pt advised this can be side effect per mfr. Pt advised to ice rash & take Ibuprofen OTC for 24-48 hrs.
some of the medicine leaked out of the syringe; she was administering Arexvy, some of the medicine leaked out of the syringe (and also went onto the patient's arm).; she was administering Arexvy, some of the medicine leaked out of the syringe (and also went onto the patient's arm); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9994M, expiry date 21-MAR-2025) for prophylaxis.   On 02-NOV-2023, the patient received Arexvy. On 02-NOV-2023, an unknown time after receiving Arexvy, the patient experienced accidental underdose (Verbatim: some of the medicine leaked out of the syringe), inadvertent exposure to vaccine (Verbatim: she was administering Arexvy, some of the medicine leaked out of the syringe (and also went onto the patient's arm).) and exposure via skin contact (Verbatim: she was administering Arexvy, some of the medicine leaked out of the syringe (and also went onto the patient's arm)). The outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt date: 02-NOV-2023 The pharmacist stated that when she was administering Arexvy, some of the medicine leaked out of the syringe (and also went onto the patient's arm), which led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up via postal.
Guillain-Barre Syndrome. Vaccination 10/18/12, symptoms began 10/31/12.
Patient erroneously received a varicella vaccine at their 2 month well check. Parents counseled on symptoms to monitor for at home.
Adacel approved for ages 11-64yrs; was given 2 months before turning 11 years. No adverse reaction.
12/12/07 Patient present to clinic with a papular erythematous rash, afebrile, good appetite. 12/11/07 Influenza vaccine administered.
approx 18 days p/vax pt devel inject site rash described as erythemic w/some raised areas, also devel 5 raised, itchy lesions the size of pin heads.
This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneous (strength, dose and lot # were not reported). There were no concomitant medications. It was reported that the patient was administered 2 doses of ZOSTAVAX on 08-OCT-2014. Patient did not receive any treatment. She did not seek medical attention. Additional information has been requested.
Macular/papular rash - started face, neck, chest, arms, abdomen - progressing and + blanching, + clear nasal discharge.
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On 10-SEP-2014 the patient was vaccinated with one dose of VAQTA (lot number reported as 5B23A, dose and route were unknown) which underwent an unsupported temperature excursion. No adverse effects reported. The lot number 5B23A is an invalid lot number for VAQTA. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine received 9/23/09 afternoon in left deltoid. Usual anticipated muscle soreness 9/23 and 9/24. On 9/25/09 pain increased and extended to left forearm and involved elbow. Managed pain with ibuprofen q 6 hr for 3 days but continued to worsen. 9/26/09 unable to grasp items due to pain. 9/28/09 lessening of pain. 9/29/09 continued aching pain which becomes sharp stabbing pain at elbow when attempt to carry or pull more than 10 pound item.
Swollen arm 9 days after shot, lasted about 5 days. Arm at the site of the vaccine shot became red, swollen, hot, tender & very itchy. Face was also itchy with rash. Don?t know if that?s related.
When drawing up a dose of the Shingrix vaccine, there was a vial malfunction. The medication leaked around the stopper when trying to draw up the medication into the syringe.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (unknown strength and dose) lot # L016428 and expiry date of 30-JUL-2017. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
I am positive for covid at this time; Dizziness; I feel sick; Did not feel good; Patient stated that she didnot feel normal; Felling fatigued; Headache; Seeing spots; Felt was like having motion sickness; Scary feeling because she couldn't feel herself/Patient stated that she didn't feel normal/Didn't feel good; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (I am positive for covid at this time), DIZZINESS (Dizziness), ILLNESS (I feel sick), VISUAL IMPAIRMENT (Seeing spots) and MOTION SICKNESS (Felt was like having motion sickness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VISUAL IMPAIRMENT (Seeing spots), MOTION SICKNESS (Felt was like having motion sickness) and FEELING ABNORMAL (Scary feeling because she couldn't feel herself/Patient stated that she didn't feel normal/Didn't feel good). On an unknown date, the patient experienced COVID-19 (I am positive for covid at this time), DIZZINESS (Dizziness), ILLNESS (I feel sick), ILLNESS (Did not feel good), FEELING ABNORMAL (Patient stated that she didnot feel normal), FATIGUE (Felling fatigued) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, COVID-19 (I am positive for covid at this time), DIZZINESS (Dizziness), ILLNESS (I feel sick), VISUAL IMPAIRMENT (Seeing spots), MOTION SICKNESS (Felt was like having motion sickness), FEELING ABNORMAL (Scary feeling because she couldn't feel herself/Patient stated that she didn't feel normal/Didn't feel good), ILLNESS (Did not feel good), FEELING ABNORMAL (Patient stated that she didnot feel normal), FATIGUE (Felling fatigued) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medicines were not provided   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Significant Follow-up as event added
Slight chill started about 7:15 p.m. and within minutes my entire body was shaking uncontrollably.  After about 1 and 1/2 hours extreme shaking stopped.  Felt very wiped out the following day with slight headache and legs hurting.
