chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1.3.22 After positive Covid tests (at home & at doctors) a hideous itching rash spread on my arms, legs and back. Painful and quite uncomfortable. No salve helped. Prior to this a small bit of rash had appeared on my back but was not bad. Backstory: After 1st Moderna shot (2.15.21) I experienced a mild rash. It was improving until I had the scond shot (3.15.21) when the rash was exacerbated. The rash finally went away in June. I did not connect the rash to the vaccinations. Booster received 9.3.21. Rash started 11.22.21. The rash was mild until received the 4 Regen-Cov injection (lot 84346000003) ib 1.3.22. It continue to spread and itch terribly.
run fever all weekend up to 104 even w/APAP, vomiting x1, coughing & pulling @ ears
Onset within an hour of administration: Difficulty breathing (mild, felt like an elephant sitting on my chest), mild shortness of breath Onset within 8 hrs of administration: severe fatigue, moderate lightheadedness, sore muscles (arm the most but also the whole body)
Death by massive heart attack.  Pfizer-BioNTech COVID-19 Vaccine EUA
Pt stated after taking JE #3, that he had groin pain about 6 days past 1st shot, but because he lifts weight, did not relate to shots. About 3 days after 2nd shot, while getting out of bed, he felt groin pain. Pt stated he did not think it was from the shot, but he wanted us to know. Pt consulted with MD.
After immunization, patient has been experiencing pain on the site of injection and has been receiving physical therapy.
administered past published expiry; fever; headache; body ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past published expiry), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body ache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past published expiry), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body ache). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past published expiry) had resolved and PYREXIA (fever), HEADACHE (headache) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment medications were not reported no concomitant medications were reported
morning p/vax pt awoke unable to move lt shoulder & had pain chest that made it difficult to take a breath;pt saw MD;pain in shoulder & chest cont;deep aching & throbbing in shoulder joint;dx intercostal inflammation d/t tetanus;tendonitis
Initially nausea and lower back pain writhing 3 hours or so. This was on Friday morning. By the following Tues my right-side from hip to foot swollen 3 times the size and very painful. I drove myself to the hospital. Their report inconclusive. Eventually they told me to go home and take some aspirin and come back if it got worse. I'm still suffering agony in my lower legs and swelling and it seems to come and go. It has affected everything. I can't work alot and I get tired so quickly. My usual life is spent hiking, kayaking, fishing, doing things outdoors and eating healthy. This is new and horrible.
I immediately felt sick within an hour, had confusion later at night. Where friends asked if I was ok. My legs felt achy, symptoms like sciatica and trans ischemic attack, numbness in face, sick w/flu symptoms x 3 days then ended up w/major pain and sciatica diagnosed later (right leg to toes) and TIA.
pt recvd vax 27APR94 mom states pt c/o h/a; about 5PM arm started swelling & turning red; about 6PM most swelling & soreness between 6-8PM; pt was given APAP & DPH; This morning mom states arm is large area of redness w/swelling 2" x 2";
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Severe
After PEDIARIX, Hib, PREVNAR, ROTATEQ - 30 minutes after develops swelling, pruritus, and fussiness. All resolved by next morning 12-18 hours later. No problem with Hep B #1 at birth. But unsure of cause: Dtap #1, Hib #1, IPV #1, PREVNAR #1 or ROTATEQ #1. Mother did not come to us then. No respiratory problem nor visible rash. Referring to Allergist.
Although shot was painful no reaction for 2 days then a great deal of pain tingling up my neck and down my upper right arm where shot was given. The pain comes in waves. This started 10/20 and has continued.
