chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 year old received Kinrix; Kinrix as 2nd dose of DTaP and IPV; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   Previously administered products included Pediarix (1st dose received on an unknown date).   On 29-MAR-2023, the patient received Kinrix. On 29-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 3 year old received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Kinrix as 2nd dose of DTaP and IPV). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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: 17-APR-2023 The nurse reported that a patient received a dose of Kinrix. The reporter clarified regarding the Kinrix that was administered was the patient's 2nd dose of DTaP and 2nd dose of IPV.  The reporter consented to follow-up via email. The patient received 2nd dose of DTaP and IPV as Kinrix at inappropriate age, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered
severe joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (severe joint pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for an unknown indication.     The patient's past medical history included No adverse event.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On an unknown date, the patient experienced ARTHRALGIA (severe joint pain). At the time of the report, ARTHRALGIA (severe joint pain) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Friday morning 2:00 AM fevers of 104.5 and higher for 3 full days. Hives, wouldn't eat or drink. Hardly slept. Took them 10 full days until December 12 to call me and tell me they accidentally gave her the adult flu shot.
Vaccinated a 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccinated a 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccinated a 16 year old). On 13-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccinated a 16 year old) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
headache, fatigue, dizziness, nausea. Not explainable by other cause. Tested for COVID and negative.  Clinically well appearing with normal VS and exam so elected expectant care, supportive care, monitoring.
Information has been received from a physician concerning a 10 week old male with no allergies, who on 15-OCT-2007 received his first oral dose of Rotateq (lot # "1168U"). Concomitant vaccination included Hib conj vaccine and Tripedia. It was reported that he developed constant diarrhea and bloody stool for about a week or so after the dose. The patient's mother had sought unspecified medical attention for him from the patient's physician. The physician reported that the patient developed an anal fissure because of the constant diarrhea. The physician reported that the patient's mother on 23-OCT-2003 and 08-NOV-2007, brought in multiple stool sample and all the tests came back negative (unspecified studies). The physician also reported that there was no intussusception and the patient's stool was starting to firm up. As of this report, it was reported that the patient was recovering. A product quality complaint was not reported. Additional information was not available. Upon internal review "bloody stool for about a week or so after the dose" was determined to be an other important medical event. Additional information has been requested.
Sore throat and ear ache only on the side of the vaccine site; Ear ache only on the side of the vaccine site; This is a spontaneous report from a non-contactable consumer, the patient. A 28-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 19Sep2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome (POTS), gastroparesis, Ehlers Danlos and hashimoto's thyroiditis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), naltrexone (MANUFACTURER UNKNOWN) and fludrocortisone (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. On 21Sep2021, 24 hours after the vaccination, the patient experienced sore throat and ear ache only on the side of the vaccine site and it had been a week at the time of report, with little change. The events 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 events. The clinical outcome of the events sore throat and ear ache only on the side of the vaccine site was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a little bit of a sore arm the same day, I tested for covid Jan 16 and tested negative in the urgent care, I had a slight headache and fatigue, I laid down all day on Saturday.
Cellulitus with reaction to vaccine on left deltoid-edema and erythema 10cm X 16cm. Treatment-Keflex 250mg/5cc- give 10cc twice a day times 7 days. Ice pack to area as needed for pain/edema. Follow up with doctor for any problems as needed.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 15-OCT-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 376 hours, with the recorded temperature of -1.66 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
COVID vaccine breakthrough case. Pfizer 3/16/21 EN6205, 4/6/21 ER8732, 8/23/21 FD8448, 4/10/22 FJ1614 and 9/6/22 bivalent GH9694
Pt w/ flattened erythematous rash to bilat posterior arms, L>R. No pain/ pruritus or open lesions. Pt's partner noticed it, pt did not see him until partner noted this.
mom reports pt got immun in AM & by PM lt arm was swollen-no pain; mom has been giving APAP but did not use cool packs; mom has sent pt to school w/o incident; mom says pt is better today;
Pt had a 7cm x 12 cm  redness and indentation of 6cm x 9cm
7/25/07 Td Decavac, Hep A and B patient states? Pertussis. 7/27/ Phone call from 12:00 noon cold chills, fever, swollen, redness (25 cent), temp 102 - decrease appetite, headache, Tylenol and Motrin called - recommend see MD. 7/28/07 Seen MD adverse reaction given Zyrtec 10mg x qd. See attached.
THE RIGHT ARM WHERE I RECEIVED THE VACCINE BECAME VERY SWOLLEN AND SORE. HAD ACHES AND PAINS. TOOK MY TEMPERATURE AND IT WAS OVER 100 DEGREES. I ALSO HAD THE SWEATS AND CHILLS.
