chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2022 as dose number unknown, single (Lot number: En6200) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other medical history: No. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
by approx 730PM of date of shot  pt had chills & couldn't warm up despite heavy sweaters & robe;about 12MN & devel fever, next day fever, weakness, rubbery weak legs;felt simply drained;7 days later still not way back to nl;
Severe coughing on 12/15/2022 and I tested positive for COVID-19. I went to the health clinic where a prescription for PAXLOVID and benzonatate was prescribed for me. Around 12/21/2022 I tested negative for COVID-19 but then on the evening of 12/24/2022 I took another test for COVID-19 and the test was positive at that time it was like a bad head cold. On 01/01/2023 my COVID-19 test was negative.
Pt called and stated "I have the worst diarrhea of my life". Instructed to go to ER if condition worsens or call MD, stay hydrated and may take Immodium to decrease diarrhea.
renal infarctions; Acute Renal Failure; flu-like symptoms; wobbly/not stable on their feet; feeling sick; dizziness; tiredness; headache; This spontaneous case was reported by a consumer and describes the occurrence of RENAL INFARCT (renal infarctions) and ACUTE KIDNEY INJURY (Acute Renal Failure) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS) and SODIUM BICARBONATE for Anticoagulant therapy.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), GAIT DISTURBANCE (wobbly/not stable on their feet), VACCINATION COMPLICATION (feeling sick), DIZZINESS (dizziness), FATIGUE (tiredness) and HEADACHE (headache). On an unknown date, the patient experienced RENAL INFARCT (renal infarctions) (seriousness criterion medically significant) and ACUTE KIDNEY INJURY (Acute Renal Failure) (seriousness criterion medically significant). At the time of the report, RENAL INFARCT (renal infarctions), ACUTE KIDNEY INJURY (Acute Renal Failure), INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION COMPLICATION (feeling sick) and HEADACHE (headache) outcome was unknown and GAIT DISTURBANCE (wobbly/not stable on their feet), DIZZINESS (dizziness) and FATIGUE (tiredness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Computerised tomogram: abnormal (abnormal) revealed renal infarctions.. On 03-Mar-2021, Magnetic resonance imaging: abnormal (abnormal) renal infarctions.         The patient is still experiencing the tiredness, dizziness, and not being stable on their feet. The patient did not take anything to help with the symptoms. The patient has gone to see their health care provider for the symptoms being experienced. The patient had a CT scan and it revealed renal infarctions. A MRI was done as well and confirmed both kidneys have renal infarctions. The patients health care provider diagnosed the patient with Acute Renal Failure.  The daily medications the patient is taking are a blood thinner eliquis and sodium bicarbonate.  The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) was Not applicable.  Company comment: 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. Advanced age could be a  potentially confounders/co-suspects for the events.; 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. Advanced age could be a  potentially confounders/co-suspects for the events.
pt recvd 1st dose of vax w/no noted problem; pt recvd 2nd dose of vax 18AUG92 & w/in an hr following vax, pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs;
developed muscle and joint pains; developed muscle and joint pains; felt sore; sore on her arm; Tiredness; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 24Mar2021, Tuesday (at the age of 45-Years-old) (Batch/Lot number was not reported) as DOSE1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 25Mar2021, the patient experienced tiredness. she was tired a little the day after vaccination. She had tiredness on the 26Mar2021. That was fine by the 27Mar2021. On 26Mar2021, 2 days after vaccination, she experienced felt sore and had sore on her arm. She clarified the pain in her legs started on 30Mar2021 and not on 29Mar2021. On 30Mar2021, she developed muscle and joint pains. It was on and off. It was not unbearable, it was bearable. It may be a little bit better, it has moved from legs to kind of like just her quads or her thighs. It was reported that ever since she started having muscle and joint pain in her legs and she was researching that and it seems like it was a common thing but she was concerned that it happened like 7 days later she was wondering if there was any information on that or if she was in the right place to ask about that. It was reported that she had just finished her period which she knows was a little bit gross but that just finished right before this, she does not know if that had anything to do with it, it does not seem that way though. At the time of this report, the outcome of event felt sore and sore on her arm was unknown, developed muscle and joint pains was recovering and tiredness recovered on 27Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Within a few hours my entire right arm, underarm, and chest was extremely sore, progressed to my entire body hurting and fever. That lasted for 48 hours but the arm, underarm, and chest pain remained . I noticed then my underarm hurt because there was a massive, swollen lymph node (I assume). The next day a bruise started to appear around the mass. The swelling went down some but the bruise continued to grow. It has now spread to my right breast, is still growing and red.  I feel terrible.
