chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt states lt arm swollen of inject site then to lt neck & shoulder couldn't use arm, no strength in arm, painful burning in arm; hand turned blue; t101-102 for 2 days; 14FEB94 nauseated; off work 4 days;
Starting at 11am the day after-dizziness, body aches, nausea, chills for about an hour.
Severe headache, Body Aches, Chills, night sweats, frequent urination and frequent stool. Slight fever at 100 degrees
Sore ribs. Sore joints (shoulder, hip, knee, jaw). Sore throat / hurts to swallow. Symptoms came on after tetanus shot (4/24/04) and progressed over weekend. Better today. Mainly ribs are sore 4/26/04. Doing better.
Patient called on 9/30/17 complaining of swelling around injection site. Patient states swelling occurred on 9/28/17, the day after receiving the injection. Patient describes grapefruit-sized swelling around the injection site and reports it has since decreased to an orange-sized swelling on 9/30. Reports labored breathing, but not too difficult. No other signs of rash or allergic reaction. Advised patient to use BENADRYL to help with swelling and difficulty breathing. Advised patient to seek medical attention right away if symptoms worsen or do not improve.
Fever, Chills, Tremors, Paleness, Redness, swelling, Behavior Changes (Irritability).
The Product Must Be Received On or By 02/12/2019 date printed on the packing slip, vaccine was received 02/13/2019, the vaccine was not delivered within the allowable time. Vaccines were stored and administered. Parents were been notified that they have received expired or non-viable vaccine will need doses repeated.
was diagnosed with Covid-19; first dose on 30Jan2021; second dose not received yet; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (was diagnosed with Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 30Jan2021; second dose not received yet) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced COVID-19 (was diagnosed with Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 30Jan2021; second dose not received yet). At the time of the report, COVID-19 (was diagnosed with Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 30Jan2021; second dose not received yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
MODERNA COVID-19 VACCINE EUA: The patient was given Moderna 0.25mL IM x 1 instead of Moderna 0.5mL IM x 1 as dose #1 of the primary series. The patient was immediately called in an attempt to inform him of the administration error once it had been identified and also to have the patient return to the clinic for a repeat dose. However, the patient was not able to be contacted, and a voicemail was left requesting call back.
Patient found dead after receiving vaccine. At 11:44 on 3-30-2021 Medical Investigator was able to return call  after leaving scene where there was no phone service. Police were on the scene requesting Medical Investigator Contact was made between Medical Investigator and member of the police force. Narrative was that the patient, who is handicap with considerable health issues which he was born with, and his parents had been to healthcare facility to receive COVID vaccination. Returning they had traveled in order to arrive at their residence. The decedent had asked to be dropped off close to parents home. The parents arrived at the residence and after waiting ten to fifteen minutes walked searching for the decedent. He was located unresponsive and 911 was initiated.
Suspected spread of smallpox due to drying self with towel that may have had possible contact with vaccination area. 2/10/09 Per reporter-pt was not seen at any medical office or hosp. Reaction turned out to be possible mosquito bites.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The event lasted a few days, and then resolved. The reporter was from the GlaxoSmithKline outbound vaccines service center. He was notified last night during an outbound sales call to the pharmacist. There was no QA to report. This case has been linked with US2018GSK148719, reported by same reporter.
Patient received an expired dose of Pfizer covid 19 vaccination ndc 59267-1025-04. Dose was expired by about 17 hours.    No adverse reactions have been reported at this time.
Had shot (shingles - ZOSTAVAX) on 12/21/11. On 12/25/11 began experiencing pain under right breast & inside of right arm. Got worse over next couple of days. Rash appeared 12/28/11. Went to urgent care - physician diagnosed it as shingles. Started antiviral.
Tested Covid-19 positive; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested Covid-19 positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced COVID-19 (Tested Covid-19 positive). At the time of the report, COVID-19 (Tested Covid-19 positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, COVID-19: positive (Positive) COVID positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment for the events was unknown.
Swelling, redness, warm to touch, pain at site of administration: (R) deltoid.
Cardiac issues with classic COVID+ admitted for chest pain, chills, body aches loss of taste/smell admitted for telemetry cares.
Shortly after receiving his Moderna booster on 1/19/22 (after having received the Pfizer 2 doses  6/25/21 and 7/19/21), he did not feel well and developed increasing exertional shortness of breath and fatigue. He presented with cardiac syncope on 8/22/22.
