chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle and joint pains that got progressively worse over the next 24 hours; muscle and joint pains that got progressively worse over the next 24 hours; body pain/body aches; I also have shaking chills; throbbing headache; tender anterior cervical lymphadenopathy; runny nose; dry cough; chest tightness; First dose of bnt162b2 on 18Dec2020/ second dose on 04Jan2021; This is a spontaneous report from a contactable physician (patient). A 27-year-old female patient (pregnant: No) received of bnt162b2 (Pfizer), via an unspecified route of administration in left arm on 04Jan2021 07:15 at single dose (second dose), via an unspecified route of administration in left arm on 18Dec2020 12:30 at single dose (first dose dose) for COVID-19 immunization. Medical history included asthma, allergies from an unknown date and unknown if ongoing. Allergies to medications, food, or other products was none. The patient's concomitant medications were not reported. Around 12 hours after the second dose, the patient started feeling muscle and joint pains that got progressively worse over the next 24 hours. She had to miss 1 work day so far due to body pain despite alternating taking ibuprofen and paracetamol (APAP) around the clock. It was now 48 hours after the vaccine, and she still have severe body aches. She also had shaking chills, throbbing headache, tender anterior cervical lymphadenopathy, runny nose, dry cough and chest tightness. Of note, she was a healthcare worker and tested negative for COVID PCR immediately after she received my second dose of the vaccine. She was tested due to a low-suspicion possible workplace exposure 5 days prior. She had no symptoms before the vaccine. The patient underwent lab tests and procedures which included nasal swab test: negative on 04Jan2021. The events were reported as non-serious. The adverse event didn't result in emergency room visit or physician office visit. No treatment received for the adverse event. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Birth control pills.  Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the had patient been tested for COVID-19. The outcome of events was resolving.   Information about lot/batch number has been requested.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 06-FEB-2013 the patient was vaccinated with a dose of expired live, oral, ROTATEQ (lot # 670243/0921AA, expiration date 15-DEC-2012). It was not known which dose in the live, oral ROTATEQ vaccination series this dose was administered. No adverse effect reported. This is one of the several reports from the same source. Additional information has been requested.
got the shot, I have it again/ suspected vaccination failure; I have it again; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 15 years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was self-reported by the patient. The age at vaccination was not reported. The patient had shingles fifteen years ago and got the shot when it was over. The patient again got shingles after the shot and made doctor's appointment before it got worse. The patient thought he/she was safe.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
vomiting - Information has been received from a consumer concerning her 12 month old female daughter who on 02 feb 2001 was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  Concomitant therapy included one dose of heamophilus b conjugate vaccine manufacturer unknown.  Other concomitant therapy that day included one dose of paliovirus vaccine and one dose of diphtheria toxoid/pertuesia vaccine/teta, On 15 Feb 2001 at 4:00 am the patient began vomiting.  The mother reported that her brother had a seizure after receiving measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation waes 01021357.  The patient received unspecified medical attention.  Additonal information has been requested.
Mother called 9/16/04 and stated patient right arm red and feverish 3-4" in diameter. This started the previoius night , denies nay pain. Advised cool compress, Tylenol and Benadryl as needed. Spoke to mother on 9/17/04 area improved somewhat. Advised to cal back if any change.
nausea,; headache; This is a spontaneous report from a contactable consumer, the parent. A 16-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 12Apr2021 at 17:00(at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not received within two weeks of the COVID vaccine. The patient previously took  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:EP6955) via an unspecified route of administration in the right arm on 22Mar2021 at 17:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After the second dose on 13Apr2021 at 09:00 the patient experienced nausea and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events.  The clinical outcome of the events nausea and headache was recovering, at this time of this report.  No follow-up attempts are needed. No further information is expected.
Right after vaccination recipient became pale, cool, had narrowing vision, near syncopal episode, bradycardia, and increased BP. Recipient was stabilized by onsite EMS and transferred to the hospital.
Information has been received from a registered nurse concerning her 17 month old son with penicillin and egg allergies who on 07-APR-2005 was vaccinated intramuscularly with a first and only single dose of MMR II (lot number 647647/0991P, expired in June 2006). Concomitant vaccination included HIB vaccine (unspecified carrier). In June 2005 (also reported as within two months of getting the vaccine), the patient went from speaking 20 to 30 words to not speaking at all. The patient also started having really bad tantrums and "be spaced out" and stopped responding to his name. In January 2006 he was diagnosed with autism. It was also reported that recently he had his measles antibody titer drawn and results revealed the measles titer "5 times higher than normal". Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Upon internal review, autism was determined to an other important event. Additional information has been requested.
I was treated at the Emergency Department for an adverse drug reaction, i.e., swollen lymph nodes (Cervical Lymphadenopathy); starting from about 40 minutes after SHINGRIX injection was administered, my symptoms included sharp pain on left side of throat and even sharper pain after each attempt to swallow (also, elevated blood pressure). I was given 600 mg of Ibuprofen; after nearly 3 hours in the ER, I was sent home. It has taken almost 24 hours for most of the symptoms to go away.
