chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to 1-3 patients of age ranging from 9-18. The patients were vaccinated with VARIVAX (dose, duration and lot number not provided) on unknown dates "last month", in June 2012. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patients experienced severe local injection site reaction, reported as injection site soreness, injection site swelling and injection site redness. The patients had sought medical attention via calling the office and were given BENADRYL and ice for the adverse events. None laboratory diagnostics studies were performed. The outcome of the patients' adverse events were unknown. This is one of several reports received from the same source. Additional information has been requested.
On 05/27/2000, this male pt received first dose of vax. Reportedly since receiving the vax, the pt has had his left knee aspirated three times.
Patient completed Moderna COVID vaccine on 3/11/2021 and 4/8/2021. Patient received Pfizer dose on 7/31/2021 at our location as listed on this report.
diaphoresis, vertigo, and dry mouth. patient was hydrated and chair was reclined with additional rest
1st shot sore arm for 5 days. By day 8 post shot a larg red, ich, painful, swollen site... felt like shingles. 5 more days, site spreaded and more pain. That's today so far.
shingles shot did not work/got shingles in incision/suspected vaccination failure; Broke my hip; Got shingles in my incision/Shingles; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: shingles shot did not work/got shingles in incision/suspected vaccination failure) (serious criteria GSK medically significant), fractured hip (Verbatim: Broke my hip) (serious criteria GSK medically significant), shingles (Verbatim: Got shingles in my incision/Shingles) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the fractured hip, shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, fractured hip, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, fractured hip, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-Mar-2023 The case was received from the patient via interactive digital media. The patient had the shingles shot and it did not work for him/her.  The patient had broke his/her hip and had a hip replacement and before incision healed, got shingles in his/her incision.  The patient stated that hip replacement was less painful than the shingles. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
SORE ARM - 4 days after the first and second shot - Not treated. HEADACHES - Bad headaches 2 1/2 weeks after the first shot for about 4 days.  More mild headaches again after the second shot continue.  I rarely get headaches.   Not treated BODY ACHES  - for 4 days after the first and second shot - Not Treated FEVER - of about 99.5 F for 3 days after the first and second shot. Not treated. LEFT KIDNEY PAIN - For six days after the second shot which has gone away.  Not treated VASCULITIS -  Bulging temporal veins on the side of my forehead for 3 days after the second shot.  Not treated.
I had a rash that was really hot to touch, it covered pretty much my whole upper arm.  This lasted for about 3-4 days. I called the telehealth and they prescribed a antibiotics and they believed it was cellulitis.   After my second dose I didn't have this rash but some moderate flu like symptoms.
Patient had rash on back and side. The rash then spread to hips/legs and arms. The rash on legs slightly clearing up. Discoloration on part of arms as well.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 immunisation.     No Medical History information was reported.  On 27-Apr-2021 at 1:51 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 1:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 58.33.  Concomitant product use was not provided by the reporter.  Batch number 007C21A underwent temperature excursion on 27-Apr-2021 with temperature 35 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 19-Apr-2021, beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 27-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a temperature monitor at every hour.  Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).
pain all over his body.; Caller states her husband is not able to do things he used to be able to do, like he can't run or play outside with his grandkids.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558).  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose 2, 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, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "pain all over his body."; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "Caller states her husband is not able to do things he used to be able to do, like he can't run or play outside with his grandkids.". Therapeutic measures were taken as a result of pain, loss of personal independence in daily activities. The reporter stated that after his husband got the second dose of the Pfizer-BioNTech COVID-19 Vaccine, he started experiencing pain all over his body. He's in a lot of pain everyday, not able to do things he used to do before taking the vaccine. It doesn't matter what medication he takes, it doesn't help.  He has visited different doctors and no one is really able to help him. Caller states her husband is having a lot of pain and he has been in a lot of pain. Caller states he has been in and out of the doctor and he has been on all kinds of medicine and nothing is helping him. Caller states her husband is not able to go to work, because he is in pain every single day. Caller states her husband is not able to do things he used to be able to do, like he can't run or play outside with his grandkids. Caller states it hurts her seeing him in pain and not able to play with the grandkids, it is horrible. Caller states it started after his 2nd dosage and he has been in pain ever since. Caller states if, they give him a different pain med, it will kind of ease up for a while but it will never go away. Caller clarifies his pain is all over.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Left leg hurting bad, cramping really bad, Charlie Horses, knee hurting and calf muscle area, my sugar levels were a little higher because of the pain for the first 72 hours now just a little elevated
Severe itching that lasted a few days along with inject site swelling. Events started 2 hours after the injection
This is a 62-year-old male with a history of high cholesterol, coronary artery disease and stents, who presents to the emergency department with a complaint of 4 to 5 days of dizziness.  Patient describes the dizziness as a combination of presyncope and ataxia.  He says he has been walking into things and falling into things for the last 4 days.  He also describes symptoms of a headache that goes from the left posterior neck and radiates up the left side of his head sharp pain moderate in intensity.  He also reports that today he had some sharp left anterior chest pain that lasted only a few minutes and is spontaneously subsided.
No ADR Resident received her first primary dose as a Bi Valent dose on 12/8/2022.
