chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. {Additional information has been requested.
Monday 5/11 onset erythematous confluent skin rash on trunk. Wed onset low grade fever and vomiting. Vomiting resolved this morning. Skin rash spread to face, but is now resolving on body.
I contracted COVID-19 on 07/10/2022 with symptoms of scratchy throat, fever of 100.6, headache, body aches, fatigue, sore throat, and shallow cough. I was not prescribed any medications. I was ill for 8 days before my symptoms began to resolve. I am still experiencing a lingering scratchy throat.
syncope, occured about 2 min after administration of 3 IM vaccines -- MCV4, Hep A, and Tdap.  Child c/o headache and dizziness, and a couple of seconds later collasped, hitting head on wall on the way down.  Eyes were open but dazed, within 15 seconds he regained consciousness, BP and pulse were normal.
Severe rigors, aches and pains for 22 hours. So intense I had to call off work, which I never do.
Itching; Hives on his back; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching) and URTICARIA (Hives on his back) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PRURITUS (Itching) and URTICARIA (Hives on his back). At the time of the report, PRURITUS (Itching) and URTICARIA (Hives on his back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD21-072253 (E2B Linked Report).; Sender's Comments:  MOD21-072253:
Fast heart beat lasting at least 9 hours. Heart felt odd in the beginning for a few hours. Rested, drank water. Went to bed and appeared fine the next morning.
first dose on March 9 2022, has not yet received second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had received her first dose of Shingrix on March 9 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's comment: The patient reported that he did not receive the 2nd dose yet. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
The patient called in the day after his vaccine was administered (6/22/18) and reported that he developed a fever of 100F and had a pulse of 120 BPM and also a elevated blood pressure of 160/100 sometime after he received his second dose of SHINGRIX. He also said he had severe flu like symptoms and could not get out of bed. When he called in the following day he did say he was feeling better and that the symptoms did start to subside. We followed up with the patient on Monday (6/25/18) to see how he was feeling and he stated that everything is back to normal and he feels fine he also stated that the symptoms lasted almost exactly 24 hours and he returned to normal feeling.
Stomach crampy; Tingling sensations in feet and hands; Sharp pain on the right side of chest; Burning sensations in feet and hands; sore legs; Sore arm; Body aches; Chills; Slight fever; This is spontaneous report from a contactable patient. A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the right arm on 06Mar2021 at 15:00, (at the age of 31-years-old) as a single dose for COVID-19 immunization. It was unknown whether the  patient was pregnant at the time of vaccination. Medical history included sinusitis, asthma, gastroesophageal reflux disease (GERD), allergy to penicillin and shellfish. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Symbicort , Budesonide (sinus rinse) (MANUFACUTRER UNKNOWN) and  Azelastine (MANUFACUTRER UNKNOWN), all for unknown indication from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the right arm on 11Feb2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunization. The patient didn't received any other vaccines within 4 weeks prior to the COVID-19  vaccination. On 15Mar2021, the patient had a nasal swab (Covid antigen) test and the test result was negative. On 07Mar2021, the patient experienced  normal side effects such as sore arm, slight fever, chills and body aches and was fine after that. On 14Mar2021 at 12:00, the patient  experienced tingling and burning sensations in feet and hands, legs were  very sore like she had done a difficult work out which was actually not done and also had a sharp pain on the right side of chest and stomach was crampy. It was unknown whether the patient received any treatment for the events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events sore arm, slight fever, chills and body aches was resolved. The clinical outcome of the events sharp pain on the right side of chest, burning sensations in feet and hands, stomach crampy, tingling sensations in feet and hands and sore  legs was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
dermatitis; This is a spontaneous report from a contactable consumer (patient, reported for self). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration in Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were reported as none. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine two weeks ago, five days later he started experiencing a rash from his face to his neck. He consulted his doctor, and he was diagnosed with dermatitis. Patient would like to know if this has been reported. The outcome of events was unknown.  No follow up attempts were possible. Information about lot/batch number could not be obtained.
I was fine then week later got a big rash on left arm at the injection site about 8 inches length wise. The rash lasted 5 days.
prior trauma to toe, was healing slowly; after moderna 2nd dose, pain in right toe became unrelenting and constant.  This developed over months and has not subsided. now have associated lower back pain and stiffness, bilateral ulnar neuropathy worse at night, and joint stiffness that lasts about 30 minutes in the morning.  another trauma (ground level fall) perhaps in April, and that has not resolved as well. X-ray showed no fractures.
area is warm to the touch; arm started itching; redness started to expand; A Spontaneous report was received from a physician's assistant concerning a 43 year old female patient and developed itching, redness, and warmth at the injection site on her arm.   The patient's medical history and relevant concomitant medications were not reported.   On 23 Dec 2020, approximately eight days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in her arm for prophylaxis of COVID-19 infection.   The patient experienced itching, redness, and warmth at the injection site on her arm beginning on 01 Jan 2021.  The affected area measured approximately 6 cm by 10 cm.  A steroid was prescribed to treat the events.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events itching was reported as recovered on 04 Jan 2021 and redness and warmth at the injection site on her arm were not reported.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Initial report received from a healthcare professional on 02 July 2013. A 24-year-old female patient may be inadvertently received an intramuscular dose 2 of ADACEL vaccine (batch number: U4586AA, site of administration was not reported) on 02 July 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 05 December 2012 and estimated date of delivery was 11 September 2013. The patient had received dose 1 of ADACEL vaccine (lot number, route and site of administration was not reported) on 14 June 2013 during current pregnancy as well. Thus the patient received an extra dose of ADACEL. The patient had no risk factors. Medical history, concomitant medications and treatment for infertility were not reported. At the time of the report, the patient had not experienced any adverse events. Follow up information received from a healthcare professional on 15 August 2013: The patient had no family history of congenital abnormality. The patient had not received any treatment for infertility. The patient had one previous pregnancy with a live birth with no congenital abnormality. The patient had no pre-term births, no elective abortions and no spontaneous abortions or fetal deaths (>20 weeks gestation). The patient had not received any drug during or prior pregnancy that could remain present at the time of fertilization. The patient did not have any pregnancy complications. On an unspecified date, Quad AFP test was done which was positive for increased risk for Down syndrome. On an unspecified date, the patient gave birth to a single male baby vaginally at 40 weeks of gestation. The weight of the baby was reported as "6.5" oz. The baby had no congenital abnormality. The baby's APGAR score was not reported. List of documents held by the reported: None. Follow-up information received from a healthcare professional on 10 October 2013. The patient had no history of congenital abnormality. The patient had anemia. The estimated date of delivery was 30 August 2013. Number of previous pregnancies was 2 (live birth of male baby vaginally at 40 weeks of gestation and weighed 6.5 kg and live birth to a female baby at 38 weeks of gestation). Prenatal testing for alpha foetoprotein was done which was positive for Down's syndrome.
p/vax bilat thighs red raised area approx quarter sized, has increased in size since that time to approx 2 inches in diameter, recv additional APAP for elevated temp;referred to Md;
Very sore muscle after vaccine, difficulty extending and lifting arm. Pain then improved. Left shoulder tingling and numbness developed 4 days ago.
I felt anaphylactic, I felt like I had Covid again. I body aches, fever, couldn't move, hard to swollen. I took 2 50mg Benadryl and those symptoms lasted around 24hours but the Benadryl did stop the hard to swallow feeling.
I did not experience an immediate reaction to the shot as they had me wait 30 mins to assure that I was not allergic to the shot as I do have allergies.  Not sure if the medical complications that I experience a week later after having the shot is related to the shot or not and my primary doctor or my endocrinology dr. is not sure either and had concerns as to weather I should take the second shot or not. I went to the emergency dr. because the (burning, itching, pain, pins/needles) were so bad in my upper and lower extremities.  They prescribe me pain med and another med that has help a lot.  I visited my endocrinology dr. for my dietetics.  After running all kinds of test she stated that my A1C levels were a 6.point.  She could not attributed my severe neuropathy to diabetics or to the virus shot.  She set me for an appointment to see a neurologist.  I also developed a week later severe bumps on my face, neck and both arms.  I went to urgent care and they gave me a shot of some sort and sent me home with steroids and take Benadryl.  My skin cleared up in a few days.  I had never had that happen to me.
Patient received Moderna vaccine instead of Pfizer vaccine for second dose two dose vaccination series. The patient received Pfizer for first dose COVID-19 vaccination.
pt recv varicella vax in 7/95 & in 3/98 pt devel approx 20 pox. 5 days later pt recovered
Soreness at injection site (3 on pain scale of 1-10); body aches (2 on pain scale); headache (3 on pain scale); tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Nov2021 17:15 (Lot number: FH8030) at the age of 47 years as dose 3(booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), intramuscular, administered in arm right, administration date 16Nov2021 17:15 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Date: 16Mar2021, Site of Injection: Left upper arm, Lot: EP6955(Pfizer)), administration date: 16Mar2021, when the patient was 47 years old, for Covid-19 immunization; Bnt162b2 (Dose: 2, Date: 06Apr021, Site of Injection: Left upper arm, Lot: EP0955(Pfizer)), administration date: 06Apr2021, when the patient was 47 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Soreness at injection site (3 on pain scale of 1-10)"; PAIN (non-serious) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "body aches (2 on pain scale)"; HEADACHE (non-serious) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "headache (3 on pain scale)"; FATIGUE (non-serious) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, fatigue. Therapeutic measures were taken as a result of pain, headache. Additional information: Concomitant Drugs; List below concomitant drugs taken within two weeks before the event onset. Exclude all drugs only administered more than two weeks before the event, and any drug used to treat the event or taken after event onset: was not provided. Patient's Medical History (including any illness at time of vaccination) was not provided. Family Medical History Relevant to AE (s) was not provided. RELEVANT TESTS List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebro-spinal fluid culture, pleural fluid culture, urine culture, diagnostic imaging, (e.g., chest  X-ray, MRI).  If COVID-19 testing has been conducted, provide test dates and results was not provided. Specific relevant test for Thromboembolic event with Thrombocytopenia was not provided.  No follow-up attempts are possible. No further information is expected.
Rash at injection site, on lower back, left hip, chest, arms, inner thighs, armpits, Swelling, itching, burning on both hands and fingers. Itching and burning on lower back.  These symptoms began a day following injection and grew much worse on the second day after injection. Prescribed a prednisone steroid, zertec, over the counter Benadryl, and an epipen
Felt fine for a few hours when I got home. Then felt woozy, had chills and hot flashes, exhausted (slept for 14 hours straight), muscle pain for over 18 hours, pain at injection site from when I got the shot to now, decreased appetite, headaches
On 12/25/2021 fatigue and headache. On 12/30/2021 congestion and issues breathing.
A report was received from a health care professional in the USA on 7/5/04 concerning a 10 month old male vaccinee who inadvertently received Fluvirin on 11/6/03. This report was received as follow up and involves a group of 10 children under the age of 4 years who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.
vial was punctured more than 20 times.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (vial was punctured more than 20 times.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (vial was punctured more than 20 times.). At the time of the report, PRODUCT ADMINISTRATION ERROR (vial was punctured more than 20 times.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was given.   Reporter did not allow further contact
Two days after taking the Covid vaccine on Wednesday 1/6/21, patient developed abdominal pain.  The next day, he began to have what appeared to be petechial hemorrhaging in his abdomen. By Sunday, the hemorrhaging had spread from his neck to his knees.  On Monday, he saw his primary care physician, who sent him to hospital ER. After performing extensive tests, the ER doctor stated that the test results were normal, and he could find no reason for most of his body being purple. By Tuesday, he was returning to normal.  The abdominal pain was gone by Tuesday as well.
I woke up with terrible stomach pain. I assumed it was the flu, but the pain was much sharper than a normal stomach pain. The symptoms lasted about 4 or 4 days then became a dull pain, I followed up after the new year and had an ultrasound and they discovered I had very large gall stones on February 3rd. I met with a general surgeon, and we decided surgical removal was the best course of action and that is scheduled for next week Friday. I did try PEPTO BISMOL and an over-the-counter acid reducer to help with symptoms. Now I can manage it from my diet as I better understand the source.
New onset of redness and warmth of LUE, denies pain.  Skin with blanching, erythematous, edematous.  Diagnosed with cellulitis and treated with antibiotics.
This client came to the clinic, denied having a vaccine card and stated she presented for her first Pfizer vaccine. She was looked up in the  and the staff missed looking at the record correctly and that she was already fully immunized with 2 doses of Moderna. This error was caught while the client was still at the facility in observation. When asked if her record was correct in her already receiving 2 doses of Moderna, she said yes. She stated that she takes immunosuppressive medication and her immunologist told her to get another vaccine any way she could so she was protected against Covid.
Myalgia, Fever, Chills Narrative:  Missed Work  Other Relevant History:
Large swollen itchy red blotch on arm, slightly overlapping bruise at injection site; noticed 6 days after injection
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 27-AUG-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
went to inject syringe into patients arm and noticed as I depressed the syringe it leaked and ran down patients arm
Activity in three places; One possible malignant lymph node felt under the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Activity in three places) and LYMPHADENOPATHY (One possible malignant lymph node felt under the arm) 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 Mammogram.   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 an unknown date, the patient experienced VACCINATION COMPLICATION (Activity in three places) and LYMPHADENOPATHY (One possible malignant lymph node felt under the arm). At the time of the report, VACCINATION COMPLICATION (Activity in three places) and LYMPHADENOPATHY (One possible malignant lymph node felt under the arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy lymph gland: inconclusive (Inconclusive) The surgeon that performed a biopsy on one possible malignant lymph node felt that the one under the arm was most likely a result of shots as the surgeon could feel nothing in the area to cause cancer concern.. In 2021, Positron emission tomogram: inconclusive (Inconclusive) PET scan noted activity in three places. Two of which had nothing to do with vaccine injections. However the third was under the arm pit of both shots..         No relevant concomitant medications were reported. The patient had declined a mammogram as there have been some possible ties to a mammogram in the time span of the shots. The surgeon that performed biopsy of lymph node reported of feeling nothing in the area under arm to cause cancer concern.  No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-033076 (Patient Link).
Injection given in left deltoid region. Patient received Tdap vaccination on 4/25/07; on 4/26/07 evening pt noted area around injection site looked like a "welt, very reddened, sliver dollar size and itchy." Pt directed to primary doctor for further instruction; patient stated she already notified him. Information per RN.
received vaccine on 01/20/2021, on 02/03/2021 rt noted to be actively bleeding from rectum, sent to hospital with GI bleed
swelling and tenderness at site, within 8 hours --hives covering most of body, red and raised by third day, pain and weakness in thighs, tricpes and back