chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received the vaccine while being pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Received the vaccine while being pregnant) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007320A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-Sep-2020 and the estimated date of delivery was 27-Jun-2021. On 04-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Received the vaccine while being pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  On 04-Feb-2021, EXPOSURE DURING PREGNANCY (Received the vaccine while being pregnant) had resolved.        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.
pt recv vax 16FEB99 & later pt c/o SOB & chest pain;adrenalin given;still c/o SOB;neb treatment given;c/o itchy & hives;
Patient with history of cluster headaches.  Recently started on topamax.  Headaches controlled.  Approximately three minutes after administration of Gardasil vaccine, the patient experienced onset of severe headache
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had Antiviral treatment for COVID-19 on 23Aug2022 to 28Aug2022 and patient had Rebound of symptoms 3 days after completing treatment. Mostly sore throat and exhaustion has returned, but also increased congestion too.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2015US022656 is an initial spontaneous report from a health care professional received on 03 Nov 2015. This report refers to a patient of an unknown age and gender. Medical history and concomitant medications were not reported. The patient received  FLUVIRIN (batch number: 1515701) incorrectly at  a dose of 0.1 ml intradermal on an unknown date. On 02 Nov 2015 the patient experienced redness, swelling and itching at the injection site. Events stop date was reported as 02 Nov 2015. Final outcome of the events were not reported. Seriousness and causality of the events were not reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Known allergies: Seasonal allergies" (unspecified if ongoing); "Known allergies: cats" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: tested and I had two strongly positive tests; Positive, notes: tested and I had two strongly positive tests; Negative, notes: I tested negative 3 times on Friday; Negative, notes: I tested negative 3 times on Friday; Negative, notes: I tested negative 3 times on Friday. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient took anti viral Paxlovid starting on 28Aug2022 and stopped on 02Sep2022 for the treatment of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
24 hours after immunization given, developed had raised area 3 inches long x 1 inch wide area, warm to touch, itchy, tender to touch. Needle insertion site in the middle of red area
05/20/21 Approximately 5:30 pm, during meal, consumed steak, rice, corn. Felt like "air bubbles" in throat; felt like "throat was closing", patient coughed. Symptoms resolved in "maybe" 3 to 4 minutes.
Injection Site Soreness and Throbbing ongoing, SOB x 2 days Narrative:  Other Relevant History:
Flu-like symptoms; Super tired; Lethargic; Felt achy; Sick; Muscle ache; This case was reported by a consumer via patient support programs and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2019, the patient received Shingrix. On 26th September 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, tiredness, lethargy, pain, sickness and muscle pain. On 27th September 2019, the outcome of the tiredness, lethargy and muscle pain were recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms and sickness were recovered/resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the influenza-like symptoms, tiredness, lethargy, pain, sickness and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The vaccine was administered at a pharmacy, so patient did not have access to the vial of vaccine that was administered. The patient had flu-like symptoms for a day and a half after getting the Shingrix vaccine.  The patient was not sick to the patient's stomach but was super tired and lethargic and felt achy and sick.  The patient had to leave the call to take an incoming call from patient's daughter, so patient was unable to obtain additional information. The permission to contact HCP was not provided.
Patient experienced severe redness, pain, and some swelling around injection site and running down arm from deltoid to elbow. Persisted for several days.
Pfizer-BioNTech COVID-19 Vaccine EUA.  Bad headache, fever of 100.7, chills, nausea, fatigue, injection site pain.  Headache started approx. 12 hours after injection of second shot. Fever, chills and nausea began approx. 24 hours after receiving shot. Symptoms lasted approx. 24 hours.  Received 2nd shot Wednesday at 5:30 pm, Thursday around 7:00 am woke up with bad headache. Symptoms continued throughout day getting worse around 5:00 pm.  Friday morning around 7:00 am woke to find symptoms were mostly gone.
Reaction: patient developed flu-like symptoms (nausea, chills, diarrhea, headache, fatigue, dizziness, and body aches), injection site warmth and swelling approximately 6 hours after receiving the pneumococcal-23 and influenza vaccines in the same arm. Management: Patient refused appointment and therefore received care at home to manage symptoms. Instructed to seek urgent care if symptoms worsened.
c/o sore throat. Resolved after benadryl  Narrative:  c/o sore throat. Given Benadryl. BP 147/101, 68, 18, 100% O2Sat. resolved.
Pt received 1st dose Moderna vaccine is 16 and 6 months old.
