chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart disease. The patient was previously received with Covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of Covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received booster dose of Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient was on blood thinner. On an unspecified date, the patient had been so sick and wanted to sleep all the time. The patient also experienced diarrhea real bad (all events in dose number series 2). Patient did not know that patient can take Imodium or not because patient took blood thinner and had heart disease. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the so sick, want to sleep all the time and diarrhea real bad was not reported. This report was non-serious.
He tested positive for COVID-19 after being fully vaccinated.; He tested positive for COVID-19 after being fully vaccinated.; This is a spontaneous report from a other health care professional. A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscular route of administration in right arm on 26Jan2021 (at the age of 51-year-old) (Batch/Lot Number: EN5318) as dose 1, single and via intramuscular route of administration in right arm on 16Feb2021 (at the age of 51-year-old) (Batch/Lot Number: EN5318) as dose 2, single for COVID-19 immunisation at workplace clinic. Medical history was not reported. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient experienced he tested positive for covid-19 after being fully vaccinated on 28Jul2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included PCR (sars-cov-2 test): positive on 28Jul2021, test type was nasal swab. The patient did not receive any treatment for the events.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of COVID-19. The case will be reassessed once new information is available.
I had the Moderna vaccine in January and February...i now have covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I had the Moderna vaccine in January and February...i now have covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (I had the Moderna vaccine in January and February...i now have covid). At the time of the report, COVID-19 (I had the Moderna vaccine in January and February..i now have covid) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
Woke up at night with hot flashes, stomach abdominal pain, nausea, fever. Taken to ER 8/15 discharged with heat stroke diagnosis, given Motrin. 9/10/09 Back to ER with rash on lower legs and back pain in ankles and knees, low grade fever. Given Motrin and IV for dehydration. Diagnosed with HPS (Henoch-Schonlein Purpura). 9/12/09 Back to ER. hands and feet swollen, rash turned purple like bruising, pain on extremities unable to work. Chest pain/discomfort. Rash has moved since 9/10 under his hair, entire body eyelids swollen, this testicles got swollen and taken to ER on 9/14; was admitted overnight discharged on 9/15. Seen at Hospital. 9/18/09. Swelling continues to go up and down, migrates all over body.   8/22/09 MR received for DOS 9/14-15/09 with dx:  Henoch-Schlonlein Purpura.  Abdominal Pain resolved.  Pt initially presented to ER on 9/9/09 with erythematous marks on the legs and ankle swelling. DX:  HSP.  Pt developed increasing pain over the ankles and swelling of the legs and lower back. Later developed pain/swelling in the wrists and hands, eyelid swelling, nausea and difficulty walking 2' to knee pain. Further developed abdominal pain and lack of appetite and intake and arrived at the ER at this point.  PE (+) for purpura and swelling as above.Greatly improved after IVFs. Some difficulty voiding with residual urine of 30ccs after voiding which resolved. Recent episode of heat exhaustion.
Extreme pain in my left arm which started almost immediately after injection s were  given.  I have been unable to move my left arm due to the pain.  Shots to my left arm were administered on a Friday afternoon and am still experiencing pain on Sunday.  There was only slight pain in my right arm at the injection site where the COVID shot was given.    I have been taking Tylenol but experienced fever of 100.8 on Saturday night.
Shingles outbreak; Blisters; Injection site pain; Injection site swelling; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain), injection site swelling (Verbatim: Injection site swelling), shingles (Verbatim: Shingles outbreak) and blister (Verbatim: Blisters). The outcome of the injection site pain and injection site swelling were resolved (duration 9 days) and the outcome of the shingles was resolved and the outcome of the blister was not reported.   It was unknown if the reporter considered the injection site pain, injection site swelling, shingles and blister to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling, shingles and blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JUL-2023 The reporter reported that the patient received Shingrix vaccine and experienced injection site pain and swelling that was lasted for 9 days. The reporter stated that the patient also had a small shingles outbreak, reportedly the size of a silver dollar with blisters in it. The reporter reported that the patient received Shingrix vaccine in a different state, so reporter did not know the date of vaccine, but stated that it was within a window for the second dose. The reporter did not know which arm the injection was administered and did not know the location of the shingles outbreak.   The reporter reported that the shingles was resolved now, but she was unsure how long it lasted or if it was treated with any medication.   The reporter stated that at the time of reporting, the second dose of Shingrix has not been administered. The reporter did consent to follow up.
Patient was given an outdated medication of ProQuad: MMR/Varicella. Expired on 03/22/2016. Lot #: T031825. Manufacturer: Merck & Co.  No adverse reactions noted. Manufacturing company was called and reported no changes or adjustments needed as vaccine is a live virus.
Mild arthritis joint pain in my hands, and feet/The pain and inflammation has significantly increased; Mild arthritis joint pain in my hands, and feet/The pain and inflammation has significantly increased; pain and inflammation has significantly increased; feels very sharp especially in my hands in my back near my scapula, and my knee joints; My muscles also feel tight in these areas; The pain and discomfort are significantly greater than normal; This is a spontaneous report from a contactable other hcp. This 47-year-old female other HCP (patient) received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 30Dec2020 09:00 at single dose on right arm for COVID-19 immunisation. The patient was mostly healthy, no chronic health conditions. No known allergies. Her family had a lot of auto immune disease history. Concomitant medication included paracetamol (TYLENOL), ibuprofen. The patient had mild arthritis joint pain in her hands, and feet that were usually resolved with OTC pain medications. The pain and inflammation has significantly increased since the COVID-19 vaccine injection and felt very sharp especially in her hands, in her back near mhery scapula, and her knee joints. Her muscles also feel tight in these areas. The pain and discomfort are significantly greater than normal. Symptoms were the worst 2-5 days Post injection and have not resolved. All of the events were on 31Dec2020 09:00 and no treatment was received, all considered as non-serious. No COVID tested post vaccination. The outcome of the events was not recovered.  Information on the Lot/Batch number has been requested.
Moderna dose 2 was given one week early.  First dose was given on 7/20/2022.
1) Soreness on (L) arm 5/10 2) Red, swollen & firm area (27cm around the upper arm x 17cm from upper arm to elbow) noted on (L) arm 3) Treatment was for cellulitis (prophylacticly) - KEFLEX 250mg QID 5 days.
Large circular rash/welt appeared near injection site pain s/p 7 days after injection. Also, continued joint pain and fatigue (10 days out from vaccine today).
Within 24 hours, local site inflammation. Induration macule 4.6cm. Benadryl q 6-8 hrs for 2-3 days.
Received 2 doses of VACCINE Dose 1 12/17/20 Dose 2  01/07/21 Tested Positive for Covid on 4/8/21.  Mild symptoms.  Family members were Covid +
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 20-May-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
Patient notices redness and mild soreness of injection site, appr. 2" square in size.
Sore arm/swollen injection site lasting 6 days headache lasting one day. Fever the next day lasting one day. SOB lasting two days. Sense of unease lasting 6 days.
pt recv vax; pins & needle & numbness; burning sensation in lt upper arm which spread into lt chest; could not fall asleep at noc;
This spontaneous report as received from a physician refers to a patient of unknown age. Respectively on 12-NOV-2012 and 28-FEB-2013 the patient was vaccinated with the first and second dose of VAQTA (15/0.5 U/ML) (dose, lot number not reported). No other co-suspect product were reported. No concomitant medications were reported. No adverse event reported. It was unspecified if the patient had sought medical attention. Action and causality of VAQTA was not reported. Additional information has been requested.
The patient presented with left forearm redness and pain that radiated proximally.  The patient's main complaint was a sense of anxiousness and shortness of breath.
Tinnitus, on scale of 1-10 With 10 the highest, it is a 6-7.  No treatment. The sound is unending.
ADMINISTRATION OF ONE DOSE OF JNJ COVID-19 VACCINE AND ANOTHER ONE DOSE OF PFIZER BIONTECH COVID-19 VACCINE; This spontaneous report received from a pharmacist concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced administration of one dose of jnj covid-19 vaccine and another one dose of pfizer biontech covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of one dose of jnj covid-19 vaccine and another one dose of pfizer biontech covid-19 vaccine was not reported. This report was non-serious.
progressive swelling from injection site down L arm to forearm. warm, swollen, red. mildly tender at injection site, improving. no fever. no drainage from injection site. normal strength.  she had a milder reaction to the flu vaccine last year- more localized.
Inadvertently given 2nd Booster to patient that did not qualify due to age.
