chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 10:00 as dose 5 (booster), single (Lot number: Gh9693) at the age of 73 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25May2022 at 14:00 as dose 4 (booster), single (Lot number: Fn9992), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Waldenstrom macroglobulinemia" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: Jan2019, stop date: Dec2022. 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.  No follow-up attempts are possible. No further information is expected.
Feeling unwell; She felt like she had flu; No energy; Felt yucky and terrible; lethargic; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), INFLUENZA LIKE ILLNESS (She felt like she had flu), ASTHENIA (No energy), FEELING ABNORMAL (Felt yucky and terrible) and LETHARGY (lethargic) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteoporosis, Lactose intolerance, Vitamin D3 deficiency and Coeliac disease. Previously administered products included for an unreported indication: FLU VACCINE VII (flu shot every year). Concurrent medical conditions included Fibromyalgia, Chronic fatigue syndrome and Allergy (pt. is allergic to at least seven antibiotics.). Concomitant products included CALCIUM CITRATE, FISH OIL, LINUM USITATISSIMUM SEED OIL (FLAX OIL), UBIDECARENONE (COQ 10), GLUCOSAMINE & CHONDORITIN, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE), POLYCARBOPHIL CALCIUM (FIBER), DOCUSATE SODIUM (STOOL SOFTENER) and WARFARIN for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced MALAISE (Feeling unwell), INFLUENZA LIKE ILLNESS (She felt like she had flu), ASTHENIA (No energy) and FEELING ABNORMAL (Felt yucky and terrible). 17-Feb-2021, the patient experienced LETHARGY (lethargic) and FATIGUE (Felt tired). At the time of the report, MALAISE (Feeling unwell), INFLUENZA LIKE ILLNESS (She felt like she had flu), ASTHENIA (No energy), FEELING ABNORMAL (Felt yucky and terrible), LETHARGY (lethargic) and FATIGUE (Felt tired) had resolved. Not Provided          Patient got tested for Covid following first dose on 22-JAN-2021 but was negative. No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-021025 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-May-2021: date of birth; other relevant history; Concomitant medication; outcome (unknown to resolved) were updated
Vasovagal Response. Patient fell unconscious on exam table then his eyes rolled in the back of his head and he had began to have seizure like activity and episode of incontinence of urine. Patient was pale excessive sweating and dis oriented upon awakening.
could not sleep last night; shooting pains above ear into head; rheumatoid arthritis, it was the worst she's ever had her arthritis in 78 years/Her right arm, she couldn't lift her arm, her wrists, her arms, her foot.  She knows this was her rheumatoid arthritis; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.  Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization; she had mild symptoms and was fine by the third day. The patient's concomitant medications included unspecified autoimmune pill.  On Wednesday the day after second shot (10Mar2021), the patient was okay but from Thursday (11Mar2021) until Saturday (13Mar2021) she had shooting pains above her ear into her head. Every day the pains got milder. She's never had a migraine. She went to the dentist yesterday (15Mar2021). She was using process of elimination to figure out what was wrong. If it was her bridge or anything in her mouth. The dentist took x-rays and everything was normal. She was wondering what those shooting pains in her head could have been.  She also stated that her rheumatoid arthritis, it was the worst she's ever had her arthritis in 78 years. She could not sleep last night. Her right arm, she couldn't lift her arm, her wrists, her arms, her foot.  She knows this was her rheumatoid arthritis. When she goes to the bathroom, she can't even do that, her arm hurts so bad. She was on an autoimmune pill and she can't take her autoimmune medicine with the Covid shot. She started taking her medicine today.   Information about lot/batch number has been requested.
Headache, Myalgia, Fever & NauseaVomiting Narrative: Missed work on 01-20-21 as felt ill.
Developed varicella rash 1/21/04. Received Varivax 1/9/04.
13 minutes after the injection haves on right side of my neck. 10 min  48 hours after I had body ache, chills, headache, arm tenderness, lymph nodes on left side.
Patient received the 2nd dose of the Pfizer COVID-19 Vaccine in her left arm on 4/28 at 12pm.  At 9pm that even she developed symptoms of heaviness, weakness, numbness, tingling and intermittent pain from her left upper arm to her left hand and fingers.  She had fever for 2 days.  The symptoms resolved after 48 hours.  She started having the same symptoms in her left upper arm to her fingers yesterday.  She started to have right lower leg pain, numbness and tingling yesterday.  She has had no chest, pain, cough, SOB, headaches, blurred vision, dizziness or fever.  She has no neck or back pain.  She has no rash or bruising.  She received the first Pfizer Vaccine on 4/7/21.
Patient felt very shaky, lightheaded, hot, and tingly.  She felt like she was going to pass out.
pt recvd vax & devel a react descrived as mild erythema & swelling @ the inject site which resolved in 3 days;
Information has been received from a pharmacist concerning a male who was vaccinated wth the first and second doses of hepatitis B virus vaccine. Subsequently, the patient experienced increased LFT's (they went from 40u/L to 120u/L). No other information was provided. Unspecified medical attention was sought. There was no product quality complaint. Upon internal review, increased LFT's was considered to be an other important medical event (OMIC). Additional information has been requested.
