chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 50-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. There had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. Were filling out a temperature excursion assessment with the State at the time of report. It was reported that no adverse reactions were reported by any patients. No treatment medication was provided.
administered 0.1ml of MENQUADFI, which is kept in the same storage container in the refrigerator as the TUBERSOL with no reported adverse event; When she prepared to administer, she removed product from refrigerator and administered with no reported adverse event; Initial information received on 12-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 47 years old female patient who experienced administered 0.1ml of menquadfi, which is kept in the same storage container in the refrigerator as the tubersol with no reported adverse event and when she prepared to administer, she removed product from refrigerator and administered with no reported adverse event after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Dec-2022, the patient received a suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE(Dose-0.1mL)(Frequency-Total)( Strength = standard)(Formulation-Solution for injection) (Batch/lot number-U7294AA)(Expiry date-23-May-2024) via intradermal route in unknown administration site for Prophylactic vaccination   On 12-DEC-2022 the patient developed a non-serious events administered 0.1ml of menquadfi, which is kept in the same storage container in the refrigerator as the tubersol with no reported adverse event (wrong product administered), when she prepared to administer, she removed product from refrigerator and administered with no reported adverse event (product preparation error) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.(Latency-Same day)  It was reported Treatment- TUBERSOL will be repeated  Action Taken : not applicable.  At time of reporting, the outcome was Unknown for the events  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 guidelines. 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.
mild sore arm and hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 25 year-old female patient received bnt162b2 (BNT162B2) (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), outcome "unknown", described as "mild sore arm and hand".  Additional information: The patient asked if she can use a self-tanner like a mousse. She had 1st dose of Pfizer vaccine. Also mentioned had a mild sore arm and hand, nothing major.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
died; This is a spontaneous report from a contactable pharmacist. A 37-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FK0112; Expiration Date: 30Jan2022), via an unspecified route of administration on an unspecified date (37-year-old at time of vaccination) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died on an unspecified date. Verbatim: The reporting pharmacist states that she is located in the (country A) but has patients in (country B) who travel back and forth for business. These patients are stuck in (country B) due to the high rates of the delta variant there the pharmacist explained. She states that Pfizer COVID 19 vaccines as well as Moderna COVID 19 vaccines are being donated by other countries to (country B) to help provide vaccination. She states that one of her patients who is in (country B) received one of these donated vaccine with lot number FK0112 and customer service was again to look up this lot number and provide the expiration date of (30Jan2022) stated the pharmacist. She relays that there have been multiple adverse events that have happened with this lot number and she would like to know if it is possible that there was something wrong with that lot. Her patient who was a 37-year-old healthy female received the vaccine from this lot and died 4 hours later. She would like to know why this could have occurred. What data is available on deaths being reported. It was unknown if an autopsy was performed. The cause of death was unknown.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   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.; Reported Cause(s) of Death: died
Scar on arm post vaccine administration; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 46-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 46-years-old) as single doses for COVID-19 immunisation.. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. It was not known, whether the patient received any medication within two weeks of vaccination. On 16Apr2021, the patient experienced scar on arm post vaccine administration. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether the patient had tested for COVID-19, since the vaccination. It was unknown if the patient received treatment for the event. The clinical outcome of the event scar on arm post vaccine administration was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced URTICARIA (hives). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form; FAMOTIDINE (PEPCID AC) for Antihistamine therapy, at a dose of 1 dosage form and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at a dose of 1 dosage form. At the time of the report, URTICARIA (hives) was resolving.            Concomitant product use was not provided by the reporter. Patient took other treatment medication included a week worth of steroids and lotion also helps temporarily.
Sl fever; general malaise; generalized muscle pain w/sl nausea; devel severe abdominal cramps w/t105; dx w/viral gastroenteritis;
complaints of persistent vomiting following her initial Covid vaccine today at approximately 11 AM. Patient states that starting approximately 4 hours after injection, she began having multiple episodes of vomiting.  Patient states that she has not been able to even keep water down.  She does complain of pain in her abdomen but states it is muscular from "so much puking ".
The patient was vaccinated with Varivax 08/05/1998. The patient developed chicken pox 10/24/2001.
Vaccinated: 12:43PM Reaction: 12:45PM Patient reported syncope, nausea, stomach pain 2 minutes after vaccination Vitals: 126/73, 72, 20 Patient was given water and stated ""feels better"" @1300. Patient stable and released from vaccination site at 13:05 "
After my 15 minute wait period was up I left the facility to go home.  Within 20-25 minutes of the Vaccine my lips were swelling and my face was itching and burning.  My throat felt like it had a big lump in it.  I went to the ER and was seen.  Was given diphenhydramine, Prednisone, and famotidine.  Was sent home with prednisone and an epi pen.   Was told by Doctor not to get the second dose due to immediate reaction.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates the patients were administered improperly stored ROTATEQ oral (unknown strength). Concomitant medications were not reported. There was no known adverse effect. The outcome of the event was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
fevers and chills by 10pm that night with fevers lasting till Sunday. injection site starting to feel itchy on Sunday. Now arm/abdomen/chest has a slight rash.
Initially, you sit there for 15 minutes after you get the injection. At that time, my eyes felt grainy/sandy. My arm hurt a bit but I didn't think anything of it. About 36 hrs. I got hit with severe nausea and I think I was vomiting for 3 days straight. I could hardly walk for a week, stumbling everywhere. I felt like a drunken sailor. I was incapacitated for the first week, and the dizziness I had was intense, and blurry vision for the 3 or 4 days. The dizziness lasted for a month to two. It took a good month before I could function back to my normal capacity. Walking and driving almost 2 months.
