chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient requested trivalent flu vaccine. We gave him this. He later came back and said he had already received vaccine this season.
patient was administered with vaccine that has been stored in the refrigerator for 31 days; patient was administered with vaccine that has been stored in the refrigerator for 31 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered with vaccine that has been stored in the refrigerator for 31 days) and PRODUCT STORAGE ERROR (patient was administered with vaccine that has been stored in the refrigerator for 31 days) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered with vaccine that has been stored in the refrigerator for 31 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient was administered with vaccine that has been stored in the refrigerator for 31 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered with vaccine that has been stored in the refrigerator for 31 days) and PRODUCT STORAGE ERROR (patient was administered with vaccine that has been stored in the refrigerator for 31 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Days after vaccine 30 days use by expiry -1. The vaccine was stored in refrigerator on 15-Feb-2022. The patient didn't experience any adverse event so far. No treatment medications was reported.
My uncle started feeling unwell the evening he got his 2nd Covid 19 vaccine. By the next evening, he started vomiting violently, trembling and sweating. He lived in country and his caregiver didn't think to take him to the hospital. The symptoms calmed down after a while, but he was not able to hold any food or liquids down. Eventually, he fell asleep and his caregiver left for the night. He returned on Easter Sunday at 9:30 am and found my uncle deceased.
Moderna Covid-19 vaccine that underwent a temperature excursion in freezer administered to patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that underwent a temperature excursion in freezer administered to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that underwent a temperature excursion in freezer administered to patient). On 17-Nov-2021, PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that underwent a temperature excursion in freezer administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided  Moderna Covid-19 vaccine in Freezer underwent temperature Excursion.The Freezer reached 53 degrees Farenheight. and was administered to patient.
(?)Erythema, Warmth, edema, Starting on day #3, Rx- Keflex 300 mg bid X7 days.
Patient was administered the Moderna vaccine for the first dose, but intead received a 0.25ml dosing from the pediatric (6-11 age group) vial. No adverse effect was reported, just an error had occurred in terms of what vial was used.
Pain, redness, swelling for the first 2-3 days, then hot to the touch at the injection site 5 days after injection given.
Nausea, Chills, Fatigue, Fever, Muscle and Joint Pain, Headache
Pt reported that before the shot got in, my heart started racing. Also stated that when she returned to work her arm started tingling down into fingers and she3 became dizzy. She was taken to Hospital and evaluated by RN NP and given steroid injection and an anti anxiety med Xanax. She was informed by nurse practitioner that she could not be sure if SX were r/t vaccination or not.
my legs started itches; I noticed hives on both my legs; the rahses/hives still spreading to different place on my body; I also have a constant mild headache; The hives leave dark scar on my body; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 28Sep2021 (Lot number: FF2589) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EA0186, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 11Aug2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 29Sep2021 11:00, outcome "not recovered", described as "my legs started itches"; URTICARIA (non-serious) with onset 29Sep2021 11:00, outcome "not recovered", described as "I noticed hives on both my legs"; RASH (non-serious) with onset 29Sep2021 11:00, outcome "not recovered", described as "the rahses/hives still spreading to different place on my body"; HEADACHE (non-serious) with onset 29Sep2021 11:00, outcome "not recovered", described as "I also have a constant mild headache"; SCAR (non-serious) with onset 29Sep2021 11:00, outcome "not recovered", described as "The hives leave dark scar on my body". The events "my legs started itches", "i noticed hives on both my legs", "the rahses/hives still spreading to different place on my body", "i also have a constant mild headache" and "the hives leave dark scar on my body" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus, headache. Therapeutic measures were not taken as a result of urticaria, rash, scar.  No follow-up attempts are possible. No further information is expected.
