chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness at injection site after first vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Apr2021 (Lot number: ER8131) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune" (unspecified if ongoing), notes: 2 years ago she had an ultrasound and was told she had a minor autoimmune. The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Soreness at injection site after first vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was taking a birth control pill and a multivitamin. The patient had no prior vaccinations within 4 weeks. With the first dose of the COVID Vaccine the patient stated she only had soreness at the injection site. It lasted for about 2 days and she could not sleep on that side of her body. Patient was not visited to Emergency Room or Physician Office .  No follow-up attempts are possible. No further information is expected.
positive for COVID; Felt weakness; slight ache; Pain in center of his back and upper back; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weakness), PAIN (slight ache), BACK PAIN (Pain in center of his back and upper back), COVID-19 (positive for COVID) and FATIGUE (tiredness) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced FATIGUE (tiredness). On 25-Jan-2021, the patient experienced ASTHENIA (Felt weakness), PAIN (slight ache) and BACK PAIN (Pain in center of his back and upper back). On 26-Jan-2021, the patient experienced COVID-19 (positive for COVID). On 25-Jan-2021, FATIGUE (tiredness) had resolved. On 26-Jan-2021, BACK PAIN (Pain in center of his back and upper back) had resolved. At the time of the report, ASTHENIA (Felt weakness), PAIN (slight ache) and COVID-19 (positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, COVID-19: positive (Positive) positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Stuffy nose, cough,lost sense of smell, lost sense of taste were considered as symptoms and are subsumed under Covid-19.  No concomitant medications were reported. No Treatments were reported.
headache, fever of 102.3, general aches and pain, lips puffy and swollen
Severe itching on chest, neck, face, throat felt like it was closing up, benadryl was taken twice
Medical Assistant did not realize that the Pentacel had to be reconstituted and mixed with a powder in order for a complete dose to be received with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information(Reference number- 00345628) and transmitted to Sanofi on 04-Nov-2020.  This case involves a three months old male patient who was administered with the liquid portion (0.5 mL) of the DTAP/IPV DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ224AAA and expiration date 23-Apr-2021) via intramuscular route in the right thigh for prophylactic vaccination on 27-Oct-2020 as the medical assistant did not realize that the vaccine had to be reconstituted and mixed with a powder in order for a complete dose to be received (product preparation issue).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was a case of actual medication error due to inappropriate reconstitution technique (latency on the same day).  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 holders 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.
After both shots became extremely fatigued, had horrible headache, temperature and chills, cough, congestion, muscle aches( not injection site). Was not sick in the days leading up to either shot. Both times it lasted exactly 24 hrs and then completely disappeared.
Later that evening arm was very sore.  Next day was aching all over; stayed in bed and had joint pain. Patient did not take medications, nor contacted doctor or pharmacist.  Patient felt better by 5/5 but soreness in arm lasted for 1 week.  As of today, patient has recovered completely.   First dose of vaccine was in January 2019; same pharmacy and sore arm lasted for 3 days.
patient when showing up today with his wife reported that he had sudden hearing loss after he got his first Shingrix dose. The patient already had hearing issues and when he went to see his MD hey told him it is probably linked to the vaccine and he advised him against getting the second dose. Patient was treated and says he gained almost 70% of his hearing back.
Seizure occurred while sleeping. Woke up sweating. Dr. Thinks from Fever.
first injection - sore arm for few hrs, fatigued 2 days, felt cold (wore jacket).; first injection - sore arm for few hrs, fatigued 2 days, felt cold (wore jacket).; first injection - sore arm for few hrs, fatigued 2 days, felt cold (wore jacket).; This is a spontaneous report from a contactable other hcp (Nurse) (patient). A 57-year-old (non-pregnant) female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ELO140) via an unspecified route of administration, administered in arm right on 18Dec2020 10:00 (at the age of 57-year-old) at dose 1, single for covid-19 immunisation. Medical history included hypothyroidism, mild latex and mild food allergies associated with latex. Covid prior vaccination was unknown, covid tested post vaccination was no. Concomitant medications included thyroid (ARMOUR THYROID) taken for hypothyroidism; levothyroxine (LEVOTHYROXINE); ergocalciferol (VIT D); ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10 [ASCORBIC ACID; BETACAROTENE; CUPRIC OXIDE; MANGANESE SULFATE; SELENIUM; TOCOPHERYL ACETATE; UBIDECARENONE; ZINC OXIDE]); asa (ASA) at 81 mg, 1x/day, 350 mg, 2x/day. On an unspecified date in Dec 2020 the patient experienced first injection - sore arm for few hrs, fatigued 2 days, felt cold (wore jacket). Adverse event-(First injection-sore arm for few hrs, fatigued 2 days, felt cold(wore jacket).x2days (afebrile)). Second injection - very sore arm x 3days, 48 hr after injection developed PVC's - in/out of geminy for 3 days then geminy resolved but remained with what seemed like unifocal pvc's at first, which slowly progressed into more frequent and multifocal pvc's, worsening with any increased activity (ex: walking from parking lot to work place), generalized fatigue which worsened over time with worsening of pvc frequency. Lasted almost exactly 4 months from day of injection (15 weeks). Abt to request cardiology referral, increased ASA intake to 350 mg bid (was 81 mg qd) (self prescribed) and pvc's progressively resolved over 4-5 day period then stopped completely. Energy returned. Also, developed scalp pain (abt 10 resolved then returned), then developed Shingles-type nerve pain left trunk, and also 2x over that 4 mo had near-eruption of herpes in corner of mouth (in remission x40 yrs), adverse event start date-12Jan2021 adverse event start time-01:00 PM, (Lot number-EL3302, Lot unknown- False, administration date-10Jan2021, administration time-03:00 PM, dose number-2, vaccine location-Left arm). Patient did not receive treatment for the adverse events. Outcome of the events was resolved on an unspecified date.   Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.
