chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious courtesy case received from Merck Research Laboratories via Non-Healthcare Professional or consumer. This case involves a 71 years old female patient who experienced severe hair loss, hair continues to come out when she combs it or wipes it, while she received vaccines FLUZONE HIGH DOSE and PNEUMOVAX 23. The patient's past medical history included Drug hypersensitivity (allergy to Sulfa drugs). Also no medical history of hair and no concomitant medication was administered. On 11-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and PNEUMOVAX 23 (lot number, Exp. Date, route and administration site not reported for both vaccines). On an unknown date, the patient developed non-serious severe hair loss, hair continues to come out when she combs it or wipes it few days to a week following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and PNEUMOVAX 23. No lab studies/ diagnosis performed. Final diagnosis was severe hair loss hair continues to come out when she combs it or wipes it. The patient did not receive any corrective treatment. The event outcome was not recovered. List of documents held by sender: none.
patient missed his dose at 4-6 years/no AE; Initial information was received on 26-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a male patient of 4-6 years who missed his dose (product dose omission issue) of IPV (VERO) [IPOL] (batch number and expiry date not reported) on an unknown date for prophylactic vaccination. They were trying to get him caught up for school.  At the time of report, patient was 17-year old and he was new to that practice and wanted to know if he can have a booster.   The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   It was a case of actual medication error due to missed dose.  At the time of report, no adverse event reported.  Result of assessment was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Breakthrough case admission after 5 vaccines Moderna 1/29/21 Lot# 004M20A;  Moderna 2/26/21 Lot# 002A21A;  Moderna 10/26/21 Lot# 006D21A;  Moderna 5/12/22 Lot# 004M21A;  Moderna 11/3/22 Lot# 060F22a
Patient became unresponsive for prolonged time over 3 plus minutes. Patient came back around but she was unable to feel strong enough to stand.
they said it was a site reaction and they were just going to monitor her for cellulitis; Her arm was hot, red and swollen and she did go to the doctor, they said it was a site reaction; Her arm was hot, red and swollen and she did go to the doctor, they said it was a site reaction; Her arm was hot, red and swollen and she did go to the doctor, they said it was a site reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation; for immunisation; bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 2023, outcome "recovering" and all described as "Her arm was hot, red and swollen and she did go to the doctor, they said it was a site reaction"; VACCINATION SITE CELLULITIS (non-serious) with onset 2023, outcome "recovering", described as "they said it was a site reaction and they were just going to monitor her for cellulitis". The events "they said it was a site reaction and they were just going to monitor her for cellulitis" and "her arm was hot, red and swollen and she did go to the doctor, they said it was a site reaction" required physician office visit. Therapeutic measures were not taken as a result of vaccination site cellulitis, vaccination site swelling, vaccination site erythema, vaccination site warmth.  Additional information: The patient had the Pfizer COVID Vaccine about 2 weeks before 02Nov2023 and about a week before 02Nov2023, received a Prevnar 20 at the same arm and had a reaction. Her arm was hot, red and swollen and she did go to the doctor, they said it was a site reaction and they were just going to monitor her for cellulitis.   Causality for "they said it was a site reaction and they were just going to monitor her for cellulitis" and "her arm was hot, red and swollen and she did go to the doctor, they said it was a site reaction" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein) (malfunction).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein) , bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Pt recvd 3 doses of Hep B vax 3rd dose on 2MAY92, & on 20MAY91 sx recurred but were worse than w/the prev 2 doses; tx in ER w/Steroids, Seldane, Hismanal, Atarax, Axid; later seen by allergist;
Patient developed a red itchy rash about the size of a golf ball. For the 1st 2 days it was swollen and hard and warm to the touch.  On the third day the swelling has flattened and widened a bit, no longer warm
Pt developed fever 103.1, severe headache, body aches, numbness in fingers and toes, visual disturbances.
This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 91-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date unknown). On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injected limb mobility decreased was unchanged. The reporter considered the injected limb mobility decrease to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to a doctor. The patient experienced lack of arm mobility in the vaccinated arm. The reporter was unable to provide additional details and stated that he filed a VAERS report regarding this information.
Pt fainted immediately after giving the GARDASIL vaccine, she mildly jerked 3 times with eyes wide open, incident lasted about 5 seconds.
