chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose 04Dec2019, 2nd 1Dec2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number 43Y5R, expiry date 8th February 2024) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (first dose was received on 04 December 2019).   On 1st December 2022, the patient received the 2nd dose of Shingrix. On 1st December 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.      Additional Information: GSK Receipt Date: 01-DEC-2022 Reporter's comments: The pharmacist had reported that a patient did not receive the second dose until 01 December 2022. The pharmacist did not had the lot number information from the first dose and had provided the lot number information from the second dose administered to the patient. The reporter had consented to follow-up. Additional supportive information: The patient had received the second dose later than the recommended interval, which led to lengthening of vaccination schedule.
Redness & swelling at injection spot. Itching at injection spot. Fatigue, headache, nausea, & fever
No adverse events; Patient was given two dose of PedvaxHIB accidentally / Two doses given in the same day; This spontaneous report has been received from a nurse concerning a 18-month-old male patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 11-JUL-2022, the patient was accidentally vaccinated with two doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter (lot number U034521 has been verified to be a valid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), expiration date reported and confirmed as 21-JUN-2024) (formulation and route of administration were not provided) in his left thigh as prophylaxis (Accidental overdose). The patient was held for thirty minutes after these doses were given and then released by the doctor. The patient had no adverse events reported before he was discharged.
p/vax pt awakened during the noc w/a low grade fever 100 & c/o h/a, body aches;
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of influenza like illness (1st dose received on 4th August 2018. Please refer the case US2019065834). On 4th April 2019, the patient received the 2nd dose of SHINGRIX. On 4th April 2019, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too long. In April 2019, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms and drug dose administration interval too long were unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient experienced flu like symptoms. The patient two months late for 2nd dose, which led to lengthening of the vaccination schedule.
I had a sore arm for a couple of days after the vaccine - at the site of injection. I was tired for a couple of days.  Two days after the injection - I started experiencing a  chalky layer on my tongue. I felt like my tongue was a little bit swollen slightly. Two days after that, I started having a sour taste and white bumps towards back of tongue. I showed my OB/GYN and she told me go to the my primary care doctor.  My primary care provider wasn't sure what it was - could have been thrush - she put me on an anti-fungal mouthwash called Nystatin. I've been doing that - 5 ml rinse four times a day for seven to 14 days. The mouthwash isn't  helping so I will be scheduling an appt with my PCP for next week.   1st Pregnancy
This spontaneous report was received from an office manager in charge of vaccine storage and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-DEC-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M042504 with expiration date of 30-NOV-2017, for prophylaxis (strength, dose, route and frequency were not reported). No adverse effects were reported in the patient.
chills; arm pain; rash all over body; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 at 10:00 as dose 3 (booster), single (Lot number: FK9894) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EW0185, Location of injection: Left arm, Route of Administration: Intramuscular), administration date: 29Jul2021, when the patient was 34-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: FD8448, Location of injection: Left arm, Route of Administration: Intramuscular), administration date: 19Aug2021, when the patient was 34-year-old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Apr2022, outcome "recovered" (Apr2022), described as "arm pain"; CHILLS (non-serious) with onset 19Apr2022, outcome "recovered" (Apr2022); RASH (non-serious) with onset 19Apr2022, outcome "recovered" (Apr2022), described as "rash all over body". The events "chills", "arm pain" and "rash all over body" required emergency room visit. Therapeutic measures were taken as a result of chills, pain in extremity, rash.  Additional information: The Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received within 2 weeks of vaccination any other medications was not applicable. treatment received for the adverse event was Benadryl. Seriousness criteria did not leads to death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect . Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Patient had a positive COVID test on 1/31/2022 and passed away on 2/13/2022.
