chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case PHEH2106US025144 is a spontaneous report initially received from a pharmacist on 27 Sep 2016. This report refers to 74 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with single dose of FLUAD (batch number: 165902, expiry: not reported) on 27 Sep 2016. On the same day, it was reported that, when the pharmacist administered the vaccine, part of vaccine leaked out of pre filled syringe and patient only received the partial dose. No adverse event was reported following this medication error (underdose). Non significant information received from a pharmacist on 27 Se[ 2016: Updated reporter information.
Information was received from a pharmacist concerning a 5 year old patient of unknown gender. Information on pertinent medical history and concurrent condition was not reported. On an unknown date, the 5 year old patient was vaccinated with ZOSTAVAX lot # M010472, expiry date: 01-JUN-2017, subcutaneously (inappropriate schedule of vaccine administered). No adverse effects were reported. No PQC involved. Additional information has been requested.
Covid; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 23Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got his 1st dose on 23Mar2021 and then 4 days later got covid. He wanted to know if he should keep the 2nd dose appointment or not. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Next morning onset: headaches, respiratory distress, site swollen, red, arm pit swollen and very hard up into shoulder, hand swollen and numb, pain in fingers and toes, difficulty swallowing. Later symptoms: started after a cough, infection around sutured wound blistered, pain in lymph nodes in neck, tender and swollen around mastoid bone, numbness in hands after sleeping, or light activity, headaches.
Information has been received from a consumer concerning her now 12 year old nephew who on an unspecified date was vaccinated with a dose of MMR II. It was reported that the patient developed autism "from MMR II." It was reported that he was fine before the vaccine was given. Upon internal review, autism was determined to be an other important medical event. It was also reported that the patient's brother developed autism after vaccination (WAES # 0904USA00236). No further information is available.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients' were vaccinated with and improperly stored doses of RECOMBIVAX HB (strength, dose and route of administration were not provided) (lot # L010565 expiration date 12-NOV-2016, lot # L033343 expiration date 13-SEP-2017 and lot # L042846 expiration date 15-SEP-2017). The registered nurse stated that RECOMBIVAX HB was exposed to the following temperature conditions: 34 F degrees for an unknown period of time. Previous temperature excursion was unspecified. No adverse event was reported and no product quality issue was involved. Additional information has been requested. This is one of several reports received from the same reporter.
all the systems of her body began to collapse'; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adolescent female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (medically significant), outcome "unknown", described as "all the systems of her body began to collapse'". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Menstrual changes: menstruation started earlier than expected (3 days early) and menstrual side effects were more intense than usual (cramping, menstruation was much heavier than normal). The period also lasted 9 days, whereas 5 days is usual for me.   Additionally, I experienced persistent gum pain and sensitivity for a week and a half after my first vaccination. That also started on the same day as my early period.
On 10/03/2021, I started off with a fever, low grade fever, body aches, and headache. By the 4th day, fever was 100, by the 5th day fever of 102, body aches, chills, headache and runny nose. Called my physician for guidance for over-the-counter medication. The fever lasted 7 days. 11/02/2021- The only symptom lingering is the fatigue. I ended up with a sinus infection at the end of everything.
Significant pain at injection site immediately upon (and during) both first and second injections (12/14/2006 lot 0688f and 2/16/2007 lot 1447F). Pain decreased rapidly within a minute but ache remained for approximately an hour. Daughter described pain as "worst pain after any injection she's ever had".
vaccine was accidentally left out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT STORAGE ERROR (non-serious), outcome "unknown", described as "vaccine was accidentally left out". Prevnar 13 or Prevnar 20 was unable to be verified as the suspect product as the caller disconnected the line prior to speaking to the call handler.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a possible transient ischaemic attack; the patient began retaining water; This is a spontaneous report from a non-contactable consumer (patient).   An 87-year-old male patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 19Jan2021 for Covid-19 immunisation. Medical history included mitral valve replacement, pacemaker. The patient had not experienced Covid-19 prior vaccination. Concomitant medication included blood thinner, atorvastatin calcium (STATIN), lisinopril (manufacturer unknown), warfarin (manufacturer unknown).  No other vaccine received in four weeks. In 2021 a few days after 1st vaccination the patient began retaining water. On 04Feb2021 the patient was hospitalized for a possible transient ischemic attack. The patient was hospitalized for a possible transient ischaemic attack and began retaining water from 04Feb2021 to an unknown date. Therapeutic measures were taken as a result of events. The outcome of unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
SMALL RED BLOTCHES ON FACE AND NECK; RAISED RASH ON HIS RIGHT HIP, NECK AND FACE; TINGLING IN ARMS AND BACK; FOGGY; FATIGUE; ABDOMINAL PAIN; LOW GRADE HEADACHE; INJECTION SITE PAIN; UNUSUAL PAIN THROUGHOUT BODY; PAIN AT LOWER EXTEMITIES; DARK SKIN ON BACK; WEIRD SENSATION WITH ROUGH SKIN; STRETCHED SKIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 13:45 for prophylactic vaccination on upper right arm. No concomitant medications were reported. On MAR-2021, the subject experienced weird sensation with rough skin. On MAR-2021, the subject experienced stretched skin. On 21-MAR-2021, the subject experienced abdominal pain. On 21-MAR-2021, the subject experienced unusual pain throughout body. On 21-MAR-2021, the subject experienced pain at lower extremities. On 21-MAR-2021, the subject experienced low grade headache. On 21-MAR-2021, the subject experienced injection site pain. On 22-MAR-2021, the subject experienced foggy. On 22-MAR-2021, the subject experienced fatigue. On 24-MAR-2021, the subject experienced tingling in arms and back. On MAR-2021, the subject experienced dark skin on back. On 02-APR-2021, the subject experienced small red blotches on face and neck. On 02-APR-2021, the subject experienced raised rash on his right hip, neck and face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from unusual pain throughout body, pain at lower extremities, low grade headache, and injection site pain, was recovering from abdominal pain, had not recovered from foggy, fatigue, tingling in arms and back, dark skin on back, and raised rash on his right hip, neck and face, and the outcome of weird sensation with rough skin, stretched skin and small red blotches on face and neck was not reported. This report was non-serious.  Additional information was received on 05-Apr-2021: The following information was updated and incorporated into the case: events feeling tingling in arms, weird sensation with a rough skin, darker skin, stretched skin, raised rash on hip, neck and face, small red blotches on face and neck added.
