chrisvoncsefalvay/vaers-outcomes huggingface dataset:
already had both doses of Shingrix in 2019 / 3rd dose; tired; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received a dose in 2019 in an unknown arm) and Shingrix (received a dose on 15th March 2019 in an unknown arm).   On 22nd June 2020, the patient received Shingrix (intramuscular). In June 2020, less than a week after receiving Shingrix, the patient experienced tiredness. On 22nd June 2020, the patient experienced extra dose administered. On an unknown date, the outcome of the tiredness and extra dose administered were unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The patient's wife reported that, her husband was at his physician's office for a pre-op appointment on Monday, 22nd June 2020 and the office suggested that he never received the second dose of Shingrix so they administered the dose.  When he arrived home, his wife informed him that, he already had both doses of Shingrix in 2019.   They contacted the physician's office and they claim that there was a 3rd dose now and that he would not be charged.   The patient's wife was concerned about him getting the extra dose because he was so tired now.   She claimed that, the patient started to get tired later in the day on Monday or Tuesday, on 23rd June 2020. The patient's wife claimed that he stated that, on the day of reporting he could go back to bed in the morning after getting up.   The patient's wife did not have information on when the patient got the 3rd dose.   The patient's most recent dose was administered in his right arm and the other two were in different arms. The reporter was consented to follow up.
after 5-7 minutes after the administration of the vaccine, patient approached the counter to report that he had fainted between the isles. in doing so, he fainted for  and fell down. regained consciousness immediately. but patient was very warm and clammy to the touch.. patient complained that his skin felt burning and  his right knee was hurting. Patient was tended until 911 personnel arrived.
headaches , sometime so severe that wake me up from sleep. happening every night  for last three nights, it started after 30 hours of getting the vaccine.  Headache is so severe that I feel like i will collapse.  during the day feels like weight on head and eyes feel heavy.
Mom called 11MAR92 to report pt had devel "hives" on back of neck spreading to back & trunk areas; Pt scratching @ these; Mom requested that pt be seen @ clinic; 18MAR92 pt has mild "cold";
Low grade fever  and general body aches starting at 1:00 AM (12 hours after injection).  At 9 AM, passed out in shower.  When I awakened (about a minute later) I was unable to stand so I crawled to from the shower to bedside, but passed out again when I tried to pull myself up from the floor into bed.  My wife called 911 and the local fire department responded.  The EMT took my blood pressure while I was lying on the floor with my feet elevated and it was 78/34.  The EMT called an aid car and I was transported to a local ER.  At the ER, I received 2 liters of fluids over the next 4 hours.  I had an EKG, chest X-ray, blood work, and urine analysis which all were clear.  After 4 hrs, I was released and returned home.
Information has been received from a healthcare worker, public health consultant, referring to unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of GARDASIL (lot # K008931, route, dose and expiration date were unknown) which were improperly stored (lot # K008931 in 30.6 Fahrenheit (F) for 69 hours). There was no previous temperature excursion. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Imbalance-immediately after vaccine. Two hours after being in bed, pain (fierce) woke me-shoulder upper arms and wrist continues. A month later pain of shoulder and hip area began. Got worse. End of third month, legs hurt all over in am. The leg pain has ceased. Shoulder and lower back continue
The patient first started to feel really warm. The patient felt like her head was swimming. Then the patient had chills. Her vital were prefect.
pt recv vax 19FEB95 & on 22FEB95 pt exp muscle weakness all over aching joints, tenderness, & fatigue;p/ 3 to 4 wk pt exp some improvement in sx;pt devel aching in rt arm which pt felt was unrelated to vax;
left arm hurt for 4 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Apr2021), described as "left arm hurt for 4 weeks".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The usual arm soreness and feeling of fatigue for a few days after.  Not sure the following is related, but mentioning here due to the small number of women who experienced severe issues related to blood clots. Light nose bleeds - mostly when blowing nose - chunks - persists. Also, have been menopausal but am now having a cycle - thin and light bleeding.
patient not feeling well after immunization, last night (9-26) blood pressure spiked to 180 / ? and daughter took her to ER. Was monitored for 2 hours and diagnosed with serum sickness per ER doctor.