Numb finger tips on left hand.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Aug2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Sep2021 at 14:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 16Sep2021 at 14:00, the patient experienced numb finger tips on left hand. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event numb finger tips on left hand was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
4:00 phone call mom-states pt had hives on both arms & back;flu vax given 1yr ago;
Swelling glands in my neck more pronounced in my left side; Itchy; Hives around the upper body (shoulders, back, neck); Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchy), URTICARIA (Hives around the upper body (shoulders, back, neck)) and LYMPHADENOPATHY (Swelling glands in my neck more pronounced in my left side) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (45 allergens) and Seafood allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, METHIMAZOLE for Asthma, OMEPRAZOLE for GERD, TRAZODONE for Insomnia, GABAPENTIN and ALPRAZOLAM (XANAX) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 28-Feb-2021, the patient experienced PRURITUS (Itchy) and URTICARIA (Hives around the upper body (shoulders, back, neck)). On 03-Mar-2021, the patient experienced LYMPHADENOPATHY (Swelling glands in my neck more pronounced in my left side). On 28-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 05-Mar-2021, LYMPHADENOPATHY (Swelling glands in my neck more pronounced in my left side) had resolved. On 10-Mar-2021, PRURITUS (Itchy) and URTICARIA (Hives around the upper body (shoulders, back, neck)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information included asthma inhaler. Gabapentin was indicated to used as Mood Stabilizer. Treatment Medication includes: Counter allergy meds (Zyrtek).   This case was linked to MOD-2021-105816 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI from Email Follow up. On 05-May-2021: Follow up received: Added Event outcome, Concomitant Medication along with Indications, Medical History.
pt devel initial crying w/shots, greater than 6hr w/high fever 104;taken to ER sent home brought back to ER by paramedics for three episodes of either apnea or sz;adm to hosp for 3 days;discharged 9JAN98;dx adverse rxn to pertussis in vax;
I developed ITP and was hospitalized June 2-4 to stabilize my platelet numbers after hemorrhaging on my period for the second month in a row.
no additional adverse events; improperly stored dose of VAQTA was administered to a patient; This spontaneous report was received from a medical assistant referring to a specific patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-MAY-2021, the patient was vaccinated with an improperly stored dose of  hepatitis a vaccine, inactivated (VAQTA), pre-filled syringe, lot # T008697, expiring on 04-JUN-2021, 0.5 milliliter, for prophylaxis (route and site of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 46.9F for 84 hours and 30 minutes. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008697; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA001537:
PATIENT SAID ABOUT 1.5 - 2 HOURS AFTER INJECTION SHE HAD MUSCLE WEEKNESS.  LATER ON THAT NIGHT SHE HAD REDUCED RANGE OF MOTION AND DIFFICULTY MOVING HER ARM AS WELL AS PAIN, PAIN IN HER BACK AS WELL.  SHE SAID SHE COULD NOT MOVE HER ARM BECAUSE OF THE PAIN AND WEEKNESS.   TODAY SHE SAID SHE IS STILLHAVING RANGE OF MOTION ISSUES, BUT THE PAIN HAS SUBSIDED.
55 year old patient was treated with Fluzone HD, with no adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 55 years old female patient who was treated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 31-Oct-2022, the 55 year old patient received 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ927AC and expiry 30-06-23) (product administered to patient of inappropriate age, latency same day) (formulation and strength: unknown) via intramuscular route in the left arm for Immunization.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
9:44 AM vaccine  9:48 AM Fingers begin curling backwards, noticed slight twitching in butt cheeks, throat felt hot and tight, felt like someone had a hand around my throat, felt chills, began sweating, legs, arms, jaw began spasming violently, tachycardia reaching 163, unable to walk due to severe spasms, symptoms continued and worsened  10:30 Needed to be transported to the emergency room  Could not walk needed to be lifted into a wheelchair, lifted into a vehicle, lifted out of the vehicle and transported into emergency room with symptoms worsening and the beginning of a severe headache  11:50 in emergency room symptoms continued
Within 1/2 hour, patient developed wheezing and urticaria to face/neck/abd. Epinephrine 0.15 ml given subcutaneous at 25 min after vaccine and helped with symptoms. Clarinex 2.5 ml given to. Mom said patient did have similar reaction to her 5yo shots.
