chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild body aches; Dose number 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 20-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in right arm, administration date 31Dec2021 (Lot number: 33030BD) at the age of 20 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EP6955; Route of administration: Unspecified), administration date: 27Mar2021, when the patient was 20 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EP6955; Route of administration: Unspecified), administration date: 17Apr2021, when the patient was 20 years old, for COVID-19 immunisation.   The following information was reported: IMMUNISATION (non-serious) with onset 31Dec2021, outcome "unknown", described as "Dose number 3"; PAIN (non-serious) with onset 01Jan2022, outcome "recovering", described as "Mild body aches". Therapeutic measures were not taken as a result of pain.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA: Was perfectly fine for the first 10 hrs following injection. Then 11pm Sar night sudden intense pain at inj site spreading rapidly around back of neck and down other arm and up to head. Wracking chills for about 8  hours. Shaking uncontrollably, aches and pains, very weak, exhausted,  nauseous. About 8 hours later, 7am Sunday, fever developed, eye pain with severe headache. In bed 30 hours. Monday morning felt much better but still fever @100 and weirdly dizzy. Ate and drank water.  Today, almost 72 hours later fever gone, still very dizzy. Drinking water to see if that will help.
11/8/2006 EVENING, FIRST NOTICED RED, SWOLLEN, LUMP AT INJECTION SITE. SLIGHTLY WARM. HURTS TO LIFT ARM. REDDENED AREA IS 2"X1".  DOESN'T ITCH.
About two months ago I developed a very bad skin rash. All over my body that itchy and red. If I scratch the rash rise. Have been given 3 different medications. Skin rash is very uncomfortable.
This spontaneous report as received from a nurse refers to a 15 month old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 23-MAY-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (lot # L012838, expiry date 10-MAR-2018, dose and route of administration were not provided). The vaccine was stored between 0 and 1 Celsius degree for 60 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of two cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA014603.
Within one hour of injection, a hard and painful red knot appeared roughly 1.5 inches in diameter. This persisted for about 4 days.
(02/2021)Discomfort and pain up until (05/2021) Gallbladder and Kidney Stones, currently ongoing to determine with doctor if need surgery or not.
I accidentally gave the patient a pediatric dose of Hep A.  Per guidelines, I gave the patient a second pediatric dose to complete the adult dose.  Patient denied negative S/E associated with the vaccinations.  I contacted our state reporting system for vaccinations, who updated her shot record to reflect both doses.
23SEP92 mom states last noc pt ran t102 today still has fever 102; c/o throat, legs, & stomach hurting;
Received flu vaccine 11-6-06 at 15:15pm and patient awoke on 11-7-06 she had reddened rash on both arms, legs and torso. And itching at those sites. Denies respiratory difficulty.
Immunocompromised patient may have received half a dose; Four months since the patient received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient may have received half a dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Four months since the patient received the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ACCIDENTAL UNDERDOSE (Immunocompromised patient may have received half a dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Four months since the patient received the second dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient may have received half a dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Four months since the patient received the second dose) outcome was unknown.            No concomitant products were reported.   No treatment information was reported.   This case was linked to MOD-2021-132127 (Patient Link).
4/6/21: starting 11 p.m., and lasting all night - fever, chills, full body muscle aches, headache, fatigue, sore arm 4/7/21: full body muscle aches, fatigue, sore arm 4/8/21: full body muscle aches, fatigue, sore arm 4/9/21: fatigue, sore arm
Patient is complaining swelling, redness and pain at/around injection site. The symptoms are finally getting better on 4th day after vaccine administration.
Tennitus, hearing issues, trouble swallowing, diziness.  Tennitus HAS NOW BECOME CONSTANT.  Prednisone, antihistamine, PT.  Vertigo was ruled out
Son received flu shot. Within days, a phycological breakdown occured. Became incoherent, and violent. This had happened about 5 years ago as well, and I reported it to you also.
Patient was given a 3rd dose of Shingrix -- vaccination record was not complete / up to date and patient could not produce dated proof of vaccination.
