chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose on April 14th, shingles outbreak several days later Five weeks later I had a second, VERY minor outbreak in a different location of my body; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th April 2022, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-Jun-2022 Reporters comment: The patient self reported the case.  The patient received a dose of Shingrix and experienced severe shingles outbreak several days later. The patient experienced second very minor outbreak five weeks later in a different location of body. The patient had never had an outbreak prior to this vaccination. The patient had been discussing with primary physician and pharmacist whether or not to have the second dose, and what did the manufacturer recommended to which they disagreed. Consent to follow up was requested.
Second influenza vaccine given on 12/11/14 was not sent to ER by nurse that entered and gave it. ER on 3/16/15 reflected pt was due for influenza so above nurse administered. When filling out parents imm record realized the 2nd dose of influenza was already ginve. No reaction to this vaccine given on 3/16/15.
Fever (102) Chills Body ache Fatigue  This all lasted from 4 or 4:30 pm on November 21 until 2 am on November 22
Initial misuse report received from a healthcare professional on 20 March 2013. A 15-Month-old patient had received 2 DAPTACEL vaccines at 2 different sites in the right leg on 20 march 2013. The patient was also due for MMR, Hepatitis A and Varicella vaccines on 20 March 2013. No adverse event was reported. List of documents held by sender: none.
Patient claims the arm in which the vaccine was given has had pain and numbness since he received the vaccine.  We called his doctor and advised the patient to do the same.
my friend's mom died with the vaccine you guys gave; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "my friend's mom died with the vaccine you guys gave". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The reporter stated that lot of people the patient know were died because of the vaccine and that the vaccine is not safe for COVID.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: my friend's mom died with the vaccine you guys gave
First shot was administered Friday, I had notified everyone that I have a history of reactions to prior vaccines that have resulted in multiple GI issues. Saturday I began to have a sore throat  Sunday evening developed severe nausea with 14+ episodes of emesis with increasing fever. Monday went to get tested with a rapid test and ended up testing positive for COVID.
BLOOD CLOTS IN LEGS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 1 total for prophylactic vaccination. The batch number was not reported and had been requested. No concomitant medications were reported.  On an unspecified date, on 2021, the patient experienced blood clots in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in legs. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210515265-covid-19 vaccine ad26.cov2.s-thrombosis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous report as received from a medical assistant refers to an 62 year old male patient. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not reported. On 28-MAR-2017, the patient was inadvertently vaccinated with a dose of PROQUAD (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis instead of M-M-R II. The medical assistant confirmed that the event was not related to product confusion. No adverse events were reported. No additional information was provided. Additional information has been requested.
Patient called pharmacy to report the she had gone to urgent care on 8/15/16 because she noticed a pustule at site of injection that progressively got worse.  At urgent care they diagnosed it as Cellulitis (per patient) and she was given antibiotics to treat it.
Itchy, sore area with some swelling, report by patient to Doctor at today's visit.
Unwell feeling; Nausea; diarrhea; heart beats a bit higher than normal at rest (+10 mre than usual); This is a spontaneous report from a contactable Other Healthcare Professional. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on Left arm on 11Feb2021 at 02:30 PM, (at the age of 45-years-old) as a 1st dose single for COVID-19 immunization at Public Health Clinic The patient's other medical history was not reported. Patient had Advil PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) the day before, and a Pre-workout supplement in two weeks both on unspecified dates. Patient did not have any known allergies. The patient did not receive any vaccine within 4 weeks prior to the dose of vaccine. He did not have covid prior vaccination. On 12Feb2021 patient experienced Unwell feeling. Nausea, diarrhea and heart beats a bit higher than normal at rest (+10 mre than usual). Patient did not have any treatment for the events. He had tasted for covid post vaccination for Nasal Swab, on 02Jul2020 which was Negative. The Outcome of the events was not recovered.  Information about lot/batch number has been requested.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Vaccine administered 9:45am, Symptoms started a few minutes later.  Feeling like something was inside her throat, coughing, clearing throat, metallic taste in mouth.  Epi-Pen administered 9:50am. Symptoms better, not completely resolved.  .  10am Prednisone 60mg and Benadryl 50mhg  orally ordered by our MD and administered.  Observed in nursing until 10:30am.
No symptoms involved. The Pfizer vaccine was given to an 11 year old and is only for 12 years and up.
bruising at injection site reaction but then redness and alittle puffy underneath about 2 inches in diameter
Blurred vision suddenly onset. Right eye diagnosed with posterior vitreous detachment and left eye liquefaction. Both eyes have floater with right eye very significant visual disturbance.  No safe treatment (surgical) so it is wait and see to determine if retinal will be affected
Provider hospital summary " 51 YO year old female with past medical history of psoriatic arthritis on Celebrex and Xeljanz, hypertension  presenting to Hospital with complaint of worsening Covid symptoms." Patient was discharged home with home O2
patient stated that about 2 and 1/2 weeks after receiving  her 2nd dose of moderna she broke out with almost dime size bumps/whelps all over her body that are very itchy.
