chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for Covid on 06Aug2021/Tested positive for Covid 19 virus/3 weeks after receiving the Covid 19 vaccine first dose; tested positive for Covid on 06Aug2021/Tested positive for Covid 19 virus/3 weeks after receiving the Covid 19 vaccine first dose; This is a spontaneous report from a Pfizer-sponsored program contactable consumer or other non hcp (Patient's mother). A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm on 16Jul2021 at 14:00 (Age at vaccination:16year-old), as DOSE 1SINGLE for covid-19 immunisation at Pharmacy/Drug Store. Medical History (including any illness at time of vaccination) was reported as none. The patient's concomitant medications were not reported. Vaccine administered at facility was reported as no. The patient tested positive for covid on 06Aug2021 tested positive for covid 19 virus/3 weeks after receiving the covid 19 vaccine first dose. Caller on the line who was calling on behalf of her daughter who received the first dose of the Covid 19 vaccine and before getting her second dose of the Covid 19 vaccine her daughter tested positive for the Covid 19 virus. She was calling for information on when her daughter can receive her second dose. She reported her daughter's nose was swabbed and the Covid 19 virus test was the quick test and she received the answer right away which was positive. She was due to receive her second Covid 19 vaccine on 06Aug2021 but tested positive for the Covid 19 virus on 06Aug2021. When probing NDC/Lot/Expiry for the Covid 19 vaccine she stated she knows it is a Pfizer product but she did not have the Covid 19 vaccine information card with her at the time of this call. She was not sure which arm her daughter received the Covid 19 vaccine in. Any AE(s) did not require a visit to emergency room and physician Office.  The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Nurse reported on 10/14/06 that the "left upper deltoid w/ reddened, slightly raised area where pt had pneumovax given the night before.  Pt. reports that it itches, area slightly raised about 0.1 cm, measures about 1.25 cm x 1 cm."  Reported to pharmacist, stated was dermal reaction and to watch it for increase in swelling or warmth.  On 10/16/06 it measures 17 cm x 10 cm, is very tender to the touch, red, warm and swollen.  Reports her arm is aching.  Dr. thinks the area is possibly a secondary reaction and started her on Cipro 500 mg po BID for 7 days and started her on Vicodin for c/o pain.
Case number PHEH2013US015499 is a combined spontaneous report received from a nurse on 16 Jul 2013 and 18 Jul 2013, with a follow up received from the QA department (241596) on 20 Aug 2013. This report refers to an adult female patient (who is a nurse, doing her internship to become a nurse practitioner). This nurse while reconstituting MENVEO, (batch number: 12131), when putting needle in vaccine vial, no glass was shattered but the vaccine exploded and got all over the nurse hand (unspecified date). No other information was reported following medication error (accidental exposure while preparing drug for administration). Non significant follow up received from the QA department on 20 Aug 2013: Updated QA reference number.
Left supraclavicular lymph node swelling was noticed on 12/29 after I received the first dose of the vaccine. It continue to persists even today  and fluctuates in size and temperature throughout the day with the lymph node being largest in the morning. NP has prescribed doxycycline and prednisone to see if the swelling will reduce.
Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc.
Patient received vaccine in his former clinic but the system did not have update, so it seemed like he was missing those vaccines. No adverse events were noticed. No signs or symptoms were reported.
