chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a male twin with no other medical history who was vaccinated SC with a single dose of ZOSTAVAX. The physician reported that the patient subsequently developed a rash. Medical attention was sought via telephone call. No laboratory/diagnostic tests were performed. At the time of this report, the patient's rash persisted. This is one of several reports from the same source. Additional information has been requested.
No additional AEs were reported; Pharmacist reported that on 7/26/2022, a 28 year old patient received PROQUAD that was reconstituted with a diluent.   No additional AEs were reported.  No further information provided.; This spontaneous report has been received from a pharmacist and refers to a 28-year-old patient.  The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 26-JUL-2022, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live  (rHA)(PROQUAD), lot number W004029, expiration date: 02-AUG-2023 as prophylaxis (dose description, vaccination scheme and route of administration were not provided); reconstituted with a sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion, lot number u008044, expiration date: 06-JUL-2023, as prophylaxis (strength, and route of administration were not provided) (Inappropriate age at vaccine administration). No additional adverse event were reported.
fever; chills; vomiting; This is a spontaneous report from a non-contactable Other HCP. This Other HCP reported for a 13-year-old Male patient that:  A 13-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), intramuscular on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. No known allergies. It was unknown, the patient receive any other vaccines within 4 weeks prior to the COVID vaccine and whether the patient received other medications within 2 weeks of vaccination. On unspecified date in May202, the patient had experienced fever, chills and vomiting.  It was unknown if the patient received treatment  in response to the adverse events. It was unknown, the patient was covid prior vaccination or if covid tested post vaccination. On an unspecified date in 2021, the events were recovered.  Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected.
Cold sweats; Nausea; High blood pressure; This spontaneous case was reported by an other health care professional and describes the occurrence of COLD SWEAT (Cold sweats), NAUSEA (Nausea) and BLOOD PRESSURE INCREASED (High blood pressure) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for an unknown indication.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced COLD SWEAT (Cold sweats), NAUSEA (Nausea) and BLOOD PRESSURE INCREASED (High blood pressure). At the time of the report, COLD SWEAT (Cold sweats), NAUSEA (Nausea) and BLOOD PRESSURE INCREASED (High blood pressure) outcome was unknown.        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.   No concomitant information provided. No treatment information provided.
Breakthrough case admission after two vaccines Pfizer 6/4/21 Lot# Ew0180;  Pfizer 7/9/21 Lot# Ew0191
pt recv vax 19FEB99 c/o aching in lt arm since recv vax 25JAN99;has deep pain in lt arm & joint pain in lt wrist;pain travels down lt arm & lt leg & joint pain in lt ankle;no pain in rt arm;
In addition to the five main side effects (fever, chills, headache, nausea, and muscle pain), I also had severe lower body pain in my legs. I couldn?t walk. It felt like my limbs were cut off from the rest of my body. I had an intense sensation of knives stabbing me in different places all over my body. I couldn?t sleep the night of the shot due to the pain. Today marks 15 days since getting it, and I still have fatigue, radiating pain down my left arm and leg, and brain fog. I had a pretty bad migraine the other night. I have not received any treatment. I called my doctor who told me to go to the ER to get checked for a blood clot using a Doppler. I haven?t gone yet because it?s expensive and I?m still functioning. I?m considering going if I don?t get better.
Started with arm being sore and tender next day 11/19/15 also started having a little dizziness around 4:30p and worsened that evening, also arm started swelling and getting hot.  11/20/15 - (Friday) continued with above listed symptoms of arm being swollen, hot not feeling well and also started getting nauseated and vomited.  Patient went to ER on Saturday 11/21/15 - treated for cellulitis - put on antibiotics and meclizine for dizziness.
Migraine with aura on day of vaccine 12/23/2020. Hemiplegic migraine with right side weakness and visual aura 01/09/2021 with no history of motor symptoms with migraine for 37 years. Migraine with aura 01/12/2021. Hemiplegic migraine 01/14/2021.
Information was received from a registered nurse, concerning an approximately 5 year old who was vaccinated with a first, second and third dose of RECOMBIVAX HB, (lot numbers 638078/1474K, 638715/0004L). It was not known which lot number corresponded with which dose. Subsequently, the patient was "developmentally late". Unspecified medical attention was sought. The patient has not recovered. No product quality complaint involved. Additional information has been requested.
PATIENT FELT LIKE HE IS ON DEATH BED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient felt like he is on death bed. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient felt like he is on death bed was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Pt. fainted in the lobby following Tdap/ADACEL vaccine et Mantoux TST. BP 114/20, pulse 60. After pt laid down for approximately 10 min. helped her into a wheelchair et out to her father's car.
I had just returned to the pharmacy and I heard shouting. I looked and saw that the patient was on the floor.  I grabbed our emergency kit and went to patient's aid.  He was on the floor with his head against the shelving.  He was not conscious.  I instructed a staff member to call 911. I put my hand on his arm and the other on his chest and asked several times if he was ok.  After approximately 30 seconds he looked at me and regained consciousness.  He knew where he was and recognized his wife in the immediate vicinity.  He said that he has a history of fainting and he thought maybe seeing his wife get vaccinated and seeing a small amount of blood on her arm before I put a band-aid on her arm triggered his fainting spell.  EMS arrived after about 10 minutes and shortly thereafter he fainted again.
