chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intense chills; 101 degree fever; Muscle pain; Headache; Nausea; Intense dizziness; Skin pain; Tooth pain; Hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0150) via an unspecified route of administration in the left arm on 19Apr2021 at 15:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. It was reported that the patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included citalopram hydrobromide (CELEXA) 40mg taken for an unknown indication, from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 20Apr2021 at 05:00, the patient experienced intense chills, 101 degree fever, headache, nausea, intense dizziness, muscle pain, skin pain, tooth pain, hot flashes and scared to hold her newborn child. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intense chills, 101 degree fever, headache, nausea, intense dizziness, muscle pain, skin pain, tooth pain and hot flashes was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
exclusively breast feeding; exclusively breast feeding; Started vaginally bleeding; Started vaginally bleeding on the day of my second vaccine very heavily.; This is a spontaneous report from a contactable 29-year-old female consumer reported for herself. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown) via unspecified route of administration, on 30Aug2021 (at the age of 29-year-old) as a single dose for COVID-19 immunization. Patient had no medical history. The patient concomitant medication was not reported. Patient had not taken any other vaccine in four weeks. Patient had not COVID prior to the vaccination and was not tested post COVID vaccination. Patient had no known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0202), via an unspecified route of administration, in right arm on 09Aug2021 at 15:00 (at the age of 29-year-old) as a single dose for COVID-19 immunization. Other vaccine administered on the 09Aug2021 was Pfizer (unknown manufacturer, Lot number: FC3184) administered in the right arm. On 30Aug2021 at 15:00, patient started vaginally bleeding on the day of her second vaccine very heavily. She was only 2.5 weeks postpartum and exclusively breast feeding. The patient has not received any treatment for the reported events. The clinical outcome for started vaginally bleeding on the day of her second vaccine very heavily was recovering and other events unknown.  Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101218839 Maternal case
severe itching at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (severe itching at the site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (severe itching at the site). At the time of the report, VACCINATION SITE PRURITUS (severe itching at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.
Numbness on one side of face for 3-4 days 2 days after receiving vaccination.
More pain in left arm than the first dose; Did not feel well; Felt a little feverish; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (More pain in left arm than the first dose), MALAISE (Did not feel well) and PYREXIA (Felt a little feverish) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 026L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (More pain in left arm than the first dose), MALAISE (Did not feel well) and PYREXIA (Felt a little feverish). At the time of the report, PAIN IN EXTREMITY (More pain in left arm than the first dose), MALAISE (Did not feel well) and PYREXIA (Felt a little feverish) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Anti-thyroid antibody: high (High) high. On 15-Mar-2021, Blood thyroid stimulating hormone: high (High) High.         No treatment information was provided. The action taken with the drug was Not applicable.   This case was linked to MOD-2021-054736 (Patient Link).
Began with itching of the scalp and neckline 11 days after booster, thought it was dry skin. Next morning began random patches of itchiness and welts all over. Once I itch it causes a chain reaction in random places.  Itching leaves raised red streaks all over my body.  Showers make the itching worse, So Ive been doing cool rinses only. Have been alternating Benadryl, Zyrtec, Allegra trying to find what is best along with cortizone and aveeno anti itch. I have purchased humidifiers for my home. There are times of relief and times of complete discomfort affecting my daily life.  I have not had any major allergic reactions to anything before.
lighter and shorter periods; blood has been more clotted than normal, the blood is darker brown instead of red; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 06Feb2021 (at the age of 19-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 28Feb2021 (at the age of 19-years-old); each as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, patient had not been tested for COVID-19. Since the first vaccination, on an unspecified date in Feb2021, the patient experienced lighter and shorter period. The blood was more clotted than normal and darker brown instead of red. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the lighter and shorter period and menstruation abnormal was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Urticaria in the whole body, red spots in the skin accompanied by itch. It appears in a region of the body and then disappears after 15 min or so and appears in a different region. Mostly in the chest, back, and arms.
