chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; she has had a rash down there, has a red belly; skin feel achy; Can't sleep good; Lower back is killing her; Can't sit still; anxious; eyes have become weird; really red in the corners and foggy; eyes have become weird; really red in the corners and foggy; Rash down there where you go pee and poop; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 12Sep2021 (Lot number: 1113687) as dose 1, single and administered in arm right, administration date 03Oct2021 (Lot number: 1117702) as dose 2, single for covid-19 immunisation. Relevant medical history included: "celiac" (unspecified if ongoing), notes: celiac; "gluten free" (unspecified if ongoing), notes: gluten free; "allergic to soy" (unspecified if ongoing), notes: allergic to soy, she tried soy and it gave her eczema on her leg; "allergic to soy and diary" (unspecified if ongoing), notes: allergic to soy and diary; "eczema on her leg" (unspecified if ongoing), notes: eczema on her leg. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; RASH ERYTHEMATOUS (non-serious), outcome "unknown", described as "she has had a rash down there, has a red belly"; PAIN OF SKIN (non-serious), outcome "unknown", described as "skin feel achy"; INSOMNIA (non-serious), outcome "unknown", described as "Can't sleep good"; BACK PAIN (non-serious), outcome "unknown", described as "Lower back is killing her"; SITTING DISABILITY (non-serious), outcome "unknown", described as "Can't sit still"; ANXIETY (non-serious), outcome "unknown", described as "anxious"; OCULAR HYPERAEMIA (non-serious), VISION BLURRED (non-serious), outcome "unknown" and all described as "eyes have become weird; really red in the corners and foggy"; RASH (non-serious), outcome "unknown", described as "Rash down there where you go pee and poop". The event "rash down there where you go pee and poop" was evaluated at the physician office visit. Additional information: After getting the two shots of vaccine patient really doesn't want another shot. She really didn't want to get the shots at all, but her husband works at the hospital and he convinced her to get it. She is so tired she can't stand. It's changed her life and she is not happy. The time of vaccination given was around noon. No additional Vaccines administered on same date of the Pfizer Suspect. Adverse effects did not require a visit to emergency room. She visited physician office for a couple of times and is going in Mar2022. No prior vaccinations within 4 weeks prior to Covid vaccine. No adverse events reported following prior vaccinations. No follow-up attempts are possible. No further information is expected.
crying lasting 6-8 hrs 29AUG93, off & on x 30; vomiting x 3 28AUG93, x 2 vomiting 29AUG93; leg pain 28AUG93 7PM- 30AUG93 7AM;
Rash; Muscle pain; It is red and sore; like somebody punched me in the arm; Muscle pain; It is red and sore; like somebody punched me in the arm; Muscle pain; It is red and sore; like somebody punched me in the arm; This is a spontaneous report received from a contactable consumer (patient's boyfriend) or other non-healthcare professional. A 57-year-old female patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0183, Expiry Date: un-known), via an unspecified route of administration on 20May2021 (at the age of 57-year-old), as a single dose for COVID-19 immunization. Medical history included hypertension, hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included Lisinopril taken for hypertension, start and stop date were not reported, alendronate taken for hypothyroidism, start and stop date were not reported. On 20May2021 the patient experienced rash, muscle pain it is red and sore like somebody punched me in the arm. Patient had first shot yesterday (20May2021). 5 hours after patient got the shot (20May2021) had Muscle pain; It is red and sore; like somebody punched me in the arm, stated that It started last night little bit this morning patient's arm is sore and red." It was like somebody punched me in the arm. So, he soreness. That is what it felt like. Patient had some muscle pain and some rash on it. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