Information has been received from an office manager referring to an 1 year old female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the one-year-old patient might have been given a dose of PNEUMOVAX 23 (lot #, expiration date, dose and route were not reported) (product use in unapproved population). It was also reported that the reporter was not sure if the patient received PNEUMOVAX 23 or instead PREVNAR 13 (manufacturer unknown). No adverse effect was reported. Additional information is not expected as there is no consent for follow up.
C/O DIZZYNESS AND FEELS LIKE PASSING OUT PROCEEDED WITH L ARM PAIN AND CHEST PAIN. EMS CALLED AND ADMITED BUT DISCHARGED OUT OF THE EMERGENCY ROOM.
This is a 67y.o. male . Patient carries a diagnosis of schizophrenia. This time he presented with depression, hearing voices telling him to kill himself and was paranoid towards people. He felt uncomfortable among people and was socially isolated. Patient needed to be transferred off the unit to general medical floor due to becoming positive for COVID. He is readmitted to monitor his condition and complete quarantine before discharge. Patient has been improving. Patient reports feeling much better. Suicidal ideation are completely gone. Voices are less intense. His mood is much better. He has started to eat better.
The patient received the first dose of Pfizer COVID vaccine on 08/30/2021 and the 2nd dose on 09/23/2021. The patient presented to the emergency department on 09/25/2021 with complaints of chills, body aches, and chest discomfort since 09/24/2021. The patient also reported a cough, chest tightness relieved by leaning forward, 1 episode of vomitus, nausea, lightheaded and dizziness with standing. The patient was admitted, and is currently admitted at time of note. The patient was diagnosed with acute pericarditis and acute myocarditis.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 04-DEC-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0079AE, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Received a COVID-19 vaccine and contracted COVID shortly afterwards; Received a COVID-19 vaccine and contracted COVID shortly afterwards; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Received a COVID-19 vaccine and contracted COVID shortly afterwards".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Administration error: A 37-year-old female patient with a dose of Janssen and a booster of Moderna receives a second booster of the Moderna vaccine.
EXTREME shivers starting at 1:00 a.m.:  I could not get out of bed (to retrieve the thermometer), did not have the ability to move to notify my husband who was next to me in the bed (to ask him to leave the bedroom in case I had COVID or to call an ambulance), could not get warm.   I was so cold that I thought my heart would just stop.  I gave up and looked forward to the relief that death might provide.  These extreme shivers lasted until approx 5:00 a.m.   From 5:00 to 7:00 a.m., less severe shivers.  By 7:00 a.m., a feeling of sickness, malaise and lethargy for the rest of the day and evening.   The day after (2 days after vaccine), I was relatively normal.
A LITTLE BIT OF ACHES AND PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 20-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 20-APR-2021, the patient experienced a little bit of aches and pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a little bit of aches and pain was not reported. This report was non-serious.
Patient started sweating profusely and leaned back in her chair as if she was going to faint
1. fever, 2. body aches, 3. chills, 4. nausea, 5. redness at injection site
18 hours post-dose #2; fever, sore throat, muscle aches, joint pain/aches, lethargy; resolved within 48 hours
Patient was to get TDAP vaccine, was administered DTaP instead.  No adverse reactions noted.
as inadvertently given 2 shots by vaccinator. The vaccinator thought that the vaccine had not been administered when the 1st shot was given because the syringe would not retract on the vanish point syringe and she removed the shot from patient's arm she thought the vaccine was still in the syringe and had not been given to the patient so she administered a 2nd shot. Patient was notified that she most likely received 2 full doses of the vaccine or possibly 1 full dose and 1 partial dose. Discussed expected/common possible side effects of vaccine. She waited in monitoring area for 15 min after vaccine and I gave her my office number to call if any unexpected reactions or concerns.
Approximately 48 hours after receiving the Zostavax vaccine, the patient developed a red, itchy lump the size of a fist at the injection site.  While the entire lump was red and itchy, the symptoms were most sever at the actual site of the needle penetration.  Patient has been treating with Benadryl and hot compress.
Patient felt very ill after 3 days-weak, tired, swollen glands, fever.  Reported feeling as if he "couldn't move his eyes".  This lasted 4 days-treated on 06/27/2003.
After 2nd dose, buzzing sensation got worse and he still has buzzing sensation; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (After 2nd dose, buzzing sensation got worse and he still has buzzing sensation) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 012L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 16-Feb-2021, the patient experienced TINNITUS (After 2nd dose, buzzing sensation got worse and he still has buzzing sensation). At the time of the report, TINNITUS (After 2nd dose, buzzing sensation got worse and he still has buzzing sensation) had not resolved. Not Provided          No concomitant medication and treatment information were provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-091861 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091861:First dose case
shaking; Fevers; chills; headache; achiness; This is a spontaneous report from a non-contactable consumer or other non hcp. A 25-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on 10Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient didn't had covid-19 prior to vaccination. Medical history included drug hypersensitivity(penicillin) from an unknown date and unknown if ongoing, food allergy(seafood) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was not tested to covid-19 to post vaccination. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number not reported) via unspecified route of administration in Arm left on 20Jan2021(age at vaccination 25 Years) as DOSE 1, SINGLE for covid-19 immunisation. On 11Feb2021 the patient experienced shaking, fevers, chills, headache, achiness. No therapeutic measures were taken for the events. The outcome of the events tremor, pyrexia, chills, headache, pain was not recovered.  No follow up attempts are possible. Information about lot/batch has been requested. No further information is expected.
