chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme fatigue; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6199) via an unspecified route of administration in the left arm on 15Mar2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included slight sensitivity to histamines. Concomitant medications included colecalciferol (VITAMIN D), ascorbic acid (VITAMIN C), tocopheryl acetate (VITAMIN E), cod-liver oil (FISH OIL) and zinc (MANUFACTURER UNKNOWN) for unknown indication and on unknown date within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021 at 07:00, the patient experienced extreme fatigue and slight headache. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events extreme fatigue and slight headache was recovered in 2021, at the time of this report.  No follow-up attempts are needed. No further information is expected.
Site: Pain at Injection Site-Mild, Additional Details: muscle rigidity on one arm. feels heavy
scratchy and also the area feels warm; redness and tiny bit of puffiness and itching below injection site in left arm; redness and tiny bit of puffiness and itching below injection site in left arm; redness and tiny bit of puffiness and itching below injection site in left arm; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0198, patient was 70-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 09Jul2021 as single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0191), via an unspecified route of administration, administered in Arm right on 18Jun2021 as single dose for covid-19 immunisation. It was reported that patient got the second dose of the Pfizer- BioNTech COVID-19 vaccine on friday, 09Jul2021, states she was looking at her arm today, states it is not at penetration site of the needle, but down below it, there is some redness, itchiness and it is a tiny bit puffy. She said that it is getting better, but it is "scratchy" and also the area feels warm. and it has been very minimal looking at in now and the redness may be due to her scratching. States it is itchy and she has scratched so that could be contributing to the redness, wants to know if this is related to the vaccine or may be a blood clot. She is also asking if these symptoms doesn't go away when will she need to consult her doctor. On 14Jul2021, the patient experienced redness and tiny bit of puffiness and itching below injection site in left arm, on an unspecified date, the patient experienced scratchy and also the area feels warm. The outcomes of events (redness and tiny bit of puffiness and itching below injection site in left arm) were not recovered, and the outcome of event (scratchy and also the area feels warm) was unknown.
Erythema 1.5 " warm to touch advised cool compresses, Advil call if worse.
Information has been received from a health care professional concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot#644106/0819M) intramuscularly in the deltoid. Subsequently, the patient developed redness,swelling and soreness at the injection site and down the arm as well as a rash and vomiting. On Dec 18, 2002, it was reported that the patient's symptoms had subsided by the next day and that no treatment, testing or work-up was necessary. It was also reported that two other patients were vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot#644106/0819M) and developed swelling of the arm, a rash, and nausea and vomiting (WAES0212USA01110 and 0212USA02496). Additional information is not expected.
Breakthrough case of COVID; my symptoms were a sore throat and a cough and fatigue. It started the Saturday before, the Thursday before I tested positive, which was the 23rd of July which was the first day of my symptoms and on the 28th of July I took the at home text and it was positive. I spoke to my Dr. via virtual visit on the 29th of July and by that time I had no symptoms at all. I took a second at home test on the 3rd of August and it was negative.
10 hours after shot I started to have chills, went to sleep, woke up at around 6:40a, fainted after going to the bathroom, while I was washing my hands
Hives rash beginning on arms; have more spots mostly on arms and wrist and other random areas; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 at 19:15 as dose 3 (booster), single (Lot number: FJ9943) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: KIRKLAND SIGNATURE ALLERGY MEDICINE taken for hypersensitivity. Past drug history included: Known allergies : cephalexin, reaction(s): "Known allergies : Cephalexin". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: FC3182, Location of injection: Arm Left, Vaccine Administration Time: 08:00 PM), administration date: 30Aug2021, when the patient was 40-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: FF2588, Location of injection: Arm Left, Vaccine Administration Time: 08:00 PM), administration date: 20Sep2021, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 18Apr2022, outcome "not recovered", described as "Hives rash beginning on arms"; RASH MACULAR (non-serious) with onset 18Apr2022, outcome "not recovered", described as "have more spots mostly on arms and wrist and other random areas". The events "hives rash beginning on arms" and "have more spots mostly on arms and wrist and other random areas" required physician office visit. Therapeutic measures were taken as a result of rash, rash macular.  Additional information: Hives rash beginning on arms started two to three weeks after injection on 30Mar2022. Been almost six weeks since vaccine and have more spots mostly on arms and wrist and other random areas. Rash does not itch but gets spots get bigger if scratched. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.