Immediately following administration of High Dose Flu the patient complained of a metallic taste in his mouth. This lasted for 20 minutes and then went away.
she was tested positive from COVID 19 six days ago; she was tested positive from COVID 19 six days ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Nov2022, outcome "unknown" and all described as "she was tested positive from COVID 19 six days ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Nov2022) Positive, notes: tested positive from COVID19 six days ago; (Dec2022) Negative, notes: negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller mentioned she had taken all the vaccines and booster shots from Pfizer, even she received the Omicron formulation in Sep2022. But she was tested positive from COVID 19 six days ago. After that she took Paxlovid and already finished her treatment. She has later tested negative, but still had some cold symptoms. She wanted to know if she could take cold medicines at the time that she finished Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Patient developed a new onset petechial rash, significant bruising, and mild nose bleeding several weeks after receiving her vaccinations (symptoms developed around 1/28/22). She was found to have a platelet count < 10 on screening labs at that time. Diagnosed with immune thrombocytopenia after being seen in the ED and referred to pediatric hematology. Given mild bleeding symptoms decision made to observe without initiating therapy.
Vaccine administered on 07/26/02. Mother states child began complaining of swelling left upper arm on 07/28/02. Mother states arm became very hot and "bruised" Pt stares she was notified her pediatrician and was told it was probably a reaction to DTA. Was advised to give Tylenol and apply compresses. on 07/28/2002, child seen @ HD. Left arm approx. 22 mm induration, warm to touch, WNL  skin slightly bruised around indurated area
Patient called following evening stating that the evening after getting both vaccines, patient broke out in all over body rash.  Patient took benadryl otc the evening of reaction and was instructed to take another dose of benadryl and if no improvement to seek medical attention.  Followed up with patient who did contact md who believed pt reaction is likely due to her recent use of amoxicillin due to patient family history of penicillin allergy but it was not concluded to be the sole cause.  Patient received additional recommendations from their doctor and is following their care.
I developed Shingles about a week after receiving my first dose. Extremely strange because I'm otherwise in great health.
He had the injection, had the sore arm and approximately 3 hours after the vaccination he began to experience severe chest pain across his entire chest and into his jaw, which was exacerbated upon taking a deep breath.  He called his cardiologist who advised him to go to the ER.  He was worked up, subsequently admitted from 2/8/21 to 2/11/21, a lot was ruled out but no specific diagnosis made at that time.  They did note some pleural effusion and pericardial effusion at that time.  Upon discharge on 2/11/21, starting Thursday evening he continued to have pain in the chest, but not as severe as when he entered into the hospital.  Every evening including last night has began with severe night sweats, low grade fever and the chest pains have continued.  Went to see his PCP,  Cardiologist and his Electrophysiologist several days later the following after discharge, he does have a pacemaker, and was told by all three of them that he has pericarditis and that the reaction could have been related to the vaccination.  It seemed more than coincidental that the symptoms did not appear until 3 hours after the vaccine.  Was put on Colchicine to treat the pericarditis and then received a 2nd opinion and has reinstituted the colchicine.  His low grade fever has finally dissipated.  During the day he feels okay, but still continues with the chest pains and the night sweats.  His hemoglobin dropped in the hospital possibly related to the heparin and then put on Eliquis postop, and now discontinued, and received an iron infusion to boost his hemoglobin.  He is scheduled for another iron infusion this Wednesday.    He  went to see GI physician and feels that he may have a bleed due to the infusion.   He has had an anastomosis due to Crohn's disease and feels that's where the bleed may have been coming from as he did have an ulceration at last colonoscopy.  He did have atrial flutter due this and was advised to have an ablation, and trying to reduce the pericarditis and FU later with other heart related problems.
diarrhea; muffled hearing in waves; Arm pain; Fatigue; BP went up to 159/94; "Maybe I was having a panic attack"; heart rate went up; heart rate went up and down in waves; warm sensation; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (BP went up to 159/94), DIARRHOEA (diarrhea), FEELING HOT (warm sensation), HYPOACUSIS (muffled hearing in waves) and HEART RATE INCREASED (heart rate went up) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (BP went up to 159/94), FEELING HOT (warm sensation) and HEART RATE INCREASED (heart rate went up). 31-Jan-2021, the patient experienced HEART RATE DECREASED (heart rate went up and down in waves) and PANIC ATTACK ("Maybe I was having a panic attack"). On 01-Feb-2021, the patient experienced DIARRHOEA (diarrhea), HYPOACUSIS (muffled hearing in waves), PAIN IN EXTREMITY (Arm pain) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE INCREASED (BP went up to 159/94), DIARRHOEA (diarrhea), FEELING HOT (warm sensation), HYPOACUSIS (muffled hearing in waves), HEART RATE INCREASED (heart rate went up), HEART RATE DECREASED (heart rate went up and down in waves), PAIN IN EXTREMITY (Arm pain), PANIC ATTACK ("Maybe I was having a panic attack") and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Blood pressure measurement: 159/94 (High) BP went up to 159/94. On 31-Jan-2021, Heart rate: 97 (High) heart rate went up to 97.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Outcome of the events updated to resolved.
Been experiencing mild symptoms of the following since Tuesday morning post first dose of vaccination: Headache Body aches Fatigue/Tiredness Diarrhea Loss of Appetite Overall Head Fog Sore throat
TOOK THIRD DOSE TOO EARLY; This spontaneous case report (PVX2019-2086) was received from a physician on 12-Aug-2019. It described a female consumer who "took third dose too early" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took the third dose of Vivotif too early.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took third dose too early" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose too early" was considered as not applicable.
8pm day of vaccine - fever in the 99's started w/ body aches & headache next morning - fever ranging from 101-102.1, body aches, headache, diarrhea, dizziness 5/9/21 same symptoms with worsening dizziness and oxygen dropping as low as 82 maintained for several minutes at a time, spent most of the evening until bedtime in the 91-95 range now day 13  and I'm having bouts of low oxygen off & on all the  time, mostly ranging from 91-94, then back to 95-98 I have had markedly increased fatigue since they vaccine that I can't seem to get rid of
Pt's husband said pt's arm still hurts and unable to raise her arm. I suggested him to call pt's doctor as it has been over 3 week. Arm suppose not to be sore any more.
Irregular menstrual cycle- Cycle is currently on day 39. Cycles are tracked monthly and are typically between 26-28 days in length.
lymphadenopathy in axillary nodes same side as where vaccine was given; lymphadenopathy in axillary nodes same side as where vaccine was given - 10% larger now; lymphadenopathy in axillary nodes same side as where vaccine was given - palpable; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lymphadenopathy in axillary nodes same side as where vaccine was given 4 to 5 days after receiving the vaccine. It was painful and palpable. The patient's medical history was not provided. No relevant concomitant medications were reported.    On 26-12-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscular in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced lymphadenopathy in axillary nodes same side as where vaccine was given  painful, lymphadenopathy in axillary nodes same side as where vaccine was given  palpable, lymphadenopathy in axillary nodes same side as where vaccine was given - 10% larger now.    Laboratory details was not provided.  The patient was given ibuprofen as treatment medication.  Action taken with mRNA-1273 in response to the events was not reported.   On 14-01-2021, The outcome of the event lymphadenopathy in axillary nodes same side as where vaccine was given  painful was resolved. The outcome of the events lymphadenopathy in axillary nodes same side as where vaccine was given  palpable, lymphadenopathy in axillary nodes same side as where vaccine was given - 10% larger now.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
On 5-5-07 child had a "hot", swollen and red arm from shoulder to elbow. Child told parent arm hurt since evening of 5-3-07 when shot was given. Child given Tylenol on 5-4-07 and started on ibuprofen on 5-5-07. Mom was called on 5-7-07 and arm is lots better. Red at site of injection only.
Breakthrough COVID-19 case with unknown symptom onset: Fever, Aches, Shortness of breath/difficulty breathing, Fatigue or tiredness, Cough. Hospitalized 9/2/2021-9/17/2021. Death 9/17/2021. Vital Records data not available yet. Patient was hospitalized for UTI and was diagnosed with pneumonia. Patient was retired.
Soreness at the location of shot, fever, chills accompanied by shaking, bad headache, body aches, general weakness and fatigue. Began about 11 hrs after vaccine was administered.
After about 5 minutes, lips started to tingle - they then felt swollen and hurt.  I had difficulty breathing (mild), and difficulty swallowing.   Symptoms increased until about 15 minutes.  Then leveled out.   They were mild to moderate.  I spoke to the EMT (not helpful).  I waited 30 minutes and left.  Took a Benadryl  25mg tablet (generic) after getting to my car.  The symptoms lessened.  By the time I got home (30 minutes) the only thing that bothered me was painful lips.  That lasted a few hours.  My allergist has advised against the 2nd dose.
metal taste in mouth for a couple of hours after vaccine. started about 30 minutes after vaccine.
Information has been received from a nurse referring to multiple unspecified patients of unknown ages and gender. On unknown dates the patients were vaccinated with doses of improperly stored PROQUAD (lot# L033696, expiry 28-FEB-2017 and L033698, expiry 28-FEB-2017; strength, dosage, frequency and route unspecified). The vaccines were exposed to -2.6 degree C for 1 hours and 45 minutes. No previous excursions. Data logger was unspecified. No adverse effects were reported. No product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Two doses of Hepatitis B given at today's office visit.  No signs or symptoms noted. MOC notified of mistake. No further action taken.
This spontaneous report was received from a medical assistant refers to a currently 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. The patient's concomitant medications included DILUENT MRK INJ lot# L040453 expiration date 17-MAY-2018. On an unspecified date, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD injection, subcutaneously, lot # N014758, and expiration date 08-NOV-2018, route not specified, for prophylaxis (dose number and anatomical location were not provided). The vaccine experienced a temperature excursion in the range between 6°F to 14°F during 36 hours as recorded by a data logger. Also, the vaccines had a previous temperature excursions in the range between 6°F to 14°F during 24 hours. There was no adverse effect reported. No further information was available. This is one of the three reports received from the same reporter. Sender's Comments: US-009507513-1804USA007011: US-009507513-1804USA002530.
pt recvd vax;woke up w/ whelps all over body;mom took pt to MD;felt it was an allergic rxn;
- Tight Chest - Tight Throat - Lots of mucous/coughing - Fever (101.3) at 9:00 PM Treatment (Benadryl, Solumedrol) @ 6:00 PM Possible immune system reaction to flu vaccine?
This spontaneous report as received from a consumer via company representative who was also a friend of patient and refers to a female non-pregnant patient of unknown age. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with GARDASIL or GARDASIL 9 (dose, site and route of administration, lot # and expiration date were not reported). On an unknown date in 2016 (reported as last week), the patient was diagnosed with Bell's Palsy lasting for an unspecified duration of time. The outcome of Bell's Palsy was unknown. The relatedness between adverse event and suspect therapy was not reported. Additional information has been requested.
The patient reported to me in a televisit, the event which occurred on 12/13/2021. She received the booster, Pfizer that morning at local hospital. She sees me for her MS. She went back to work at noon the same day as the COVID booster and then she was found down by her colleagues at work at 3pm. No one is certain what happened prior to finding her down. No evidence for seizures, though this cannot be ruled out. She was admitted to local Hospital and had extensive workup from there. I am working to get records from that hospital stay. She notes no conclusion exactly was made from that workup other then an adverse reaction to the booster. You may want additional information from those hospital records.
My right knee became very sore and it was difficult for me to walk on about February 13, 2023. I visited my doctor about 2 weeks later. My doctor told me it was arthritis. I was given a anti inflammatory shot.
On 6/17/18 in the afternoon, noticed a golf ball size lump on neck and under arm, both on the right side. It was quite painful. By 6/19/18 it was the size of 1/2 a grapefruit. Went to see the doctor and they determined since she had not been bitten by anything and wasn't taking any meds that it had to be from the vaccine. Told her to take ALLEGRA and use ice and to come back if not better in a week. By 6/23/18 she was all better.
Pfizer vaccine mistakenly reconstituted with 0.8ml of sodium chloride instead of 1.8ml. Pt was administered 0.3ml of Pfizer vaccine IM in left arm. Pt was observed for 15 minutes after administration and reports no adverse reactions.
Patient was scheduled to recieve second dose of Pfizer vaccine series but was given Moderna covid vaccine. No adverse reactions noted. Patient was made aware of situation.
Pt's left arm became red, slightly swollen, and itchy. Pt treated with OTC diphenhydramine, hydrocortisone, and ice.