TIREDNESS; LOSS OF CONSCIOUSNESS; MUSCLE CONTRACTION; LOSS OF SPHINCTER CONTROL; BLANK EYES; This spontaneous report received from a patient concerned a 32 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAY-2021, the subject experienced loss of consciousness. On 11-MAY-2021, the subject experienced muscle contraction. On 11-MAY-2021, the subject experienced loss of sphincter control. On 11-MAY-2021, the subject experienced blank eyes. On 12-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, muscle contraction, loss of sphincter control, and blank eyes on 11-MAY-2021, and the outcome of tiredness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210530640- COVID-19 VACCINE AD26.COV2.S - Loss Of Consciousness. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Swollen lymph nodes in the armpit starting 24 hr. afterwards. Tender and painful for 7 days. Experienced migraines for 3 days 36 hrs. after the vaccine. Over the counter pain medication was not effective.
Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case involves 18 years old female patient who received expired 0.5 ml dose of MENACTRA (batch number U5567AA, expiry date 17 June 2017) intramuscularly in left arm on 27 June 2018. Patient had not received any other vaccines. It was actual medication error due to Expired vaccine used as an Expired MENACTRA vaccine was administered to a patient on 27Jun2018. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Information has been received from a physician concerning a 50 year old female with PENICILLIN allergy and "a lot of medications" allergies and a history of "PEG tube" and gastrointestinal problems who on 19-NOV-2008 was vaccinated intramuscularly with first 0.5 mL dose of PNEUMOVAX (LOT # 661529/0868X).  On 21-NOV-2008 the patient experienced swelling, warmth and redness at the site of injection about 8cm by 17cm. The patient was treated with TYLENOL, BENADRYL and cold compresses. Complete cell count and "CHEM14" were performed and no results were provided. Subsequently, the patient recovered from the events. The patient sought medical attention in the office. This is one of several reports received from the same source. Additional information has been requested.
I went into the room where Patient was sitting on the table he was due for BEXSERO, HPV and PPD. While getting the vaccine ready he was talking to me about school. I proceeded to give the BEXSERO and HPV and his left deltoid. Again he was still engaging in conversation about school and what class he had tonight. When I gave the vaccines he still seemed fine and I then proceeded to throw the needles in the Sharps container while he was still sitting on the table and again he still seemed fine. I had him stand  up and sit in the chair that I had pulled closer to the computer desk so I can administer his PPD. I proceeded to give his PPD and right as I was finishing I'd seen that his hand jerked that made me look at him and he was getting pale his eyes rolled back, and his head fell back but I caught his head before it went all the way back, I thing went to call his name multiple times to try to wake him. At this time I try to grab the door to call for help. I called a name because that was the name I could think of first. When she came in so did Dr. I then sent her to get the LPN. Dr. and try get the patient to come back too, he did for a second and then past out again. After a few second he came back too. We got him up and on the table where Dr. asked him questioned to see how responsive he. We gave him water and had him lay down for about ten minutes. The got him sitting in a chair for another ten minutes; Dr. assessing him in the meantime. After about 30 minutes of sitting he was fine and was allowed to leave.
Hard on Injection Site; Itchiness; Rash; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard on Injection Site), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swollen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hard on Injection Site), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE INDURATION (Hard on Injection Site), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16-Apr-2021, email id received. On 20-Apr-2021: Follow up received on 20-Apr-2021, no new information was recorded
Had Hep B immunization #2 on 4/18/05 next day began with generalized body itching and saw red bumps on skin, seen 4/22/05 for same, no skin findings at that time but still some mild itching.
