chrisvoncsefalvay/vaers-outcomes huggingface dataset:
period bleeding started immediately after the vaccine; Period/bleeding started immediately; hives; Immunisation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 09Dec2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, prev dose product=COVID 19, prev dose brand unknown=True,, prev dose brand name unknown=COVID19 Vaccine,, prev dose lot unknown=True, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion, prev dose dose number=1), for Covid-19 immunization, reaction(s): "hives in the evening"; Bnt162b2 (Dose 2, prev dose product=COVID 19, prev dose brand unknown=True,, prev dose brand name unknown=COVID19 Vaccine,, prev dose lot unknown=True, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion, prev dose dose number=2), for Covid-19 immunization, reaction(s): "After the 2nd dose, it made me skip a period". The following information was reported: HAEMORRHAGE (medically significant) with onset 09Dec2021, outcome "not recovered", described as "period bleeding started immediately after the vaccine"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Period/bleeding started immediately"; URTICARIA (non-serious) with onset 09Dec2021, outcome "not recovered", described as "hives"; IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "Immunisation". Therapeutic measures were not taken as a result of haemorrhage, heavy menstrual bleeding, urticaria, immunisation. Additional information: The patient was not received any other vaccines within 4 weeks. Patient was not diagnosed with COVID-19 prior vaccination and not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It was unknown to pt and staff, but at the time of the vaccination, pt was 11 wks pregnant.
The day after receiving the COVID vaccine, patient had headaches, body aches, chills and fatigue. Plans to treat with ibuprofen and/or tylenol
Soldier developed fever and chills about 8 hours after receiving 1st Anthrax vaccination. Temperature to 103.1F at home. Did not seek medical aid until 2 days after fever resolved. Developed nausea, vomiting and diarrhea.
Began with rash 3/5.  Got worse.  Came for evaluation 3/6.
Information has been received from a female who in 2006 was vaccinated orally with GARDASIL and just recently had been diagnosed with human papillomavirus. The patient was not sure what type but was upset to find out she now had human papillomavirus. The patient experienced colposcopy but the result was unknown. The patient sought unspecified medical attention and outcome was unknown. The patient refused to provide any demographics. No further information is available.
Nasal Swab: Positive on 03Jan2022; Nasal Swab: Positive on 03Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2021 as dose 1, single (Lot number: FC3182), in right arm and on 28Sep2021 as dose 2, single (Lot number: FF2589) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "Nasal Swab: Positive on 03Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2022) Positive, notes: Nasal Swab.
welps over body, rt eye edematous, drag's rt leg; took to ER seen by MD given inject sx cleared on 9JUL93 sx reappeared;
Severe headache (migraine), body aches, chills, temp of 101 (highest), joint aches, sensitive skin, fatigue, site hurt worse than first vaccine.
got up real dizzy; slight headache; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 28Feb2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "problems with vertigo" (unspecified if ongoing), notes: she has a spell every three to four years. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 02Mar2021, outcome "unknown", described as "got up real dizzy"; HEADACHE (non-serious) with onset 02Mar2021, outcome "unknown", described as "slight headache".  Additional information: The reporter stated that when she got her vaccine, the people told her that if she had side effects, she could take paracetamol (TYLENOL). She has medicine prescribed to her for her history of vertigo, and she was just calling to seek information on if the medicine she takes for vertigo is contraindicated with the COVID vaccine at all, before she takes it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Palpitation, Hyper-ventilation, tingling in the fingers, dizziness, Headache started in July
Warm to touch, painful. 48 hours after injection a 15 cm x 6 cm induration 4cm below the injection site.
intense pressure in chest with heart flutter; Rash; itching; shivers/chills; burning and tingling sensation; burning and tingling sensation; intense pressure in chest with heart flutter; rapid heartbeat; difficulty breathing; weird sound in ears; fever (101-102); fatigue; poor balance; confusion; pain in injected arm; very swollen arm; moderate to severe shooting joint pain; neurological pains; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FE5S92), via an unspecified route of administration in the right arm on 21Sep2021 at 14:15 (at the age of 32-year-old), dose 2, single for COVID-19 immunisation. Medical history included fibromyalgia, post-traumatic stress disorder (cPTSD), hypermobility, peanut allergy, scoliosis, allergic rhinitis, underweight, and chronic pain. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, zinc oxide (ONE A DAY WOMEN'S). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FC3183) administered via an unspecified route of administration in the left arm on 31Aug2021 (at the age of 31-year-old), dose 1, single for COVID-19 immunisation and the patient experienced skin peeling near injection site, chills, shivers, burning sensation entire body, itching, rash, difficulty breathing, swelling at injection site to the point the bandaid cut into the skin, fever, severe pain next day left arm, headache, fatigue. The patient previously took amoxicillin, codeine, and azithromycin (AZO) and the patient had allergy to these medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 21Sep2021 at 16:00, the patient experienced rash, itching, chills, shivers, burning and tingling sensation, intense pressure in chest with heart flutter, rapid heartbeat, difficulty breathing, weird sound in ears, fever (101-102), fatigue, poor balance, confusion, pain in injected arm, very swollen arm, moderate to severe shooting joint pain, neurological pains, and was bedridden the next day. The patient took Benadryl and Tylenol for the events. The patient called nurse and was under observation. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101147783 Same reporter/patient/product, different dose/similar events
pulse rate was elevated; This case was reported by a consumer via interactive digital media and described the occurrence of pulse rate increased in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2020, the patient received Shingrix. On 17th October 2020, 1 days after receiving Shingrix, the patient experienced pulse rate increased. On an unknown date, the outcome of the pulse rate increased was unknown.   It was unknown if the reporter considered the pulse rate increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but taken as adult as per vaccine indication. The patient received Shingrix and experienced pulse rate elevated all day. The information regarding consent to follow was not reported. No further information was available.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Clinic consulted with the health department and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Clinic is working with the health department on a compliance improvement plan and has been reinstated vaccination privileges.