Caller is a pharmacy technician (listed as technician in additional case contacts, as pharmacy technician is not listed) who is reporting that a dose of PROQUAD was administered with VARIVAX for 8 different patients. Caller reports the information; Caller is a pharmacy technician (listed as technician in additional case contacts, as pharmacy technician is not listed) who is reporting that a dose of PROQUAD was administered with VARIVAX for 8 different patients. Caller reports the information; This spontaneous report was received from a pharmacy technician referring to a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not reported.   On 29-MAR-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (Rha) (PROQUAD) (lot number U028179 has been verified to be valid, expiration date reported and established as 08-MAR-2023). On the same date, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U024221 has been verified to be valid, expiration date reported and established as 04-AUG-2023) (product use issue, inappropriate schedule of product administration). Both vaccines were administered as prophylaxis.; Sender's Comments:  US-009507513-2204USA004906: US-009507513-2204USA005095: US-009507513-2204USA005731: US-009507513-2204USA005733: US-009507513-2204USA005079: US-009507513-2204USA005707: US-009507513-2204USA005707:
chills; didn't feel very well; headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; MALAISE (non-serious), outcome "unknown", described as "didn't feel very well"; HEADACHE (non-serious), outcome "unknown", described as "headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recv vax on 1/26/99; on 1/27/99 pt exp headache, nausea/vomiting, diarrhea 4x, sweats, weight loss x 24 hr
Chills, Fever of 100- 101 F, slight headache for 8 hours duration.  Totally normal by 48 hours post vaccination.
Increase in blood pressure, feeling of "ice sensation down vaccination arm  (Left), was ok during the 15 minute observation period then returned and requested EpiPen, felt swelling may be starting, 1 Epi pen administered and 911 called, EMS took patient to local hospital for additional observation and treatment if needed.
pt recvd 3 doses of hep B;began to exp fatigue,bruising observed dec92 & hemorrhaging red spots;noc sweats;dx w/ immune thrombocytopenia;tx w/out success w/ steroids,splenectomy,danazol & vicristine;as of 30aug exp,stomach pain,back pain
Information has been received from a pharmacist concerning a pt who was vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed an injection site reaction that included itching, swelling and redness on the underside of the arm that was injected. Additional info has been requested.
Tingling in my hands. Soreness at vaccine site. The soreness spread to lower arm and shoulder, within 2 weeks full blown flu symptoms, followed by difficulty breathing....
Patient received first dose of moderna on 19 March 2021 and came for second dose on 2 April.  Pt was screened via standardized screening form.  Screening form did have date of first dose but screener missed it and patient was cleared for vaccination with a 14 day interval instead of the 28 day interval.  Pt did not have negative outcome or side effects at all after second dose.
This case was reported by a physician via sales representative and described the occurrence of injection site infection in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On 15 September 2010 the subject received a dose of FLUARIX (.5 ml, unknown, unknown arm). On 16 September 2010, 1 day after vaccination with FLUARIX, the subject experienced injection site infection. The subject received FLUARIX on 15 September 2010 and returned to the office the next day due to an infection in their arm at injection. The subject may have required medical treatment. At the time of the report no further information was available. At the time of reporting the outcome of the injection site infection was unspecified. The physician reported two subjects were given FLUARIX and returned to the office the next day due to an infection in their arm at injection. Please see case A088299BA for the second subject. Follow-up information was received on 05 November 2010 via physician. The subject's injection site infection had an onset date of 14 September 2010 (previously reported as 16 September 2010) been diagnosed as cellulitis with abscess and swelling of arm. On an unspecified date the injection site infection, cellulitis, abscess and swelling of arm resolved. The patient had no experience any adverse events following previous vaccinations.
Mom reports huge swelling, pain at inj site last PM. This AM there is no obvious swelling, redness or any tenderness at site, however 50 cent sized inflammation palpable.
Pt had been fine, awoke on 11/9/00 at 04:00 and cried X 15 minutes like in pain, no fever, face swollen and took to ER but seemed fine. Seen by doctor in the afternoon and had enlarged parotid glands, bilaterally, no tenderness. No treatment, just to observe.
Itch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itch) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced PRURITUS (Itch). On 28-Jan-2021, PRURITUS (Itch) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-032567 (Patient Link).
I received my vaccine six weeks ago. My arm still hurts as if I got the vaccine yesterday.
BLURRED VISION; HEADACHE; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, non alcohol user, sensitive to latex, and bees venom, and other pre-existing medical conditions included the patient had no illicit drug use. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203a21a, expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced blurred vision. On 23-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from blurred vision, and headache. This report was non-serious. This report was associated with product quality complaint: 90000180537 The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/ investigation performed.