Fever, chills, muscle and joint pain, headache, exhaustion, and lack of appetite
pt c/o neck discomfort (rt sided);tiredness, eye pressure & both eyes were swollen (eyelids puffy);back hurting;19FEB97 still has some neck discomfort;
Client was vaccinated with Pfizer vaccines for Covid on/about July 15 and on/about August 8, 2021.  Covid symptoms started 9/28: nasal congestion, cough, fatigue, weakness, headache, loss of taste and smell.  Still has some weakness.  Reported as a breakthrough Covid case in previously vaccinated person.
thyroid pain; low grade fever; joint pain; headache; acute thyroid inflammation; This is a spontaneous report from a contactable consumer (patient herself). A 79-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6201) via an unspecified route of administration in arm (unclear whether left or right) on 30Jan2021 03:30 PM at single dose for COVID-19 immunisation. It was unclear whether the patient received the first or second dose. Relevant medical history included allergy to penicillin and sulfur drugs, breast cancer in 2018, surgery, chemo and radiation. The patient had no COVID prior to vaccination. The patient did not receive any other vaccine in four weeks. Concomitant medications included anastrozole (ARIMIDEX) and multimineral supplement. The patient developed acute thyroid inflammation 10 days after her second shot with thyroid pain (thought it was a sore throat), low grade fever, joint pain and headache. It lasted for 3 weeks, diagnosis was made two weeks after onset of symptoms. Onset date for acute thyroid inflammation was Feb2021, while onset for the other events was 23Feb2021. No treatment was received. Acute thyroid inflammation was serious due to disability, while other events were non-serious. The patient was tested for COVID post vaccination: nasal swab was negative on 05Mar2021. The events resolved with sequelae (lasting effects).  Information on Lot/Batch number was available. Additional information has been requested.
Fever & chills began at 11:30pm the same day. Beginning 24 hours after the vaccine, I began getting burning in both knees and my left hip. That lasted for about 12 hours and seems to have subsided as of now.
Patient states that the morning following the vaccination, her right underarm was swollen and very tender to touch and believes it to be a swollen lymph node caused by the vaccine. Patient reported the incident to the pharmacy on 1/3/2022 and to her medical provider, Dr. for documentation in her medical chart.
This case was reported by a physician via sales rep and described the occurrence of thinking reduced in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced thinking reduced (serious criteria GSK medically significant), headache, tiredness, weakness, confusion, disorientation, joint pain, stiff neck and impaired work ability. On an unknown date, the outcome of the thinking reduced, headache, tiredness, weakness, confusion, disorientation, joint pain, stiff neck and impaired work ability were recovered/resolved. It was unknown if the reporter considered the thinking reduced, headache, tiredness, weakness, confusion, disorientation, joint pain, stiff neck and impaired work ability to be related to SHINGRIX. Additional details reported as follows:  Few days after receiving SHINGRIX, the patient experienced confusion, disorientation and inability to think for an unknown duration. Less than a year after receiving SHINGRIX, the patient experienced a constant headache, joint aches, and overall tiredness that lasted for one month. Also, the patient had weakness for an unknown duration, and a stiff neck for several weeks.The patient missed ten days of work. The field representative was unable to provide additional information.