chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11yo patient received an adult dose; 11yo patient received an adult dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 11-year-old female patient who received HAV (Havrix 1440) (batch number km72c, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th May 2022, the patient received Havrix 1440 and Havrix Pre-Filled Syringe Device. On 16th May 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporters comment: 11-year-old patient received an adult dose of Havrix. The reporter consented to follow up. Additional supportive information: 11-year-old patient received an adult dose of Havrix, which led to overdose and adult product administered to child.
Ten hours later felt achey, then chills, and fever of 101-102 all night with SEVERE joint pain. I have a herniated disc in my lower back and this was severely aggravated by the vaccine. My back and fingers hurt so bad I couldn?t sleep at all. Tried not to take Tylenol finally took some after 3-4 hours and it helped a lot with fever and joint pain. Also had a headache. Fever and pain was gone after 8 hours. Then felt very low energy with a headache all the second day. Third day I felt great except are sore.
SHOOTING PAIN LIKE CHARLEY HORSES GOING DOWN BOTH LEGS; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 01-APR-2021, the subject experienced shooting pain like charley horses going down both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shooting pain like charley horses going down both legs on 02-APR-2021. This report was non-serious.; Sender's Comments: V0: MAC comment is not required for nonserious case as per standard protocol
fever, aches, head pain, elevated heartrate, fatigue for 24- 48 hrs, elevated hr still intermittent
No adverse event; bivalent was given in the 0.3 ml instead of the 0.5 ml to a patient today 28Dec2022; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (bivalent was given in the 0.3 ml instead of the 0.5 ml to a patient today 28Dec2022) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .3 milliliter. On 28-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ACCIDENTAL UNDERDOSE (bivalent was given in the 0.3 ml instead of the 0.5 ml to a patient today 28Dec2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (bivalent was given in the 0.3 ml instead of the 0.5 ml to a patient today 28Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 assessment was provided for ACCIDENTAL UNDERDOSE (bivalent was given in the 0.3 ml instead of the 0.5 ml to a patient today 28Dec2022).    No concomitant medications details were reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Moderna was not authorized to communicate with the patient's primary healthcare professional regarding this notification. The nurse stated their facility provides Moderna vaccines. The nurse declined to provide further patient information.  No treatment medications details were reported.
COVID-19 vaccine given after BUD date of 5/3/22.  Expiration date:  5/31/22.
Fever Started 8/17/2021 0000 headache and temp aching joints Friday experienced Chest Pain. SOA, Chest Tightness
Patient had inflammation and redness around the injection site and for up to 4 inches around the site. She also experienced a little pain as well.
A non-serious spontaneous report of administration to a 75-year-old was received from a health professional concerning a 75-year-old female. Neither relevant past medical history nor concomitant medications were reported for this patient. The patient was given FLUMIST on 26-Sep-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 28-Oct-2011 in which reporter stated that the patient did not experience any adverse events.
left upper arm/shoulder pain started at time of vaccine, waxed and waned over subsequent 11 months. Treated with NSAIDs and ice and activity modification without resolution.  Currently referred to orthopedics for management.
7/15/2023 - 7/18/2023 (3 days) emergency department for shortness of breath rocephin and zithromycin - completed Remdesivir 039B21A 4/21/2021 027C21A 5/24/2021
ON early am 2/6,severe body aches & weakness began and continued until later that morning.  then it continued  as mild weakness and light headedness.  These slowly disapated and finally disappeared.
Redness first noted 08/01/2002 pm. Awoke this am with increased redness, Denies tenderness. Area of redness- 3 cm X 3 cm noted @ left deltoid, Borders marked with ink pen. Mom to seek MD evaluation if redness spreads.