Fatigue; fever; chills; Nausea; Vomiting; This is a spontaneous report from a contactable physician. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date (dose number= 1, lot number: EK5730) then on 06Jan2021, 11:30 (dose number= 2, lot number: EL3248), both at a single dose, via an unspecified route of administration (anatomical location: Arm Left) for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient experienced fatigue few hours after the second vaccine (06Jan2021) followed by fever, chills and nausea/vomiting. The latter lasted about 6 hours but was horrible. Treatment received for the adverse event were paracetamol (TYLENOL) and ondansetron (ZOFRAN). The outcome of the events was recovered on Jan2021.
diffuse total body rash, fever, body aches; onset of sx 4 days p/immun; sx resolved 2 days following onset;
Information has been received from a licensed visiting nurse concerning a 14 year old female who on an unspecified date was vaccinated with a first dose of Gardasil.  Subsequently after receiving the first dose of Gardasil the nurse wanted to draw blood from the patient and the patient started having a seizure.  The patient was taken to the emergency room (ER).  The representative does not know if the patient was admitted.  At the time of reporting the patient had recovered.  No further information was provided.  Upon internal review, seizure was considered to be an important medical event.  Additional information has been requested.
This spontaneous report as received from a registered nurse (also reported and "medical assistant") refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD injection (dose, lot # expiry date, route of administration and anatomical location were not specified). No adverse reactions were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Eyes became itchy 1 1/2-2 hours after flu shot.  During night yellow discharge from eyes and puffy lids. Eyelashes were stuck together. This lasted for about 24 hours.
Vaccine dose may have been administered about 25 hours after vial was punctured which is out of the 12 hour time frame so unable to determine viability of dose administered. Vial was still kept between 2-8 degrees Celsius during this period.
Fatigue, nausea, chills, flu symptoms, arm red and swollen at sight of injection, black-and-blue bruise on underside of upper arm opposite side of arm from injection site
Mild reaction; Left arm swelling; This is a spontaneous report from a contactable nurse.  A 57-year-old female nurse reported for herself that received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0142, Expiry Date 31Mar2021), intramuscular into the left arm on at single dose on 05Jan2021 for COVID-19 immunization. The patient's medical history was none and the patient did not receive other products.  The patient reported that when I received the vaccination she patient experienced mild reaction left arm swelling.  She did not had it before this vaccine. At the time of reporting it is gone down now. She did not take any treatment.
Exposure of lactating female; left deltoid pain around vaccine administration site; This spontaneous case was reported by an other and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Exposure of lactating female) and VACCINATION SITE PAIN (left deltoid pain around vaccine administration site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Exposure of lactating female) and VACCINATION SITE PAIN (left deltoid pain around vaccine administration site). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Exposure of lactating female) and VACCINATION SITE PAIN (left deltoid pain around vaccine administration site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Report 20010094981 described coughing in a 6 year old female who received hep b vaccine. The reporter denied allergies, medical history and concomitant medications. On 04/10/2001, the vaccinee received her 3rd dose of Engerix-B. Four hours post vaccination, she experienced wheezing, hoarseness, and a cough which produced phlegm. On 04/11/2001, the injection site was red and hard from shoulder to elbow, and the vaccinee ahd a "lump about size of tennis ball (at the injection site)." The vaccinee was seen by a physician. As of 04/12/2001, the outcome of the events was unknown.
Patient vomited one time, 1 hour after administration, observed by nursing staff, Patient had no other complaints or signs prior to vomiting,   patient monitored for additional 15 minutes, and did not develop any other symptoms.
I developed trigeminal and eye shingles at 7 months of Long Covid and was on Valtrex to keep the virus dormant. After the 2nd vaccine dose, and after 2 days had passed, I developed shingles lesions in the exact same location as I had when I developed eye shingles. I had 4 raised lesions, a swollen left eye and cheek, a tender left cheek, and nerve pain. The shingles outbreak lasted for 3 days and then subsided. I was consistently on Valtrex before, during and after my vaccination and the lesions still occurred.
