chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting feeling pain in left armpit of arm shot was given on 7/29 on 7/30 I woke up to a small red spot under the arm. On 7/31 spot got bigger and noticed another spot on the other side of same arm pit.  On 8/01 red spots became larger, bumpy and more red, burning and tingling sensation. Spots are very painful. On 8/2 I went to emergency road where a doctor took a look and diagnosed me with Shingles, he stated it was due to the ingredients in the moderna shot causing shingles to surface as a reaction. I've never had this before. Never any skin issues like this. And it's very painful.. I now have noticed a red painful mark on the left side of my neck.
Patient got flu vaccine & shingles vaccines on 11/27/2019. He was admitted to hospital with a septic right elbow requiring IV antibiotics for weeks. He had the same thing happen 1 year ago after he received his flu shot on 9/17/2018. He had a septic right elbow and was hospitalized with IV antibiotics.
had her first dose this morning/She received a notification that her second dose was today as well at 4 p.m.. She mentioned that her last name was misspelled/wanted to reschedule the second dose; She doesn't feel good; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2, via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient had her first dose this morning (21Jan2021). She received a notification that her second dose was today as well at 4 p.m.. She mentioned that her last name was misspelled. She wanted to reschedule the second dose. She asked if she could take a second dose at a later time. She said she didn't have time and she didn't feel good. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On 25-JAN-2017, the patients were vaccinated with improperly stored doses of VARIVAX (lot number M037008 with an expiration date of 25-AUG-2018, lot number M031969 with an expiration date of 30-JUN-2018, lot number M017292 with an expiration date of 04-APR-2018, and lot number M008173 with an expiration date of 16-FEB-2018; strength, dose, route of administration and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 1 hour and 10 minutes at a temperature of -0.5 degrees Celsius on unspecified date. No previous temperature excursion was reported and a data logger issue was involved. No adverse event and no product quality complaint (PQC) were reported. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA000894:
body aches; fever; stuffy nose; no appetite; headache; sick; runny nose; sleeping all day; Initial information received on 27-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who had developed body aches, fever, stuffy nose, no appetite, headache, sick, runny nose and sleeping all day while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site (dose, frequency, route, formulation, strength, lot/batch number and expiration date: not provided) as prophylactic vaccination.  On an unknown date the patient had developed a non-serious body aches (pain),fever (pyrexia), stuffy nose (nasal congestion),no appetite (decreased appetite), headache,sick (illness),runny nose (rhinorrhoea) and sleeping all day (hypersomnia)(unknown latency) following the administration of Influenza vaccine.  It was reported I got mine the beginning of December & I've been sick. I got the Flu body aches fever stuffy nose runny nose. No appetite sleeping all day etc. Now I've been sick for 3 days with funny nose headache body feeling tired etc. And i got the high dose because of my age.  Action taken- Not applicable.  It was not reported if the patient received a corrective treatment for the events (body aches, fever, stuffy nose, no appetite, headache, sick, runny nose, sleeping all day).  At time of reporting, the outcome was Unknown for all the events.
Vertigo, fluid in right ear, loss of hearing in right ear for 3 weeks, whooshing and high pitched noises in ear during hearing loss; varying degrees of dizziness 1-2 days after booster I needed help to walk; 2 weeks after booster needed to hold on to things when walking; 3-4 weeks after booster still dizzy. it feels like the room is tipping down left and right
One hour after vaccine, pt states she had a grand mal seizure. She felt fine for 25-30 minutes afterwards; she stayed at the pharmacy about 20 min. Pt was in the pharmacy about 2 weeks later, broken clavicle. No previous history of seizure.
0843:  POST VAC. ADMIN. C/O:  DIZZINESS, NAUSEATED, SLUGGISH FEELING.  VS:  98.3, P:  78, R:  18; BP:  128/70.   ESCORTED, AMB. TO EHS.
erythema, mild edema (area measured 6cm x 4cm) p/vax administered; sx w/in 24 hrs of inject; symptomatic treatment used;
The pt experienced redness/warmth over the left arm area about 12 hours with increased in redness and swelling until evaluated 36 hours later. Advised ice to area and hydrocortisone cream.
an expired Adacel vaccine was administered, with no reported adverse event; Initial information was received on 15-Jun-2021 regarding an unsolicited valid non-serious case from other health professional (GMI Inquiry number: 00642258).  It was reported that an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6321AA, expiry date: 07-Jun-2021) was administered to a 11-year old female patient on 14-Jun-2021 via an intramuscular route at left arm for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient had prior allergic reaction to tetanus shot in 2007. Also given diagnosis of mast-cell disorder, she pre-medicated with Benadryl 25mg, then received the vaccine. After about 15 minutes, she started to feel itchy and transient chest tightness. No rash noticed pulse-ox 98-100%, Heart rate 75 and BP 123/80. She was given 25mg more of Benadryl and observed for another 20 minutes. She said her symptoms has completely resolved and she went home with her husband after being given strict instructions to return.
Electrical fizzing sensation in right leg below right knee. This sensation has occured multiple times each day since receiving the vaccine and lasts about 3-5 seconds each time. The sensation does not hurt, but creates a very odd and noticeable sensation.