Erythema & swelling upper arm (16 cm) - to arms elbow.  Circumference 23 cm vs 20 cm other arm.  Pt reports chest pain X 3 days after injection.
I woke up and was feeling tingling all up and down the left side of my body. I felt nausea and got up to go to the bathroom in case I vomited. I was dizzy on my walk over there. When I got to the bathroom I decided instead to lie down on the floor. After about 20 minutes the feeling subsided. Since then I've noticed my blood pressure seems to fluctuate more than usual (30 points difference between systolic readings in the same week); this has abated somewhat but I still have to stand up more slowly (and breathe deeply several times) in order to prevent lightheadedness.
arm sore; nausea; chills; This case was reported by a consumer via patient support programs and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included niraparib (Zejula).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and an unknown time after starting Zejula, the patient experienced pain in arm, nausea and chills. On an unknown date, the outcome of the pain in arm, nausea and chills were unknown.   It was unknown if the reporter considered the pain in arm, nausea and chills to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The shingles vaccine made her arm sore, nausea and chills. This case has been linked with case US2019TSO237002 reported by the same reporter.
Vision changes in left eye, vision field changes smaller view, pain in jaw, eye, and radiating down left arm.
soreness; This spontaneous case was reported by a patient and describes the occurrence of PAIN (soreness) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LEUPRORELIN ACETATE (LUPRON) for an unknown indication.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started LEUPRORELIN ACETATE (LUPRON) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (soreness). At the time of the report, PAIN (soreness) had resolved.      No concomitant medication was provided by reporter. It was reported that in 2022, the patient experienced soreness and in 2022 the event resolved. Causality of Leuprorelin Acetate (Lupron) for the event pain was reported as probable. It was unknown If the patient was enrolled in a COVID-19 vaccine trail.  No treatment medication was provided by reporter.
Almost 2/3 of pt's right upper arm became edematous and indurated with erythema, warmth to the touch and pain. She had a severe localized reaction to DaPT. She was treated with Prelone, ice and elevation.
dizziness, blurred vision, myalgia, arthralgia, rash, redness @ site;treated w/Pred & feeling better
I had been to a store, ATM and pharmacy. Got a flu shot in left shoulder and shingles in the right shoulder. Was in my house with my few purchases, leaned over to pick up an item and things got blurry and dizzy and I fell to the floor. Went to hospital about 12 hrs. later due to extreme pain - I assume from the fall.
Pt experienced fever of 103, headache, lethargy after receiving vaccine. Said she took ibuprofen.
She got her vaccine, started hurting, felt real bad like she was sick.  She hurt all over.  Then when she had shingles in the past she had terrible pains in her legs and pains that would shoot all over her leg.  Then she was over the shingles, and then waited a year to get the vaccine.  She then had the same symptoms with the pains like she had when she had shingles.  The feeling went from her foot all the way up her leg, in her back with pains as well, and pains all over, and a sick feeling.  The feeling covered her whole body and her arms, which her whole body ached.  It crippled her up to the point that she could not walk very well.  She went to a few doctors and they said that the shingles vaccine would not hurt her, which she believes they didn't know what to do.  One doctor asked if she wanted PT, but she said that it felt like something grabbed her body and just hurt and ached all over up her leg, and started the nerve pains again.  She has not seen a doctor recently for it.  She had gone to 2-3 different doctors who did not know what to do about it.    When she had shingles it went from her hip to her foot including the bottom of her foot.  She did not get the break out but had similar to the pain she had with the shingles, but with the vaccine it affected her all over especially down her leg where the shingles were.  She still has the nerve pain, not as bad, but it's still there.
Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            This case was linked to MOD-2021-036522 (Patient Link).
Passing out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Heart disease, unspecified.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passing out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passing out) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. However, patient's underlying heart disease and pacemaker insertion may have been contributory.   This case was linked to MOD21-065383 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. However, patient's underlying heart disease and pacemaker insertion may have been contributory. MOD21-065383:Crosslinked
developed a fever/felt warm; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 12-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), 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: PYREXIA (non-serious), outcome "unknown", described as "developed a fever/felt warm". Additional information: the patient developed a fever. His mom thinks he was overreacting. He had the shot and then went to the buffet for dinner and said he felt warm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
husband said wife  was  out of it yesterday (the day of the shot), had bad nightmares last night and today is still out of it.
