chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 16-year old male patient, who had no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccination with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 20-JAN-2014 at 10:10 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The parents were going to consult with physician and declined to repeat vaccination. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Covid arm. Rash appeared 2 weeks after 1st vaccination shot on the arm around the injection site. Rash about 3-4 inches, only slightly itchy intermittently, disappeared after 4 days.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 30-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 720 hours, the lowest recorded temperature was 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Lump in arm; redness is the size of half dollar; a little itchy; Like a shooting pain up until her head; experiencing pain from the bottom of skull to the top of her head; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump in arm), ERYTHEMA (redness is the size of half dollar), PRURITUS (a little itchy), PAIN (Like a shooting pain up until her head) and HEADACHE (experiencing pain from the bottom of skull to the top of her head) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included RAMIPRIL, AMLODIPINE, EZETIMIBE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE MASS (Lump in arm), ERYTHEMA (redness is the size of half dollar), PRURITUS (a little itchy), PAIN (Like a shooting pain up until her head) and HEADACHE (experiencing pain from the bottom of skull to the top of her head). At the time of the report, VACCINATION SITE MASS (Lump in arm), ERYTHEMA (redness is the size of half dollar), PRURITUS (a little itchy), PAIN (Like a shooting pain up until her head) and HEADACHE (experiencing pain from the bottom of skull to the top of her head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
During vaccination, the needle went in and the patient moved away/needle came out, small teardrop amount of the vaccine had dripped from arm, no AE; During vaccination, the needle went in and the patient moved away/needle came out, small teardrop amount of the vaccine had dripped from arm, no AE; Initial information received on 31-Jul-2020 regarding an unsolicited valid non-serious case from a Nurse.  This case involves a 4 year old male patient who was administered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and the needle went in, the patient moved away and the needle came out, it was noted a small teardrop amount of the vaccine had dripped from his arm (Underdose and Exposure via skin contact).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.    Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination.  On 30-Jul-2020, the patient received a fifth Booster dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5688AA, expiry 26-Nov-2021) once via unknown route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to vaccine underdose and Exposure via skin contact  At the time of report, no adverse event was 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
Patient received PPV-23 8/2/12 (L) deltoid and called Today with c/o (L) arm swelling, redness and pain feeling nauseated. -On exam, Redness, warmth, swelling from axilla to elbow inner aspect (L) arm. Prescribed VICODIN.
Patient received first dose of COVID Moderna vaccine on 1/7/21 On 1/21/21 she noted redness to the injection site.  On 1/22/21 the redness spread to the entire upper arm and was warm to touch
Patient has a history of anyphylaxis reaction to bees. Patient started with small rash on left hand two spots. Wanted to go to the ER due to history. RN took her. No shortness of breathe at that time, no swelling, itching, dizziness, or weakness, patient denied rapid heart rate.
Hard knot, redness, swelling, warm to the touch, pain, itch (all at/around injection site).
From initial information received on 3/9/05 from a licensed practical nurse regarding an adverse event occurring in the USA, it was reported that a six month old female received her third dose of DAPTACEL, lot number C1625AA, administered on 3/18/04. The route and site of administration were not reported. 315 days later, at 15 months of age, the patient was diagnosed with no IgG and pertussis. Previous Daptacel vaccination dates reported included 11/5/03 and 12/20/03 with no reactions reported. The patient also has a 13 year old brother, who was diagnosed with pertussis on 1/4/05. It was not reported whether the patient recovered from this event. The reporter of this case is the same reporter as case 200500532. (OMIC)
28 patient received expired vaccine; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer on 24-Mar-2021 and Pfizer on 14-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
11/12/15 - Well visit, received Tdap and flu vaccines. Dr 11/14/15 started feeling pain behind right ear. Pain increased over the next 2 days. Went to urgent care and was diagnosed with Bells Palsy. A CT scan was ordered on 11/17/15 and completed on 11/18/15. Primary doctor continued Bells Palsy diagnosis.
local reaction (redness, soreness, itching) @ site, treated with ice, Acetaminophen, monitoring. no systemic signs of allergic reaction
Receive dose #1 of Moderna  Covid 19 vaccine on 2/3/21, experienced sore left arm, arm pit and breast.  6 days after shot pt started severe vomiting (q hr x 18 hrs).  Contacted MD  and was rx Phenergan which helped a little with the vomiting.  When vomiting subsided her body was sore, she was dizzy disoriented.  Left arm became sore again with an increasing red spot.      S/S reported to nurse hotline 9 days after vaccine.  Advised to take pain meds PRN, increase fluids, rest, cold packs on arm.  Advised of emergency protocol.      Called back the next day, pt feeling better, arm soreness, redness and swelling decreases.  Advised to discuss with MD if pt should get 2nd Dose of vaccine.
