chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist concerning a 66 year old female patient. The patient did not have any concurrent conditions, medical history, concomitant medication or drug reactions/allergies to be reported. It was reported that on 29-NOV-2018, the patient was vaccinated with PNEUMOVAX 23, lot number: R016640 (expiration date: 28-JAN-2020) (strength, doses and frequencies not reported), administered in the patient's left arm for prophylaxis. On the same day of vaccination, the patient experienced swelling, tenderness, redness and was uncomfortable at the injection site (injection site swelling, pain, erythema and discomfort) (non-serious adverse events (NSAEs)). She sought the pharmacist advice, but no treatment was administered for the events. No lab diagnostics or studies were performed. At the time of this report, the subject had not recovered from the events. There was no product quality complaint (PQC) reported. The causal relationship between the events and PNEUMOVAX 23 was unknown.
Significant hives and rash throughout the body 2 days after the Pfizer vaccine (2nd dose). Started late at night around 11:00 PM, engulfing the whole body by 3:00 AM. Made a telemedicine call with a doctor who prescribed Prednisone 40 mg daily. Started taking the meds the next morning. The problem continued on the next day with high severity. Went to urgent care, to see an in-person doctor. At that time, the doctor injected me with Epinephrin and gave me a dose of Dexamethasone. He increased the dose of Prednisone to 60 mg and added Benadryl to be taken every six hours 50 mg each does. The hives move around the body, they appear and disappear within a few hours and then return. Several times a day. This is day 7 since it started and in the last two days, with so much meds, the occurrence is less frequent and less sever. But the problem has not completely cleared up. Furthermore, I continue to be very agitated and sedated at the same time by the meds. Not knowing when I can stop them. I read there are others with this issue after vaccination and hope that this can get urgent attention by CDC and medical community.
no additional advers events; Caller reported vaccine administered after temperature excursions.  No other information provided.  No additional AEs or PQC reported.  ?    Names of vaccines involved (including lot/exp) PROQUAD W017567  11/29/2023        ?    Temperature 10.9F; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 08-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #W017567, expiration date: 29-NOV-2023, administered subcutaneously as prophylaxis (strength was not provided), after a temperature excursion of 1 hour and 30 minutes at a temperature of 10.9 Fahrenheit degrees (product storage error). No previous temperature excursions and no additional adverse events were reported.   This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2209USA000437: US-009507513-2209USA000235: US-009507513-2209USA000179: US-009507513-2209USA000350: US-009507513-2209USA000177: US-009507513-2209USA000361: US-009507513-2209USA000255: US-009507513-2209USA000374:
This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received the first dose of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) (Lot. R19477, Expiration date: 31Jan2018) on 09Dec2016, at single dose, for immunization. The patient's second dose (Lot. R41774, Expiration date: 30Apr2018) was received on 20Feb2017; the third dose (Lot. R49357, Expiration date: 31May2018) was received on 21Apr2017 and the fourth dose (Lot. T08483, Expiration date: 30Sep2019) was received on 27Oct2017; all at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient had ear infections and his IgG levels were low. Inappropriate schedule of vaccine was reported. Clinical outcome of the adverse events was unknown at time of this report. Pfizer is Marketing Authorization Holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)has submitted the same report to the regulatory authorities.
FATIGUE, CHILLS, PAIN/SWELLING INJ SITE,  RUNNY NOSE Narrative:
Pt. recd flu vaccine on 10-9-07 and awoke with sores on inside of upper and lower lips on 10-10-07 which had actively bled overnight causing lips to "stick together" Pt. given lidocaine viscous 27 sol. for ulcers
Student vaccinated, reported  back to class. Student fainted in class. Health Room notified. Student escorted to health room. Laid down, cool compress applied. School nurse and clinic nurse notified and went to health room to second assess. Student alert, oriented, still pale. Given fluids, parents notified. Parent took student home. Student recovered.
Woke from nap, had a diaper change, walked into living room and collapsed. Caregiver reported she was lifeless, temp 103.5. Ambulance called and transported to hospital. Temp 102.5 upon arrival to hospital. She was kept overnight and discharged home on 6/25/2010. Diagnosis at hospital: Febrile Seizure. No further seizure activity.
7/29/99 call recv from HRS; pt admit to med center w/body rash & multiple papules
This spontaneous report was received from a physician via a sales representative concerning a 16 years old male patient with sinus infection, who on 08-JAN-2013 was vaccinated with dose 1 of GARDASIL (route, lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient was being treated for sinus infection simultaneously to receive the first dose of the vaccine and the patient developed fainting spells and dizziness on 09-JAN-2013, 24 hours after receiving the vaccine. The patient sought medical attentions. No treatment information was reported. The outcome of fainting spells and dizziness was unknown. The relatedness for fainting spells and dizziness was unknown for GARDASIL. Additional information has been requested.