24yr AD male that presents on 28Mar2021 with left arm pain and concern that it may be related to the Johnson&Johnson COVID-19 vaccine that he received on 17MAR2021.  He describes 2 days of post vaccine fatigue/chills/myalgias that resolved with rest.  On day 3 post-vaccination, he states he had a circumferential rash from bilateral feet to upper thigh that lasted approximately 24hrs.  The rash resolved without intervention.    He states that he has had new onset left arm pain (side of injection) that started in his left hand 7 days after his shot and begin radiating up the arm into the neck over the next 4 days.  He has been lifting weights but denies any changes in workout habits or a perceived injury.  Pain is 6-7/10 per patient but has difficulty articulating the quality of the pain.  He has no associated weakness/numbness/paresthesias.  He denies any rash to the left arm.    He has not utilized any medications for the pain.  He does not have any functional limitations of the LUE.  He was discharged to follow up with his PCM.
The pt developed 6x8cm area of erythema with mild swelling and no induration on left deltoid. Treated with Benadryl and Tylenol.
sore arm at injection site; headache; tired feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administration date 19Feb2021 (Lot number: EN6200) at the age of 76 as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Excedrin for headache, notes: Took Excedrin 5 hours before 1st dose on 29Jan2021, The headache was before the 1st dose, Not after. Vaccination history included: Bnt162b2 (1st dose, Lot number: EL3247), administration date: 29Jan2021, for COVID-19 immunisation; Bnt162b2, for COVID-19 immunisation, reaction(s): "slight headache", "injection site sore arm". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "sore arm at injection site"; HEADACHE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "headache"; FATIGUE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "tired feeling".  Additional information: It was reported that, patient did not take any pain medicine before receiving the 2nd vaccine injection on 19Feb2021. At this point, stated that did not have any significant adverse reactions/events from either the 1st or 2nd COVID-19 Pfizer vaccine injections. Specifically, all had after the 1st shot was an injection site sore arm for a day and a slight headache, which could have been from earlier that morning, as stated above. The 2nd shot gave me a sore arm at the injection site, a headache and a tired feeling, all of which went away after 24-36 hours. To sum up, all of these side effects were mild and short lasting. Event experienced: He took Excedrin, before the first dose of covid vaccine. Took Excedrin 5 hours before 1st dose on 29Jan2021 and experienced Headache. The headache was before the 1st dose, Not after.  No follow-up attempts are possible. No further information is expected.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  Date of refrigeration was given as 07-MAY-2021.
Hot flashes; Cold a few days after the second dose.; Alternating sweating; No appetite; Very tired; Very sore arm; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 18Apr2021 at 13:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimotos thyroiditis and other autoimmune disease. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 75 mg, liothyronine sodium (CYTOMEL) 5 mg, valsartan (DIOVAN) 160 mg; all for unknown indications, from unknown dates and unknown if ongoing. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Previously, the patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 27Mar2021 at 13:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 10:00, the patient experienced hot flashes with alternating sweating and then cold a few days after the second dose. Shortly, after the second dose, the patient had very sore arm for three days, as well as was very tired with no appetite. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as result of these events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very sore arm was recovered on 22Apr2021 at 10:00, and the clinical outcome of the events hot flashes, alternating sweating, cold a few days after the second dose, very sore arm, very tired and no appetite was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
My daughter lost consciousness either from passing out or seizure; My daughter lost consciousness either from passing out or seizure; This is a spontaneous report from a non-contactable consumer (patient's mother). A 14-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right at the age of 14-year-old on 04Jun2021 12:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant. The patient previously took first dose bnt162b2 for COVID-19 Immunization. The reporter stated that 'my daughter lost consciousness either from passing out or seizure'. Event start on 05Jun2021 08:00. AE resulted in: Emergency room/department or urgent care.  Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included investigation: unknown results in Jun2021. Therapeutic measures were taken as a result of events (Testing and pain meds /IV fluids). The outcome of event was recovering.  Information on lot/batch number has been requested.
