chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 01-SEP-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Possible late 2nd dose of Shingrix; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Possible late 2nd dose of Shingrix). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2023 The reporter reported that the patient possibly late received second dose of Shingrix vaccine. The vaccine administration facility was the same as primary reporter. The reporter stated that additional adverse event details are not available. The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
The pt developed a seizure activity on 03/23/2002. Seen in ER and follow up by a physician.
I had the vaccine on 12-30-20. I became ill on January 9th. I had a fever, chilling, body aches,  head ache and terrible fatigue.  this lasted for 10 days.  I have been sick every 2-3 weeks since. January 25-28th:  chilling, body aches, head ache, fatigue. No fever. February 6-7 : same as above. March 5-6: same as above but, very mild. March  26-28: 1st 24 hours very sick.  I ran a fever of 99.1. the 2nd 24 hours quite sick but, not as bad. much better on the 28th.  So far I have been sick 5 times. It's generally the same symptoms.   Each time I get checked for COVID and it's negative.
This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, drug reactions, allergies and concomitant medications. On an unknown date the patient was vaccinated with Measles, Mumps, and Rubella (wistar ra 27-3) virus vaccine, live, (recombinant Human albumin) (M-M-R II) 0.5 milliliter (ml) (unspecified route, lot # S036664, expiration date: 14-NOV-2021), for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) (lot# T009584 is an invalid lot number for sterile diluent (STERILE DILUENT) and a request for lot verification was sent to Lot Verification team, dose and anatomical location was not reported), both for prophylaxis. It was reported that patient received an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, (recombinant Human albumin) (M-M-R II) vaccine which did not have any temperature excursions. The vaccine had expired on 14-NOV-2021 and was administered on 07-DEC-2021. No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
Immediately after receiving vaccines patient had full body seizure. Did not void. Remained unconscious over five minutes, until revived with ammonia inhalent. Upon being awakened, c/o severe abdominal pain, all quadrents. VS 118/76, 72, 18. Transported to ER with EMS and mother in attendance.
Faulty syringe/needle. Administration Error. Patient was given IM injection in the right arm. As I was giving the injection, the needle syringe was not put together properly and the dose went out of the side of the dead space between the needle and syringe. Since this was detachable. Patient did not receive proper dose.
Patient has had menstrual cycle for 3-4 months non stop. She was regular for 1 year prior to immunization.
Swollen tongue, swollen and numb left arm, pain in arm, pain behind ear.
Extreme fatigue, body and headache. Ibuprofen, acetaminophen and rest. Recovered in 24-hours.
1) 2 hours after inoculation felt extremely nauseous warm and fatigue. 2) approximately 26 hours after shot had hives at site of injection. 3) 48 hours after injection had hives all over body- primarily back & arm.
Very high fever of 104.3 on Saturday, June 29, 2019 at 10pm. Gave 7.5 ml of Tylenol to reduce fever. Fever has continued from June 30th - today, July 1st, 2019. temperatures between 103 - 103.7. Continue to give 7.5 ml of Tylenol to reduce fever. Seeing Dr. today at 1:45pm.
Approximately 3 am extreme fatigue, chills, bones body aches, headache, nauseous.  Symptoms  were severe enough that I did not have the strength or the energy to attend work the next day.
tingling on right side of torso; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 29Apr2021 13:00 (Lot number: EW0170) at the age of 59 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19", start date: 03Sep2020 (unspecified if ongoing); "Lyme Disease", start date: Aug2021 (unspecified if ongoing); "shingles", start date: 2006 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1; Lot number: ER 8734; 13:00 in the left arm), administration date: 01Apr2021, when the patient was 59 years old, for COVID-19 Immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 07May2021, outcome "not recovered", described as "tingling on right side of torso". The event "tingling on right side of torso" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had a COVID-19 polymerase chain reaction (PCR) (Accula) test done on 23Nov2021 (nasal swab), which was negative.
Between 10 hours and 15 hours after the shot, my pressure dropped to 7/3 resulting in fainting. The pressure continued low (around 9/4) and after around 16 hours after the shot it stabilized again in a normal range (11/7).
Stopped needing a cane to walk/ Knee 80% better; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Stopped needing a cane to walk/ Knee 80% better) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Knee arthroplasty (He had multiple problems ever since.) in 2020.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Stopped needing a cane to walk/ Knee 80% better). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Stopped needing a cane to walk/ Knee 80% better) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.  The day after his 2nd dose he stopped needing a cane to walk and his knee was 80% better.
This spontaneous report as received from a 67 year old male consumer reporting on himself with osteoarthritis and allergy to codeine who on 12-JUL-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). Concomitant therapies included NEXIUM and NIASPAN. The consumer reported that on 23-JUL-2012, he was admitted to the hospital for 17 days with chronic pancreatitis. Unspecified intravenous medication was given as a treatment for the experience. CAT Scan, blood work, MRI and upper and lower GI were performed and unspecified date (results not provided). At the time of the report, the patient had not recovered. The relatedness for chronic pancreatitis and ZOSTAVAX was unknown. Upon internal review chronic pancreatitis was considered to be medically significant. Additional information has been requested.