This spontaneous report as received from a physician refers to multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, lot # K021483, expiration date: 05-NOV-2016, (dose, route of administration and injection site were not reported). NO adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Left deltoid with 2-4 cm bruising. C/o pain and tenderness at site. Impression: minor injection site reaction. Symptoms resolved as of 11/14/03.
The patient reported that following the vaccine she felt nauseous throughout the night.  She got up and felt nauseous and reported shortly after that she passed out for approximately 10 seconds.
Rash developed in same area; Back of thighs felt like pins & needles; This is a spontaneous report received from a contactable consumer, the patient. A 64-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 14Mar2021 at 13:15 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Medical history included anaphylaxis reaction to food in 2015. Concomitant medications taken within 2 weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN). The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 15Mar2021 (Monday) at 21:00, the patient experienced back of thighs felt like pins & needles. On 16Mar2021 (Tuesday) rash developed in the same area. No therapeutic measures were taken for the events. The outcome of the back of thighs felt like pins & needles and rash developed in same area was not resolved. No follow-up attempts are possible. No further information is expected.
3 people died; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter reported for three patients.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: DEATH (death, medically significant), outcome "fatal", described as "3 people died". The patient date of death was unknown. The reported cause of death was "Unknown cause of death". It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200073487 Same reporter/drug/AE, different patient;US-PFIZER INC-202200073488 Same reporter/drug/AE, different patient; Reported Cause(s) of Death: Unknown cause of death
2 days after shot, fatigued, minor muscle ache, dizziness, blurry weak vision. Some nausea in a.m., then today, 7 a.m. nausea and weakness, chilly and extreme fatigue, in bed all day so far.  Feeling like not enough air all week since shot.
Tenderness; headache; tired; bad shivering for about 1 ½ hours. (AE: Shivering); rash / tender in touch / no itching / 5 inches away from injection site/rash on arm/Vesicular rash/it feels like shingles; it tingles; feeling ill; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th October 2020, the patient received the 2nd dose of Shingrix. On 5th October 2020, 8 hrs after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced shivering. On 6th October 2020, the patient experienced headache and tiredness. In October 2020, the patient experienced vesicular rash, tingling and feeling unwell. On an unknown date, the patient experienced tenderness. On an unknown date, the outcome of the vesicular rash, tingling and tenderness were unknown and the outcome of the shivering was recovered/resolved and the outcome of the headache, tiredness and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash, shivering, headache, tiredness, tingling, tenderness and feeling unwell to be related to Shingrix.  Additional details were reported as follows: The reporter is the patient herself. The patient 2nd dose of shingrix and experienced bad shivering for about 1 and half hour, headache, tired, rash almost like shingles, does not looked like shingles, but feels it, because it tingles. The patient described rash as tender in touch with no itching. The reporter mentioned that, rash was not at injection site, but was in same arm, 5 inches away from injection site and felt still ill at the day of reporting. The patient also experienced aches, was tired and flu like symptoms which lasted for 36 hours after receiving 1st dose of shingrix 2 months ago. Lot and expiration date were not provided. The reporter did not consent to follow up. For tolerance of 1st dose, refer case US2020201539.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020201539:same reporter
COVID 19 Treatment; COVID 19 Treatment; Rebound - Tested positive after several days testing negative; interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EN200), in right arm and on 21Mar2021 as dose 2, single (Lot number: EN6206) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Nov2021 at 17:00 as dose 3 (booster), single (Lot number: 071F), in right arm and on 02May2022 at 15:00 as dose 4 (booster), single (Lot number: 027L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Clear cell carcinoma, right kidney (removed 11Jul2022)" (unspecified if ongoing); "Obese (204#, 5'8")" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Clear cell carcinoma, right kidney (removed 11Jul2022)", start date: 11Jul2022, stop date: 11Jul2022. No known allergies. There were no concomitant medications in 2 weeks.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 03Nov2021 at 17:00, outcome "unknown"; DISEASE RECURRENCE (medically significant) with onset 12Jun2022 at 17:00, outcome "recovered" (17Jun2022), described as "Rebound - Tested positive after several days testing negative"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient received paxlovid from 30May2022 to 03Jun2022 as treatment of COVID-19. On 12Jun2022 17:00, the patient experienced rebound - tested positive after several days testing negative. Therapeutic measures were not taken as a result of disease recurrence.
