chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gave the Tdap 1st left arm.  She had had one Tdap previously on 8/20/09.  She did fine.  Gave the HPV in the right arm.  Almost immediately she said she didn't feel right and fainted.  Was out for a short time, upper extremity movements when she awakened.  Monitored her for a while and she recovered and felt fine.  Had the doctor check on her also.  Let her go 20-30 minutes later as she was feeling ok.  She was there for a doctor appt and vaccines were ordered at the end of the visit.
This spontaneous report as received from a pharmacist refers to a 41 year old female patient (also reported as: in her late 40's). The patient's medical history included shingles. On 19-SEP-2013 the patient was vaccinated with ZOSTAVAX (Subcutaneous, 0.65 ml, single dose, lot# J003808 exp 03-JUL-2014). The pharmacist reported a patient in her "late forties" received ZOSTAVAX based on past history of shingles. No adverse effects reports. Additional information has been requested.
Arm hurts; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), HEADACHE (Headache) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Arm hurts), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant product used included thyroid medication NOS and herbal medication NOS.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-May-2021 and doe not contain any new information.
On 12/18/2021 I woke up and felt nauseous and I was very tired. My injection site was sore and my arm hurt. The following day I started to feel better in the A.M., but around 3PM I got a really bad sore throat and ran a fever of 101. I was feeling nauseous again and had a bad cough. I got tested for COVID on 12/20/2021 and tested positive.
one day after vaccine patient suffered acut retinal artery occlusion due to embolus resulting in total and permanent unilateral vision loss
Patient received vaccines. Approximately 2-4 minutes later, patient stated that she didn't feel good and that her stomach was hurting. She then complained that she "can't see too good". She then fainted a few seconds later. V/S were taken. BP: 90/61, P 95, T-97.7, O2 sat 98%. Child came around and began to talk to her mother and staff after approximately 5 minutes.
Patient had hardness with swelling and bruising at site on right upper arm where DtaP was given, site was also warm to touch.
Pt called in and c/o a golf ball size lump under left Arm. Pt reports the lump is painful. Pt was advised by RN at medical facility to contact her PCP if does not get better in the next 24 hours.
A physician reported that a child (age and gender unspecified) with nephrotic syndrome received a dose of Prevnar and subsequently developed perionitis, possibly due to Streptococcus pneumoniae. The event was considered medically important. No further information was available at the date of this report
Starting 2 days after the vaccine my son experienced abdominal pain, nausea, aches and chills for 7 days.; Starting 2 days after the vaccine my son experienced abdominal pain, nausea, aches and chills for 7 days.; Starting 2 days after the vaccine my son experienced abdominal pain, nausea, aches and chills for 7 days.; Starting 2 days after the vaccine my son experienced abdominal pain, nausea, aches and chills for 7 days.; This is a spontaneous report from a contactable consumer, the parent. A 13-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 14May2021 at 15:30 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as no. The patient was allergic to chemicals (reported as red dye allergy). Concomitant medications taken within two weeks of vaccination were not reported. 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 16May2021 at 08:00, starting two days after the vaccine, the reporters son, the patient experienced abdominal pain, nausea, aches and chills for seven days. The events resulted in doctor or other healthcare professional office/clinic visit. The events resulted in emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events starting two days after the vaccine the patient experienced abdominal pain, nausea, aches and chills for seven days was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Several days with flu like symptoms.; Developed a cough that took about a week to go away.; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP75533), via an unspecified route of administration in the right arm on 07Apr2021 at 10:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included landau-kleffner syndrome and gene mutation. Concomitant medications were not reported. 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 08Apr2021, the patient experienced flu like symptoms for several days and had developed a cough. The event resulted in doctor or other healthcare professional office/clinic visit. On an unknown date, the patient underwent COVID-19 antibody blood test and the result was negative. The clinical outcome of the events cough was resolved on 15Apr2021 (took about a week to go away) and flu like symptoms was resolved in Apr2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169), via an unspecified route of administration in the left arm on 28Apr2021 at 11:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
swollen lymph nodes; feels like cold is coming on; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes) and NASOPHARYNGITIS (feels like cold is coming on) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination.     No medical history was not provided by reporter.  Concomitant products included VITAMIN D3 and FISH OIL for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes) and NASOPHARYNGITIS (feels like cold is coming on). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 milligram and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 650 milligram. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) and NASOPHARYNGITIS (feels like cold is coming on) outcome was unknown. Not Provided          Treatment medications also included ethylprednisione. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-089498 (Patient Link).
Case previously recorded as MA2009-6262. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN influenza A intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Agency reference no. NA09-008851.