Did and still got the flu and still not over it 1 month now; Initial information received on 09-Jan-2023 regarding an unsolicited valid social media non-serious case received via consumer/non-hcp.  This case involves adult and unknown gender patient who experienced did and still got the flu and still not over it 1 month now while receiving vaccine Influenza Vaccine (flu shot).  It was unknown if the patient had any medical history, concomitant disease, or risk factor.   On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination. Information regarding batch number requested.  On an unknown date, the patient reported still got the flu and still not over it 1 month now (influenza) at unknown latency following the administration of Influenza Vaccine.  Action taken: Not applicable. It was unknown if there were lab data/results available.   It was unknown that if the company suspect product inappropriately used as per local Marketing authorization.  Corrective treatment: not reported.  At time of reporting, the outcome was not recovered for the event Influenza.
Pt had a mild cold at time of vaccination. Pt had been asked to stay at clinic after vaccination for 15 min, no reaction reported then. Per family, the afternoon after receiving the vaccination, pt was confused/ didn't know where or who he was for 5 minutes. Symptoms resolved spontaneously. It was discovered p 2/8/17 that he had already received the vaccine from an outside pharmacy- they didn't inform us of the vaccine administration. Pt was evaluated by provider on 2/8/17 and is currently asymptomatic.
4 doses IM EPI along with IV drip, Diphenhydramine, and solumedrol. Required admit to ICU for airway watch.   Pt reported to ER with shortness of breath and feeling that her tounge was swelling.
Moderna Bivalent came from our central fill facility. On paperwork, beyond use date was labeled 4/5/23, but on bag that vaccine came in, beyond use date was labeled 5/15/23. Patient received vaccine on 4/21/23.  Clinical pharmacist checked with the manufacturer and determined the doses that were administered were valid.
Today 06/03/2021 at 1600 the patient came to receive her second dose accompanied by her father. The patient received her first Pfizer dose on 05/13/2021 at school, as stated on her vaccination card. Lot # EW0177.  The assigned vaccinator for her second dose, verified the patient's name and age. Patient stated her age was 11 years old .The parent was pulled aside and was asked to explain how the patient was vaccinated the first time. The patient  came with her mother on 05/13/2021 pre registered for her first dose. The parent stated the patient did not have any side effects or reactions from the first dose. It was explained to the parent that since patient is under 12 years old, it has not been approved by CDC guidelines to be vaccinated.
About an hour after receiving the first dose, I encountered a severe rash on my body. My lips and tongue were swollen. The rash was very itchy and burning. I also developed a rash on my right foot and there are blisters. I contacted my doctor and they advised me to go to urgent care. I went to urgent care. Dr. gave me an injection and medication to combat the rash. After that, I went home and about 2-3 days later I started feeling nauseous. I developed a cough and there is a lot of phlegm. This kept increasing and is still going on today. Lately, I have been tasting a very strange taste in my mouth. I am still getting a rash that will pop up. Today I have a rash on my arm and they are leaving scars on my body.
Pt complain of mild pain of the arm and fever (described as warm head). Advised pt to take TYLENOL 1000mg every 4 to 6 hours if needed. max 4gm/day.
Seizure, reported it to baby's nurse at clinic, she notified her pediatrician. Told to bring baby to the ER which we did. Treated in the ER, diagnosed as having a seizure.
"How long will my arm hurt; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY ("How long will my arm hurt) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY ("How long will my arm hurt). At the time of the report, PAIN IN EXTREMITY ("How long will my arm hurt) had not 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 relevant concomitant medications were reported. No treatment information was provided.
SEVERE CHILLS AND SHAKING - BURNING UP AND SWEATING AT TIMES - HIGH TEMPERATURE OF 101.9 LIGHT HEADED, - HEADACHE - COULD NOT STAY AWAKE AT TIMES
Pain at site of injection for 3 days.  Muscle twitching and spasms in eye, arm, shoulder, leg starting on day 5 and continuing  thru today day 11.  Large raised itchy hot rash appeared on day 7 around the injection site.   Extreme fatigue day 8. Constant muscle pain in legs just above knees.  Pain that comes and goes in head, neck and right arm.
Initial unsolicited report received from physician on 24 May 2018. This case involves eight-month-old patient (gender not reported) who was vaccinated with a dose of PENTACEL and ACTHIB (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to extra dose administered. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder' compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient was given Moderna which should not be given to patients under the age of 18.    Per CDC guidelines 2nd dose was given on 07/22/2021.  patient turns 18 years of age on 08/03/2021.
Patient states she started having a red rash develop on her back that were itchy about 8 hours after she received the vaccine.  She used anti-itch lotion and diphenhydramine which helped with the itchiness.  The next morning she started to have red, itchy welts develop on her chest, however her back was improved.  She is still using the lotion and diphenhydramine for her symptoms.  Recommended she continue to use these therapies, and if her symptoms worsen then to contact her provider.  The patient also stated this was the second time in her life that she got a flu vaccine, the first time was in 2018.
