chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine ruined her implants/implant and boob are separated 2 days afterward; 2 days later her left arm was hard to move it; her left saline implant looked like a cow's nipple, breasts are like cow nipple, ruined chest; 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 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "breast implant" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: DEVICE PHYSICAL PROPERTY ISSUE (non-serious), outcome "unknown", described as "vaccine ruined her implants/implant and boob are separated 2 days afterward"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), outcome "unknown", described as "2 days later her left arm was hard to move it"; NIPPLE DISORDER (non-serious), outcome "unknown", described as "her left saline implant looked like a cow's nipple, breasts are like cow nipple, ruined chest".  Additional information: The patient received the 2nd dose of the Pfizer COVID-19 Vaccine in her left arm. She states that she had trouble moving her left arm and 2 days after the vaccine her saline breast implant was ruined. The patient's breasts are like cow nipple 2 days later. Now right, 2 days after as well. She states she will have to get reconstructive surgery to get implants out. The patient describes her breasts as being cow tits and now the patient had worst chest. You ruined chest. The patient states her left implant and boob are separated 2 days afterwards.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 26 year old female patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Information has been received from a RN concerning a pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The pt complained of arm pain and tenderness. The pt was treated with ibuprofen (Advil) for pain relief and ice packs. It was noted that the pt recovered within a day or so. Unspecified medical attention was sought.  There was no product quality complaint involved. Followup information on 19Nov03 from the reporter indicated that two of the pt's may have had the vaccine a while ago and that she was not aware if any of the pts had any previous reactions to any other vaccines. The reporter expressed concern about the particular lot of the vaccine and mentioned that several pt's developed severe local reactions from what appears to be the same lot and what appeared odd to the doctor was a man and his wife received pneumococcal. polysaccharide vaccine from two different lots and the male that had the different lot that the one mentioned had no adverse reaction but his wife complained of arm pain and tenderness. The records of testing prior to release of this lot have been check by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The reporter mentioned two other pts who developed a similar reaction after vaccination with pneumococcal 23v polysaccharide vaccine. No further information is expected.
COVID-19  02/02/2022  1 of 2  Comirnaty-PFR 30mcg   COVID-19  02/24/2022  2 of 2  Comirnaty-PFR t-s 30mcg     Patient admitted with COVID infection 8/1/22.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored (Merck) VARIVAX (lot # K021484 and expiry date on 03-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. Follow-up information was received on 03-AUG-2015 and 05-AUG-2015 from a certified medical assistant, who reported that she would have to research for the request made for the patient identifiers, lot number and expiration date and the dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12 months-old patient of unknown gender. On 22-JUN-2015 the patient was vaccinated with a dose of (Merck) VARIVAX (lot # was confirmed as K021484 and expiry date was 03-NOV-2016). This is one of several reports received from the same source. Additional information has been requested. Patients's details, product, event and narrative were updated.
The patient states he is still having joint pain at the arm and shoulder. He explained it as pain the joint and not the muscle.
PAtient had no adverse event.   The adverse effect is an error in administration  because patient was 16 years old almost 17 and we administered MODERNA   PATIENT HAD NO ADVERSE EFFECT
Patient still hospitalized.  is a 72 y.o. female with h/o COPD, ANCA-associated vasculitis, microscopic polyangiitis, chronic quadriparesis and depression, presenting to the ER on 1/12 with c/o increased weakness over the past two weeks.  She is chronically bedbound but has been feeling weaker than her baseline over this interval.  Symptoms reportedly began around 1/1/22 and have been associated with transient fever, occasional dry cough, sore throat and nasal congestion.  Over the past 24 hours, she has begun having loose, non-bloody stools and nausea with dry heaves without associated abdominal pain.  Her gastrointestinal symptoms have thankfully resolved now, but have resolved in diminished oral intake.  She has received her initial COVID vaccination series and her booster.  She denies any other complaints or concerns, is feeling better than she was on arrival, but is very hungry.   In the ER, she was afebrile, normotensive, with normal HR and elevated RR, hypoxic into the 80?s on baseline RA.  She has been started on 6L via NC and is maintaining SpO2 in mid-90?s now.  Initial labs are notable for mild AKI, hyponatremia, hypoalbuminemia, transaminitis, normal CBC, normal procal, normal lactate, and UA with pyuria and bacteriuria.  COVID screen was positive.  EKG with SR and PVC?s, non-specific ST changes.  CXR with bilateral pneumonia (R>L).  She was treated with CAP coverage (Rocephin + Zithromax), Decadron, and IV fluids.