Client received AstraZeneca Covid vaccine with no reaction. Previous vaccine unavailable in the. Janssen given as an alternative on 9.15.21.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 15-OCT-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L018499; expiry: 25-FEB-2017 (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
hives, tight throat, bottom lip swollen  took benadryl, warm bath, tylenol  symptoms subsided for the most part except itchy swollen hands
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: ptient has swollen red arm
Shaking chills; nausea; tired; couldn't sleep; Wrong vaccine administered; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 18Sep2023 as dose 5 (booster), single (Lot number: HP9275) at the age of 48 years, in left arm for covid-19 immunisation. The patient didn't receive bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Single, Manufacturer Unknown), for COVID-19 immunization.  The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 18Sep2023, outcome "unknown", described as "Wrong vaccine administered"; CHILLS (non-serious) with onset 18Sep2023 at 22:30, outcome "recovering", described as "Shaking chills"; INSOMNIA (non-serious) with onset 18Sep2023 at 22:30, outcome "recovering", described as "couldn't sleep"; NAUSEA (non-serious) with onset 18Sep2023 at 22:30, outcome "recovering"; FATIGUE (non-serious) with onset 18Sep2023 at 22:30, outcome "recovering", described as "tired". Therapeutic measures were taken as a result of chills, nausea, fatigue, insomnia.  Additional information: AE treatment: Extra strength Tylenol  No follow-up attempts are possible. No further information is expected.
Patient received the first dose on 05Feb2021 Patient is present for second dose of the Moderna Vaccine today 17june2021, (132 days after 1st dose)/132 days since the first dose and no second dose taken yet; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received the first dose on 05Feb2021 Patient is present for second dose of the Moderna Vaccine today 17june2021, (132 days after 1st dose)/132 days since the first dose and no second dose taken yet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received the first dose on 05Feb2021 Patient is present for second dose of the Moderna Vaccine today 17june2021, (132 days after 1st dose)/132 days since the first dose and no second dose taken yet). On 17-Jun-2021, PRODUCT DOSE OMISSION ISSUE (Patient received the first dose on 05Feb2021 Patient is present for second dose of the Moderna Vaccine today 17june2021, (132 days after 1st dose)/132 days since the first dose and no second dose taken yet) 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.   No concomitant medication was reported. Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: NNI FU - No new information was provided.
This 79 year old white  female received the Pfizer Covid shot on 2/11/21    and went to the ED on  2/24/21     and was admitted  on 2/24/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident) (CMS/HCC)
The patient suddenly developed right sided Bell's Palsy on 4-13-2021 after her second dose of the COVID-19 vaccine (the second dose was given in the morning and by the afternoon the facial weakness started).  She was evaluated in the ER and was treated with Valtrex and Prednisone.  The right side of her face slowly improved however on 9-01-2021 she developed similar left sided facial weakness consistent with Bell's Palsy.  She is still struggling with the weakness on the left side of her face.    She was evaluated by a neurologist after the initial right sided facial weakness and was asked to return to them for further recommendations.
Suspected vaccination failure; Got them; Still got them. Very painful!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the shingle shots and still got shingled. It was very painful. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were not reported.
This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 29-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 025J20A) for COVID-19 vaccination. The patient's past medical history included Sleep apnea (Stable) in 2015 and Narcolepsy (Stable) in 2015. Concurrent medical conditions included Hypertension since December 2020, Hypothyroidism (Stable) since December 2020, Migraine (Stable) in November 2020 and Heartburn since 2015. Concomitant products included FAMOTIDINE for Heartburn, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Hypertension, LEVOTHYROXINE for Hypothyroidism, MAGNESIUM OXIDE for Migraine, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 29-Sep-2020 and the estimated date of delivery was 07-Jul-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2020, Pregnancy test: positive (Positive) Positive. In January 2021, Ultrasound foetal: inconclusive (Inconclusive) Inconclusive and inconclusive (Inconclusive) Inconclusive. In 2021, Glucose tolerance test: 105 (normal) 105. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Treatment information was  provided. The patient's date of conception was 12-Oct-2020. The patient had a miscarriage on 14-May-2020.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Initial report received from a non-health care professional on 04 DECEMBER 2012. A 23-year-old female patient, the patient has no medical history and no concomitant vaccine. Illness at the time of vaccination , and pre-existing diagnosed allergies were none. The patient had received a dose of FLUZONE ID (dose number, lot number, route and site of vaccination not reported) on 27 NOVEMBER 2012. On 28 NOVEMBER 2012 after one day of vaccination patient presented marble size lump on neck. As of 04 DECEMBER 2012 one week later still lump on neck but decreased in size. Relevant diagnostic tests and laboratory data was not reported. At the time of this report, the patient was not recovered. Documents held by sender: none.