This spontaneous report was received from a Certified Medical Assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 08-JAN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot number M006102, expiration date 01-AUG-2017, (dose, route and anatomical location were not reported), for prophylaxis. The temperature was greater than -10 Celsius degrees but less than 8 Celsius degrees for a time frame of 40 hours. The vaccines did not experienced any previous temperature excursion, and, digital data logger was not involved. The outcome was reported as "Supported". No adverse effects were reported. No product quality complain was involved. No other suspect or concomitant therapies were reported. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005613:
I know four people who had a stroke; This is a spontaneous report from a contactable consumer. Case is for number three of four patient who had a stroke. A patient of an unspecified age and gender received unspecified dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), unspecified dose via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The caller reported that, caller know four people who had a stroke post vaccination. The outcome of the event was unknown.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
9/26/03 Mother concerned, advised to come by. Left upper arm reddened area 2" induration. Fever 103 9/26/03. Recommended ice, pain meds, watch. 9/29/03 - Mom states swelling down, some redness, doing better.
Stiffness of joints in hand. Mainly in right hand in middle and pointer finger. Hard to close hand.
Information has been received from a health professional concerning a 9 year old 75 lb. male with no known allergies and no pertinent medical history, who on 16-MAY-2007 was vaccinated with a second 0.5 mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) (lot number: 657195/0366U). There was no concomitant medication. There was no reported illness at the time of vaccination, and no adverse events following prior vaccination. On 27-FEB-2008, (also reported as 26-FEB-2008), the patient developed pruritus and varicella of 15 to 20 blisters. No other symptoms were noted. There was no laboratory or diagnostic studies performed. On an unspecified date, the patient had recovered. His vaccination history included on 10-MAY-1999, a first dose of varicella virus vaccine live (Oka/Merck) 9lot# 630027/0312). Follow-up information indicated no new information. This is one of two reports from the same source. No additional information has been requested.
I had " severe " allergic reaction to second dose of Shingrix; This case was reported by a consumer via (Shingrix Facebook) interactive digital media and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The reporter had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient had severe allergic reaction. The patient was trying to figure out if there might be a common ingredient with any of the three covid vaccines to avoid another similar reaction. The reporter wanted to know what it was folks might be reacting to Shingrix vaccine.
Received his first dose of the Moderna vaccine Jan2021 and the second dose on 27May2021,; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his first dose of the Moderna vaccine Jan2021 and the second dose on 27May2021,) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his first dose of the Moderna vaccine Jan2021 and the second dose on 27May2021,). On 27-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his first dose of the Moderna vaccine Jan2021 and the second dose on 27May2021,) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-149035 (Patient Link).
Patient woke up from bed 4 hours after receiving the vaccine complaining of discomfort all over her body. Hives covered roughly half her body (thighs, trunk, arms). Parent administered 5mL Benadryl and 7.5mL Motrin and placed cold compresses on the hives. Hives changed in pattern over the course of the next hour, moving to the lower legs/feet, hands/palms, and face. About 6.5 hours after vaccination, child's lips and tongue became swollen and EMS was called. Paramedics administered epinephrine injection and solu-medrol injection in ambulance. A second epinephrine injection was given at the hospital, along with Zofran, Pepcid, and a sodium chloride IV. Hives fully subsided after second epinephrine, but lip swelling lasted about 12 hours since symptom onset. Child was prescribed an Epi-Pen and advised to follow up with an allergist.
Initially (11/15/21) lymph nodes under left arm swelled for a few days.  On 11/19/21began experiencing what felt like ear issues that led to full onset of Bells Palsy (11/24/21).
This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for 5 patients. This is 1st of five reports. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced high fever on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016581035 as same reporter/drug/event, different patient. US-PFIZER INC-2016580774 as same reporter/drug/event, different patient. US-PFIZER INC-2016580585 as same reporter/drug/event, different patient. US-PFIZER INC-2016580625 as same reporter/drug/event, different patient.
Information has been received from a physician concerning an approximately 6 month old female who on 14-SEP-2007 and 19-NOV-2007 was vaccinated PO with her first and second doses of Rotateq (no lot number provided).  Concomitant vaccinations administered on 19-NOV-2007 included a dose of PEDIARIX, a dose of Hib conj vaccine (OMPC) (MSD) and a dose of PREVNAR.  On 17-OCT-2007 the patient experienced diarrhea and was treated.  In November 2007, after the second dose of Rotateq the patient experienced "gastroenteritis."  The patient was seen for a follow-up visit in the office on 05-DEC-2007.  On 02-JAN-2008 the patient returned to the physician's office for a lab test that revealed negative results for "rotavirus."  The outcome was unknown.  The physician also reported that the patient was due for a follow-up visit on 19-JAN-2008.  There was no product quality complaint.  Additional information has been requested.