chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bumps that scabed over; rash; This is a spontaneous report from a contactable consumer. This 61-year-old male consumer reported in response to Non-HCP letter sent in a cross-referenced case.  A 61-year-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: GL9204, Expiration date: unknown), via unspecified route, administered over right arm on 04Feb2021 02:19 AM (at the age of 61-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ELQ142, Expiration date: unknown), via unspecified route, administered on 12Jan2021 01:27 AM (at the age of 61-year-old) as dose 1, single for COVID-19 immunization and patient experienced Tingling on outside of left arm where he had the shot that progresses to his pinkie finger which is most numb. The patient medical history and concomitant medications were not reported. On 07Feb2021, 3 days after the vaccination, the patient experienced Rash on right arm lasted 2 weeks and on unspecified date several bumps that scabbed over clear today. The events assessed as non-serious. The outcome of the events was recovered on 27Feb2021.  No follow-up attempts possible. No further information expected.
Initial unsolicited report received from a consumer (patient's parent) on 6-April-2015. A female patient, whose medical history and concomitant medications were not reported, had received a intramuscular dose of MENACTRA (batch number, expiry date, dose number and site of administration were not reported) and a intramuscular dose of ADACEL (batch number, expiry date, dose number and site of administration were not reported) on an unspecified date (about four years ago). Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were not provided. On an unspecified date after vaccination, the patient experienced arm became swollen from the deltoid to the elbow. Laboratory investigations and corrective treatment were not provided. On an unspecified date, the patient had recovered from the above mentioned event. Documents held by sender: none. Follow up information received from a Physician on 04-May-2015. The physician reported that he did not report any information about the event. There was no additional information provided.
received 4 vaccinations of Pfizer Biontech Covid 19 vaccine and has recently tested positive for Covid 19; received 4 vaccinations of Pfizer Biontech Covid 19 vaccine and has recently tested positive for Covid 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  An 85-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL8982), on 19Feb2021 as dose 2, single (Lot number: EL9264), as dose 3 (booster), single (Lot number: FE3592) and on 02Jun2022 as dose 4 (booster), single (Lot number: FM2293) at the age of 85 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "received 4 vaccinations of Pfizer Biontech Covid 19 vaccine and has recently tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: recently tested positive for Covid 19. Bebtelavimab may be name of infusion caller received but is not sure. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Caller has received 4 vaccinations of Pfizer Biontech Covid 19 vaccine and has recently tested positive for Covid 19. The patient had each dose in different arm and was rotated.
Pregnant patient received the 1st dose of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a physical therapist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the Moderna vaccine) in a 35-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (spontaneous abortion) on 27-Aug-2019. Concurrent medical conditions included Drug allergy (Codeine). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 01-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 30-Jun-2020 and the estimated date of delivery was 12-Apr-2021. On 01-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 01-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the Moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2020, Pregnancy test: positive (Positive) Positive. On 17-Feb-2021, Ultrasound foetal: normal (normal) everything okay.     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.   Estimated date of conception:18-Jul-2020 No treatment medications were provided
ON 6/9, CHILD DEVELOPPED RASH, AND HAD A FEVER OF 101.9 F. WAS SEEN AT A CLINIC WAS DIAGNOSED WITH STREP THROAT (NO RECORD OF ANY TESTING DONE). CHILD WAS STARTED ON KEFLEX. ON 6/9, HAD HIGH FEVER 105 THAT WASN'T REDUCED BY TYLENOL ALTERNATING WITH MOTRIN. SHE WAS SEEN AT CLINIC. (FAMILY WAS TRAVELING). AT THE CLINIC, THE CHILD WAS ASSESSED AS HAVING MINOR LYMPHADENOPATHY, CONTINUED RASH, MOUTH SORES. STREP SCREEN WAS NEGATIVE. CHILD WAS TREATED WITH BENADRYL AND MAALOX, AND TO CONTINUE KEFLEX, TYLONOL AND MOTRIN. ON 6/13, CHILD WAS REFUSING TO EAT OR DRINK, WITH LITTLE URINE OUTPUT, SO SHE WAS HOSPITALIZED. DIAGNOSES WERE DEHYDRATION, BRONCHITIS. SHE WAS DISCHARGED ON 6/15.
Patient administered 0.5mL dose instead of 0.25mL booster dose for their fourth dose of Moderna.
Information has been received from a nurse practitioner concerning a 33 year old female pt who 3 years ago in approximately 2000, prior to her pregnancy, was vaccinated IM with a booster dose of MMRII. The pt was vaccinated with a dose of MMRII as a child. It was reported that recently her rubella titer came back negative. No additional information was available. Additional information has been requested.
