chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got COVID Disease 2 weeks after receiving  booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID Disease 2 weeks after receiving  booster dose of Moderna COVID-19 vaccine) in a 64-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Got COVID Disease 2 weeks after receiving  booster dose of Moderna COVID-19 vaccine). At the time of the report, COVID-19 (Got COVID Disease 2 weeks after receiving  booster dose of Moderna COVID-19 vaccine) outcome was unknown.            No concomitant drug was reported. No treatment drug was reported.  Company comment: This spontaneous case concerns a 64-year-old female patient with no medical history reported, who experienced the unexpected non serious ADR of COVID-19, approximately 2 weeks after the booster dose of mRNA- 1273 vaccine. Information regarding the initial schedule of vaccination was not disclosed. Very limited information is available regarding clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2022-465333 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 64-year-old female patient with no medical history reported, who experienced the unexpected non serious ADR of COVID-19, approximately 2 weeks after the booster dose of mRNA- 1273 vaccine. Information regarding the initial schedule of vaccination was not disclosed. Very limited information is available regarding clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
The symptoms were quite long lasting. Chest congestion, nasal congestion, sneezing and cough, 101 degree fever, body aches. I'm going on my 5th day.
sx started approx 7 minutes after vaccine.  C/o itching left hand spreading to bl arm and lower ext Wheal on left foot under chin, felt heart race.  Denies shortness of breath, denies chest pain, denies palpitations.
This spontaneous report was received from a consumer concerning her daughter of 6 months. Concurrent conditions, medical history, concomitant medication and drug reactions/allergies were not reported. It was reported that on an unspecified date, the patient was vaccinated with either improperly stored or expired dose of ROTATEQ (strength, dose, unit, frequency, lot number and expiration date not reported) for prophylaxis. No adverse effects were reported. Temperature and timeframe of the vaccine were not reported. There was no product quality complaint (PQC) reported.
Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not function as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 10-JUN-2016, the patient was treated at hospital medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
high fever, cough, stuffy nose, hives, itchy and burning rash (still on my body even after using prednisone for 5 days), tiredness, dry and sore throat
Pfizer-BioNTech COVID-19Vaccine EUA I received my shot on 01/06/2021 at 0830 a few minutes after receiving the vaccine I became dizzy and lightheaded. I let the nurse in the observation area know and honestly didn't think much of it. It lasted about a minute or two. I was fine for several hours after just experienced the normal soreness and kind of achy tired feeling. Around 1700 I began to itch, my whole right arm and upper torso area was itchy. I did not take any medications for this and it subsided around 2000.
Resident c/o cough and congestion. Rapid tested with positive results. Placed on isolation precautions x5 days
I was feeling a lot of inflammation in my sinuses. I had a runny nose with fatigue and a slight headache. I had aches and pains and chills. I had a great loss of energy. This was the 17th so I called my doctor's office that same day. They told me to take TYLENOL and MUCINEX D. I am back to normal now, I started feeling better on the 24th.
Swollen, red, hot upper arm at site. Prednisone and Keflex.
Patient received Pfizer COVID-19 Bivalent Booster vaccine which was beyond the manufacturer recommended use time of 10 weeks at the refrigerated temperature.  has been in direct contact with the vaccine manufacturer regarding this issue. Pfizer has data to support the stability of the vaccine up to 45 days at refrigerated temperatures. The vaccine given was within this range which is supported by the above data. Clinically, the patient is considered to have adequate protection against COVID-19 from this vaccine dose compared to if the dose was administered within 10 weeks. Thus, there are no additional clinical recommendations at this time. Patient should continue to receive the recommended COVID-19 vaccination doses on the usual schedule.
Initial report received from a health care professional on 09 August 2007. A 55 year old, female patient (with an allergy to sulfa drugs) developed a large local reaction of redness, swelling and pain at the injection site that has progressed halfway down the left arm, after she received Adacel (lot number C2731AA) intramuscularly in the left deltoid and Tubersol (lot number C2508AA) intradermally in the right forearm on 01 August 2007. She also received Hep B (lot number 0420) in the right deltoid on 25 July 2007 and Hep (lot number 00420) in the left deltoid on 25 June 2007. The patient was treated with Keflex. She reported the adverse event to the physician on 08 August 2007 and is being evaluated a second time on 09 August 2007. After the time of the report, the patient had not recovered.
Hives neck, shoulders, back, chest, waist. Took Benadryl allergy liquigels pm Feb.17. AM Feb. 18, hives were reduced to only a rash and redness.