1st dose - Soreness and swollen at injection site for around 8 days; 2nd dose - Soreness at injection site and fever of up to 100.7 for approximately 24 hours..
approx 2 1/2hr p/vax pt devel a shrill scream which lasted 3hr;would not take the bottle during this time;was restless throughout the noc-sleeping & eating much less than usual T102 w/APAP being given q4hr;lt leg was very sensitive to touch
reaction: chest discomfort, SOB, urinary frequency, redness and swelling at injection site. hypertension, muscle ache and low grade fever of 99.9. Treatment: EKG. tylenol, ice to area Improved at discharge Seen in office on 6/24/19 at 1pm and swelling has gone down, denies chest pain and shortness of breat. Arm is still red, and warm to touch but improving
The pt received bother her five year old DPT and MMR. She went out  to the waiting room and was playing with her brothers for approximately 10 to 15 minutes. She then developed sudden pallor, marked diaphoresis, weakness and perioral cyanosis. He mother brought her back in the exam room where she was place on the exam table, he blood pressure was initially 100/70 and dropped to 90/60. She was very lethargic and oxygen was started. He pulse was approximately 111. She was responsive, but very sleepy. she had not stridor and no rales, no wheezes. The Rescue Squad was called and she was taken to the ER. At this time her blood pressure is better at about 116/80. She has less pallor, her pulse is 100. She is still markedly lethargic. She continues to be without stridor. Two physicians feel that this is compatible with a vascular anaphylaxis and she will be admitted for IV fluids and observation.
Pt recvd 3 doses of Engerix-B 13MAR90, 2MAY90, & 13SEP90 & was found to be a non-responder;
Patient was given the wrong dose of  Pfizer Covid vaccine on 6/15/2021 at 9:30AM. Administering nurse, RN, did not dilute doses in vial and administered 0.3ml of undiluted Pfizer covid vaccine. Administering nurse stated that she had three other nurse verify the dose in syringe and the vial, prior to injection. Immediately following injection and noting that the vial did not contain enough for subsequent doses administering nurse reported to Healthcare administrator, of the error.  Report was then given to Medical Director, . Employee, at Department of Public Health, who then reported to her immediate supervisor at DPH.  Patient was then advised by DPH to submit VAERS form, and to inform patient of event and instruct patient to report any signs and symptoms of Covid vaccine overdose. Medical Director advised that patient could remain in room, that monitoring inside infirmary was not necessary at this time.     Patient was brought back to the healthcare unit,  at 12:10PM, and informed of the error,  educated on signs and symptoms of Covid vaccine overdose and instructed to report any noted immediately. Patient verbalized an understanding and denied any signs and symptoms at that time.
Left cheek and jaw pain, followed by erythematous macular rash on trunk (primarily on left side), headache, fatigue, diarrhea, chills.
2/24/22 pt admitted to hosp from transitional care center (after having a stroke and experiencing deficit) positive for COVID; increasing SOB; suspected aspiration pneumonia; transferred to ICU; required ventilator (x 21 days); given ABX; despite treatments, pt was brain dead; family made pt a DNR, comfort care and pt expired in the hospital
up feeling really dizzy; bad headache; felt like she couldn't walk; This is a spontaneous report from a contactable consumer.  This female consumer (patient) of unknown age reported that received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown) on 10Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. The next day she woke up feeling really dizzy, like a really bad headache, felt like she couldn't walk. At the time of reporting the outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
chills; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID:   A 33-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 included: "Cold" (unspecified if ongoing), notes: Never had anything in his life other than regular cold in cold season; "droopy eyelid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "chills". The following information was reported: CHILLS (non-serious), outcome "unknown".  Additional Information: It was reported that does not know dates of vaccines. He got the first two like a few months after they became available to the general public beyond the front line workers and he was fine after those, he had the usually expected like chills. Patient was ocular he has a droopy eyelid and usually within 2-3 years will progress generalized to other muscles. She thinks it was his left eye and started like 5 weeks ago.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202201369613 same patient/drug/AE, different dose; PFIZER INC-202201368953 same patient/drug,different AE/ dose;
She had a deep croupy cough that lasted 12 hours. We administered some ibuprofen, Motrin and Tylenol for the first few days. She only coughed for one day. We tested her for COVID-19 on Wednesday August 03, 2022. We just watched to ensure symptoms but they were got worse. She has completely recovered but is still testing positive.
