chrisvoncsefalvay/vaers-outcomes huggingface dataset:
internal bleeding; cardio issues; This is a spontaneous report from a non contactable consumer. An 86-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported: "Consumer calling about her Mother in law dying from the side effects of the Pfizer Covid Vaccine at 3:00 am Sunday, 15Aug2021. Caller asked How many deaths have there been called that they believe was caused by the Pfizer vaccine? My MIL was 86 y/o and she had just started PT in the hospital. She started having cardio issues and internal bleeding and now she is dead. She had started PT and was up walking, so her doctor suggested she get the this because she was having PT, then she started having internal bleeding and cardio issues and now she's dead. With in 48 hours of taking that vaccine. She developed symptoms where there was blood gushing out of her mouth and my father in law saw this. They couldn't stop the bleeding because of her health condition." The patient experienced internal bleeding, cardio issues on an unspecified date. The outcome of events was fatal. The patient died on 15Aug2021. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: internal bleeding; cardio issues
Skin/ body rash. Patient is not getting better. On antibacterial soap and avoiding  fragrances in detergents.
At site of Shot leg became swollen, red, hard, warm, redness spreading over time.
When I got the vaccine, I had a fever, chills and cramps the day after the vaccine. It lasted for 30 hours. Three weeks after the vaccine I had a miscarriage at nine weeks gestation. I had some bleeding and I went to the doctors office between seven and eight weeks. I had chosen the J&J because it was not MNRA.  Due Date-11/27/2021 Pregnancy-Third Pregnancy
This spontaneous report as received from a Registered Nurse (R.N.) refers to two patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 10-MAR-2016 the patients were vaccinated with improperly stored GARDASIL 9 (lot # L018351, expiration date 11-AUG-2017, dose and route were not reported). The vaccines were in 8.9 Celsius degree for 15 minutes as well as 1.0 Celsius degree for 10 minutes without any previous temperature excursion. Concomitant drug was not reported. No adverse effect was reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 25-JAN-2016 the patient as vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L030587, expiration date 10-FEB-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Rash on right arm around injection site. Benadryl given to patient after patient was evaluated by provider. Patient rash resolved after twenty minutes and she was able to be discharged
Immediately after injection c/o itching at injection site, raspy voice, Used asthma inhaler, felt better after 30 minutes but went to ER to get checked out.
Chills, fever, whole body ached, vomiting, headache, some swelling in hands and face, flushed
sore, red welt lasting over 2 weeks-still unresolved with remaining painful pebble sized lump tender to touch
no adverse event; Medical assistant reported VAQTA was administered after temperature excursion. See full details below. The operator of the device was a healthcare provider. HCP provided lot number that did not appear to be similar to other Merck vaccine lot numbers;; This spontaneous report was received from a medical assistant, regarding an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 18-SEP-2023, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) (route and dosage information were unknown; lot number reported as Y3ME2 expiration date: 23-FEB-2025) for prophylaxis. It was reported that the administered dose had suffered a temperature excursion (incorrect product storage).  On 14-AUG-2023, the dose was stored at a temperature of 8.9 degrees Celsius with a time frame of 12 hours 20 minutes and 0 seconds. On 28-AUG-2023 it was stored at a temperature of 9.4 degrees Celsius with a time frame of 8 hours, 20 minutes and 0 seconds.  There was no previous temperature excursion.  No adverse events were reported.   Lot number Y3ME2 is an invalid lot number for hepatitis a vaccine, inactivated (VAQTA).
was very Cold; Difficult to get up this morning; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (was very Cold), ASTHENIA (Difficult to get up this morning) and HEADACHE (Headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced FEELING COLD (was very Cold), ASTHENIA (Difficult to get up this morning) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING COLD (was very Cold), ASTHENIA (Difficult to get up this morning) and HEADACHE (Headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.   This case was linked to MOD-2021-099009 (Patient Link).
