chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A physician reported the occurence of an injection site reaction in a 5-year-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The subject's medical history, concurrent conditions, and concurrent medications were not provided.  On 06/05/2002, the subject received his fifth injection of Infanrix (lot DTPA552A2).  He also received injections of inactivated poliomyelitis vaccine (IPOL) and measles, mumps and rubella virus vaccine (MMR II).  In addition, he received an application of tuberculin purified protein derivative.  On 06/06/2002, one day post-immunization, the subject experienced an injection site reaction characterized by a 7.5 cm by 8cm area of swelling, tenderness, and redness.
stuffy nose; This is a spontaneous report from a Pfizer-sponsored program and a contactable consumer(patient). A female patient of unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Formulation: Solution for injection, Lot number and expiry date were unknown) via an unspecified route of administration on an unknown date in Jan21 as a single dose for COVID-19 immunzation. The patient medical history and concomitant mediations was not reported. On an unknown date patient had stuffy nose.Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Pt was here for annual physical, requested second Covid vaccine. She incidentally was given the entire vial of undiluted vaccine by MA. Pt experienced no adverse symptoms while in office. Reported to other staff that she was a bit dizzy and nauseated, but she had not ate due to fasting labs. Unsure if this was side effects or symptoms of being hungry. She was sent home with precautions and pt was contacted later in the day and reported her arm hurt and was a bit nauseated but no other symptoms.
A non-serious spontaneous report of a we gave expired H1N1 to several patients was received from a registered nurse/health professional concerning a four-year-old female out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date 12-Feb-2010, had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 23-AUG-2013 and 28-OCT-2013, the patient was vaccinated with the first and second dose of GARDASIL (first dose lot # J002641, second dose lot # J007354). On 13-JUL-2017, the patient was vaccinated GARDASIL 9 (lot # N007931) reported as an "altered dosing schedule". No adverse event was reported. The outcome of inappropriate schedule of drug administration, no adverse event and interchange of vaccine products is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to GARDASIL 9 and GARDASIL. The reporter considered interchange of vaccine products to be not related to GARDASIL and GARDASIL 9. Additional information has been requested.
After a week- daily headache, arm numbness/tingling accept at injection spot. Injection spot is red, bumpy, itchy, painful to touch, and the rash grows daily. I feel fatigued and my joints are weak.
Started with hearing loss in the left ear, fullness in the left ear, mild headache on the left side, Tinnitus started after 6 months, Severe Vertigo (spinning) since June 2021 with severe vomiting (occurrence 3 episodes per week lasting 5-6 hours)
chills; fever; body ache; This is a spontaneous report from a Pfizer-sponsored program via a Contactable female consumer (patient, self-reported). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number and Expiration date were not reported) via an unspecified route of administration, on 19Mar2021 (age at vaccination was 54 years) as a DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated, 'She received her first dose of Pfizer Vaccine (COVID 19 vaccine) on 19Mar and she had no side effects but then 7 days later on 26Mar she had chills, body ache and fever and she was wondering if you have heard of any-one experiencing a delayed adverse reaction like that because if it happens, it happens within first couple of days and she thought if it is because of the vaccine or can't think of any other reason. Patient was informed about Medical information department and was provided with the number. In response to further probing, Patient stated, she had already called, and they have got lot of information from her and right now she needs to drove home. She would call back in a little while. Lot: Patient stated, ENG208 or it could be EN6208. It was hard to read. Event date, Patient stated, It started on the first day I got the Vaccine and it lessen on each day, but I kept carrying a low-grade fever around 99.7. So, she was just trying to figure out if it from the vaccine or is it from something else. The outcome of the event body ache and chills was unknown and for fever was not resolved.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained.
Erythema, pain, tenderness, swelling, warmth at injection site of ZOSTAVAX in left arm occurred 24-48 hours after injection.
It was painful and warm the day of and two days after the injection. Then it was fine for 6 days. Now 9 days after the injection, the area is red, warm, and painful.
CLIENT RECEIVED PEDIATRIC PFIZER FORMULATION OF 0.2ML APPROVED FOR AGES 5-11YO. CLIENT 12YO AT TIME OF VACCINATION, SHOULD'VE RECEIVED PFIZER GRAY CAP FORMULATION OF 0.3ML.
5 to 10 min after the shot pt just froze sitting down. had normal pulse and was breathing but couldnt move. could hear me and could nod his head but was in some kind of frozen state. after 5 min he just became normal . was sweating a lot and then noticed a rash on his left hand ( near the wrist area).he was able to swallow and drink water properly without any issues. called 911 and they checked him out and said he was fine and if anything feels wrong he was adviced to go to the er. He said he was totally fine and left with his friend.