High fever x for several days (chills shakes) Arm hot- Hard- red- large area swollen nausea; headache brown urine, weak, felt miserable! (102 degrees)
Death 5/7/2021 Causes of death listed on death certificate: 1) Ventricular fibrillation  2) Covid19 pneumonia  Other: Diabetes
adverse reactions; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (adverse reactions) in a female patient of an unknown age 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 ADVERSE EVENT FOLLOWING IMMUNISATION (adverse reactions). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (adverse reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received on 29-Jun-2021 contains no new information; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Bodyache; Fatigue; Headache; Fever; Overall not feeling well; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE BIONTECH, Lot number: EP6955) via an unspecified route of administration in the right arm on 24Mar2021 at 13:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was allergic to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE BIONTECH, Lot number: EN6198) via an unspecified route of administration in the left arm on 03Mar2021 at 14:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 24Mar2021 at 19:30, the patient experienced fatigue, headache, body ache, fever and overall not feeling well. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of the events fatigue, headache, body ache, fever and overall not feeling well was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Pediatric dose was accidently given. It was corrected by giving the adult dose. No adverse effects reported by client
One day post vax pt developed an injection site reaction characterized by redness, swelling, pain, and warmth. Raising her arm was painful. Her mother treated her with acetaminophen and diphenhydramine without relief. MD recommended treatment with loratadine.
CIPD; This spontaneous report was received from a nurse practitioner via company representative and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date in September 2021, the patient was not able to put weight on her left lower leg and had to go to see a specialist. The specialist reported that the patient had chronic inflammatory demyelinating polyneuropathy (CIPD). The outcome of the event was unknown.  Causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event was reported as related.  Upon internal review, the event of chronic inflammatory demyelinating polyneuropathy was considered to be medically significant.
First pregnancy.  Singleton. Diagnosed with gestational diabetes at 12 weeks. At the time of the vaccine, I was 26 weeks 4 days (first does, 4 weeks prior). Delivering at approximatly 39 weeks due to gestational diabetes diagnosis.  The evening (around 7/8pm) of the day I got my vaccine I started to feel generally unwell. Woke up at 1 am shivering uncontrollably. Took 1000mg extra strength Tylenol (No fever yet). Woke up around 4 am sweating. Slept for a little longer. Took 1000mg extra strength Tylenol as directed through the rest of the day. I had a fever of 100 degrees around 10 am and called the nurse line for my delivery hospital, concerned about my fever. Talked to Dr.  and she said to keep taking Tylenol, a lukewarm bath, lots of fluids and continue to monitor fever. If gets to 102, then would be of concern. Around noon I was feeling a little better, took a nap, and woke up with 101 fever so I took a bath and that helped my temp drop. Between the bath and about 7pm I felt better again. Before bed, my temp jumped up again to 100 but woke up in the morning with no fever. Felt good most of the day Sunday until later afternoon where I had stomach/intestinal pain and just overall fatigue. Rested the rest of the night. Felt normal on Monday. From the date of vaccination- Tuesday my arm was sore and had a little bit of swelling.