Patient received shot and after about 30 seconds got up to leave immunization room and lost consciousness.  Was examined immediately upon falling and was alert with no allergic reaction signs.
Patient received the Flu vaccine in the right deltoid and developed swelling and the swelling spread through out the arm and still present (Extensive Limb swelling).
Transverse Myelitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 09-DEC-2012 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after the vaccination, unsure it's in December 2012 or 2013), the patient suffered from and was diagnosed with transverse myelitis. As the result of vaccine live(ZOSTAVAX), the patient suffered serious, progressive, severe, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of transverse myelitis was considered as not recovered. The lawyer considered it to be related to zoster vaccine live(ZOSTAVAX).  Upon internal review, transverse myelitis was determined to be medically significant. Transverse myelitis was considered as disable by reporting lawyer.
13 weeks preg? severe fever, rigors, aches, insomnia, gi sx
developed Bell's palsy/face is not straightened out; it got a form of allergic reaction; I became ill; vision on right side is slightly blurry; It's also messing with my speech a little /it's messing up with the 'teeth' a little like talking; This is a spontaneous report received from a contactable consumer or other non HCP from medical information team. The reporter is the patient. A 54 year-old male patient received bnt162b2 (COMIRNATY), administered in deltoid left, administration date 22Oct2021 (Lot number: FM2588) at the age of 54 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medications included: AMLODIPINE; METFORMIN. Vaccination history included: Bnt162b2 (first dose), administration date: 2021, for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 30Oct2021, outcome "not recovered", described as "developed Bell's palsy/face is not straightened out"; HYPERSENSITIVITY (non-serious) with onset 30Oct2021, outcome "unknown", described as "it got a form of allergic reaction"; MALAISE (non-serious) with onset 30Oct2021, outcome "unknown", described as "I became ill"; VISION BLURRED (non-serious) with onset 2021, outcome "unknown", described as "vision on right side is slightly blurry"; SPEECH DISORDER (non-serious) with onset 2021, outcome "unknown", described as "It's also messing with my speech a little /it's messing up with the 'teeth' a little like talking". The events were evaluated at the emergency room visit. Therapeutic measures were taken as the result of the events. The patient thought he had a heart attack but it was determined that he had developed Bell's palsy and his face has not straightened out. It was also reported that his vision on right side was slightly blurry and messing with his speech a little. The patient would like to know if Bell's palsy is related to the Pfizer Covid 19 vaccine.  Follow-up attempts are completed. No further information is expected.
I had mouth sores that spread around my entire mouth, followed by a body rash. I had a fever as well. I am still dealing with this at this time, but it is much better. I was prescribed Valacyclovir, Triamcinolone, and Prednisone.
Expired engerix B was administered; This non-serious case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a male patient who received HBV (Engerix B) (expiry date JAN-2023) for prophylaxis.   On 16-MAR-2023, the patient received Engerix B. On 16-MAR-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired engerix B was administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-MAR-2023 The reporter did not consent to follow up. The patient received a Engerix B vaccine which was already expired, which led to expired vaccine used.
antibody deficiency; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (10Oct2023), this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 21-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GT0538) for immunisation, Device Lot Number: GT0538. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANTIBODY TEST ABNORMAL (non-serious), outcome "unknown", described as "antibody deficiency". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After receiving the vaccine, a blood test was performed to identify what antibodies she developed after receiving the vaccine. The blood work indicated that she only developed antibodies for serotype 19F. Patient stated that she developed a response to most but are low. Patient added that she also developed a response for serotype 33F. As of 10Oct2023, patient was tested for 14 serotypes on the blood work as she's being evaluated for antibody deficiency.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
The patient experienced no symptoms; a dose of PROQUAD was administered to a 20 year old on 6/22/2020; This spontaneous report was received from an office manager and refers to a 20-year-old patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies was not provided.  On 22-JUN-2020, the patient was vaccinated at inappropriate age with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # S027467, expiration date not reported, but upon internal review established as 02-MAR-2021, subcutaneously (exact dose, dose number and vaccination site were not provided) for prophylaxis. The patient experienced no symptoms.
FEB 15 I  experienced headaches, light sensitivity, chills, temp of 96.6 DegF, vomiting, was unable to go to work.