NO adverse effect; imrpoerly stored vaccine administered; This spontaneous report as received from a medical assistant refers to a 11-week-old patient.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # S005874, expiry date:31-OCT-2020, strength, dosage information, route of administration and anatomical locations were unknown) for prophylaxis (product storage error).  It was reported that the vaccine was exposed to a temperature of 33.8 fahrenheit for a time frame of 4 hours and 5 minutes. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report. No adverse effects reported. No additional information. The outcome of product storage error and no adverse event was unknown.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Additional Details: 911 WAS CALLED
Pt had a seizure by history on 1/16/01, 7 days, post vax. There was no associated illness or fever.
have administered expired act-hib to a patient, with no reported adverse event; Initial information received on 21-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 months old male patient who was administered expired act-hib, with no reported adverse event while receiving vaccine HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Jul-2022, the patient received a  dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE (lot UJ525AA and expiration date: 11-Jul-2022) at a dose of 0.5ml via intramuscular route in the left thigh for immunization.  On 19-Jul-2022 (latency: same day), the patient was administered expired act-hib with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) VACCINE.  Action taken: was not applicable.  It was not reported if the patient received a corrective treatment for the event .   Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Site of inject has quarter size red, swollen area on thigh. Buttock area adjacent is red.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Weakness-Severe, Additional Details: DIZZINESS AND LEGS \"FELT LIKE JELLY\". RESOLVED AFTER AND HOUR OR SO.
The patient developed lethargy and a cough that has persisted greater than 2 weeks.
INCREASING MUSCLE SORENESS, INCREASING PROGRESSIVELY FROM DAY TO DAY, FROM 10/20/2014 TO DATE OF REPORTING AT PHARMACY, UNABLE TO RAISE ARM FULLY ABOVE HEAD.
Received shingles vac in Lf arm, woke up hot, achy, with headache. Felt weak, achy, very stiff neck for 2 days. Broke out in fluid filled itchy pustules Mon. AM. Itchy all over, but only a few spots, One large on on RT forearm. Felt much better Tues, less itchy. All symptoms gone Wed. except a few itchy pustules which are crusty now. Had chicken pox as a child.
Patient experienced events of apnea for a period of 6 to 8 hours after 2:00 pm.  Patient's procalcitonin was 1.13 at 3:37 pm on 3/11/2012.
Narrative: COVID infection following COVID vaccine series 04/12, Pfizer, dose #1 NON-FACILITY 04/26 , Pfizer, dose #2 NON-FACILITY 08/24 pt cc: cough, headache, loss of taste or smell, headache myalgias exposure: unknown 08/25 COVID swab, result: detected 08/25 SARS-COV-2 Variant Sequencing result: pending
Night sweats starting 5 or 6 nights after vaccine and lasting through  at least last night.
Little discomfort; Body aches; Injection arm was warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection arm was warm), DISCOMFORT (Little discomfort) and MYALGIA (Body aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Thyroid operation (Thyroid removed). Concurrent medical conditions included Diabetes. Concomitant products included INSULIN, FOLIC ACID, CALCIUM and MELOXICAM for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection arm was warm). On 05-Feb-2021, the patient experienced DISCOMFORT (Little discomfort) and MYALGIA (Body aches). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of Every 4 hours. At the time of the report, VACCINATION SITE WARMTH (Injection arm was warm), DISCOMFORT (Little discomfort) and MYALGIA (Body aches) outcome was unknown.            Treatment details include ice.   This case was linked to MOD-2021-318648, MOD-2021-318659 (Patient Link).
Patient received flu vaccine injection at 0925. Reported back to station at 1000 am reporting CP, SOB, and throat constriction. BP 170/110. EPIPEN injected into (R) lateral thigh. EMS called. PT stated he was starting to feel better. BP 140/90. Transported by EMS.
MENACTRA and Hep A given on 4/23/18, 2 days ago- Last night seemed irritable and got MOTRIN, but no redness noted at that time - This morning in shower noticed significant redness on R upper arm; has decreased in size somewhat over the course of the morning today- No fever- Does feel hard and warm to touch but he does not wince in pain when it is touched. His nurse doesn't think he feels external pain so might not react even if the area was painful. She has been told he has a congenital indifference to pain externally. Has a mouth ulcer under his tongue; using magic mouthwash- Got botox injection under R chin yesterday; R cheek looks red today but has been drooling and rubbing his face a lot.
Pt reports fever up to 101.5 and severe joint pain lasting approx 48 hrs. No treatment. Resolved.
Menstrual cycle start date was delayed 5 days.  Additionally, menstruation was lighter and a shorter duration than usual - lasting four days instead of six.
Started with fever, chills, body aches at 7:00 p.m. Tried to get up from bed at 1:00 a.m. to use bathroom and was overcome by nausea. Vomited. Was too weak to stand and collapsed. Found on bathroom floor by son. Overcome by severe nausea at any attempt to speak or move. Was carried to bed by son. Developed an excruciating headache. This state continued for the next 24 hours as I vomited continually and shook with chills and fever. Was too weak to lift my head. Sone called PCP who said I could take Extra Strength Excedrin along with Advil for headache, but to expect symptoms to continue for several days. Fever ran between 101.7 and 102.4 from 3/17 through 3/20. Nausea and vomiting stopped on 3/20. Fever, headache, weakness, chills, body aches, and severe fatigue continued through through 3/21. Fever came down to 99 -100 and headache was slightly better.
pain; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events usual, some soreness in the arm, a little bit more than the flu shot.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 028L20A) via unknown route for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 016M20A) via unknown route for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the event(s) usual, some soreness in the arm, a little bit more than the flu shot.  Treatment details included Not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), usual, some soreness in the arm, a little bit more than the flu shot was unknown.