Delayed injection site reaction following injection; Drug use for unapproved indication; This non-serious case was reported by a consumer and described the occurrence of injection site reaction in a 69-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number 35AD3) for prophylaxis.   Concurrent medical conditions included necrosis. Concomitant products included cefalexin (Keflex).   On 24-SEP-2023, the patient received RSV vaccine. On 24-SEP-2023, an unknown time after receiving RSV vaccine, the patient experienced drug use for unapproved indication (Verbatim: Drug use for unapproved indication). On 30-SEP-2023, the patient experienced injection site reaction (Verbatim: Delayed injection site reaction following injection). The outcome of the injection site reaction was not resolved and the outcome of the drug use for unapproved indication was unknown.   It was unknown if the reporter considered the injection site reaction to be related to RSV vaccine.     It was unknown if the company considered the injection site reaction to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 16-OCT-2023 This report was submitted via the online direct entry reporting system. The patient was not pregnant. The reporter seriousness for Delayed injection site reaction following injection: Intervention required. The patient received RSV for the indication Necrotic tissue, which led to drug use for unapproved indication.
Day 01 Day of Vaccination. Slight swelling of injection site. Fatigue and general stiffness. Day 02  More swelling of injection site. Slight headache starting in the afternoon. 6-7PM, chilled. Changed to overly warm by the time I retired for the evening. Day 03, all other symptoms gone except the swelling of the injection site, which was also turning red, and becoming slightly itchy. Day 04 Injection site swelling, redness, itchiness, and a slight sensation of an armpit gland swelling. Day 05 Injection site swelling, redness, itchiness. Day 06 Injection site swelling, redness, itchiness. Day 07 Injection site swelling, redness, itchiness.
No additional adverse event; MA reports a dose of ROTATEQ was given during a temperature excursion, later found supported; This spontaneous report was received from a medical assistant and refers to a 3-month-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 20-NOV-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 ml, orally, lot # 1660954, expiration date 07-MAR-2021, for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 48.4 degrees Fahrenheit for 15 minutes and 32.7 degrees Fahrenheit for 47 hours. Data logger was not involved. There were no previous excursions reported. There was no adverse effect reported.
Prevnar vaccine 9/11/06 10:00 onset aching and swelling left deltoid at injection site. Increasing NOC of 9/12/06 fussy, restless, poor sleep, 5x4 1/2 cm redness.
Ever since my first dose of my vaccination my left hand is stiff  in the early morning hours, I wake up about 4 AM It takes a while for my hand to be able to move comfortably.
Today (04/28/16) patient came to the pharmacy to ask to the Pharmacist, what should she apply to her arm where the vaccine was applied on 04/26/16. The injection site is red, itchy, inflamed, since last night (04/27/16). She reported that the night before, she start feeling an itch at the injection site. She applied Vicks in the injection site, scratched the affected area, and her slept the night before laying over the injection site, also she reported that she does not feel pain.
the patient received the unauthorized vaccine/ patient was not age 12 at the time that the vaccine was administered
Non-exertional chest pain with normal EKG, normal cardiac echo and a troponin elevation Question of myocarditis/pericarditis
I administered a flu shot to this emp who then C/O of pinching and burning in her (L) deltoid Ice was applied she was advised to us TYLENOL or Ibuprofen. She felt some better after 45 min. I followed up next day, she said burning and pinching gone but some soreness remained.
Within 5 minutes I had tingling in my neck/face in the chin area. That lasted for about an hour and then went away. I had arm pain at the injection site the same day and into the next. Then about 4 days later I started to have some lymph node pain in the same arm under my armpit. It is now 6 weeks later and I still have pain at the injection site and lymph node pain in my armpit.
