chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist and a male consumer, concerning the consumer, who in December 2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 658075/0962U). The pharmacist reported on 13-DEC-2007, that the patient had a high fever after the vaccination, and that the patient had swelling and local induration at the injection site. On 13-DEC-2007, the patient also reported that he had a fever of 102 degrees, and that he "cannot stop throwing up." The consumer called to ask for treatment recommendations. Additional information has been requested.
Initially on day of vaccine 2/15 arm became moderately sore.  Next day awoke with slight asthma and some coughing.  Did not need inhaler.  Arm soreness gone by 2/17 One week later on  2/22 arm became very sore.  On 2/23 arm sore and noticed some itching.  Red rash on upper arm surrounding injection area.  Over the course of 4 days soreness subsided, rash lessened but still faint in blotches by Friday evening 2/26.
Fever up to 103.3 deg C, Cough, Sore Throat, Vomiting.
Got 2 Shingrix doses, Got Shingles outbreak/Suspected vaccination failure; Shingles outbreak in 2021; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Got 2 Shingrix doses, Got Shingles outbreak/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles outbreak in 2021). 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 Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 27-JUN-2023 The physician reported that her and her partner medical provider had between 5 to 7 patients experience a shingles outbreak after the patient completed the full 2-dose series of Shingrix, doses unknown, 2 doses each patient at unknown intervals. One patient had the shingles outbreak in 2021.  The outcome of the shingles outbreaks was reported as unknown. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up. This case is 1 out of 5 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR089463:Same reporter US-GSK-US2023AMR089464:Same reporter US-GSK-US2023AMR089467:Same reporter US-GSK-US2023AMR089457:Same reporter
Significant redness, pain at inject site still 1 wk later. PT came in for recheck. Told to monitor. No evidence of infection or other trauma.
Pt born w/chromosomal & cardiac abnormalities; Hospitalized 6NOV91 w/UTI per clinic; died 11NOV91 COD bradyarrhythmia due to CHF due to congenital heart defect;
Patient received the vaccine today at 9:30 am  at 7 pm the patient called the pharmacy and stated that they had broken out in a rash at the bottom of her throat and in her private parts.  The patient was instructed to take 2 benadryl 50 mg tablets for the reaction and to follow up with the er if there is difficulty breathing.
Pt was given first dose of Moderna vaccine while inpatient today (02/09). I sent the after visit summary and discharge summary to his nursing home. Was then notified by nursing home liaison that the pt had already received both doses of the Pfizer vaccine at the nursing home (second dose on 02/03).
a pregnant patient was inadvertently administered GARDASIL 9 prefilled syringe yesterday, instead of TDAP vaccine; a pregnant patient was inadvertently administered GARDASIL 9 prefilled syringe yesterday, instead of TDAP vaccine; This spontaneous prospective pregnancy report was received from a registered nurse referring to a 32 years old female patient. No information regarding pertinent medical history, concomitant medication, drug reaction or allergies was provided.    On 01-DEC-2020, the patient was inadvertently administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687292, expiration date 25-AUG-2022; dose number and route were unknown) for prophylaxis instead of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (TDAP) (exposure during pregnancy, wrong product administered). The patient was 30-week pregnant. Last menstrual period was on 05-MAY-2020. Pregnancy outcome was pending. The outcome of the events was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
breaking out in hives about two weeks after the booster shot. this also happened after my first booster shot a year ago. the hives are chronic and previously lasted for about 4 months. i treated with zyrtec once a day which helped stop break outs, but my skin would immediately become red and streaky in the shower, when i sweat, or if i scratched anywhere even once. symptoms this time have been increasingly getting more severe over the last week. i am taking zyrtec once a day.
Pt 4 mo pregnant and was given H1N1 FLUMIST which is contraindicated.  When I got the H1N1, I had home test pregnancy that came out positive, but week later had another one and it was false alarm.  (negative) Pt confirmed not pregnant at time of vaccine.
fainted; low blood pressure; fever; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 01May2021 (Batch/Lot Number: Unknown) as 2nd dose, single dose (at the age of 28-years-old) for COVID-19 immunization. Medical history was not reported. The patient did not have concomitant medications: the patient did not have any other medications the patient received within 2 weeks of vaccination. The patient received the first dose of 12Apr2021 BNT162B2 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks. On 02May2021, around 24 hours after receiving the second shot of COVID vaccine the patient fainted due to fever and low blood pressure. The patient required emergency room/department or urgent care. The patient did not receive treatment for the events. The patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Heart palpitations immediately (2/16 at 6:15pm) but subsided within 10 minutes. Nausea started about 8pm night of vaccine along with extremely sore arm. Nausea persisted all night and at 5am felt like I was going to be sick so went to bathroom. Sat down on toilet and don?t remember anything until I woke up on bathroom floor with two knots on my head. Unsure if syncopal episode or seizure as I have multiple knots on head and my belongings from my pockets were strewn about the floor. Body aches began around noon day after shot along with low grade temps and chills. Nausea and headache persists today (2/18) but I am unsure if that is from vaccine or head injury.