Patient received vaccine after the BUD; Vial was stored in refrigerator on 23-Dec-2022; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the BUD), PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the BUD), PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the BUD), PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 23-Dec-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the BUD) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 23-Dec-2022).    No concomitant medications were reported.  Vial size was reported as.4 ml per vial. The vial was initially stored in the refrigerator 23-Dec-2022. The vial did not undergo any temperature excursions. The patient received vaccines on 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023, 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17Feb2023 and 21-Feb-2023.  No treatment medications were reported.  This case contains information for the 4th of 42th patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Master case
Patient presented to the ED and was subsequently hospitalized for hypothermia due to exposure, frostbite of both feet, frostbite with tissue necrosis of abdominal wall within 6 weeks of receiving covid vaccination.
Fever; chills; body aches; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old non-pregnant female patient received  bnt162b2 (BNT162B2, Formulation:Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Apr2021 (at the age of 56-year-old) as Dose 2, Single for covid-19 immunization. The patient received first dose of BNT162B2 (Lot number: EN6206) via an unspecified route of administration in Mar2021 09:15 at left arm as Dose 1, Single for Covid-19 immunization and experienced Pain in neck, down arm, numbness in arm, loss of range of motion, weakness. Dr. believes Parsonage Turner Syndrom. Medical history included hypothyroidism, hypertension and penicillin allergy. Concomitant medications included Losartan and Synthroid. It was reported that patient was not received any vaccine in four weeks. The patient had no covid prior to vaccination nor been tested covid post vaccination. On an unknown date, the patient experienced fever, chills and body aches. The patient received Prednisone as therapy for the events. The patient was recovering at the time of report.  No follow-up attempts were required; information about lot/batch number cannot be obtained. No further information was expected.
Information has been received from a medical assistant concerning a 53 year old female employee in the doctor's office with hypertension allergies and shoulder pain who was vaccinated with pneumococcal 23v polysaccharide (lot # 0386P/649694) on 11/17/04. Concomitant therapy included unspecified hypertension medication, montelukast sodium, and Bextra. The medical assistant reported that within 24 hours the patient experienced severe pain and had a reaction in the vaccinated arm as if she had been smacked with a brick on the side of the arm. The medical assistant reported that at the time, the office was concerned that she could go into anaphylactoid shock. The medical assistant described the area on the patient's arm as a large area, infected and it was actually shaped like a brick. The patient recovered completely after a week. The health care provided reported that the patient is probably allergic to the vaccine and would not be receiving the shot again. Injection site infection, allergy to vaccine and injection site pain were determined to be other important medical events (OMIC). Additional information has been requested.
Severe chills around 1:30am (15 hrs after shot) headache around 2:300am and fatigue that lasted 48 hrs post injection.   Maintained him on 400mg Advil every 6 hrs for 24 hrs after his reaction.
This non-serious spontaneous case, was initially received on 23-Oct-2017 from the pharmacist, concerns a 14-year-old adolescent male patient. The subject had no relevant medical history and concomitant medications. On 23-Oct-2017, the patient administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195210A, expiry date: Mar-2018, route of administration: intramuscular, anatomical location: left deltoid). It was reported that, the patient received the vaccine, which undergone the maximum temperature excursion of 55-degree F overnight. It was reported that, the patient did not experience any adverse events after the administration of the vaccine. Follow-up report received on 27-Nov-2017: Gender of the patient (male) was added. Route of administration (intramuscular), anatomical location (left deltoid) was updated. It was reported that, the patient did not experience any adverse events after administration of the vaccine. Amended narrative accordingly. Significant case correction received 27-Nov-2017: The event 'no adverse event' was deleted.
Pt vaccinated with DTP developed temp 105 X 12 hrs after vaccine. No sx in follow-up  48 hrs.
This is an initial spontaneous report by a contactable physician. This Pfizer Sales Representative reported on behalf of a physician for an adult patient who began on PREVNAR 13 unknown dose intramuscular injection unknown frequency on upper arm for immunization for the prevention of pneumonia in Apr2013. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines taken on the same day were unknown. Vaccines taken within the last four weeks were unknown. In Apr2013 while on PREVNAR 13 unknown dose unknown frequency patient experienced moderate redness, pain and rash at the site of injection. Therapeutic measures taken in response to above mentioned evens included TYLENOL. Relevant lab data was unknown. At the time of the report it was unknown if patient was still administering PREVNAR 13. At the time of the report patient had recovered from above mentioned events in Apr2013. The physician considered there was a reasonable possibility that the above mentioned events were related to PREVNAR 13. Follow-up (12-JUN-2013): Follow-up attempts completed. No further information expected.
received a dose from a punctured vial after the 12 hour timeframe in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a punctured vial after the 12 hour timeframe in the refrigerator) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a punctured vial after the 12 hour timeframe in the refrigerator). On 19-Mar-2021, EXPIRED PRODUCT ADMINISTERED (received a dose from a punctured vial after the 12 hour timeframe in the refrigerator) 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 medications were reported. No Treatment information was reported.