highest temperature it reached was 11.5C for a total duration out of range 1 hour and 15 minutes with no reported adverse event; open IPOL has been administered post excursion with no reported adverse event; Initial information received on 15-Nov-2022 regarding an unsolicited valid case received from a other health professional.  This case involves an unknown age and gender patient who was  administered IPOL vaccine whose highest temperature reached to 11.5 Celsius for a total duration out of 1 hour and 15 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of poliomyelitis vaccine (inactivated)IPV (VERO)( lot  no.-V1B891M )(Expiry date-01Jun-2024) (with unknown formulation, strength, dose, route and administration site)for immunization.  On an unknown date, highest temperature it reached was 11.5c for a total duration out of range 1 hour and 15 minutes with no reported adverse event (product storage error) and  open ipol has been administered post excursion (poor quality product administered) (unknown latency)  1 day following the administration of IPV (VERO).  It was also reported that The products unopened were: Adacel, Menquadfi, IPOL (open and closed). . Caller asking for stability information. Extended stability data covers unopened products with the exception of the open IPOL. Caller reporting a temperature excursion due to putting away a shipment received and the refrigerator door was open  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for all  events   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.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Is cold all the time), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient reports that she got to Pfizer vaccines 9 months ago, and 3Dec2021, doctor gave her the Moderna booster), FATIGUE (Fatigue/Is tired), CHILLS (Chills) and NAUSEA (Little nausea  but not vomiting or anything) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: COVID 19 Vaccine Pfizer (Got to Pfizer vaccines 9 months ago and had a sore arm) in March 2021. Past adverse reactions to the above products included Pain in arm with COVID 19 Vaccine Pfizer.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FEELING COLD (Is cold all the time), FATIGUE (Fatigue/Is tired), CHILLS (Chills), NAUSEA (Little nausea  but not vomiting or anything) and HEADACHE (Headache). On 03-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient reports that she got to Pfizer vaccines 9 months ago, and 3Dec2021, doctor gave her the Moderna booster). On 03-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient reports that she got to Pfizer vaccines 9 months ago, and 3Dec2021, doctor gave her the Moderna booster) had resolved. At the time of the report, FEELING COLD (Is cold all the time), FATIGUE (Fatigue/Is tired), CHILLS (Chills) and NAUSEA (Little nausea  but not vomiting or anything) had not resolved and HEADACHE (Headache) had resolved.            No concomitant medications were mentioned. No treatment details were reported.
heart rhythm changes/ resting rate changes; excess bleeding; excruciating cramps; shaking; high fevers (105-106); chills; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of ARRHYTHMIA (heart rhythm changes/ resting rate changes) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (3 times patient had COVID (2 prior to getting vaccinated and once while pregnant).).    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (heart rhythm changes/ resting rate changes) (seriousness criterion medically significant), HEAVY MENSTRUAL BLEEDING (excess bleeding), DYSMENORRHOEA (excruciating cramps), TREMOR (shaking), PYREXIA (high fevers (105-106)), CHILLS (chills) and MYALGIA (body aches). At the time of the report, ARRHYTHMIA (heart rhythm changes/ resting rate changes), HEAVY MENSTRUAL BLEEDING (excess bleeding), DYSMENORRHOEA (excruciating cramps), TREMOR (shaking), PYREXIA (high fevers (105-106)), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided.  Company Comment: This spontaneous case concerns a female patient of unknown age, with no relevant medical history, who experienced unexpected, serious (medically significant) AESI arrhythmia with other non-serious events, after receiving a second dose of mRNA-1273 on an unknown date.  She reported heart rhythm changes and resting rate changes shortly after vaccination.  Clinical course, diagnostic evaluation, concomitant medications, and treatment details not reported.  Outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no relevant medical history, who experienced unexpected, serious (medically significant) AESI arrhythmia with other non-serious events, after receiving a second dose of mRNA-1273 on an unknown date.  She reported heart rhythm changes and resting rate changes shortly after vaccination.  Clinical course, diagnostic evaluation, concomitant medications, and treatment details not reported.  Outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.