Fever 101, muscle aches, hip pain, high pulse 168 at rest, restless legs, severe headache, redness/ rash to chest.
pt exp elevated fever during evening p/immun Tempra given; by 2Am or 3AM 15OCT92 fever 104 by head tape; taken to ER rx'd oral fluids & APAP; fever came down to 99 (ear), shaking during fever but no sz;
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 years old male patient was vaccinated with lot # (671994/1537AA) dose 3 GARDASIL on 24-MAY-2012. On the same day, the patient complained of numbness in left leg after the shot given in left arm. The outcome of the event was unknown. The patient did not seek medical attention. The event was considered to be non serious. Additional information is not expected.
Redness at injection site (L) thigh, hot, tender, approx 3" in diameter with fever.
Weakness; Dizziness; Ache; Fever; Chills; Nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizziness), PAIN (Ache), PYREXIA (Fever) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in June 2020.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizziness), PAIN (Ache), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, ASTHENIA (Weakness), DIZZINESS (Dizziness), PAIN (Ache), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: TCR attached. NNI.
CANNOT REMEMBER THING LATELY/WORRIED ABOUT FORGETTING ADDRESS/HEAD NOT DOING WELL/PROBLEMS WITH MEMORY/IT HAD BEEN BOTHERING FOR A LONG TIME AND SHE HAD NOT BEEN THE SAME; This spontaneous report received from a patient concerned an 84 year old female. The patient's weight was 140 pounds, and height was 64 inches. The patient's concurrent conditions included: blood pressure, sugar, sulfa allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 84 years old. Concomitant medications included acetylsalicylic acid, and metformin. On 2022, the patient experienced cannot remember thing lately/worried about forgetting address/head not doing well/problems with memory/it had been bothering for a long time and she had not been the same. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cannot remember thing lately/worried about forgetting address/head not doing well/problems with memory/it had been bothering for a long time and she had not been the same. This report was non-serious.
UrticariaPruritus mild face, neck itching, felt tightness in throat Narrative:  Employee was given IM epi L leg, benadryl 50mg R arm
This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 46-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCNE, solution for injection, Batch/Lot Number: EL9266), via intramuscular route of administration on 11Feb2021 09:30 as single dose, for covid-19 immunization. (Vaccination facility: Hospital). (Vaccine administered at military facility: No). Patient medical history was reported as none. Family Medical history was that her father died heart attack(58years), mother high blood pressure, glaucoma, (Mother side) Grandmother (Heart Attack, died 72), (Father side) Grand Mother (Heart Attack, Diabetes). 75 died, (Father side) Grand Father, Heart Attack (78 died). The patient concomitant medications were not reported. patient did not receive any other vaccine within 4 weeks. Patient also received second dose of bnt162b2: Lot no. EN6202, Route of administration: intramuscular received on 03Mar2021. On unspecified date the patient experienced swollen and pain in joints. The outcome for the events swollen and pain in joints was reported as unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a registered nurse refers to a current 47 year old female patient without drug reactions or allergies. On an unknown date the patient was vaccinated with M-M-R II (lot number, dose, route and injection site were not reported) when the patient was young and again when she was 19 years old (approximately in 1985). On unknown date the patient had never developed immunity and also experienced a bad reaction and got really sick. The nurse did not know when the patient experienced this bad reaction and got really sick. The outcome of adverse event was unknown. Additional information has been requested.
Patient is fully vaccinated. Chief complaint is fatigue. 91-year-old male presented to the ER with positive outpatient Covid 19 test. Patient is asymptomatic, but he was tested because his wife and daughter were exposed Covid 19 and tested positive. He denies any decreased appetite, shortness of breath, chest pain, nausea, vomiting, fever. Patient has no complaints at this time. Patient was sent to the emergency room by his daughter because of the Covid 19 test. Patient was vaccinated with the Johnson & Johnson Covid 19 vaccine.He currently has no complaints, he is not hypoxic and has no other abnormal vital signs on physical exam.Return precautions for SOB, CP. Discharged