chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pronounced soreness near injection site; Mild flu-like symptoms; vivid dream; This is a spontaneous report from a contactable consumer (patient).  A 76-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration in left arm on 22Jan2021 21:30 at a single dose for COVID-19 immunization. Medical history included none. Concomitant medication included levothyroxine sodium (THYROXINE), vitamin D, tamsulosin. The patient experienced pronounced soreness near injection site, mild flu-like symptoms, and vivid dream on 23Jan2021 01:00. Pronounced soreness near injection site. Mild flu-like symptoms strong for two hours and then diminishing with time. Very, vivid dream, detail rich, color, flashing light. No treatment received for the events. The outcome of the events was recovered on an unspecified date. The events were assessed as non-serious. Facility where the most recent COVID-19 vaccine was administered was Hospital. No other vaccines received within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been been tested for COVID-19.
When I got the 2nd dose I was fine at first but then after about 12hrs I felt kind of sick for the next couple of weeks, All over body pain seem to last longer than the two weeks and was associated with my fibromyalgia. After 3 months in June, I sought care from my PCP. After a physical, I was given Gabapentin to help and currently am taking 300mg 2xper day. Since June, I was only given an X-ray for my lung issue and was put on oxygen for night use. This issue with my fibromyalgia has been MUCH worse since my 2nd dose and it has kept me from doing most of my usual activities even interfere with my work. No current appointment for test or labs. Considering changing doctors for better treatment.
Felt terrible; This case was reported by a consumer via call center representative and described the occurrence of feels awful in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Customer reported that her friend had the Shingrix vaccine and felt terrible. The reporter did not consent to follow up.
Breakthrough COVID infection in fully vaccinated patient. Positive date 09/20/2021.
Information has been received from a certified medical assistant concerning a 13 month old female who on 25MAR2003 was vaccinated with a dose of varicella virus vaccine live (lot #643593/0868M). On 18APR2003 the patient's mother noted a rash on one foot and hand. On 25APR2003 the patient presented to their office with a rash on the left side as well and it was diagnosed as shingles. Unspecified medical attention was sought. It was unknown if treatment was required for the shingles.
Headache, Myalgia, Diarrhea, NauseaVomiting, chills Myalgia, headache, diarrhea, nausea, chills; taking tylenol
Red swollen bicep on left arm, warm to the touch, saw pt on 10/23/18.
Server Rash and sores in  armpit he has been dropped of at school in Virginia and we are working on getting him into a doctor to get looked at.
Patient complaining that since he received his COVID vaccine on 2/25/2021, he has experienced tingling with the loss of feeling to the top outer edge of his right great toe.
Information has been received from a physician concerning a 23 year old female patient with no other pertinent medical history and no allergies who on approximately 23-JUN-2010 ("two weeks ago") was vaccinated intramuscularly with the first dose of GARDASIL (lot# not reported). There was no concomitant medication. On approximately 24-JUN-2010 ("the day after receiving her first dose of GARDASIL") the patient experienced fatigue, body aches, nausea, menstrual irregularities and vaginal secretions. The patient had been seen twice in an urgent care center and once in the physician's office. Blood work had been performed but were unremarkable. At the time of this report, the patient had not recovered. Additional information has been requested.
Patient has had right arm pain for the 6 weeks post-vaccine. Cannot raise arm above a certain level without pain
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 05-DEC-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX, 0.65 ml, once, subcutaneously (expiry date: October 2016, lot # unknown) for prophylaxis. No adverse effects were noted. Product quality complaint was not involved. Additional information has been requested.
"Covid Arm" - red swollen, warm, 2x4 inch oval developed about one inch below the injection site. Slightly itchy and sore to touch.  Also happened with my first shot, but there was a longer delay - roughly a week after the injection. This time, for the second shot, it was the next day.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 25-SEP-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot #L024997, expiration date: 06-OCT-2016), which was improperly stored for 11 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a consumer concerning her daughter who in 1995 was vaccinated with RECOMBIVAX HB.  In 1995 the patient was born and in hospital she was given RECOMBIVAX HB, but the nurse who given the injection did not write that the injection was given and when the next nurse came in she gave another dose of RECOMBIVAX HB to the patient.  It was reported that the patient Subsequently developed jaundice and her mother stated that she did not breast feed her daughter, and believed the jaundice was from getting two dose of RECOMBIVAX HB.  In 2008 the mother stated that her daughter's liver was positioned the area was harder and bigger and she was bloated.  At the time of this report, the outcome was unknown.  The reporter felt that jaundice was related to therapy with RECOMBIVAX HB.  No product quality complaint was involved.  No further information is available.
pain in hands/ pain in calves; pain in wrists/ pain in knees; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in hands/ pain in calves) and ARTHRALGIA (pain in wrists/ pain in knees) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in hands/ pain in calves) and ARTHRALGIA (pain in wrists/ pain in knees). At the time of the report, PAIN IN EXTREMITY (pain in hands/ pain in calves) and ARTHRALGIA (pain in wrists/ pain in knees) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medication included medication for cholesterol and blood pressure. Treatment medication was not provided.
