chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from Consumer on 21-Aug-2018. This case involves an 18-years female patient (also reported as 11-years old) who received an extra dose of MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A for Immunisation; and HPV VACCINE for Immunisation. The patient received a 0.5ml first, second and inadvertently received third dose of MENACTRA (Batch number: U5984AC) via intramuscular route in right deltoid on 04-Sep-2012, 29-Aug-2017 and 17-Aug-2018 respectively. It was a case of actual medication error due to extra dose administered. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
I experienced soreness in the muscle near the injection site with an onset the evening of the vaccination.  The next day, I experienced muscle soreness / achiness, a mild headache, and fatigue for the majority of the day.  I did not have chills, but had difficulty feeling / getting warm for a period of several hours. Minor body aches have persisted 2-3 days after the vaccination.  Noticed more pain/discomfort in the armpit area of arm where injection was given on day 3.
pt recvd vax; devel non raised rash on chest, which spread to the trunk;
6 hours post injection my lower lip began to have spasms. This continued intermittently for 33 hours post injection.
almost incapacitating muscle and joint pain, from neck to the bottom of feet. Currently on Prednisone
Patient described perioral numbness 15 minutes after administration of the vaccine. No sign of edema on exam. She was given 25mg of diphenhydramine PO. She was observed for 40 mintues total, then discharged home as she reported resolution of sx.
Horrible headache (lasted 3 days); fever; chills; extreme body aches; nausea; dizziness; fatigue
Information has been received from a nurse concerning a 7 year old female who on 03-MAR-2003 was vaccinated SC with VARIVAX (lot number 643529/0598M). Secondary suspect therapy included MMR II and concomitant vaccinations included a dose of ACTHIB. After having VARIVAX, on 24-SEP-2008 the patient developed chickenpox. The patient developed approximately 20 lesions on her face, arm, and trunk. No further information is available. The patient sought medical attention., Follow-up information was received on 29-JAN-2009 from a physician indicating that he did not known who this patient was and could not provide any additional information. Follow-up information was received on 03-FEB-2009 from a nurse indicating that the office had no additional information about the patient. This is one of several reports received from the same source. Additional information is not expected.
I contracted COVID-19. I had severe chills and a fever of 103. Soon after, I developed a cough, severe headache, back pain, fatigue, general weakness all over my body, and a lack of appetite. I spoke to my doctor and she prescribed me PAXLOVID and a back up of antibiotics called ZITHROMAX. COVID-19 also reactivated my asthma as well, so I had to take a nebulizer treatment every 6 hours for a week that was given to me when I went to urgent care. I had a cough, fatigue, and asthma issues for about 6 weeks later but it has now cleared up.
Excruciating headache, severe nausea, frequent vomiting, body ache. Treatment 1: anti-nausea medication (1000mg Ginger Root  taken 3 times) to help prevent vomiting.  Treatment 2: acetaminophen to reduce headache and body ache symptoms. Outcome: 24 hours after adverse events presented, the symptoms have all subsided.
Pt was administer havrix,Menveo and Bexero today in office at 2:17 pm.After the vaccine were administer pt turn white and pass out.Pt was laid  down  and Dr was call to evaluated the pt.
Hx of cold, COPD and asthma which all exacerbated after getting pneumonia, shot recommended by clients regular ARNP. Client had increased phlegm, increased difficulty breathing, N + V and lost 4 lbs
tested positive for Covid 19 after vaccination; tested positive for Covid 19 after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and on 07Apr2022 as dose 5 (booster), single (Lot number: FK9894) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: Diagnosed before receiving COVID-19 vaccines. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid 19 after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: wife tested positive for COVID-19 after vaccination. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient's husband reported that it was his wife, who tested positive after vaccination.  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) : US-PFIZER INC-202200720139 same patient/product; different dose/events
she finished the Moderna primary series over a year ago.; she had a fast heartbeat after receiving the Pfizer COVID-19 Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine moderna (Primary Immunization series complete), for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "she finished the Moderna primary series over a year ago."; HEART RATE INCREASED (non-serious), outcome "unknown", described as "she had a fast heartbeat after receiving the Pfizer COVID-19 Vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient who got the booster was asking if it was okay to take dreps/drops as well. She stated she finished the Moderna primary series over a year ago. She then mentioned that she had a fast heartbeat after receiving the Pfizer COVID-19 Vaccine. She stated "it wakes me up at 7 o clock in the morning".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt exp malaise & joint pain following vax w/Hep b vax; No further details were provided;
Woke up 7/17/07 with left side of neck hurting, felt sharp pain when he turned his head. Came in on 7/18/07 and was treated with Valium 2mg QID x2 days and had full recovery.