Patient reported "mosquito bite-like rash on arms (unsure if rash was on other parts of body)" that was moderately "itchy" that started "a few days after the injection" and lasted for 7-10 days.  Patient denies any shortness of breath, fever, or any other systemic reactions.
Information has been received from a physician concerning a cluster of among six girls in one classroom who were approximately 11 years old who on unspecified date had received 2 doses of MMR II vaccine (doses, duration and lot numbers were not reported). The physician reported that he had done some laboratory work to confirm the diagnosis of mumps in a few children. He indicated that he did not find any children who were immunoglobulin M (IgM) positive for mumps, but most were immunoglobulin G (IgG) positive. The physician said that most children had parotid gland swelling. At the time of the report, the patient's statuses were unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested
This spontaneous report as received from a Registered Nurse refers to a patient ranging from 25 to 84 years old of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On unspecified date between 19-APR-2017 and 01-MAY-2017, the patient received an intramuscular dose of PNEUMOVAX 23 (lot: N003997; expiration date: 20-OCT-2018) to prevent pneumococcal infection (dose was not provided). On an unspecified date in 2017, within 24 hours of receiving the dose of PNEUMOVAX 23, the patient developed a red, swollen, warm, sore area at the site of injection. Additionally the patient experienced cellulitis which was treated with BACTRIM DS and prednisone (manufacturer unknown). The patient called the nurse for medical attention. There were no laboratories performed. On an unspecified date in 2017, the patient recovered from the events. The relatedness of the events with PNEUMOVAX 23 was not reported. This is one of several reports from same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA005377: US-009507513-1705USA005378.
Left thigh swollen, tight & red (4 inches), visibly larger than right thigh, warm to touch. S/P vaccines 2 days ago. Patient limping slightly. Seen by MD 9/1/11. No treatment - observe, ice, BENADRYL, TYLENOL - return if symptoms worsen.
mix Moderna series and Pfizer booster; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mix Moderna series and Pfizer booster) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mix Moderna series and Pfizer booster). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mix Moderna series and Pfizer booster) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
spotty bumps in patches, not confined to 1 area.  no pain just irritating itch.
Day 1 post vaccine- headache, nausea, hot sweats, chills, loss of appetite, fatigue, overall aching
Breakthrough case admission after 3 vaccines Pfizer 3/25/21 Lot# EP6455;  Pfizer 4/15/21 Lot# EW0164;  Moderna 11/24/21 Lot# 052E
The evening after patient received vaccine, she started to develop low grade fever and urticarial rash at the vaccine site. The urticaria improved the following day, as did the fevers. Then 3/5, the fevers started again, several times per day, as high as 102 at home.  In association with the fever she has had some mild nausea, x1 non-bloody emesis last night, as well as rigors/night sweats.  She went to urgent care and eventually was admitted to the hospital for the following 9 days. During this admission, she continued to have fevers intermittently as high as ~103. She also developed more generalized urticarial rash (worst on trunk), and lab abnormalities including low platelets and elevated liver function tests. She had extensive testing, ultimately determined likely vaccine reaction, started on prednisone 40 daily and improved for discharge to home on 3/17 without fevers x48 hours and with improving labs.
Right deltoid with erythema, swelling, and slight tenderness from shot to elbow.
Information has been received from an unspecified reporter via TeleRx referring to a 40 year old patient of unknown gender. Information regarding concurrent conditions and medical history was not provided. On 01-MAY-2015 the patient was vaccinated with a dose of PNEUMOVAX23 (dose, dose #, lot #, route and application site were not reported) (inappropriate schedule of drug administration). This is one of two reports received from the same source. Additional information has been requested.
wrong vaccine was given.  That vaccine is not approved for children under 4 .  No known adverse symptoms.
tunnel vision; 2 minutes after injection Heart rate went to 138/Hr 110/elevated heart rate.; dizziness; This is a spontaneous report from a contactable nurse reporting for herself. A 46-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number Ek9231, via an unspecified route of administration in left arm on 28Dec2020 at 11:45, at 46 years of age, at single dose for COVID-19 immunization. The patient was not pregnant when she was vaccinated and received the vaccine in Hospital. She didn't receive any other vaccine in the previous 4 weeks. Medical history included Meniere's disease with sudden hearing loss in left ear from an unknown date, gastrooesophageal reflux disease from an unknown date and allergy to penicillin and sulfa drugs. Concomitant medication included famotidine (PEPCID), paracetamol (TYLENOL), ergocalciferol (VITAMIN D) supplements and cetirizine hydrochloride (ZYRTEC). On 28Dec2020, 2 minutes after vaccine injection, the patient experienced tunnel vision, assessed as medically significant, her heart rate went to 138 and she experienced dizziness. The same happened again "at the 8 min mark": heart rate at 110 and dizziness. The events resolved on their own. Dizziness and elevated heart rate happened again later that evening. At the time of the report the reported events had resolved without any treatment.; Sender's Comments: Based on the compatible time association, the events tunnel vision, heart rate increased and dizziness are reasonably related to suspect BNT162B2 administration. 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.