I woke up last night, in the middle of the night; Chills/shivering; Fever; body ache; fatigue; hard time even standing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 52-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Oct2021 10:00 (Lot number: 3203080) at the age of 52 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "non-Hodgkin lymphoma" (unspecified if ongoing), notes: Verbatim: Non-Hodgkin lymphoma. The patient took concomitant medications. The following information was reported: MIDDLE INSOMNIA (non-serious) with onset 21Oct2021, outcome "unknown", described as "I woke up last night, in the middle of the night "; CHILLS (non-serious) with onset 21Oct2021, outcome "unknown", described as "Chills/shivering"; PYREXIA (non-serious) with onset 21Oct2021, outcome "unknown", described as "Fever"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "body ache"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "fatigue"; DYSSTASIA (non-serious) with onset Oct2021, outcome "unknown", described as "hard time even standing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information Prior vaccination (4 weeks prior) she waited she want to get flu shot but she did not, wanted to do them after same time so. Other Medications was just vitamins, nothing prescribed. The patient stated that she was just calling to report some side effects. she received the Pfizer Booster yesterday at 10 'o' clock and she felt fine all day, but she woke up last night, in the middle of the night with chills, fever. she was having body ache, fatigue. She was just having hard time even standing. Laboratory Test:, When was my last lab blood work. Last Wednesday I had some blood work done. Treatment for Adverse Events: she did take some Tylenol in the middle of the night because She had a fever. She was shivering at about midnight. Dose for Tylenol It is two 500mg capsule. Yes should we say' the medicine and then two again at 6:30 this morning so half an hour ago back.  No follow-up attempts are possible. No further information is expected.
Awoke with rash of small red dots over abdomen, chest and thighs, took Zyrtec which takes for allergies. I suggested Caladryl lotion. Had similar rash years ago.
Patient was given vaccine that had been in refrigerated temperature for 7 days (outside length of time advised in EUA). No adverse events have been reported at this time. We are speaking with Pfizer regarding re-immunization.
Staff member vaccinated 2 days to soon.  Patients 1st dose was on 01/20/21.
Experienced nausea, stomach cramps & diarrhea one week after receiving flu shot. Reports experienced same symptoms one week after receiving last year's flu shot as well.
Hip pain on the right side. Limping.  Doctor diagnosed her with toxic synovitis. Treatment was to give Motrin three times a day.
Pt. was very sick the day after the shot, then Friday morning his heart was going into atrial fibrillation and jumping between 110 heart rate and 160+. He was out golfing when he noticed this. He rested later that day but was extremely tired and felt sick. Saturday morning (2.5 days after vaccine) he needed to go to the emergency room because his heart rate was back over 160. The EKG showed sinus tachycardia and gave him a message for it but it made it worse and the rate was over 200. They had to stop and start his heart then put on beta blocker which brought it to 180, then another beta blocker brought to 150. Following EKGs showed atrial fibrillation, postural orthostatic tachycardia syndrome, and super ventricular tachycardia. Pt. had this about a year ago but was fine after a few days. This was the first time he was hospitalized for it and is now on daily medications. He fears the Moderna vaccine triggered it and is very worried about the second dose.
I did not feel very well after neither of the vaccine; A rash appeared all over, itchy. It started after the vaccine was given and progressed day after day; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (A rash appeared all over, itchy. It started after the vaccine was given and progressed day after day) and VACCINATION COMPLICATION (I did not feel very well after neither of the vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 017c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced RASH PRURITIC (A rash appeared all over, itchy. It started after the vaccine was given and progressed day after day). On an unknown date, the patient experienced VACCINATION COMPLICATION (I did not feel very well after neither of the vaccine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (A rash appeared all over, itchy. It started after the vaccine was given and progressed day after day) and VACCINATION COMPLICATION (I did not feel very well after neither of the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) not applicable.    This case was linked to MOD-2021-234333, MOD-2021-234333 (Patient Link).