About 8 days after receiving my first covid shot, I had a swollen ,hard , red and warm area on my arm about the size of an egg.  As the days progressed (now day 10) it became very itchy and increased in size.  it is now about 4 inches long. The itching has decreased.  Took some benadryl.
Information has been received from a health care professional concerning a 74 year old female who on 6/13/00 was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent. In 6/00, the pt experienced redness and warmth at the injection site. The pt sought unspecified medical treatment. On an unspecified date, the pt recovered. No further information is available.
My left arm pit Lymph Node started swelling 4/11/2021 and the pressure/swollen feeling lasted 4 days ending on 4/15/2021. Also I got a cold sore in my left nostril on 4/15/2021 currently irritated.
8/3/12 Around injection site was red & swollen, & hot. 8/4/12 red & swollen area was considerably large & had a red line going up her arm. Went to ER & received a prescription for cephalexin.
red rashy areas that were in several areas of body / These areas included; arms, legs, scalp, back of neck and chest.; rashy areas that were itchy in several areas of body; several periods of dizziness; eczema; This spontaneous case was reported by a patient and describes the occurrence of RASH ERYTHEMATOUS (red rashy areas that were in several areas of body / These areas included; arms, legs, scalp, back of neck and chest.), RASH PRURITIC (rashy areas that were itchy in several areas of body), DIZZINESS (several periods of dizziness) and ECZEMA (eczema) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (red rashy areas that were in several areas of body / These areas included; arms, legs, scalp, back of neck and chest.), RASH PRURITIC (rashy areas that were itchy in several areas of body), DIZZINESS (several periods of dizziness) and ECZEMA (eczema). At the time of the report, RASH ERYTHEMATOUS (red rashy areas that were in several areas of body / These areas included; arms, legs, scalp, back of neck and chest.), RASH PRURITIC (rashy areas that were itchy in several areas of body), DIZZINESS (several periods of dizziness) and ECZEMA (eczema) had not resolved.            Around 2 weeks following the second administration of the vaccine, the patient began to experience the events. The areas included in itchy rash are arms, legs, scalp, back of neck and chest.  The treatment information includes eczema medications, steroid creams, anti-itchy cream, peppermint oil, hydrocortisone cream.
Post menopausal bleeding.  Have not had bleeding for almost a year, and as soon as i recieved vaccine it started spotting
Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On unknown dates, the unspecified patients received doses of improperly stored PROQUAD (rHA) (strength, dose, frequency, route were not reported, lot # N031929, expiry date 12-MAY-2019) for prophylaxis. Concomitant therapy included sterile diluent (lot # and expiry date were unknown). Sterile diluent used to reconstitute PROQUAD was stored properly. The temperature and time frame were unknown. There were no previous excursions reported. The call was because of a data logger. No adverse effects were reported. Follow up information was received on 05-SEP-2018 from the nurse and from the physician. The reporters stated that three female children and five male children between the ages of 1 year and 4 years received doses of PROQUAD on an unspecified date in the past 3 months in approximately 2018. The patient was female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. There had been no adverse events following the administration of the improperly stored PROQUAD vaccinations. This was just temperature issue where temperature reached -12 Celsius degree. Sender's Comments: US-009507513-1808USA010810: US-009507513-1809USA004055: US-009507513-1809USA004056: US-009507513-1809USA004057: US-009507513-1809USA004058: US-009507513-1809USA004059: US-009507513-1809USA004060.
Patient came to ED with shortness of breath, generalized weakness, and cough.  Patient admitted to hospital with Covid and treated with remdesivir.