patient with new LLE peroneal DVT 2 weeks post vaccine. Left leg swelling
administration of an expired vaccine to a patient with no reported adverse event; Initial information received on 21-Dec-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2-month-old female patient who had administration of an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine (HEPATITIS B [HEPATITIS B VACCINE]), rotavirus vaccine and pneumococcal vaccine CONJ (Pneumococcal Conjugate Vaccine) all for prophylactic vaccination (Immunisation).  On 21-Dec-2022, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) Vaccine at a dose of 0.5 ml once (lot U7054AA, UJ590AA, expiry date: 18-Dec-2022 for both) via intramuscular route in the left upper thigh for Immunization.  On 21-Dec-2022 the patient had administration of an expired vaccine with no reported adverse event (expired product administered, latency: same day).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
No adverse effects reported; An unknown number of unspecified patients may have been administered vaccines improperly stored; This spontaneous report was received from a nurse and an office manager and referrs to an unknown number of patients of unknown age and gender. There was no information provided about the patients' concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or medical history.  On multiple unspecified dates, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R025725, expiration date 25-MAY-2021) (exact dose, frequency, route and site of administration were not reported); with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (lot# R000550, expiration date 08-JAN-2020) (exact dose, frequency, route and site of administration were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate (LIQUID PEDVAXHIB) (lot# R000877, expiration date 24-SEP-2020) (exact dose, frequency, route and site of administration were not reported) all administered for prophylaxis. The administered doses were exposed to a temperature below 36 Fahrenheit degrees (F): 31.6 F for 2 hours and 13 minutes and 25.7 F for 1 hour and 35 minutes, and temperature above 47 F: 50.5 F for 18 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  Follow-up information was received from a physician's receptionist on 01-AUG-2019. The patient was a 13-year-old female. On 04-JUN-2019, she was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R025725, expiration date 25-MAY-2021) 0.5 mg in left deltoid (frequency and route of administration were not reported). It was clarified that no patient received measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) and haemophilus b conjugate vaccine (meningococcal protein conjugate (LIQUID PEDVAXHIB). The reported temperature excursion occurred from 30-MAY-2019 to 22-JUL-2019. The reporter stated that the temperature probe was misplaced, which resulted in an incorrect reading. No adverse effects were reported.  This is one of 3 reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA011013: US-009507513-1908USA003825:
13 y/o patient was administered Moderna 0.5 ml instead of Pfizer vaccine.  Pt did not show any immediate adverse and/or allergic  reaction after 15 minutes post vaccine administration. Organization Vaccine Coordinator and Medical provider were informed. Pediatrician called patient's mother the next day  to inform her about vaccine error administration. Mother stated patient had side effects from vaccination of fever and nausea. No fatigue, headache, chills, body and joint aches. Has some pain in arm where she received the vaccine. No lethargy, eating and drinking well.
Soreness and swelling at injection site. Nausea, runny nose, headache, severe abdominal pain and achiness.
Right side of body (mostly face) went numb about 20 minutes after shot.  After sleeping, 14 hours later still have minimal signs of numbness.
Information has been received from a nurse concerning an approximately 14 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot # not reported). Concomitant therapy included MENACTRA and other unspecified injections. The nurse reported that a few minutes after receiving the vaccination the patient had no color in her face. The nurse stated that it was a "near fainting episode". The nurse laid her down and gave her apple juice. Subsequently the patient recovered. She stated that she works in a large clinic and they have now made it a policy to observe the patients for 20 to 30 post vaccination. Additional informtion has been requested.
Chest turned black and blue, large lump. Had mastectomy's 5-13-20 so lump and bruising was disturbing.  Dr. appt 4-6-21 for ultrasound.
12/29-12/31--Left arm pain from injection. Arm pain subsided and was no longer an issue.  1/6- Injection site began to hurt again and minor swelling. A rash occurred later that night.  1/7-rash is now bigger around the injection site. Itching tenderness continues to worsens throughout the day.
Pt received Moderna doses on 3/5/21 and 4/2/21 at another location.   She came to the pharmacy on 8/6/21 and reported that she was here for her first dose of Covid vaccine and would like the Pfizer one.  She received the Pfizer for her booster dose.
Initial and follow up information has been received from a Licensed Visiting Nurse concerning a 50 year old male patient, who on an unknown date was given a dose of pneumococcal 23v polysaccharide vaccine by the intravenous route, while at a dialysis clinic. No symptoms were noted. No further information was provided. Additional information is not expected.