This spontaneous report was received from a physician via company representative referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions /allergies were unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX, (lot number and expiration date were not provided), dose and anatomical location were unknown subcutaneous injection as vaccine for shingles (prophylaxis). On an unknown date, three days after received a ZOSTAVAX injection, the patient experienced a rash on the side of the face that effected the her eyes. The outcome of rash was reported as not recovered/not resolved. The patient sought for medical attention. The reporter did not assess the causal relationship between the adverse event rash and the vaccination with ZOSTAVAX.
This spontaneous report as received from a consumer refers to her husband, a 69 year old male patient. Patient's relevant medical history included heart disease. No drug allergies reported. On 16-JAN-2013 the patient received dose 2 PNEUMOVAX23 0.5 mL (route not reported). He had already had PNEUMOVAX23 on 07-NOV-2010 and did not experience an adverse reaction after receiving the first dose. Concomitant medications included CRESTOR, amlodipine, metoprolol and PLAVIX. On 16-JAN-2013, the patient's arm at the injection site was extremely painful after receiving the second dose of vaccine. No treatment was given, no lab test was performed. Patient did not seek medical attention. At the time of reporting the patient did not recovered from the event. Additional information has been requested. The consumer also reported AE regarding herself (captured in Case # 1301USA009248).
vaccines being given post temperature excursion (with no reported adverse event); Initial information received on 06-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient  to whom  diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] was given post temperature excursion (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE; and measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (Proquad).  On 04-May-2022, the patient received 0.5 ml  dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection (lot C5916AA; expiry date: 06-Jul-2023) via intramuscular route in the right deltoid for prophylactic vaccination vaccine was given post temperature excursion (with no reported adverse event) (product storage error) (latency: same day).  Action taken :not applicable.  At time of reporting, the outcome was Unknown for the event vaccines being given post temperature excursion (with no reported adverse event).   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 guidelines. 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.; Sender's Comments:  01092869: 01092879: 01092814: 01092832: 01092687: 01092746: 01092709: 01092741: 01092787: 01092803: 01092850:
On 3/6 pt's mother called and states pt. had immunizations on 3/4 and now pt. has "a large tennis ball sized knot on his (R) deltoid area - it's very hot and red" Mother states pt says it's painful.
Vaccinated: 11:17 am. Reaction: 11:27 am. Patient reported dizziness and ringing in ears. Vitals: 142/86, 84 and 18. Patient stabilized and released from vaccination site.
Pt noted injection was given high in right arm.  Felt liquid disperse as vaccine was given.  No other issue at time of administration.  Felt soreness starting at 10:30pm but in am when woke could not lift arm and arm was swollen at site of injection.  No bruising no readness noted, slightly warm.  Notified employer (Vaccine clinic was hosted on site at work by the Health Department).  Pt had  continued swelling and pain symptoms on 11/11/21.  Patient took picture and is forwarding to me to have if needed.  She went to urgent care, on 11/12/21 and provider recommended 1000mg ibuprofen to treat.  Symptoms continued, unable to lift arm, pain with movement, muscle spasms, weakness when trying to lift items.  Saw PCP on 12/21/21 and was referred to orthopedics.  Saw Orthopedics on 1/6 and was diagnosed with impingement syndrome and tendonitis of right rotator cuff.  Patient has started twice a week physical therapy per orthopedic order.  Next follow up with PCP is 2/3/22 and Orthopedics 3/8/22.
like a bronchitis; cough; wheezing; coughing up phlegm; Fever; body aches; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received secondo dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181), via an unspecified route of administration, administered in left arm on 26Aug2021 at 16:30 (at the age of 34-years-old) as dose 2, single for COVID-19 immunisation. Previously the patient received the first dose of bnt162b2 (lot number: EW0180) on 04Aug2021 for COVID-19 immunisation. The patient did not receive any other vaccination in 4 weeks. The patient's medical history and concomitant medications were not reported.  The patient experienced like a bronchitis on 27Aug2021. The onset time was reported as 00:30-01:00. The patient was at a urgent care for like a bronchitis she thought, and they told her that she needed to call and report her symptoms since her symptoms started after her second dose of the Covid-19 Vaccine. She said that she had a little bit of a cough on 27Aug2021 and it has progressively gotten worse. She said that she had a fever, and body aches for a couple of days and at the time of reporting she felt like she has intermittent wheezing and she was coughing up phlegm. The events resulted in Urgent care and Physician Office visit. The reporter assessed the event bronchitis as related to suspect product. Bronchitis and coughing up phlegm were not resolved, pyrexia and body aches were resolved and the outcome of the other events was unknown.; Sender's Comments: .As per temporal association , causal association of events(pyrexia , Bronchitis, cough, wheezing, pain, Productive cough  ) 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.