Silver dollar-sized red hot area about 3 inches below injection site. Painful when move arm.
administration of two doses; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administration of two doses) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Kidney stones. Concomitant products included MELOXICAM (MOBIC), LISINOPRIL and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administration of two doses). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administration of two doses) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided,
Pt vaccinated with Influenza/Pneumococcal/TD developed numbness, tingling of lt side of body (arm upward to back, & down leg rt side (arm & leg) also have intermittant numbness & tingling.
Prolonged period - light bleeding, cramping. Some fatigue. No end in sight, tragically.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 15-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H0112576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
101 fever not resided for after Tylenol and ibuprofen after 54 hours.  Stiff neck  Sore throat  Muscle aches  - extreme unable to walk down stairs without assistance  Vomiting
Bad Headache,  tiredness. Intermittent chills, arm pain. Intermittent nausea.  Arm pain.
have a very bad itch sinch the shot.; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (have a very bad itch sinch the shot.) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (have a very bad itch sinch the shot.). At the time of the report, PRURITUS (have a very bad itch sinch the shot.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported patient went to doctor and took all the creams made. No treatment medication was reported.
she is having regular knee pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 27Mar2021 as dose 1, single for COVID-19 immunization. Medical history included arthritis. The patient's concomitant medications were not reported. The patient experienced regular knee pain on an unspecified date. Therapeutic measures taken as a result of the events included Aleve (for pain). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After receiving vaccine, c/o burning throat, coughing, face itching, hot flashes.
Upper arm three times the size and black and blue- still swollen, black and blue and itchy, fever, chilly, nausea, very weak, entire body ached I literally could not move out of bed for two days- it felt like I had a bad flu.
Pfizer 12+ COVID-19 vaccine administered accidently when patient was due for second dose of Pfizer 5-11 year old vaccine.
Nausea Vomiting c/o nausea, no vomiting Narrative:  Felt nauseated about 15-20 min. after immunization. vss. Given water and felt better and said he felt ok to return to work. D/C'd in stable condition to work.
felt like pulling sensation under heart that lasted a day; had  crazy muscle twitches that don't go away for 4 weeks/She feels muscle twitches inher fingers, left pinky toe, bottom lip, and throughout her whole body; Started having muscle spasms under her left rib cage; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Started having muscle spasms under her left rib cage), CHEST DISCOMFORT (felt like pulling sensation under heart that lasted a day) and MUSCLE TWITCHING (had  crazy muscle twitches that don't go away for 4 weeks/She feels muscle twitches inher fingers, left pinky toe, bottom lip, and throughout her whole body) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D2A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced MUSCLE SPASMS (Started having muscle spasms under her left rib cage). On an unknown date, the patient experienced CHEST DISCOMFORT (felt like pulling sensation under heart that lasted a day) and MUSCLE TWITCHING (had  crazy muscle twitches that don't go away for 4 weeks/She feels muscle twitches inher fingers, left pinky toe, bottom lip, and throughout her whole body). At the time of the report, MUSCLE SPASMS (Started having muscle spasms under her left rib cage), CHEST DISCOMFORT (felt like pulling sensation under heart that lasted a day) and MUSCLE TWITCHING (had  crazy muscle twitches that don't go away for 4 weeks/She feels muscle twitches inher fingers, left pinky toe, bottom lip, and throughout her whole body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Throat started closing, entire body swollen and is blotchy and red.  Unable to walk.
Patient received Moderna COVID vaccine from different vendor on 7/8/2021. Patient then received J+J COVID vaccine from us at Affiliated Physicians on 8/4/2021 per NYC CIR look up.
pt called today @ 10:09 on 04/12/2021 and stated that over the weekend, her lower lip swollen up. She contacted her dr. and was instructed to take benadryl. That's the only symptom she experienced.
Fatigue; Body aches; Diarrhea; Swelling in the arm; Covid toes; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 30Apr2021 at 10:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included the patient had known allergies to penicillin and latex. Concomitant medication was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the arm left on an 02Apr2021 at 18:00 (at the age of 37-years-old) , as a single dose for COVID-19 immunisation. 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 four weeks prior to the vaccination. On 01May2021 at 09:00, the patient experienced fatigue, body aches, diarrhea, covid toes, swelling in the arm. Therapeutic measures taken were not reported. The clinical outcome of the events fatigue, body aches, diarrhea, covid toes, swelling in the arm was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-395985.