Chills, body aches, vomiting. Lasted one day.  Sore arm lasted 3 days then went away.   Exactly one week later, I woke up and my arm was itchy and hurt really badly. It hadn?t hurt me since last week. I took Advil.
No additional adverse effects were reported.; two patients received improperly stored PROQUAD; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 13-MAR-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S022109 with expiration date of 12-JAN-2021, for prophylaxis (route of administration and frequency were not reported). The sterile diluent (STERILE DILUENT MRK) used to reconstitute measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored.    No adverse effects were reported.    It was stated that the vaccines underwent a temperature excursion of 47°C (degrees Celsius) to 8°C (-7C) for 41 minutes on 20-DEC-2019. Previous temperature excursion was done. The call was because of a "data logger".  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2004USA000405: US-009507513-2003USA008859:
A pharmacist with a history of multiple sclerosis (dx'd at age 45) reported that he received an injection of Flu Shield (1996-1997 Formula) in 1996 and approx. 2 weeks later, was unable to control his legs, had blurred vision and was unable to write. The pt was hospitalized for "several weeks" and a dx of "a flare up of pre-existing multiple sclerosis" was made. Therapy with baclofen, lisinopril, fluoxetine hydrochloride and diphenoxylate hydrochloride/atropine sulfate was initiated. He was then transferred to a rehabilitation facility to learn to walk again. The pt regained his ability to walk: however, he dragged the right side of his body.
tested positive today for the rapid test; This is a spontaneous report from a Pfizer sponsored program. A Non-contactable consumer reported for a patient (reporter's wife) reported that:   A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 04Sep2021 as dose 1, single for covid-19 immunization. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported. The caller wanted to know that if his wife take  2nd dose since his wife got covid-19 vaccine yesterday and she tested positive today (i.e. 05Sep2021) for the rapid test. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
I have extremely painful period cramps and symptoms; With both doses, I had a reaction on the right side of my face. Little bumps and "dents".; With both doses, I had a reaction on the right side of my face. Little bumps and "dents".; Since my 2nd dose, my period has either been late or not at all.; This is a spontaneous report from a contactable consumer (Patient). A 48-year-old non-Pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732, Expiry Date was not provided), via an unspecified route of administration, administered in right arm, on 02Apr2021 at 11:00 (age at vaccination was 48-Years) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient known allergies and medical history included Hypothyroidism, asthma. Concomitant medication included Levothyroxine sodium (Synthroid 100 mcg), ASCORBIC ACID (vit C), COLECALCIFEROL (D3), ECHINACEA PURPUREA ROOT, OLEA EUROPAEA LEAF, SAMBUCUS NIGRA FRUIT (Elderberry) and Biotin. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207, Expiry Date was not provided), via an unspecified route of administration, administered in right arm, on 12Mar2021 at 11:45 (age at vaccination was 48-Years) as DOSE 1, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines in four weeks. Patient did not had COVID prior vaccination. Patient has been tested COVID post vaccination. With both doses, patient had a reaction on the right side of her face. Little bumps and "dents". It eventually went away. The main issue she was having is her period. She had her period before the first dose, March 9th. Her second dose was on April 2nd and she was due for her period on April 4. She got her period every 26 days. She was not on birth control. Since her 2nd dose, her period has either been late or not at all. She saw her primary provider on August 9 and she said she was not going through menopause that a lot of women were having the same issues. She said it could take 4 months to go back to normal but it has been more than 4 months. She had extremely painful period cramps and symptoms when she was supposed to have her period but no menstruation. The patient underwent lab test and procedure included Nasal Swab with negative result on an unspecified date of 2021. COVID test name post vaccination was Rapid test. Adverse Event did not result in anything. Patient did not receive treatment for any event. The outcome of all events was not resolved.  Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101182522 same reporter/patient/product, different dose/event.
pt recvd vax & exp dry mouth, loss of taste, tongue felt thick & tongue hypersensitive to touch;
Became extremely hot, sweaty, shaky, nauseous, and had ringing in her ears.  She did not lose conscious at all but EMS was called since she has active history of passing out.  They came and checked her vitals when she asked them to, she left on her own and declined to be taken to the hospital by EMS.
Hep A dose was given as an adult dose instead of a pediatric dose. Patient did not report any negative symptoms.
Patient Received Pfizer mRNA COVID-19 vaccine August 20, 2021.  No issues immediately.  She describes feeling of sensation of spasm at her left leg Tuesday September 14, 2021 with no sequela.  On September 17 she experienced spasms at her left leg again followed by complete paralysis of her left side, aphasia.  Admitted to the hospital from 9/17/2022 and diagnosed with multifocal right MCA strokes in the setting of right carotid mural thrombosis.