chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 20-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp 06-NOV-2016) (dose and site not reported). On and unspecified dates, the GARDASIL vaccine had a temperature excursion: 48 hours. The highest recorded temperature was 47 (8.333333333 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Grandson is very sick; Grandson is very sick from this vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Grandson is very sick; Grandson is very sick from this vaccine.".  The lot number for bnt162b2 was not provided and will be requested during follow up.
0530- abdominal pain, nausea, chills, aches muscle and joint, 103 F temp , 24 hours on 1/14/2021 vomiting, diarrhea, chills, fever, myalgia , joint pain. 1/15/2021 headache, left axilla lymph node swelling, nausea
Woke while sleeping to intense pain in my left arm with burning and sharp pain down my arm to numbness on my half my hand and fingers. The pain continued to get worse along with pain in my mid back and upper next area on left side. The same symptoms have continued now for a week with no changes or relief. Pain and numbness is constant however intense pain surges happen frequently throughout the day.
This non-serious initial spontaneous case, was received from Other Non-Health Professional on 24-Oct-2017, concerning a 61-year-old adult female patient. The patient had no relevant medical history and concomitant medication was not reported. On 09-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, batch number: 179103, expiry date: May-2018, route of administration: intramuscular, anatomical location: left deltoid). The patient received the vaccine under 65 years of age (explicitly coded as inappropriate age at vaccine administration). The reporter assessed the event as non-serious.
Swollen lymph gland under his left arm, the same arm he had received the seasonal flu vaccine in.
patient received a dose of fluzone hd qiv in November and then another in December with no reported adverse event; Initial information received on 27-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Elderly male patient who received a dose of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] in november and then another in december 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 COVID-19 vaccine for Prophylactic vaccination.  On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Strength = High-Dose) at a dose 0.7 ml total (lot UT7715BA) (form, expiry date: unknown) via intramuscular route in unknown administration site for Immunization.  On an unknown date the patient received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE in november and then another in december with no reported adverse event (extra dose administered) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-MAY-2014 the patient was vaccinated with an improperly stored dose of VAQTA 50unit/ml (lot # J001396, expiration date 02-AUG-2015, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time of the first time was 152 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 32 hours with the lowest recorded temperature of 31 Fahrenheit degree. The total cumulative excursion time of the third time was 288 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the fourth time was 584 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment/ mild symptoms, runny nose, sneezing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 02Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 28Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "Known allergies: sensitivity to peanuts" (ongoing), notes: Known allergies: sensitivity to peanuts and peppers; "Known allergies: sensitivity to peppers" (ongoing), notes: Known allergies: sensitivity to peanuts and peppers. Concomitant medication(s) included: ROSUVASTATIN, start date: 03Jan2022, stop date: 15Jul2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "unknown", described as "COVID 19 Treatment"; COVID-19 (medically significant) with onset Jul2022, outcome "unknown", described as "COVID 19 Treatment/ mild symptoms, runny nose, sneezing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 treated with Paxlovid started on 15Jul2022 and stopped on 19Jul2022.  Clinical course: Adverse events reported were mild symptoms, runny nose, sneezing which started on 25Jul2022 07:00 AM and was recovering.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A little bit of sore arm, sore only when moving and elevating it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A little bit of sore arm, sore only when moving and elevating it) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced VACCINATION SITE PAIN (A little bit of sore arm, sore only when moving and elevating it). On 20-Jul-2021, VACCINATION SITE PAIN (A little bit of sore arm, sore only when moving and elevating it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details not provided. Patient reported that he had virtually no reaction but did mention having a little bit of sore arm. It was after falling asleep on the side of injected arm. It was sore only when moving and elevating it.    Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: FU Received on 21 Sep 2021 and contains no new information but initial version missed to capture dose number as 1 and relevant information captured in inarrative.
The vaccine was mixed incorrectly: The 12+ vial that should have been diluted with 1.8 ml's of 0.9% sodium chloride was instead diluted with 1.8 ml's of sterile water.    Patient was still given 0.3 ml's but we spoke with Pfizer and they stated  they could not clarify validity or stability because they have not run any tests regarding diluting with sterile water. Basically to review it with the medical director of the clinic and that dose is invalid so revaccination is necessary.  Patient's mother was notified and patient did have fever of 102 degrees and body aches that lasted 3 days.  He was seen 3 days later by his PCP due to these symptoms.  A Covid test was done which was negative.  Supportive treatment recommended.
Site: Pain at Injection Site-Medium, Additional Details: Patient described mild constant pain on his left arm that sometimes extends to his shoulder. He said he got this pain after his first COVID dose and the pain has not gone away till now.
2 days after immunization developed Arthus reaction (erythema) at site of DTaP right thigh. No fever.