Got Covid about 48 hours after getting the first shot; Headaches went away after receiving the vaccine; This is a spontaneous report from a contactable physician (patient's husband). A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included headache from an unknown date to 2021 (She had always gotten headaches). The patient's concomitant medications were not reported. She had always gotten headaches and she wasn't getting them anymore. It was statedthat it's very obvious that it's the Covid Vaccine that had gotten rid of headaches (Headaches went away after receiving the vaccine). She got Covid about 48 hours after getting the first shot (in 2021), so she was probably exposed to it before getting the vaccine. But she got better right away, so the Covid vaccine helped her. The patient underwent lab tests and procedures which included COVID test: positive in 2021. The outcome of the event COVID-19 was recovering, of the other event was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Vaccine BNT162B2 requires atleast a period of 14 days to be effective since vaccination of the first dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Marked erythema 20ccm x 12cm in diameter w/swelling more around the site of inject in rt arm; Started on Atarax & Augmentin;
Second dose.  First and second dose resulted in fever followed by chills and extreme fatigue for 2 days.  On day 3 noted a sensation in right leg.  I could palpate a superficial thrombosis in my right leg below the knee.
No symptoms other than a small bruise approximately 1cm in diameter that appeared 4 hours post injection. The bruise has slowly grown with more purple spots (bruise itself is greenish yellow) to 3.5 cm as of 2pm 2/13/2021.
Swelling of all upper arm, heat, itchiness, and vesicles at injection site.
FEVER; FATIGUE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced fatigue. On 23-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on MAR-2021, and had not recovered from fatigue. This report was non-serious.
At 1PM on 01/02/05 had a temperature of 103, a seizure that lasted 60 to 90 seconds, breathing stopped and child turned blue. The patient was take by ambulance to the ER, where it was diagnosed they had bilateral otitis media and put on Zithromax for 5 days. Has been afebrile since the morning of 1/3.
Sometime that evening, patient reported: difficulty breathing, profuse sweating, swelling at injection site, swelling of face, and eyes (swollen shut). Patient reports being treated with steroids and antihistamines at hospital.
Rash on torso started 6/16/14. Irritable and complains of itch. No documented fever, respiratory symptoms or GI sx.
Injection site pain, 2 days.   Metallic taste in mouth, especially eating, ongoing.
The patient developed localized hives at the injection site with redness and warmth. The patient was treated with ice compresses and Benadryl.
Cramping muscles, tense muscles, muscle spasms 9 days later partial paralysis.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date (also reported as several months ago), the patient was vaccinated with dose of PNEUMOVAX 23, lot # M006139, expiry date 13-MAY-2017, intramuscularly, (dose and frequency not reported). On an unknown date, the patient developed redness and pain on arm. Reporter did not recall any further details about the event "since it was so many months ago". The outcome of the events was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information provided. This is one of three reports received from the same reporter. Additional information has been requested.
This is a 60-year-old male patient with a past medical history of coronary artery disease a recent diagnosis of atrial fibrillation status post ablation a month ago started having shortness of breath after ablation. Shortness of breath was initially off and on. It got worse in last 2 days Patient denies any chest pain Shortness of breath was worse on laying down
expired since 15Jul2021/3 doses were administered; This is a spontaneous report from a contactable other hcp. This HCP reported similar events for three patients. This report is for 2nd of 3 patients. A 62-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EW0186; Expiration Date: 15Jul2021), dose 2 via an unspecified route of administration, administered in Arm Left on 20Jul2021 as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot EW0186 and Expiration date 30Aug2021), via an unspecified route of administration Administered in the Left arm on 28Jun2021 as single dose for COVID-19 immunization. The patient experienced expired since 15jul2021/3 doses were administered (medically significant) on 20Jul2021. Reporter stated that they received Covid-19 vials from a different office and realized that they were already expired since 15Jul2021, and 3 doses were administered today to patients. The outcome of event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100924541 Same reporter/SD/AE, different patient;US-PFIZER INC-202100924476 Same reporter/SD/AE, different patient
passed out; seizure; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and SEIZURE (seizure) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criteria hospitalization and medically significant) and SEIZURE (seizure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 5 days due to LOSS OF CONSCIOUSNESS and SEIZURE. At the time of the report, LOSS OF CONSCIOUSNESS (passed out) and SEIZURE (seizure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant product information was provided.  No treatment information was provided.  Company Comment: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Heart palpitations, consistent for two weeks.  Bilateral +2 ankle edema on day 14 post vaccine number two with 102 fever.