her periods has been much worse; cramps has been very difficult to manage; her periods has been much worse; cramps has been very difficult to manage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14 year-old female patient received bnt162b2 (BNT162B2), administration date 03Sep2021 (Batch/Lot number: unknown) at the age of 13 years as dose 2, single and administration date 12Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious), DYSMENORRHOEA (non-serious), outcome "unknown" and all described as "her periods has been much worse; cramps has been very difficult to manage". Therapeutic measures were taken as a result of dysmenorrhoea. Additional information: Reporter was calling to report about the adverse reaction for daughter. She has the 'fungus' (voice not clear). She had the Pfizer vaccine in Sep when she was 14, she was 15 now but she was 14 and her periods has been much worse and reporter have heard that the people have that side effect (general statement, further clarifications unknown hence split not made). And the cramps have been very difficult to manage. First or the second shot were only a couple of weeks apart, so reporter don't know she had both. LOT#: Pfizer 10121 (Not clarified hence not captured) and that was on (12Aug2021). The date was 12Aug2021 with the first one. The second was LOT#8448 and that was given on 03Sep2021. Patient did not receive Any prior vaccinations. For the cramp patient have been using the heating pad and Midol.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Narrative: Patient receive flu vaccine on 10/06/2020 and came in on 10/30/2020 complaining of an itchy rash at the injection site. Physician prescribed diphenhydramine for patient to take. Was still having itchy rash after visit. Seen by dermatology on 11/17/2020 and they prescribed cetirizine 20 mg daily instead to help with rash. Was seen again on 12/27/20 where patient reported that condition is improving. Symptoms: Rash, UrticariaPruritus & RASH Treatment: DIPHENHYDRAMINE 1 TAB QID Take one capsule by mouth every 6 hours as needed
Patient received Pfizer bivalent age 5-11 and patient is 12 years old.
PSORIASIS BREAK OUT ON ELBOWS AND RIGHT ELBOW/PLAQUES ON KNEES AND ELBOWS/PLAQUE PSORIASIS FLARE UP; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PSORIASIS BREAK OUT ON ELBOWS AND RIGHT ELBOW/PLAQUES ON KNEES AND ELBOWS/PLAQUE PSORIASIS FLARE UP), PYREXIA (Fever) and FATIGUE (Fatigue) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS).   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in pre-filled pen. In 2021, the patient experienced PYREXIA (Fever) and FATIGUE (Fatigue). On an unknown date, the patient experienced PSORIASIS (PSORIASIS BREAK OUT ON ELBOWS AND RIGHT ELBOW/PLAQUES ON KNEES AND ELBOWS/PLAQUE PSORIASIS FLARE UP). At the time of the report, PSORIASIS (PSORIASIS BREAK OUT ON ELBOWS AND RIGHT ELBOW/PLAQUES ON KNEES AND ELBOWS/PLAQUE PSORIASIS FLARE UP) had not resolved and PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.            There was no reported medical history.  Concomitant drugs not reported. On unknown dates, the patient experienced PSORIASIS BREAK OUT ON ELBOWS AND RIGHT ELBOW/PLAQUES ON KNEES AND ELBOWS/PLAQUE PSORIASIS FLARE UP and DID NOT FEEL HUMIRA WAS WORKING. In 2021, the patient experienced FATIGUE and FEVER.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of FATIGUE and FEVER with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event of PSORIASIS BREAK OUT ON ELBOWS AND RIGHT ELBOW/PLAQUES ON KNEES AND ELBOWS/PLAQUE PSORIASIS FLARE UP with HUMIRA(ADALIMUMAB) was a reasonable possibility and for the event of DID NOT FEEL HUMIRA WAS WORKING was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Live Significant Follow-up received: Age was added. Batch number for humira was added. Moderna booster dose regimen was added and administration dates for dose 1 and dose 2 were added.  New events fatigue and lack of drug effect were added. As reported term for the event Psoriasis flare-up was updated. Onset date for the event fever was added. Causality for fever was updated for Moderna suspect.