Received both doses of Pfizer covid vaccine, but became symptomatic on 4/17/21 and tested positive for covid on 4/18/21.
soreness injection site; I have disturbing ringing in the ears; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site pain and ringing in ears. On an unknown date, the outcome of the injection site pain and ringing in ears were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and ringing in ears to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced soreness at the injection site and disturbing ringing in the ears.
his rate rate has elevated; soreness and body aches presented last night; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2020, the patient received the 1st dose of Shingrix. On 28th January 2020, less than a day after receiving Shingrix, the patient experienced general body pain. On 29th January 2020, the patient experienced heart rate irregular. On an unknown date, the outcome of the general body pain and heart rate irregular were recovering/resolving.   It was unknown if the reporter considered the general body pain and heart rate irregular to be related to Shingrix.  Additional information was provided as follows: The patient experienced soreness and body aches. On the day of reporting, the patient's heart rate was elevated. It went up to 110 beats per minute then down and then up to 160 beats per minute and then down again. The reporter consented to follow up. The outcome of events were reported as recovering/ resolving in the database however in source document, it was mentioned as not recovered/ not resolved.
Menstruation cycle began early - on day 10 post vaccine - and lasted twice as long as normal. I have not had another period since; time will tell if I do. I've been very regular, historically.
This case was reported by a physician, via GSK representative, and described the occurrence of tenderness around injection site in a 28-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included 6 weeks post-partum. On 25 May 2010 the subject received 1st dose of BOOSTRIX (unknown route, unknown arm). On 26 May 2010, 1 day after vaccination with BOOSTRIX, the subject experienced tenderness around injection site, injection site induration and injection site redness. The subject was treated with non-steroidal anti-inflammatory and warm compress. At the time of reporting the events were improved. The physician considered the events were probably related to vaccination with BOOSTRIX. The subject was seen at the physician's practice on 08 May 2010 and reported that she had developed a large red, tender, indurated area (approximately 8 cm) at the site of vaccination approximately 24 hours after the vaccine was administered. The subject reported that the size had decreased since it first appeared.
Woke morning after the shot with pain alone right side of the body from head to hip, worst in arm,  low grade fever and earache right side only.
This spontaneous report was received from a nurse concerning an unspecified number of patients (demographics unknown). On unspecified dates since 25-AUG-2015, the patient were vaccinated with doses of M-M-R II (lot # L004658; expiration date: 11-FEB-2017) which were exposed to temperature outside of the recommended range. No adverse experiences had been reported. This is one of several reports received from the same source. Aditional information has been requested.
This patient is an 86-year-old woman.  The patient developed a fever several days ago, apparently this last Friday.  She lives at an assisted living facility with staff, it seems like she is isolated her to her room.  Today, she states she continued to feel fine and staff tested her for COVID. She apparently was tested positive and was sent here for further evaluation.  On evaluation here, she was found to have a pulse ox of 90% on room air.  We were contacted for admission.  The patient, otherwise, is without much complaints.  She does have COPD and has oxygen that she does not use but does state that she has been using that in the last several days for some shortness of breath. She has had some mild myalgias as well.  She is fully vaccinated. DISCHARGED 08/24/2021: Patient verbalizes understanding of discharge instructions including medications (prednisone), when to take them, home oxygen therapy, and when to call healthcare provider. Patient connected to portable oxygen tank and transported here for ride. Taken via wheelchair to main lobby and home with home health care.
Had a seizure, then passed out about 20 minutes after having the shot with no prior history of seizures
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The case was originally opened on 06-OCT-2014 to evaluate improperly stored vaccines. On an unknown date (also reported as since the first call) those patients were possibly vaccinated with an improperly stored doses of ROTATEQ (therapy route defaulted to oral, dose, units, lot number were not reported). No adverse effects reported. Additional information has been requested.