Headache, Myalgia,  fatigue, sore arm, chills Narrative:  Headache, myalgia, fatigue, sore arm,  chills. Took Tylenol and Advil.
left arm started getting red, itchy, rashy, hot, and swollen; left arm started getting red, itchy, rashy, hot, and swollen; left arm started getting red; left arm started getting red, itchy, rashy, hot, and swollen; left arm started getting red, itchy, rashy, hot, and swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (left arm started getting red, itchy, rashy, hot, and swollen), VACCINATION SITE PRURITUS (left arm started getting red, itchy, rashy, hot, and swollen), VACCINATION SITE ERYTHEMA (left arm started getting red), VACCINATION SITE RASH (left arm started getting red, itchy, rashy, hot, and swollen) and VACCINATION SITE SWELLING (left arm started getting red, itchy, rashy, hot, and swollen) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019821A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE WARMTH (left arm started getting red, itchy, rashy, hot, and swollen), VACCINATION SITE PRURITUS (left arm started getting red, itchy, rashy, hot, and swollen), VACCINATION SITE ERYTHEMA (left arm started getting red), VACCINATION SITE RASH (left arm started getting red, itchy, rashy, hot, and swollen) and VACCINATION SITE SWELLING (left arm started getting red, itchy, rashy, hot, and swollen). At the time of the report, VACCINATION SITE WARMTH (left arm started getting red, itchy, rashy, hot, and swollen), VACCINATION SITE PRURITUS (left arm started getting red, itchy, rashy, hot, and swollen), VACCINATION SITE ERYTHEMA (left arm started getting red), VACCINATION SITE RASH (left arm started getting red, itchy, rashy, hot, and swollen) and VACCINATION SITE SWELLING (left arm started getting red, itchy, rashy, hot, and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Back in 1998 or 1999 had shots from a drug called LYMERIX from my Dr. for Lyme disease because I work outside a lot having a lot of pain and other symptoms just found out that the FDA took it off the market around 2002 what can I do?
very dizzy; headache; joint pain; "burning" in her stomach when she ate or drank anything,; diarrhea; fever that went from 99 to 100; This is a spontaneous report received from a contactable consumer. This consumer reported for herself (patient) that:   A 74 years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 26Apr2021 as SINGLE DOSE for covid-19 immunisation The patient medical history was not reported.The patient's concomitant medications were not reported. The patient experienced very dizzy headache ,joint pain ,burning in her stomach when she ate or drank anything, diarrhoea,fever that went from 99 to 100 on 26Apr2021.The patient underwent lab tests and procedures which included body temperature: 99-100 on 26Mar2021 that went from 99 to 100.Question: E-transmit Potential Duplicate AE report to DSU: caller states she just spoke to DSU and gave them "all my information." No reportum number given.Caller states she received her 2nd Pfizer vaccine dose on 24Apr21. She states she had "a little red spot on Sunday. My friend told me to get online and I put ice on it for 10 min 2x/day."On Monday, 26Apr21, the red area started to "spread like rash around where the injection was, it was not hurting and using my left arm was no problem." Tuesday, 27Apr21, "the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up." Are these normal side effects and what should I do Response: Referenced the PI: section 6.1 table #1 and  section 6.2: LAB-1457-7.0 Revised: 06Apr2021 The events were assessed as Non serious by health authority and outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient/ received Kinrix as a 10-year-old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th November 2018, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 5th November 2018, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The nurse reported finding a vaccine record for a patient who received Kinrix as a 10 year old, which led to inappropriate age at vaccine administration. The reporter consent to follow up.
Immediate shooting pains in head. Within 3 hours had headache & fatigue. 6 hours post vaccination hypotension and tachycardia, increasing over next 4 hours. Resulted in heart palpitations. BP 80/53. HR 122. Considered going to ER. 13 hours post-vaccination normal BP and HR. Day 2 BP and HR normal. Day 3 BP very high 162/89, HR normal. Day 4 BP and HR normal, no headache, no fatigue. Normal since. Been taking BP/HR daily for last 3 months. Normal for me is 135/75 BP, 80 HR. Have not had heart palpitations in very long time prior to this vaccination. Contacted  doctor and was strongly advised not to get second dose of Moderna due to probable allergic reaction. No other allergic symptoms to the vaccination.
bloody diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA HAEMORRHAGIC (bloody diarrhea) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 7006320005 and 7006320001) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Sep-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (bloody diarrhea) (seriousness criterion medically significant). At the time of the report, DIARRHOEA HAEMORRHAGIC (bloody diarrhea) outcome was unknown.            No concomitant medication information was mentioned by reporter  No treatment medication information was mentioned by reporter.  Company comment: This case concerns a 30 year-old female with no medical history provided, who experienced the unexpected event of Diarrhoea Haemorrhagic. This event occurred one day after the third dose of Moderna COVID-19 Vaccine.The benefit-risk relationship of Moderna COVID-19 Vaccine  is not affected by this report.; Sender's Comments: This case concerns a 30 year-old female with no medical history provided, who experienced the unexpected event of Diarrhoea Haemorrhagic. This event occurred one day after the third dose of Moderna COVID-19 Vaccine.The benefit-risk relationship of Moderna COVID-19 Vaccine  is not affected by this report.
