chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. This consumer reported similar events for two patients. This is the first of two reports. A female patient of an unspecified age and ethnicity received TRUMENBA, (batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain injection site on an unspecified date. The outcome of the event was unknown. The information on the batch/lot number and expiration date has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018163454 same reporter/drug/event, different patient.
The pt developed swelling in throat, tingling in tongue, flushed feeling chest and back. Pt had elevated pulse and BP. Hyperemia noted. A follow up report received on 5/30/2002 adds: Hyperemia noted on chest. Rx: IV and PO Benadryl, observed for 4 hours. Home without recurrence of problems.
Chills, shaking, nausea, vomiting, dizziness/light headedness, tired, extremely sore arm, achy, extreme headache
Tinnitus started in both ears when I waked up in Day 3 after first dose shot of Pfizer Covid vaccine, and it lasted whole day and evening. In Day 4, the left ear's Tinnitus resolved, but the right ear's Tinnitus persisted with reduced volume, and on and off.  In Day 5's morning, right ear's Tinnitus can be still felt, at a sale of volume 2 (full scale is 0-10).  I hope the Tinnitus will eventually resolve as the time pass by, but I think I should report it to Vaers.
The morning after pt received her shots she woke up with a sore arm and a fever. Her arm became increasingly more swollen over the next several days with the fever persisting, going as high as 102.8 but maintaining around 101, mostly in the evening time. Today, 10/14, pt is still experiencing a red swollen arm and is having trouble lifting her arm. She went to a health clinic and was diagnosed with Cellulitis. She informed the doctor she received the shot on 10/8, the doctor instructed her to call us and report the event.
Right after I got my second COVID vaccine in late September I had a very strong reaction to it- severe chills, extremely swollen lymphnodes in neck even causing redness on my skin in that area, and diarrhea. I thought I had gotten past my symptoms but I began having a much higher sensitivity to lung irritants like smoke and steam and allergens, things like that, but in those instances I would have some shortness of breath for half a day or so but it usually went away with no trouble.  Beginning on Friday October 15th, some time in the evening, I became slightly short of breath. Throughout the night it got worse and was more difficult to breathe. I thought it may have been another symptom associated to my strong allergy symptoms I was experiencing that same day, so I took my over the counter allergy medicine. That did not help and my symptoms continued to get worse through the weekend so all I did was try to rest and treat it with what I had in my medicine cabinet. By Sunday night-10/17- I was unable to sleep because it was so difficult to breathe. I tried everything I could think of to alleviate my symptoms- hot shower, Mucinex (even though it did not feel like a build up of mucus and I was not coughing anything up I wanted to see if it would help), Delsym cough medicine, lots of fluids and rest, allergy medicine: bednadryl & xyzal- but nothing was working so I finally called the Teladoc line to speak with a doctor.  I spoke with a doctor first thing Monday morning and he prescribed me an Albuterol inhaler, benzonatate for coughing, and some steroids to improve my lungs. The medicine helped right away, but it was still a little difficult to breath for the next few weeks. At this point 2 months later I still have to use my inhaler several times a week and am very sensitive to things like smoke, dust, steam, etc anything that could irritate my lungs. Sometimes I wake up in the middle of the night with trouble breathing and have to go use the inhaler. I have an appointment scheduled with a doctor in February for further testing since I have not fully recovered.
seizure; This is a spontaneous report from a contactable consumer (patient's wife). A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EH9899, expiry: 31Mar2021), via an unspecified route of administration on 16Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included diabetes, cholesterol (abnormal), kidney (disorder), heart (disorder) and thyroid (disorder).  Concomitant medications included insulin aspart (NOVOLOG) for diabetes, insulin glargine (LANTUS) for diabetes, atorvastatin for cholesterol, tamsulosin, valsartan (DIOVAN) for the kidneys, levothyroxine for thyroid, diltiazem for heart, metformin hcl, macrogol 3350 (MIRALAX) from 01Feb2013, aspirin [acetylsalicylic acid], vitamin D3 and cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]). It was reported that the patient had seizures between his first and second dose of the COVID vaccine on an unspecified date. He has never had a seizure in his life, and he had the Covid shot last Saturday a week ago, not yesterday but the week before (16Jan2021). The patient's wife was asking if they are suggesting that a seizure could have been an allergic reaction and if there has been any other call with someone having a seizure after having the COVID 19 vaccine. The patient was admitted in a hospital from 22Jan2021 to 23Jan2021. Friday of this week (Jan2021), they did a CT scan, blood work, and an MRI. The doctor gave him a pill, anti-seizure pill to start taking. It is Keppra low dose, one in the morning and one in the evening. The patient's wife was not stating that the seizure is caused by Pfizer, but her husband has no history or family history of seizures and is wondering if her husband should take his second shot on 06Feb2021. The outcome of the event was unknown.
