chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painful arm/deltoid; Painful arm/deltoid; Swelling in muscle; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the left arm on 30Sep2021 at 00:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit disorder (ADD) and known allergies to mold, seasonal and pet dander. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included fish oil (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), multivitamin injection (MVI) (MANUFACTURER UNKNOWN) and vitamin b complex (B COMPLEX); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 30Sep2021 at 20:00, the patient experienced painful arm/deltoid and swelling in muscle. The events did not result in doctor or other healthcare professional office/clinic visit, 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 pain in arm/deltoid and muscle swelling was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Mom had mild fever for half a day; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as Dose number Unknown, Single for COVID-19 immunization. The patient's medical history was not reported and concomitant medication included esomeprazole (ESOMEPRAZOLE) 20mg orally taken for heart burn from an unspecified start date and ongoing. Patient did not receive any other vaccines prior to the COVID vaccine. It was reported that the patient had mild fever for half a day on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021166822 Same reporter/ drug, different patients/ events;US-PFIZER INC-2021363192 Same reporter/ drug, different patients/ events
Skin Lesion, Vesiculobullous Rash - Information has been received from aphysician concerning an 11 month old caucasian female who on 01 May 2000 was vaccinated with one dose of varicella virus vaccine live SC in the leg.  on 15 May 2000 the patient experienced 20 lesions in the diaper area that were diaper rash like.  She also experienced a few bumps on the upper thigh.  She was afebrile.  On May 20000, she experienced papuloveficular eruptions that went all the way up to her neck.  The eruptions spead to the trunk.  The physician thought it was chickenpox.  but had not definitively diagnosed as such.  The patient recovered by 25 may 2000.  Medical attention was sought.  No further information is available.
PATIENT HAS CELLULITIS THAT EXTENDS FROM INJECTION SITE AROUND THE ARM AND DOWN TO THE ELBOW.
Eyes rolled back, trembled all over for approx 10 seconds 1 1/2 days p/vax;
Began with extreme weakness (had to go to bed in the early evening on the day of the shot), pain at injection site, headache, nerve pain, sharp nerve zaps, involuntary muscle movements (jerking), tingling , burning feeling in both feet with some numbness, general feeling of nerves abnormally firing all around my body, preventing sleep.  Headache and tinging/burning feeling along with jerking continues today (2 days after shot).  Stayed in bed all day on the day after shot due to weakness, headache, tiredness and general ill feeling.  I do not know if this will get better over time or if these neurological symptoms will continue - they are ongoing at this time.
This spontaneous report was received from a nurse and health professional and refers to a 4 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (rHA), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
I have been on my period for 27 days now and it doesn't look like it's about to stop. I have never had any issues like this in the past, I believe it is related to the vaccine.
Local reaction at site of IM injection within about 8 hours - redness, swelling, pain (lasted about 2 weeks). At about 24 hours post vaccine: fever of 100.9 degrees F, chills, flu-like symptoms.  Stayed home all day. Fever down by next day but muscle aches & fatigue continue for about 2 weeks total with some activity limitations. Only home treatment with TYLENOL- did not see my doctor. NOTE: I had a similar reaction to the first SHINGRIX Vaccine given on 6/12/2018 (TP5E5) except that problems only lasted about a week.
pt recvd vax & exp burning upon inject, pain at inject site, flu-like symptoms & a flare up of psorissis after vax;
Information has been received from a registered nurse concerning a 35 year old female who in 1997 was vaccinated with the first and second doses of varicella virus vaccine live. Laboratory evaluation on 6/25/99 revealed a lack of response. No further information is available.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. In approximately July 2012, about 1 year ago, the patient was vaccinated with a dose of ZOSTAVAX. On 22-JUN-2013 recently, 30 days ago, the patient came down with shingles which had now subsided and the rash had cleared. He wanted to know if he might get a second dose of zoster vaccine live. Additional information has been requested.
STARTED FEELING NAUSEA, PAIN ON THE RT SIDE OF ABDOMEN THE DAY VOMITED STARTED A LOW GRADE TEMP. OF 99.5, TEMPERATURE 98.6 ON 6/22/13 CONTINUES WITH NAUSEA NO PAIN ON RT SIDE AT THIS TIME.