The patient had completed prescreen and states he has not had another vaccine for COVID prior. He was given the vaccine on 9/1/2021. I was unable to get in the system to be able to verify this information and document vaccine. I had sent several emails at this time to the Help desk. When I had access to chart this I had noted he had already received the Johnson and Johnson vaccine on 4/7/2021.
o The next day, December 31, I felt like I did when I had the COVID virus (chills/fever/headache, weak feeling), but again with no chest pain, sore throat, coughing, trouble breathing, etc.  I did not notice that I had a big red patch on my arm close to the injection site with fever until probably Saturday, January 2nd.  I wore long sleeve pj?s most of the time while I was sick and didn?t bother looking at my bare arms when I was in the shower.  The fever at the red site on my arm finally went away and so did the red patch, but the red patch never itched.   o From December 31st to Saturday, January 2nd, I felt poopy and did not start feeling better again until Sunday, January 3rd. o I did return to work on Monday, January 4th and have felt good.
This spontaneous report was received from a certified medical assistant and refers to a 4 month old (at the time of the report the patient was 6 month old) male patient. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 28-APR-2016 at 11:28, a the age of 4 month old, the patient was vaccinated with his first dose of ROTATEQ (lot# number reported as L033543, expiration date 30-MAY-2017, orally, dose was not reported). The temperature of excursion was 34F and the time frame was 65 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse events, signs or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of several reports received from the same source. Lot number L033543 has been verified to be a valid lot number for ROTATEQ. Additional information is not expected as all required correspondence has been received.
She is not sure whether it was given intramuscularly because when it is given intramuscularly it is usually painful and she would know; first dose on 12 Feb2021 and second dose on 12May2021; Issues with her stomach, GI issues; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  (psychologist). The reporter is the patient.   A 72 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 12May2021 (Lot number: EN6208, Expiration Date: 30Jun2021) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 01, Lot number: EN6201 , Location: Right arm, Expiry Date of Pfizer Biontech Covid Vaccine: 30Jun2021), administration date: 12Feb2021, when the patient was 72 years old, for Covid-19 immunization; Flu shot (She does usually feel the shots, the flu shot and Shingrix); Shingrix (She does usually feel the shots, the flu shot and Shingrix). The following information was reported: GASTROINTESTINAL DISORDER (non-serious) with onset May2021, outcome "not recovered", described as "Issues with her stomach, GI issues"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 12May2021, outcome "unknown", described as "She is not sure whether it was given intramuscularly because when it is given intramuscularly it is usually painful and she would know"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12May2021, outcome "unknown", described as "first dose on 12 Feb2021 and second dose on 12May2021". The event "issues with her stomach, gi issues" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Dates for Pfizer Biontech Covid Vaccine: (Start: 12Feb2021 Stop: Unspecified). NDC number of Pfizer Biontech Covid Vaccine: Unknown. Expiry Date of Pfizer Biontech Covid Vaccine: 30Jun2021. She is calling about the Pfizer Biontech Covid vaccine. She just got both doses and she is 72. She got one dose in late feb and second dose in March as reported. She is having a lot of issues with her stomach, GI issues. She is calling to see if we have any information about GI issues. Caller is a psychologist. Her GI Issues started last week. She is not sure about the outcome, states it seems to be persisting. She went to urgent care.Treatment: declines any. Indication: She gets vaccines due to her age and she is proactive about her health.  She hardly felt the injection. She does usually feel the shots, the flu shot and Shingrix but she did not feel this covid vaccine. She is not sure whether it was given intramuscularly because when it is given intramuscularly it is usually painful and she would know. She does not have lot, ndc, or expiration date for flu shot or Shingrix. She had blood work done. She declined to continue with report and requested to be transferred for her question. No further details.  No follow-up attempts are possible. No further information is expected.