During the night woke up tongue felt swollen. Got up at 5:00 AM looked in mirror right side of tongue 3 times larger than left side. Called 911 taken to hospital by ambulance.
Dizziness Narrative: At approximately 0820 returned to the covid vaccine clinic reporting lightheadedness/ Dizzness. She stated that she had the vaccine 30 mins prior ton returning. Vitals assessed BP-143/98, HR 74, O2-99 via room air, RR-16. Pt given water, placed in a recliner and remained at the clinic for 30 mins. Pt refused to go to the ER stated she would return to her work area and lay down. Pt left via wheelchair being pushed by colleague in stable condition.
I developed imbalance, when lying down.  I got really dizzy.  I thought the symptoms would go away as part of the vaccination.  I also developed upset stomach , but that one went away.  The dizziness continued into the second dose and still continues.  The second dose is EP 7533.  I still get dizzy when i lay down and when get up, then it sort of normalizes, but when i lay down flat back and head up, dizziness starts.  I have to be careful when i get out of bed and have to wait until i gain my balance back.
at 1am after vaccination, woke up with body aches, couldn't sleep, restless till 0430. Woke up with mild congestion, cough, fatigue, lt. arm sore at site.  Body aches continued throughout day.  Contributed it to shot. Slept good Friday night, woke up Friday with mild cough, congestion, fatigue, runny nose, sore throat.  Tested for COVID Friday morning with Binax and was positive.  Symptoms have worsened since then; loss of taste and smell.  Has had temp as high as 101 on Saturday, low 99's on Friday.  Chills, SOB, and fatigue. on Saturday
Lymphadenopathy; Mild pain in left breast which was on and off/m pain has become more intense/continuous after second dose; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Mild pain in left breast which was on and off/m pain has become more intense/continuous after second dose) and LYMPHADENOPATHY (Lymphadenopathy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), SIMVASTATIN, RAMIPRIL, UBIDECARENONE (COQ 10), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B12), FISH OIL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D3) and CINNAMOMUM CASSIA BARK, THIOCTIC ACID (CINNAMON) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced BREAST PAIN (Mild pain in left breast which was on and off/m pain has become more intense/continuous after second dose). On an unknown date, the patient experienced LYMPHADENOPATHY (Lymphadenopathy). At the time of the report, BREAST PAIN (Mild pain in left breast which was on and off/m pain has become more intense/continuous after second dose) had not resolved and LYMPHADENOPATHY (Lymphadenopathy) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications include Curalin and centrum along with above mentioned. Treatment drugs mentioned were Tylenol, Ibuprofen.  No medical history was reported   This case was linked to MOD-2021-067479 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Additional info-1 : Outcome of AE
48 hours after Tdap-large 8x10 cm area of induration at site-tender.
Information has been received from a physician concerning an 18 year old female with no pertinent medical history or drug reactions/allergies who on an unspecified date was vaccinated with a third dose of Gardasil.  Subsequently the patient may have been pregnant when she received the third dose of Gardasil.  The doses of Gardasil were administered at another physician's office.  Unspecified medical attention was sought.  On an unspecified date the patient had a positive beta-human chorionic gonadotropin test (unspecified).  The patient's LMP date was 13-FEB-2008.  The patient's estimated date of delivery is 19-NOV-2008.  Follow-up information was received from the physician's office.  On an unspecified date the patient had terminated her pregnancy.  The patient's outcome was unknown.  Upon internal review abortion induced is considered to be an other medical event.  Additional information has been requested.
11 YO girl who received the Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (11 YO girl who received the Moderna Covid-19 vaccine.) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (11 YO girl who received the Moderna Covid-19 vaccine.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (11 YO girl who received the Moderna Covid-19 vaccine.) had resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
w/in 24 hrs p/immun, pt exp fever 103-104 x 6 days & inject site rxn which included swelling, redness & tenderness; Pt also had lethargy & irritability on 2nd day p/immun; APAP given;
Per client, he was vaccinated with HPV in 3/2023. Following vaccination, he states that he experienced extreme pain in his right shoulder/upper arm. He delayed calling our office because he stated he thought it would go away. Since then, his pain has increased, and he feels a burning and numb sensation in the right shoulder extending down to his elbow, which he rates at a 10/10. He describes it as constant in nature, and it is worsened if he sleeps on his right side. He has attempted to take ibuprofen or Aleve, but states that the pain is still barely tolerable. He feels a pop in his right shoulder when he moves arm. The pain is making it difficult for him at work (hairdresser) as the arm is his dominant side, and it makes it difficult to sleep.
Red, crying, temperature, irritable. Given Tylenol, same day, sick with ear infections for weeks after. Given antibiotics. Was drooling 6-8 weeks later, lost eye contact 4 months later and weakness 4 months later. Auto-immune disorder; encephalopathy, apraxia hypotonic. The 60 day follow-up report states neurological immune disorder gastrointestinal. This child was developing normally and was insulted by vaccines over a period of time not a single vaccine caused this much regression on his systems. Missing vaccine information not available. Dx autoimmune encephalopathy, high functioning autistic. Tx aricet solu- Medrol and IVIG. Poor social skills. Limited eye contact. low mptor strength. Encorpresis. Also notes generalized weakness and droopy eyes before 8 months of age. Onset unrecalled.
This spontaneous report as received from a health professional refers to a multiple unspecified patients of unknown ages and genders. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # L001325, expiration date: 13-JAN-2017; lot # L026410, expiration date: 15-FEB-2017; dose and route of administration were not reported). No adverse effects reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Info. has been received from a nurse practitioner concerning a 37 y.o. HIV positive female w/no known allergies, who on 8/13/02 was vax'd w/the 2nd dose of a 2nd series of Hep B vax recombinant. Concomitant therapy included sulfamethoxazole / trimethoprim (Bactrim), tenofovir disoproxil fumarate (Viread), lamivudine (Epivir), efavirenz (Sustiva), dicyclomine HCl (Bentyl) and fexofenadine (Allegra). On 8/14/02 the PT developed a red rash distal to the inject site. Unspecified medical attention was sought. At the time of this report, the outcome of the rash was unknown. Add'l info has been requested.
COVID-19; COVID-19; Achy bones; Two dry patches; incorrect route of administration; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4267780-00 (Agency).  A 54 year-old female patient received bnt162b2 (BNT162B2), subcutaneous (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single, subcutaneous (Batch/Lot number: unknown) as dose 2, single and subcutaneous (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (Batch/Lot number: unknown) for psoriasis. Relevant medical history included: "Dry patches" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (medically significant), outcome "unknown", described as "incorrect route of administration"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; BONE PAIN (non-serious), outcome "not recovered", described as "Achy bones"; DRY SKIN (non-serious), outcome "not recovered", described as "Two dry patches". The action taken for risankizumab was unknown.  Clinical information: Solicited report from a consumer of an adult female with events of non-serious COVID, ACHY BONES and DRY PATCHES with SKYRIZI (RISANKIZUMAB). The patient had a relevant medical history of DRY PATCHES. On unknown dates, the patient experienced COVID, ACHY BONES and DRY PATCHES. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient got sick from booster, got covid, achy bones, and two dry patches that came back. No concomitant drugs were taken. No adverse event Information was provided by patient related to covid vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No Known allergies  Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event(s) of COVID, ACHY BONES and DRY PATCHES was not provided. Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN): The reporter's causality for the event(s) of COVID, ACHY BONES and DRY PATCHES was provided as possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Written to doctor on 11/4/21 - I received my 2nd Covid vaccine (on Oct 11) and since then, some unusual things have been happening. The first is that shortly after, all of my eczema issues started flaring at the same time (I have different types and they started to flare. It is mostly under control now). And secondly, my left hand started aching terribly around the middle, ring and pinky fingers about a week later (took both shots in left arm).  After about a week, the pain shifted to my thumb, where it is hard to grip things bc the pressure pushing my thumb outward hurts. Just making note because the flare ups don't normally happen at the same time and the hand pain has never happened. I have photos of all these random red, raised, itchy areas that showed up on my hands, neck, etc. April 2022 I had an abnormal WITH TITER AND PATTERN tests that were unusual and unexpected. I met with a Rheumatoid doctor to figure out if I was at the beginning stages of Lupus or Rheumatoid Arthritis. This was weird because those don't run in my family.
Severe shaking & chills for 2/3  hours 2:00 am to 4:00am and again for an hour 10:00 am.
malaise; fever; chills; This is a spontaneous report from a non-contactable Nurse via sales representative.  A nurse of unspecified age reported that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), on an unknown date at single dose for COVID-19 immunization.The patient medical history was not reported.  The patient's concomitant medications were not reported.  12-48 hours after the vaccine administration, the patient felt malaise, fever, and chills  The outcome of the events was unknown.
(AM after rcvng.) Patient's mom called stating her daughter had just called her stating that her arm she got her flu shot in was extremely sore, "hard as a rock", and "fiery hot", and bruised. Patient called nurse direct and took diphenhydramine as a result. 2 days later, arm is fine, just slightly tender, but bruise is gone and not hot or hard to the touch.
CAN HARDLY WALK; SWOLLEN KNEES; SEVERE PAIN ON BOTH KNEES BUT  WORSE IN LEFT KNEE; FEVER; HEADACHE; SLEPT POORLY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included right knee replacement surgery, and concurrent conditions included osteoarthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced slept poorly. On 17-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced can hardly walk. On 20-MAR-2021, the subject experienced swollen knees. On 20-MAR-2021, the subject experienced severe pain on both knees but worse in left knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and headache on 18-MAR-2021, was recovering from slept poorly, and had not recovered from can hardly walk, severe pain on both knees but worse in left knee, and swollen knees. This report was non-serious.
all her vitamins are gone, Vitamin C, Vitamin D, potassium, and Vitamin A gone; tiredness was bad, described as its being beyond tiredness,could not get out of bed to cook a dinner because of the tiredness symptom; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness was bad, described as its being beyond tiredness,could not get out of bed to cook a dinner because of the tiredness symptom) and HYPOVITAMINOSIS (all her vitamins are gone, Vitamin C, Vitamin D, potassium, and Vitamin A gone) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019821A) for COVID-19 vaccination.     The patient's past medical history included GERD, Kidney stones, Bladder disorder and Spasms. Concurrent medical conditions included COPD and Arthritis. Concomitant products included BACLOFEN, MONTELUKAST SODIUM (SINGULAIR) and baby aspirin 81 mg 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 April 2021, the patient experienced FATIGUE (tiredness was bad, described as its being beyond tiredness,could not get out of bed to cook a dinner because of the tiredness symptom). On an unknown date, the patient experienced HYPOVITAMINOSIS (all her vitamins are gone, Vitamin C, Vitamin D, potassium, and Vitamin A gone). At the time of the report, FATIGUE (tiredness was bad, described as its being beyond tiredness,could not get out of bed to cook a dinner because of the tiredness symptom) and HYPOVITAMINOSIS (all her vitamins are gone, Vitamin C, Vitamin D, potassium, and Vitamin A gone) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medications include blood pressure medicine, acid reflux medicine, anxiety medicine, Proair, COPD inhaler. No treatment medication was provided by the reporter. No lab data was provided by the reporter.
Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender with egg allergy. On unknown dates the patients was vaccinated with doses of M-M-R II, subcutaneously (dose and lot# unknown). On unknown dates the patients experienced a reaction that consisted of redness, and swelling at the injection site following the administration of M-M-R II. The nurse stated the reaction was due to an egg allergy. Some of those patients might have received less than a full dose (less than 0.5ml) (Underdose) of M-M-R II due to an unspecified error during administration (medication error). No PQC (product quality complaint). The outcome of the events was unknown. Additional information has been requested.