A report was received from a healthcare professional on 10/31/2002, concerning a group of vaccinees less than 4 years old who had been vaccinated with Fluvirin from 10/21/2002 to 10/31/2002. Between 10/21/2002 and 10/31/2002, an unreported number of vaccinees less than 4 years old inadvertently received 0.25ml Fluvirin intramuscularly.  No adverse events were reported. There was insufficient information to determine the reporter's causality assessment.
Muscle twitching that started in the arm where the vaccine was give . Muscle twitching spread throughout my body: arms, thighs, calves, abdomen, eyelid, cheek, lips, chin.  Strongest twitches are in the arm muscle where the vaccine was injected.  Vibrations/tingling  in  thighs and calves when at rest.
About 8 hours after immunizations, patient developed a temperature of 104.5, excessive crying and fussiness, lethargy, firm/bulging anterior fontanelle. Child was admitted to the hospital. Had full septic workup. All cultures negative; Positive URI for 3 days without temp.  Nurse follow up on 07/26/04 states: "Viral Syndrome, fever, URI, runny nose X 3 days."
12/21/21 Received 3rd Covid vaccine.  1/17/22 Had a seizure.  Followed up with a neurologist unable to determine the cause of the seizure. No family history of seizures. All testing came back negative; EEG, CT Scan, MRI.  Started on Keppra XL 1500mg daily . Had a second seizure on 3/17./22. Medication dose adjusted  no seizures since.
Heart palpitations.  Both at rest and during activity.  Lasted 18 days.
Loss of hearing, Ringing in ears all day similar to riding airplane, headache. dizziness. Ear pain to loud noise.
sore arm, achy body, muscle aches from head to toes, headache: these were all within an hour. it progressed that night to:  sinus pressure/teeth even hurt, hurt to move or shift body, chills, fever- my whole body was puffy, red and hot. fever broke the next morning and chills returned. Exhaustion, muscle pain, weakness, headache, sinus pressure the entire next day. drank lots of water and ate crackers. woke up the 3rd day a bit drained but by mid morning I felt back to normal
8 days after injection, severe swelling, itching, pain, hot to the touch and bright red at injection sight. Severe hives all over body. This is day 13 and there is no improvement.
pt recvd vax; pt devel high pitched cry, sleepiness but unable to sleep; pt devel jerky breathing pattern & devel rythmic tongue thrusting activity, stiffened when cried; pt lethargic & had a brief apneic spell, pt taken to ER;
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-week-old patient of unknown gender. On 12-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
4/6/21: unwell , tested for Covid 4/15/21: Patient condition continues to decline - family informed 4/15/2021, 8:56am Patient expired
On 1/7/01 the pt had a fever of 102, trouble breathing, ataxia. Was seen by a doctor at 1/11/01. Fever has resolved. The pt was still slightly ataxic, no stagmus.
covid symptoms of sob, fever, cough, positive antigen test at home on 12/11/22
This spontaneous report was received from a male patient of unknown age referring to himself. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced unspecified adverse effects (adverse event). At the time of reporting, the outcome of the event was unknown. The causality assessment between the event and PNEUMOVAX 23 was not provided.
Woke up due to pseudo seizure, migraine like headache, unbearable lower back pain, fatigue, and nausea
No adverse effects; a 13 month old patient was inadvertently administered an expired dose of VAQTA; Information has been received from a medical assistant, referring to a 13 months old patient of unknown gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 21-JUN-2019, the patient was inadvertently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) (strength and route unknown; lot# R013859 and expiration date 14-JUN-2019) for prophylaxis (expired product administered). No adverse effects.
Redness, swelling and itching to the left upper extremity. Localized hard area in upper arm at injection site one day after injection.  Day 7 reported to office.
Swelling of face with minor swelling at injection site. No redness, rash or swelling elsewhere.
pt recv vax OCT95 & devel inj site rxn characterized by a 5 to 6 cm area of redness, warmth, itching & a lump;these sx persisted for 1wk; also exp pain @ inj site described as deep muscle pain;
Rash on Back, Neck, and Scalp/rash over my back and arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on Back, Neck, and Scalp/rash over my back and arms) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     The patient was very healthy.  Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine (primary dose 2) and Pfizer COVID-19 vaccine (primary dose 1). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced RASH (Rash on Back, Neck, and Scalp/rash over my back and arms). The patient was treated with CORTISONE (topical) at an unspecified dose and frequency. In March 2022, RASH (Rash on Back, Neck, and Scalp/rash over my back and arms) had resolved.            The patient was not on any maintenance medications.  The patient visited a dermatologist who prescribed topical Cortisone. Dermatologist also prescribed a palliative cream to manage the symptoms. About five months later, the rash subsided.  The patient reported that he did not make the connection that the rash was due to the booster shot.   This case was linked to MOD-2022-557977 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2022: Follow-up information was received on 03-May-2022, treatment medication was added.