diffuse erythematous rash on extremities & face (primarily) w/circumscribed fairly annular wheals consistent w/urticaria; tx Atarax & pt improving p/1 day;
looks like acne but she said it's painful on her forehead./Broke out in a rash that looks like acne or white heads on her face and it is more prominent on the forehead; The forehead was little bit, some of it is inflamed and she said it looks like white head all over her forehead actually on her cheeks and even on her chin like more dominant on her forehead; broke out in a rash that looks like acne or white heads on her face and it is more prominent on the forehead; This is a spontaneous report from a contactable physician. A 15-year-old female patient received bnt162b2, intramuscular, administered in Arm Left on 27Sep2021 17:45 (Batch/Lot Number: 301458A) as DOSE 1, SINGLE at age of 15-year-old for covid-19 immunization. Patient History was No. No Other medical Conditions and Drugs taken, she doesn't have any medical problems or allergies. The patient's concomitant medications were no. Patient is a 15 year old female (15 Years 11 months, almost 16) who received the first dose of the vaccine on Monday (27Sep2021). One day later on Tuesday (28Sep2021) she got a rash like acne and painful all over her face. It looks like white heads and is more on her forehead. She has had no changes in detergents, lotions or anything. On Tuesday (28Sep2021) the patient broke out in a rash that looks like acne or white heads on her face and it is more prominent on the forehead. The reporter said the patient has had no change in detergent or lotions or anything like that and she wanted to know if there any other reports of rashes like that has been reported and she said she is not sure how to treat it. It looks like acne but she said it's painful on her forehead. The forehead was little bit, some of it is inflamed and she said it looks like white head all over her forehead actually on her cheeks and even on her chin like more dominant on her forehead. Yesterday (28Sep2021) and today (29Sep2021) things are a little bit worse. She got a couple more on the chin that she didn't have before. Patient feels it's a little worse from yesterday. She got a couple of new ones. She got the COVID shot on the 27th and then she said on the 28th she got this rash on her face. It was also reported that the patient got the painful looks like almost like white head acne lesion all on her face and this develop yesterday (28Sep2021), painful all over her face, did not notice anything anybody else reporting something like that, white head. Scheduled Date and Time of second shot was on 18Oct2021 at 17:45 PM. No Prior vaccination(4 weeks). Causality was no, the reporter hasn't seen anything like this. No Lab tests, haven't done any lab tests. Treatment for adverse events included Benadryl, she took it one time. The outcome of the events was not recovered.; Sender's Comments: Based on known disease pathophysiology, the events of rash, acne and dermatitis are assessed as not related to BNT162B2 and more likely due to underlying hormonal imbalances.
Two days after I got mouth sores that hurt, inside front lip and on tongue (I believe it was two or three sores, and they lasted about 5 or 6 days.)   I share this because I got my second dose 2/17/21 batch EL9266 in left arm and again two days out got sores on my lip and tongue (total of 2 sores that hurt). The one on my tongue has made it hard to swallow, because it is far back on my tongue. I have used a peroxide product to lesson the pain. I am 5 days out from my second vaccine, and the sores are not getting worse and I hope they lesson and go away as the first batch did after about 6 days.
Within 24 hrs I had a red rash at the injection site which increased in size for 7 days ending up being about 2" x 4". 2 days post injection I was placed on KEFLEX 500mg bid x5 days and CLODERM CM. Even after 2 weeks an itchy red rash 1 1/2 x 3" remains.
Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech/Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 at 14:00 as dose 3 (booster), single (Lot number: Fh8020), in left arm and on 22Apr2022 at 13:00 as dose 4 (booster), single (Lot number: Fma992) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Jan2021 at 14:30 as dose 1, single (Lot number: 007M20A), in left arm and on 26Feb2021 at 12:00 as dose 2, single (Lot number: 001a21a), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Oct2021 at 14:00, outcome "unknown", described as "Pfizer / BioNTech/Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
fatigue, SOB, decreased appetite, not feeling right, increased with exertion and stairs, occasional tachycardia (120's max), facial flushing lasting 10-15 minutes
Pt recvd DTP 17MAR92 & MD called  23MAR92 pt had bad local rxn red, swollen, cellulitis;