Patient stated that she had an episode of palpitations that woke her from sleep. She said that this occurred over 2-3 minutes in the middle of the night while she was sleeping. Pt denies having chest pain, dizziness, SOB, or other cardiac symptoms. Pt denies increased caffeine use or performing activities that may increase HR or cause chest discomfort. Pt stated that after episode, she went back to bed and it has not happened again. She did not seek out advise from PCP or vaccine-administering clinic. Pt denies any cardiac symptoms on day of 2nd dose. Pt requested to have 2nd dose.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Red marks on right arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Red marks on right arm). At the time of the report, VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Red marks on right arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient post receiving their first dose of Moderna vaccine reported that their site of injection began itching and developed red marks.   On 23-Apr-2021, the patient reported that the patient was feeling fine and received their 2nd dose a month ago with no side effect.  No Concomitant product use was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: TCR Received. Updated the outcome of the event. Updated the action taken as per received information.
Warm, red, swollen and bruised at injection site and around sit eon Rt upper arm. Tx: give Benadryl, Motrin and place cool wash cloth on site. Pt doing well after 12/24 hrs. No further problems noted per mom.
Vaccine was given in left leg and pt. instantly became red and blotchy on legs, arms, stomach and back. Pt reported no itching or difficulty in breathing. Pt. was given 1 tsp. BENADRYL and observed for 20 mins.
4MAR92 screaming cry approx 3 hrs p/vax; t100, rt leg swollen & red, cried until exhausted, eyes appeared to cross; APAP given; 5MAR pt ok; MD felt pertussis induced & ordered to eliminate further pertussis;
Suspected vaccination failure; Shingles; This case was reported by a nurse via call center representative and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. The reporter asked if after the Shingrix shot within days, someone was having a shingles outbreak, were they able to start on Valtrex or would this effect replication of the vaccine. Specialist attempted to clarify, but the reporter ended the chat without confirming whether this was a hypothetical inquiry, or if there was a patient involved. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.
Patient was given PREVNAR and a few days later developed irritation and swelling on site (Left arm).
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned an 84 year old male. The patient's height, and weight were not reported. The patient's past medical history included: heart surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection (breakthrough infection), and suspected clinical vaccination failure, and was hospitalized (date and days unspecified). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The day before reporting the patient's lungs were clear and had no fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product ra: 90000196454.; Sender's Comments: V0: 20211014653-COVID-19 VACCINE AD26.COV2.S-Suspected covid-19 infection. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20211014653-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Initial case was received from a health care professional on 09 October 2013. A 69 years old male patient had no medical history reported, received a dose of FLUZONE HD vaccine intramuscularly on 06 October 2013 (batch number U4764AA). Patient had not reported concomitant medication. It was reported that on 06 October 2013 patients had dizziness which was worsen in 09 October 2013. No corrective treatment was reported. At the time of report the outcome of event was not recovered.
Flare of pain psoriatic arthritis. Swelling of joints in hands and toes, swelling of nose and face with flaking lesions on chin and scalp.  tremendous pain in shoulder blade joints and chest and rib cage, fatigue, placed on methotrexate in July and starting Orencia infusions middle of August
Red welt-like increased in size, itching. OTC Hydrocortisone 1% cream did not help itch. Current size: 3inches in diameter. Change from circle to oval. Pt says 1st appear 2 hr after shot. 1-2 days later increasing to quarter sized and now 3 inches in diameter. (Pt also on PLAVIX). Pt complaining of Left arm shot-PREVNAR.
Information has been received from a 72 year old physician, with an allergy to Sulfa and ("VERAPAMIL"), who in December 2007, was vaccinated intramuscularly in the left deltoid with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine. The physician stated that the injection was painful. Subsequently, the physician experienced redness and swelling at the injection site, and the swelling continued to descend below the elbow, and he could not move his arm. Two days later, the physician went to the local emergency room and was treated with dexamethasone sodium phosphate (MSD), 10 mg Intravenously and given an unspecified antibiotic for possible cellulitis. Diagnostic lab studies were performed, indicating white blood count was normal. The physician was not hospitalized. He then had a follow up appointment with a nurse practitioner specializing in Infectious Disease who told him to discontinue taking the antibiotic as he did not have cellulitis. Subsequently, the physician recovered. No product quality complaint was involved. Additional information has been requested.
patient received improperly stored vaccine; no adverse event; This spontaneous report was received from another health professional and referred to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-MAY-2023, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5ml/once, with a reported an validated: lot number of x004813, and an expiration date of 28-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was improperly stored and the medical assistant was reporting that a patient received improperly stored vaccine. The vaccine presented a temperature excursion with a temperature above 46.74Fahrenheit (F) for 2 minutes. No previous temperature excursion were reported. And no adverse events were reported. No further information provided.