Fever, followed by non purulent conjuctivitis.  Onset of erythematous maculopapular rash, some confluence.  c/w measles-like rash.
my left arm and side of face went numb; my left arm and side of face went numb; felt ill for 2 wks; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 19Apr2021 as dose 1, single (Lot number: Er8731) at the age of 47 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications in two weeks.  Patient has not received other vaccine in four weeks. Patient has no known allergies. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The following information was reported: MALAISE (non-serious) with onset 19Apr2021, outcome "not recovered", described as "felt ill for 2 wks"; HYPOAESTHESIA (disability) all with onset 19Apr2021 at 16:30, outcome "not recovered" and all described as "my left arm and side of face went numb". Therapeutic measures were taken as a result of hypoaesthesia, hypoaesthesia, malaise. AE treatment (reported as): Doctor, therapy, chiropractor and even heart doctor. Clinical course: On 19Apr2021 patient received my first shot...30mins later his left arm and Side of face went numb...felt ill for 2 wks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200716747 same reporter/patient, different dose/event
This spontaneous report was received from a physician via Company Representative concerning a 13 year old female patient. On an unknown date, the patient was vaccinated with the third dose of GARDASIL (route, lot # and expiration date not reported). About a month later, on an unspecified date, the patient demonstrated unspecified multiple sclerosis symptoms. The 13 year old patient had a magnetic resonance imaging (MRI) performed and it was determined that she did not have multiple sclerosis. Patient's outcome was unknown. The patient sought medical attention, she went to the physician. This is one of two reports concerning the same source (MARRS # 1311USA008518). Additional information has been requested.
fever (101.1); chills; fatigue; resting heart rate 125; This is a spontaneous report received from a non-contactable consumer. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular, on 15Jan2021 19:00, at single dose, for COVID-19 immunization, at the hospital. The patient medical history and concomitant medications were not reported. The patient has no known allergy. The patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient received his second dose on 15Jan2021 (Friday) at 19:00 and felt okay. On 16Jan2021 (Saturday) at 10:00, the patient experienced fever (101.1) and chills, fatigue, resting heart rate 125. The patient took acetaminophen and went to bed. On 17Jan2021 (Sunday), the patient woke up feeling normal (as if nothing happened) and he has been feeling normal since then. The patient underwent COVID test since vaccination in Jan2021 with unknown results. The outcome of the events was recovered on 17Jan2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Next day developed approx. 2.5 x2.5 inch,  round, reddened area around vaccine site,  told to ice site & contact if any worse. 12/22/2020 improved site reaction
Approx 4 hrs p/pt recvd vax awoke w/an unusual high-pitch cry, sl elevated temp & very agitated; this episoded last approx 1 hr & mom took pt to pvt MD; pt rt thigh extremely red, swollen;
On 7/17/00, temperature increased to 104 for 3 days. Pt was given Tylenol and fever went down.
On 10/7/15, Patient developed severe left arm pain, the next day (10/8/15), welts formed on left arm as well. Pain does radiate into left hand and neck. Rash has since resolved.
CHILLS; FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
Patient received PNEUMOVAX - 10/4/13. Arm was just slightly sore that night, The next day it was very sore, ROM very limited. Said if he had had to work, could not have. The next day much improved, day after fine.
On the evening of 07/14/2022 I felt like I was getting a bad cold or the flu, I was having body aches, chills and sore throat. All during that time I could barely speak to the point I had to take off work one day. The following day I had a COVID-19 test on 07/15/2022 and it was negative. I did try to isolate myself even though the test was negative because I thought maybe I had a false negative. I also did have some swollen lymph nodes under my left arm after I got the shot, it was swollen huge and painful and now is still there but smaller.
extremely itchy palms and bottom of feet for two days. started a little later the day she got the covid19 vaccine and extremetly the next day.
Dizziness, hypertension 210/120, chest tightness, normal HR. Treatment: 0.1mg Clonidine tablet x2PO. Improved sypmtoms, BP was stable at 160/69.
DAY AFTER 2ND DOSE: HEADACHE LASTING 48 HOURS... PAIN AT INJECTION SITE LASTING 72 HOURS... SORENESS IN JOINTS AND BONES (especially neck and hips) LASTING 24 HOURS....TIREDNESS LASTING 48 HOURS....
This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) (product storage error) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patients identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 16 year old patient (gender not provided) who on 02-JAN-2018, was vaccinated with improperly stored dose of GARDASIL 9, lot number: N021475 and expiration date: 31-JAN-2020, (strength, dose, frequency and route of administration were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Sender's Comments: US-009507513-1801USA008060.
patient stated 24 hrs. after injection woke up with extreme lower back pain, extreme weakness, difficulty walking, symptoms lasted 4-5 days
Parent reported itchy hives that worsened today, but dx ERYTHEMA MULTIFORME by me
Have a small case around lower ribs; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Have a small case around lower ribs).The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that also after his/her shingles shot he/she did have a small case of shingles around his/her lower ribs but not severe. The follow up would not possible as no contact details were available.