Developed tinnitus; Severe lightheadedness; Nausea; Sweating; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 29Mar2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included sciatica. The patient had penicillin allergy and egg intolerance. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included curcuma longa (TURMERIC) and multi vitamin (MANUFACTURER UNKNOWN); both taken for unknown indications from unknown dates and unknown if ongoing. On 29Mar2021 at 12:03, about 3 minutes after the first vaccination, the patient experienced initial reaction of severe lightheadedness, nausea and sweating which lasted about 10 to 15 minutes. A few days later, on 01Apr2021, the patient developed tinnitus. She never had it before and it was going on 3 weeks then. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events lightheadedness, nausea and sweating was resolved on 29Mar2021 while that of the event tinnitus was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Pt stated that had an event with flu vaccination 17 years ago, but has had several flu shots without incident since then.  I verified 2 shots in the system.  On 11/9/2006, at approximately 0900, after consulting me, I advised to give it. She received it, but within several minutes had a local reaction, with a 1 cm wheal (dark complexion makes for more difficult assessment). Noted swelling, redness, warm to touch, and blister at site of injection. Requested that the patient wait. I arrived approximately 0930 am with a frozen cold pack wrapped in a blue chucks. She applied this to the site.  I advised that normal protocol would be to be monitor for 4 hours following the injection. Pt states that she felt better and that she was remaining on post.  I instructed her to seek immediate care should she note symptome worsening or respiratory involvement. She called me at approximately 1700 to confirm that she is feeling fine.
The pt developed lightheadedness at around 10am with fever of 100.8 deg. F.
RASH ON RT THIGH- ON 2/29/2008- CAME IN BECAUSE OF ITCHING. ON EXAM PT HAS A 7 CM X 8 CM ERYTHEMATOUS INDURATED AREA ON THE RT. ANTERIOR THIGH. CONSISTENT WITH REACTION TO VARICELLA. - LARGE VARICELLA VACCINE REACTION.- RECOMMEND BENADRYL AND MOTRIN. RTC IF ANY WORSENING.
Full-body aches; Extreme fatigue; Arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 12:15 (Lot number: EW0164) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: TRELEGY; SINGULAIR; FLONASE [FLUTICASONE PROPIONATE]; AMBIEN; ALBUTEROL [SALBUTAMOL SULFATE]. Vaccination history included: Bnt162b2 (dose 1, single, lot number=EW0150, administration time=03:00 PM, vaccine location=Left arm), administration date: 05Apr2021, when the patient was 40 years old, for Covid-19 Immunization, reaction(s): "Fatigue", "Arm pain". The following information was reported: PAIN (non-serious) with onset 26Apr2021, outcome "not recovered", described as "Full-body aches"; FATIGUE (non-serious) with onset 26Apr2021, outcome "not recovered", described as "Extreme fatigue"; PAIN IN EXTREMITY (non-serious) with onset 26Apr2021, outcome "not recovered", described as "Arm pain". Therapeutic measures were not taken as a result of pain, fatigue, pain in extremity.  Additional information: There were no known allergies. Facility type Vaccine was Hospital. The patient did not receive other vaccine in four weeks. It was unknown whether the patient had covid prior vaccination. The patient did not test covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Associate was administered Moderna vaccine at time of 2nd vaccine administration.  First vaccine adminstration was the Pfizer BioNTech vaccine.
Fever, body aches, headache, stomach pain, red swollen arm, felt like throat was closing up, unable to eat or drink, pain  to touch.  Patient sought medical attention from her primary care physician.  Doctor recommended OTC medications (tylenol and claritin) and cold compression.
Patient called and stated that she had "pain, swelling, redness, and bruising at the injection site"
A medical assistant called and wants to know if there is any side effects because the both administered ACTHIB & Vaxelis to a patient. They concern was it both contains HIB; This non-serious spontaneous Safety Report was received by partner on 19-APR-2023 and forwarded to agency on 21-APR-2023 from other health professional.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "A medical assistant called and wants to know if there is any side effects because the both administered ACTHIB & Vaxelis to a patient. They concern was it both contains HIB".  Further information is expected.
mom reported pt had several hrs of unconsolable crying p/vax on 4MAY94;states it was more than 3hrs but is unsure of the specific time; had rt OM @ time of vax; fever, irritability
FEVER 103.1; NASAL CONGESTION; A spontaneous report has been received from a consumer. The report concerns a female patient (age 6 years, height 47 in, weight 50 lb).    No medical history was reported.     No concomitant products were reported.    The patient received FluMist Quadrivalent (influenza virus vaccine live, intranasal) (batch number MH2204) 0.2 ml as required, via nasal route, for prevention on 30-OCT-2020.     On 30-OCT-2020, the patient experienced fever 103.1 (preferred term: Pyrexia) and nasal congestion (preferred term: Nasal congestion).     The patient recovered from the event(s) of nasal congestion on an unspecified date. At the time of reporting, the event of fever 103.1 was ongoing.     The events were considered non-serious.     Laboratory values are available.