Extreme fatigue, very sore muscles (which is normal), but also extreme hand cramping that was diagnosed as stenosing tenosynovitis (trigger finger from inflamed tendons), and temporary facial paralysis.  I have never had these conditions before, so the doctor said to report them.
This case was reported by a health professional and described the occurrence of fever in a 3 year old female pt who received Havrix. At the time of administration of Havrix, the pt was not receiving any concurrent medication. On 8/4/04, the pt received the 1st dose of Havrix (lot VHA776B2). Approximately 1 day, post/vax of Havrix, on 8/5/04, the pt experienced fever and unspecified "behavior problems". The pt was seen at a physician's office. The outcome of the events is unknown at the time of initial reporting. The health professional conseidered the events to probably be related to vaccination with Havrix.
She has recently fallen and broken her hip which caused her to have surgical repair; She has recently fallen and broken her hip which caused her to have surgical repair; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was scheduled to receive the second dose on Monday, 15Mar2021. She has recently fallen and broken her hip which caused her to have surgical repair on 03Mar2021 and now she was in a nursing home recovering. She wanted to know what she should do about postponing her second dose. The reporter considered the events as non-serious. Therapeutic measures were taken as a broken hip which included surgical repair. The patient was recovering from the events.  Information on lot number/batch number has been requested.
irritation at injection site; itchiness at injection site; pain at injection site; swelling at injection site; nausea; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), the first episode of VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE IRRITATION (irritation at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PRURITUS (itchiness at injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced NAUSEA (nausea), the first episode of VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE SWELLING (swelling at injection site). On 06-Feb-2021, the patient experienced VACCINATION SITE IRRITATION (irritation at injection site), VACCINATION SITE PRURITUS (itchiness at injection site) and the second episode of VACCINATION SITE PAIN (pain at injection site). On 02-Feb-2021, NAUSEA (nausea) and VACCINATION SITE SWELLING (swelling at injection site) had resolved. At the time of the report, VACCINATION SITE IRRITATION (irritation at injection site), VACCINATION SITE PRURITUS (itchiness at injection site) and the last episode of VACCINATION SITE PAIN (pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant medications reported were low dose diuretic. Treatment details included Tylenol, ice.
Dizziness & Tachycardia Narrative: Participant C/O dizziness upon ambulation shortly after completing a 15 minute observation period. Noted tachycardia with a heart rate of 137. Pt transported VIA wheelchair to the Emergency room triage area for further evaluation.
Dizzy, strong smell of medicine/metal, nausea, numbness hands, fingertips & lips.
Pt complains of pain at injection site. Cannot lift arm without pain -> this is now 2 months later after immunization.
case of shingles with ocular involvement after / case of shingles is currently occurring / suspected vaccination failure; case of shingles with ocular involvement after / second dose 9/7/18. / case of shingles is currently occurring; case of shingles with ocular involvement after; This case was reported by a physician and described the occurrence of suspected vaccination failure in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 7th September 2018, the patient received the 2nd dose of Shingrix. On 27th June 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient experienced shingles with ocular involvement after 2nd doses of Shingrix. The case of shingles was currently occurring with the patient. The patient did not had shingles between the two doses. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The reporter consented to follow up. This case has been linked with US2021AMR097927, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR097927:same reporter
Case number PHEH2014US014112 is an initial spontaneous report received from a physician on 11 Jul 2014. This report refers to a 20-year-old female patient. Her medical history included asthma. It was reported that she used an inhaler due to asthma; however she did not require it as she grew older. Her concomitant medications were not reported. On 07 Jul 2014, she was vaccinated with MENVEO (batch number: A13016) intramuscularly. Following the vaccination on 10 Jul 2014, she developed a non-itching rash that closely resembled eczema or psoriasis which originated at the nape of her neck and was progressing towards her scalp. It was reported that the event was ongoing and appeared to be worsening. The seriousness and causality of the event were not reported.
Information has been received from a registered nurse concerning a 11-year-old female who on 05-JUN-1998 was vaccinated SC with a 0.5 mL dose of VARIVAX (Merck) (Lot #625047/1574E). The RN reported that on 05-APR-2008, the patient developed chickenpox. It was unknown if medical attention was sought. In April 2008, the patient's chickenpox resolved. All pertinent information given was via phone. No further information is expected.
Information has been received from a Registered Nurse (R.N.) concerning a four year old female patient with immune suppression disease (state was unknown) who on 18-NOV-2004 was vaccinated with Pneumovax 23.  The patient was presenting with low titers.  In March, 2007 the physician wanted to give the patient another dose.  The nurse stated the patient reported no adverse reactions.  Unspecified medical attention was sought.  The patient's outcome was unknown.  Additional information has been requested.