chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after the 3rd dose, both of them experiences soreness/Soreness of right arm after each injection 1-4/both had arm soreness after each injection, not just the 3rd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 20Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 301558A) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA taken for colitis. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6199; Anatomical location: Left arm; Vaccination time: 11:00), administration date: 06Mar2021, for COVID-19 immunization, reaction(s): "Soreness of right arm after each injection 1-4"; BNT162b2 (DOSE 2, SINGLE; Lot number: EP6955; Anatomical location: Left arm; Vaccination time: 11:00), administration date: 27Mar2021, for COVID-19 immunization, reaction(s): "Soreness of right arm after each injection 1-4", "first 2 doses 2 weeks apart". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Oct2021, outcome "recovered" (Oct2021), described as "after the 3rd dose, both of them experiences soreness/Soreness of right arm after each injection 1-4/both had arm soreness after each injection, not just the 3rd dose".  Additional information: Reporter was reporting for his wife. Patient had no other Conditions. Patient had other products. They had both had the series of Pfizer injections where they got the first 2 doses 2 weeks apart. After the 3rd dose, both of them experiences soreness that went away after 3 or 4 days. Patient had arm soreness after each injection, not just the 3rd dose. Each time they had injection they had soreness of arm. All injections for wife on same arm, left arm. All soreness started the evening of the injection, and really noticed it the next day. Eventually in a couple or 3 days, the soreness was gone. She only took one other medication, which he stated was Humira 40mg/0.4ml Injection twice monthly, every 2 weeks given in leg for Colitis. Patient started Humira about 2 years ago (from the day of this report) that last November. Soreness of right arm after each injection 1-4. No Investigations were conducted. There was no family Medical History Relevant to Adverse Events (AEs). The report was not related to a study or programme.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201368860 same reporter and drug, different patient and event;
Not able to use one of the syringes because it was leaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), outcome "unknown", described as "Not able to use one of the syringes because it was leaking".  Additional information: caller received five doses of the Abrysvo vaccine but was not able to use one of the syringes because it was broken and leaking. It was confirmed that this dose was not administered to any patients (they were unable to put the diluent with the vaccine to use this)  Causality for "not able to use one of the syringes because it was leaking" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Severely elevated liver function tests following 2nd dose of vaccine.   Have fallen nearly back to baseline over 2 week coarse.
Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In June 2014, the patient was administered the ZOSTAVAX vaccine (lot # and route not specified) by a healthcare provider. On an unspecified date, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
severe vertigo; could not control her bowels, either way; basically couldn't stand; motion sickness; still can't sleep on her right side. If she does, it triggers her./Driving for her, is very minimal and she hardly ever drives anymore. She can't drive at night anymore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing), notes: had cancer but that was years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "Felt sick". The following information was reported: VERTIGO (hospitalization) with onset Apr2021, outcome "unknown", described as "severe vertigo"; ANAL INCONTINENCE (non-serious) with onset Apr2021, outcome "unknown", described as "could not control her bowels, either way"; DYSSTASIA (non-serious) with onset Apr2021, outcome "unknown", described as "basically couldn't stand"; MOTION SICKNESS (non-serious) with onset Apr2021, outcome "unknown", described as "motion sickness"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Apr2021, outcome "not recovered", described as "still can't sleep on her right side. If she does, it triggers her./Driving for her, is very minimal and she hardly ever drives anymore. She can't drive at night anymore". The patient was hospitalized for vertigo (hospitalization duration: 1 day(s)). The event "severe vertigo" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vertigo, anal incontinence, dysstasia, motion sickness, loss of personal independence in daily activities. Clinical information:Clarified that the caller's mother had taken the first two doses of the Pfizer Covid vaccine and the Covid booster. He clarified that the he thinks she had the booster in Aug2021 or Sep2021 but states that when she had the booster, she had nothing.  With her first shot, she felt sick for a day and it was the second one that got her Tests: She didn't really know much, she went to the hospital and was released. She was real low key about everything until the other day. He states that she is now having diarrhea of the mouth, telling everything about what happened to her.   The lot number for bnt162b2 was not provided and will be requested during follow up.
