chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS (autoimmune shostayed the samelgreens syndrome.). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), PARACETAMOL (TYLENOL) and AMOXICILLIN for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was in October 2020 and the estimated date of delivery was 09-Jul-2021. On 05-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 05-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound scan: normal (normal) normal.     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.   Reported that patient has taken Tylenol and amoxicillin during this pregnancy. No treatment details reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Mar-2021: Internal review on 29-JUL-2021 resulted in update of Case setting, lab data, Concomitant drugs and narrative regenerated
Post first dose of comirnity: headache and tired for 48 hours; Post first dose of comirnity: headache and tired for 48 hours; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. Post first dose of comirnaty, patient experienced headache and tired for 48 hours on an unspecified date. The outcome of events was recovered on an unspecified date.   Information about batch/Lot number has been requested.
eye pain from movement,eye pain from light and light changes, eye ball pain; when he moved his eyes side to side and up and down he had eye pain; seeing red/black in the dark; eye pain from light and light changes; mild fever between 101.5 -102; very tired, fatigue; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (eye pain from movement,eye pain from light and light changes, eye ball pain), EYE MOVEMENT DISORDER (when he moved his eyes side to side and up and down he had eye pain), CHROMATOPSIA (seeing red/black in the dark), PHOTOPHOBIA (eye pain from light and light changes) and PYREXIA (mild fever between 101.5 -102) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Patient had the first two doses of the Pfizer where he experienced fever, swollen lymph nodes, mild symptoms), Pfizer vaccine (Patient had the first two doses of the Pfizer where he experienced fever, swollen lymph nodes, mild symptoms), PFIZER BIONTECH COVID-19 VACCINE (Patient had the first two doses of the Pfizer where he experienced fever, swollen lymph nodes and mild symptoms). Past adverse reactions to the above products included Fever with Pfizer vaccine; Swollen lymph nodes with PFIZER BIONTECH COVID-19 VACCINE; and Vaccination adverse reaction with Pfizer vaccine. Concomitant products included OMEPRAZOLE, MAGNESIUM, FISH OIL, AZELASTINE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced PYREXIA (mild fever between 101.5 -102) and FATIGUE (very tired, fatigue). On 19-Nov-2021, the patient experienced EYE PAIN (eye pain from movement,eye pain from light and light changes, eye ball pain), EYE MOVEMENT DISORDER (when he moved his eyes side to side and up and down he had eye pain), CHROMATOPSIA (seeing red/black in the dark) and PHOTOPHOBIA (eye pain from light and light changes). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE PAIN (eye pain from movement,eye pain from light and light changes, eye ball pain) had resolved and EYE MOVEMENT DISORDER (when he moved his eyes side to side and up and down he had eye pain), CHROMATOPSIA (seeing red/black in the dark), PHOTOPHOBIA (eye pain from light and light changes), PYREXIA (mild fever between 101.5 -102) and FATIGUE (very tired, fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5-102 (High) Experiencing a mild fever.         Patient received Aleve for eye pain and treatment information for other reported events was not provided.    Reporter did not allow further contact
Mother called 1/21 at 1:15PM to report that infant has fever between 100-102 past few days since receiving vaccinations denies cold sx. When questionably states infant has small (size of quarter) redness at vaccine sites-both thighs.
Patient is homebound and had received Moderna has her primary series of COVID vaccine on 3/4/2021 & 7/29/2021.  She requested a booster dose of Moderna.  When nurse went to patient's home on 2/11/2022 to give booster shot, patient was given a dose of Janssen vaccine in error. Patient was notified of error and side effects to watch for.  Patient not upset about receiving wrong vaccine but appreciative of being given the vaccine.
Left hand paresthesias; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2022 (Lot number: Fk9895) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid diagnosed between 2nd vaccine and booster" (unspecified if ongoing); "known allergies: Tree nuts" (unspecified if ongoing), notes: known allergies: Tree nuts. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Fc3182), administration date: 21Aug2021, when the patient was 16 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0186), administration date: 21Jun2021, when the patient was 15 years old, for COVID-19 Immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 07Mar2022, outcome "not recovered", described as "Left hand paresthesias". The event "left hand paresthesias" was evaluated at the physician office visit. Therapeutic measures were taken as a result of paresthesia.  Additional information: Report was about COVID vaccine. Yes other vaccine in four weeks. Adverse event: I have been experiencing extreme hair loss since my second dose of the Pfizer Vaccine, AE resulted in: [Doctor or other healthcare professional office/clinic visit] AE: treatment Physical therapy had been ordered, Known allergies : Tree nuts, Yes had COVID prior vaccination.  Follow-Up (05Apr2022): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Patient developed red inflamed patch at site of injection that is puffy and itchy, the size of 2 quarters.