Non bilious non projectile vomiting occurring 3 to 4 times 1 day after administration.
COVID; COVID; 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 71-year-old 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; bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "laryngitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
24 hours after immunization: right arm was sore. 48 hours after immunization, felt ill, nauseated and dizzy. Ached all over. 4 days after vaccine redness, heat and swelling below shot site.
No additional AE reported; an improperly stored VARIVAX was inadvertently administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not provided.  On 14-SEP-2022, the patient was inadvertently administered an improperly dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot# W016747 with an expiration date on 23-MAY-2024) for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  The administered dose of the vaccine was stored at a temperature of 8.4 degrees Fahrenheit (F) during a time frame of 34 minutes. There was no previous temperature excursion reported. No additional adverse events were reported.         ?
The patient received the Moderna COVID-19 vaccine on 4/30 and presented to the ER 5/4 with complaints of bilateral knee pain described as heavy aching while resting, and sharp when ambulating. The patient does have a history of  psoriasis and erosive psoriatic arthritis, and is on Remicade (last infusion 03/15/21). It is possible that the vaccine, which triggers an immune response, aggravated his erosive psoriatic arthritis causing the pain he experience
Soreness of arm; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Tiredness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Tiredness). At the time of the report, PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported
A female patient received vaccine on 06/09/08 and on 06/13/08 she came to doctor's office with symptoms of cellulitis - swelling, redness, warmth and a feeling of a knot at the injection site.  Patient was given antibiotics to treat the adverse reaction.
Positive for Covid-19 Infection; positive for Covid-19 Infection; This is a spontaneous report from a contactable consumer. A patient (reporter roommate) of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), in Mar2021 (Lot number: EP7534, Expiration date: not reported) as dose 1, single and on 08Apr2021 (Lot number: EW0153, Expiration date: 31Jul2021) as dose 2, single, both via Intramuscular for covid-19 immunization. Medical history and concomitant medications were not reported. On 11Apr2021, the patient had symptomatic and positive for Covid-19 Infection after being fully vaccinated with the Pfizer BioNTech Covid-19 Vaccine. The outcome of events was unknown.
Patient was sitting on Mom's lap, and I was injecting the needle, she jerked back and the needle came out and scratched her arm. The vaccine itself had not been injected. I was able to clean her up with a tissue and put a bandaid on it. The patient was very upset, but Mom and Dad were ok. Mom admitted she didn't have a good grasp on her. We went ahead and gave her the shot in the other arm (left arm) with Dad holding her and she did fine.
Both shots made my daughter very sick.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "ALLERGIES". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Both shots made my daughter very sick.".  Additional information: Patient had not received any other vaccines in four weeks. It was reported that exact symptoms as covid in Feb nausea, body aches, earache, sore throat, eyes burning, fever(had no fever with covid) extreme fatigue, heaviness in chest. It lasted 48 hours. This was with the first shot and reporter stated that was unsure to make take the second. Both shots made reporter daughter very sick. Patient not tested to COVID post vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.
LT deltoid redness, radiating to LT side of chest; full face flushing; This is a spontaneous report from a contactable other healthcare professional, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730), via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer for which she was on aromatase inhibitor. Concomitant medication included exemestane (MANUFACTURER UNKNOWN), Vitamin d (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN); all for unknown indication. The patient had a history of allergy to iodine contrast dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 23Mar2021 at 14:15, the patient had experienced left deltoid redness which was radiating to left side of chest and full-face flushing. The patient also reported that it lasted approximately for 90 minutes. Adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events left deltoid redness, radiating to left side of chest and full face flushing was resolved on 23Mar2021 at 15:45.  No follow-up attempts are needed. No further information is expected.
BOOSTRIX May 3, 2022, not needed, prior vaccination 4/28/2017; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Boostrix (received a dose of Boostrix on 28th April 2017).   On 3rd May 2022, the patient received the 2nd dose of Boostrix (intramuscular) .5 ml and Boostrix Pre-Filled Syringe Device. On 3rd May 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 04-May-2022 Reporter's comment: Medical Assistant was the reporter.   The reporter stated that the patient received a dose of Boostrix in left arm that was not needed.   Consented to follow-up. Additional Supportive Information: The patient received an extra dose of Boostrix, which led extra dose administered. The case was linked with case US2022AMR073182, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR073182:Same reporter
Patient ate lunch and afterward began to feel lightheaded and complained of an itchy throat.  No stridor/voice change, shortness of breath, or other symptoms.
I started having charley horses in my right calf in the middle of the night. I didn't think anything of it until my ankle, back, leg, and hip started hurting and swelling all on the right side a couple weeks later after the charley horses. I went to the urgent care, and they did some testing and found blot clots all through my leg. I went to a radiologist, and he found a bigger blood clot in my pelvis, and I went into surgery. He removed the blood clot in my pelvis. I still have blood clots in my right leg, and I must take XARELTO.
vax site sl reddened;1SEP96 febrile 103-104.5, irritable, screaming, lost appetite, began v;couldn't keep APAP down;devel red spots w/white heads on back & chest;3SEP96 shaking, startled when aroused;febrile sz;lethargic;to ER;
pt recv vax 110PM & 2min p/vax pt passed out & immed/simultaneously began seizing;pt was lowered to floor & sz persisted 30sec;eyes rolled back in head arms straight @ sides, ridged w/decrebrate-like posturing evident;
Expired Drug Used; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old male patient who received HAV (Havrix) (batch number 4KJ79, expiry date 30th October 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th November 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 24th November 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received expired Havrix vaccine, which led to expired vaccine used. No additional details were provided by the caller. The reporter did not consent to follow up