Sore Arm with Moderate Pain, Muscle Pain, Headache, Mild Fever, Mild Stomach Pain, Nausea, Swollen Lymph Nodes, and Moderate Pain in Underarm Lymph Nodes.
Information has been received from a physician concerning a female patient over the age of 65 who on an unknown date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed swelling localized at the injection site and it appeared as a hard lump. It was also reported that the patient also experienced a fever that lasted for about a week. Unspecified medical attention was sought. On an unknown date, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Severe rash developed on right side of patient: back side of leg, buttocks, inner thigh and groin area.  Minor rash on top of right foot.  The rashes are red and include blistering.  At first, the rashes included itching sensation but at this point the itching is being replaced with sensitivity and pain. Patient had a virtual visit with GP who concluded this was an adverse reaction to the COVID vaccine and prescribed a series of steroids which the patient will begin taking after 2 weeks from the COVID vaccination.
brought to ER on 1DEC apparently had been put down for a nap that afternoon when mom checked on pt was unresponsive; preliminary autopsy results consistent w/SIDS;
Initial report received on 18/Aug/2006 from a health care professional.  A 32-year-old female patient with no current illnesses had received a right deltoid dose of Adacel on 14/Aug/2006, with a 25g 5/8 inch needle. The route of administration was not reported. The next day, the patient developed a 4x5 cm of local redness, induration and warmth at the right deltoid injection site.  Per the reporter, the patient experienced no fever, and a diagnosis of possible cellulitis was made.  The patient was treated with antibiotics.  Diagnostic testing and laboratory data were not reported.  the recovery status of the patient was reported as not recovered.
Receiving expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported. Date the vial was initially stored in the refrigerator: 31-Aug-2021.
A report was received from a healthcare professional on 10/16/2003 concerning a 2 year old vaccinee of unknown sex who received Fluvirin on 10/16/2003. On 10/16/2003 the vaccinee received Fluvirin.  The vaccinee did not experience any adverse symptoms. There was insufficient information to determine the reporter's causality assessment. Update 2, 10 February 2004: Further information was received from a healthcare professional on 02/10/2004 indicating that the vaccinee was male and experienced no sequalae of any type in the six weeks post vaccination. No follow up pending, all information received.
A week after receiving the shot, I was supposed to have my menstrual, but only received it for a day- from that point, I felt really cold and my right leg started to hurt. After a couple of days, I decided to go to the emergency room, which was when I found out I had severe sepsis and severe cellulitis in my right leg. I have been hospitalized twice from 11/14/21 to 11/23/21 and then from 12/10/21 to 12/13/21 due to the cellulitis being partially treated. I have not been in any accidents or have been cut or scratched in any way for this to happen. I am currently still home and not at work due to my leg still being swollen and much darker than my left leg. My right leg still is in pain and I cannot stand on it/ put pressure on it for very long.
Site: Pain at Injection Site-Severe, Additional Details: patient is having pain at injection site and is having hard time using her hand
Rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 2021SA346608 (SANOFI).  A 74 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; dupilumab (DUPIXENT) (ongoing) (Batch/Lot number: unknown) at 150 mg/ml (300 mg,qow) for dermatitis atopic; influenza vaccine (FLU VACCINE VII) (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "Egg allergy" (ongoing); "Food allergy" (ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Rash". The action taken for dupilumab was unknown.  Additional information: In the context of COVID19 crisis, then batch number and expiration date were not requested. On an unknown date the patient developed a non-serious event rash (unknown latency). The event (rash) qualified for Adverse Event of Special Interest. It was reported Consumer of DUPIXENT 300mg Auto-injector is inquiring about receiving the Pfizer Covid booster shot and flu shot, and wondering if there are any data or studies, consumer stated that her last injection she developed a rash and she stated she would ask her doctor about the rash and the Covid Booster and Flu shots, she stated she is very allergic and cannot take any vaccines with egg components, she does not have the lot numbers of the product as she already discarded it  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 28Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes II" (unspecified if ongoing); "HBP" (unspecified if ongoing); "Sarcoidosis" (unspecified if ongoing); "Gout" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt was nervous because the shot  due the fact she does not like needles. Pt was starting to feel nauseous after the shots . Pt was overall okay and left the pharmacy after 15 mins with her family.
Nausea; Lightheadedness; Fatigue; Headache; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, lightheadedness, fatigue and headache.  The patient's medical history was not provided. No concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced nausea, lightheadedness, fatigue and headache. No treatment information was reported.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, nausea, lightheadedness, fatigue and headache was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
After receiving the vaccines I woke up with an itch and a burn and it appears that I got shingles. It lasted for about three weeks and then it went away and I had just burning and a rash.