RA; This is a spontaneous report from a contactable Other HCP (patient). A 71-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL 9261) via an unspecified route of administration, administered in Arm Left on 11Feb2021 10:00 (at 71-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Hypertension (HTN), hyperlipidaemia, seasonal allergies. No Covid prior vaccination. Concomitant medications included enalapril; atorvastatin calcium (LIPITOR); and amlodipine. No other vaccine in four weeks. The patient previously received the first single dose of bnt162b2 on 14Jan2021 10:00 AM (Lot No: EL 3246) at Left arm for covid-19 immunisation. The patient reported that she had no reaction to either shot. However 3 weeks post 2nd shot she developed a severe inflammatory condition, mainly left sided which was diagnosed as RA. Prior to vaccination, she had never had even an achy joint. Adverse event start date reported as Mar2021. AE resulted in: [Doctor or other healthcare professional office/clinic visit]. The outcome of the event was not recovered. Treatment received for the event included Plaquenil, prednisone, methotrexate.; Sender's Comments: As there is limited information in the case provided, the causal association between the event rheumatoid arthritis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Rabavert received on 06Apr2021 and 13Apr2021, Imovax received on 11-May-2021; Case reference number US-BN-2021-001691, spontaneous case report initially received on 12-May-2021 from a physician via regulatory authority (reference number: USBAV21-0211) and concerns a 10-month-old male patient.  The patient's medical history and concomitant medication were not reported.  On 06-Apr-2021, the patient was vaccinated with the first dose of RabaVert (Inactivated Rabies Virus Vaccine; batch number: not provided) *at a dose reported as a full dose*, administered intramuscularly, for a bat exposure as indication.  On 13-Apr-2021, the patient received the second dose of RabaVert (Inactivated Rabies Virus Vaccine; batch number: not provided) *at a dose reported as a full dose*, administered intramuscularly, for a bat exposure as indication.   On 11-May-2021, on day 35, the patient was vaccinated with Imovax (rabies vaccine; batch number: not reported) at a dose reported as a full dose, via unknown route of administration, for an unknown indication (explicitly coded as 'Inappropriate schedule of vaccine administered').   At the time of initial reporting, it was not known whether the patient experienced any adverse event.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).   Follow up information was received from a physician on 28-Jun-2021: New information included one additional reporter and a confirmation that the patient was vaccinated with a full dose, rather than half a dose as previously reported (''underdose'' removed as an event).; Reporter's Comments: Inappropriate schedule of product administration for RabAvert is listed by convention. Reportedly, 10-months old patient received first and second dose of RabAvert at full dose. On day 35 the patient was vaccinated with Imovax and that is considered inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered are not related to the suspect product but to a human action. The case is considered as non-serious.; Sender's Comments: Inappropriate schedule of product administration for RabAvert is listed by convention. Reportedly, 10-months old patient received first and second dose of RabAvert at full dose. On day 35 the patient was vaccinated with Imovax and that is considered inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered are not related to the suspect product but to a human action. The case is considered as non-serious.
Blood was coming through; Slight bee stings all over and thigh; Scabs on me; my eyelids have been a little itchy too; that was the only way that I am able to get some sleep; was miserable; consumer was in pain; hives; the same day I started to itch, it was mild across my breast and my stomach but my thighs and my bottom legs were turning red, swelling; but my thighs and my bottom legs were turning red/Thighs/Legs turned red; but my thighs and my bottom legs were turning red, swelling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 71-year-old, via an unspecified route of administration on 10Apr2021 13:30 (Lot Number: EN6207) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included apixaban (ELIQUIS), tamsulosin, and iron. The patient got her first injection on Saturday, 10Apr2021 at 1:30 pm in the afternoon around 7 o'clock the same day she started to itch, it was mild across her breast and stomach but her thighs and bottom legs were turning red, swelling, hives there too, and she rubbed alcohol (treatment) on this to stop the itch, that seems to helped a little bit, but the swelling was not that bad today but the redness was still there. She has scabs on her, blood was coming through, and slight bee stings all over and thigh on an unspecified date, she used hydrocortisone cream (treatment), she was lucky she have some of that here because she keep that when going or here but she rubbed that on last night and that was the only way that she was able to get some sleep. The patient doesn't think that she was going to get the second shot, she doesn't want to experience that again. It feels like that today it was not that bad itching today but at 71 that was miserable yesterday so probably she would not get the second shot. She hopes that the first one can protect her to a point, but she cannot subject herself to that again, that would be senseless for her to experience that again and get a second shot. The patient also stated that her eyelids have been a little itchy too so hopefully you all understand it was 71 years old was suffering from that kind of misery second time. The patient was unable to probe the more question, patient was in pain and not willing to proceed. The outcome of the events was unknown.
hypertension, increased temp, increased HR, c/o dizziness, disoriented, fatigue, metalic taste.  8 days later pt developed 1.5 inch nodule with 5 inch diameter rash to site lasting for 4 days.
Approx. 2 days following vaccination, pt. experienced minor systemic fatigue and muscle ache. At day 3, pt. developed a cough with continued fatigue. At day 4, pt. developed a worsening cough with yellowish, thick sputum, 100.7 fever and urinary hesitancy. On days 4-6, productive cough persisted with fever ranging 100.7-101.4. By day 7, pt. reported improving condition and temperature within normal limits.
awoke on 21OCT97 noticed a rash all over body had c/o flu like sx on 20OCT97 evening recovered in 1 day;
About 20 minutes after the shot the left side of my face felt tingly and number.  It sort of felt like I had dental work done and the Novocain was wearing off.  It lasted about 2-3 days.   I could still smile and function fine.
dose 1 of Shingrix Dec 25th 2019 / because of Covid situation patient did not come back for dose 2; This case was reported by a pharmacist and described the occurrence of social problem in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shngrix on 25th December 2019, batch no T44C7 and expiry date 25 February 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. All patient identifiers were reported as well as batch number and expiration date. The reporter informed patient had received dose of Shingrix and because of Covid situation patient did not come back for dose 2. No further details provided. The reporter consented to follow up.
chills for approximately 12 hours, thru the night;  back muscular pain for same amount of time. weak.