the patient is "not feeling the best today" as she received multiple vaccines yesterday; adult patient was administered a pediatric dose of VAQTA yesterday, 21-APR-2022; adult patient was administered a pediatric dose of VAQTA yesterday, 21-APR-2022; This spontaneous report has been received from a registered nurse and refers to an adult female patient.  The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 21-APR-2022, the adult patient was administered a 0.5 milliliters (ml) pediatric dose of hepatitis a vaccine, inactivated (VAQTA) for hepatitis A prophylaxis (valid lot number U012525 for vial formulation, with expiration date 06-FEB-2023) (product administered to patient of inappropriate age and underdose). On the same date, the patient received varicella zoster vaccine rge (cho) (SHINGRIX) and unspecified rabies and typhoid vaccines (formulation, dose, indication, lot number, and expiration date were not reported). The dose number, vaccination scheme, route of administration, and anatomical location were not provided for any of the suspect vaccines.   On 22-APR-2022, the patient was not feeling the best (malaise), unresolved by reporting time.   The nurse reported that the patient was not feeling the best as she received multiple vaccines.
Mother, stated that he developed a red itchy area from the deltoid until the elbow last night, 11/07/23. Suggested following up with his pediatrician and suggested Benadryl 25mg 3-4 times a day for the itching and ibuprofen if there is pain.
Initially the usual fatigue, aching and mild fever which subsided; then 48 hours after injection, severe nausea for several hours; a round of violent vomiting then within an hour after vomiting,  discomfort was gone; no fever. I would?ve assumed it was possibly unrelated, however, 3 weeks later, the exact same symptoms occurred.
This spontaneous report as received from a nurse prescriber refers to a 22 year old female patient. The patient had no pertinent medical history, drug reactions/allergies and concomitant medications. On an unknown date "in the beginning of August 2017", the patient was vaccinated with first dose in the series of GARDASIL 9 (strength, route, lot/batch# and expiration date were not reported) for prophylaxis. On an unknown date in August 2017 (reported as"fairly soon after, receiving GARDASIL 9", the patient felt tired, nauseated and achy. It was reported that treatment was provided, however, it was not specifically known what treatment was provided. No lab diagnostics/studies were performed. There was no product quality complaint(PQC) involved. The symptoms of the events lasted for "3-4 days" and were then recovered. The causality assessment was not provided by the reporter.
pt recv vax & 4 hr p/vax exp rash on arms & hand;rash cleared w/in 24hr;RN was not aware @ time of vax that pt had already had 3 doses of Engerix-B @ a prior time;
soreness in wrist and elbow; soreness in wrist and elbow; forearm ligament is inflamed; wrist was making a clicking sound; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetic and thyroid. The patient previously took internal iodine for unknown indication and unknown start date and experienced iodine allergy. Concomitant medications included Insulin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID) and simvastatin (MANUFACTURER UNKNOWN) all from an unknown date and for unknown indication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6199) via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Mar2021 at 06:00 approximately after 36 hours of vaccination, patient woke up in the morning and experienced clicking sound in the left outer wrist every time he did the movement, this was ongoing for two weeks and had not gone away. On 25Mar2021, the patient also experienced soreness in wrist and elbow. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient went to the chiropractor twice to get help and the chiropractor stated that the forearm ligament was inflamed. Therapeutic measures were taken as a result of the reported events which included treatment with massage, manipulation and taping of arm and wrist. The clinical outcome of the event clicking sound in the left outer wrist, soreness in wrist and elbow were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient given vaccine that was improperly stored (placed in freezer) and considered expired by manufacturer at time of administration
pain at injection site within 24 hrs. Now fever, chills, body aches (101.4)
Constipation started on Friday and has continued all day Saturday.  This did not happen after either of the first 2 doses.
Patient brought to the ED by EMS on 12/12/22 for evaluation of shortness of breath and increasing weakness. Prior to arrival, he was tested for COVID by staff from his assisted living facility and the test returned positive. Additionally he was tested for COVID by PCR in the ED and this also returned positive. Patient was admitted 12/12/22 - 12/19/22 for acute hypoxic respiratory failure and COVID-19 pneumonia, among other diagnoses. Over the course of his hospitalization, he was treated with steroids and antibiotics and was transitioned back to room air.
received a dose of Boostrix that had been frozen; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 40-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st July 2022, the patient received Boostrix (intramuscular) .5 ml and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving 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: 05-JUL-2022 Reporter's Comments: The reporter reported that the patient received a dose of Boostrix in right arm that had been frozen. The patient was getting the vaccine because he was due for his 10 year booster. The patient was not exhibiting any symptoms. The reporter consented to follow up. Additional Supportive Information:  The patient received Boostrix that had been frozen, which led to incorrect storage of drug.