No reactions between June 9tha and June 14th.  Sudden death on June 15th in am.  No Autopsy Done.
Patient received 2nd covid vaccine on 1/25/21. That evening, EE experienced left shoulder pain and difficulty with range of motion.  Has experienced 5/10 pain at same location every day since, for almost one month.  Tylenol and Motrin have not helped to reduce the shoulder pain.  EE has been unable to sleep on her left side.  Per EE email; "The RN that gave me the vaccine went very high and injected at my shoulder bone."  No other symptoms.  EE stated that she is visiting her NP next week for an assessment of left shoulder.
Patient complained of itching at injection site. Injection site also swollen. Vital signs stable. Patient given 50 mg of Benadryl. After 30 minutes, patient left with no itching and swelling went down. VS normal.
A legal complaint was received from an attorney alleging that a male child received Hib-TITER, Acel-Imune, and hep B vaccines from April 1999 through July 2000. According to the legal complaint, the child subsequently "was poisoned" by the cumulative doses of the mercury preservative, thimerosal, in the vaccines. It is alleged that the child "now suffers, and in the future will continue to suffer, from the toxic neurolgoical effects of mercury poisoning." No further info was available at the date of this report. This case was serious since these events are considered medically important (OMIC).
The patient developed an injection site reaction that occurred later after the shot (approximately 6 hours). It included erythema moderate swelling and warmth and tenderness.
Feel sleepy; Arm pain; This is a spontaneous report from a contactable consumer (patient) communicated through Pfizer sponsored program.   A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date (75-year-old at the time of vaccination) as unknown, single dose for COVID-19 immunization. The patient's medical history was not reported. The concomitant medications included Tofacitinib citrate (XELJANZ XR) at 11 mg. During inbound call from the patient, the patient stated that the Pfizer Covid vaccine, patient experienced feel sleepy, arm pain. Patient was not transferred to Pfizer Safety. Patient was prescribed Xeljanz XR 11mg. The outcome of the event was unknown.  Information about lot/batch number has been requested.
pain in lymph node under the arm; This case was reported by a consumer via call center representative and described the occurrence of lymph node pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced lymph node pain. On an unknown date, the outcome of the lymph node pain was unknown.   It was unknown if the reporter considered the lymph node pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had pain in the lymph node under the arm, after first shot of Shingrix. The reporter consented to follow up. For tolerance to the 2nd dose of Shingrix, refer case US2019171918.
lethargic; weak; lousy; voice is very low; headache; very sore arm; trouble raising his arm above his head; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (very sore arm), LIMB DISCOMFORT (trouble raising his arm above his head), LETHARGY (lethargic), ASTHENIA (weak) and MALAISE (lousy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL TARTRATE (LOPRESSOR) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced PAIN (very sore arm) and LIMB DISCOMFORT (trouble raising his arm above his head). On 17-Feb-2021, the patient experienced LETHARGY (lethargic), ASTHENIA (weak), MALAISE (lousy), DYSPHONIA (voice is very low) and HEADACHE (headache). At the time of the report, PAIN (very sore arm) had not resolved and LIMB DISCOMFORT (trouble raising his arm above his head), LETHARGY (lethargic), ASTHENIA (weak), MALAISE (lousy), DYSPHONIA (voice is very low) and HEADACHE (headache) outcome was unknown.            Other concomitant medications included cholesterol medicine. The patient did not receive any treatment medications for the symptoms.   This case was linked to MOD-2021-203598, MOD-2021-203598 (Patient Link).