Pt. c/o "feeling high" like she had some drink.  She felt light headed. Denies SOB denies chest pain.  @ 1040 BP 160/100, HR 84, RR 18.  @ 11:49 BP 160/82.  @ 1050 BP 160/90, HR 80, RR 18, no dizziness, O2.Sat 97%,  160/82.  Stated she is fine and wants to go home.  @ 11:22 pt left accompanied by her husband.
This spontaneous report as received from a physician refers to a patient of unknown age. On 18-JUN-2013 the patient was vaccinated with the third dose of GARDASIL (Lot # not provided) (dose, route not reported) No other co suspects were reported. No concomitant therapy was reported. The physician reported that the patient was administered the first two doses in the GARDASIL vaccination series on time five years ago, with the second dose being administered in 2008, and the third dose in the series was administered on 18-JUN-2013. No adverse effect reported. Additional information has been requested.
Severe pain in left shoulder (9/10). Feels very similar to the pain I felt post-op in my right shoulder after my rotator cuff surgery.  Cannot sleep for extended periods of time.
Immediately after immunization of the vaccine, the patient started  shaking and sweating, and laid on the floor.  The pharmacist then picked up the patient and ask the technician to call 911. The patient continued to have shakes and sweats, and the patient vomited for 15 sec. Staff was instructed to not give the patient water or food, and to not have patient lay down. EMT arrived within 5-10 minutes and reported that the patient's heart rate was high and blood glucose was low. EMT offered to take her to the hospital, but she signed waiver to not go to the hospital and she left with a friend.
Site: Itching at Injection Site-Severe, Systemic: Exhaustion-Mild, Systemic: Other- Itching,Swollen tongue, Difficulty in breathing
A spontaneous, non-serious report of erythema multiforme has been received from a physician concerning a four year old female patient subsequent to the administration of FLUMIST. On 17 Nov 2009, the patient received FLUMIST. On 29 Nov 2009, the patient developed a rash. She was seen by a dermatologist who diagnosed the ash as erythema multiforme. The patient was treated with antibiotic (no topicals given). The event of erythema multiforme was resolving. The outcome of the event, erythema multiforme, was resolving.
FLUBLOK was administered to 16 years old patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00414283) and transmitted to Sanofi on 04-Jan-2021.  This case was linked with 2021SA002156, 2021SA002607, 2021SA002631, 2021SA002726, 2021SA002799, 2021SA002850, 2021SA003080, 2021SA003127, 2021SA003182, 2021SA002085 (same reporter)  This case involves a 16 year old male patient who was administered with a standard 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe, lot UJ509AA, expiration date 10 May 2021) once via intramuscular route at the left deltoid for prophylactic vaccination on 30-Dec-2021 (Product administered to patient of inappropriate age).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.   It was a case of actual medication error due to inappropriate age at vaccine administration (latency-same day).   Reporter stated that FLUBLOK had been administered to 11 pediatric patients and would like to know if patients were covered for influenza vaccination for the season  At the time of reporting, no adverse event reported (reported as none).  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 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.
This spontaneous report was received from a 66 year old female patient, who was referring to herself. The patient's medical history included dry eye and drug hypersensitivity to DEMEROL. The patient's other medical history, concurrent conditions were not reported. On 11-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 injection, route of administration reported as "injection" for prevention of pneumococcal disease (strength, dose, frequency, lot #, expiration date were not reported). Concomitant therapies included TRANXENE, RESTASIS and CLIMARA. On 12-OCT-2018, the patient woke up during the night with a fever and a headache. The patient also reported that she woke up in the morning with a large lump about 2 inches below the injection site which she reported as being rock hard like a stone, was painful, and could not move her arm. The patient reported that on 13-OCT-2018, reported as the following day, the lump started to go away and there were 4 red blotches that appear to be hives in that arm area. The patient also reported that she was using a hydrocortisone cream as well as BENADRYL for treatment. The patient also had diarrhea for a 3 day duration as well as pressure in her right ear and pain and swelling on her glands on her right side that was puffy. No lab diagnostics/studies were performed. The patient sought medical attention and spoke with physician. The patient was currently getting better although she was still had a pain in her neck. Outcome of the events was reported as recovering. Outcome of the pain in her neck was considered as not recovered. Causal relatedness was not provided.
