chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First vaccination in January 2021 then contracted covid; Had to wait 90 days before they could receive the second dose and now it is past the 90 days; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (First vaccination in January 2021 then contracted covid) and PRODUCT DOSE OMISSION ISSUE (Had to wait 90 days before they could receive the second dose and now it is past the 90 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (First vaccination in January 2021 then contracted covid) and PRODUCT DOSE OMISSION ISSUE (Had to wait 90 days before they could receive the second dose and now it is past the 90 days). At the time of the report, COVID-19 (First vaccination in January 2021 then contracted covid) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Had to wait 90 days before they could receive the second dose and now it is past the 90 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-138799 (E2B Linked Report).; Sender's Comments:  MOD-2021-138799:Same reporter (wife case)
3 inch diameter redness seen in ER on 6/29  called PCP on 6/19.   ER 6/20 diagnosed with cellulitis.
Pt had measles rash 10 days after vaccine administered. PCP told mom that child had measles from vaccine.
She states that approximately 1 week after receiving the immunization, her shoulder began hurting. She states that it is progressively getting worse. It has reached the point that the pain is causing her issues with sleeping, decreased mobility in that shoulder, and that she's unable to raise that arm.
swelling in her armpit; experiencing some pain in her left wrist; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid 19" (unspecified if ongoing), notes: She also mentioned that she has had Covid 19 two times. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 03Apr2022, outcome "unknown", described as "experiencing some pain in her left wrist"; LYMPHADENOPATHY (non-serious) with onset 04Apr2022, outcome "unknown", described as "swelling in her armpit". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Serious: No. Caller received the booster shot of the Pfizer-BioNTech Covid 19 Vaccine on 02Apr2022 and yesterday she was experiencing some pain in her left wrist. She also started experiencing today some swelling in her armpit. She wants to know if these are common side effects due to the vaccine. She also mentioned that she has had Covid 19 two times.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
2 days after receiving Varivax had more than 40 smallpox-like bumps scattered on body some with small pustules.
First shot, the arm was sore and she had a headache for a few days. The second shot totally messed up her monthly cycles along with more headaches. Months later had a massive pulmonary embolism which resulted in a thoracotomy.  She came out of the OR on ECMO and Life Support. Was in a coma for 5 days. During this time she had a right frontal lobe stroke with subsequent seizures. She now takes blood thinners and two types of seizure medication. All genetic testing for clotting issues have been negative.
Felt severely depressed for at least 5 hours --completely resolved when she awoke the next morning.
Generalized rash, mouth swelling began 7/13/22. Took OTC antihistamine. Prescribed steroids.
Fever started approximately 12 hrs after injection - persisted for 72 hrs. Max - 102.0. Red raised warm area 12 x 12 cm. - painful - improved start at 96 hrs.
pt sibling recv vax & pt devel rash;pt eval & rxn was a viral infect not rxn to the vax;
induration, erythema, and pain  at the injection site progressively worsening 48 hours post injection. chills.
Fever up to 105, seizure. Mother states that child had a rash on skin and had a febrile convulsion and she took him to the ER on 12/24, he had a temp of 105, He had received DTaP, Hib, PCV 13 and Flu vaccine on the 12/23 and fever started that day. He was seen here 3 days ago for an ER follow up visit. On day following shots he also had redness in the tongue and a 3 day loss of appetite. Child had a similar rash and had fever the day following his 1 yr vaccines. His fever following the his vaccines at his 1 yr visit, he received MMRV, and Hep A was not as high as this recent episode. The rash then started on the legs and spread to other areas. He also had lesions in his mouth and perioral area. He was seen in our office for that episode and diagnosed with Hand foot mouth disease. The rash seen after his recent 15 month visit is very much in keeping with a rash seen in Hand foot and mouth syndrome also.