Rash still around site of injection.  General dermatitis that is dry, itchy with moderate bumps.  Enflames randomly and is itchier at some times more than others.
Diabetic ketoacidosis, been in ketosis (sometimes ketoacidosis) ever since.
Patient received second Moderna vaccine. Went to observation room and complained of weakness, dizziness and felt faint. Patient did not faint; remained conversant and drank a bottle of water. VS stable.
rash appeared on torso day 5, diffuse blanching, slightly itchy, progressed, covering entire back by day 5 post vaccination.
Itching Injection Site; Roughness in the skin of the Injection Site about 2" inches.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching Injection Site) and VACCINATION SITE REACTION (Roughness in the skin of the Injection Site about 2" inches.) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) 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) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching Injection Site) and VACCINATION SITE REACTION (Roughness in the skin of the Injection Site about 2" inches.). At the time of the report, VACCINATION SITE PRURITUS (Itching Injection Site) and VACCINATION SITE REACTION (Roughness in the skin of the Injection Site about 2" inches.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Information has been received from a nurse at the physician's office concerning a 14 year old female patient who on an unknown date was vaccinated with the first dose of GARDASIL (lot # and route not reported). On an unspecified date the patient received the second dose of 0.5 ml GARDASIL intramuscularly (lot # not reported). Concomitant therapy was not reported. After getting the second dose of vaccine the patient experienced seizure like reaction. The nurse also reported that the patient had a similar reaction after the first dose as well. The patient had sought medical attention and had recovered from the seizure like reaction "after stopping therapy". Upon internal review, seizure like reaction is considered to be an other important medical event. Additional information has been requested.
Initially when I received the vaccine, I had tremendous pain in my arm that lasted for days.  Then two months later I started having shortness of breath and chest tightness.  Six months after the vaccine I was diagnosed with a DVT in my left leg and massive bilateral pulmonary emboli.  I was hospitalized for 5 days and put on heparin.  I am now on Elequis.  I am under the care of a pulmonologist.  I saw a hematologist and am following up with Cardiologist.
The morning after my second vaccine I had pain in hands. It lessened for about 2 weeks but increased and has not stopped. Both hands are equally effected. All fingers hurt, have carpel tunnel symptoms too and now wear braces at night.  Difficult to grip, weak, not just joints but bones in fingers as well.   Nothing worsens or improves it. I am taking meloxicam 15 mg with minimal improvement. Following up with Rheumatology.     I had no symptoms prior and since day after second vaccine have had significant hand and finger issues.
Diagnosed March 11th with APL. No family history. Injected with first round of HPV vaccine February 14, diagnosed with APL March 11th. Acute onset; no tangible symptoms until roughly 10 days before diagnosis (anemia, fever, night sweats)
sz occurred for 2-3 mins; MD was aware of sz hs/ spent 4-5 days in hosp in NOV93;
was really sick w first dose; was due for 2nd dose of vaccine in January; This case was reported by a consumer via call center representative and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced malaise and incomplete course of vaccination. On an unknown date, the outcome of the malaise and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose. The age at vaccination was not applicable for this report for the 2nd dose. The age group was not reported but it was selected as adult as per the vaccine indication. The patient was sick with 1st dose and was due for 2nd dose of vaccine in January, which led to incomplete course of vaccination. The reporter wanted to know  was it too late to get on at the time of reporting. The reporter asked would it affect patient ability immune system to fight off Covid.
After my covid shot (Moderna) on June 17, my are hurting in that area for at least a month.  Sometime in late July early August the soreness when from my arm to underneath my arm close to my right breast area.  At time I would feel a sharp but bearable pain in my chest area.  I would not lost longer than a second or two.  Than the soreness moved to the lower area of my breast, than to the top area of my breast.  In mid to end September I decided to have a mammogram as I thought I had breast cancer.  The test came back negative.  However the uncomfortable feeling which is now mild, but is still very noticeable is still in that area.  I never had any of these symptoms until I took the covid-19 vaccination.
Patient said that she is experiencing extreme fatigue and chronic pain in her hip back neck. she can hardly walk. She stated that she falls asleep any where. She has a strange feeling in her chest. She is experiencing breathing complications. She has a hard time drinking water without choking. She stated that she has a high tolerance for pain, but this pain is unboreable.  She stated that she was taking walks and now she can barely walk to her car without loosing her breathe.