3.5 cm x 5.0 cm area of induration and erythema at injection site.
Approx 10 minutes after dose patient said she was feeling dizzy, lightheaded and flushed. She asked for a glass of water which we provided.  We placed an instant cold compress on her neck and she held one to her forehead, and rested her head between her knees.  We also placed a fan in the area to circulate the air.  She said she was nervous because she had an appt at another pharmacy during her lunch hour and they couldnt give her the scheduled dose so she was driving all over town to find a dose in 100 degree heat before her lunch hour was over.  She also stated she had a 'rough time' after her first dose and was concerned about the second.  We had her call someone to pick her up and drive her home- she was feeling better by the time they arrived (approximately one hour).  She believed her reaction was primarily due to anxiety
This spontaneous report as received from a registered nurse refers to a 8 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 15-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Initial unsolicited report received from a health care professional on 07 June 2018. This case involves a patient (age and gender not reported) who was vaccinated with expired dose of PENTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error as expired vaccine used. No adverse event was reported. 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 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. Documents held by sender: none.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 47-year-old male patient who received BOOSTRIX. The patient's past medical history included myalgia (statins medication). Concurrent medical conditions included diabetes, fibromyalgia, rhabdomyolysis and hypoxia (sore prone on right side, foot). Concomitant products included cod-liver oil, COLACE, influenza vaccine unspecified, HALDOL, Levothyroxine, magnesium, Metformin, MIRALAX, potassium chloride, vitamin B complex, Vitamin C and Vitamin D. On 10th October 2015, the patient received the 1st dose of BOOSTRIX .5 ml. On 11th October 2015, 2 days after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be relate to BOOSTRIX. Additional details were received as follows: This case was not previously reported to anyone. The patient received BOOSTRIX in left shoulder. The patient noted that, he does not usually experiences soreness after vaccinations. The patient stated that, he did not usually get the vaccinations in his right arm, due to the lower oxygen levels on right side. The patient experienced sores on his right foot due to lower oxygen levels. No further information was available.
had his first shot on 08FEB2021 and is about to go beyond the 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT AVAILABILITY ISSUE (had his first shot on 08FEB2021 and is about to go beyond the 42 days) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (had his first shot on 08FEB2021 and is about to go beyond the 42 days). At the time of the report, PRODUCT AVAILABILITY ISSUE (had his first shot on 08FEB2021 and is about to go beyond the 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  He was scheduled for second one on 07-Mar-2021 but something occurred in the system that it was not Moderna that they were giving at the site. No treatment information was provided.
Headache, feels like the Flu, fever 101.00.  Body aches,
Approx 12 hours after shot I felt chills and body aches. Symptoms worsened when I woke up the next morning and could hardly get out of bed... felt like I had the flu. By midday I could move around a bit but still felt crummy (nausea, headache, chills, aches). The next day I still felt off but was functional.
Moderna COVID-19 Vaccine EUA.  Starting the next morning, Fever, body ache, headache, back/joint pain,  something in my left armpit swole up between a golf ball to tennis ball size, throat sore, swelling in tongue and gums (kind of blistery like I burnt it on hot pizza is the best way I can describe it). most of the symptoms lasted for a day and a half or so. Four days later, still feverish at times, mouth is still tender (most of the swelling went down but not all)  swelling in armpit has went down but not gone.
Dizziness, Headache & Nausea Vomiting Narrative: Left arm pain at injection site Nausea Headache Dizziness