chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented at office of Dr. on 10-25-2017, with hives on back of neck, right shoulder and lower back and a few spots on right knee. Does not have any reaction in either site of injection. Has been on MACROBID antibiotic for IC symptoms once a day for the past 12 days as a precaution. Took ½ tablet of plain ZYRTEC earlier and was a bit edgy. Also tried a new fruit yesterday, persimmon and had nausea off and on. Has been caring for husband that is ill with norovirus and has been using bleach and other antiseptic sprays. Has not changed personal hygiene products, except new brand of clothes dryer sheets. Prescribed Ranitidine 150 mg oral tablet, one tablet BID x 14 days, ALLEGRA 24-hour allergy tablet, Triamcinolone 0.5 % topical cream, apply topically BID on affected areas. Stop MACROBID. Hives continued to spread on 10-26-2017, with worsening symptoms, hives continued to spread to larger area on her back, intergluteal area, anterior thighs and neck area. Patient complained of warmth and itching. Administered KENALOG 60 mg IM right buttock Lot # AAR1751 expires 02-28-2019. Prescribed Ranitidine 150 mg oral tablet, one tablet BID x 14 days, ALLEGRA 24-hour allergy tablet, Triamcinolone 0.5 % topical cream, apply topically BID on affected areas. Stop MACROBID. Advised that cannot confirm that this is a reaction to the rabies vaccine since there are other potential exposures and no local reactions occurred. Patient advised to avoid new products and foods. Keep a diary of exposures.  Advised on potential angioedema symptoms and if that is the case will need to go to the ER.  Consider Allergist consultation for evaluation. Patient deferred referral at this time. 10-26-2017 Patient called Dr. again due to concern of heart racing, pulse > 100 bpm, temp of 99.4, lesions still itching and neck warmth and tightness is improving. Patient has been resting. Advised to stay well hydrated and monitor for gastrointestinal symptoms, respiratory distress, mucosal lesions and angioedema. Tachycardia can be side effect of steroids vs. increased temperature from allergic reaction vs. incipient vial infection.
As I had expected from earlier Moderna vaccinations, 12 hours after I developed a low grade fever and chills that resolved in about four hours. The next day, I began having migraines and they continued daily despite taking Sumatriptan 25 mg. T On October 28, I had two dizzy spells. The nest day I had two more that were more pronounced. Then on October 30, while sitting in a chair, I had major vertigo that lasted almost 30 minutes. We went to an emergency room, and an MRI ruled out a stroke.  Previously, I tested positive for COVID on July 26 and started Paxlovid 7/28 through August 1. Tested positive on 8/02, negative on /3 and 9/04 morning positive that afternoon and for the next 8 days. Worst symptoms, migraines.
Received second Covid booster shot on 20 April.  Next day, 21 April, woke up in the morning feeling nauseous and vomited. On 22 April was still feeling nauseous and vomited again. Saw primary care doctor, Dr.  Since then, off and on, almost every other day, have been feeling "unbalanced" like she cannot walk steady. Also lack of appetite. (Normal weight usually around 136lbs. As of today, 16 May, weighed 129.4lbs. Almost daily, right nostril and right ear clogged/stuffy.  15 May (Sunday) was the only day since 19 April that my wife as faired ok; normal day, church services, eating ok. Now, 16 May, she started day very dizzy and vomiting around 7:30am. Unsteady, slight nausea throughout day. Resting in bed. Now, 2:15pm, no nausea, no vomiting, can walk by herself to the bathroom. Again, this unbalanced, wobbly feeling is off and on just about every other day.
pericarditis. 1/13 chest pain, fatigued. 1/14 pain worsened, short of breath, bp elevated. 1/15 mild pain at night. 1/16 mild pain. 1/18 went to the ER convinced that it was pleural effusion, x-ray didn't show any fluid. 1/19 saw cardiologist for echo, she thought it might be pericarditis. pain still there a week later, started on colchicine.
No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 11-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 01-JUL-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012222: US-009507513-1907USA012231: US-009507513-1907USA012224: US-009507513-1907USA012225: US-009507513-1907USA012226: US-009507513-1907USA012227: US-009507513-1907USA002267: US-009507513-1907USA012229: US-009507513-1907USA012230: US-009507513-1907USA012221: US-009507513-1907USA012220: US-009507513-1907USA012219: US-009507513-1907USA012223:
Patient was given 0.5ml instead of 0.25ml. Patient was called and states his arm was sore at injections for a few days, denies any other problems since vaccination. Letter sent to patient with dosage given
started to shake; felt like she was getting the flu; Dizzy; didn't feel right; arm hurt a bit; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (started to shake), INFLUENZA LIKE ILLNESS (felt like she was getting the flu), DIZZINESS (Dizzy), FATIGUE (didn't feel right) and VACCINATION SITE PAIN (arm hurt a bit) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (prior covid-19 infection.) from 24-Nov-2020 to 15-Dec-2020.    On 09-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 VACCINATION SITE PAIN (arm hurt a bit). On 10-Jan-2021, the patient experienced TREMOR (started to shake), INFLUENZA LIKE ILLNESS (felt like she was getting the flu), DIZZINESS (Dizzy) and FATIGUE (didn't feel right). On 13-Jan-2021, TREMOR (started to shake), INFLUENZA LIKE ILLNESS (felt like she was getting the flu), DIZZINESS (Dizzy), FATIGUE (didn't feel right) and VACCINATION SITE PAIN (arm hurt a bit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2020, SARS-CoV-2 test positive: positive Positive. On 15-Dec-2020, SARS-CoV-2 test negative: positive Positive.     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.; 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.
After 24 hours of administration of ipv IM right deltiod, client's arm is swolen and hard . States pain in AM. Active, no fever.Advised Tylenol.
18 hours after receiving vaccine woke up with eyes extra watery/ discharge/ dryness around eyes  4 days after receiving vaccine (1/14) woke up with intense eye left eye irritation, swollen, discharge, extra watery, inflamed
Delayed tender spot at injection site. Raised area about 2 inches in diameter with whitish center and red perimeter. Noticeable for about three days. Did not increase in size after first identified as a ?rash? (day two after onset).
where the red rash is, it feels warm to the touch, like a pink rash; feels warm to the touch; The upper arm pretty much is red and it itches; feels tired; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (where the red rash is, it feels warm to the touch, like a pink rash), FEELING HOT (feels warm to the touch), PRURITUS (The upper arm pretty much is red and it itches) and FATIGUE (feels tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (where the red rash is, it feels warm to the touch, like a pink rash), FEELING HOT (feels warm to the touch), PRURITUS (The upper arm pretty much is red and it itches) and FATIGUE (feels tired). At the time of the report, RASH ERYTHEMATOUS (where the red rash is, it feels warm to the touch, like a pink rash), FEELING HOT (feels warm to the touch), PRURITUS (The upper arm pretty much is red and it itches) and FATIGUE (feels tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
had the shingles had it for 3 weeks but very little because I had the vaccine 4 years ago/Suspected Vaccination failure; very little pain; had the shingles had it for 3 weeks; 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, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got very little Shingles after vaccination. The patient had vaccine 4 years ago from reporting day and very little pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
little pain in the arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little pain in the arm after first dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN and LEVOTHYROXINE for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (little pain in the arm after first dose). At the time of the report, PAIN IN EXTREMITY (little pain in the arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter No treatment information reported by the reporter   This case was linked to MOD-2021-228288 (Patient Link).
Patient present from dialysis where they became extremely hypotensive and feeling unwell. Ended testing positive for COVID-19. Patient was fully vaccinated
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 17-AUG-2016, the patient was vaccinated with unknown doses of VARIVAX and KINRIX (route, lot # and expiry date were not reported for both vaccines). On 22-AUG-2016, the patient to another office and was vaccinated with an unknown dose of M-M-R II (route, lot # and expiry date were not provided). No adverse symptoms were reported. Additional information has been requested.
Vaccine administered 9/3/15, patient came by today 2/11/16 said that her arm does not hurt but doesn't "feel right" and she said she read an article how other people have had the same situation following a flu vaccine.  Patient did not state any treatment or therapy following vaccine administration.
patient received a dose from an expired Moderna vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 037F21A, 032M20A and 024M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Hives; fever; This is a spontaneous report received from a non-contactable other hcp. An 22 year old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 27Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 28Jan2021 patient experienced hives and fever. The outcome of the events was recovered.  No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Narrative: Pt attributes covid vaccine to GI issues. Evening after first and second COVID-19 shots, she had worsening heartburn. Had covid vaccines in August (8/7/2021 and 8/28/2021 - both Pfizer per patient). Pt reports after vaccine started having worsening reflux. Declines any medications. "I feel like esophagus down to stomach was messed up with the covid vaccine: "I feel like esophagus down to stomach was messed up with covid vaccine" "I get food stuck in my throat. "The covid shot caused belly pains" and Pt feels like food particles "get hung intermittently." "The covid shot has affected my heart I have chest pains all the time and do not know if the heart was affected or my acid reflux is causing the pain" "When I was young I was diagnosed with mitral valve prolapse." c/o chest pain pt reports she feels short of breath and wakes up in the night with night sweats. 4/5/2022 - Pt presents for recall with concerns of breaking out in hives since receiving the COVID-19 vaccine. Hives are intermittent to arms and legs since Aug. 2021. Had vaccine and reportedly developed hives three days later. Within 6 h of of vaccine felt like she was having breathing problems and GI tract was upset. Pt reports breathing problems after COVID vaccine and worsening the reflux. C/O nausea with acid reflux.
11/1/12 Wrong strength of Hep B vaccine given to patient. Adolescent dose instead of adult strength. Pt. has now completed adult Hep B series as of 6/26/13.
Immunized 6/18/2013 presented to clinic 6/20/2013 with rash and swollen/red arms. (L) arm 25 cm (R) arm 22.5 cm. Raised red welts on arms, trunk, legs. Warm to touch, itchy.
Client received second dose COVID vaccine @ 10:10 am, complained of shortness of breath similar to asthma @ 10:23 am.  Client had rescue inhaler in car, self administered albuterol 5 puffs.  Observed and vital signs monitored.  Client reported shortness of breath improved with use of inhaler, left observation area @ 10:46 am once her symptoms improved and left with her husband,
Case number PHEH2016US028354, is an initial spontaneous report received from a consumer on 26 Oct 2016. This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1619301, Expiry date: Apr 2017) at a dose of 0.5 intramuscularly on 25 Oct 2016. It was reported that, 2 employees were administered FLUVIRIN MDV that reached 77 F for 4 days. No adverse event was reported following this administration error (incorrect product storage). The case was assessed as non serious by the consumer.
Day of injection brusing and pain at injection site and in muscle, flu like symptoms that went away after a few days.  16 days later injection sight has become swollen, red, sore, and hot to touch.
I had a scratchy throat and congestion. I was feeling achy and the sore throat and congestion was really bad. I had a loss of appetite. I went into the doctor for the bug bite. I did a rapid test at home and at pharmacy and tested positive for both. I ended up on antibiotics as I had a bug bite I was being treated for as well as COVID-19. It was about 2 weeks before the symptoms improved. The cough is still pretty bad along with fatigue.
significant joint pain; fever; chills; headache; swelling and soreness at injection site; swelling and soreness at injection site; facial rash; an hour of diarrhea; Onset of extreme fatigue; This is a spontaneous report from a contactable nurse. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration in the left arm on 23Mar2021 at 15:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history of patient included asthma, diastolic heart failure, CKD (chronic kidney disease) stage 2; all from unknown duration. The patient was intubated and ventilated at time of COVID-19 infection in Nov2020. The patient did not had allergy to any medications, food, or other products. The patient previously received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in the left arm on 03Mar2021 at 15:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Mar2021, at 19:15, 20:15 the patient had an onset of extreme fatigue, followed by an hour of diarrhea respectively. On 24Mar2021, the next morning, the patient experienced significant joint pain, fever, chills, headache, swelling, and soreness at injection site and facial rash. Therapeutic measures were taken as a result of adverse events with TYLENOL. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue extreme, diarrhea, joint pain, fever, chills, headache, vaccination site pain, vaccination site swelling, facial rash were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Exposed to varicella about 5 weeks ago. Has about 10 vesicular lesions on upper thighs.
This case was reported by a consumer via call center representative and described the occurrence of swelling in a 75-year-old male patient who received SHINGRIX for prophylaxis. On 26th February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced swelling, erythema and pruritus. On an unknown date, the outcome of the swelling, erythema and pruritus were unknown. It was unknown if the reporter considered the swelling, erythema and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient had the shot three days ago before date of reporting. The shot was administered at a pharmacy, not in the doctor's office. The patient asked how long after a dose of SHINGRIX, the swelling and redness take to relieve itself. The patient asked whether any suggestion as to hot or cold compresses to relieve, the redness, itching and swelling.
A few days after the vaccine, my heart was doing the same after the 1st vaccine, at that point, I saw my doctor and went to a Cardiologist. I had a monitor, but it did not happen at the period of time I had the monitor, it was not significant findings, and then it went away until Feb 2022 that came back andwent away after that. I had my 2nd shingles in January I have then ever since after. I was diagnosed with PDC. The heart palpitations did not happen with Pfizer.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events was unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756553A, A0756555A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there were 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA 320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
I had a huge lump under my left armpit. I went to the doctor stated felt like a boil which has been noted as a normal reaction to follow up 10 days.