Ears ringing too much; Nauseated; Loses balance, like he was going to fall; Dizzy or feels drunk; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of an unspecified age received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 12Feb2021 (age at vaccination was unknown) as dose number unknown, single for COVID-19 immunization. The patient's medical history included diabetes (diabetic) from an unknown date. The patient's concomitant medications were not reported. The patient reported that he got the vaccine on 12Feb2021, 3 days ago and thought he got some side effects. On 14Feb2021, the patient was nauseated and kind of lost his balance and was dizzy or felt drunk. The patient stated that he was fine the first day with no side effect and last night the side effects started and didn't go away and have been going on more than 12 hours. The patient provided that yesterday around 6 in the afternoon he felt something weird like he was drunk and then went to bed and felt like he was losing his balance like he was going to fall. He lay down on his bed and woke up still feeling the same. Felt like he was going to fall and had nausea which also started last night. The patient stated he felt like he was going to fall and was scared and nervous. The patient also stated his ears were ringing too much on an unspecified date. The patient wanted to know what he could to do help with these. The patient was recommended to call his doctor. The patient stated he could go to his doctor at that time, would go to an urgent care. The patient asked if that was normal as he was scared it could be something and wondered if the vaccine causes bleeding in the abdomen. The patient stated he would go see his doctor to see about treating his side effects. The patient relayed that he was diabetic and his blood sugar was 114 at that time on 15Feb2021. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Weak feeling in left hand, unable to move hand normally, pain in hand and leg, unable to stand due to pain in leg.
Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, M012M20A and M-13L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for an unreported indication: FLU on 08-Feb-2021. Concomitant products included ATORVASTATIN for Cholesterol, METFORMIN for Diabetes, LISINOPRIL for Hypertension, MULTIVITAMINS [VITAMINS NOS] for Supplementation therapy, AMLODIPINE from 23-Aug-2021 to an unknown date for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.            No treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Significant Follow-Up received on 5-Oct-2021.Updated concomitant medication, event start date and stop date, Updated event ADR term to Pain in Arm.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 03Feb2021 as dose 2, single (Lot number: EM9810), in left arm, on 23Sep2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 15Apr2022 at 15:30 as dose 4 (booster), single (Lot number: FK9893) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "polymyalgia rheumatica" (unspecified if ongoing); "osteopenia" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: 02Dec2021; NEXIUM [ESOMEPRAZOLE SODIUM]; VITAMIN D [COLECALCIFEROL]; VITAMIN C [ASCORBIC ACID]; XYZAL; CALCIUM CARBONATE; ALBUTEROL [SALBUTAMOL]. The following information was reported: COVID-19 (medically significant) with onset 28May2022, outcome "not recovered", VACCINATION FAILURE (medically significant) with onset 29May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28May2022) negative; (29May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid, treatment start date 20May2022, treatment stop date 24May2022 for Treatment of COVID-19. Clinical course: Other medication in 2 weeks product Iron supplement. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Completed Paxlovid on Tuesday evening felt fine. Did rapid test 28May2022 (Saturday) morning and was negative. 28May2022 (Saturday) afternoon started sneezing, runny nose. Symptoms continued to worsen on 29May2022 (Sunday) so patient did a rapid test and it was positive. Patient had no known allergies.; Sender's Comments: Based on the information in the case report, a causal association between reported events and suspect BNt162B2 cannot be excluded.
Initial misuse case was received from a health care professional on 18 October 2013. Cases were received on 21 March 2014 at GPV. Two patients whose demographics details, medical history and concomitant medication were not reported received a dose of FLUZONE High Dose and a dose of ADACEL on an unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received unstable vaccine. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: none
Within < 24 hrs after receiving VZV #2 in right arm, pt developed redness and swelling at the site. See 24 hrs later in ER, noted to have hive on right arm (redness, induration about 3 cm diameter.
TRANSIENT TRANSAMINITIS; This spontaneous report received from a physician concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: hepatitis c, and other pre-existing medical conditions included: The patient's hepatitis C well controlled on unspecified anti-virals. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced transient transaminitis. Laboratory data (dates unspecified) included: Transaminases (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from transient transaminitis. This report was non-serious.
This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE BRUISING (slight bruise) and VACCINATION SITE PAIN (slight injection site pain) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055Z22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (slight bruise) and VACCINATION SITE PAIN (slight injection site pain). At the time of the report, VACCINATION SITE BRUISING (slight bruise) outcome was unknown and VACCINATION SITE PAIN (slight injection site pain) was resolving.            No concomitant medications were reported.   The patient received his first vaccine on 29-Jan-2021 (lot number: 004M20A) on left arm. The patient received his second vaccine of the primary series on 04-Mar-2021 (lot number 032M20A) on left arm. The patient received his third Moderna vaccine as a full dose on 18-Aug-2021.
Patient was given the Moderna Covid-19 vaccine, dose #1.  When the information was being entered, documentation showed te patient had received the Pfizer vaccine on 1/21/2021.
Increased thoughts of suicide occurred 4 hours after 2nd dose of vaccine and then booster. Each episode lasted 12 hours.