Breakthrough case admission after 3 vaccines Pfizer 5/21/21 Lot# Ew083;  Pfizer 6/12/21 Lot# EW0186;  Pfizer 5/12/22 Lot# FM7553
Groggy; Mild dizziness; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 08Mar2021 at 11:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, sinusitis, rhinitis, latex allergy and allergy to bee stings, tree nuts, peanuts, nightshades, apricots. The patient  was allergic to codeine (MANUFACTURER UNKNOWN). 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 Asthma Meds (unspecified), Zyrtec (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 08Mar2021 at 12:30, the patient experienced groggy, exhaustion and mild dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, 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 groggy, exhaustion and mild dizziness was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
pt recvd vax; LOC, grand mal sz, possibly 2;to hosp; sz occured one-four hrs following vax;
Patient stated he was feeling "dizzy", felt clammy, diaphoretic, cool to touch, blurry vision. No visible rashes. A&Ox4. Strong bilateral grip strength. Treatment included giving patient apple juice and took vital signs at 6pm (T: 96.5, P: 71, BP: 99/38, O2: 100%). Patient's color returned, dizziness and blurry vision subsided and he stated he was feeling "better"and stable. Took another set of vitals at 6:15pm (T: 97.6, P: 88, BP: 108/65, O2: 100%). Patient remained stable and observed patient leave witout distress. Advised parent to continue to observe and monitor for further or worsening symptoms, contact Provider if he has any questions and ED precautions given.
Swelling and redness in left arm, no fever, no pain. Stable on 4/18/06.
runny nose; feeling like flu; my whole body is hurting; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), INFLUENZA (feeling like flu), PAIN (my whole body is hurting), CHILLS (chills) and PYREXIA (fever) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced RHINORRHOEA (runny nose), INFLUENZA (feeling like flu), PAIN (my whole body is hurting), CHILLS (chills) and PYREXIA (fever). At the time of the report, RHINORRHOEA (runny nose), INFLUENZA (feeling like flu), PAIN (my whole body is hurting), CHILLS (chills) and PYREXIA (fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: inconclusive Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Went  into the ED for bilateral hand and feet tingling.  Worked up for possible Guillain Barre.
Allergic to Flu vaccine; This case was reported by a consumer via patient support programs and described the occurrence of allergy in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included breast cancer. Concurrent medical conditions included atrial fibrillation, drug allergy (paxil), penicillin allergy and spice allergy (garlic).   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Flu vaccine.     Linked case(s) involving the same patient:  US2023AMR027301   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: This case was reported by a consumer via (Patient Brochure Fulfillment/Shipment; Nurse Calls to Patients) patient support programs. The patient reported that she received flu vaccine. The patient stated that after received Flu vaccine she experienced allergy. The reporter did not consent to follow up. Additional supportive information: For tolerance to the pharma case refer US2023AMR027301; Sender's Comments:  US-GSK-US2023AMR027301:Pharma case
By Sunday 3-11-12 patient had a 6 1/2 cm x 4 cm red, warm raised lump where injection was given. PCV-13 is what was given in that thigh that he reacted to (R thigh).
Bell's Palsy; A spontaneous report was received from a Consumer regarding his wife who received the first dose of Moderna Covid-19 vaccine and have experienced Bell's palsy.  The patient's medical history was not provided. Her concomitant medication is thyroxine. No information on allergies.   On 04-FEB-2021, prior to the onset of events, the patient received first of two planned doses of Covid-19 vaccine intramuscularly for the prophylaxis of Covid-19 infection.   On 11-FEB-2021, patient noticed excessive watering from her right eye, next day on 12-FEB-2021, she felt jaw pain on right side of her mouth and her lip began to droop. On13-FEB-2021, patient was taken to ER where she was diagnosed with Bell's Palsy. She was treated with antivirals and steroids. She is recovering, but still side effects are present.   Action taken with the 2nd dose of vaccine was not reported.  The outcome of the event Bell's Palsy is still recovering at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient had no relevant medical history. The patient's concomitant medications were not reported (Other medication in 2 weeks reported as unknown). Patient had no known allergies. Reaction allergy for relevant past drug history (as reported). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid from 11Oct2022 to 15Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hot, swollen arm around and distal to injection site, low grade fever, nausea.
This spontaneous report as received from a physician refers to a female patient of unknown age. The reporter reported the patient was vaccinated with VARIVAX (Merck) (lot # unspecified), injection (dose, frequency, route and indication unspecified) at an unknown time in the past and now had a negative titer for varicella. No adverse effect reported. Outcome of the event was not reported. Additional information has been requested.
