chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cough; body ache,; headache.; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), COUGH (cough), PAIN (body ache,) and HEADACHE (headache.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced COUGH (cough), PAIN (body ache,) and HEADACHE (headache.). At the time of the report, COVID-19 (COVID-19), COUGH (cough), PAIN (body ache,) and HEADACHE (headache.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.  For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.
Patient contacted clinic the 17th stating she developed small hives and redness and itching 2 1/2 hrs after vaccine given. Stated she applied HC cream.
Wheezing, tired, joints ache, headache, increased BP 162/90 HR 92, clammy, chills, spiked temp twice 102.4 degrees.
8NOV94 time 1100 extreme irritability x 12 hrs; w/fever to 101-t100.0/ APAP 4 hrs PRN; no P next shot;
ONLY SLIGHT SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced only slight side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of only slight side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20211242092 and 20211242345.
On day 8, I woke up for work at 3 am and my arm felt hot and itchy, and I went to get in the shower and caught a glimpse in the mirror and there was a big red spot by injection site. For the next couple of days, it continued to get bigger, at which point I went to a doctor, and I never took anything for it and Doctor said if it continued to grow, she would put me on something for it, but it resolved itself a couple of days later. I had a lot of soreness in arm and shoulder blade, and it was uncomfortable for a couple days. I started having heavier bleeding and change in menstrual cycle which is still ongoing. Duration has gotten very unpredictable and at least a single day with clots and it's more intense.
NAUSEA; HEADACHE; This spontaneous report received from a consumer concerned multiple patients. 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 nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and headache was not reported. This report was non-serious.
within 3 minutes of vaccine, pt complained of dizziness, lightheadedness. Pt stated may be hypoglycemia or anxiety.  Pt waited 30 minutes, drank water and orange juice. symptoms subsided
Evening of injection arm tender.  In AM 03/28/2002 when awoke was lightheaded, and backache.  Took Tylenol and went to school.  By 14:30 that afternoon had throbbing headache and states "temples were swollen".  Temperature 100.7-101.  Lighheaded.  Again took Tylenol.  Slept off and on.  Called MD who also advised taking Benadryl which he did.  On 04/01/2002 in AM felt much better.  Was seen at health department.  No swelling at temples noted.  Injection site not red.  Only slightly tender to touch. No other symptoms noted or experienced.
9/14/02 pm L arm red, hot, swollen size of small apple, no fever-was seen in ER on 9/14/02 late pm-was given antibiotics. Saw Md on 9/16/02.
No additional AE reported.; A HCP called and reported that an expired dose of MMR II was administered to a patient on 5 JUL 2022.; This spontaneous report was received from a registered nurse and refers to a 48-year-old patient. The patient's medical history, and concurrent conditions were not provided. Concomitant therapies included sterile diluent  On 05-JUL-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) lot # T013003, expiration date 15-APR-2022, 0.5 milliliter/once (rout of administration was not provided) for prophylaxis (expired product administered). No adverse event was reported.
Approximately 10 minutes after receiving a Moderna booster dose, patient complained of feeling "feeling flushed and itchy throat". V/S obtained: B/P128/86 P90 R18 o298. Patient waited and monitored by nursing staff in 15 minute monitoring zone for 30 minutes.  Before leaving patient was offered further medical attention via EMS, patient declined and departed the premises.
C/O headache, upon arriving home around 3pm went soak in hot tub of water. After getting out and cooling down still felt hot. Fever 102 F. orally. Motrin 800mg po with relief. Slept but awoke w c/o aches in legs and fever returned, 102 orally. This went on for 3 days.
anxiety; depression; rash; red blotch; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), RASH MACULAR (red blotch), ANXIETY (anxiety) and DEPRESSION (depression) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for an unknown indication.     The patient's past medical history included Parkinson's disease (Takes Carbidopa/levodopa 2 25/100 mg tablets thrice a day.). Concomitant products included TRAZODONE for Anxiety depression, CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA) for Parkinson's disease.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced RASH (rash) and RASH MACULAR (red blotch). On an unknown date, the patient experienced ANXIETY (anxiety) and DEPRESSION (depression). At the time of the report, RASH (rash), RASH MACULAR (red blotch), ANXIETY (anxiety) and DEPRESSION (depression) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Reporter did not allow further contact
Itchiness, hives, swelling to arms, chest, abdomen, legs. Lips became swollen.