SORE BODY; SORE ARM; This spontaneous report received from a patient concerned an 85 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUN-2021, the subject experienced sore body. On JUN-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and sore body was not reported. This report was non-serious.
Rash on right side of face, right ear, and right hand, and around injection site.
I have been menstruating (spotting to heavy flow) since about a week after my second shot. As of today, August 25th, I have had only 6 days interspersed where I was not on my period. At about 6 weeks of being spotting/on my period, I contacted my primary physician. I had a full panel of blood work and internal ultrasound performed and found nothing indicating a problem. Upon visiting the OB/GYN NP, we narrowed it down to starting after my second vaccine. She advised that I report it here (sorry that it took me a couple of weeks.) We tried an elevated hormone (Medroxyprogesterone) for 10 days. The menstruation stopped for 2 days, then bled through that as well.
Temperature excursion of 28.9°C; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Nov-2022 Reporter's comment: The nurse reported that Bexsero, Pediarix, Kinrix, Engerix-B and Boostrix was administered to several patients (number was not provided) after temperature excursion of 28.9 degree Celsius.  This excursion took place on 14th October 2022. No information was provided about the patients as the person whom reported the incident stated she did not had that information on hand but that she would try to reach out or that she would respond to inquiries from the safety department to her registered email. The information was solicited multiple times, yes the reporter stated on multiple occasions that she did not had it. The reporter consented to follow-up. Additional supportive information: The patients received Bexsero, Pediarix, Kinrix, Engerix-B and Boostrix after temperature excursion, which led to incorrect storage of drug.
Achy; Feels terrible; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), FEELING ABNORMAL (Feels terrible), CHILLS (Chills) and PYREXIA (Fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (Achy), FEELING ABNORMAL (Feels terrible), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PAIN (Achy), FEELING ABNORMAL (Feels terrible), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Tested Positive for Covid; Tested Positive for Covid, Experienced congestion, loss of smell and taste.; This is a spontaneous report from a contactable nurse. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administered in Arm Left on 23Feb2021 06:00 (Lot Number: EL3247) (at the age of 54-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had not had Covid prior vaccination. The patient tested positive for covid, experienced congestion, loss of smell and taste. The adverse events were occurred on 09Apr2021. No treatment was received. The patient had covid tested post vaccination. The patient underwent lab tests and procedures which included Covid test Nasal swab (Saliva) on 11Apr2021 with result of positive. The outcome of the events was recovered in Apr2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Arm started aching, then felt warm, got very swollen (at least 4 inches diameter) red with white ring, which remained for 6 days and was itchy. Had to take Benadryl/Tylenol q4h for 5 days.  Now swelling gone down and still a little red/brown, itching subsided.
The patient did not have an adverse reaction to the immunization. There was no redness or inflammation or hives. Patient was fine when the vaccine was administered but about 15 minutes after the vaccination was administered. Patient presented back to the pharmacy and started showing signs of a stroke. Patient was then taken away on an ambulance. This event is likely unrelated to the administration of vaccine but reporting as it happened within 30 minutes of administering the vaccine.
Pt. developed slight tightness in her chest felt flushed, had some mild erythema at her injection site. After medical evaluation, she felt reassured and did not want to use her inhaler, said she would use it later if tightness returned.
Dizziness & Bradycardia Narrative:  EMPLOYEE HAD SECOND DOSE OF COVID VACCINE AND APPROXIMATELY 9 MINS AFTER RECIEVING VACCINE , SHE REPORTS  DIZZINESS AND SWEATING. PT INITIAL BP 90/31, HR-55. BP CHECKED AGAIN- 106/92, HR 55. PT TAKEN TO ER VIA WHEELCHAIR PER  RN.