Face became red and blotchy. Left leg and left buttock was red and blotchy,within 5 minutes of giving vaccine. She was given 6ml of Benadryl PO and all red areas ( except for leg) were gone after 15 minutes. The area on her leg was improving but still red.
Information has been received from registered nurse (R.N.) concerning a 65 and a half year old female with no pertinent medical history who in approximately March 2010 ("spring 2010"), was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported) into right arm below the deltoid. Concomitant therapy included estrogens (unspecified). The reporter stated that the patient developed ulna neuritis in the right arm following vaccination with ZOSTAVAX (Merck). The patient noticed initial redness and swelling at the site of the ZOSTAVAX (Merck) vaccination that resolved (unspecified date of resolution). In approximately March, 2010, the patient developed nerve pain that became apparent 4 to 6 weeks after vaccination. The nerve pain has continued to the present time. The patient had no weakness in the hand or arm just the nerve pain. Right elbow and neck X-ray were performed with no result provided. The patient sought unspecified medical attention. Additional information has been requested.
Fever nausea, loss of appetite, sore throat, fatigue, Fluids  and Aspirin used for fever.
Immunizations given 3/6/19, developed URI symptoms with fever on 3/13/19, seen in office on 3/18/19 and diagnosed with bilateral otitis media. Started on amoxicillin. Seen in urgent care on 3/24/19 for persistent otitis symptoms and a rash. Switched to azithromycin 3/24/19. Seen again on 3/27/19 for rash. Noted to have a crop of three vesicles on left upper leg at site of injection with a satellite papule at 4 o'clock and surrounding erythema. Also noted to have a vesicle on (R)upper lip, (L) temple, (R) upper abdomen, and a red macular-popular lesion on right labia majora.
Minor headache; This is a spontaneous report from a contactable nurse (patient).  A 39-years-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular at 10:30 22Dec2020 at the first single dose for covid-19 immunisation. Vaccine location was Left arm. The patient medical history was not reported. No covid prior vaccination; No covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported.  The patient experienced minor headache in Dec2020.  The outcome of event was unknown.  Information on the lot/batch number has been requested.
Reports headache a few hours after vaccine. Took TYLENOL. Then went to bed. Woke up at 2 am with severe headache pain 8/10. Took more TYLENOL. Reports headache lasted 24 hrs. Pt seen 7/28/14 H/A resolved.
pt recv vax 11MAR96 in rt arm noticed a knot in deltoid muscle when got home that eve-knot still present on 14MAR96 w/sm amount redness-cont to be sore;advised cold packs-observe for inc redness-swelling f/u as needed;
generalized weakness; flushing; my BP is high; dose 1 start date 19Dec2020; dose 2 start date 8Jan2021; This is a spontaneous report from a contactable pharmacist. A 34-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular in left arm on 08Jan2021 at a single dose for COVID-19 immunization. Medical history included chronic HTN and allergies to baclofen and statins. The patient's concomitant medications were unspecified medications taken for hypertension. The patient previously received the first dose of bnt162b2 on 19Dec2020 via intramuscular in left arm, lot EL0140. On 08Jan2021, the patient was brought into ER as code MET. Patient was receiving her second vaccine for COVID-19 when she experienced generalized weakness and flushing. She stated that she knew her BP was high. Endorses hx chronic HTN, reports she took all three medications this AM. The patient denied any headache, new visual change, CP, SOB, or focal weakness. The events recovered on an unknown date in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events.; Sender's Comments: Based on the time association, the events asthenia, flushing and hypertension are possibly related to suspect BNT162B2 administration. 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.
patient had the flu one time in the past 15 years; Initial information regarding an unsolicited valid non-serious case was received from a consumer via social media and transmitted to Sanofi on 13-Dec-2020.  This case involved patient with unknown demographics who had the flu one time in the past 15 years (Influenza), while patient received vaccine INFLUENZA VACCINE.  Relevant medical history and concomitant medications were unknown.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date (latency unknown), after administration of INFLUENZA VACCINE, the patient developed a non-serious flu one time in the past 15 years (influenza) was reported.  Final diagnosis was influenza.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, event outcome was unknown.  There would be no information available on batch number for this case.
pt recv vax; sz; ran fever; got stiff; eyes fixed & shaking; to er via amb;