lymph nodes left arm pit very sore; Soreness at injection site; Chills; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non pregnant female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: unknown), via an unspecified route of administration on 12Feb2021, 10:45 AM at arm left as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.no other vaccine was administered in 4 weeks. The patient was on birth control. On 13 Feb 2021, at 05:00Am the patient experienced Soreness at injection site Chills and No fever. on 14 Feb 2021, she had lymph nodes left arm pit and it was very sore. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
SMALLER HARD SORE BUMP; SICK; SHOT HURT GOING IN AND  STUNG; FELT TIRED; NAUSEOUS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced smaller hard sore bump. On MAR-2021, the subject experienced sick. On MAR-2021, the subject experienced shot hurt going in and stung. On MAR-2021, the subject experienced felt tired. On MAR-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, felt tired, and nauseous on MAR-2021, and the outcome of shot hurt going in and stung and smaller hard sore bump was not reported. This report was non-serious.
pt recv vax 29JUL96 & acquired varicella 18FEB97;
Could not lift left hand/ could not get dressed; Movement was painful; Left arm is still weak; This case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 4 hrs after receiving Shingles vaccine, the patient experienced mobility decreased, pain upon movement and weakness of arms. The patient was treated with non-drug therapy (Physical Therapy). On an unknown date, the outcome of the mobility decreased and pain upon movement were recovering/resolving and the outcome of the weakness of arms was not recovered/not resolved.   The reporter considered the mobility decreased, pain upon movement and weakness of arms to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient received second dose of Shingles vaccine and four hours after vaccination the patient could not lift her left hand higher than her behind.  The patient could not dress herself and movement was painful. The patient took physical therapy and took 5 months to recover mostly. The patient reported that her left arm was still weak. The patient had no idea this might happen after the jab and neither doctor and patient saw reported reaction to VAERS.    Additional Supportive Information: The follow-up would not possible as no contact details were available.
DTaP given 10-7-04 left deltoid.  On 10-12-04 in AM the area about 2 inches below injection site was red, warm to touch, almost vesicular like area appearing in a semi circular pattern.  No temp, did not itch, not painful.
After the shot the ATM starred to hurt by the elbow and feels no strength in arm. Getting worst
It hurt much more than the first shot. The pain subsisted for days and then traveled from my left arm to my left upper back. To this day I still have muscular pain.
Fever 102 degrees F. For two days parents report infant staring episodes and less interactive, difficult to engage, then improved gradually until at on week was normal.
I got my second vaccine on 2-24. For 2 days after the vaccine, I experienced chills, a high fever (102), sweats, and overall body aches. By 2-28, I was feeling tired but no symptoms. By March 3, I started to experience severe exhaustion again, plus unusual brain fog, and paresthesia. I went to ER and was checked for stroke. Given MRI and blood tests. Some energy returned by 3-6. On 3-9, severe fatigue returned along with increased cognitive confusion. I was unable to function as I was sleeping up to 15 hours a day 3 or 4 x's a week. I had to stop working. I was referred to a rheumatologist in March and started getting blood tests. Blood tests show high titers of AMA, ANA,RNAl.Doc suspected AI disease and begin elimination testing. In May 2021, I had a liver fibroscan, ultra sound,  and biopsy. Biopsy showed bile duct inflammation. In early June 2021, a gastroenterologist, gave Dx of Primary Biliary Cholangitis. Rx Eursodiol. (Rheumotologist had Rx Hydroxychlorquine before PCB Dx but I never started that.) I have been taking Ursodiol for 2 weeks. Still battling fatigue but it is lessening. I still get fatigued if I do simple adult activities like grocery shop, do light house cleaning, go out for simple dinner.
Approximately 30 min after injection pt reported burning in her throat, numbness and swelling of her tongue.  At no time did she report shortness of breath.  Vital signs were acquired , pt stayed in our vaccine clinic for approximately an hour without improvement and was then taken to our ER to be further evaluated
On 19May2022 I had cold like symptoms; tested positive for COVID with a home test; tested positive for COVID with a home test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 20Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 71 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "tested positive for COVID with a home test"; NASOPHARYNGITIS (non-serious) with onset 19May2022 at 01:00, outcome "not recovered", described as "On 19May2022 I had cold like symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of nasopharyngitis. It was reported that patient also received Paxlovid from 07May2022 to 12May2022 for the Indication treatment of Covid-19.
she had a minor sore arm the next day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (she had a minor sore arm the next day) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced MYALGIA (she had a minor sore arm the next day). At the time of the report, MYALGIA (she had a minor sore arm the next day) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment details were reported. Patient reported that she probably received her first shot in her right arm.   This case was linked to MOD-2021-308014, MOD-2021-308023 (Patient Link).
A 34 year old health care worker presented 12/19/00to request the Hep B vaccination, PPD placement, and the flu shot. On 12/21/00 the patient presented complaining of swelling and tenderness in the right supraclavicular area, no previous episode. No other area of tenderness, PPD negative. The area was examined by the RN and the MD. The right supraclavicular lymph node tender, moveable, 1 cm palpable. Injection site normal. The patient was told to take Tylenol or Motrin when necessary and return if not resolved in one week. Numerous follow up phone calls made unable to reach the patient. The patient presented to the MD today for unrelated problem. Reports that right supraclavicular pain and swelling completely resolved in 1-2 weeks after the injection. Area was examined no swelling, no tenderness, no cervical lad injection site WNL.
Torso is still Itchy; Tired and slept part of day; Diarrhea; Could not move; Could not eat; Did not feel good for 3 days; Head ache she said was indescribable; Chills; Stayed in bed all day Friday; Red; Kicked my ass; Itchy around injection site; Moderna arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Kicked my ass), DIARRHOEA (Diarrhea), MOVEMENT DISORDER (Could not move), EATING DISORDER (Could not eat) and SOMNOLENCE (Tired and slept part of day) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Kicked my ass), TYPE IV HYPERSENSITIVITY REACTION (Moderna arm), VACCINATION SITE PRURITUS (Itchy around injection site) and VACCINATION SITE ERYTHEMA (Red). On 09-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), MOVEMENT DISORDER (Could not move), EATING DISORDER (Could not eat), MALAISE (Did not feel good for 3 days), HEADACHE (Head ache she said was indescribable), CHILLS (Chills) and FATIGUE (Stayed in bed all day Friday). On 10-Apr-2021, the patient experienced SOMNOLENCE (Tired and slept part of day). On an unknown date, the patient experienced PRURITUS (Torso is still Itchy). On 10-Apr-2021, HEADACHE (Head ache she said was indescribable) and FATIGUE (Stayed in bed all day Friday) had resolved. On 11-Apr-2021, MUSCULOSKELETAL DISCOMFORT (Kicked my ass), DIARRHOEA (Diarrhea), MOVEMENT DISORDER (Could not move), EATING DISORDER (Could not eat), SOMNOLENCE (Tired and slept part of day) and CHILLS (Chills) had resolved. On 12-Apr-2021, MALAISE (Did not feel good for 3 days) had resolved. At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Moderna arm), VACCINATION SITE PRURITUS (Itchy around injection site) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown and PRURITUS (Torso is still Itchy) had not resolved.            No concomitant medications were provided.  Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-077925 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Updated Contact details. Added patient demographics, Lot number (1st dose and 2nd dose). Added New event (Torso is still Itchy)
After 10 minutes of receiving  the Pfizer Covid 19 vaccine the patient felt light headed and laid down on the chair. Patient sat back up and was alert and oriented. Knew his name, the day, and where he was.  There was no signs of anaphylaxis. His pulse was faint. After 3 unsuccessful attempts at getting a blood pressure  5 minutes apart  I called 911. The paramedics came and the first BP was 107/80 and  pulse was 60. After they took a finger stick glucose reading His BP dropped to 80/44. They waited 5 minutes and rechecked . His BP came back up to 100/60 and his pulse was WNL. They told the patients mom it was ok to go home and monitor the patient. If it reoccur or PT is not feeling well call 911 or go to the ER
Headaches, body aches, shortness of breath, difficulty breathing, chest tightness since Apr 26th (2 weeks and continuing). ER visits on May 4, 2021 and May 10,  2021.
"Allergic urticaria" after receiving vaccines according to Pediatrician. The child was admitted for observation (24 hrs) and sent home the next day. Was in ED at 10:15 p.m. and admitted at 11:30 p.m.