Information has been received from an investigator concerning a 3 month old female who received her 1st injection of Prevnar, Hib-Titer, Infanrix and IPV vaccines and her 2nd injection of Recombivax-HB vaccine on 7/19/00, as part of a study trial. On 8/27/00, the child died due to sudden infant death syndrome. Both the investigator and the medical monitor agree that this event was not related to vaccine administration.
Severe lower and mid-back pain. Urine dip mod leukocyte via 6-10 WBC. Urine C/S 10,000 Grp B Strep.
foggy brained after second dose; sore arm after second dose; 104°F pretty high fever for a a day and a half,; They were also tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (foggy brained after second dose), MYALGIA (sore arm after second dose), PYREXIA (104°F pretty high fever for a a day and a half,) and FATIGUE (They were also tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Scleroderma. Concomitant products included LOSARTAN POTASSIUM (AVANTAR) for an unknown indication.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (foggy brained after second dose), MYALGIA (sore arm after second dose) and PYREXIA (104°F pretty high fever for a a day and a half,). 2021, the patient experienced FATIGUE (They were also tired). At the time of the report, FEELING ABNORMAL (foggy brained after second dose), MYALGIA (sore arm after second dose), PYREXIA (104°F pretty high fever for a a day and a half,) and FATIGUE (They were also tired) outcome was unknown.            No treatment details were provided by reporter.   This case was linked to MOD-2021-294926, MOD-2021-294974 (Patient Link).
Information has been received from a physician concerning an adult patient who "over the last week" on approximately 07-OCT-2005 was vaccinated with a 0.5 ml intramuscular dose of pneumococcal 23v polysaccharide vaccine. (lot 650453/0791P).  It was reported that the patient developed a severe local reaction at the injection site including, redness, swelling and pain.  The patient was seen at the emergency room.  The patient also developed hives and was treated with diphenhydramine hydrochloride (BENADRYL), intravenously.  It was reported that the patient had recovered or was recovering.  The reporter expressed concern about the lot 650453/0791P for pneumococcal 23v polysaccharide vaccine.  A lot check has been requested.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.
This spontaneous report (conflicting information reported as "being in an unknown Clinical Trial") has been received from a consumer referring to himself, a 35-year-old male patient. The patient's concurrent conditions included drug hypersensitivity to penicillin and cephalosporin. His medical history included asthma, clostridium difficile infection and avian influenza. Concomitant medications included "inhalers" (unspecified) and a "narcolepsy medication" (unspecified). On unspecified date in June 2020 (also reported as "8 months ago"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, anatomical location, lot number and expiration date were not reported) administered  intramuscularly (IM) for prophylaxis. On that same day, he was also started with other suspect medications: benzylpenicillin (dose, lot number, expiration date and indication were not reported) administered IM. On unknown date, he was also started with other suspect medication: cephalosporin C (dose, route, lot number, expiration date and indication were not reported). On unspecified date in February 2021, the patient stated having "irritation where the tumor was" (skin irritation). He did not provide any additional details in regard to the tumor or where the tumor was located. Also, the patient stated that the irritation could be costochondritis, but stated that had not been diagnosed. The patient stated that there could be a new tumor, or the current tumor could be worsening (disease progression). The patient did not seek for medical attention. On unknown date, the patient also reported experiencing hives (an allergic reaction) (urticaria and hypersensitivity) with other suspect medications included benzylpenicillin and cephalosporin c. Moreover, on unknown date, a computerized tomography (CT) scans were completed with no results reported.  At the reporting time, he had not recovered from all the event. Additionally, the patient stated having tried reaching out to the study site, to report this adverse event, multiple times, but never received a response. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was reported as not applicable (conflicting information also reported as therapy discontinued no); and regarding benzylpenicillin and cephalosporin c was not reported. The causal relationship between all the other events, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and other suspect medications: benzylpenicillin and cephalosporin c were not reported. Upon internal review, disease progression was considered a medically significant event.