itching on her upper body; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient).A 49-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 23Feb2021 16:00 (at the age of 49-years-old female) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient previously took copaxone for multiple sclerosis and experienced anaphylactic reaction. On 24Feb2021 15:00, the patient experienced itching on her upper body and allergic reaction to the vaccine.The clinical course as follows caller is calling about the covid 19 vaccine. The caller had the first vaccine 2 days ago then yesterday, 24 hours after the vaccine, she became itchy on her upper body, mostly on her back and head. The caller took Benadryl. The caller thinks it may have been an allergic reaction to the vaccine. The caller is concerned because she had anaphylactic reaction in the past not to a vaccine, but to a medication, clarified as an injection, she received for her Multiple Sclerosis. The caller wants to know should she have the second vaccine or not,what should she do in advance of the vaccine, and what should she do after it, what precautions and what aftercare. Therapeutic measures were taken as a result of itching on her upper body and allergic reaction to the vaccine. The outcome of events was recovered on an unspecified date in 2021.   Information on the lot/batch number has been requested.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with two PNEUMOVAX 23. Other suspect therapies included PREVENAR 13. On an unknown date, the patient experienced localized arm swelling with that PNEUMOVAX. Pharmacist reported that patient who had the reaction to PNEUMOVAX 23 was getting PREVNAR 13 instead. Pharmacist reported that he believe it was his personal experience, the patient had got PNEUNMOVAX 23 for the second time and had this reaction and wanted to know if he can get the PREVNAR 13. Patient did not have the PREVENAR 13 before but he only wanted to it get now as he was looking for the alternative of the PNEUMOVAX 23. There was no product complaint to report. The Pharmacist called in to know if the patient can get any data about the previous patients who had previous interaction with PNEUMOVAX 23 and the PREVNAR 13. Patients who have reaction with PNEUMOVAX 23 now wanted to take the PREVNAR 13. The outcome of localized arm swelling was unknown. The reporter considered localized arm swelling to be related to PNEUMOVAX 23. Additional information has been requested.
Initial information received on 02-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2019SA004554 (same reporter). This case involves a six-year old male patient who was vaccinated with a single dose of FLUBLOK QIV (lot QFAA1804 via intramuscular route in the left thigh on 14-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant medications were not reported. It was an actual medication error case due to inappropriate age at vaccine administration. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
After the 15 minute waiting period, I was released. While driving home, I experienced swelling in my throat. This persisted and worsened until 5 pm. At 5 pm I had fatigue, muscle pain, and joint pain, as well as dizziness. By 5:30 my condition worsened, and I have a fast heartbeat, significant dizziness, and chills. At 5:40 I contacted my wife to leave work to drive me to the hospital. We arrived at the hospital around 6:15; by 8 pm most symptoms except dizziness had disappeared. By 9 pm the dizziness had abated. It is 10:40 pm and I am still a little dizzy, but able to move and operate fine.
Vaccinated on August 21, 2015. Symptoms began on Sat. AM, September 19, 2015.
The Night of the vaccination the patient reported feeling very cold had the chills. The following day the patient developed a 102 degree fever
Patient said he received vaccine yesterday and woke up with a rash on his forehead this morning that has progressively gotten worse as the day went on.
muscle soreness; This is a spontaneous report from a contactable healthcare professional. An adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 in left arm at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had historical vaccine of first dose of BNT162B2 on unspecified date. The patient had no allergies to medications, food, or other products. On 07Jan2021, the patient experienced muscle soreness the day of the injection. No other symptoms were reported. No treatment was given to the patient for the event. The outcome of the event was unknown. The facility where the most recent COVID-19 vaccine was administered was in the hospital. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient was tested for COVID-19. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 34 year old male vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.
Swollen lymph node around left collarbone; This is a spontaneous report from a contactable consumer. A 49-year-old adult non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 04Mar2021 at 17:15 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient medical history included obesity, arthritis and back stenosis. The patient had nuts allergy. Concomitant medications included unspecified antibiotic, vitamins and cough medicine from an unspecified date. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On an unspecified date in Mar2021 at 12:00, the patient experienced swollen lymph node around left collarbone. No therapeutic measures were taken as a result of adverse events. The clinical outcome of swollen lymph node around left collarbone was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
HCP stated 2 doses of Moderna COVID-19 Vaccine Bivalent were administered after the expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated 2 doses of Moderna COVID-19 Vaccine Bivalent were administered after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Unknown.     On 07-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated 2 doses of Moderna COVID-19 Vaccine Bivalent were administered after the expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated 2 doses of Moderna COVID-19 Vaccine Bivalent were administered after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated 2 doses of Moderna COVID-19 Vaccine Bivalent were administered after the expiration date).    Concomitant medication was not provided. It is unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions Treatment information was not reported.   This case was linked to PR-MODERNATX, INC.-MOD-2023-730068 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2023: Live followup received.; Sender's Comments:  PR-MODERNATX, INC.-MOD-2023-730068:patient 1
Erythematous papular rash on posterior upper thighs near gluteal fold and above penis at pubic symphysis. Started 1-2 hours after vaccine. No pain or itching or discomfort. Was improving by the time he was seen again in office 7 days later.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 22-APR-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Fever, redness, swelling to rt arm where immun given & felt warm to touch all over; Md prescriped warm compresses, DPh & Zonea lotion; MD felt was rxn to DTP
suspected vaccination failure; 15 people I have spoken to who said they experienced shingles / all of them say they got it after; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was one of the 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476: US-GLAXOSMITHKLINE-US2021AMR088498:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088496:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088503:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088504:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088507:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088497:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088500:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088501:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088502:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088506:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088495:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088494:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088505:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088531:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088531:Original Case : US2021AMR088476