chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3rd in the series of Guardasil on 7/24/2008.  On 9/10/2008, patient went to emergency room in ambulance due to rash and difficulty breathing, assumed allergic reaction to something.  On 9/20/2008, patient had 2nd reaction with severe hives, shaking, jerking spasms and dehydration, assumed allergic reaction.  Both times treatment was IV benedryl and prednazone pack.  Allergist consultation visit the following day resulting in his prescribing use of over the counter allergy meds; Claritin in the AM, Pepsid mid day, Zyrtec at bedtime, benedryl as needed.  9/25/2008 patient was asleep and woke up choking with extreme breathing difficulties, resulting in another ambulance ride and a 3rd emergency room visit.  Treatment was IV benedryl and Prednazone pack.  Over the next 5 months several (5-7) cases of mild to moderate hives during which patient took over the counter benedryl and hives went away.  On 2/09/2008, patient had severe abdominal pain, began having difficulty breathing and noted hives.  This resulted in 3rd ambulance ride to emergency room.           For 5 months, patient has taken over the counter allergy meds regularly as described above.  Up to this point in her life she has had no known allergies, no anaphylaxis and has been in very good health, active in sports.   During this 5 months, she has been to the emergency room 4 times, 3 of those with severe breathing difficulties.              Symptoms include hives, abdominal pain, swelling of hands and fingers, difficulty breathing all occurring rapidly.  This is considered to be a life threatening situation.  It appears that this response could have been caused by Guardasil injection from 7/24/2008. 3/17/09-received office records for date of vaccine. Well visit. krk 4/6/09-records received-ED visit 9/O itching and diffuse swelling, facel feels swollen. PE:eyelids slightly swollen. DX:acute allergic reacion. acute allergic rash. ED visit 9/20/08-C/O allergic reaction, ithcy urticarial rash suddenly with some shortness of breath. Previous episodes of urticaria a week ago. DX:allergic reaction. allergic dermatitis. ED visit 2/9/09-C/O allergic reaction. Onset acute. Pain pruritus. DX:allergic reaction,  anxiety and urticaria.  4/13/09-records received for DOS 10/2/08-C/O hives. History of chronic hives began on 9/10/08 after lying on a rug, pruritic welts with some throat tightness. Repeat reaction week later.Assessment:idiopathic urticaria probable viral in nature. Allergic versus non-allergic rhinitis. Chronic nasal congestion. Mild angioedema.
Syncope - fainted shortly after leaving our office in the hall way of our building. He hit his head - laceration - we cleared and he was able to go home.
Can't smell or taste since a month after having vaccine.  I had to get vaccine since I'm in healthcare field.  Never had Covid prior or during my vaccine.   Did not go back for any other vaccines.  Left the healthcare field.
I got the coronavirus the first time and had a severe case on January 13th 2021 on March 10th 2021 I received the Johnson & Johnson vaccine at my local doctors office on April 16th 2021 I tested positive once again for the Coronavirus very few symptoms will present this time as opposed to a severe case I had in January
After receiving the Pfizer 2nd dose covid vaccine, the patient sat down in the waiting area chair, as per the 15 minutes post vaccination wait time, and then the patient slid down to the floor. Staff asked the patient if he hit his head, or injured himself in any other way, he said no. He was asked if he blacked out, the patient said "maybe". He was also asked if he needed medical attention, he rejected that as well. He was asked if he had any reactions during his 1st dose and he stated he did not.
Sore arm for first 3 days Rash at injection site  Large lump at injection site  after 9 days  Itchy
11/4/11 - Presented to ED for dizziness. 11/9/11 - Seen in clinic. Local reaction R thigh where IPO given.
Patient is 4 years old but was given 0.5ml dose for 12+ years instead of the 0.25ml dose for 6mo-11yr
fever of 104F; Muscle ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 104F), MYALGIA (Muscle ache) and CHILLS (Chills) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (fever of 104F), MYALGIA (Muscle ache) and CHILLS (Chills). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency; IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and ibuprofen at an unspecified dose and frequency. At the time of the report, PYREXIA (fever of 104F), MYALGIA (Muscle ache) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 104 f (High) 104 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided
site reaction; swelling, huge welt the size of the palm of her hand that was raised half and inch; swelling, huge welt the size of the palm of her hand that was raised half and inch and changed different colors; bruising; arm soreness; huge welt the size of the palm of her hand that was raised half; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 58-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   On 13th October 2018, the patient received the 1st dose of Fluarix Quadrivalent 2018-2019 season (intramuscular). On 14th October 2018, 1 days after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced injection site reaction, swelling, skin coloring, contusion, pain in arm and welts. On an unknown date, the outcome of the injection site reaction, swelling, skin coloring, contusion, pain in arm and welts were recovered/resolved.   It was unknown if the reporter considered the injection site reaction, swelling, skin coloring, contusion, pain in arm and welts to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were provided as follows: The case was reported by the consumer for herself. The patient received Fluarix in her left arm and experienced a site reaction,had swelling, huge welt the size of the palm of her hand that was raised half and inch and changed different colors, she also had bruising and arm soreness. No further information was reported. The reporter consented to follow up.
Janssen COVID-19 Vaccine EUA 4-9-21: Unusual and painful muscle cramps in both legs and left foot/ Nausea/ Vomiting random muscle twitching through out trunk and legs. Cramps ending by mid morning.  In general not feeling well through out day.  4-10-21 onset of severe to mild headache.  Again, general not feeling well.  All days following  moderate headache.  To this date 4-13-21 not feeling back to self 100%.
Pain, tenderness, redness & swelling of the left upper arm where the Tdap (Adacel) vaccine was administered, pt states that she also had a fever.
the patient had stridor and high-pitched screaming and high-pitched crying after was administered MMR II as child; High-pitched crying; High-pitched screaming; the patient had titers drawn which were low; This spontaneous report was received from a registered nurse and refers to a currently 32-years-old male patient. The patient's concurrent conditions included seizures, craniosynostosis syndrome and developmental delay. The patient's allergies include cheddar cheese, cottage cheese, cow's milk, mozzarella cheese, yogurt, brewers yeast, lettuce, mushrooms, peas, lima beans, peanuts, soybeans, cashews, safflower, sesame, coconut, lemon, watermelon, barley, bran, corn, gluten, malt, rye, wheat, and dill. The patient's concomitant medication included aspirin.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported).    On an unknown date, the patient experienced stridor and high-pitched screaming and high-pitched crying after was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) as a child. The patient was seen by the pediatrician on an unspecified date who recommended not to receive another dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). Since then the patient had titers drawn which were low. No treatment was received for the adverse events. The outcome of stridor, high-pitched crying and high-pitched screaming was recovered. The outcome of the adverse event the patient had titers drawn which were low was unknown at the moment of this report.  The relatedness between the events occurrence and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) administration was not reported.
Pt recv vax on 1/7/99; on 1/9/99 pt exp swollen left thigh w/ tightness, stiffness, red streaks
Sxs 5 minutes post vax with tingling in LUE, but vaccine given in RUE. Tingling is persistent.   No improvement. Persistent sxs.
Patient states that she developed a large, red welt on her arm the day after she had received the vaccine. She states that it took 5 to 7 days to resolve and states it was painful.
10:27 am Pt stated she had tingling in her tongue. Pt was asked to stay an extra 10 minutes 10:50 am Pt stated shes feeling much better 0/10 scale no other symptoms.  10:55 am Pt left the site
Suspected vaccination failure; me also on my right foot; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the dose of Shingles vaccine and had shingles. It was stated that patient also on his/her right foot and had the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was linked with US2021AMR097839 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR097839: US-GLAXOSMITHKLINE-US2021097954:Same reporter
Fever - Highest recorded was 100.7 Body Aches - Both last all day (the day after receiving shot)  Treatment: Drank water and slept a lot during the day
injection site swelling, redness. Fever, body aches, Chills, painful arm, chills, nausea, headache, no appetite.
Was to receive SARS-2-COVID booster dose of 0.25ml instead received 0.50ml dose. Denies any symptoms
Broke out in hives.  They start at about 10pm nightly.  Come on her arms, legs, thighs and sides. Itches in palm of hands.  Looks like ring worms and boils .  They disappear in the morning time then reappear every night around 10 pm.
Got omicron booster at pharmacy on 09/21/22 at 3:30 pm started with level 7 backpain about 7 hours later, now at 16.5 hours later I'm having to take 800 ibuprofen (mind you i already take 5/325 oxycodone daily) Also this morning about 5 am i woke up with 2 molars hurting (did not have tooth pain prior) took 800 ibuprofen again it helped some. I thought these were strange reactions that's why I'm reporting
Pain under the right clavicle that has not gotten better.  Tried over the counter remedies (motrin and bio-freeze).
Triage call to office. Patient with signs and symptoms of varicella. Triaged per office protocol. History by guardian.
Immediate swelling at the injection site after administration; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE SWELLING (Immediate swelling at the injection site after administration) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Immediate swelling at the injection site after administration). At the time of the report, VACCINATION SITE SWELLING (Immediate swelling at the injection site after administration) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  The patient was monitored for 30 minutes in the waiting area and the reaction was subsided by then.
Had atrophy of muscle @ site; Cried almost non stop fr 1PM to 3PM; 29APR91 mom states cried a lot yesterday, better today;
10-12 hrs after receiving immunization pt broke out in flat red rash starting at bra line progressed lower abd, thighs, and onto back no itching, no lesions, no hives, no c/o problems with breathing, no SOB no difficulty swallowing. Had nausea off and on no emesis. HA occasionally. Rash lasted 2-8 weeks. 9/19/01 MD visit to PMD and given Keflex and antihistamine.
body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and HEADACHE (headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LABETALOL for Blood pressure high.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced MYALGIA (body aches) and HEADACHE (headache). On 04-Sep-2021, MYALGIA (body aches) and HEADACHE (headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-344340 (Patient Link).
Patient began to have a severe reaction to the vaccine starting at 9pm.  She became feverish, itchy and a headache.  She was very congested and had difficultly breathing.  She was gasping for air all night and not able to lie down to sleep.  She has had a poor appetite and was very tired in the morning.  The symptoms were mildly better in the morning.  The patient is waiting to hear back from her primary care physician.
Patient received Pfizer COVID vaccine on 2/1/21 (lot # EN5318), 2/28/21 (lot # EN6198), and 9/24/21 (lot # 30145BA). On 7/12/22, patient admitted to our inpatient facility (med/surg unit) with COPD exacerbation (chronic respiratory failure with hypoxia on home O2 4LNC) and COVID-19 virus infection.  As of today (7/21/22), patient is still admitted in the med/surg unit.
Patient states that she had acute onset of left arm weakness, numbness, difficulty speaking and slurred speech that started at 22:50.  Patient was seen as a code stroke, was FANG?D +.  Patient underwent MRI and MRA of the brain which showed multifocal small acute infarcts along the right frontal and right parietal lobes, as well as punctate acute infarcts in the right occipital lobe.  No evidence of intracranial bleeding.  Also noted a filling defect in the right carotid bifurcation causing severe stenosis of the right ECA origin and moderate stenosis of the right ICA origin.  Patient was not given TPA, and was started on heparin drip and admitted to the ICU.  Patient did receive the Johnson & Johnson Covid?19 vaccine on 4/9. Patient also complained of right ear and right jaw discomfort, pain behind L eye and L aura, as well as burning discomfort of the back of her tongue for the past two days  Started on heparin drip initially and then converted over to argatroban drip based on CDC guidance.  No IVIG given as platelets are > 500
Painful, red, warm, indurated/swelling in arm below injection site - inner arm extending down to 1 inch above antecubital. Periodic itching. Treatment= alternating Advil/Aleve for pain. Getting progressively more pronounced.
Patient vomited approximately 10 to 15 minutes after receiving shot. Patient then got water and hard candy. After speaking with patient she said she felt better and went home. Called several hours later - patient said she had eaten, and felt much better. Patient stated she had not eaten all day before shot. Husband stated when her blood sugar gets low, she vomits.
Arm turned red, swollen up like a huge baseball in arm, itched, hot,  very sick: fever, flu-like symptoms, unable to work for 3 weeks.
This spontaneous report as received from a nurse refers to a 10 week old patient of an unknown gender. On 19-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Convulsive syncope approximately 5 minutes after receiving injection.  No treatment given and patient came out of it on his own after approximately 30-60 seconds.
Noticed redness and warmth 11/5/03 while at school in AM. Area 4cmx6cm approximately 1/2" below injection site. No welts, non-pruritic, afebrile.
the first dose of the Moderna Vaccine, and had a bad reaction to it; Patient took the first and second dose with different products; Patient took the first and second dose with different products; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (the first dose of the Moderna Vaccine, and had a bad reaction to it), COVID-19 IMMUNISATION (Patient took the first and second dose with different products) and INTERCHANGE OF VACCINE PRODUCTS (Patient took the first and second dose with different products) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (the first dose of the Moderna Vaccine, and had a bad reaction to it), COVID-19 IMMUNISATION (Patient took the first and second dose with different products) and INTERCHANGE OF VACCINE PRODUCTS (Patient took the first and second dose with different products). At the time of the report, IMMUNISATION REACTION (the first dose of the Moderna Vaccine, and had a bad reaction to it), COVID-19 IMMUNISATION (Patient took the first and second dose with different products) and INTERCHANGE OF VACCINE PRODUCTS (Patient took the first and second dose with different products) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Patient got the first dose of the Moderna COVID-19 Vaccine, and had a bad reaction to that, and he spoke to an HCP and recommended he to get Pfizer COVID-19 vaccine for his second dose and he took Pfizer vaccine for his second dose. Patient completed the first and second dose with different products.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
4 to 8 hours after vaccination she had severe seizure stayed in the hospital overnight for observation unknown cause for seizure she was between 15 and 18 months when this happened.
Flu vaccine given on 9/28/11. 9/30/11 started with URI symptoms and "red spots" on back of hands. Within one week "red spots" had become generalized over entire body. Currently being treated by Dermatologist for full blown exacerbation of psoriasis.
allergies; cough; soreness in the arm; every time she touches the injection site, she feels the soreness more; This is a spontaneous report from a Pfizer-sponsored program. A Contactable consumer (patient) reported that a 80-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 80-year-old at the time of vaccination), on 18Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, the patient experienced allergies, cough, soreness in the arm because of the injection, every time she touches the injection site, she feels the soreness more. It was reported that she understands that sometimes this soreness comes and goes after injection. The outcomes of events (allergies, cough) were recovered on an unspecified date in 2021 and the outcomes of events (soreness in the arm, every time she touches the injection site, she feels the soreness more) were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Allergic reaction; This spontaneous case was received on 02-Dec-2020 from physician via Med Communications (reference number: SEQW20-05537) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza vaccine, that the reporter believed was Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose, route of administration and anatomical location: not reported) as protection against seasonal influenza, but was not completely sure. The batch number was not reported.   On an unknown date, an unknown amount of time after receiving Flucelvax QIV, the patient developed reaction to vaccine, which was assumed to be an allergic reaction. The reporter did not know any additional information.   The outcome of the event was not reported.   The reporter assessed the event as related to Flucelvax QIV.  The reporter assessed the event as non-serious.  Case updated on 10-Feb-2021: Correction made to information received on 02-Dec-2020: Company causality changed from related to unassessable for the event of 'allergic reaction'. No changes were made in narrative. Company comment updated accordingly.   Company comment: The event of 'allergic reaction' is considered as unassesseable to Flucelvax QIV.; Reporter's Comments: Patient received an influenza vaccine and developed a reaction to it.; Sender's Comments: The event of 'allergic reaction' is considered as unassesseable to Flucelvax QIV.
Hard, 3 inch round, red lump at injection site. Painful, tender., slightly itchy.