On Saturday 10/25/14 she had a flu mist vaccine and developed a cough that night.  Mom started giving albuterol twice a day for the cough on Sunday 10/26/14, which is per her asthma action plan with the PCP.  She was doing well, going to school, and went to a pumpkin patch on 10/29/14.  On Thursday 10/30/14 she woke up with "blood shot eyes," swollen face and lips, sores inside her mouth, and a rash on her chest that looked like "pin prick red marks."  On Friday 10/31/14 she only took in 8 oz of water and 2 popsicles, voided 3 times.  Mom gave Tylenol about 6 pm then took her to the ED. She was transferred to the PICU for further care. She was given Benadryl, Tylenol, and Zofran for supportive therapy, remains on IVFs because of mouth pain and poor PO, and Burn surgery, Ophthalmology, and Dermatology were consulted. She was placed on 1L O2 for sats in the upper 80s. She eventually was able to breath without oxygen support and was transferred to the main floor for continued management of her skin lesions with Meplex, Triamcinolone, Atarax.  Her pain continues to be managed with PCA IV push and IV Tylenol.
Patient's parent reported that patient was experiencing itching sensation around the injection site. With parent's consent, staff administered 5mL Benadryl. Patient reported no further issues and left with parent shortly thereafter.
12/7/02 office visit about 11am and immunizations given. 12/8/02 to ER about 10:30pm fussy, cranky, not eating, and doesn't seem himself. Admitted to hospital. 12/9/02 child had seizure, neurologist consulted, and saw child. Child was transferred to another hospital. 12/10/02 neurologist assumed primary care of child while at the hospital. 12/18/02 continues to be hospitalized.  Reported on 03/31/2003: "The patient is a two month old white male transferred to ER after episodes at home of flailing his arms back.  Patient's eyes were open and dilated.  The patient had no apnea or loss of consciousness.  He had a foul-smelling stool at the time.  The patient had a fever and was diaphoretic with the episode.  These episodes happened every two hours while at the ER.  The patient received an EEG which showed seizure activity according to history.  The patient's feeding had decreased as wwell as his urinary output.  While in the ER, the patient was given Valium, Ativan and phenobarbital.  He had a postietal temperature of 100.8 rectally.  Of note, the patient received his two month immunizations on the morning of 12/07/2002.  Past Medical History: Thirty-seven and a half week gestation, 7 pound 12 ounce, spontaneous vaginal delivery, no complications.  No past surgical history.  Newborn screen was negative.  Medications: Mylicon.  NKDA. Immunizations: Up to date.  Family History: Non contributory.  Social History: The patient lives with mom and dad.  There is smoking in the house.  Developmentally considered to be normal.  Physical Examination: Temperature: 37.4; Heart rate: 169; Respiratory rate: 27; Blood pressure: 110/71; O2 saluration: 100% on room air; mass 5.6kg, lenth 61cm, head circumference: 38cm.  Physical examination was significant for erythema on the patient's back, milia on the forehead and proximal right corneal abrasion, otherwise exam was negative.
Pt states 2-3 days post vacc., noticed swelling at inject site and very painful.  Area continues to swell with pain extending to r/shoulder.  C/O nausea past 24 hours.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Lamb" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: 31May2022, stop date: 20Jun2022; VITAMIN D NOS, start date: 31May2022, stop date: 20Jun2022; VITAMIN B [VITAMIN B COMPLEX], start date: 31May2022, stop date: 20Jun2022; ACIDOPHILUS, start date: 31May2022, stop date: 20Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Horrible metallic taste in mouth noted 24/7.Rebound COVID a week after finishing Paxlovid reported. Tested positive and having all the symptoms come back (slight fever, tearing eyes, sinuses clogged, runny nose, sore throat & cough. Symptoms started on 18Jun2022 at 07:00 PM, outcome reported not recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
6/3/21: started having left eye watering with the inability to close the eyelid 6/6/21: received 2nd covid vaccine 6/8/21: Developed inability to close his mouth and to smile which has persisted 6/10/21: Seen in clinic and diagnosed with left Bells Palsy and prescribed prednisone
Increase in Afib; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (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: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Increase in Afib". The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event atrial fibrillation with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
When she got home from appt, @ 4:30 pm, had a slight headache, laid down took a nap.  Mom woke her at 5:30 for dinner, had headache, pain in jaw and chills, no fever.  Gave 600 mg ibuprofen, had an orange soda, and a gatorade, went to bed.  Woke this morning with no issues.  Took Covid home test, negative
body aches; This spontaneous report has been received from a physician referring to a male patient. The patient's age was reported as 60 (units unknown). The patient's concurrent conditions included diabetes, hypertension and hypercholesterolemia. No known drug allergies. The information of concomitant medication was unknown.    On 10-DEC-2013, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 milliliter, route was reported as injected, once, strength, lot number and expiration date were unknown) for vaccination.         On an unknown date in 2013, following the administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient experienced body aches. Information about treatment given for the event, lab diagnostics/studies and medical attention was unknown. The outcome of body aches was reported as recovered. The causality between this event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported by the reporter.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history and drug reactions were not reported. The healthcare worker reported that the patient received a dose of GARDASIL in 2009 (reported as 5 years ago) and also on 21-MAR-2014. No known adverse effects. Additional information has been requested.
Left thigh large area redness/heat denies itching mildly painful area raised warm area breadth of thigh with central clearing around vaccine site.  Benadryl & ice prn.