This spontaneous report was received from a licensed practical nurse refers to a 31 year old patient of unknown gender. On 09-SEP-2013 the patient received a 0.5 ml dose of VARIVAX (Merck) (lot # 1210AA, expiration date: 26-JUL-2013), subcutaneously at left arm that was expired. The patient had not reported or demonstrated any adverse effects. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Jaw issue/jaw joint was restricted; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Jaw issue/jaw joint was restricted) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced JOINT STIFFNESS (Jaw issue/jaw joint was restricted). At the time of the report, JOINT STIFFNESS (Jaw issue/jaw joint was restricted) outcome was unknown.            It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter. No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
pt recvd vax 1MAR96 & 4MR96 fever & vomiting x 1;5MAR96 father called to report spasm, fever & ER persons responding & pt taken to ER;fever on 106.6R; febrile seizure, vax rxn
stinging, aching arm (even @ present 13NOV95) red bump (fifty cents piece size), when pt's hand is under cold water pain shoots up arm to shot site, fatigue
Systemic itchiness starting around the face/head. Arm also itches along with torso. Right arm is starting to show signs of a rash near & below injection site.
Fever, chills, body and  joint aches, slight nausea, headache, lack of clarity (fatigue)=48 hours
On the morning of January 15th around 3 AM I woke up to hear my daughter let out a loud squeak. She started shaking her head back and forth really fast and then she started shaking head to toe, I rolled her onto her side and it subsided after 25-30 seconds. There wasn't any symptoms before hand, I checked her temp afterwards and it was 99.8 by underarm.
Patient passed out after receiving vaccine.  She regained consciousness without any intervention.  She reports she frequently passes out after vaccinations.
The vaccine was expired on 01-Jun-2023 and was administered on 05-Jun-2023; No adverse event; a 67-year-old patient received an expired 1st Booster (4th dose) Bivalent Moderna COVID-19 vaccine 05-JUN-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a 67-year-old patient received an expired 1st Booster (4th dose) Bivalent Moderna COVID-19 vaccine 05-JUN-2023), PRODUCT STORAGE ERROR (The vaccine was expired on 01-Jun-2023 and was administered on 05-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (a 67-year-old patient received an expired 1st Booster (4th dose) Bivalent Moderna COVID-19 vaccine 05-JUN-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was expired on 01-Jun-2023 and was administered on 05-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a 67-year-old patient received an expired 1st Booster (4th dose) Bivalent Moderna COVID-19 vaccine 05-JUN-2023), PRODUCT STORAGE ERROR (The vaccine was expired on 01-Jun-2023 and was administered on 05-Jun-2023) 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 (a 67-year-old patient received an expired 1st Booster (4th dose) Bivalent Moderna COVID-19 vaccine 05-JUN-2023) and PRODUCT STORAGE ERROR (The vaccine was expired on 01-Jun-2023 and was administered on 05-Jun-2023).    No concomitant information was reported. The 2.5 ml vial was initially stored in the refrigerator on 01-JUN-2023 and was administered on 05-Jun-2023 and did not underwent temperature excursion. No treatment information was provided.
EXPIRED DOSES OF THE VACCINE WERE ADMINISTERED; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-SEP-2021, the patient experienced expired doses of the vaccine were administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired doses of the vaccine were administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211011801, 20211012209, 20211012114 and 20211012383. This report was associated with product quality complaint : 90000196306.
Patient had a syncopal episode. No fall. She was caught by MA and mother. Patient recovered within 15 seconds, her legs were elevated and the patient was monitored. She was released after 40 minutes of monitoring without symptoms.