feels like i had a bruise; Stated" probably i got a reaction; and tender on the injection site , Caller also stated that it is sore on the injection site , on her left side it is tender; within half an hour she got really bad cramps on her chest; almost like gas; like indigestion; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (within half an hour she got really bad cramps on her chest), FLATULENCE (almost like gas), DYSPEPSIA (like indigestion), CONTUSION (feels like i had a bruise) and VACCINATION SITE REACTION (Stated" probably i got a reaction) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 044A21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, the patient experienced MUSCLE SPASMS (within half an hour she got really bad cramps on her chest), FLATULENCE (almost like gas) and DYSPEPSIA (like indigestion). On an unknown date, the patient experienced CONTUSION (feels like i had a bruise) and VACCINATION SITE REACTION (Stated" probably i got a reaction). an unknown date, the patient experienced VACCINATION SITE PAIN (and tender on the injection site , Caller also stated that it is sore on the injection site , on her left side it is tender). On 27-Dec-2021, MUSCLE SPASMS (within half an hour she got really bad cramps on her chest), FLATULENCE (almost like gas) and DYSPEPSIA (like indigestion) had resolved. At the time of the report, CONTUSION (feels like i had a bruise), VACCINATION SITE REACTION (Stated" probably i got a reaction) and VACCINATION SITE PAIN (and tender on the injection site , Caller also stated that it is sore on the injection site , on her left side it is tender) outcome was unknown.            patient concomitant medication 3 high blood pressure pills   This case was linked to MOD-2021-435768 (Patient Link).
Moderate to significant muscle aches in entire body started to develop about 7 hours after the vaccine. Mild headache and moderate mental fogginess started about 8 hours after receiving the vaccine.
Syncope occured about 30 seconds after the vaccines were given. Patient was placed in supine position with legs raised, she woke up a few seconds later. No oxygen was needed. Patient felt week and tired. She rested for a few minutes(15 minutes), color returned to her face and she stated she "felt better". After 30 minutes, patient left clinic walking and talking. Mother was encouraged to observe for any changes in appearance and cognitive characteristics and to report them as soon as possible.
Pt spouse reported lethargy and muscle pain/weakness for a few days after receiving dose one of the Shingrix series. No fever presented or hospitalization was required, pt just presented with some flu-like symptoms for 3 or so days after receiving the shot.
Pt has phobia of needles. He received flu vaccination and left the office. His mother and LPN advised him to wait but he said he felt fine. Before he got out of the office, he fell (passed out) in waiting room. Pt then taken to exam room and given water, cold rag and BP checked. He left with mother when BP returned to normal and he felt better.
Client reports he got his 2nd dose of Pfizer vaccine on 09/29/2021 approximately 1600. He started having chest pain, lightheadedness, and shortness of breath around 2230 while at work. Client reports he felt that he couldn't breathe well so he put his arms above his head but he then had numbness in both arms. Client reports informed him he was very pale. Client left work due to symptoms. Client reports he isn't currently experiencing these symptoms while at rest, but they occurred when he is being active at work. Client reports he woke up really cold today. Strongly recommended for client to be evaluated by a physician regarding these symptoms.
could not taste or smell; could not taste or smell; nasal congestion; Achyall over; Vomited; Migraine; lungs started burning; persistent dry cough; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 21Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced achy all over, vomited, migraine, lungs started burning, and persistent dry cough on 21Dec2020 and could not taste or smell and nasal congestion on 22Dec2020 at 15:00. The clinical course was reported as: The patient felt a little achy, then vomited. She had a migraine for 2 hours, lungs started burning, and had a persistent dry cough. The patient was achy all over. At about 3:00 PM the next day, the patient could not taste or smell and had nasal congestion. The patient stated that this could be typical for positive COVID-19 infection. The patient was later getting better and feeling better. The clinical outcome of achy all over, vomited, lungs started burning, persistent dry cough, could not taste or smell, and nasal congestion was recovering and of migraine was recovered in Dec2020.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
First vaccine I had extreme sore arm for day 2-4 day 5 I couldn?t move my arm at all and end up with bursitis for 3 weeks.
bad vertigo with vomiting and dizziness and seen by over 15 doctors and couldn't recover.
No adverse event; Received  0.25ml  instead of 0.5ml for bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.  On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 15-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose).    The age of patient was more than 18 years.  The patient had 2 primary and 2 monovalent booster of Moderna COVID-19 Vaccine.  No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 3rd of 7 adult patients described by the reporter.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648798: