chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via Pfizer regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacture unknown) (dosing details, frequency, route of administration, lot number and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced bradycardia and tachycardia (moderate). Outcome of bradycardia and tachycardia was unknown. The reporter considered the events, bradycardia and tachycardia to be related to varicella virus vaccine live (Oka/Merck) (manufacture unknown). Upon internal review, the event bradycardia was determined to be medically significant.
weird neurological sensation that felt like pressure and a cold sensation on her head; weird neurological sensation that felt like pressure and a cold sensation on her head; check the back of my head because it felt like it was wet. It's hard to describe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (COMIRNATY), administration date Sep2021 (Lot number: 32030BD, Expiration Date: 30Nov2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: HEAD DISCOMFORT (non-serious), FEELING COLD (non-serious), outcome "unknown" and all described as "weird neurological sensation that felt like pressure and a cold sensation on her head"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "check the back of my head because it felt like it was wet. It's hard to describe".  Additional information: Patient said that she experienced a "weird neurological sensation that felt like pressure and a cold sensation on her head almost immediately after receiving my second dose. It lasted until day 3 and then it was intermittently happening. Sometimes I had to check the back of my head because it felt like it was wet. It's hard to describe."  Case was reported as non-serious.  No follow-up attempts are possible. No further information is expected.
(R) deltoid red, swollen, tender 5x5 cm area, no fluctuance. Positive temp at home.
Dots on  chest. Skin was completely smooth. It appears to be under the skin.; Small, tiny, reddish/purplish dots. Those appeared 1-2 days after 1st vaccine shot on arms (forearms + near elbow crease).; This is a spontaneous report from a contactable consumer, the patient. A 28-years-old non pregnant female patient received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration in left arm on 30Mar2021 at 14:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included HIV (but undetectable). The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had been tested for COVID-19. On 31Mar2021,after getting first vaccination shot the patient had experienced rash erythematous and rash on chest. (Patient had small, tiny, reddish/purplish dots which were appeared 1-2 days after her 1st vaccine shot on her arms (forearms + near elbow crease), then those went away. The patient had noticed the same dots on patient chest later. patient skin was completely smooth and the rashes were appeared to be under the skin). The patient underwent lab tests and procedures which included SARS-CoV-2 test on 31Mar2021 and was tested negative. No therapeutic measures were taken as the result of adverse events. The clinical outcome of the events rash erythematous and rash were not recovered.  No follow-up attempts are needed; information about lot number cannot be obtained.
SICK; This spontaneous report received from a consumer via social media via a company representative concerned a 75 year old of unspecified sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (Dose number series 1) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The patient was sick on the same night with first dose of covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s  (Dose number series 2) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 8 decade old. No concomitant medications were reported.  On an unspecified date, the patient experienced sick (Dose number series 2). As per reporter " I had the J&J and was sick on night that I got shot Then got booster shot. Was sick again. But I'm not getting any more booster's I'm 75. I don't think they even offer another booster for J&J ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious. This case, involving the same patient is linked to 20221241808.
cold feet and she cannot get warm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (cold feet and she cannot get warm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PERIPHERAL COLDNESS (cold feet and she cannot get warm). At the time of the report, PERIPHERAL COLDNESS (cold feet and she cannot get warm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-073718, US-MODERNATX, INC.-MOD-2021-073718 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073718:1st dose US-MODERNATX, INC.-MOD-2021-073718:
Redness and swelling of the site. temperature of 102-told to apply warm compress, take Tylenol and Benadryl.
On Aug. 18, 2009, patient came for a well child check and she was given DAPTACEL as catch up - last imm given at 15 m/o.
One day post vax the pt developed 25 red lesions. The lesions were described as wheals and bumps and was diagnosed with urticarial reaction. The pts mother is pregnant and has never had chickenpox.
Headache; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 15Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 15Feb2021, the patient experienced headache. It was reported that patient got the second vaccine 2 hours ago and she was fine at first. She waited the 15-20 minutes after getting the vaccine there. However, once she got in her car the drive on the way home, she started to get a headache. She has had a headache ever since. She knows headache is one of the side effects and wants to know if it is okay to take Tylenol. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
POUNDING HEADACHE, COULDNT SLEEP, PAIN UNDER ARM PIT, NECK PAIN, SWELING UNDER ARM PIT
First symptoms - arm pain, back pain, tiredness, lack of sleep. Next - difficulty breathing, fast heart beat, dizziness, weakness, vomiting, diarrhea, mild fever.
pt brought from home to hospital with c/o altered mental state, cough, SOB; positive for COVID; decreased oral intake while in hospital with weight loss; failure to thrive; became hypernatremic; family decided to withdraw care; DNR; comfort care measures; pt died in the hospital
GBS after flu shot; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a Unknown number of patients who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The reporter stated that guillain barre syndrome (GBS) it was a horrible disorder.  The reporter knew a couple people who got it taking a flu shot.  Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR133022:same reporter
Developed chills, fever to 102, nausea and vomiting with increasing cough and resp distress.  Presented to Emergency Department 10/28 at approx 5:30a with resp distress.  Found to have RML/RLL pneumonia, asthma exacerbation, requiring admission.
p/vax pt devel rash;had congestion in nose;rash broke out around face & arms, legs & feet;has papular diffuse rash ;TM's sl dull;eyes have conjunctival;mild eczematous;erythematous macular pap lesions;allergic rxn to MMR;
She noticed her arm swollen, red and hot to the touch on 9/27/2016 then she went to her pcp on 9/28/2016 and was diagnosed with infection at injection site. She was given Augmentin and prednisone, started Augmentin 9/28 in the evening and was starting to improve on 9/29 in the afternoon.
Five to seven days post vax pt developed a fever, rash and lymphadenopathy. Pt recovered with no treatment. Follow up states patient experienced joint pain.
Pt recv vax on 3/8/99; on same day pt exp problem breathing & turned blue
Tingling, in both feet; Numbness in both feet; Burning in both feet; she saw her doctors because it was getting worse; doctor thinks that the booster shocked her system; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 02Sep2021 as dose 3 (booster), single (Lot number: FC3182) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (dose 1, single, Lot/batch number: EL3249 Expiry Date: unknown, Route, Anatomical Location: unknown), administration date: 15Jan2021, when the patient was 59-year-old, for COVID-19 Immunization; BNT162b2 (dose 2, single, Lot/batch Number: EM9809, Expiry Date: unknown, Route, Anatomical Location: unknown), administration date: 05Feb2021, when the patient was 59-year-old, for COVID-19 Immunization. The following information was reported: BURNING SENSATION (non-serious) with onset 12Sep2021, outcome "not recovered", described as "Burning in both feet"; HYPOAESTHESIA (non-serious) with onset 12Sep2021, outcome "not recovered", described as "Numbness in both feet"; PARAESTHESIA (non-serious) with onset 12Sep2021, outcome "not recovered", described as "Tingling, in both feet"; CONDITION AGGRAVATED (non-serious) with onset 12Sep2021, outcome "unknown", described as "she saw her doctors because it was getting worse"; SHOCK (medically significant) with onset Sep2021, outcome "unknown", described as "doctor thinks that the booster shocked her system". The events "doctor thinks that the booster shocked her system", "tingling, in both feet", "numbness in both feet", "burning in both feet" and "she saw her doctors because it was getting worse" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: normal, notes: everything is normal; Diabetes mellitus: normal, notes: everything is normal; Electromyogram: normal, notes: everything is normal; ultrasound: normal, notes: everything is normal. Clinical course: It was reported that about 10 days later, she experienced tingling, numbing, and burning in her both of her feet. Caller states that she saw her doctors because it was getting worse. Caller states that she saw a neurologist, and a dermatologist, and saw a total of four physicians, including her primary care doctor and she had all kinds of tests, including EMG, bloodwork, ultrasound, and a diabetic test, and everything was normal. It was reported that her doctor thinks that the booster shocked her system, but he was not really sure.
Splitting headache; Fever of 99.8; Chills; Muscle Soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Splitting headache), PYREXIA (Fever of 99.8), CHILLS (Chills) and MYALGIA (Muscle Soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in May 2020.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (Splitting headache), PYREXIA (Fever of 99.8), CHILLS (Chills) and MYALGIA (Muscle Soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Mar-2021, HEADACHE (Splitting headache), PYREXIA (Fever of 99.8), CHILLS (Chills) and MYALGIA (Muscle Soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       List of concomitant medication were not given.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EW0151), in left arm, on 27Apr2021 as dose 2, single (Lot number: EW0165), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Occasionally allergic reactions to metals" (unspecified if ongoing), notes: Known allergies: Occasionally allergic reactions to metals; "Other medical history: Good condition. Slightly high cholesterol" (unspecified if ongoing), notes: Other medical history: Good condition. Slightly high cholesterol. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood cholesterol: high cholesterol, notes: Other medical history: Good condition. Slightly high cholesterol. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid for COVID-19 treatment with start date 06Sep2022 and stop date 09Sep2022. Patient took Nyquil Liqui Caps cold & Flu Night-time relief (only 1 night), Vicks with start date 04sep2022 and stop date was 05sep2022, Tylenol 8hr (only 1 night), with start date 05sep2022 and stop date was 06sep2022. On 07Sep2022 patient experienced skin rash on her breast, abdomen, back, arms, legs. For the treatment of adverse event patient received prednisone 20MG tablet and diphenhydramine 25 mg cap.  No follow-up attempts are possible. No further information is expected.