fell to the ground; bolted for the emergency exit to breathe; joints began to ball up and hurt for 4 days; Started to get hot; Face started to tingle; joints began to ball up and hurt for 4 days; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Started to get hot), PARAESTHESIA (Face started to tingle), JOINT SWELLING (joints began to ball up and hurt for 4 days), FALL (fell to the ground) and DYSPNOEA (bolted for the emergency exit to breathe) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OXYCODONE, Fiorinal and ZOLMITRIPTAN (ZOMIG) for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced FEELING HOT (Started to get hot), PARAESTHESIA (Face started to tingle), JOINT SWELLING (joints began to ball up and hurt for 4 days) and ARTHRALGIA (joints began to ball up and hurt for 4 days). On an unknown date, the patient experienced FALL (fell to the ground) and DYSPNOEA (bolted for the emergency exit to breathe). On 01-May-2021, JOINT SWELLING (joints began to ball up and hurt for 4 days) and ARTHRALGIA (joints began to ball up and hurt for 4 days) outcome was unknown. At the time of the report, FEELING HOT (Started to get hot), PARAESTHESIA (Face started to tingle), FALL (fell to the ground) and DYSPNOEA (bolted for the emergency exit to breathe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient called 24May2021 to report side effects for 1st  vaccination of Moderna received 27Apr2021 in the left arm Lot Number for 1st vaccination:038B21A. Patient reported severe reactions within minutes after receiving the 1st vaccination while at the clinic. Patient reported 7 minutes after the administration they "started to get hot." Patient also stated that they felt like their wasn't much air, and that they felt as though they needed fresh air. Patient stated within 10 minutes their face started to tingle. 10 minutes passed and the patient stated that they bolted for the emergency exit to breathe. Patient stated that they used the wall in the hallway to try to hold themselves up and fell to the ground.  Patient also stated that about an hour and a half after the administration while in the car with wife joints began to ball up and hurt for 4 days. Patient wants to receive the second dose but doesn't know if they should based upon their reaction to the first vaccination. Patient provided consent for follow up for safety. Preferred Method contact telephone.  no treatment details reported.
Leg with severe swelling, hot, red spots about the size of quarters and non stop crying for more than 3 hours.
Patient reported swelling on back of the neck about 5 minutes after receiving vaccine, was given Benadryl 25mg. Several minutes later reported difficulty swallowing and was administered 0.3mg of epinephrine. Daughter called 911, patient reported feeling better after emergency response arrival.
Information has been received from a medical assistant concerning a patient of unknown age and gender, who on 24-AUG-2012 was vaccinated with a dose of ZOSTAVAX subcutaneously (dose not reported) (lot # 671022/0745AA) which expired on 18-AUG-2012. No known adverse effects. Additional information has been requested.
Patient presented  to ED on 5/12  with complaints on  gradually worsening left leg swelling and pain for 3 days, no with difficulty ambulating.  Patient reports she received the J&J vaccine 5 weeks prior.
Severe headache, severe fatigue 12-24 hrs after injection. Fever of 100.6 and body aches 24-48 after injection.
I had was muscle pain for couple of days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In JAN-2023, the patient received the 1st dose of Shingles vaccine. In JAN-2023, an unknown time after receiving Shingles vaccine, the patient experienced muscle pain (Verbatim: I had was muscle pain for couple of days). The patient was treated with paracetamol (Tylenol). In JAN-2023, the outcome of the muscle pain was resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingles vaccine.   It was unknown if the company considered the muscle pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient received shingles shot last month (3 weeks ago).  The only side effect he/she had was muscle pain for a couple days and Tylenol helped. The reporter had a friend that had the shingles so bad she was sick and off from work for 3 months. The reporter told to get your shingles shot. The follow up would not possible as no contact details were available.
Patient presented with tongue swelling and facial swelling, it was barely perceptive to medical personnel but patient has subjective symptoms.  Symptoms started 30 minutes after her injection and worsened over the course of 30 minutes.  Symptoms then stabilized and she was seen in the ER 2-1/2 hours after symptom onset.  She was treated with epinephrine 0.3 mg IM with improvement.  She was observed in the ER for 2 hours.  She had subjective return of sensation of tongue swelling though no objective findings.  She was observed for another hour with no change in status.  No further intervention initiated.
1. Fever of up to 100F max.  Onset appx 10 hours after shot.  Duration 12 hours.  No treatment. 2. Sore muscles (both arms, shoulders, neck).  Onset appx 10 hours after shot.  Duration 2 days. Treatment 400 mg ibuprofen in PM both days. 3. Low back arthritis flare up.  Onset appx 10 hours after shot.  Duration 2 days.  Treatment ibuprofen as stated for item 2. 4. Eczema flare up in both arm pits.  Onset appx 24 hours after shot.  Duration 24 hours.  Treatment prescription Protopic cream.
paralysis; Guillain Barre syndrome (GBS) diagnosis; allergic reaction; Initial information was received on 01-Nov-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown demographic patient who experienced paralysis, Guillain barre syndrome and allergic reaction (hypersensitivity), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious paralysis and Guillain barre syndrome (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  On an unknown date, the patient developed non-serious allergic reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events. It was reported "Still recovering from my 2019 Fllu Vaccine. Allergic reaction, paralysis, GBS diagnosis."   At time of reporting, the outcome was recovering for the events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns an unknown demographic patient who had paralysis, Guillain barre syndrome and hypersensitivity after receiving INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Furthermore information regarding medical history, past medical treatment, vaccinations, concomitant medications, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
On 4/12/01, around noon today, observed right more than left upper arms and when dressing, mother noticed a pink, raised area on back. No treatment by mother. Brought to HD and saw RNC who said it was a topical immunization reaction. Mother said she had Caladryl at home to apply. Call Pediatrician if changes or any worse.