Inflammation in left arm post-vaccination; Pain in left arm post-vaccination; This is a spontaneous case from reported by other health professional to agency (Case: SEQ19-04738), and initially retrieved on 15-Oct-2019, concerning female patient of unknown age.  The patient's medical history and concomitant medications were not reported.  On unspecified date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose, batch number, expiration date, route of administration and anatomical location: not reported] for unknown indication.  On unspecified date, unknown time after vaccination, the patient experienced pain and inflammation in her left arm.  The outcome of the event pain and inflammation in her left arm was not reported.  Non-significant follow-up reported by other health professional to agency [reference number: SEQ19-05586]: Additional agency reference number added (SEQ19-05586). No changes in narrative.  Company Comment: The patient experienced vaccination site inflammation and vaccination site pain after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product is assessed as related.
Chills; Fever; feeling so weak; Sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2) formulation solution for injection, dose 1 (Lot Number: EN6208; Expiration Date: Jun2021) via an unspecified route of administration at arm left on 10Mar2021 13:40 (at the age of 76-years-old) as a single for covid-19 immunisation. The patient medical history was not concomitant medications were not reported. Prior Vaccinations (within 4 weeks) None. Reporter was a consumer that was called about the Covid-19 vaccine and reported that she received the vaccine on Tuesday and reported that she experienced chills and fever of 102 all day yesterday. She said that she was wiped out. She said that she was amazed because people said that there were no side effects, but she said that she had side effects. The reason she called was that she received a text message to report her symptoms and that was what she was doing. She was healthy and she was not sure if she should get the vaccine and since she was older, she did. She was much better today, and her symptoms just lasted the whole day. She said that it was like the flu that she gets, but it lasted all day. She went grocery shopping today. Reporter does not have the physician email or mailing address to provide. Reporter said that her symptoms started when she woke up at 0600 on 11Mar2021. She was feeling so weak, and she had chills all day. She said that she had a sore arm too. She said that she noticed the sore arm on the evening of the 10Mar2021. Reporter said that it was still ongoing, but it has improved. Reporter clarified that she received the vaccine on 10Mar2021 Wednesday. She took her temperature this morning and it was 99.2. She said that she was fine now though. She hopes the second vaccine does not do anything. Reporter said that this was her first dose. She received the vaccine at 1340 10Mar2021. Reporter said that she wanted to take ibuprofen for her achiness but thought that she better not. Reporter wanted to know if it was ok to take Ibuprofen for her achiness?. Outcome of the events chills was recovered on 11Mar2021, Fever, Sore arm, recovering, feeling so weak was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Localized macular rash left upper arm, at site of injection of MMR given on 4/5/17. Complaint of tenderness and itching at site of rash. Advised to take TYLENOL or ibuprofen OTC for pain and BENADRYL for itching. Patient state will take TYLENOL P.M. Give cold pack to apply to rash.
No additional AE; Patient was inadvertently administered PROQUAD after the labeled expiration date; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies was not reported.      On 27-JAN-2022, the patient was inadvertently vaccinated after the labeled expiration date Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 ml (lot# T025510 and expiration date 23-JAN-2022) (Expired product administered) (route of administration and anatomical site of vaccination were not reported), as prophylaxis. It was reported that, Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) did not experience any temperature excursion.   No additional adverse event (AE) (No adverse event). No PQC reported.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On unknown dates, the patients were vaccinated with M-M-R II lot # L011528 (recombinant human albumin) for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On unknown dates, the patients experienced incorrect product storage. No adverse event was reported.    The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II. The reporter considered no adverse event to be not related to M-M-R II, ROTATEQ, GARDASIL 9, GARDASIL, VARIVAX and VAQTA. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA006858: US-009507513-1708USA006859: US-009507513-1708USA006860: US-009507513-1708USA006861: US-009507513-1708USA006862:
This literature marketed report was received from the authors of published literature article and refers to a male pediatric patient of unknown age with natural killer T-cell deficiency. On an unknown date, the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) (dose and route of administration were not reported). On an unknown date, the patient experienced diffuse varicella infection. The outcome of the event was unknown. The reporter considered diffuse varicella infection to be related to varicella virus vaccine live (manufacturer unknown).
Severe arm pain thorough out the night, unable to move or lift arm due to pain. My arm was somewhat sore after procedure, but in the very early morning hours I felt the intensity increase. It?s gotten worse as the day has progressed. I also felt very sleepy afterwards and foggy/not clear headed .
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 16 year old patient. On 21-SEP-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N008077, expiration date: 09-MAR-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.