Severe body aches, fever (101.5), malaise, fatigue.  Patient was advised to take ibuprofen for 24-48 hours.
she was always regular with her period.  she was due to get her period on June 21.  She never got it.  She finally got it during the week of July 19th, but only for 2 days and very light.  Usually she is regular, with a 28 -30 day period cycle. Last about 6 days, usually comes with a lot of back pain and starts light, then heavy, then light as it ends.  It was very strange she not only missed it, but the following one was for 2 days and more spotting then an actual flow.
numbness with two of his toes and in both legs; pain in both legs; This case was reported by a consumer via other manufacturer and described the occurrence of numbness in toes in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020, an year ago from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced numbness in toes and leg pain. On an unknown date, the outcome of the numbness in toes and leg pain were unknown.   It was unknown if the reporter considered the numbness in toes and leg pain to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. Within 60 days of having the 2nd dose of Shingrix, the patient started to have numbness with two of his toes. Then within 6 months of the symptoms starting and less than 9 months after receiving 2nd dose of Shingrix, the patient started to experiencing pain and numbness in both legs from his toes to right above his knees. The reporter stated that, he visited many different specialists (i.e. neurologist, podiatrist, etc) and had several tests done (i.e. Magnetic resonance imaging, computed tomography (CAT) scan, etc) and no one had been able to figured out the main cause. The reporter was asking information related to Shingrix. No other information was provided. No Product complaint was reported. The follow-up would not possible as no contact details were available.
Patient was supposed to receive second Pfizer dose and received 0.3ml of Janssen instead. Only effects patient stated that he has felt is a sore arm.
Information has been received from a registered nurse concerning a patient who on approximately 14-JAN-2008 "2 months of age" and 14-MAY-2008 ("6 months of age") was vaccinated with a first and second dose of ROTATEQ.  No adverse symptoms were reported.  A product quality complaint was not involved.  Additional information has been requested.
After the second dose of the Pfizer covid vaccine, the caller was chilled during the night and it was one night; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported) via an unspecified route of administration on 28Mar2021 (age at vaccination 70-year-old) as DOSE 2, SINGLE for covid-19 immunization. Patient had historical vaccine of first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported) via an unspecified route of administration on 07Mar2021 (age at vaccination 70-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included hypertension, glaucoma, basal cell carcinoma (The caller had surgery on this). Reason for non availability of lot number as the caller was not having her vaccination card. The patient was taking Pfizer covid vaccine for the protection. Concomitant medications included hydrochlorothiazide, timolol, paracetamol. On 28Mar2021 after the second dose of the pfizer covid vaccine the patient experienced chilled during the night and it was one night. The clinical outcome of the event was recovered on 28Mar2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
0908 vaccine given, 0925 patient says itchy on face, back ,neck, chest, 0930 Benadryl 50mg Im L arm given.  0950 patient states feels better, no other symptoms.  1020 symptoms gone
Patient seen about 1 month after for diffuse internal itching. Lasted several sweeks to months. Now with vitiligo per patient. Started about 1 month after vaccine. has since spread over large portion of her body.
Extreme fatigue and severe arm pain 2 hours after injection.  Following day, April 16 I could function much better.  April 17 fatigue again.
pt reports swollen area of arm slightly above elbow but lower than where injection occurred. vaccine was administered yesterday afternoon and she made us aware of this at 9am the following day when the pharmacy opened. Patient reports that it is swollen and red, warm to touch. Patient was advised to go to urgent care.
Patient presented with complaints of growing hot erythema and tenderness left deltoid are since and surrounding DTAP. Mild aching. Fever previous night 100.5. Site red hot and swollen.
Patient had first moderna dose. She had a itchy ,funny sensation in throat. I called the paramedics. They arrived and took patient to the hospital.
1MAY97 in evening had h/a;2MAY97 in morning lt arm was red & purplish, hot & itching;per mom there was a lump the size of a baseball;
Information has been received from a health professional concerning a 15 month old patient who on 01-MAR-2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. "Approximately 13 days after receiving the vaccine", on approximately 14-MAR-2006, the patient experienced a generalized maculopapular rash and low grade fever. No other symptoms were reported. The rash lasted approximately 24 hours, and was fading. It was reported that the patient was doing well. At the time of the report the patient was recovering. Additional information has been requested.