Pharmacist states they gave full doses (0.5ml) for boosters instead of half doses (0.25ml); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses (0.5ml) for boosters instead of half doses (0.25ml)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses (0.5ml) for boosters instead of half doses (0.25ml)). On 25-Oct-2021, ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses (0.5ml) for boosters instead of half doses (0.25ml)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Depression.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified antidepressant and blood pressure medication.  No treatment information was reported.
After the patient got home her eyes began to swell shut and then she felt a funny feeling in her throat and went to the emergency room
Patient had severe left shoulder/arm pain around the site of injection that continued after injection, worsened by his physical job as a custodian, he had to miss work due to this for several days, still moderate/severely painful to complete physical tasks using the left arm 5 days later (today, 6/8/21)
Information has been received from a patient who was vaccinated with a dose of RECOMBIVAX HB.  Subsequently, the patient reported that she fell sick.  She did not know the name of the vaccine.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Had the shot, got the shingles/suspected vaccination failure; got the shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was not reported. The patient got Shingles after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
swelling & soreness of lt deltoid region; fever 102; 2-3cm area of erythema;
Moderna vaccine was administered outside of the clinic - reported by patient   ACUTE PULMONARY EMBOLISM 12/8/2021 ATRIAL FIBRILLATION, PAROXYSMAL  ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 12/8/2021 ATRIAL FIBRILLATION, PAROXYSMAL  HYPOTENSION 7/2/2021 ATRIAL FIBRILLATION, PAROXYSMAL  ACUTE PULMONARY EMBOLISM 12/8/2021 PYONEPHROSIS  ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 12/8/2021 PYONEPHROSIS  HYPOTENSION 7/2/2021 PYONEPHROSIS  ACUTE PULMONARY EMBOLISM 12/8/2021 ATRIAL FIBRILLATION, PAROXYSMAL  ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 12/8/2021 ATRIAL FIBRILLATION, PAROXYSMAL  HYPOTENSION 7/2/2021 ATRIAL FIBRILLATION, PAROXYSMAL  ACUTE PULMONARY EMBOLISM 12/8/2021 SEPTIC SHOCK  ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 12/8/2021 SEPTIC SHOCK  HYPOTENSION 7/2/2021 SEPTIC SHOCK
Vaccine given to a minor; A spontaneous report was received from a health care professional concerning a minor patient who received Moderna's COVID-19 Vaccine, and vaccine given to a minor (Product administered to patient of inappropriate age).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273.   Vaccine given to a minor. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, vaccine given to a minor was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
p/vax pt rt side of throat hurting;by evening both tonsils inflamed 7 had fever;fever on 10/14/99 was 104;SAW md-MD did not feel this illness d/t vax;given ATB inj & one for fever;recovered;
Rash on trunk and thighs with severe itching. Rash began approximately 6 hours after receiving vaccination. Treatment prednisone IM and PO.
Client reported nausea, headache, fatigue, and diarrhea starting at 6PM and extending through today. Client reports taking tums and ibuprofen last night with some relief. Reports some improvement today (5/18/2016) but continues to have fatigue and headache.
Sudden onset of shortness of breath, weazie, difficulty breathing. This caused lots of coughing. This lasted until 11:40 pm that night. I tried taking a hot shower to help with my breathing, but that did not help. Then the symptoms then went away rather suddenly. I did have some peppermint tea to help sooth my throat. I did not call the doctor since it was so late.
Headaches from time administered up to 6 weeks; never had headaches before that. Took TYLENOL. Also pressure in the eyes.
Dizziness, vertigo during/after specific movements. i.e. attempting to lay down or turning head to the right when seated.  Symptoms have persisted for over a month.
Moderna COVID-19 Vaccine: While giving the patient their second dose of the Moderna vaccine with the BD Integra their was syringe failure and the vaccine leaked all over the patients arm.  The dose was re-administered in the other arm.
Per mom: Patient was more tired than usual on the evening of 6/7 after receiving his second Hep B vaccine and went to bed at 7p. Mom reports at 1020p, over the baby monitor mom heard him scream then make a gurgling noise. Mom reports that when she looked at the video on the baby monitor that he "did not look right," so she and dad "rushed to his room." Mom reports that first she "immediately knew it was a febrile seizure because her other son had one as an infant," and later in the conversation reported that it "took a few minutes to figure at that he was having a seizure. " Mom reports that when they realized it was a seizure they "immediately put him in the bath and that his temperature was 103.8 with a temporal themometer."  Mom reports the seizure lasted two minutes and he was "out of it and listless for 30 minutes before he was able to make eye contact." Mom reports that Patient slept on her, skin to skin, until his fever broke. Mom reports that he was "totally normal when he woke the next morning, had no further fever, or any concerning symptoms. " Mom stated that it was "very clearly the Hep B that caused the febrile seizure." When asked why the parents did not take patient to the emergency room, mom reported that she did not want him to have an IV, blood draw, or imaging because her other son had to go through that and it was aweful." Mom has requested a letter for vaccine exemption (I have denied this request). On a side note mom has only allowed one vaccine be given at a time,  and he is not up to date on his vaccines.