chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received the third/booster dose of BNT162b2; Begin menstrual cycle two weeks early each covid vaccine.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Jan2021 (at the age of 38-years-old), received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Feb2021 (at the age of 38-years-old) and also received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Oct2021 at 16:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluticasone furoate (ARNUITY ELLIPTA), citalopram (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took iodine(MANUFACTURER UNKNOWN) and experienced drug allergy. On an unknown date in 2021, the patient's menstrual cycle began two weeks early after each covid vaccine. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event began menstrual cycle two weeks early each covid vaccine was resolved with sequalae on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Swelling to 6 inches, hard lump in center, lasted 6 days, redness.
Initial unsolicited report received from a physician on 11 November 2016. This case involves a 41-years-old female patient who was vaccinated with first a 0.5 ml dose FLUZONE QIV (Batch number-UI678AA, expiratory date-30 June 2017) in left deltoid; first dose of ADACEL (Batch number-U5489AA, expiratory date-17 November 2018) in left deltoid and first dose of MEASLES, MUMPS AND RUBELLA VACCINE (MMR) (Batch number-M008589) (expiratory date and dose was not reported) in right deltoid (Route of administration was not reported for all vaccines) on 22 October 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none. Concomitant medications were not reported. On 29 October 2016, seven days following the vaccination, the patient had experienced pain in finger joints and thighs and also pain in muscles of her back and shoulders. It was reported as on 10 November 2016 notified that the patient still has muscle pain, muscle cramps, and was unable to work or lift anything. Patent was required ER visit. Relevant laboratory data was reported as none. It was reported as the doctor was prescribed anti-inflammatory to patient for discomfort. The outcome of events was reported as unknown. List of documents held by sender: none.
Loss of smell; Loss of taste; This spontaneous case was reported by a dentist and describes the occurrence of ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste). At the time of the report, ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) 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.   No relevant concomitant medications were reported.  No treatment information was provided.  Company Comment: 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. No further information is expected.; Sender'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. No further information is expected.
Patient felt adverse effects after receiving vaccination. Approximately two hours after her vaccination, patient felt a radiating pain on lower right back down the right leg to the point where she could not walk. She used an ice pack and took an OTC pain medication (she could not remember name of) as well as an old gabapentin prescription later in the night. She states she could not walk from the pain all night. Her left knee experienced pain as well but for a shorter period of time. The next morning she can walk and feels it is improving, but there is still pain.
Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates the patients received an improperly stored doses of GARDASIL 9 (dose, route and frequency unknown) (lot # M023169, expired date 13-JUN-2018) for prophylaxis. No adverse effects reported. The GARDASIL 9 was exposed to 54.32F for a time frame of 8 hours. There were no previous temperature excursion and no data logger involved. Follow-up information was received on 29-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated.; Sender's Comments: , MERCK 1611USA000999:Mfr number.
crying, fussing constantly starting 2hrs p/vax;would calm to eat & when picked up & walked;slept @ noc & late PM but seemed exhausted;fewer daytime naps & does not nurse as well as previously;APAP helps calm pt;crying increases in intensity
Upset stomach starting about 3.5 hours after the vaccine administration and continuing through today (48 hours later). It's not debilitating, but it's unpleasant. I also feel a bit tired, but it's hard to say if that's an additional side effect or if it's the effect of not eating much because my stomach is upset.
Post vax, this pt experienced localized slightly raised (4-5cm), red area around injection site. within 20 minutes post vax, pt presented to physician with symptom. Subsequently he recovered.
Pt also states that he has, had an allergy to the flu shot. My arm swelled up and was painful and reddened - maybe a little larger than a quarter. It still is hot to touch and itchy but isn't swollen or painful now. I don't think I should get the flu shot again!
Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestion; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown, vaccine location: right arm), intramuscular on 04Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included hypertension/high blood pressure controlled, GERD/acid reflux, fast heart rate, and prediabetic. Concomitant medications included losartan, metoprolol, gemfibrozil (LOPID), aspirin [acetylsalicylic acid], atorvastatin, vitamin D3, zinc, magnesium, ascorbic acid (VIT C), vitamin B complex (VIT B COMPLEX), alpha-d-galactosidase (BEANO), angelica keiskei leaf, sambucus nigra extract (SAMBUCOL), and unspecified stress supplement. The patient is not pregnant. The patient received a flu shot administered on the right arm on 28Oct2020 and pneumo vacc administered on the left arm on 28Oct2020. The patient received no other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: COVID PCR) on 22Dec2020 with result negative. On 04Jan2021 13:15, the patient experienced bumpy red rashes in arms and legs, shortness of breath, mild chest pain, severe dizziness, and congestion. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering.  Information about lot/batch number has been requested.
Besides expected head ache and slight fatigue, I woke up on the night of 3/17 (day 2 following 2nd vaccine dose) with extreme pain in my right big toe and foot, with some cramping in the right calf.  It was difficult to walk.  I stayed in bed most of the next day with right leg elevated, and using ice to help pain and swelling. My wife and I suspected Gout, however it would have been a first for me to have it.  By 3/19 it felt a little better, but right foot still swollen, and my wife and I noticed a pronounced vein from the right knee down. She got scared that it could be a blood clot, so we called Dr and he ordered ultra sound, which was done on 3/19 in afternoon, but technician said that saw "nothing".  Today (3/20) foot still sore and it's hard to put wight on it still.
SCIATIC NERVE ACTING UP; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (SCIATIC NERVE ACTING UP) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced SCIATICA (SCIATIC NERVE ACTING UP). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SCIATICA (SCIATIC NERVE ACTING UP) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Both cheeks feel heavy/ numb(not really.numb) to touch. Just feel odd.
Hives all over my body; Chills; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Jul2021 (at the age of 38-year-old) (Lot Number: EWO196) as dose 2, single for COVID-19 immunization. Medical history was none. The patient's concomitant medications were none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 15Jun2021 11:30 (at the age of 38-year-old) (Lot Number: EWO217) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced hives all over her body and started getting chills with the hives on 08Jul2021 23:00. The patient did not receive any treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Patient c/o palpitations and itching all over, Rash developed torso, arms 2 Benadryl tabs 25mg ea.(=50mg) administered Right away. 20-30 minutes later sx's decreased Rash did remain chest, neck pt eval. by M.D. in office sent home stable
21 1/2 hours after receiving immunizations, mom found him in crib looking "dazed".  He stared and did funny things with mouth.  Episode lasted 45 minutes.  He was seen at health center where neuro exam was normal.  He was returned to hospital and admitted.  He had a negative sepsis work up, normal EEG, CT of head.  He was felt to have had a probable seizure.  Temperature was 100.6. 3/10/08-records received-EEG normal. Seizure like activity, staring, unresponsivel, slept after episode. Adverse reaction to vaccine.Temp 100.
1ST DOSE CHARTED IN EMR AS PFIZER 2ND DOSE CHARTED IN EMR AS MODERNA VACCINE CARD IS WRITTEN MODERNA 1ST AND 2ND DOSES  CHARTING ERROR VERSES A MEDICATION ERROR-UNABLE TO CONFIRM.
After injecting, the patient immediately began to bleed and upon inspection, a large welt (~1.5" diameter, raised ~0.5") had developed at the injection site. The patient stopped bleeding quickly, the area was cleaned with alcohol wipe, and a Band-Aid was applied. Patient did not feel any pain nor was he concerned. Patient was counseled that the needle most likely hit a vein and to reach out to his PCP if he had worsening of symptoms. Patient remained seated for 15 minutes following the injection, reported he felt well, and left.
abdomnial cramps with loose stool, nausea, severe headache, chills, fatigue, all body muscle aches, dry heaves x2days. Unable to toletate liquid or food until  afternoon of day 2 which started with ice chips.
This spontaneous report as received from a physician refers to a 15 month old male patient. The patient's current conditions included asthma. Drug reactions/allergies were none. On 20-JUN-2011, the patient was vaccinated with M-M-R II, 0.5 ml, subcutaneously. Concomitant therapies included albuterol and PULMICORT. On 20-JUN-2011, the patient developed hives on an unspecified location of his body, wheezing, and difficulty breathing "within an hour or so after receiving MMR II". No lab diagnostic studies were performed. The patient's parent sought medical attention and called physician's office on 20-JUN-2011 and was instructed to give BENADRYL as treatment for the events. The patient recovered from the events on 20-JUN-2011. The causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Pt exp lightheadedness, abd cramps, tremors, apprehension; wheezes, fine hand tremors, facial flush;
LIGHTHEADEDNESS, LYMPH NODE PAIN & SWELLING, NAUSEA Narrative:
Information was received from a medical assistant (also reported as office manger) referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates between 2009-2011, the patient received 3 doses of GARDASIL (dose, frequency, route, lot # and expiration date unknown). The patient was inadvertently administered an additional dose of GARDASIL injection (lot # K006124, expired on 02-FEB-2017) (dose and route unknown) in 06-DEC-2014 and another additional dose (lot # K011325, expired date 08-APR-2017) (dose and route unknown) on 12-MAY-2016. No adverse effect was reported. Additional information has been requested.
vaccine administered on 2/13, reaction on 2/21.  Site itching, redness, 2 swollen areas.
Patient experienced chills/tremors and nausea after 1 1/2 hours after vaccine administered.
Information has been received from a lawyer concerning a 30 month old male who on 10/13/95, 11/27/95 and 6/27/96 was vaccinated with the 1st, 2nd and 3rd doses of Hep-B vaccine recombinant (yeast) (dose not reported). Concomitant suspect therapy included MMRII, given on 10/16/96 and 2/27/98 (dose not reported). It was alleged that through these vaccinations, the pt was exposed to Thimerosal and that each injection exposed the pt to between 12 and 25 micrograms of ethyl mercury. In approx. 3/98, the pt began to display symptoms of neurological damage and mercury poisoning with regression of language skills, developmental delay, lack of fine motor skills, limited attention span and diminished cognitive ability. The pt received and at the time of this report, was continuing to receive medical treatment in an effort to remove toxic and neuro-toxic mercury from his body. It is reported that as the pt's mercury levels have decreased, there was a modest improvement in his symptoms. The reporter felt that neurological damage, mercury poisoning, regression of language skills, developmental delay, lack of fine motor skills, limited attention span and diminished cognitive ability were related to therapy with Hep-B vaccine recombinant (yeast) and MMRII. Upon internal review, the pt's neurological damage, mercury poisoning, regression of language skills, developmental delay, lack of fine motor skills, limited attention span and diminished cognitive ability were considered to be an "Other Important Medical Event". No further information is available.
A few minutes after vaccine (Influenza), patient's LOC became altered - he was cold and clammy.  I injected him with Epi-Pen Jr.  V/S B/P 83/47, HR 59, RR 16, T 97.4.
On 7/9/2018, client was given MENVEO vaccine, not reconstituted with the powder prior to immunization, so client only received vaccination against CWY strains and not the A strain. Upon reviewing the state registry, it was noted that the client recieved his Meningococcal vaccine on 5/22/2018 at a different location, so revaccination is not needed. Client's mother was informed of the situation.
Unconsolable crying, sleeplessness, loss of speech 2 weeks after injection, recurrent ear infections with ruptured eardrum. Tantrums that lasted over an hour.
This spontaneous report as received from a licensed practical nurse refers to a 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUL-2016, the patient was vaccinated with the dose of GARDASIL (lot # L010596, expiration date unknown; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one several reports received from the same reporter. Additional information has been requested.
Dose received: 3; Exhaustion; sleeping since 4 hours post vaccination through to next day.; Chills through the night after vaccination.; Joing aches; Muscle aches; Arm pain; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administration date 12Dec2021 (Lot number: unknown) at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? :Yes. Concomitant medications included: FLU. Vaccination history included:  Bnt162b2 (DOSE 1 SINGLE, Lot number: unknown, Route of administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2 SINGLE, Lot number: unknown, Route of administration: unspecified), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 12Dec2021, outcome "unknown", described as "Dose received: 3"; FATIGUE (non-serious) with onset 12Dec2021, outcome "recovering", described as "Exhaustion"; HYPERSOMNIA (non-serious) with onset 12Dec2021, outcome "recovering", described as "sleeping since 4 hours post vaccination through to next day"; CHILLS (non-serious) with onset 12Dec2021, outcome "recovering", described as "Chills through the night after vaccination"; ARTHRALGIA (non-serious) with onset 12Dec2021, outcome "recovering", described as "Joing aches"; MYALGIA (non-serious) with onset 12Dec2021, outcome "recovering", described as "Muscle aches"; PAIN IN EXTREMITY (non-serious) with onset 12Dec2021, outcome "recovering", described as "Arm pain". Therapeutic measures were not taken as a result of fatigue, hypersomnia, chills, arthralgia, myalgia and pain in extremity.  Additional Information: The patient's known allergies were reported as not applicable. Prior to vaccination, the patient was 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.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient vaccinated with pfizer COVID vaccines 02/26/21 and 03/18/21 Patient presented to ER due to nonhealing lesion of right heel as well as erythema and was admitted on 06/15/21 Patient tested negative for COVID-19 on 06/15/21 Patient deteriorated and tested again for COVID-19 and positive on 06/28/21 Patient expired on 07/01/21
Dizziness, weakness, fatigue, muscle pain (shoulders, neck and lower back), local shoulder/arm pain, joint pain, sunshine very strong (hurting) for eyes (had to squint).
Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Mild, Additional Details: Patient experienced numbness in the face along with difficult swallowing and an itching and closing sensation in the throat starting about 30 minutes after the injection. patient remained conscious and the symptoms subsided within an hour of the injection. no medications needed to be administered.
Approx  20 min after injection developed erythema, non raised rash to chest, upper back and lower back with pruritis. Pt given 25mg diphenhydramine in clinic and monitored for another 20 min. Patient observed until 4pm, still had non raised erythema with pruritis. No difficulty breathing or facial swelling.
injection site reaction; welling on her arm, 3" or 4" in; burning; red; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (injection site reaction), PERIPHERAL SWELLING (welling on her arm, 3" or 4" in), BURNING SENSATION (burning), ERYTHEMA (red) and INJECTION SITE PRURITUS (itchy) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Chicken pox (historical condition include chicken pox).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE REACTION (injection site reaction), PERIPHERAL SWELLING (welling on her arm, 3" or 4" in), BURNING SENSATION (burning), ERYTHEMA (red) and INJECTION SITE PRURITUS (itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (injection site reaction), PERIPHERAL SWELLING (welling on her arm, 3" or 4" in), BURNING SENSATION (burning), ERYTHEMA (red) and INJECTION SITE PRURITUS (itchy) outcome was unknown. Not Provided      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.   No relevant concomitant medications were reported. Treatment details included Benadryl 25mg liquid and ice pack.
Bad abdominal pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN (non-serious), outcome "unknown", described as "Bad abdominal pain".  Additional information:patient reported receiving both doses of Pfizer Covid-19 Vaccine, after each dose she had experienced bad abdominal pain. She had experienced those abdominal pain now after having that second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.