On 12/29 started with a headache took Ibuprofen. I slept if off took another dose drunk water. I woke up at 11pm went away started feeling better. This morning had a headache around 10:00 am took Ibuprofen again. Pt 5/19/2021 estimated date of delivery.
This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced upset stomach, lymphadenopathy inguinal, joint pain, headache, fatigue and groin pain. On an unknown date, the outcome of the upset stomach, lymphadenopathy inguinal, joint pain, headache, fatigue and groin pain were unknown. It was unknown if the reporter considered the upset stomach, lymphadenopathy inguinal, joint pain, headache, fatigue and groin pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient asked was there any reports of swollen groin glands. The patient had been experiencing stomach, joint, headache and fatigue for 4 days. Everything seems much better but now patient's groin hurts.
Except for headaches everyday I felt like I had restless leg syndrome. Then, I had a Heroes outbreak, which I haven?t had in over ten years. Not sure if vaccine or not but rather odd, IMO.
Adverse event: Vasovagal syncope , nausea 2 minutes after injection , treatment - supine leg elevation -- ice - water , outcome :  patient felt better after 15 minutes , left pharmacy observation after 30 minutes after injection
Headache, Fever, Rash, UrticariaPruritus, NauseaVomiting, fatigue Narrative:  Other Relevant History:
Medical assistant was doing Quality Measures for Well child exams. Once she got to the list with patient's name she went to schedule her for MA visit and noticed the child had already had the 2nd Covid vaccine. Medical assistant then made me aware that I am the one who administred the vaccine 1 week before it was due. Medication protocol double check was performed by a registered nurse.
Left arm swollen and painful, painful to move it. Pt had 2 office visits as a result of this and was started on antibiotic on 5/11.
Seen in Emergency Department on 3/3/17 for epilepticus due to refractory epilepsy.
Developed rash on legs that spread up his legs to his arm; Legs itch; Rash at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Legs itch), RASH (Developed rash on legs that spread up his legs to his arm) and INJECTION SITE RASH (Rash at the injection site) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE RASH (Rash at the injection site). On 18-Jan-2021, the patient experienced PRURITUS (Legs itch). On 19-Jan-2021, the patient experienced RASH (Developed rash on legs that spread up his legs to his arm). The patient was treated with PREDNISONE on 29-Jan-2021 at an unspecified dose and frequency; FAMOTIDINE on 29-Jan-2021 at an unspecified dose and frequency and CETIRIZINE on 29-Jan-2021 at an unspecified dose and frequency. At the time of the report, PRURITUS (Legs itch), RASH (Developed rash on legs that spread up his legs to his arm) and INJECTION SITE RASH (Rash at the injection site) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported The patient went to a doctor and was confirmed to have a typical drug allergic reaction. He was given a steroid shot (unknown) and prescribed with Prednisone, Famotidine and Cetirizine
About 10-15 min after shot pt reported itchy eyes and "itchy sensation" all over body.  No rash apparent.  No dizziness, no SOB or breathing difficulty - gave 50mg oral Benadryl, pt waited another 20 min with no worsening symptoms - was with husband .
Patient felt tired after receiving vaccine. The following Monday/tuesday, he received a scheduled IvIg treatment.  He developed acute pancreatitis and was hospitalized on 3/18/21
Discovery of sub therapeutic dose of vaccine. Pt received 0.3ml of Moderna vaccine; patient notified and returned to receive additional 0.2ml Moderna vaccine lot #002C21A; issue resolved
Grandmother called HD and said Dr. said 6 month old shouldn't get flu vaccine That it made baby very sick and they were taking baby to Dr. the next day. Regular immunizations and flu were given 11/21/2006. Baby was taken to doctor 6 days later 11/28/2006. Upon talking to baby's mother on 11/29/2006, she stated the baby ran temp 100.4 on the day after the shots.  States doctor gave cough and cold medication.