This spontaneous report was received from a physician via field representative referring to an 1 year old female patient. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date (at the age of 1 year), the patient was vaccinated with VARIVAX (strength, dose, route of administration, lot # and expiry date were not reported) for prophylaxis. The physician informed that on 16-NOV-2018, the patient came into the office for something unrelated (unspecified). The patient mentioned that she had a rash on her right thigh and had been there since receiving the shot with varicella VARIVAX at the age of one year. The patient had not been to the doctor or emergency room and had not received treatment for the adverse event. The event was not life-threatening. The outcome of rash was unknown. Causality assessment was not provided. There was no product quality complaint (PQC) reported.
No additional AE; PROQUAD was administered after a temperature excursion; This spontaneous report was received from a Medical Assistant and refers to a patient of an unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 01-SEP-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #W006585, expiration date: 23-AUG-2023) (strength, and route of administration were not provided) for prophylaxis. No adverse events were reported. According to the reporter, the temperature excursion was 1.6 degrees Celsius for a time frame of 2 hours 10 minutes on an unknown date, without any previous temperature excursion.
On third day my left hand swelled and turned red, was very sore, could not drive 1st day, in 2 days I could drive, gone in 4 days but on Wed. Nov 12, my teeth became very sensitive to cool and cold drinks, OK by Sunday 11-16-14.
fever; injection site is red; injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced PYREXIA (fever), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site swollen). At the time of the report, PYREXIA (fever), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site swollen) outcome was unknown.            No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.
Patient was vaccinated on 1/22/21 and 2/12/21, so was fully vaccinated when testing positive for COVID-19 on 9/26/21.
I got the 2nd dose Moderna vaccine yesterday and was up all night with chills, fever, aches and by far the worst headache I have ever had. I almost went to the ER it was so bad. I have had burns, kidney stones, migraines and all kinds of pain in my life but this may have been the worst. Still feeling ill today but somewhat better. I had a reaction in the 1980's to a tetanus vaccine that was just a high fever. The headache was intolerable so I took some Aleve
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date not reported) for long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, the patient was treated by a physician for shingles. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX), Plaintiff has and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not reported.
3 weeks post-immunization patient started experiencing left elbow pain followed shortly by shingles-type rash on left hand and burning sensation at night localized to left arm. The rash on hand worsened and within a few days resulted in full thickness skin loss on middle finger of left hand.  Patient is a plastic surgeon and put himself on a 7 day course of valacyclovir 1 gram three times day. He then went to his PCP and prescribed Gabapentin 100mg 3 times daily. By 7/27/19 the pain was gone but the skin damage remained although was in the healing stages. Patient is convinced that the Shingrix vaccine caused him to have a shingles outbreak.
I did not have an adverse event to the vaccine but I did contract Covid so I was told to fill out this form anyway.  I started out with a runny nose and cough. It turned into severe fatigue and total loss of smell. It lasted about 2 weeks. I regained 50%+ of my smell since then, and most of my energy back, but still have a cough.
Fainted around 3:00 am on 4/17/2021. Fortunately, I was able to catch my fall by holding on to things, so  no major injury.
Pt mom called on 15OCT91 & stated pt had sz on the evening of 14OCT91 while in ER for tx of fever & ear infect;
Several minutes after vaccine patient complained of dizziness and "feel funny".  Also complained of "legs feel weak".  Stated she usually does not have issues after vaccines/shots.  States left arm "hurts" but had vaccine in right arm.  She has history of cardiac stents.
2 hours post injection patient vocalized lower abdominal discomfort accompanied by multiple episodes of diarrhea following day diarrhea subsides but patient notes lethargy, blurred vision, chills/fever (max 102) and itchy, tender,  red induration to left deltoid at injection site. Induration has enlarged to current 11cmx9cm in size.  Area marked for monitoring
Information has been received from a consumer concerning a female who was vaccinated on an unknown date with a dose of MMR II (lot not given). The reporter stated "a little girl up the street died after an allergic reaction to MMR." It was also indicated that it was unknown if the pt sought medical attention. Additional info has been requested.
Flu symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu symptoms). At the time of the report, INFLUENZA (Flu symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.    Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: Follow-up information received on 02-JUN-2021 does not contain any new information.
pt recv vax 17APR98 & w/in 24hr blood lab values revealed some viral lymphocytes: lymphocytes 70% segmented neutrophils 26%, monocytes 2%, eosinophils 2%;
Low grade fever (100.4) General acheyness,  Chills all lasting about 21hrs Took Tylenol PM at bedtime
5 PM-11/5 Thursday-Friday night 11/6 8:30 PM-starting to itch arms and legs, bottom and 1 on face-hives-10 P BENADRYL by MD order. Cleared by 8 AM Sat. Sat 11/7 9 PM-wake up itching-arms, legs, bottom, some hives on face, BENADRYL. Sunday AM 11/8-1 more dose BENADRYL.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from product quality group.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 as dose 1, single (Lot number: EK4176), in left arm, on 26Jan2021 as dose 2, single (Lot number: EL3247), in left arm and on 08Oct2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 66 years oral, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: VALACYCLOVIR HCL oral; LEVOTHYROXINE SODIUM oral; ATORVASTATIN CALCIUM oral. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Vaccination failure", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Headache, Myalgia, Arthralgia, 99.5 h/a muscle aches, joint aches Narrative:  Other Relevant History:
inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for an unknown indication.   Previously administered products included Shingrix (1st dose was received on 23rd November 2018).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. The action taken with Shingrix was unknown. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient wanted to receive 2nd dose at the time of reporting. The batch number and expiration dates were not provided as the first dose of the vaccine was administered in another facility.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Known allergies: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.