She reports the rash started on her upper body; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Feb2021 14:00 at single dose in arm for COVID-19 immunization. Medical history included allergic to sulfa drugs. Concomitant medication included BP medications. The patient received her first dose of Pfizer-Biontech Covid19 vaccine, yesterday 05Feb2021 around 2pm. She reported an all-over body rash that woke her up at 3am which she treated with a ointment that she had "and that helped". She reported the rash started on her upper body, but now radiated all the way down her buttocks and legs. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Pt reports face flushed and metallic taste in mouth after receiving the first dose of Pfizer vaccine on 4/20. Pt arrived for 2nd dose today and stated it was discussed with pcp who advised pt to take benadryl before receiving the 2nd dose. Clinical lead called to clarify whether or not she should receive second dose. Vaccine was administered at 3:35pm. 3:40pm pt states she is starting to feel the same symptoms again. Upon assessment face red, sts having an "odd sensation on left side of neck", A&O, BP 102/78, 99% on RA, HR 70. Respiration's even/nonlabored. Denies any difficulties breathing. Refuses transfer to hospital. Pt walked out of clinic at 16:11.
Fatigue (10 hours post), headache (3+ days) , severe pain under right armpit (10 hours post--lasting  2 days), dull pain under right arm 3+days, chills 36 hours post vaccine
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 09-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
it hit her like boom and she needed to pass out; feeling exhausted; Extremely Tired/feels so tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 09:06 (Lot number: EN6207, Expiration Date: 31Jul2021) at the age of 59 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Verbatim: High Blood Pressure" (ongoing), notes: Verbatim: High Blood Pressure; Diagnosed 4 years ago. Concomitant medication(s) included: LOVASTATIN taken for hypertension (ongoing). The following information was reported: FATIGUE (non-serious) with onset 11Mar2021 11:30, outcome "recovering", described as "Extremely Tired/feels so tired"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it hit her like boom and she needed to pass out"; FATIGUE (non-serious), outcome "unknown", described as "feeling exhausted".  Additional information: Caller stated by saying her son and her, then shouted something to her son in the distance and stated there were bears up here and he didn't take the bear spray, tells him don't go for a hike and stay put, she did not want him in the woods by himself, stated his dad usually goes with him but was yapping on the phone like usual. Her son had his shot today too. At his injection site, he felt numbness and the site became swollen and enlarged to the size of the palm of your hand. He complained about it on the one-hour way home. She thought, does she need to take him to a doctor? The swelling went down but now he was tired. She went to bed at midnight, but she was ok on 5.5 hours of sleep She could say hers was from the vaccine because it hit her like boom, and she needed to pass out. Vaccination Facility Type was Drive Thru. No additional vaccines administered on same date of the Pfizer suspect. Adverse event did not require a visit to Emergency Room/Physician Office. No vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. No Adverse events following prior vaccinations. No relevant family medical history to adverse event. She stated that her mom was 97 and got 2 Moderna with no symptoms, she didn't even know she got it.  No follow-up attempts are possible. No further information is expected.
Blurred vision; The left eyelid uncontrollably jumps unexpectedly and continue from then until now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 24Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE), administration date: 13Oct2021, for COVID-19 immunisation, reaction(s): "Blurred vision even in Daytime/ Vision was blurred"; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VISION BLURRED (non-serious) with onset Jun2022, outcome "unknown", described as "Blurred vision"; EYELID DISORDER (non-serious) with onset Jun2022, outcome "not recovered", described as "The left eyelid uncontrollably jumps unexpectedly and continue from then until now".  Additional information: Inquiry: After the booster shot on 24Jun2022 and the morning after he started to experience even longer periods of blurred vision along with another symptom. The left eyelid uncontrollably jumps unexpectedly and continue from then until now. medical inquiry was forwarded.  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) : US-PFIZER INC-202300133428 same patient/drug, different dose/event;
Information has been received from a medical assistant referring to an patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 26-NOV-2018, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # R018731, expiration date: 27-FEB-2020, strength, dose, frequency and route unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (PCN) and Drug allergy (Amoxicillin).    On 21-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  On 16-Dec-2021 vial was initially stored in the refrigerator. The Moderna Covid-19 Vaccine was given past the beyond use date of 15-Jan-2022. Patient was notified of the error and patient denied adverse effects.  Treatment information was not provided.
PT ARRIVED AT THE PHARMACY AND APPEARED SLIGHLTY ANXIOUS BECAUSE SHE ALMOST DIDN'T MAKE IT TO THE PHARMACY IN TIME TO RECEIVE HER VACCINE AND SHE WAS ALSO BEING REQUIRED TO GET THE VACCINE BY HER COLLEGE PROGRAM. ABOUT 2 TO 3 MINUTES AFTER RECEIVING THE VACCINATION THE PT SAID SHE FELT FUNNY. SHE EXPERIENCED FLUSHING OF THE FACE AND CHEST, TACHYCARDIA, HYPERTENTION AND COLD CLAMMY HANDS. SHE ALSO SAID SHE HAD A SLIGHT TINGLING FEELING IN HER HANDS. AFTER ABOUT 10 MINUTES SHE SAID SHE WAS FEELING A LITTLE FAINT SO SHE WAS MOVED TO THE FLOOR BUT NEVER FAINTED. THE PATIENT WAS VISUALLY ANXIOUS AND HAD A FAIRLY FAST RATE OF BREATHNIG.   PT WAS GIVEN PALITIVE CARE INCLUDING COOL WATER AND AN ICE PACK TO HELP WITH THE FLUSHING. PT WAS ALSO ENCOURAGED TO TAKE SLOWER, DEEPER BREATHS TO REDUCE ANXIETY, BLOOD PRESSURE, AND HEART RATE. WE OFFERED TO CALL FOR AN EMT A NUMBER OF TIMES BUT PT REFUSED. AFTER ABOUT 45 MINUTES OF MONITORING PT SAID SHE FELT OK TO LEAVE.