Felt hot and sweaty x 10 min.  Felt like she needed to take her mask off. Denies SOB difficulty breathing  or swelling of the tongue or throat  1445 BP was 133/89 P 76 R 16 O2 100% 1500 BP 116/81, P 73, R 16, 02 100%
vaccine was assumed to be injected subcutaneously; wrong needle size used; A spontaneous report was received from a nurse concerning a 44-year-old, female consumer who received Moderna's COVID-19 vaccine with the wrong sized needle and by the wrong route of administration (subcutaneously).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, the patient received a dose of mRNA-1273 (Lot number: 031L20A) subcutaneously in the left arm for prophylaxis of COVID-19 infection.    On 27 Jan 2021, the patient was administered the vaccine with the wrong sized needle, and it was assumed to have been injected subcutaneously.  The HCP is unaware of any side effects experienced from the patient. No treatment information was provided.  Action taken with the mRNA-1273 in response to the event was not reported.  The events, wrong sized needle and wrong route of administration was considered resolved.; Reporter's Comments: This case concerns a 44 year old female who received a dose of mRNA-1273 (Lot number: 031L20A) subcutaneously in the left arm for prophylaxis of COVID-19 infection with the wrong sized needle and vaccine was injected subcutaneously. There were no reported adverse events after the vaccine was administered in this case of needle issue and vaccine injected subcutaneously.
Information has been received from a pharmacist concerning a 62 year old female with no pertinent medical history and no drug reaction or allergies who on 09-MAY-2011 was vaccinated SC with 2 doses of ZOSTAVAX (Merck) (lot # 669260/0152AA; exp. 01-MAY-2012) at 7:30 pm and 8:45 pm. Concomitant therapy included zolpidem tartrate, VERAMYST, VALTURNA, LIPITOR, XYZAL, PRISTIQ and NAPROSYN. The pharmacist reported that the patient was experiencing severe chest pain on 09-MAY-2011 and she was directed to seek emergency treatment. At the time of the report, the status of the report was not reported. Additional information has been requested.
A 67 years old patient came to the pharmacy with spouse and requested COVID Immunizations . During the administration process patient received RSV instead of SPIKEVAX 12+ .
My arm was sore yesterday after I got the shot. Today (the second day) I have migraine and my body is sore like when I had the flu a long time ago.
pt fainted just p/the vax where still sitting on table;used smelling salts;recovered uneventfully & didn't fall;
little ache/pain on the left shoulder, where they put the shot in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little ache/pain on the left shoulder, where they put the shot in) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PAIN (little ache/pain on the left shoulder, where they put the shot in). At the time of the report, VACCINATION SITE PAIN (little ache/pain on the left shoulder, where they put the shot in) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was scheduled for second dose on 27-Feb-2021 but he still has a low grade ache on his arm. Concomitant medications were not provided. Treatment information was not reported.
Suspected  that pt developed aggressive immune activation after Vaccination that resulted in  hepatitis flare and breakthrough viremia despite having completion viral suppression for years on Entecavir.  I saw pt on 3/17/21. She reported symptoms of fever, and dizziness after the shot which confirms immune response from Moderna.
Patient was hot, sweaty and shaky. Her face was extremely pale. I had her lay down on the ground with an ice pack and some gatorade.
Had first dose of Pfizer covid vaccine administered on Saturday the 14th, on Sunday felt run down, stating Monday and c tinging through today I have not been able to sleep, throat hurts badly, lymph nodes in neck swollen and painful, feeling tired and run down, and diarrhea.  Monday and Tuesday had body aches and muscle and joint soreness.
This case was reported by a physician and described the occurrence of serum sickness in a female subject aged between 30 and 39 years old who was vaccinated with hepatitis A vaccine inactivated for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date the subject received 1st dose of Havrix at 1440 ELISA units, IM to  the left arm. The lot number and expiration date were not provided. At an unspecified time after vaccination with Havrix, the subject experienced serum sickness, atrophy of soft muscle tissue at the injection site, fever, and body pain. At the time of reporting, serum sickness, fever, and body pain had resolved, but the soft tissue atrophy persisted. No additional information was available. This case was assessed as medically serious (OMIC). At the time of reporting, the events were unresolved.
This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea came back and never went away), FLATULENCE (Flatus), ABDOMINAL DISTENSION (Bloating) and DYSPEPSIA (Heartburn) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 013M20A) for COVID-19 vaccination. Concomitant products included PRIMIDONE, MELATONIN, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), COLECALCIFEROL (VITAMIN D3), ACETYLSALICYLIC ACID (BABY ASPIRIN), DICLOFENAC SODIUM, LEVOTHYROXINE, ROSUVASTATIN CALCIUM (CRESTOR), SERTRALINE, QUETIAPINE FUMARATE (SEROQUEL) and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced DIARRHEA (Diarrhea came back and never went away). On an unknown date, the patient experienced FLATULENCE (Flatus), ABDOMINAL DISTENSION (Bloating) and DYSPEPSIA (Heartburn). The patient was treated with ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) for Heartburn, at an unspecified dose and frequency and DICYCLOVERINE HYDROCHLORIDE (BENTYL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHEA (Diarrhea came back and never went away) had not resolved and FLATULENCE (Flatus), ABDOMINAL DISTENSION (Bloating) and DYSPEPSIA (Heartburn) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-305229.