Body muscle aches especially in legs, irregular sinus feelings (not serious-just unusual), sore left arm, 98.8 fever had a hard time sleeping last night.
Breakthrough case admission after 5 vaccines Moderna 2/25/21 Lot# 010A21A;  Moderna 3/25/21 Lot# 017B21A;  Moderna 10/24/21 Lot# 039D21A Moderna 4/2/22 Lot# 048L21A;  Moderna 9/20/22 Lot# AS7145B
Approximately 5 hours after vaccine, she started experiencing slight confusion.  By morning she was completely confused, didn't know where she was,  didn't know her daughter, was trying to take her medication by chewing them, couldn't speak, etc. BP extremely elevated. CT and labs all negative.  Admitted to hospital.  By the next morning she was more clear, but is still somewhat confused and still has memory loss.
no additional AEs; administration of vaccines that experienced temperature excursion on 10/13/22; This spontaneous report was received from other health professional and refers to a 5-month-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 13-OCT-2022, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #W011278, expiration date: 01-NOV-2023, administered orally for prophylaxis (strength was not provided) and improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter, lot #U034522, expiration date: 22-JUN-2024, administered for prophylaxis (strength and route of administration were not provided) (product storage error). No additional adverse event was reported (no adverse event).
polyarthritis 2-3 wks p/1st shot & pain inc w/resulting disability 2-3 wks p/2nd shot;20% pain reduced p/6mo & another 20% pain deduction p/1yr; 60% remaining pain & disability chronic; tx anti-inflammatories, PT, hot & cold packs;
Child was in car seat leaving from office visit. Child had stridorous cough followed by projectile vomiting thru Nissen. Then cried and went limp for a few seconds then cried normally.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-DEC-2018, the patient was inadvertently orally vaccinated with an expired dose of ROTATEQ lot # N009964, expiration date 22-NOV-2018 (dose was not reported). No adverse effects were reported.
Received vaccines in afternoon on 11-8-11. Seizure at 0230 on 11-9-11. Generalized tonic clonic SZ lasting 3 hrs. Received phenobarbital 10 mg/kg & ATIVAN (0.5 mg x 2) & VALIUM IV. (1mg x 4) at Q5H; VALIUM PR 5 mg x 1 in transport; started on KEPPRA in hospital.
Vaccinated 11/4/06 Saturday 10am. Symptoms at 9pm Saturday night. Hives all over body. Breathing difficult, throat tightened, hoarseness. Felt relief Sunday morning 11/5 1am.
Affected my menstrual cycle by 18 days.  I am very regular and never more than 3 days late
Shingrix dose 1 of 2 received 8/16/21.  Patient reports experiencing 4-5/10 epidermis-level, neuropathy-like neck pain/paresthesia at base of skull lasting for 1 day, about 3 days after administration of dose 1. Resolved within a day without intervention or recurrence. Patient states was able to continue and complete ADLs during that day.  Patient consents to receive today's dose 2 of 2. Advised patient to contact PCP if this reaction happens again.
The pt developed a bump on head and behind one ear that appeared on 02/08/2002. No other bumps until two days later, client had bumps all over head (02/10/02) then moved down to neck and chest the next day, worse under arms, few down the arm and very few on legs. Saw a physician on 02/11/2002. Doctor ordered Bactroben ointment and Benadryl.
Wrong vaccine administered. Patient received Kinrix vaccine when he was 10 years old when cut off age is 6. Staff from clinic was contacted and asked how to proceed. She informed us that Kinrix dose will count.
Swelling of the face and throat. Unit doctor instructed me to go to the ER ( Hospital). After triage, I was given prednisone, benadryl, and pepcid, and then observed for several hours to ensure symptoms subsided. At discharge I was prescribed a dose pack in the event symptoms returned or worsened.