Patient developed allergic reaction to immunizations given in office 8/19/2019. Patient started to not feel well after MA administered vaccines (hepatitis A and Shingrix) and became nauseated, short of breath and anxious. Patient was reporting that she felt like her throat was shutting. 911 was called as patient was placed on nonrebreather at 8L. Patient given diphenhydramine 50mg IM along with dexamethasone 4mg IM. Patient then given EPIPEN 0.3mg IM injection into left thigh. Patient's HR 55 and O2 saturation 99%. Patient then transported to the hospital with EMS. Dr. at bedside giving verbal orders for medication and treatment plan.
Received ROTATEQ #2, vomiting began 4/5/12 with diarrhea. Rapid weight loss. Hosp x 2d then home x 24hr - vomiting, diarrhea cont, rehosp -> severe dehydration -> PICU. Still in PICU but better.
Vial was stored outside of parameters, spoke to manufacturer and determined that patient is safe and revaccination is not recommended. called pt and they are ok.
Had diarrhea on April 16th day after the se ond shot, and extreme headache, with fever. April 17th started having a cough, wheezing, and fever.  It is now the 26th and the onky that has changed is I have no fever, cracked rib from coughing and im not better i am still wheezing.  I have missed almost a week of work.
Patient developed shingles 4 hours after the shot. The patient had never had a case of shingles before. Still dealing with these symptoms three days later. His primary care doctor put him on Valtrex for treatment.
At 10:18am patient felt dizzy and became clonic for 15 seconds as we were about to slide patient to floor he reacted. Alert and oriented X3 but SOB, diaphoretic, pulse 30, respiration 12. As per MD orders oxygen 2L p/min via nasal cannula and Epi-pen was administered 0.15mg to right thigh at 10:20am, blood sugar 93mg/dL. Patient left in ambulance at 10:29am O2 99 and pulse 63.
High fever (103.5 degrees F) over a 4 day period, severe fatigue, chills, arm pain, swelling of joints (hands, knees and feet), headaches.  All symptoms except for the swelling of hands and knees have been resolved.  Swelling is worst in the early morning but consistent since the 2nd vaccine with no improvement.
This spontaneous report received from a nurse regarding multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD (Merck) lot # L030586, expiry date: 10-FEB-2017 (dose, route and frequency: unknown). No adverse effects were reported. There was no product quality complaints (PQC). This is one of the several reports from the same reporter. Additional information has been requested.
weeks h/o cough and atypical chest pain w/ the cough abdominal pain with N/V/D x 2 weeks tested positive for COVID on 12/25 required 2L O2
A non-serious spontaneous report of administration of expired dose of FLUMIST was received from a healthcare professional concerning a 15-year-old male. Neither relevant medical history or concomitant medications have been reported for this patient. The product expired on 18-Jan-2010 and was administered to the patient on 28-Jan-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Feeling dizzy, shakiness, and face pulsing.  States "I fell like lost control of my body." Denies nausea, shortness of breath, reash, or itching. She did have hives when she was given  a flu shot last year.
Cataract; This is a spontaneous report from a Pfizer-sponsored program Support from a contactable consumer (patient). A male patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unknown date. The patient had both doses of the vaccine. He had the second dose 26Dec2020. However, the caller will have a Cataract operation on 07May2021. His doctor asked him to prove that he already got both doses of the vaccine but he went to the facility to get the records, the facility was already closed. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Mom found pt not breathing & blue eye open, not moving: mom did CPR - pt coughed & hypertonic started to breath epi lasted less than 5 min;
18cm x 14cm red, firm/raised, hyperthermic area noted over upper lateral aspect of right upper arm which was the site of recent Covid booster.