Initial report received from a nurse on 25 Jun 2010: This patient was vaccinated with MENVEO (batch number 028011/091001), (dose unspecified), on an unknown date. The customer reported of trouble in withdrawing the full amount from the reconstituted vaccine. The reporter stated that they were withdrawing every thing from they can get out of the liquid component (which according to nurse is 0.5 ml at best), leaving a little air in the syringe and inserting into the lyophilized powder. From they were swirling/shaking for 15-20 seconds. According to the reporter the rubber stopper in the lyophilized vial is "too attached to the sides of the glass" and was unable to get full 0.5 ml dose. The reporter stated that no doses were discarded and the entire dose was administered to the patient but often they are only getting 0.3 or 0.4 ml out. The outcome of the event was not reported.
In June, 2021, one month post 2nd Moderna vaccination (C161321A), patient developed night sweats and fevers 103-104 degrees F. In 7/2021, he was noted to have anemia and elevated CK 6000. Since then, he has had persistently elevated CK 1000-7000. CK declines to <1000 with prednisone.  IL2R also elevated during episodes.
3/17/21 patient developed body aches, headache, nasal congestion, and pharyngitis. tested COVID positive.
shortness of breath; Chest pain; severe abdominal pain; nausea; frequent diarrhea; This is a spontaneous report from a contactable nurse (patient).   A 38-years-old non pregnant adult female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EK4176) administered in left arm via an unknown route of administration (at the age of 38 years old) on 15Jan2021 as dose 2, single for covid-19 immunisation.  Medical history included depression, obesity and known allergies to Hydrocodone, sulfa, Trintellix, Nickel, Amitriptyline. The patient previously received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EH9899) administered in left arm via an unknown route of administration (at the age of 38 years old) on 28Dec2020 at 03:30 pm as dose 1, single for covid-19 immunisation and experienced no adverse event. It was reported that there was no covid prior vaccination. There was no covid tested post vaccination. It was reported that no other vaccine received in four weeks. Other concomitant medications in two weeks medications included Cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), Colecalciferol (VIT D3), Lamotrigine (LAMICTAL), Omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), Propranolol (PROPRANOLOL). On 16Jan2021 at 09:00, the patient experienced shortness of breath, chest pain, severe abdominal pain, nausea and frequent diarrhea. The adverse events resulted in emergency room/department or urgent care. No treatment was received for the events. The outcome of all the events was reported as recovered with lasting effects on an unknown date in Jan2021. No follow up attempts are possible. No further information is expected.
hives / generalized, everywhere; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives / generalized, everywhere) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064H21A, 039K20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives / generalized, everywhere). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 5 days and LORATADINE (CLARITIN [LORATADINE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, URTICARIA (hives / generalized, everywhere) had not resolved.            No Concomitant medication was reported.
Palpitations; Panic attack; Could not function; Was not herself; Little fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PALPITATIONS (Palpitations), PANIC ATTACK (Panic attack), COGNITIVE DISORDER (Could not function) and DISCOMFORT (Was not herself) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Z8L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-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 PAIN IN EXTREMITY (Sore arm) and FATIGUE (Little fatigue). On 13-Feb-2021, the patient experienced PALPITATIONS (Palpitations), PANIC ATTACK (Panic attack), COGNITIVE DISORDER (Could not function) and DISCOMFORT (Was not herself). The patient was treated with METRONIDAZOLE from 11-Feb-2021 to 15-Feb-2021 for Infection, at an unspecified dose and frequency. On 11-Feb-2021, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Little fatigue) had resolved. On 15-Feb-2021, PALPITATIONS (Palpitations), PANIC ATTACK (Panic attack), COGNITIVE DISORDER (Could not function) and DISCOMFORT (Was not herself) had resolved. Not Provided      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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: event outcome updated
On the same day of the vaccine later on around 9pm I got a headache, then about 10 min later my throat felt itchy & dry. then after 10 min after I had body aches, I kept shaking & felt nauseous. Around 10pm I had a fever of 102.4 it continued for about 3am I fell asleep for about 2 hrs. Then I started feeling nauseous again but I never threw up. My arm was hurting a lot where I got the vaccine it was very itchy & it was very hot the itchiness started coming to my face as well this lasted all day long on 12/29/2021. Then on 12/30/2020 the fever stopped the chills where still there. Also on July 2nd I caught covid & since then I was not able to smell since then. After I got the vaccine I was able to smell but it only lasted for about 5 days. The vaccine made a knot the swollenness in my arm & itchiness lasted for about 2 weeks to go away.
Increased redness and swelling, hot to touch at 4/11/06 had varicella on 4/5/06. Seen in office 04/14/2006 placed on Augmentin X10d. F/U in office 4/17/06 changed antibiotic Keflex x 7 days.
Developed shingles (herpes zoster) in the week following vaccination. It happened after resolution to other systemic reactions including fever, chills, fatigues, full body aches, etc.
Information has been received from a registered nurse who reported that GARDASIL (dose, route and lot number were not provided) was exposed to 57F for 418 hours. The excursion was not supported. He stated that he was not sure if any of the doses were administered to patients. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Body aches, headache, fever, chills, nausea, vomiting and severe abdominal cramps.