Headache; fever; chills; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP6955), via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 56-year-old), dose 2, single for COVID-19 immunisation. Medical history included casein allergy, coffee allergy, wheat intolerance, and COVID-19. Concomitant medication included sertraline hydrochloride (ZOLOFT); losartan; diclofenac (VOLTAREN); alpha lipoic acid. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247) administered via an unspecified route of administration in the left arm on 02Mar2021 at 12:00 (at the age of 56-year-old), dose 1, single for COVID-19 immunisation and experienced pain at injection site, tiredness, headache, fever. Prior to vaccination, the patient was diagnosed with COVID-19 but did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 24Mar2021 at 07:00, the patient experienced headache, fever, chills. The patient received treatment medications acetaminophen and advised to sleep. The events were reported as non-serious. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovered in Mar2021.  No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021235505 same reporter/patient/product, different dose/similar event
This spontaneous report as received from a licensed practical nurse refers to a 13 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-OCt-2016, the patient was vaccinated with a dose of PROQUAD (lot # M006105, expiration date 01-AUG-2017, 0.5 ml, subcutaneously). On an unknown date in 2016, the patient experienced a red reaction at the injection site (on the leg), a low grade fever and a runny nose. The outcome of the adverse events was unknown. The relatedness between the adverse events and PROQUAD was not provided. Additional information has been requested.
Information has been received from a nurse concerning a 31 year old female with a history of 3 cervical disk problems in her neck and who gets sick with pain medications who on 26-MAR-2007 was vaccinated intramuscularly with her first dose of GARDASIL vaccine (yeast) (lot# not reported). On 21-MAY-2007 the patient was vaccinated intramuscularly with her second dose of GARDASIL vaccine (yeast) (lot# not reported). On 20-NOV-2007 the patient was vaccinated intramuscularly with her third dose of GARDASIL vaccine (yeast) (lot# not reported). Concomitant therapy included hormonal contraceptives (unspecified). Some time after her third dose of GARDASIL vaccine (yeast) the patient was not able to feel her arm for an hour. She was able to lift the arm. Following this incident the nurse mentioned that the patient had two similar episodes that lasted for a much shorter time where her arm felt funny.  It was not known if the incidences occurred in the injection site arm or not. The patient has been referred to a neurologist for evaluation. The patient sought unspecified medical attention by calling the office on an unspecified date. The patient is recovering from her arm being numb and feeling funny. Additional information has been requested.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 25-APR-2013 at 07:35, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14 hours. On 07-MAY-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Beginning after 12 hours from time of injection and lasting for 16 hours - fever of 102 degrees, chills, exhaustion, headache, chest pain, achy body Bed rest, fluids, Tylenol
Fatigue; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and FATIGUE (Fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hearing impaired.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced HERPES ZOSTER (Shingles). On 26-Apr-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, HERPES ZOSTER (Shingles) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant has been reported.  Treatment medication included unspecified antibiotics.   This case was linked to MOD-2021-092108 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: non-significant followup was received on 28may-2021.no significant updates.
tested positive for covid 19 on 14Apr2021; tested positive for covid 19 on 14Apr2021; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received second dose of BNT162B2 (BNT162B2), intramuscular, administered in Arm Right on 08Jan2021 10:00 (Batch/Lot Number: EL3246) as single dose for covid-19 immunization. Medical history included inappropriate sinus tach (sinus tachycardia), chronic back pain and costochondritis all from unknown dates and unknown if ongoing. The patient received first dose of BNT162B2 on 18Dec2020. Concomitant medications included carvedilol (COREG), gabapentin (GABAPENTIN), colecalciferol (D3), duloxetine hydrochloride (CYMBALTA), ibuprofen (MOTRIN [IBUPROFEN]), zinc (ZINC), ascorbic acid, quercetin (QUERCITIN), calcium (CALCIUM), ascorbic acid, dexpanthenol, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopheryl acetate (MVI [ASCORBIC ACID;DEXPANTHENOL;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]), oxycodone hydrochloride, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]), cyclobenzaprine hydrochloride (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), magnesium (MAGNESIUM) all taken for unspecified indications, start and stop dates were not reported. It was reported that the patient tested positive for covid 19 on 14apr2021, event was reported as medically significant.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Apr2021. No treatment was received for the event. Outcome of the event was recovering.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported Vaccination failure / COVID-19 cannot be ruled out.