I received my first Pfizer Covid-19 vaccine shot on March 5, 2021, and my second shot on March 26, 2021.   After my first shot, I had minor chills, no fever, and was a little tired for two days.  However, approximately 12 hours after my second shot, I had a 101.0 F fever, with a heart rate of 105.  I did not take any fever reducing medicine.  I had a fever for two days, and slight elevation in my temperature on the third day.  My heart rate decreased over the second and third day, and went back to my normal 50s-60, four days after my second shot.  I had slight nausea the first day, and a loss of appetite two additional days.  My appetite is now back to normal.  Furthermore, I had a lot of soreness in my lower back, neck, shoulders, and knees that lasted 5 or 6 days after my second shot.  Also, I had a low-level intermittent headache the first day after the second shot.  In addition, I had significant chills that lasted 10 days after the second shot.  My chief complaint is feeling very lightheaded / unsteady when in a standing position.   Also, my exercise routine has suffered the past month.  I only walk 15 to 20 minutes and feel very tired.  Certainly, not a normal feeling for me.  I feel very tired over the past month and a half since my second shot. I have checked my EKG a few times over the past 6 weeks.  It is my normal EKG, (RBBB and LAFB) and remains unchanged.
After second covid vaccine received on 04/29/2021 my left arm , where I received both vaccinations, started to feel like pins and needles.  My arm directly under side of arm where vaccine was given is the starting point of the pins and needles.  That spot always has a tingling sensation. Then the pins and needles travel down my entire left arm and through my wrist and fingers. At one point it felt as though there was a hair under my skin on my left forearm. The hair sensation went away but the pins and needles became stronger. I have lost strength in my left hand as I cant feel to hold something in my fingers due to the pins and needles. Sometimes the sensation is so strong it is very uncomfortable. I try to shake my arm as you would when your foot fell asleep and you are trying to get the blood flow back to make the pins and needles go away.  It is very uncomfortable and can also make it hard to sleep at night.
Rash and/or sores on arms, stomach and inner thighs; Rash and/or sores on arms, stomach and inner thighs; Rash and/or sores on arms, stomach and inner thighs; Rash and/or sores on arms, stomach and inner thighs; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Current smoker" (unspecified if ongoing), notes: Current smoker. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization completed, unknown manufacturer), for COVID-19 immunization. The following information was reported: RASH (non-serious), PAIN IN EXTREMITY (non-serious), ABDOMINAL PAIN UPPER (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Rash and/or sores on arms, stomach and inner thighs".  Additional Information: It was reported patient developed rash and/or sores on arms, stomach and inner thighs 2 days after receiving her 3rd dose of the Pfizer COVID-19 vaccine. Reports symptoms have persisted for close to 1 year. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received FluMist intranasally 11/14/2008 at 11:30 a.m.  Woke up at 5:00 a.m  on 11/17/2008 complaining of watery eyes, muscle aches, weakness, dizziness, abdominal pain, headache and fever.  These symptoms lasted all day into the evening.  The fever ranged from 101-103.  By 11/18/2008 fever had subsided, continued to feel weak.
Symptoms of sore throat, fatigue, nasal congestion started on 08/02/21.  Tested positive for COVID on 8/3/2021
Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Joint Pain-Severe, Additional Details: Was given monoclonal antibody infusion 3 days post vaccination at healthcare center
tiredness; Headache; muscle pain; chills; joint pain; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 13Feb2021 at 14:00 (at the age of 64-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications were not reported. The patient did not receive any other medications in two weeks. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 13Feb2021 at 22:00, the patient experienced tiredness, headache, muscle pain, chills, joint pain, nausea, and feeling unwell. Therapeutic measures were not given for the events. The clinical outcome of the events tiredness, headache, muscle pain, chills, joint pain, nausea, and feeling unwell was not recovered.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
22 Days after receiving the above vaccines, she experienced numbness in her right hand and a headache and nausea. The next morning those symptoms were resolved. After being awake for 10 minutes she had a grand mal seizure. Duration 2-3 minutes. Emergency evaluation revealed a normal exam. PMH - significant for epilepsy. Dx 11/05 on Lamictal last seizure 1/06.
Patient admitted for COVID on 9/24/21 - 9/26/21.  Fully vaccinated for COVID.  Dose one COVID Pfizer vaccine 2/13/21, dose 2, 3/6/21
aphasia; stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BABY ASPIRIN. Vaccination history included: Bnt162b2 (Primary immunization (Pfizer COVID shots)), for COVID-19 immunisation; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER); Pfizer COVID shots and booster), for COVID-19 immunisation. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Jul2022, outcome "recovering", described as "stroke"; APHASIA (non-serious), outcome "recovering".  Clinical course: The caller (patient's wife) said she had some concerns before they took the shot, she was advised by her pharmacist and doctor to contact Pfizer. She mentioned that she and her husband had Pfizer COVID shots and boosters in the past, however, the new one sounds like it's a little different. She noticed that it says it has formaldehyde, when she was in college, she blacked out from formaldehyde. She further said she had two shots without a reaction but didn't know whether they had formaldehyde in them or not. She said her husband had a stroke in Jul2022 and has aphasia but is doing fine. She said her husband takes 4 baby aspirin a day and she noticed that it said something about blood thinners. She was concerned and wanted to know additional medical information about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.