chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presents to ED on 9/21/17 c/o n/v, C/O N/V, urinary retention, difficulty urinating, and fever after receiving influenza vaccine. Pt developed nausea and vomiting (4-5 episodes) overnight. Initially on admission she was tachycardic, leukocytosis and lactate was elevate. elevated. Given these findings it was thought that she might have an infection, however, there was no source of active infection. Urinalysis performed was negative. Foley cath pulled off 1L. Pt. started on IV ROCEPHIN for suspected UTI. She received antibiotic for 48 hours. Her urine culture came back showing mixed flora. ROCEPHIN was subsequently discontinued. Pt also experienced hypovolemic hyponatremia hyponatremia which resolved with IV fluids. Patient was observed for 24h and Foley catheter was removed. Pt successfully voiding spontaneously and returned to baseline. Pt d/c D/C 9/23/17 and instructed to follow-up with primary care physician in one week. Etiology noted as unclear but potentially related to influenza vaccine.
Above client had 3 vaccines administered on 5/26/09 @ approximately 12:00 pm. Client called @ approx 1:25 and stated "I'm having trouble breathing."  She was instructed by a nurse to go to the closest ER. If unable to drive, call 911. I received the message and try to call client (left message on phone) I called her Mom's cell phone and she said that she told client to use her asthma inhaler and see if she felt better.  I advised that patient should go to closest ER.  At approx 4.45 pm mother called to let me know that patient was in the ER and that she was told that this was probably a reaction from the vaccines she received earlier.  I followed up with client the next and she said that she doing well.
crying, 3hr p/vax fever, had jerking of arms & legs 10 times;whole episode lasted x 3hr;jerking was cont cont;
Received Tdap on 2/14. A few hours later felt headache, lightheadedness, malaise. Symptoms chronic, recurred. Also has noted intermittent palpitations, temperature around 99 degrees and left arm soreness (near site).
This case was reported by a healthcare professional and described the occurrence of injection site pain in approximately 30 adult subjects of unspecified gender who were vaccinated with TWINRIX (GlaxoSmithKline) for prophylaxis. Concurrent vaccination included unspecified vaccine given on an unspecified date. It was reported that it was possibly four other vaccines that were given on the same date as TWINRIX. On an unspecified date after September 2007 and before 07 February 2008, the subjects received unspecified dose of TWINRIX (1 ml, unknown deltoid). At the time of injection, the subject experienced injection site pain, injection site burning and injection site stinging. The adverse events resolved after the injection. This case was also associated with a pharmaceutical product complaint. The lot number that was reported was AHABB103AA. The reported noted that she had been using the thimersol free formulation based in NDC. The lot number and expiration that she reported was from January 2008 and she does not know the lot number that she used prior th that. The nurse contributes the increased discomfort to the reformulation of the product. At the time of reporting th outcome of th events were resolved. Follow-up was received on 25 February 2008 via the nurse. She reported that events resolved and she considered that the events were related to TWINRIX. She noted that the events were not serious. She noted that these events did happen to several subjects but she did not keep a list of names at the time.
patient states her left arm has been sore due to the flushot . she has not gone to doctor yet but complains of decreased range of motion. when she tries to move her arm from the front to the back, she states it hurts.
Premature ventricular contractions in large numbers, EKG verified increased Troponin level,  issue occurred 3 weeks after second dose of vaccine, gradual reduction of events over 11 months
nose bleeds; nausea; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID:   An 83-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 immunization. The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "nose bleeds"; NAUSEA (non-serious), outcome "unknown".  Additional information: Patient had frequent nose bleeds and constant nausea following the second shot.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hx of ITP with mild, progressive decline of platelets over several months. However, 2 weeks after 9/30/2015 influenza vaccine, plts dropped nearly 40,000 to 8K total platelets, with accompanying bleeding.
Breakthrough case. On 07/10/2022 I started feeling chills and had a temperature of 100.5. It came on quickly. I'm an RN and the next day I got tested for COVID-19. Tested at hospital lab. Tested positive. Called Dr. and did a teleconference. Prescribed PAXLOVID, 1 tablet for 5 days. After 2 days of taking PAXLOVID I started to feel better. I tested negative on 7/26/2022.
Moderna 4/9/21, 5/6/21. Positive on 7/24/22
Left arm upper arm deltoid redness, warm to the touch, small lump, painful. Left side of neck lump.
Patient initially had a positive COVID antigen test on 12/3/2022; He took Paxlovid and his COVID symptoms were improving. Then patient began to feel worse on 12/15/2022 with weakness, body aches, cough, shortness of breath and fever. On 12/16/2022, patient presented to the emergency department due to shortness of breath; his COVID NAA test was positive, and his chest x-ray showed left basilar infiltrate and mild right perihilar probable infiltrate. He was diagnosed with Sepsis due to unspecified organism, COVID-positive pneumonitis without hypoxia, Respiratory distress, and COPD exacerbation. Patient was treated with steroids, inhalers, and antibiotics. He was admitted to the hospital for further treatment.  Submitter does not have access to additional medical information on this case. If more information is needed, please contact the admitting hospital.
pt recvd vax 21APR92 & w/in 24 hrs devel generalized body pain & chills which persisted for approx 1 day; No further details were provided;
Pt reported nausea, sweating and dizzy. I had her come inside the pharmacy. I gave her water, Tylenol and told her to sit down. She did all that and felt better in 15 minutes.
This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 09-JUN-2015 the patient was inadvertently vaccinated with a dose of improperly stored PROQUAD (Merck) (Lot# K018143; expiration date: 10-APR-2016) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Burning lateral leg pain from thigh to ankle starting 10 days after 2nd Pfizer dose
This spontaneous report was received from a healthcare worker and refers to two unspecified siblings. On 30-NOV-2015, both the patients were vaccinated with first dose of GARDASIL 9 (lot # L016429 and expiry date: 09-AUG-2016). Both the patients received second dose of GARDASIL 9 (lot# L026602 and expiry date: 19-OCT-2017) on 04-APR-2016 and third dose (lot# M003659 and expiry date: 20-SEP-2017) on 14-JUN-2016. No adverse effects were reported. Both the siblings received doses of GARDASIL 9 outside the recommended dosing schedule. No product quality complaint (PQC) was reported for GARDASIL 9. Additional information is not expected as the reporter did not wish to be contacted.
This report describes a lump at the injection site of a 4 month old male who received an injection of Infanrix. On 06/04/01, the infant received his first injection of Infanrix. Unspecified concomitant vaccines were administered at "opposite sites" On 06/05/01, one day post-immunization, the infant developed a "large' lump at the Infanrix injection site. The infant was seen by the physician who prescribed paracetamol (Tylenol) 60 mg every four hours. The lump resolved. The reporter considered the event to be mild in intensity and related to Infanrix administration. This is one of three infants from this facility who developed an injection site reaction following receipt of Infanrix lot 992A2.
Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had vaccinated subcutaneously with a first dose of 0.5 ml of varicella virus vaccine live (Oka/Merck).Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected. This is one of several reports received from the same source.
12:35 fainted in hallway-immed awoke-skin cool & clammy, lips pale-stated got SOB & that evening went blank; took back to school nurse & pt laid down; VS taken BP 118/70,P68, still cool & clammy;stated had not eaten lunch
An expired booster dose was given to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant treatment was provided.  No medical information was provided by the reporter.
Pt.  received 2nd pfizer vaccine at 1321 left arm-patient then experienced burning sensation to throat at 1325 which lasted about five minutes. Pt. states that it resolved after five minutes and she feels fine now. Pt. denies sob, denies trouble breathing, no hives, denies any other symptoms.
Information has been received from a pharmacist referring to 2 newborns (numbered 218, and 219). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time =72 hours) that temperature was 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 23-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Patient experienced pain for several weeks in her right shoulder joint several day following the second administration of her RABAVERT series.
Day after injection; weak/tired - stuffy nose. Weakness increased and went home from work. Wednesday AM - Dizzy spells and felt "drained" Wednesday thru Saturday: Headache
DIARRHEA; BAD CHILLS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, and high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021, the subject experienced diarrhea. On 05-APR-2021, the subject experienced bad chills. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 94.7 F. On 06-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad chills on 06-APR-2021, and had not recovered from fever, headache, nausea, and diarrhea. This report was non-serious.
This case was reported by a physician via sales rep and described the occurrence of pain in arm in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm, injection site pain, large arm swelling and injection site lump. On an unknown date, the outcome of the pain in arm, injection site pain, large arm swelling and injection site lump were unknown. It was unknown if the reporter considered the pain in arm, injection site pain, large arm swelling and injection site lump to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The reporter had 5 to 6 patient with reaction after SHINGRIX this included bad arm pain, large arm swelling, knots on arm at injection site.
This spontaneous report as received from a physician and from a nurse via a field representative refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date (reported as "sometime in June"), the patient was vaccinated with his third dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). On an unknown date (reported as "sometime in July"), the patient was vaccinated with his fourth dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported as a result of the extra injection. The patient sought medical attention by seeing his physician, but he did not require any treatment. Additional information has been requested.
Pt received FLULAVAL 2009/2010 formula. No reaction or adverse reaction noted. (for ages 19 & over)
Pain and swelling at amd around injection site Joint pain all over, especial hips, knees, upper back general malaise
left side of facial swelling and swelling of the tongue lasted for a bout 2 days for swelling to go down
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unknown doses of PEDVAXHIB (lot # L030868, expiry date 09-JUN-2018; route was not reported), which were exposed to the temperature of 1.5 degree Celsius for 265 hours and 19 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PT CALLED ON 10/8/2019 AND ADVISED THAT SHE BEGAN EXPERIENCING HEART PALPITATIONS AT BEDTIME AND THEN HAD SORENESS IN ARM AT INJECTION SITE. THEN UPON AWAKENING NEXT AM, PT HAD RASH ON CHEST THAT EXPANDED TO ARM. PT TOOK "ALLERGY" MEDICINE TO ALLEVIATE SOME SYMPTOMS. WHEN SHE CALLED PHARMACY, HEAR PALPITATIONS HAD STOPPED BUT RASH PERSISTED. PHARMACIST WHO TOOK CALL ADVISED PT TO CONTINUE ALLERGY MEDICINE AND THEN USE HYDROCORTISONE CREAM. PT CONTACTED 10/9/19 IN AM AND SHE ADVISED RASH BETTER AND NO MORE HEART PALPITATIONS. PT ADVISED TO CALL BACK AND/OR SEEK MD HELP IF ANY FURTHER SYMPTOMS.
Began 12 hours post vaccination:  Fever/chills X 3 days; redness/swelling in large area over injection site, generalized arthrolgias; started to resolve after 3 days; only nsaids for symptoms
This spontaneous report as received from a pharmacist refers to a 64 year old male patient. The patient did not have any pertinent medical history and his drug reactions and allergies included an unspecified allergic reaction to an unspecified formulation of penicillin. On 29-APR-2014, the patient was vaccinated with the dose of ZOSTAVAX (dose: 0.65 ml, lot number J011550, expiration date: 19-DEC-2014) subcutaneous in the left arm. Concomitant therapies included CIALIS, Tramadol hydrochloride, ANDROGEL, and TORBADEX. On 08-OCT-2014, the patient experienced hardness under the skin and itching near the deltoid muscle of his left arm. The patient did not seek for medical attention and did not receive any treatment. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered at the time of the report. The relatedness between the hardness under the skin and itching near the deltoid muscle of his left arm and ZOSTAVAX were not provided. Additional information has been requested.
spiked fever of 101.5 severe uncontrollable chills full body aches nausea
Patient started having severe diarrhea on Sunday, April 22 after receiving the first SHINGRIX vaccination on April 20th. The diarrhea lasted for 2 days before the patient decided to go to the ER. There she was given LOMOTIL to stop the diarrhea. She started feeling better on the Wednesday following the vaccination.
UPON REVIEWING PRIOR TO 2ND COVID MODERNA SHOT (WHICH WE DID NOT GIVE), PATIENT STATED SHE HAD EXPERIENCED  THE FOLLOWING AFTER HER FIRST SHOT BACK IN 4/3/21: MINOR CHEST PAIN, SWOLLEN LYMPH NODE(SIZED HALF A GOLD BALL) ABOVE ARMPIT/CHEST AREA, ARM PAIN LASTING 1 MONTH, TWINGES, SPASMS OF MUSCLES IN RIGHT SIDE, LOWER BACK, AND LEFT LEG.. SHE DID SEEK ATTENTION OF HER PCP, WHO MONITORED HER FURTHER. WE DECLINED TO ISSUE SHOT #2 IN OUR FACILITY, BUT ADVISED HER TO SEEK SHOT #2 IN A MORE ADVANCED HEALTHCARE ENVIRONMENT FOR HER BEST SAFETY.
COVID-19 Tested on 07/10/2022 I  received my 4th dose on 04/19/2022 and my COVID-19 symptoms are  sore throat; body aches; Low grade fever.   I made a virtual appointment on Monday. My doctor  prescribed me PAXLOVIC for 5 days.
Pt developed increased sleepiness w/in hours post vax. He had no signs or symptoms of infection. Sleepiness lasted about 24 hrs.
After injection pt stated he was light headed and dizzy.  Pt assessed BP92/55 P63 R 16 pulse oximeter 99% room air.  Pt laid down with feet elevated, pt stated he had not eaten today.  MD notified, continue to observe pt after eating a snack.  Pt was observed by RN for  30 min. at time of discharge pt BP 95/55 p 61 pulse oximeter 98%. with no further complaints
Symptoms began 12/22 6 pm, roof of mouth hurt, felt burnt, woke 2am, bottom lip skin rolled inward and peeled off (NOT chapped). Burning sensation of lips/mouth continues currently. Developed lesion on roof of mouth 12/26. Developed lesion on bottom lip 12/27. Bottom lip peeled daily. Seen by Urgent Care 12/28; unsure of what it was so gave RX for thrush. Saw little improvement; lip peeling/burning continued. Developed blister inside bottom lip 01/04. Seen by primary 01/05, said it didn't appear to be thrush but believes the lesions were canker sores and to simply wait it out, gave only pain meds. Approx. 1pm 01/06, lips and skin on both sides of mouth peeled off and burning increased. I have an appointment with ENT 01/11.
suffers from anxiety; not feeling well; she got sick, specifically she got a cold; she got sick, specifically she got a cold; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, on 23May2021 (about 50 days ago) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that, after the first dose, about a week or 10 days after the vaccine, on an unknown date in 2021 (not immediately after, like 10 days after), she got sick, specifically she got a cold. She confirmed it was not COVID 19. She told that, she went to public places after she got the dose and maybe that was why she caught a cold. She reported that, because she got sick, she waited, she did not take the second dose when it was scheduled, she waited until her immune system got stronger and now it was about 50 days from time of first dose. Reportedly, she went to the facility to take her second, and they refused to administer it. She stated that, she was super delayed, and since an unknown date, suffers from anxiety and was not feeling well. The outcome of the events was unknown at the time of report.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021880663 similar report from same reporter
My daughter had redness around her eyes, when going into the sun for a short time, she developed red spots and tiny blisters on the face, she stared at things with a sense of fear almost, and developed into an intense fearful reaction, she was non-emotional, and non receptive to strangers. She grunted, and had dreamy eyes, that now I believe is consistent with seizures, which has progressed each year. She had a slow suckle, and feedings are prolonged, or more frequent short feedings.
There are no adverse reactions. The wrong vaccine was given. I gave Pfizer undiluted pediatric to an adult.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 18-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J006831 and expiry date: 14-SEP-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Upper right arm redness; This is a spontaneous report from a contactable physician. A patient of an unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA, lot 17-003292, exp.date 31Jan2019), via an unspecified route of administration on the right upper arm on unknown date at 0.5ml single dose for immunization. Medical history and the patient's concomitant medications were not reported. The patient experienced upper right arm redness on 11Jan2019. The patient recovered from the event on 13Jan2019.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
"I received the Johnson and Johnson Covid vaccine on March 9th. On March 30 I was admitted to the hospital with excessive blood clots in my right leg and right lung.  My Pulmonary Dr felt I should report this to you.  I did have blood clots last year and recently ( February 8th) had back surgery both circumstances could of contributed to the issue.  If you need any further information or have questions please do not hesitate to contact me.