Chief Complaint Patient presents with o Shortness of Breath Chest Pain  36-year-old male without significant past medical history presents with concerns for vaccine reaction.  The patient reports that he got the J&J vaccine yesterday, while at work today he developed some dizziness.  He went home, while resting at home he developed some chest pressure, shortness of breath.  He reports the symptoms have largely resolved at this time, he just feels mildly dyspneic at this time.  No known fevers.  No recent illness.  Patient does report some anxiety related to the vaccine. Well-appearing 36-year-old male presents 1 day after J & J Covid vaccine.  While he did experience some dizziness, dyspnea and chest pressures earlier, at this time the symptoms have resolved.  He appears well, is breathing comfortably, stable vitals.  Patient is PERC negative.  Will check an EKG, but otherwise recommend symptomatic management at home.   Differential diagnosis:  Vaccine reaction, viral illness, arrhythmia Low concern for PE given that the patient is PERC negative   EKG Interpretation: normal sinus rhythm, no ischemic changes   ED Course and Disposition:  Patient reassured and discharged home.
On 10/05/2021 I started sneezing got a instant headache. Had difficulty breathing. On 10/13/2021 I had difficultly breathing, bumps on my tongue.
Chronic hives all over the body which appear in random locations at random times. I have since gone to an allergy clinic and, based on the skin prick test, have no allergies. However, the hives persist, and I am taking 4x the normal dosage of allergy medicine, as the hives return whenever I decrease this. In the past, steroids have also helped prevent them.
No adverse event; Bivalent Booster was given to 5 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent Booster was given to 5 years old) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Oct-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent Booster was given to 5 years old). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent Booster was given to 5 years old) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent Booster was given to 5 years old).    No concomitant medications were reported. Patient received vaccine around 1:00 PM. It was reported that no side effects were noted. No treatment information was provided.
I immediately had nausea within the first hour. On day 2, I have body aches, it is very painful at the injection site,  I have GI upset, fatigue, chills, and headache
Worsening neuropathy: increase in paresthesias still present at the two weeks. Constant electric buzzing/pins needles sensations in legs and an increase in numbness patches all over body.
FEVER 103.5, CONGESTION, HEADACHE, REDNESS SURROUNDING INJECTION SITE AND SWOLLEN ARM, STIFFNESS IN ARM, LETHARGY, NO APPETITE FOR PAST 24-HOURS
within minutes of injection, c/o feeling like her heart was racing, feeling flushed, nausea, dizziness
Increased fatigue day or 2 following vaccine noted to have significant swelling of bilateral eyes. Fluid pockets present  eye swelling first noted on 1/11.
she was "a little fuzzy"; This is a spontaneous report received from a contactable nurse from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing), notes: taking "13" antihistamines. Concomitant medications included: TYLENOL WITH CODEINE; KEFLEX [CEFALEXIN]; TYLENOL. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "she was "a little fuzzy"".  Additional information: The reporter mentioned that her pharmacist & dentist didn't know what's safe, and was seeking guidance on her medications: antihistamines for allergies, she mentioned she was "a little fuzzy" and was taking "13" antihistamines; codeine phosphate, paracetamol (TYLENOL WITH CODEINE), but wasn't working so instead used a gram of paracetamol (TYLENOL) as needed; she was prescribed an antibiotic (cefalexin [KEFLEX] 250 mg 4x a day).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lowest temperature was -17C degrees. Total excursion time was for 63 hour and 45 minutes with no AE; Initial information regarding this unsolicited valid non-serious case via The Agency (reference number: 00316318)was received from a nurse and transmitted to Sanofi 14-Oct-2020.  This case involves a 66 years old female patient who received a 0.7 ml dose of vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]  (lot: UJ450AA, expiry date: 30-Jun-2021), via unknown route in the left deloid, on 06-Oct-2020 for prophylactic vaccination. Along with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], also IPV (VERO) [IPOL], TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM], HIB (PRP/T) VACCINE [ACT-HIB] and TUBERCULIN TEST [TUBERSOL] (unknown lot numberand expiration number) reached lowest temperature of -17 C degrees. Total excursion time was for 63 hour and 45 minutes (product storage error).  The patient's medical history, medical treatments, vaccinations, family history and concomitant medication were not provided.  It was an actual medication error due to the Product storage error temperature too low (latency same day for INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE).   At the time of reporting, the patient had no 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Breakthrough COVID infection. Symptom of shortness of breath. Onset of shortness of breath unknown. Positive test collected 08/01/2022
This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiration date and route not reported). No concomitant medications were reported. On an unknown date, the patient experienced red swollen grazed area defined as cellulitis after receiving the ZOSTAVAX. Treatment rendered for the event was antibiotics. The outcome of the event was unknown. The patient sought medical attention (doctors visit). Additional information has been requested.
12 month old Fever 101-102 x 4-5 days then resolved x 2days the Fever 104-105 x 5 days rash blanchable 10 days after vaccine. Has been at home 2nd to Covid 19 x 10-12 week no contact/decreased balance slowly improves.