Site of vaccine is warm; Site of vaccine is red; Site of vaccine is hard; A spontaneous report was received from a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced site of vaccine is red, hard and warm.  The patient's medical history was not provided. Concomitant product used was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) on (date not provided) for prophylaxis of COVID-19 infection.   A consumer who is the patient called to report he had received the Moderna COVID-19 vaccine. He reported the injection site was red, hard and warm.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, site of vaccine is red, hard and warm, was considered as unknown.   The reporter did not provide an assessment of the events, site of vaccine is red, hard and warm.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded.
had 2 hearts attacks and one of them I had a bypass surgery; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "had 2 hearts attacks and one of them I had a bypass surgery". Therapeutic measures were taken as a result of myocardial infarction.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Initial report received from a health care professional on 01 April 2011. An 18 year-old male patient who is allergic to shrimp and some beans, had received an annual intramuscular left deltoid injection of FLUZONE (lot number U3743AA) and a right forearm injection of APLISOL (King pharm, lot number 148603) on 31 March 2011 at 10:00 am. Approximately 3 hours later at 13:00 pm, the patient returned to the physician office with generalized redness, hives and difficulty breathing. His O2 (oxygen saturation) was decreased and he was medicated with epi (Epinephrine, route not reported) and transported to the ER (emergency room) via ambulance. The patient was again medicated with epi and BENADRYL with resolution of symptoms and without hospitalization. The patient had denied any concurrent illnesses or other medical conditions, but does take concomitant medication ACCUTANE (indication not reported). The patient had denied any adverse events with prior vaccinations. Documents held by sender: None.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccination indication. The health care professional stated that about 75 percent of patients had let them know that they experienced soreness that lasted about 3 to 7 days post vaccination (more than a couple hundred patients have received SHINGRIX). This was more than was seen with the flu vaccine (confirmed the flu vaccines were non-GSK flu vaccines).
On April 16th (3 weeks after first dose) I began suffering from some mild shortness of breath, after which I took a COVID-19 test and tested negative. Upon receiving a negative test, I took my second vaccine dose on April 18th. 3 days later, on April 21st, I experienced heart palpitations and went to the Emergency Room, where my EKG, chest x-ray, and various blood tests were taken. Everything looked normal except for diffuse ST elevation on the EKG, which the physicians pegged to early repolarization.   I continued to suffer from heart palpitations, chest tightness, and shortness of breath for the next few days, so I went to a Cardiologist, who again saw diffuse ST segment elevation on the EKG, which, due to my symptoms, he interpreted as a possible sign of pericarditis. I underwent a few additional tests, including an echocardiogram, chest CT, and continuous Holter monitor wearing. My doctor didn't see evidence of anything other than possible heart inflammation, so he prescribed me an NSAID (indomethacin) to be taken 3x a day for a week.   Now, 5 weeks after the start of my symptoms, I'm still suffering from chest tightness, shortness of breath, random onset fatigue, and dizziness. I've since been prescribed colchicine (0.6 mg, 2x a day) and have been taking that for 2 days.
My mouth instantly started to have a taste of metal as soon as the injection entered my arm and soon after that my lips started to tingle about 5 minutes after the injection. 20  minutes after the vaccine the roof of my mouth felt like I bit into a hot pizza, the burning mouth sensation still persist as of today. Around 5:00 pm that day , my whole body was shaking uncontrollably it lasted around 2 hours. I went to the doctor and the doctor called it a panic attack. The burning mouth sensation, I would describe as having shingles in your mouth, because I have had shingles before. I still have extreme fatigue, which causes me to be depressed , and  brain fog
a little sore arm; fever; some chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little sore arm), PYREXIA (fever) and CHILLS (some chills) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051f21a and 003a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced PAIN IN EXTREMITY (a little sore arm), PYREXIA (fever) and CHILLS (some chills). On 05-Nov-2021, PAIN IN EXTREMITY (a little sore arm), PYREXIA (fever) and CHILLS (some chills) had resolved.            Concomitant medications were not provided Treatment medications were not provided
Fevers up  to 102.8, chills, sweats and extreme fatigue including sleepiness .alternated between Tylenol 500mg and Ibuprofen for fever
This spontaneous report was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and gender not reported) were vaccinated with a dose of RECOMBIVAXHB which were improperly stored. No adverse effects were reported.  This report linked to MARRS 1410USA009955, 1410USA009956, 1410USA009957, 1410USA009958, 1410USA004588 and 1410USA009960. Additional information has been requested.
Had soreness and slight redness at the injection sight in my left arm the following day.  The soreness and redness continued and the redness continued to deepen and increase for the next week. The redness was circular/oval in nature and spread until it was about 3-4 inches in diameter covering much of my upper arm area.  The area also began to itch and continues to itch on day 13 although the redness and the severity of itching has significantly diminished over the past few days.  There is just faint redness now and slight itchiness.