Headache, Nausea, Muscle Ache, Fatigue, 102.3 Fever
chills, headache, body aches; chills, headache, body aches; chills, headache, body aches; Covid-19 Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto's" (unspecified if ongoing), notes: Take Synthroid daily for Hashimoto's. Concomitant medication(s) included: SYNTHROID taken for autoimmune thyroiditis. Vaccination history included: Bnt162b2 (DOSE: 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE:2, SINGLE), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), HEADACHE (non-serious), PAIN (non-serious), outcome "unknown" and all described as "chills, headache, body aches"; IMMUNISATION (non-serious), outcome "unknown", described as "Covid-19 Booster".  Additional information: Event took place after use of product.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Symptoms started 1/1/21 Pm.   Headache, ear ache, chills, fever.     COVID and influenza swabbed 1/5/21 both negative.   Symptoms continued ear infection 1/6/21, nausea and chest pain.    1/7/21 vomiting and diarrhea started.   Going in for COVID swab this am.  And seeing a provider.
Right hand/arm tremors, sometimes when they happen I feel like I?m shaking on the inside and my heart started pounding hard and a little faster.
I received the first dose of the Pfizer Covid-19 vaccine on April 12, 2021. I was on birth control and my period is very regular. My period should have started on or around April 18, 2021.  To date, I have yet to receive my period. I am 19 days late and 100% not pregnant.
a 26 year old / received Infanrix; Intended vaccine was Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 26-year-old female patient who received DTPa (Infanrix) (batch number XG942, expiry date 22nd August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2021, the patient received Infanrix (intramuscular) and Infanrix Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. The action taken with Infanrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong 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 details were provided as follows: The health care professional reported that the 26 years old patient inadvertently received Infanrix in the right deltoid, which led to inappropriate age at vaccine administration. The Intended vaccine was Boostrix , which led to wrong vaccine administered. The reporter consented to follow up. This is 1 of the 2  linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021173226:Same reporter
Information has been received from an office manager concerning a patient who was vaccinated with a first dose of Gardasil. The patient got dizzy and fell after receiving the injection. The patient's outcome was unknown. Additional information has been requested.
Swelling and pain at injection site and down arm for 4 days.  Raised reddened area that is slightly itchy at injecion site.  Looks like inflammed bee sting
pt states 2 days after received vaccine pt states she started having weakness and pain in arm, muscle spasms throughout entire body, and 5 days later she's having weakness in legs and arms, pain and headache. she went to emergency room we don't have records yet
Age 36, pass away on Friday 27Jan2023; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 36-year-old 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; manufacturer unknown), for Covid-19 Immunization. The following information was reported: DEATH (death, medically significant) with onset 27Jan2023, outcome "fatal", described as "Age 36, pass away on Friday 27Jan2023". The patient date of death was 27Jan2023. The reported cause of death was unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Age 36, pass away on Friday 27Jan2023
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to allergy clinic for follow-up after reaction to vaccination. Patient reports immediately following vaccination developed itchy throat and sensation of throat closure. Epi-pen immediately administered and patient evaluated in the emergency department, monitored, and discharged.
Fever like symptom onset at 3:30pm on 01/08/2020 with chills. Temp at 99.8. Observed. Then temp at 4:30pm was at 100.8.  Ibuprofen taken and sx resolved by 8pm the same day.
Vaccine was reconstituted with sterile water, no diluent that comes with menveo.
Headache, Myalgia, sore throat, congestion, fatigue Narrative:
while Driving today after lunch I noticed that everything that was white around me was glowing or to brilliant.  It looked to me like the effect one has after visiting the oftalmologist when they delate your pupils. Light was so bright it was making it hard to drive.
Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023; No adverse event; She had expired vaccine that was administered on 15-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023).    It was unknown if the patient was ever diagnosed with or tested positive for COVID-19.  Concomitant medications of the patient were not reported.  The vial was initially stored in the refrigerator on 14-Mar-2023. The vial did not undergo any temperature excursions.  HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-Mar-2023. There was potentially a second lot number that was expired and was administered to patients on 03-Mar-2023, but HCP did not have any details on this event at the time of reporting.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Rash about 2 inches below the injection site. Appeared 2 days after the immunization was delivered. Rash itched, but did not burn. From patient description, rash seemed to appear just below the deltoid and extend 2-3 inches in length. Rash went away after some time, patient unsure of exact date.