Injection site cellulitis; pharmaceutical product complaint This case was reported by a health professional and described the occurrence of injection site cellulitis in a 4 year old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix). The patient had no pre-existing medical conditions. On 07 February 2005, the patient received the fifth dose of Infanrix in the "left leg" (lot DTPA620B9). On 07 February 2005 the patient also received injections of measles, mumps and rubella virus vaccine (MMR II Merck) and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). The health professional stated that the MMR II and IPOL injections were administered "in separate areas" from the site of the Infanrix administration. At an unspecified time following the fifth dose of Infanrix, on 07 February 2005, the patient experienced swelling and redness at the injection site of Infanrix. The patient was seen in an emergency room and was diagnoses with injection site cellulitis. The patient was treated with hydroxyzine hydrochloride (Atarax). The outcome of the injection site cellulitis was not reported. The vaccine provider considered the injection site cellulitis to be possibly related to this lot of Infanrix.
I felt light headed and felt like I was going to pass out. I was later diagnosed AFIB this February.
The pt became flushed with shortness of breath, felt as though she could not breath, nausea and vomiting. Felt throat swelling.
This was for moderna booster. It was Injected high in left arm (higher than norma) and was about 1-1.5" down from top of shoulder bone.  Very large swollen glands on left side in armpit and above/below collarbone - ongoing. Red and warm to touch. - 3 days and then has slowly gotten better (it's been 1.5 weeks) but they are still swollen. But they are not red or warm anymore  Aching under arm (different than typical vaccine injection) - went away when swelling went down.  Swollen, warm, red injection site - lasted 3 days Itching at injection site and on deltoid muscle - lasted 3 days  chills and felt warm but no fever. 36 hours  Nausea lasted 2 days  Took Tylenol and/or aleeve starting at at10pm on day of vaccine. Used for 3-4 days
Information has been received from a pharmacist concerning a patient who, on 19-APR-2013, was vaccinated with the first dose of GARDASIL, intramuscularly (dose and lot # not reported). It was reported that the patient would be administered the 2nd dose of GARDASIL, approximately one month later than what was specified in the prescribing information. Additional information has been requested.
This is a spontaneous report by a non contactable nurse. This nurse reported through Pfizer sales representative for a 12-year-old male patient who was administered a dose of PREVNAR 13 on an unknown date. Relevant medical history and concomitant medication were not reported. The patient experienced streptococcus pneumoniae for which he was hospitalized in 2012. In 2012, he experienced unspecified condition due to which he passed away. At the time of the report it was unknown if the autopsy was performed.
Felt like the worst flu. Extreme nausea, fever, muscle aches, headache
No adverse effects were reported; The nurse reported that the patient was administered PROQUAD by intramuscular injection; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 28-MAY-2018, the nurse reported that the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dosage, frequency, lot number, and expiration date were not reported) for prophylaxis, by intramuscular injection (incorrect route of product administration). No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA013121:
Shingles on 25th October 2020 in his right eye; Suspected vaccination failure; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 2nd dose of Shingrix. In February 2020, the patient received the 1st dose of Shingrix. On 25th October 2020, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and herpes ophthalmic (serious criteria hospitalization and GSK medically significant). The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure and herpes ophthalmic were unknown.   It was unknown if the reporter considered the vaccination failure and herpes ophthalmic to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was diagnosed with Shingles on 25th October 2020 in his right eye and was in the hospital from 29th October 2020 to 4th November 2020. The patient was receiving the antiviral drug Acyclovir. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming herpez zoster were unknown at the time of reporting.
Information has been received from a physician via a company representative referring to a 9  year old male patient. The patient did not have any drug reactions/allergies. The patient received the first vaccination with (Oka/Merck) VARIVAX on 28-MAY-2007 and his second vaccination with (Oka/Merck) VARIVAX on 10-AUG-2010 subcutaneously (dose and lot # unknown). There was no concomitant therapy. On 05-OCT-2015, the patient came into the physician's offic4e with a rash which was diagnosed as chickenpox. Lab test was not performed. The outcome of chickenpox was reported as not recovered. Additional information has been requested.
Returned to MD office 11/28/03. Left arm presenting large red circular area over flu shot injection site very itchy.
The patient came in to get her 2nd dose of COVID-19 vaccine.  The patient is pregnant and currently enrolled in 2 trials.  She also had COVID-19 back in July.  The patient received Pfizer vaccine today (1/30/2021) as this was the only vaccine being given today.  Upon administration, it was noticed that the patient had actually received Moderna first (12/30/2020 at 9:10 a.m.) and should have received Moderna again.   The nurses stated that they informed the patient that we are giving Pfizer vaccine today. The patient disputed this and said she wasn?t told this information. However, the manufacturer and lot# were recorded on her vaccination card and this was missed before the patient got her vaccination.   In the midst of explaining about the vaccines the patient told us that she rescheduled her own appointment from Wednesday, Jan. 27 to today Jan. 30.  Apparently this was a glitch in our scheduling system and the problem has been fixed.    Patient was advised to contact her OB/GYN and clinical trial coordinators.  We also encouraged her to call V-Safe to report the administration error.
Cool odd feeling from right to left side of upper chest, tingling and numbness in right foot. Later around 10 pm same night chills and sleeplessness next day extremely fatigued too tired to walk much and too tired to chew food beyond a few bites lasted 22 hours from start to finish. More symptoms came a couple day later right foot had vibrations on bottom of foot (like stepping on a vibrating cell phone) lasted a couple days and had off/on tickle cough. Have had slight tingling in lower right leg since.