w/in seconds p/vax administered flaccid, fell, became rigid, flexed arms, tremors, ?sz;
extra dose on the same day; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 6-year-old female patient who received DTPa-IPV (Kinrix) (batch number h9fm5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 24th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient inadvertently received an extra dose of Kinrix, which led to extra dose administered.  No further events were reported.  The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Infection on the pneumonia shot (infection, (pain in extremities), (Oedema peripheral). (Erythema))
This spontaneous report was received from a licensed practitioner nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 16-MAY-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # L042257 with expiry date on 17-AUG-2018 (strength, dose, route and anatomical location were not reported). Concomitant medications were not reported. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & devel an inj site rxn (red, warm to site) in OCT96 p/vax;
Tongue became itchy and swollen, fine rash on face, inner arms, anterior thighs and head. IV BENADRYL , SOLU-MEDROL and PEPCID was given in the E.D.
From telephone contact on 05/31/01, a physician reported that a patient (1 of 3) received a Tripedia vaccination, vaccination date not specified. The patient developed a local reaction after receipt of the vaccine. No specifics were provided. Further information is requested
fever of 103, myalgias, & arthralgias;2 scratches on buttock by stray dog;
Fatigue; Fever; Muscle & body aches; Muscle & body aches; Headache; Overall sick feeling; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old non-pregnant female patient received bnt162b2 (BNT162B2) formulation solution for injection, dose 2 (Lot Number: FA7485 expiry date was unknown) via an unspecified route of administration at arm left on 18Aug2021 16:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included levothyroxine, lisdexamfetamine mesilate taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not have Known allergies. Historical vaccine dose 1, brand: Pfizer COVID 19, (lot number: FA7485 expiry date was unknown) via unspecified route of administration at Left arm on date: 24Jul2021 05:30 PM as a single dose for COVID0-19 immunisation. On 18Aug2021 23:00 Fatigue, Fever, Muscle & body aches, Headache, overall sick feeling, Nausea. No treatment was given for adverse events. Outcome of the events was not recovered.   Follow-Up (31Aug2021): Follow-up attempts are completed. No further information is expected.
Information has been received from a consumer via a company representative concerning her niece of unknown age. On an unspecified date, the patient received GARDASIL (dose, frequency, route and lot# were not reported) and experienced minor ulcers on an unknown date in an unspecified location. On an unknown date, the patient received with the third dose of GARDASIL (lot#, dose/frequency and route unknown). After vaccination, the patient experienced severe pain and to see the doctor. The pain was so much that she had to be prescribed unspecified steroids and needed to be catheterized. On an unknown date, the patient was hospitalized at an unknown hospital for an unknown amount of days. At the time of reporting, the outcome of severe pain and minor ulcers was unknown. The relationship between severe pain and minor ulcer and GARDASIL was not reported. Additional information has been requested.
Less than 24 hrs after receiving the vaccine, the left side of my neck got really stiff and achy, then my left arm was way more sore than the first two vaccines and then it travelled down to the left side of my back which was stiff and sore. I also had a dull headache which started around 11 am. I slept through the night fine and when I woke up the next day I was back to normal, but my arm was still a little sore.
p/vax pt devel a fever as high as 104, dec appetite, irritability & weight loss of 4 ounces;pt tx w/APAP which reduced the fever temporarily;
patient is experiencing pressure in right ear and feels dizzy. He went to dr there is not any obstruction. He was put on antibiotics but still experiences pressure in right ear and dizziness here and there
2 inch diameter raised, red, warm welt-like reaction.  Pt describes as uncomfortable and slightly painful.  States a hx of chicken pox, but due to enrollment in nursing school was told she had to get a varicella vaccine.
Is there any shedding with Shingrix?; This case was reported by a consumer via interactive digital media and described the occurrence of skin peeling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin peeling. On an unknown date, the outcome of the skin peeling was unknown.   It was unknown if the reporter considered the skin peeling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient asked if there was shedding with shingrix vaccine.
arm was red; arm was warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was red) and SKIN WARM (arm was warm to the touch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (arm was red) and SKIN WARM (arm was warm to the touch). At the time of the report, ERYTHEMA (arm was red) and SKIN WARM (arm was warm to the touch) outcome was unknown.            No concomitant medications provided. No treatment information provided.
After vaccination, patient developed low grade fever and a rash, which on biopsy was idiosyncratic lymphocytic vasculitis 04/18/07-records received from facility. DOS 3/21-3/21/07- DC DX: fever. Low grade lymphocytic vasculitis.Fever 101 prior to admission, reddish bumps on extremities and face. Rash itchy. PMH:bronchiolitis, rhinorrhea and cough continue