The first time I got the shot it hurt for four days but stop and all of sudden My thigh starting hurting all over again, hot to touch, aching really bad
This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On approximately 22-JAN-2017 (reported as "between 22-JAN-2017 and 20-FEB-2017"), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M017514, expiration date 07-NOV-2017) for prophylaxis (dose number, route and anatomical location of administration were unknown). The temperature excursion reported was: refrigerator: 49.8 Fahrenheit for 2 hours 30 minutes; freezer: 30.3 Fahrenheit for 4 hours. The previous temperature excursion reported was: refrigerator: 49.6 Fahrenheit for 31 minutes; freezer: 11.2 Fahrenheit for 48 minutes. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009652: US-009507513-1702USA009653: US-009507513-1702USA009133:
Tested positive for COVID - no symptoms.  Required to take test for entrance to a baby shower; Tested positive for COVID - no symptoms.  Required to take test for entrance to a baby shower; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), in right arm, on 24Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 19Jan2022 as dose 3 (booster), single (Lot number: FL3197) at the age of 64 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 22May2022 at 11:30, outcome "recovered" (May2022) and all described as "Tested positive for COVID - no symptoms. Required to take test for entrance to a baby shower". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, asymptomatic covid-19. Clinical information: Facility type vaccine was workplace clinic. No known allergies. No other vaccine in four weeks. No covid prior and post vaccination.   Follow-up attempts are completed. No further information is expected.
arm pain especially when lifting her arm; malaise; This spontaneous report was received from a pharmacist via company representative regarding to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. The pharmacist described that on an unspecified date in 2017,(also reported as 2 years ago) he had two patients with the same reaction to vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, route, lot # and expiry date were not reported) for prophylaxis. The reporter stated that on an unspecified date in 2017, the female patient had arm pain especially when lifting her arm (pain in extremity) and malaise which were resolved on an unspecified date in 2017 (also reported as with one week of the date of the administration). It was reported the pharmacist has not seen her since she recovered from her symptoms. The patient has no cancer, product quality issue and over dose.  The causality assessment between events and product was not provided.  This is one of several reports received from the same reporter.
Information has been received from a licensed practical nurse concerning an 11 year old male patient with an allergy to egg whites, no known drug allergies and history of asthma who on 09/09/2002 at 10:00 was vaccinated in the right hip with an intramuscular injection of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(642439/0234M), which had been reconstituted with a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Infanrix)(Lot # provided: U0306).  Subsequently the patient developed redness and slight swelling at the injection site.  Follow-up information received from a health care provider indicated that on 09/09/2002 at 10:00, the patient also received a dose of hepatitis B virus vaccine rHBsAg (yeast)(Lot # 641450/1498L) given intramuscular in the left arm.  In the follow-up information received it is unknown whether the patient has had adverse experiences with prior vaccination.  It was noted that no laboratory tests were performed.  Unspecified medical attention was sought.  Additional information has been requested.
Dizzy; Symptoms of the migraine still persists; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported), via an unspecified route of administration on 20Jan2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Jan2021, the patient felt dizzy. On an unknown date in Jan2021, the symptoms of the migraine was persisting. The patient was seeking information on this side effect and asked that did other people get migraine and how long was it supposed to last. The patient was seeking guidance for the second shot. The outcome of symptoms of the migraine still persists was not resolved and dizzy was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient received Pfizer vaccine on 5/26/21, 6/16/21 and 12/13/21. Presented to ER on 8/5/22 to give birth at 39 weeks gestation. Found to be COVID positive. Patient was admitted for repeat cesarean section. Please see operative note for full details. On POD#1 she was advance and reports pain is well controlled with oral medications and denies heavy bleeding. She was ambulating, tolerating regular diet, and voiding without difficulty. She was noted to have anemia and was started on iron supplementation. She was having a fever with temp 101 F, nasal congestion and headache and was noted to be COVID +. On POD#2 she was meeting all of her postoperative and postpartum milestones and was passing flatus. She was feeling better and was afebrile for > 24 hours. She is breast & bottle feeding without difficulty. Fundus is firm and below umbilicus, no LE edema. She is felt stable for discharge home. She was given standard postoperative precautions and restrictions. She was given COVID 19 precautions and restrictions. She was discharged home on Lovenox 40 mg QD and was given DVT/PE precautions on 8/7/22.
Information has been received from a registered nurse concerning a female patient in her late 30's who on approximately 17-SEP-2010 was vaccinated with the first dose of GARDASIL (Lot # and route not reported). The nurse reported that on approximately 08-OCT-2010, about 3 weeks after receiving the vaccine, the patient gained 4 pounds. At the time of the report, the outcome of the patient was not reported. The patient did not seek medical attention. Additional information has been requested.
CHILLS, TEMP 101-103, SEVERE BACK/NECK PAIN, FATIGUE X 48 HRS.