Information has been received from a consumer concerning her 12 month old son with allergies to gluten and dairy products who on 01/01/1999 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  There was no concomitant therapy.  Subsequently, in 01/1999, the patient developed a fever of 104 degrees and loss of appetite for 1 1/2 months.  Unspecified medical attention was sought.  Additional information has been requested.
ulcers in her mouth; This is a spontaneous report from a non-contactable consumer (parent). This consumer reported for the patient (reporter's niece) that A 23-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ulcers in her mouth on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
A week after the 1st dose, tested positive for COVID; This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program COVAX US Support via medical information team. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number: unknown), dose 1 via an unspecified route of administration on 30Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, tested positive for the COVID virus a week after the first dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
The child stated he felt dizzy and nauseous after receiving both vaccines. He also started to sweat profusely. I offered him water and had him sit down. He started to feel better after a few minutes of sitting. No signs of an anaphylactic reaction were present. I called 911 just in case. The paramedics checked his vitals and everything normal. He was okay to stand up and walk around.
I63.9 - Cerebral infarction, unspecified ALTERED MENTAL STATUS
Patient's mother stated that later at night after receiving her flu vaccine, her daughter had a 2 inch by 2 inch red circle around the injection site which felt warm to touch and said that it itched. She said that she gave her BENADRYL and ibuprofen which seemed to help but it still felt warm and the itching was returning. If it continued, she was going to go to urgent care to make sure that it isn't infected. Her mother said that she thinks this has happened before when patient has received vaccines.
T38-38.5 24hr p/vax w/severe total-body muscular aches which lasted 3-4 days;
EXTREMELY DIZZY, SWEATING, LACK OF APATITE. I HAD TO HOLD ONTO THING WHEN WALKING. TODAY 1/ 28/2121 I AM BACK TO NORMAL. NO SIDE EFFECTS. JUST ONE DAY OF COMPILATIONS
Caller said at this time the patient had not other issues at time of call AE letter was refused.; GARDASIL 9 was administered to a 2 month old.; This spontaneous report was received from an other healthcare professional and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 30-AUG-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age).  There were no adverse events reported (no adverse event).
Received CPX vaccine (L) arm in 10 minutes entire arm was itching, in 10 more minutes - felt tightness in throat while driving - felt like she was moving when stopping at Stop sign. Health Dept MD advised BENADRYL 25-50mg PO every 4-6 hr. Go to ER if worsens to welts or swelling of lips - tongue.
tired; she had COVID arm, clarified as a big red blotch.; she had COVID arm, clarified as a big red blotch.; weakness; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 09Feb2021 (Lot number: EL9262, Expiration Date: 31May2021) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose of the Pfizer COVID-19 vaccine: NDC: Unknown, Lot: EL1283, Expiry: 30Apr2021, Vaccine Facility: withheld), administration date: 19Jan2021, when the patient was 71 years old, for COVID-19 immunization, reaction(s): "When she received the first dose of the vaccine she only had some pain in her arm". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired"; RASH MACULAR (non-serious), ERYTHEMA (non-serious) all with onset 2021, outcome "unknown" and all described as "she had COVID arm, clarified as a big red blotch."; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weakness"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information : With the second dose Pfizer COVID-19 vaccine, she had COVID arm, clarified as a big red blotch. She had weakness, headache, but had no nausea. She felt tired. This is going back 6 months, but she states these symptoms were not near as severe as what she had with the booster. Investigations were none. She stated that she didn't go to the doctor for her symptoms because she was reading about it and read that the symptoms normally pass.   Follow-up attempts are completed. No further information is expected.
Headache, Body Aches, Fever, Chills, Coughing, Sneezing, Chest Congestion  Proscribed Paxlovid... symptoms subsided within a few days, however, on day 6, one day after completing the round of Paxlovid, symptoms started to progress and patient still tested positive for COVID. No test given to confirm or rule out if it is true rebound COVID or not.  Patient is still recovering and testing positive today, 10/31/2022. It has been 13 days since initial positive rapid test and original symptoms began.
Patient presented to clinic for a COVID-19 booster and was given a full-dose Moderna vaccine.