Tetanus vaccine given in the left arm on 06/26/2006. Now the child has a knot the size of a small lime, red, warm to touch, painful. Advised to use warm compresses, give Benadryl and Motrin.
SUSPECTED CLINICAL VACCINATION FAILURE; RECUPERED FROM COVID-19; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number: unknown, expiry: unknown) dose was not reported, dose number in series was 01, 01 total was administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, and recupered from coronavirus disease (suspected covid-19 infection) recently (dose number in series was 01). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from recupered from covid-19, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint (PQC): 90000213849 The suspected product quality complaint has been confirmed to be this record describes an adverse event (recuperated from covid-19) however, based on the updated guidance "Janssen covid-19 vaccine: definitions of lack of effect (LOE) and on-label-use for post booster dose" this case does not meet the definition for a product quality complaint (PQC) since the only indication is that the patient had covid but does not refer to any symptoms or polymerase chain reaction (PCR) tests and does not allege the vaccine did not work. This record will be voided as no pqc, based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220150309-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 24-APR-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 1.11 degrees C for 64 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Due to mis-communication with pharmacy team 1.0 mL dose was administered instead of 0.5mL dose.  No reaction noted
Cellulitis - redness, swelling, painful lump at injection site aprox 4 inch diameter
Shivers, ake all over during night starting at 1 am after  the shot.
Seizures, with bad head pain, followed with loss of speech.  High with blood cell count, indicating infection, but none found. Was on a breathing, and feeding tube. Was in hospital for one weeks time.  Now in a Rehab facility,  with loss of memory and balance.
A small red, painful rash developed in the anticubital area on Day #14. By day #15, the rash spread down towards the wrist. Continues to be painful but no itch present.
Patient called on 10/3/2018 complaining of weakness and pain in arm. Unable to lift arm very well. Said she thought shot may have been given too high.
Pt was given a dose of Tdap (Boostrix) instead of Dtap.  Pt's mother was notified on 8/8/08.  Pt received correct Dtap dose on 8/11/08.
1 WEEK AFTER INJECTION, SITE BEGAN T ITCH AND THEN TURN RED AND RAISED, FEELING HOT TO THE TOUCH. THIS BEGAN ON SATURDAY PM 7/20/19 AND CONTINUED INTO SUNDAY AM WHEN SHE CAME TO PHARMACY TO INQUIRE WHAT TO DO. I ADVISED PO BENADRYL AND COLD COMPRESSES. SHE WAS ADVISED TO SEEK EMERGENCY MEDICAL HELP IF IT WORSENED AND TO CALL US TOMORROW TO UPDATE US ON HER CONDITION.
1st GARDASIL 1-30-09 - At 2nd appt for GARDASIL 4-2-09 pt. described symptoms from first IZ admin. stated had severe headache with vomiting and heart palpitations the evening after IZ administration.
Patient had Covid in November 2020. Received a dose of covid vaccine in January 2021 and February 2021. Arrived to Regional with SOA . Covid-19 (NAA) was positive on 03/29/2021 10:17am -repeat Sars-Cov-2 (PCR)-negative on 03/29/2021 14:30 negative. Patient expired on 3/30/2021 at o146
vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity to protect against the SARS CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
Information was received via an online newspaper article concerning a 26 year old female who alleged she was left partially paralyzed as a result of GARDASIL (see report # 1409CRI014823). The article also noted the following: "In 2008, documents obtained by the Freedom of Information Act revealed that during just that year, there were 6,723 adverse effects related to GARDASIL; of those 1,061 were "serious", 142 were considered life threatening and 28 deaths related to GARDASIL were recorded". This is one of several reports from the same reporter. Additional information is not expected.
w/in 72hr of inj pt devel an inj site rxn characterized by a 5-6cm area of redness & swelling;pt was seen by MD & recovered w/in 2-3 days w/o treatment;
received an expired tenivac,with no reported adverse event; Initial information received on 15-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 68 years old male patient who was administered an expired vaccine diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac] and experienced no adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Dec-2022, the patient received a dose of expired suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT (with lot U6831AA, expiry date: 08-Oct-2022, strength, formulation: unknown) via intramuscular route in the left deltoid (expired product administered).  Action taken : Not Applicable.  At time of reporting, the outcome was Unknown for the event received an expired tenivac,with no reported adverse event.   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.
Lower back nerve pain, right leg nerve pain, right hip nerve pain, right knee to foot pain, right leg weakness, right foot partial numbness. The symptoms were present upon waking the morning after receiving the injection.  I was very active every day up till the symptoms presented, then was severely incapacitated.