High pitch screaming cry for the rest of the day any time he was awake, on and off sleeping, lack of appetite.  Low grade fever for the next 3 weeks.  Body rash started 3 days later and lasted for two months.
A week after being vaccinated with dose 1, I got a rash on the arm where I received the vaccine. It was itchy, hot to the touch, swollen, and covered a good area of my arm. I have been taking Benadryl and putting cortisone cream on it. Day 5 and the rash is still there but not as intense.
Information has been received from a health professional who was contacted by a school nurse, concerning a 7 year old male with no past medical history who on 09/10/2001 at 11am was vaccinated with the first dose of varicella vaccine in the right arm. There was no illness at the time of vaccination. On 09/17/2001 at 7:30am the pt developed a varicella like rash, along his legs and back which was described as a rash with approximately greater than or equal to 6-7 spots on the back and 2-3 spots on the back of his right leg behind the knee. It was also noted that he had 1-2 spots on the lateral aspect of his bilateral ankles. The areas were not clustered and there were singular raised scabbed centers. The pt had no appointment and was not seen by a physician. On 09/19/2001, the pt recovered. It was also reported that the pt's sister developed a varicella like rash following vaccination with varicella vaccine. Initial report indicated that three children developed the reaction; however, follow-up revealed that only these two children were affected. No further info is available.
have got constant heart attack for like 6 months; I proceed to have a heart attack all that time; swollen heart; my body was swollen, my veins; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 2021, outcome "unknown", described as "have got constant heart attack for like 6 months; I proceed to have a heart attack all that time"; SWELLING (non-serious) with onset 2021, outcome "unknown", described as "my body was swollen, my veins"; CARDIOMEGALY (non-serious) with onset 2021, outcome "unknown", described as "swollen heart". Clinical course: Concern: Consumer stated, Patient just called to let know what Pfizer did to patient to just vent, to make patient feel better. patient have got constant heart attack for like 6 months (Further clarification unknown, hence event captured as per verbatim) and in Apr2021. Patient got first shot and on May 6th patient got second shot (further clarification unknown, hence captured as unspecified shot), patient proceed to have a heart attack all that time. Patient didn't know so patient went to cardiologist in December, no October. It has some time of gap between the time patient saw last and this time, it took long time to find out that patient was a heart attack everything patients body was swollen, veins, heart (Further clarification unknown, hence event captured as per verbatim), somebody problems, patient though this was over and after coming out of it where have been feeling, it should have ended. Thank you Pfizer. Further probing could not be done as consumer abruptly hung up the call. Hence, product details (LOT#, NDC#, UPC# and expiration) were unknown and limited information available over the call. QR Comment: Reporter type could not be clarified over the call. Hence, captured as consumer or other non health care professional conservatively.  Follow-up attempts are completed. No further information is expected.
The patient describes having immediate pain with the vaccination. Within 24 hours she had pain at the injection site and limited ROM. She was seen by a doctor 11-26-13 and presented with swelling and tenderness over humerus, glenohumeral joint.
Immediately developed "metallic" taste in mouth erythema and swelling at injection site involving area at site to "shoulder" 10/16 -> 10/22 metallic taste persisted 10/16 -> 10/22.
the chills and little shaking, you know cause I know somebody that took the second shot and they have the same reaction; the chills and little shaking, you know cause I know somebody that took the second shot and they have the same reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious), TREMOR (non-serious), outcome "unknown" and all described as "the chills and little shaking, you know cause I know somebody that took the second shot and they have the same reaction".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Information has been received from a physician concerning a 3 and 1/2 year old pt who at 23 months of age was vaccinated with a dose of varicella virus vaccine live. The child was exposed to chicken pox at the day care center one week prior to the doctor's visit on 12/12/05. The physician noted that the pt did not appear ill and did not have a fever and reported that it appeared to be a very mild case. Additional information has been requested.
Vaccine was exposed to storage temperatures outside the recommended ranges. Patient presented pain on the area the vaccine was administered through her back.
Fever up to 103, headache, tiredness.  Slightly stiff neck day after (3) vaccines were administered.
redness developed from pubic area to below my neck/body turned red like a sun burn; I might have had a fever; This non-serious case was reported by a other health professional via call center representative and described the occurrence of localized erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced localized erythema (Verbatim: redness developed from pubic area to below my neck/body turned red like a sun burn) and fever (Verbatim: I might have had a fever). The outcome of the localized erythema was not reported and the outcome of the fever was unknown.   It was unknown if the reporter considered the localized erythema and fever to be related to Shingrix.     It was unknown if the company considered the localized erythema and fever to be related to Shingrix.   Additional Information: GSK Receipt date: 10-OCT-2023 The patient was healthcare profession who reported a day after receiving the Shingrix he/she developed redness from pubic area to belowneck. The patients body turned red like a sunburn. The patient front body part did not had bumps and was not itchy. The patient stated he/she might have had a fever similar reaction to other unspecified vaccine. The follow-up could not be possible as no contact details were available.