Neurological Pain in lower back, lower back muscle weakness, stiffness, and consistent discomfort for about 8 weeks. Primary Care visit ordered lab work with a follow up scheduled. Chiropracter recommended an MRI.
GGT elevated to 351; AP suddenly elevated; showing COVID induced liver injury; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04May2021 (Lot number: EW0716) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "PLD polycystic liver" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot No: EW0162), administration date: 13Apr2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: LIVER INJURY (medically significant) with onset 01Jun2021, outcome "not recovered", described as "showing COVID induced liver injury"; GAMMA-GLUTAMYLTRANSFERASE INCREASED (medically significant) with onset Nov2021, outcome "not recovered", described as "GGT elevated to 351"; BLOOD ALKALINE PHOSPHATASE INCREASED (non-serious) with onset Jul2021, outcome "not recovered", described as "AP suddenly elevated". The events "showing covid induced liver injury", "ggt elevated to 351" and "ap suddenly elevated" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood alkaline phosphatase: (unspecified date) 71; (unspecified date) 89; (Jul2021) 158, notes: AP suddenly elevated; gamma-glutamyltransferase: (Nov2021) 351; liver function test: (unspecified date) normal, notes: no abnormality in liver function tests. It was unknown if therapeutic measures were taken as a result of liver injury, gamma-glutamyltransferase increased, blood alkaline phosphatase increased. The patient was not received other vaccine in four weeks. There was no covid prior vaccination or covid tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Symptoms: body aches, headache, fatigue, left arm pain, left armpit pain Symptoms two days later: hot, painful, itchy rash (size of a half dollar) below the injection sight and fatigue Symptoms day three and four: hot, painful, itchy rash (size of a hand print)
Moderna COVID-19 Vaccine EUA 102 fever, injection site pain (hot to touch and swollen), medium headache, mild nausea, chills, achy body and fatigue.  Started 4/22 when I woke up with all of the above.  All but vaccine site issues lasted 24 hours
Pt returned to clinic to have PPD read. Nurse noticed swelling and redness on upper left arm, on 8/11/11. Redness measured 15mm x 15mm on 08/11/2011.
I tested positive by doing a at home test. My symptoms were headaches, sore throat, sinus congestion, ear pressure, chillis. body aches and fever. Then Symptoms lasted only 4 day. My last day of my fever was 02/18/2023.  I called my provider's office, and we had a telehealth visit on 02/16/2023. The provider prescribed an antihistamine and Paxlovid.
After receiving the COVID-19 Pfizer booster dose, I developed swelling in my left eyelid. The swelling was unilateral, on my left eyelid, upper lid only. This resulted in blocked vision to where 80-90% of my eye had closed. The swelling was slightly red and edamatous. When pressed, tears would flow from my eye, but otherwise did not itch and was not painful. The swelling started about 20 hours after the dose was administered.  It was accompanied by other symptoms more typical of the COVID vaccine - fever/chills, headache/bodyache, fatigue, arm pain and diarrhea that I had experienced with the second dose.   All symptoms, including swelling resolved 48-60 hours after the administration.
Had a sore left lower wisdom tooth and gum area before vaccine, but afterwards, the pain seemed to spread along my entire lower gums making it difficult to eat. Possibly inflammatory response to vaccine?
Nausea; Vomiting; Severe headaches; Fever 102; This is a spontaneous report from a contactable nurse. An 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an intramuscular route of administration in the left arm on 21Apr2021 at 16:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included asthma, anxiety and shellfish intolerance. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol; norgestimate (TRI LO MILI) taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an intramuscular route of administration in the left arm on 31Mar2021 at 16:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 22Apr2021 at 04:00, the patient experienced nausea, vomiting, severe headaches and fever 102 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen (ADVIL) (200mg) (milligrams) and acetylsalicylic acid (ASPIRIN) (81mg). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, vomiting, severe headaches and fever 102 (unspecified units) was resolved on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
I had COVID19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (I had COVID19) 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 17-Dec-2021, the patient experienced COVID-19 (I had COVID19). At the time of the report, COVID-19 (I had COVID19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company comment:  This spontaneous case concerns a patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred after the dose of the mRNA-1273. The exact time to onset and number of doses administered was not provided  The rechallenge was not applicable due to unspecified number of doses and nature of the event.  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred after the dose of the mRNA-1273. The exact time to onset and number of doses administered was not provided  The rechallenge was not applicable due to unspecified number of doses and nature of the event.  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.