High fever and measles rash head to toe causing hives on day 10 after the MMRV.
Extreme general joint and muscular pain for 5 days,  chills and night sweats
Both shots hurt / needle actually punctured my flesh, yowza. And, then, when the vaccine was pushed in, it was a different kind of pain; face was hot all the time; major body aches; sense I might vomit; upper arm hurt for days, again, more than after any other shot I've gotten; fever; This case was reported by a consumer and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date refer case US2021AMR015401).   On 12th January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, feeling hot, general body pain, nausea, pain in arm and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved and the outcome of the feeling hot, general body pain, nausea and fever were unknown.   The reporter considered the injection site pain, feeling hot, general body pain, nausea, pain in arm and fever to be possibly related to Shingrix.  Additional details were provided as follows: The patient received the 2nd shot of Shingrix and it hurt.  When the needle actually punctured his flesh and the vaccine was pushed in, it was a different kind of pain, mixed with a sudden sense of vomit right then and there. Afterward, his upper arm hurt for days, again, more than after any other shot the patient have gotten in his life.  Around 36 hours after 2nd dose, the patient was afflicted with major body aches and his face was hot all the time.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR015452:same reporter
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 11-DEC-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J014402 and expiry date: 13-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), 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 VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Onset of repeated forceful, recurrent episodes of vomiting with limited to no ability to keep fluids down.  No diarrhea.  No fever.  This lasted for nearly 48 hours before mother presented to the clinic for evaluation. Child was mildly dehydrated, had mild hypoglycemia, and mild metabolic acidosis.  He was hospitalized for rehydration for less than 24 hours.
She had 4 to 5 cold sores that lasted for weeks beginning 3 days after the shot. Her redness at the injection site lasted for 1 week and she was so weak and fatigued the next day she stayed on the couch.
awoke w/h/a;exp chills, fever, achiness, dry, hacky cough;seen by MD 19NOV96;t99, producing grayish sputum;upper resp congestion;
Patient had first GARDASIL 8-15-11. Began having bruising around Jan 2012. Had second GARDASIL 7-26-12. On 9-25-12 admitted to hosp for excessive menstrual bleeding and platelet count of 2,000.
Patient reported feeling like her tongue was tingling and felt larger than normal. She did not report having any difficulty breathing.  25mg of Benadryl was given orally.  After 10 minutes she thought she was feeling a bit better, but then continued to say that she was having tingling and not "feeling normal".  We decided to administer epinephrine instead of waiting for her to continue to get worse.  I administered an epi-pen (0.3mg) about 30 minutes after she took the Benadryl and a nurse from the SNF called 911.  Paramedics arrived and evaluated her.  Her breathing sounded okay via the paramedic's stethoscope.  Because she was still not reporting feeling "back to normal" and because she had epinephrine administered, she was transported via ambulance to the ER for continued monitoring.
The patient did not actually have an adverse event.  She received two bivalent boosters 3 months apart.  She received the first bivalent booster of moderna on 9/21 just as we were transitioning from the old booster to the new bivalent and she didn't realize it.  She saw on tv there was a new booster in December so she came in to get it and told us she needed the new booster.  Her card date said 9/21/22 so she was due for the new booster but we didn't realize she'd already received the bivalent.  The patient hasn't had any issues so far.  The doctor has been notified, and we spoke to the patient to let her know not to get anymore boosters until guidelines change or there is a different one available.
Roughly 10 days after 1st shot I began feeling painless muscle spasms/twitching all over my body (calves, back, side, hand, arms).; Roughly 10 days after 1st shot I began feeling painless muscle spasms/twitching all over my body (calves, back, side, hand, arms).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Jul2021 10:00 (Batch/Lot number: unknown) at the age of 32 years 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: MUSCLE TWITCHING (non-serious), MUSCLE SPASMS (non-serious) all with onset 10Aug2021 12:00, outcome "not recovered" and all described as "Roughly 10 days after 1st shot I began feeling painless muscle spasms/twitching all over my body (calves, back, side, hand, arms).". The event "roughly 10 days after 1st shot i began feeling painless muscle spasms/twitching all over my body (calves, back, side, hand, arms)." and "roughly 10 days after 1st shot i began feeling painless muscle spasms/twitching all over my body (calves, back, side, hand, arms)." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of muscle twitching, muscle spasms.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, has not been the patient been tested for COVID-19. Contacted my primary care physician, and did some blood tests today. Never experienced this before the shot. Unknown at this time if there's a link. Patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (07Oct2021)This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts completed. No further information is expected.