Met the worst case, purple bumps all over your body; dealing with it through tears and pain and itching; Met the worst case, purple bumps all over your body; dealing with it through tears and pain and itching; Met the worst case, purple bumps all over your body; dealing with it through tears and pain and itching; Met the worst case, purple bumps all over your body; dealing with it through tears and pain and itching; This is a spontaneous report received from a contactable consumer. This consumer reported for a Female patient (Daughter in Law). This is the first case out of 3 split cases.   A female patient of an unspecified age 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 DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included auto immune condition from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Reporter stated, My daughter in law has an auto immune condition, and after she took the shot, the vaccine (Pfizer COVID 19 Vaccine) she has met the worst case ever as I complaint this which was that where you get these purple bumps all over your body. So, I just wanted to report that, she was dealing with it through tears and pain and itching. But I really would recommend that something needs to be said prior to getting that shot. If you have an auto-immune condition that really needs to be truly discussed with their doctor because anyone with the auto-immune condition is sounds like to me they are having some trouble. It is just breaking in my heart (general sentence) So, I just wanted to report that, it is horrible. Reporter further stated, What strange was, I have met two other people that have developed the same condition So, anyway I really think a warning or just say you know kind of deal. You know, something that the person administrating the vaccine could share. But anyway, you know just like they should not take the Flu Vaccine So, it is the way that the body responding to some kind of, chemical in the vaccine (not appropriately clarified hence not captured as event). But anyway, I just wanted to report that. The outcome of the events was unknown.    The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101050810 same reporter/drug/event, different patient;US-PFIZER INC-202101051050 same report/drug/AE, different patients
patient 17 years of age received first dose; This spontaneous case was reported by a physician and describes the occurrence of UNEVALUABLE EVENT (patient 17 years of age received first dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced UNEVALUABLE EVENT (patient 17 years of age received first dose). At the time of the report, UNEVALUABLE EVENT (patient 17 years of age received first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Started with headaches on 4th day out from vaccine. By that Sunday I was lethargic, had pains throughout my body,  zaps of pain, inflammed joints, anxiety,  Stomach/acid reflux, Pains/aches in body - short temporary pains, Electrical like pulses of pain in head left front side mainly, also in right hand, felt weak - no energy, Legs felt a bit numb or tingly, hips and lower back feel tender, knees too
Patient received vaccine in left arm. She was noted to be sitting in waiting area and had been given water to drink. A few minutes later, she was observed slumping over to her left side, where she fell off her chair and her head was heard hitting the gym floor. Per EMT notes it was her left parietal-posterior area, but no lump or bump noted. Pupils equal and reactive and patient was responsive within seconds of staff arrival. Ice was applied to her C-spine area to assist in cooling her down. Patient reports that she had not had anything to eat or drink since 10:30 in the morning. It was very hot in the gym where vaccines were being given. Vital signs were stable the entire time (120/78, HR100regular, SPO2 99%, then 122/76, 80reg, resp rate of 12)  Pt is answering questions appropriately and is asking to be let go, but we did keep her for 30 minutes to ensure that she was OK. She left in the company of her mother.
right arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (right arm hurt) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (skin on some fruits including apples, pears, plums, cherries, and artichokes (highly allergic).).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (right arm hurt). On 04-Apr-2021, VACCINATION SITE PAIN (right arm hurt) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant Medication was provided. No treatment  was provided.   This case was linked to MOD-2022-442122 (Patient Link).
Fever x 3 days 101 degrees. Bodyaches, nausea and swelling and warmth 4 " across at injection site.
She can hardly walk; experiencing something in the upper part of her leg, on the muscle in the back of her leg; Muscle pain; This is a spontaneous report from a contactable consumer. A 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and  concomitant medications were not reported.  The patient experienced something in the upper part of her leg on the muscle in the back of her leg. She can hardly walk. She had muscle pain. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient reported "very woozy", pain, nausea, and "felt faint" at time of injection. The following 3 days patient had, shoulder pain, pain while trying to move shoulder, redness, weakness in L arm, "clicking" in L shoulder
temperature excursion; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.  On 26-OCT-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # S040483, expiration date 19-JUN-2021 (dose and strength were unknown, route of administration was not reported) for prophylaxis. The vaccine had reported temperature excursion (product storage error). It was not reported, if the temperature excursion was detected by digital data logger.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2011USA001282: US-009507513-2011USA001517:
Pt complained of discomfort at site we medicine. The next day she reported to her mom discomfort, swelling and mild headache. Reported SX to HD on 12/12/16. States no HA but mild discomfort and swelling. Counseled to try cold compress for a couple of hours and apply heat. Counseled that this has been reported day 1-5. Pt is immunosuppressed.
Pt recvd 1 dose of Engerix-B & 21JUL92 exp h/a; 22JUL92 then exp blurred vision & photophobia; seen by MD; treatment APAP w/o relief as of 24JUL92;
Information has been received from a consumer concerning her 66 year old husband with no known drug reactions/allergies with hypercholesterolemia and hypertension who on 08-JAN-2008 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included Triamterene, Lisinopril, Ezetimibe (+) Simvastatin (MSD), Ibuprofen and CIALIS. On 27-FEB-2009 the patient was diagnosed with shingles (the adverse event onset was on 25-FEB-2009, even though diagnosis date was on 27-FEB-2009). The patient sought medical attention went to the office. At the time of reporting the patient was recovering. Additional information has been requested.
Initial information received on 06 August 2014 from a healthcare professional. A 23 year old female patient received a first dose subcutaneous injection into the left deltoid on 22 July 2014 with YFVAX, batch number UI078AA and 13 days later on 04 August 2014 experienced tightness in her chest, palpitations and no chest pain, off and on and is currently happening. The patient's concomitant medications were not reported. The patient's medical history was reported as NKA, no known allergies and the patient was not ill at the time of vaccination. The patient will be advised to go to emergency or see a physician. No further details were reported. The patient outcome was not recovered. Documents held by sender: None.