Patient received Varicella Vaccine and ProQuad a mix of Varicella and MMR. No symptoms
Terrible aches and pains all over body; feeling tired; headache; Slightly out of normal kidney function; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL IMPAIRMENT (Slightly out of normal kidney function), PAIN (Terrible aches and pains all over body), FATIGUE (feeling tired) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation (ten year history), Congestive heart failure, Chronic rhinitis (excl allergic) (for years) and Cardiac ablation in June 2020.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced RENAL IMPAIRMENT (Slightly out of normal kidney function). On 27-Feb-2021, the patient experienced PAIN (Terrible aches and pains all over body), FATIGUE (feeling tired) and HEADACHE (headache). On 25-Mar-2021, RENAL IMPAIRMENT (Slightly out of normal kidney function) and PAIN (Terrible aches and pains all over body) had resolved. At the time of the report, FATIGUE (feeling tired) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Physical examination: showed i had a slightly out of (abnormal) showed I had a slightly out of normal range kidney function.         The patient took extra strength Tylenol three times through the day just so not to have such terrible aches and pains all over my body.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-018720 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
The patient consented to Jansen COVID-19 vaccination. Patient did not experience any adverse reactions from the Pfizer vaccine. Patient was informed of the benefits and risks of both the pfizer and Jansen vaccination. Patient was informed of the efficacy of pfizer and Jansen and the drug authority warning associated with Jansen from ages 18-49. Patient was informed that a 2nd dose of pfizer is needed to complete the entire vaccination series. Patient agreed with receiving the 2nd dose of the Covid-19 vaccine.
SOB and cough since 8/5/2021.  Found to be hypoxic in the ED.  Placed on 4L of O2.  Admitted for acute hypoxic respiratory failur due to Covid-19 PNA.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (she administered a dose of MODERNA COVID 19 Vaccine outside the normal storage range) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004c21a) for COVID-19 vaccination. The patient's past medical history included No adverse reaction. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PRODUCT STORAGE ERROR (she administered a dose of MODERNA COVID 19 Vaccine outside the normal storage range). At the time of the report, PRODUCT STORAGE ERROR (she administered a dose of MODERNA COVID 19 Vaccine outside the normal storage range) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medication were provided.
Day after vaccine given swollen glands and thickness in neck, difficulty swallowing lasting 2 days.
Patient reports event to Pharmacist 6-13-16 at 2:30 PM.  Reports swelling at injection site at first.  Now swelling "spreading to right side of arm."  Reports a fever high temp of 101.5 degrees.  Headaches, weak, general fatgiue (malaise).
increased in fatigue; muscle weakness; pain in thighs; joint pain in knees and hip; It's difficult for her to walk upstairs, she has to drag her leg up the stairs; This is a spontaneous report from a contactable Nurse (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration on 16Feb2021, (at the age of 62-year-old) as dose 1, single for COVID-19 immunization. Medical history included autoimmune disorder, ongoing migraine and hypothyroidism. Concomitant medication(s) included thyroid (NATURE THROID); citalopram (CITALOPRAM) and Rimegepant sulfate (NURTEC ODT) taken for migraine, start and stop date were not reported. Patient reported that she has an autoimmune and other health issues which are under control. On 19Feb2021, patient noticed increase in fatigue, muscle weakness, pain in her thigh and joint pain in knees, and also her hip, so joint pain and hip. It's difficult for her to walk upstairs, she has to drag her leg up the stairs and it is still ongoing, it is not getting better. She was supposed to get the second dose but she decided to postpone it, so now she is schedule on 25Mar2021, she postponed because she still having this fatigue, her doctor suggested that she speak with the neurologist but her next appointment is in April, so she wanted to know, her question was, how well she is protected and what are the recommendations on getting the second dose if she should take it or not, and finally she mentioned is she spoke with a some healthcare providers and she mentioned people took the Moderna shot and they require a root canal. Patient just little concerned that it has gone on for 4 weeks, so that is why she had originally called she was trying to figure out the timing of the second, she has been putting off the second vaccination for fear of feeling worse than she do now so. Causality: Nurse stated That's the best conclusion I can draw, I certainly don't have total certainty but I, yeah. On 12Mar2021, the patient underwent lab tests and procedures which included c-reactive protein: normal, full blood count: normal and metabolic function test: normal. No therapeutic measures were taken as a result of the events. The outcome of the events increased in fatigue, it's difficult for her to walk upstairs, she has to drag her leg up the stairs, joint pain in knees and hip was not recovered. The outcome of the events muscle weakness and pain in thighs was unknown.   No follow-up attempts are possible. No further information is expected.
A report has been received from a Health Professional concerning a 10 month old, male subject, who had been receiving FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 11-OCT-2014. IT was reported that the 11 month old patient received FLUMIST Quadrivalent on 11-OCT-2014. The patient recovered from the event of 11 month old received FLUMIST Quadrivalent on an unspecified date. The report was considered to be non-serious.
high pitch cry for 14 days, fever, vomiting (1 month), diarrhea (1 month)
I had come off blood pressure medication for about a month before the vaccine. As soon as I got the vaccine, by BP went up and I have not been able to control it again.  Back on BP meds
Development of rash; It is on left and right arm and upper leg; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of bnt162b2 via unspecified route of administration on 10Mar2021 at single dose for COVID-19 immunization. The patient's medical history included Blood pressure (abnormal). The patient's concomitant medications included spironolactone. The patient previously received the first dose of bnt162b2 via unspecified route of administration on 10Feb2021 at single dose for COVID-19 immunization. The patient reported development of rash; It is on left and right arm and upper leg in Apr2021. For a large part of this month, she experienced rash. The patient asked if she was experiencing the latent side effects after that second shot. No Investigation Assessment and no treatment for the event. The patient didn't go by a doctor, just recorded thought the site that they sent her and they kept a record of it. The outcome of the event was not resolved (persisting).   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I was feeling like I was having a seizure; after the second dose and the booster, exactly 12 hours after receiving the dose my arms started flying around out of control; I threw up; Diarrhea; I am kind of scared to get the fourth booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Reaction: I threw up), for Covid-19 immunization, reaction(s): "I threw up"; Bnt162b2 (DOSE 2, SINGLE, Reaction: I was feeling like I was having a seizure), for Covid-19 immunization, reaction(s): "I was feeling like I was having a seizure"; Bnt162b2 (DOSE 2, SINGLE, Reaction: Diarrhea), for Covid-19 immunization, reaction(s): "Diarrhea"; Bnt162b2 (DOSE 2, SINGLE, Reaction: pain and swelling in the extremities), for Covid-19 immunization, reaction(s): "pain and swelling in the extremities", "pain and swelling in the extremities". The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "I was feeling like I was having a seizure"; LIMB DISCOMFORT (non-serious), outcome "recovered", described as "after the second dose and the booster, exactly 12 hours after receiving the dose my arms started flying around out of control"; VOMITING (non-serious), outcome "unknown", described as "I threw up"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; NERVOUSNESS (non-serious), outcome "unknown", described as "I am kind of scared to get the fourth booster". The patient had a question about a reaction to the COVID shot, the second and the booster shot, exactly 12 hours after she got the shot her arm started flying out of control, it lasted with less than a minute, but it was kind of scary like she was feeling like she was having a seizure or something and then she threw up and had the diarrhea. She knew that the diarrhea and throwing up were common, but she was concerned about her arm. The way that just kind of flew out of control and now she was wondering if that was a common side effect. She had not heard anybody else have that reaction. The patient wanted to know whether it was nervous system reaction, or a basic common reaction and she was kind of scared to get the forth booster. Patient stated that her doctor wasn't aware of anything. Patient stated that she was told that the only information we had were pain and swelling in the extremities. Patient mentioned that she might not get the next booster dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
her body could not stop shaking; This is spontaneous report from non-contactable consumer. A female patient of unspecified age received BNT162B2 first dose on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received first dose of Pfizer's Covid vaccine and approximately a week later her body could not stop shaking. Consumer was taken to emergency room but no issues were found. Patient had stopped shaking by the time she got to the Emergency Department. Event took place after use of product. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
None noted. On 9/24/07 pt was given Zostavax vaccine instead of Proquad (MMR/Varicella) - Pt's mother was contacted and will bring child back in 4 wk for correct dose.