No additional AE; the vaccine was adminsitered after a temperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Information on pertinent medical history, concomitant medications and drug reactions/allergies was not reported.   On 24-JAN-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U020239, expiration date 28-JUN-2023) 0.5 milliliter for prophylaxis (dose number, route of administration and location of administration were not reported).  The vaccine was exposed to a temperature of -14.1 C for 12 minutes. There were no previous temperature excursions. No adverse events were reported.
2.5 inch bruise at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (2.5 inch bruise at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included ENALAPRIL and ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (2.5 inch bruise at injection site). At the time of the report, VACCINATION SITE BRUISING (2.5 inch bruise at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Hypertension; Tiredness; Weakness; losing some muscles; He is also experiencing muscle deterioration (no muscle pain); he's been feeling a light body (not hard to move); elevated liver enzymes; he told him he doesn't get enough sleep; nervous; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration on 22Apr2021 (at the age of 44-year-old) as dose 2, single for covid-19 immunisation. Medical history included, hypertension from 29Apr2021 to an unknown date, glucose tolerance impaired from 2010 to an unknown date Verbatim: Prediabetes, haemorrhoids from 09Mar2021 to an unknown date Verbatim: Hemorrhoids, hypovitaminosis from an unknown date and unknown if ongoing, asthenia from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL) taken for haemorrhoids, pain, start and stop date were not reported; ascorbic acid, biotin, folic acid, iron, nicotinic acid, pantothenic acid, pyridoxine, riboflavin, vitamin b1 nos, vitamin b12 nos, vitamin e nos (CENTRUM ADULT B+ IRON) taken for hypovitaminosis from an unspecified start date and ongoing; ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) taken for covid-19 immunisation from an unspecified start date and ongoing; vitamin b complex (VITAMIN B) taken for asthenia from an unspecified start date and ongoing. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration on 01Apr2021 (at the age of 44-year-old) as dose 1, single for covid-19 immunisation. On 25Apr2021, patient experienced losing some muscles, 0n 26Apr2021, patient experienced weakness, on 27Apr2021, patient experienced tiredness, on 29Apr2021, patient experienced hypertension. on an unspecified date in 2021, patient experienced muscle deterioration, he's been feeling a light body, elevated liver enzymes, he told him he doesn't get enough sleep, nervous. The patient underwent lab tests and procedures which included aspartate aminotransferase: 28 on 22Sep2020 Normal, aspartate aminotransferase: 46 on 30Apr2021 slightly elevated, blood test: elevated liver enzymes on 30Apr2021. Therapeutic measures were taken as a result of hypertension included losartan 25mg. The outcome of the events losing some muscles, tiredness, weakness were not recovered and the outcome of the remaining events were unknown.
approx. one hour after receiving vaccine pt started having throat tightness, nausea, lips tingling, SOB and "feeling weird". States has had anaphylaxis in the past from nuts and uses an EPI pen. States she used her pen but did not get relief so went to ER where she received IV benadryl, tagment and steroids. EKG was abnormal. States no problems at injection site. F/U with patient appox. 7 hours after incident and pt states she is doing fine and not having any issues now.
Patient was given flu shot on 10/13/14. Patient had arm pain and was treated at physician's office with a steroid injection into "bursa" b/c symptoms of bursitis.
Underside of arm/belly, little red bumps that itch and burn. Jaw, neck , back, head stiff, migraine, hot/sweaty. Attempted three times to contact patient for follow up. Left voice mail messages. Patient did not respond. Some questions not answered.
In addition to the typical pain at injection site, fatigue,  headache, and body aches (which I experienced with my first dose as well), this time I also had severe nausea and stomach issues that led to hours of vomiting and some diarrhea. I was vomiting so much that I was eventually just dry heaving. It started around 11:30pm (about 7 hours after my dose), and then it lasted all night and into the next morning.
Pfizer vaccine had something in it that cured my mad itch.; This is a spontaneous report from a Regulatory Authority. A 83-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on Mar2021 as dose number unknown, single for covid-19 immunisation. The patient medical history included severe pruritus of unknown origin for over two years. The patient concomitant medications were not reported. On unspecified date of 2021, the patient experienced and stated that she went to numerous neurologists, dermatologists, allergists, etc. Nothing worked to help her Pruritus. I kept very detailed records of everything, and I am sure that the Pfizer vaccine had something in it that cured my mad itch. The outcome of the event was unknown. The lot number for the vaccine, [Pfizer Covid-19 Vaccine], was not provided and will be requested during follow up.
pain (in legs) more so than she normally experiences; legs were super super sensitive; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain (in legs) more so than she normally experiences) and PARAESTHESIA (legs were super super sensitive) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included GABAPENTIN and INSULIN for an unknown indication.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain (in legs) more so than she normally experiences) and PARAESTHESIA (legs were super super sensitive). At the time of the report, PAIN IN EXTREMITY (pain (in legs) more so than she normally experiences) and PARAESTHESIA (legs were super super sensitive) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included gabapentin for neuropathy.  Action taken with mRNA-1273 in response to the event was not applicable.