Green stool for 2 days- no treatment. Stool returned to normal after 2 days. Pain in left arm and left arm pit- no treatment. Pain subsided for the most part.
watery eyes; persistent cough; runny nose; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  Caller stated she was scheduled to receive the second dose of the Pfizer COVID vaccine this afternoon around noon. Caller stated she began to have a persistent cough, runny nose, and watery eyes in Apr2021 since Easter. Caller would like to know if she should receive the second dose today. No information in PI regarding cough, runny nose, and watering of eyes after Pfizer COVID vaccine. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After administering AFLURIA influenza vaccine in right deltoid, a rash on right arm and itching began about 10 minutes later.
Rash that started on stomach and spread to extremities, I took a. prescribed medication and Benadryl for 10 days and then it cleared up.  The same thing happened after the second dose Lot # EN6200 on 02/20/2021
10-16-19 Very significant pain to entire upper L arm. 10-18-19 L arm pain continued and spread to L side of neck. 10-19-20-Pain L side of neck and L clavicle pain. 10-20-19 Pain L side of neck with decreased range of motion turning neck to left and left clavicle pain. Mild malaise. 10-22-19 Persistent clavicle and neck pain and sore throat began on L side. Mild URI symptoms. 10-23-19 Clavicle pain worsened and L clavicle swelling noted. 10-24-19 L tympanic membrane swelling noted on exam.
I had a fever and chills on the morning of 28th of March.  I was able to take some medication and was able to function.  The next morning, I woke up again with chills.  I took a COVID test, and it was positive, I had a minor cough.  I have not retested but I have been going out with a mask.  I still am feeling tired.  The main symptoms are gone sore throat and chills.  I was prescribed Paxlovid.
arm was in pain; some areas of redness on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was in pain) and ERYTHEMA (some areas of redness on arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm was in pain) and ERYTHEMA (some areas of redness on arm). At the time of the report, VACCINATION SITE PAIN (arm was in pain) and ERYTHEMA (some areas of redness on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. vaccination site pain and vaccination site erythema are consistent with the product safety profile
9cm area of tender erythematous induration surrounding injection site, flu like symptoms developed within 4 hours of injection.
Day after vaccine I had a large, red rash on left arm that was hot to touch.  6/15 I got another rash on my right knee that was red and hot to touch with blisters.  6/16 another rash (same type) on my right calf.  6/17  one above my right ankle on the inside.  6/18 another rash on my pinky toe, but left leg.  All rashes red, hot to touch, itch at first, but become painful.
This issue might/might not have impacted this individual. We identified a possible storage and handling issue of one particular vial of vaccine that might have made the vaccine less potent on June 16, 2022. Doses from this vial were given to 9 children on the date June 16, 2022. 17 children were vaccinated that day and we have been unable to identify which 9 children received doses from the vial that was impacted. The vaccine was reconstituted and replaced into the refrigerator for what inadvertently became too many hours before it was used. We did extensive research with Pfizer, the CDC and the local Department of Public Health and have received documentation back from the correct medical unit at the company Pfizer, who researched this vaccine being out of range for possibly 2 additional hours than what they had data for as of June 2022. Each of the 17 children is being offered an additional dose now, 8 or more weeks after the possibly "invalid" dose and is encouraged to discuss this with their pediatric primary care provider, who has also been notified by me. We suggested the 8 week delay to potentially reduce the risk of side effects including myocarditis in children after an mRNA if another dose was given sooner. It has now been 8 weeks since that clinic and this child has been offered an additional dose.
On April 9th, I developed a headache at 9pm while watching tv. About 15 minutes later I noticed my vision was changing so I called my daughter to come stay with me and took tylenol fast release capsules. I went to bed and woke up the next morning with the same headache so I asked my daughter to take me to urgent care. Upon arrival they did a Covid test. I told them about my previous stroke in July 2020 and that I had a PFO closure done in October and have been on Plavix (clopidogrel) since then so I wasn't worried about stroke. The dr sent me to the ER immediately and they performed an MRI scan and told me I had suffered a new stroke due to blood clot.