2 days p/vax pt devel swelling & pain @ the site of vax;pt then devel pain & swelling of the rt wrist & hand;pt wife & sister in law stated pt wrists are frequently d/t arthritis, but pt stated swelling more than usual;seen by MD in canada;
Patient reports on date of vaccine given (10/3/17), she experienced fever, chills, headache-all which resolved the morning of 10/4/17. Reports 10/3/17 to present date (10/5/17) warmth and redness to left upper arm starting out the size of an orange and gradually decreasing in size and warmth/redness.
Vasovagal syncope 12 hours after vaccine injection Resulted in fall which broke 3 teeth, split open top and bottom lip and fractured nose.
pt recvd vax & exp slight headache; pt woke up w/ HA, vomiting, fever of 104;
REALLY SICK; TROUBLE FOCUSING; TROUBLE SLEEPING; BURNING UP; FLU-LIKE SYMPTOMS; BAD DREAMS; BODY SORENESS; CHILLS; TIREDNESS; FEVERISH; SPLITTING HEADACHE; MUSCLE PAIN; This spontaneous report received from a patient concerned a 30 year old of unspecified sex. The patient's weight was 125 pounds, and height was 67 inches. The patient's concurrent conditions included non-alcohol user, non-smoker, takes medication for transgender care - estradial/estrogen, and seasonal allergies, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 07-AUG-2021) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. Concomitant medications included estradiol. On 29-JUN-2021, the subject experienced really sick. On 29-JUN-2021, the subject experienced trouble focusing. On 29-JUN-2021, the subject experienced trouble sleeping. On 29-JUN-2021, the subject experienced burning up. On 29-JUN-2021, the subject experienced flu-like symptoms. On 29-JUN-2021, the subject experienced bad dreams. On 29-JUN-2021, the subject experienced body soreness. On 29-JUN-2021, the subject experienced chills. On 29-JUN-2021, the subject experienced tiredness. On 29-JUN-2021, the subject experienced feverish. On 29-JUN-2021, the subject experienced splitting headache. On 29-JUN-2021, the subject experienced muscle pain. Laboratory data included: Fever (NR: not provided) 101.5 - 102F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the really sick, trouble focusing, trouble sleeping, burning up, flu-like symptoms, bad dreams, body soreness, tiredness, chills, feverish, splitting headache and muscle pain was not reported. This report was non-serious.
This spontaneous report as received from a physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Merck) (Lot #, dose and route not reported) instead of ZOSTAVAX for shingles. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought for medical attention. Follow-up information has been received from the physician via a telephone memo on 10-AUG-2012 concerning that 12 patients were administered VARIVAX (Merck) instead of ZOSTAVAX. The physician did not want to provide any patient identifiers, but stated that the clinic was making follow-up calls at the time of reporting to 9 patients who would be vaccinated with ZOSTAVAX 2-3 weeks later. And this is one of the 9 patients. No further information is available. This is one of several reports received from the same source. Additional information is not expected.
Flu like symptoms, injection site swollen, sore went to doctor given antibiotics BACTRIM DS. Doctor wanted to hospitalize patient refused.
Patient observed for 15-20 minutes, and Did NOT have any adverse events or outcomes. no signs or symptoms
This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 30-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Since getting both of my moderna vaccines I?ve noticed my period has been coming back monthly despite having three iuds in over the last 8 years or so.  Typically I spot after getting it replaced but this has been monthly spotting and cramps.  This iud was put in about a year prior and I hadn?t seen spotting   Since 3 months or so after having it replaced.  Everything else in my life is very regulated since I?m on disability and mostly stay at home happily.  Since my first dose I?ve gotten monthly spotting and the only correlation I can make is that it?s from the vaccine since it started just after getting the first dose.
SORENESS AT INJECTION SITE DAYS 1-7 AFTER INJECTION Narrative: