chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness, swelling & warmth, pain c/o (R) upper arm. No fever or chills TORADOL 60 mg IM given. Patient advised to use warm compresses to area. Call or return to clinic if increase redness, streaking or edema. Advised to not get pneumonia shot again.
Initial report received on 29 July 2008 from a health professional under reference number 0712041488. A 31-year-old pregnant female had received an injection of ADACEL (lot number and route/site of administration not reported) on 10 September 2007 and an injection of FLUZONE (lot number and route/site of administration not reported) on 01 November 2007. It was also reported that the patient had exposure to Varicella-Zoster Immune Globulin injection on 11 March 2008 (manufacturer not reported). Date of conception was reported as 22 August 2007. On 03 November 2007, the patient experienced a respiratory infection (cold, no fever). On 11 February 2008, the patient developed a sinus infection that was treated with Zithromax 500mg on 25 February 2008 and Zithromax 250mg from 26-29 February 2008. The patient experienced anemia and received treatment with iron 65mg from 05 November 2007 to 13 March 2008 and with an increased iron dose of 130mg from 14 March 2008 to 14 May 2008. For headaches, the patient received treatment with Tylenol and ibuprofen. The patient received Visine drops for red, itchy eyes. On 14 May 2008, the pregnancy resulted in a live birth. On 03 June 2008, the baby was diagnosed with patent foramen ovale and peripheral pulmonic stenosis. The reporter of this case is the same as case 2008-02469, which is a report of congenital anomaly (patent foramen ovale and peripheral pulmonic stenosis) for the above-mentioned baby.
. Patient stated that she is still having swelling, pain, numbness, and tingling in the arm that she received her first Moderna Covid Vaccine.
Fever; low energy; listlessness; Headache; muscle cramping, chills. I fall asleep and wake up with sweating profusely. Really bad runny nose. Still ongoing with all of these symptoms. The only thing that has improved recently - is that I felt a little more energy and a little less feverish but still have everything else.  I had the second vaccine around Feb 6th on Saturday.
About 10 days after 1st vaccine, the area around my injection site turned red and is swollen. Dr says area swollen is about 8 inches by 8 inches.  It itches at times. It is now day 15 after the vaccine and area seems to be getting worse. It is warm when touched.
Erythema, high fever 102 degrees F, swelling at injection site, severe pain in arm.
He did not get his second dose until two months later on 23-Mar2021; he had no change,Bottom line is his left foot is not back to normal/swelling procedded to lf ankle and back of calf; Some days he hasn't hardly any pain and some days it's considerable/pain proceeded to lf ankle and back of calf; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He did not get his second dose until two months later on 23-Mar2021), PERIPHERAL SWELLING (he had no change,Bottom line is his left foot is not back to normal/swelling procedded to lf ankle and back of calf) and PAIN (Some days he hasn't hardly any pain and some days it's considerable/pain proceeded to lf ankle and back of calf) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He did not get his second dose until two months later on 23-Mar2021), PERIPHERAL SWELLING (he had no change,Bottom line is his left foot is not back to normal/swelling procedded to lf ankle and back of calf) and PAIN (Some days he hasn't hardly any pain and some days it's considerable/pain proceeded to lf ankle and back of calf). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He did not get his second dose until two months later on 23-Mar2021) had resolved, PERIPHERAL SWELLING (he had no change,Bottom line is his left foot is not back to normal/swelling procedded to lf ankle and back of calf) had not resolved and PAIN (Some days he hasn't hardly any pain and some days it's considerable/pain proceeded to lf ankle and back of calf) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Magnetic resonance imaging: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.         No treatment medication information has been provided by the reporter. No concomitant medication information has been provided by the reporter.   This case was linked to MOD-2021-042428 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-06-2021: Contains no new information
severe bad cough; 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), on 01Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; epoetin alfa (PROCRIT), from 01Dec2022 (Batch/Lot number: unknown) to 01Dec2022 at 1x/every 4 weeks. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 01Dec2022, outcome "not recovered", described as "severe bad cough". The action taken for epoetin alfa was unknown.  Additional information: Patient had a bad cough after receiving the Pfizer-BioNTech COVID-19 Vaccine, Omicron Bivalent gray cap formula booster shot on 01Dec2022 (reported as yesterday). Stated as her third booster. An hour after receiving the shot; patient had a bad cough; still (at the time of this report) had the cough; further described as severe cough. She inquired if it had been reported as a side effect. Inquired if severe cough be from the vaccine. She also received her Procrit injection, she received it 1x/every 4 weeks, at the same time. The report was not related to a study or programme.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
09NOV91 became very weak, vomiting, poor appetite; continued to get weaker; 12NOV91 fever 101 continued for 2 days; 14NOV91 hospitalized for approx 1 day for tests; no rx - Home Health Nurse 3 x week;
Immediate metallic taste in her mouth at the time of injection.  Began having headache, joint stiffness, and nausea the next day.  Symptoms continued for 10 days.  Was on Macrobid for UTI.  Has history of not feeling well after annual flu vaccine and so pt plans to get flu vaccine on Friday afternoon every year so to have symptoms over the weekend and recover before returning to work the following Monday.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unknown dates, the patients were vaccinated with unknown number of doses of improperly stored ROTATEQ (dose, strength, lot # unspecified, orally). No adverse effects reported. This is one of the several reports from the same source. Additional information has been requested.
? 08/10/2021 o The patient received first Covid Moderna Vaccine and was scheduled for 2nd vaccine 2 weeks later on 8/24/2021.  ? 08/24/2021 o The patient came for second dose Moderna.  She did not bring her immunization card with her.    o Vaccine was administered after verifying correct patient name and dob.  Prior vaccine date not verified by medical assistant prior to injection. o Medical Assistant gave patient a new covid vaccine card with vaccine administration dates, and at that time noticed that the first dose was administered 2 weeks prior.  This was administered before the 24 day minimum interval between doses 1 and 2. o Patient was notified of vaccine administration error and was told that CDC does not recommend she get an additional dose at this time even though vaccine was administered early.  Pt notified of VAERS reporting. Patient not reporting any adverse symptoms at time of phone call several hours after vaccine administration.
has some enzyme issue; woke up sick; Nausea; Chills; Headache; Vomiting; A spontaneous report was received from a consumer concerning about a 65 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced enzyme abnormality and other events included sickness/illness, nausea, chills, headache and vomiting.  The patient's medical history was reported as have rheumatoid arthritis. Concomitant medications were reported as having medication for rheumatoid arthritis.  On 11 Mar 2021, prior to the onset of the events, the patient received their first planned doses of mRNA-1273 (Batch number: 04A21A) via intramuscular in right arm for the prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient woke up sick and was experiencing nausea, chills, headache, and vomiting.  On 13 Mar 2021, the patient went to the hospital and lots of test were done including a blood test. The physician mentioned she had some enzyme issue. The patient was admitted to the hospital ln 12 Mar 2021 and discharged on 15 Mar 2021.  On 16Mar2021 she went to cardiologist because she mentioned she has some enzyme issue. Treatment included paracetamol.  Laboratory results were not provided.  Action taken with mRNA-1273 in response to the events are unknown.  The outcomes of the reported events was unknown.; Reporter'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.
1 of 3 pts vaxed from the same vial who exp a localized, erythematous rash @ inject site w/in 24-48 hrs p/vax; size of react aprpox 708cm; treated w/DPH; pt recovered;
Troponin over 4000; Blood pressure over 300; Flushing beet red/erythema; Feeling groggy; Difficulty with cognition; Arm swelling; feeling hot/overheating; A spontaneous report was received from a consumer who is a 76-year-old, female patient who experienced blood pressure over 300 (blood pressure increased), troponin over 4,000 (troponin increased), flushing beet red (flushing), overheating (body temperature increased), grogginess (somnolence), difficulty with her cognition (cognitive impairment) and arm was swollen (peripheral swelling).  The patient's medical history included breast cancer in the right breast. Products known to have been used by the patient, within two weeks prior to the event, included cholesterol medication and once weekly Fosamax with calcium and vitamin D.   On 10-MAR-2021, the patient received a dose of mRNA-1273 (Batch number: 026A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 10 Mar 2021, immediately following the vaccination, the patient reported she experienced overheating, became beet red and her blood pressure was over 300. An ambulance took her to the emergency room. She had her troponin levels checked which were over 4000 that lead to a hospital admission and required a unspecified catherization. The patient was discharged home on unspecified date. She reported still feeling groggy and having difficulty with her cognition but it was improving throughout the day. The patient also reported her arm was still swollen, but improving.   Treatment for the event included diphenhydramine and other unspecified medications and treatments.   Action taken with mRNA-1273 in response to the events was unknown.  The events, blood pressure over 300 and troponin over 4,000, were considered recovering.   The events, flushing beet red, overheating, and grogginess were considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt had severe swelling and redness of arm--not at site but from above elbow to below elbow; treated with oral antibiotics and prednisone
This spontaneous report was received from a physician who reported that a female patient was vaccinated with VARIVAX (Merck) (lot not reported), and then reported that she was pregnant. The pregnancy outcome was outcome pending. Additional information is not expected.
Adult pt requested dose #2 of Moderna, reporting that her 1st dose was Pfizer. Previous vaccine records were not available. Full dose of Moderna was administered. Later it was discovered that pt had received only J&J single dose previously on 4/5/2021. Unable to reach pt by phone at this time
This spontaneous report as received from a vaccine coordinator refers to a 10 week old patient of unknown gender. On 19-FEB-2016, the patient was vaccinated with a first dose of LIQUID PEDVAXHIB (lot # L030869) (dosage and route unknown) following a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse (LPN) refers to a 41 year old male patient with HIV infection. No drug allergies were reported. On 01-APR-2013, the patient was vaccinated with adult dose of RECOMBIVAX HB injection of strength 10/1.0 microgram/milliliter (mcrg/ml) (lot # H018689 and expiry date: 07-NOV-2014). On 03-SEP-2013, the patient received RECOMBIVAX HB (lot #: H011741 and expiry date 01-FEB-2015). On 01-OCT-2013, the patient received RECOMBIVAX HB (lot #: 0384AE and expiry date: 02-NOV-2014). On 21-APR-2014, the patient received RECOMBIVAX HB (lot #: J006511 and expiry date: 28-JAN-2016). On 04-SEP-2015, the patient received RECOMBIVAX HB (lot number: L010595 and expiry date: 12-NOV-2016). Concomitant therapies included ATRIPLA. In November of 2013, the patient's anti-HBs were less than 3 (hepatitis b surface antibody negative). The patient did not experience any distress or any other adverse symptoms. The outcome of hepatitis b surface antibody negative, extra dose administered and inappropriate schedule of drug administration was unknown. The causality of hepatitis b surface antibody negative was unknown. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.
On Saturday morning, Jan. 26, 2019, I woke up and my neck was totally swollen - really big, smooth - from just under my chin to the bottom of my neck. It's possible that it started the night before, but I don't know. I had no trouble swallowing or eating or breathing. But the humongous swelling scared me. As I kept checking in the mirror periodically, the swelling was lessening. I searched the internet trying to find a cause, then remembered I had the SHINGRIX shot 2 days before, tho I couldn't imagine why an adverse effect or allergic reaction would come so long after the innoculation. Even tho the swelling kept lessening (I was in no pain), at around 3:30 p.m.,  I went to urgent care. A physician assistant or nurse practitioner, decided it was an allergic reaction to the SHINGRIX. She gave me a shot of cortisone in my rear end and prescribed the MEDROL PAK (Methylprednisolone 4 mg. dose pack) - a 6 day package to be started the day after. I followed up with my PCP a few days later, and at the time I was left with swollen lymph nodes.
Arm started hurting about 6 hours later. That night she was restless. Temp was 100.7, Took Advil, temp came down.  The next day, she experienced chills, joint pain, body ache. The next day, still had symptoms but not as bad. She is getting back to normal but is still having some mild symptoms.
patient was complaining of 'hoarseness of throat'.  This was approximately 20 minutes after the administration of vaccine.  Patient taken to ER when she arrived to ER patient stating her throat was itchy.
Got  tested  twice at their house, and tested positive and negative; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Got  tested  twice at their house, and tested positive and negative) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Got  tested  twice at their house, and tested positive and negative). At the time of the report, SARS-COV-2 TEST POSITIVE (Got  tested  twice at their house, and tested positive and negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative and positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided by reporter. Treatment medications were not provided by reporter.
relatively immediate reaction was more anxiety type symptoms: feelings of unease, or just not right, deep breathes and water helped as well as distraction. However, gassy response (belching and flatulence) was shortly after within 40 minutes of shot. I do not normally have these symptoms. The gas got worse as time wore on. 4 hours  (around 8 PM) after shot the gas was so bad, I was doubled over in pain. Then had 4 hours of diarrhea (8PM to midnight). Was able to sleep that night after midnight. I ate bland foods and drank coconut water and electrolyte fluids for several days to be sure diarrhea was over which it was. However, the belching continued though not as strong as the beginning. However, the belching has never fully gone away. Even after just drinking water or eating a cracker.
Stayed 30 minutes after vaccine at vaccination clinic to be safe in case of a reaction. About 5 minutes after leaving 11:30 I could taste the vaccine in my mouth. I immediately felt intense sharp tingling in my lower lip, it felt hot and swollen (upper lip never had a reaction). I instantly felt a lump in my throat and had a hard time swallowing. I started with chest pain that resolved itself in a minute or two. A few minutes later a family member noticed my face was red and flushed and said I looked like I had a sun burn. Swelling in throat resolved within an hour. Lip never visually looked swollen but I could feel the tightness, burning and tingling that resolved within the hour. Redness on face resolved within a couple hours. Had tiny blisters about 3 show up above upper lip I still have them the next day with a couple more but they aren't causing problems. My airway was never blocked I never had a hard time breathing. I did have a sore throat this morning March 25 day after vaccine. All other symptoms seem normal.
9/23/08 AM received PNEUMOVAX. That afternoon chills, no energy. Painful red, swelling from site extending 25cm down arm (R). Temp 103 that night. 9/26/08 - no fever, still low energy, eyelids feel heavy, nausea, myalgia in legs, shortness of breath, O2 sat 93%.
Flushed, hot first day, Pain in arm lasting more than 7 days, yellowed skin at injection site after 21 days.
On 4-5-07 pt presents to clinic, Dad states pt has had diarrhea x 3 days. Staggering like he doesn't have his Balance, vomiting. Had rash on Buttocks and facial cheeks, Pulling at his ears and acting like he has sharp pain in mouth. Mother states he could be teething.
This spontaneous report was received from a registered nurse referring to a male patient of unknown age. The patient's medical history or concurrent conditions were not reported. On 06-JUL-2017, the patient was vaccinated with "less than complete dose" of M-M-R II for prophylaxis, which had the lot number reported as N001532, expiration date 13-JAN-2019, (dosage information and route were not reported), due to syringe leakage. Information regarding concomitant medication was not provided. No adverse effect was reported. Additional information has been requested.
Information has been received from a 23 year old female consumer who in approximately 2006 was vaccinated with a third dose of GARDASIL (Lot# not reported). The consumer stated that in approximately 2006, about six months after the third dose of GARDASIL was administered; the consumer experienced red itchy warts and had been experiencing these warts for "at least 4 years". The consumer also stated that the warts were frozen off by herself not by doctor. At the time of the report the patient's red itchy warts persisted. The patient sought unspecified medical attention. (also reported as "NO medical attention has been sought). No further information is available.
This spontaneous report was received from a nurse referring to multiple unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M018810 with expiration date 28-MAY-2018, dosage and route of administration were not reported), which were exposed to temperature excursion (temperature: 51.3 degrees F, time frame: 1 hour) because of data logger. There was no previous temperature excursion. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Pt received Dtap and developed swelling and erythema of whole arm (deltoid to elbow)
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (same side effects like one she had with 1st shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. 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. On an unknown date, the patient experienced VACCINATION COMPLICATION (same side effects like one she had with 1st shot). At the time of the report, VACCINATION COMPLICATION (same side effects like one she had with 1st shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. Patient would like to know if there will be the same side effects like one had with 1st shot. Patient is Scheduled for the second dose and was also scheduled for the surgery a week following vaccination.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) in March 2021 at a dose of UNK dosage form. At the time of the report, HEADACHE (Headache) had not resolved.            Reportedly, the patient was taking concomitant medication (not specified). The patient took paracetamol, but it was not helpful.
Fever all night & next day. Headache & passed out. Had him in ER two times.