Reported fatigue, muscle aches, redness, swelling, warmth at the injection site. Benadryl self-administered per patient for relief of symptoms.
Usual pain at injection site. Severe fatigue and malaise. Rather severe body aches and joint pain. Osteoarthritis pain more severe. Low grade fever of about 100.5 for a little over a day, then normal.  After about a week, some swollen glands in my neck and some taste disturbance.  Taste somewhat altered, but NO change in sense of smell.  After about a week, fatigue and body aches have lessened but are not gone.  Joint pain and muscle pain have lessened, but persist.
denied having another COVID vaccine prior to administering dose.  When data entered into, she had received a Janssen Vaccine.  She was not willing to share where or when she had received the Janssen, but did admit she had one.
Vaccine given around 11:15 on 1/14/2021.   Around 1:30 am that night I woke up with severe chills.  Could not stop shaking.  Husband put electric blanket on and down comforter.  Severe headache, dizziness, n/v, severe joint and muscle pain and ear pain.    I had a slight fever of 100.2.  I was this way for all of 1/15/2021 and slept most of the day.   My husband called someone and was told this happens to some people.   On 1/16/2021 I felt like my old self by noon.  Not looking forward to the second shot.
After his two and four months shots he woke up three hours after the vaccines were given and screamed uncontrollable for 12+ hours. He would scream and cry himself to sleep then wake up about 20 minutes later and start screaming again. After the four month shots he had the same reaction followed by bursts of uncontrolled screaming and crying for up to two days afterwards in the evening. He ran a 100 temperature but did not have any swelling or redness at the site.
This spontaneous report as received from a physician refers to an 11 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 08-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # M040412, expiry date 30-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Began to feel uncomfortable evening of vaccine, with soreness in SHINGRIX injection site increasing. By the next morning, felt generally uncomfortable with on-and-off headaches. Large reddish area around SHINGRIX injection site (2-in in diameter). Was able to go to work, but felt sluggish. Felt good in the evening, but potentially developed a fever as I got chills mid-evening. Overnight, had alternating chills and sweats. Slept in late the following day (6/23) and felt much better. Injection site still very red, but no other effects remained. Redness mostly absent this morning (6/25).
Feel dizzy and chill whole body and vomiting till resting few hours and slowly recovered.
This spontaneous report was received from a registered nurse refers to unknown number of patients of unknown demographics. No relevant medical history of the patients was reported. On an unknown date in 2014, the patients were vaccinated with PEDVAXHIB (strength, dose, route of administration, lot number and expiration dates were not reported). No concomitant medications were reported. It was reported that since 18-AUG-2014, unknown number of patients were administered PEDVAXHIB which was improperly stored. This was supported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
This case was reported by a consumer via other manufacturer and described the occurrence of muscle pain in a male patient who received SHINGRIX for prophylaxis. On 2nd March 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain, stiffness, joint pain and pulled muscle. On an unknown date, the outcome of the muscle pain, stiffness, joint pain and pulled muscle were unknown. It was unknown if the reporter considered the muscle pain, stiffness, joint pain and pulled muscle to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced, extreme lower body stiffness including muscle pain, joint pain, and feeling as though he had pulled every muscle in his legs. By June 2018, the symptoms had progressed to his upper body. No additional adverse event information was available.
patient got first dose in April and has not gotten the second dose yet.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient got first dose in April and has not gotten the second dose yet.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient got first dose in April and has not gotten the second dose yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient got first dose in April and has not gotten the second dose yet.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided by the reporter.   Reporter did not allow further contact
Patient's VOICE BEGAN TO GET RASPY AND HER CHEST WAS FEELING TIGHT AND HEAVY ABOUT 10-15 MINUTES AFTER VACCINE GIVEN.  SHE HAD A PREVIOUS ANAPHYLACTIC REACTION TO A FLU VACCINE.  WE WAITED ANOTHER 10 MINUTES BUT HER SYMPTOMS WERE JUST GETTING WORSE SO I ADMINISTERED EPI PEN 30 MINUTES AFTER INJECTION. HER SYMPTOMS IMMEDIATELY IMPROVED AND HER HUSBAND TRANSPORTED HER TO EMERGENCY ROOM FOR FOLLOW UP
11:15 PM CHILLS WITH TEMP 99.7 3:00 AM sweating temp 101 took Advil at 11:15 pm and 3:00 AM