Severe diarrhea, vomitting, severe headache, profuse sweating, real tired and lethargic
shortness of breath that occurs with exertion; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. Other Case identifier(s): 90108767 (Agency).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA EXERTIONAL (medically significant), outcome "not recovered", described as "shortness of breath that occurs with exertion". Therapeutic measures were taken as a result of dyspnoea exertional.  Clinical course: Patient called to report a product quality issue, also reported that "about a year ago" she received the COVID vaccine and experienced a severe reaction to it which left her with shortness of breath that occurs with exertion. Patient stated that she was a very active person and did not have these problems prior to the vaccine. Patient was prescribed Asmanex Twisthalers for the shortness of breath and stated that she had several of these inhalers malfunction in the past (exact date unknown) where they "are difficult to twist." She did not call to report this issue at that time because she "was a nurse", Patient stated that these inhalers did work well at helping manage her shortness of breath but she did experience this symptom if she misses a dose. Patient did not provide any further details or information related to this event.  No additional AE reported. No additional PQC reported. There are no product to retrieve as these inhalers have been discarded. Treatment provided: Product: Asmanex Twisthaler Powder 110 mcg , Dose/frequency: 2 puffs a day, Product: COVID Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Temperature Excursion Product Administered; Initial Report Received on 07-DEC-2022  This is a spontaneous report, received from a registered nurse regarding a male patient, aged 28 years, who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 28-OCT-2022, a dose of HEPLISAV B (Lot #937783, expiration date 29-SEP-2023, NDC #43528-003-05), route and site not specified, was administered for hepatitis B immunisation.    On 25-NOV-2022, 28 days after the patient was vaccinated with HEPLISAV B, the reporter received notice that the HEPLISAV B that the patient received underwent  a temperature excursion.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sore Arm; Really Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), FATIGUE (Really Tired) and HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Hemorrhoids. Concurrent medical conditions included Diabetes and Blood pressure high.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), FATIGUE (Really Tired) and HEADACHE (Headache). On 28-Feb-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. At the time of the report, FATIGUE (Really Tired) had not resolved and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood glucose (95-130 mg/dl): 165 mg/dl (High) Increased  165 and 185mg/dl for 2 days..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Burning headaches for 2-3 days since shot. Diarrhea, dizziness.
Fever-Last week Thurs and again this week 103 last night. No rashes. Went to clinic yesterday. More crabby. Eating and drinking ok T.C. with mom. Fever broke Sat. afternoon medical thinks it's a viral illness.
sore arm, headache, sore throat, congested chest increased over the next 48 hours
I started to feel palpitations. They were getting worse after a few days. I decided I needed to go to Urgent Care - 6/17/2021 (I gave it a couple of weeks first to see if it would go away). They hooked me up to heart monitor and gave me EKG. He believed it was premature ventricular contractions. Recommended to get in touch with Primary Care doctor. I went to see him but couldn't see him until July 9th. He gave me another EKG in the office. He thought it was the same thing. He gave me a referral to get a chest x-ray, bloodwork, and to a cardiologist - Dr. We did the bloodwork - nothing significant came back on that. Everything was within limits. Chest x-ray: that came back fine. Cardiologist: He recommended I have a 10 day heart monitor to get a good idea of what was going on. He made an appt for me to get a Cardio-gram - but can't get that Sept 16th. I see the cardiologist on Sept 30th. I am still feeling the palpitations - constantly - day and night. They won't put me on medication until they get all the results. It is very bad. I am in no pain or shortness of breath but it's constant palpitations that I can feel day and night. My heart is missing beats and having premature beats. They need to know if the heart is damaged.
Fever 101.8 (axilla) at 12:30PM on 3/3/10, 24 hrs post vaccination, followed by brief seizure, gen at 1:05 PM, eyes rolled back, body stiffened with sl. jerking of arms and legs, whole episode lasted 5 sec., drowsy after, mom woke him up immediately - Family history maternal uncle had simple febrile seizure in infancy.
HIVES; This spontaneous case was received from a pharmacist on 10-Jun-2019. It describes a consumer who developed hives, after the administration of Vivotif for an unknown indication.  Case report: The consumer got hives after taking Vivotif. The consumer took 2 doses so far.  Action taken with Vivotif was unknown.  The clinical outcome of the event was unknown.  Company's Comment: In this case, it was reported that the consumer developed hives, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, hives is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer developed hives, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, hives is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Began feeling weak and almost passed out, onset of major headache, the development a fever that lasted 3 days, continued chills, fatigue, legs and arms weak, abdominal discomfort, broke out in spots over my body.