This spontaneous report as received from a pharmacist refers to a 12 years old male patient with ADD (Attention deficit disorder), autistic disorder, allergic rhinitis and penicillin allergy. The patient's medical history included hives after using penicillin. The patient was vaccinated with first dose of GARDASIL (lot number unspecified) intramuscularly on 25-JUL-2012. The patient was vaccinated with second dose of GARDASIL (lot number H010915, exp 13-FEB-2015) intramuscularly on 07-JAN-2013. No other co-suspects were reported. Concomitant medications included TENEX and ADDERALL TABLETS. On some unspecified date after 07-JAN-2013, the patient experienced right knee pain. No treatment information was given for AE. The outcome of right knee pain was unknown. The relatedness for right knee pain was unknown for GARDASIL. No lab diagnostic studies performed. The patient's mother had called the physician assistant for medical attention. Additional information is not expected.
Severe chills, severe joint pain, severe muscle aches, fever, mild headache, mild nausea, fatigue. Symptoms started the afternoon after the vaccine and got worse as the night progressed, becoming very severe around 8pm. I took generic NyQuil tablets and was able to sleep for a few hours, and was woken up after that by joint pain. Joint pain persisted Saturday (moderate, treated by ibuprofen) and Sunday (mild, no ibuprofen needed.)
His adverse event was that his arm was sore and he has not felt good since then.  He went to his doctors office and got routine bloodwork and they informed him he has a deficiency of hyaluronic acid.
contacted COVID via the latest strain; contacted COVID via the latest strain; This is a spontaneous report received from contactable reporter (Physician) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contacted COVID via the latest strain". Patient was vaccinated with Pfizer COVID 19 vaccine and contacted COVID via the latest strain. Patient had multiple medical conditions as well.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
The patient's wife called around 4pm to notify me that her husband was experiencing reactions to the Prevnar shot that he received.  I went over the side effects from Prevnar and he really didn't have any effects like redness, soreness, swelling, arm immobility, fever, or anything like that.  She said that he was having chest tightness, chest congestion,  cough, swelling inside of his mouth, and his teeth hurt.  She also said that he temporarily had issues with his vision.
More lethargic; Fever102.4F; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (More lethargic), PYREXIA (Fever102.4F) and VOMITING (Vomiting) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PHENOBARBITAL (PHENOBARBITONE COX), ONDANSETRON (ZOFRAN MELT), CYPROHEPTADINE, FAMOTIDINE, PHENYTOIN SODIUM (DILANTIN D.A.), LEVOTHYROXINE, DESMOPRESSIN, CLONIDINE, Lorazepam prn, PARACETAMOL (TYLENOL), IBUPROFEN (IBUPROFEN) and Nasal spray PRN for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced LETHARGY (More lethargic), PYREXIA (Fever102.4F) and VOMITING (Vomiting). At the time of the report, LETHARGY (More lethargic), PYREXIA (Fever102.4F) and VOMITING (Vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Shortness of breath, chest tightness, flushed face, severe back spasms, and hypertension (178/85) almost immediately after vaccination
I21.4 ACUTE NON ST ELEVATION MI 9/8/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA J96.00 ACUTE RESPIRATORY FAILURE 9/8/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA I21.4 ACUTE NON ST ELEVATION MI 9/8/2021 HEART FAILURE W REDUCED LVEF <=30%, UNSPECIFIED ACUITY J96.00 ACUTE RESPIRATORY FAILURE 9/8/2021 HEART FAILURE W REDUCED LVEF <=30%, UNSPECIFIED ACUITY I21.4 ACUTE NON ST ELEVATION MI 9/8/2021 ACUTE NON ST ELEVATION MI J96.00 ACUTE RESPIRATORY FAILURE 9/8/2021 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 9/8/2021 METABOLIC ENCEPHALOPATHY J96.00 ACUTE RESPIRATORY FAILURE 9/8/2021 METABOLIC ENCEPHALOPATHY
bad knee; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 05Mar2021 [Friday], as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On an unspecified date, patient experienced bad knee and would need a steroid shot. Patient was scheduled to receive the second dose of the vaccine on 29Mar2021. Patient asked if it would be fine. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax;noticed redness & itching of both hands;dx as erythema multiform;tx w/ claritin;
7 month old female patient inadvertently administered an expired dose of Pentacel intramuscularly with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer via Agency (Reference number- 00609761) and transmitted to Sanofi on 20-May-2021.  This case involves a 7 month old female patient who was inadvertently administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 18-May-2021, the patient received a 0.5 ml third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ262AAA and expiry date: 14-May-2021) (Suspect formulation: single dose vials) via an intramuscular route in the right leg for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that expire Pentacel was given to a baby and the vaccine was 4 days past the expiry date. Caller would like to know if they need to re-vaccinate. Reporter relationship: health care professional (HCP) Product used: used still using product: no   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 holder's compliance with the requirements set out in the 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.
Patient stood up from a seated position after receiving vaccine, lost consciousness, fell to floor. Event happened with a few mintues after receiving dose. Patient maintained open airway/breathing and had pulse. Patient was seated and regained consciousness. Emergency services arrived, assessed patient and transported to hospital.