Seizure within 20 minutes of injection and hives redness swelling at injection site within 10 hours
Patient began experiencing yellowing of the eyes, skin peeling around nose and mouth, and skin discoloration around mouth.   Pt is a 35yo AA male, with a past med hx of alcoholism, remains sober since Aug 2019, fatty liver and mild hepatomegally.   Exam of patient's skin showed diffused jaundice w/ scleral icterus. Patient also had brown plaques and macules with scaling on entire face including lips but excluding mucous membranes.
I did not have an adverse reaction to the vaccine. I was exposed to COVID-19 from my mother.  I started not feeling well on 03/20/2023 with a fever, chills and sore throat. I tested positive for COVID-19 on 03/21/2023.  I contacted my doctor and had a virtual visit. I got a prescription for Paxlovid. I tolerated the medication, but I did have dark and loose bowel movements. I felt really bad for about three weeks. As of today, I don't feel like I am up to full power. I have had sleep disturbance for several weeks.
Information has been received from a consumer concerning her daughter with no pertinent medical history and no drug reactions/allergies who on 12-APR-2007 was vaccinated with 0.5 ml GARDASIL vaccine (yeast). On 14-JUN-2007, after getting her second dose of GARDASIL vaccine (yeast), the patient experienced tingling. That same day she was also vaccinated with hepatitis A vaccine (inactive) (VAQTA). She did not seek medical attention. No lab diagnostic studies were performed. As of 15-JUN-2007 the patient had improved. No further information is available.
Pain in left chest; Blood pressure 226/110.; Respiration rate 44; Pulse 126; Fever of 101 degrees; 3 hours of not being able to catch her breath; Really bad chills / 3 hours of shivering; This case was reported by a consumer via call center representative and described the occurrence of chills in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 57EX2, expiry date unknown) for prophylaxis.   On 6th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 7th November 2020, 1 days after receiving Shingrix, the patient experienced chills, fever, shortness of breath, chest pain, increased blood pressure, respiratory rate increased and high pulse rate. The patient was treated with epinephrine and benadryl (nos) (Benadryl). On an unknown date, the outcome of the chills and shortness of breath were recovered/resolved and the outcome of the fever, chest pain, increased blood pressure, respiratory rate increased and high pulse rate were unknown.   It was unknown if the reporter considered the chills, fever, shortness of breath, chest pain, increased blood pressure, respiratory rate increased and high pulse rate to be related to Shingrix.  Additional details were provided as follows: The patient received her first Shingrix shot in her left arm. At 5 am, the next morning the patient experienced really bad chills and fever of 101 degrees. After 3 hours of shivering and not being able to catch her breath the patient called her doctor and went to the emergency room. The patient had pain in left chest. At emergency room her blood pressure was 226 by110, her respiration rate was 44 and her pulse was 126. She was treated in the emergency room for 3 hours; treated with epinephrine, Benadryl and was discharged from the emergency room with a for a steroidal dosepak. The patient did not have plan to second dose of Shingrix  pursuant to advice from doctor. The reporter consented to follow up.
Doses of PEDVAXHIB had been administered following a temperature excursion; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 20-AUG-2021, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliters (route of administration was not reported), lot # T026961 and expiration date 02-APR-2023 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion below 2 degree celsius (°C) (-40°C) and above of 8°C (9.6°C) for 15 minutes and 1 hour respectively on an unknown date; no previous temperature excursions were reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA007655: US-009507513-2108USA007711: US-009507513-2109USA006019: US-009507513-2109USA006020: US-009507513-2109USA006021: US-009507513-2109USA006023:
pt recvd vax 8DEC94 & 2-3 days later exp a marked acne-like rash of the anterior face & lt side of the neck which was more extensive than the rash which followed dose 1;
Patient tensed up and pulled away from vaccinator at the time of vaccination. Vaccinator retreated, comforted the child by talking in a calm soft voice letting her know it will be ok. Dad in room and also tried to calm child down. Child calmed down slightly so vaccinator went to give vaccine - child tensed her arm up and moved away from vaccinator while needle in arm. vaccinator followed the child and vaccine was given with Vanishpoint syringe - needle was retracted and small amount of blood came out of injection site. put cotton ball and bandaid on injection site - mom and child waited about 10 min and vaccinator took off cotton ball and bandaid and put a new bandaid on the site. Site no longer bleeding but redness and raised around injection site. counseled mom to put ice on it when she got home and tylenol or ibuprofen for any pain.