Patient incorrectly given Bivalent Booster dose and starting dose, has not completed initial mRNA series
Approximately 12 hours after receiving both the ZOSTAVAX and the SHINGRIX vaccines I experienced chills, dizziness, headache, nausea, non -productive vomiting, fatigue, extreme weakness. Following the SHINGRIX vaccine my reaction was much more severe, actually blacking out, fainting on the floor and apparently losing bladder control noticed after becoming coherent again. Fortunately my partner was there to assist and care for me, but I just slept on the floor for 4 hours as it aggravated the symptoms when I attempted to move. He said I was completely limp and could not hold myself up. I finally was able to get back in bed and slept another 4 hours. Other than a headache, sore arm and some fatigue I feel it has resolved at this time, about 23 hours after receiving the vaccine. I am a healthy active adult, quite fit through running, swimming, biking, skiing etc so this reaction was surprising to me as I have never had any reaction to a vaccine. I did have difficulty with donating blood at one time but don't think thats related.
hasn't taken second dose yet (more than 42 days following first dose); dizzy; my skin got very red in my arm; my neck was swollen with these lymph nodes; everything was sore leg, belly, breast; everything was sore leg, belly, breast; everything was sore leg, belly, breast; swollen lymph nodes; very tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ERYTHEMA (my skin got very red in my arm), SWELLING (my neck was swollen with these lymph nodes), BREAST PAIN (everything was sore leg, belly, breast) and ABDOMINAL PAIN (everything was sore leg, belly, breast) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced DIZZINESS (dizzy). In April 2021, the patient experienced ERYTHEMA (my skin got very red in my arm), SWELLING (my neck was swollen with these lymph nodes), BREAST PAIN (everything was sore leg, belly, breast), ABDOMINAL PAIN (everything was sore leg, belly, breast), PAIN IN EXTREMITY (everything was sore leg, belly, breast), LYMPHADENOPATHY (swollen lymph nodes) and FATIGUE (very tired). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (hasn't taken second dose yet (more than 42 days following first dose)). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy), ERYTHEMA (my skin got very red in my arm), SWELLING (my neck was swollen with these lymph nodes), BREAST PAIN (everything was sore leg, belly, breast), ABDOMINAL PAIN (everything was sore leg, belly, breast), PAIN IN EXTREMITY (everything was sore leg, belly, breast) and FATIGUE (very tired) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (hasn't taken second dose yet (more than 42 days following first dose)) and LYMPHADENOPATHY (swollen lymph nodes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  It was stated that Patient felt dizzy right away after the first shot. Two to 3 days later, patient felt very tired and her skin got very red in the arm, her neck was swollen with these lymph nodes (swollen lymph nodes), and everything was sore (leg, belly, breast). It took a month and a half to have the swollen lymph nodes go away.  Patient had a reaction after the first shot, and she decided to postpone second dose.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow-up information include reporter phone number added, events start date added, event outcome updated and treatment medication added.
COVID 19 INFECTION; This spontaneous report received from a patient concerned a 27 year old. 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: 1802072 and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced covid 19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid 19 infection was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-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.
Onset of urticaria that manifested on circumferential on the neck and face. Complaint of severe itch, swelling and numbness of lips, tightness in throat and chest. Evaluated in ER and treated with oxygen,pulse ox, heart monitor, iv,fluids, Epi, Steriods, Antihistamines. Had rebound reactions and admitted for treatment and observation.
Patient has started developing swollen lymph nodes an hour after administering the vaccine. Patient had to seek health care assistance from an urgent care on the next day and discharged with instructions for observation and to take otc tylenol.
Patient received 2 doses of dtap + ipv (kinrix) vaccine on the same day.
Head pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Head pain) 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 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced HEADACHE (Head pain). At the time of the report, HEADACHE (Head pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.; Sender'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.
Moderna COVID-19 Vaccine EUA         Rash upper arm by injection site.  Still have rash; treating with Cortisone 10 and Claritin antihistamine.
Heart pain/ chest pain. Hard to breathe Lack of energy Swollen legs  Erratic heart rate Outcome: death 3 days after.  Heart failure
The mother came in today to the minute clinic to describe the event as starting with swollen lips around bedtime and then numbness and then shaking. Ambulance brought him to the hospital.
i received the vaccine at 1455 ... about 3 hours after the shot there was tenderness in my arm at the injection sight ... during the night I got chills and my muscles were sore ... I got up to try and go to work at 0300 and felt faint and muscle weakness ... during the day i was just completely exhausted and had major muscle weakness where i could barely walk around at all any my skin felt like it was crawling ... i took my temp and it was 99.5 ... that night around 1800 i took nyquil and went to bed ... woke up at 0100 covered in sweat and had chills ... got up at 0300 with my alarm and have no symptoms at all except minor pain at the injection site
Large rash at injection site, approximately 6"+ in diameter, red, raised, warm to touch and very itchy.  "Covid Arm" Last approximately 48 hours. Delayed reaction beginning 4 days after injection.