Migraine  attack  that started within minutes and continued to worsen till night, then low grade fever together with chills started followed by severe body aches , muscle spasm, and feeling of pressure in my chest, the body aches was severe and Tylenol, and ibuprofen didn?t help ,,, only a pill of hydrocodone ( that I had left since my  dental implant surgery) helped, and I started to get better after , but  the muscle spasm which was basically in my neck and my back are still there.
His temperaturee at this time was 91.1/ his temperature was 100.8/ Since the vaccine his temperature is 96 or below/ His temperature during the call was 97.1; Effecting his work; He was not shivering but having whole body shuddering; Sweating; Left eye vision doesn't seem distinct; Freezing; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Left eye vision doesn't seem distinct), FREEZING PHENOMENON (Freezing), NERVOUSNESS (He was not shivering but having whole body shuddering), HYPERHIDROSIS (Sweating) and BODY TEMPERATURE FLUCTUATION (His temperaturee at this time was 91.1/ his temperature was 100.8/ Since the vaccine his temperature is 96 or below/ His temperature during the call was 97.1) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027b21a and 003b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Allergic to Doxycycline series antibiotics) and Drug allergy (Morphine). Concomitant products included OMEPRAZOLE, CEFADROXIL and FENTANYL for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced OCULAR DISCOMFORT (Left eye vision doesn't seem distinct) and FREEZING PHENOMENON (Freezing). On 20-Apr-2021, the patient experienced NERVOUSNESS (He was not shivering but having whole body shuddering) and HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced BODY TEMPERATURE FLUCTUATION (His temperaturee at this time was 91.1/ his temperature was 100.8/ Since the vaccine his temperature is 96 or below/ His temperature during the call was 97.1) and IMPAIRED WORK ABILITY (Effecting his work). At the time of the report, OCULAR DISCOMFORT (Left eye vision doesn't seem distinct), FREEZING PHENOMENON (Freezing), NERVOUSNESS (He was not shivering but having whole body shuddering), HYPERHIDROSIS (Sweating), BODY TEMPERATURE FLUCTUATION (His temperaturee at this time was 91.1/ his temperature was 100.8/ Since the vaccine his temperature is 96 or below/ His temperature during the call was 97.1) and IMPAIRED WORK ABILITY (Effecting his work) outcome was unknown.            Treatment medications were unknown.    This case was linked to MOD-2021-163566 (Patient Link).
Shortness of breath, chest pain.  Symptoms have been treated with Advair and ibuprofen.
Headache, fatigue, body aches and flu like symptoms lasting about 24 hours. Chills and shakes for about 20 minutes, 10 hours after injection.
no adverse effect; patient received improperly stored varivax; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S005078 with expiration date 19-FEB-2021 or lot # R019237 with expiration date 04-JUL-2020 (exact dose and route of administration were not reported). Concomitant therapies included properly stored sterile diluent. The temperature excursion was from -14 °C to -10 °C (-9.74 C) for unknown period of time. There was no previous temperature excursion reported. Digital data logger was involved. No adverse effect was reported. The nurse was unable to determine which lot # was given to the patient.
Information has been received on 11/27/2001 from a doctor of audiology concerning his 29 year old wife with no known drug allergies who 'about five months ago" was vaccinated with a series of varicella vaccine. There was no concomitant medication. On 11/27/2001, it was reported that a recent titer did not show seroconversion. The pt sought unspecified medical attention. Additional info has been requested.
Developed s/s of COVID on 6/28, tested positive for COVID on 7/3.
59 y/o Female PT was administered COVID Vaccine at 1800.  PT states started to notice her heart rate was increasing at a very rapid pace according to her smart watch.  General impression:f PT showed no signs difficulty breathing, skin is warm and dry to the touch, no sweating.  PT does present with mild tremor in her hands.  PT states that she has a history of getting raised heart rates after digesting food with a high sodium content.   PT states has a feeling of "panicie" and has a dry mouth / denies any difficulty breathing or tightness in her throat or chest.  No blurred vision.   Vitals where obtained at 1810 EMS was called.  PT refused medical care, and signed off with them