chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to approximately 4-5 patients of unknown age. It was reported that the patients were of age to receive the vaccine as directed. On an unknown date the patients were vaccinated with ZOSTAVAX (standard dosing (not specified)), subcutaneous for prevention of shingles during a flu clinic held at the office. Lot number: J004310, expiry date not provided. On an unknown date the patients experienced injection site redness and swelling. Some of the patients sought medical attention by contacting the office and informing them of their symptoms, and some of the affected patients came in for an office visit and showed the reporting nurse what the reaction looked like. The outcome of injection site redness and swelling was not provided. Additional information has been requested.
Amenorrhea; This is a spontaneous report from a contactable consumer. This consumer reported for patient that a female patient of an unspecified age received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that she is calling about the covid Vaccine, he is a Pfizer employee and reporting multiple patient adverse events. Pfizer employee reported that last Friday on 07May2021 he was reading comments on social media, he was social media friends with multiple customers. One was a medical assistant, she put on her social media page that she had 3 patients phone in about adverse events with the covid 19 shot, they complained of amenorrhea and haven't had their periods in 3 months. Pfizer Employee stated that he has no patient details to provided, he has no initials, height, weight, ages. When queried if he knew the patient's sex, he stated that it is a gynecologic office and they're complaining about amenorrhea. Pfizer employee has no further information to provided. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021531880 same reporter/drug/event, different patients
Following administration of vaccine (unsure of onset) she had episodes of "fast heart rate", weakness, dizziness and nausea. Episodes infrequent initially then became daily. Episodes lasted for one month.
Swollen lymph node (about the size of an almond) right at the base of my right ear followed by brain fog, neurological tingling and other sensations across my face and head. Constant fatique, slurred speed, and occasional panic attacks. No treatment has occured other than a change in diet which fixed the panic attacks. The lymph node reduced back to normal after about a week and a half, but all other symptoms remain. The worst is the neruological tingling and sensations. It is almost a kin to my head falling alseep or something crawling through my hair. Sometimes portions of my head or face are highly sensitive. Gastro-intestinal pain at night sometimes.
Pain, redness and swelling in L arm 24 hours after injection at site of Sub Q injection of VARIVAX.
I ended up having breakthrough joint pains the next day. That resulted in me calling my rheumatologist. She ended up having to double my medication (Plaquenil). I ended up going in to see her for a follow up. She ended up sending me to hematology. He drew some blood work. I was considered high risk for blood clots because of my chronic conditions. That's why she sent me to hematology. I am still having breakthrough joint pain. I am calling the rheumatologist today to find out my next steps.
Information has been received from a licensed practical nurse concerning a female patient " in her 60's" who in the "past two weeks" was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot#651329/1047P).  In the 'past two weeks" the patient experienced vomiting and local swelling at the injection site.  Unspecified medical attention was sought.  Additional information has been requested.
Could not get out of bed; Legs were hurting as if she had restless leg syndrome; Tiredness; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Could not get out of bed), PAIN IN EXTREMITY (Legs were hurting as if she had restless leg syndrome), VACCINATION SITE PAIN (Sore arm) and FATIGUE (Tiredness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Restless leg syndrome.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore arm). On 27-Mar-2021, the patient experienced BEDRIDDEN (Could not get out of bed), PAIN IN EXTREMITY (Legs were hurting as if she had restless leg syndrome) and FATIGUE (Tiredness). At the time of the report, BEDRIDDEN (Could not get out of bed), PAIN IN EXTREMITY (Legs were hurting as if she had restless leg syndrome), VACCINATION SITE PAIN (Sore arm) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
on the same evening p/flu shot pt had sx of a cold (sore throat, runny nose); p/having a cold for about 10 days, pt devel sinus infection; MD prescribed ATB & pt was better p/3-4 days;
Facial swelling, hives on stomach, arms, and thighs started about 7 days after the vaccine. Lasted 5 days until given steroids and antihistamine.
4 days after receiving shot, subject experienced severe itching, took oral BENADRYL. Day 5 - entire deltoid muscle was hard, hot and tender. Red skin covered 7x8cm square. Day 6 - Saw MD. Induration resolving, inflammation extending. Tx'd with Fluocinonide 0.05% topical. Also Advil p.o.
Pt developed a severe headache and a fever of 103F about 3 minutes, post vax. 12 hours later, pt had joint aches, a sore throat with difficulty swallowing and complained of shortness of breath 12 to 24 hours later. Fever of 100F-102F for the past 2 days with a pounding headache.
MEDICATION ERROR.  PATEINT RECEIVED AN UNDILLUTED DOSE OF PEDIATRIC PFIZER.
Peritoneal surface disease; Cancer pain in testes/had cancer cells; Mass in liver/might be in the colon; Mass in liver/might be in the colon; 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-163-4246137-00 (AbbVie).  A 42 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 14Feb2021 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single and intramuscular, administration date 24Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALIGNANT PERITONEAL NEOPLASM (medically significant), outcome "not recovered", described as "Peritoneal surface disease"; CANCER PAIN (medically significant), outcome "unknown", described as "Cancer pain in testes/had cancer cells"; INTESTINAL MASS (non-serious), HEPATIC MASS (non-serious), outcome "unknown" and all described as "Mass in liver/might be in the colon". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab): The reporters causality for the event(s) of peritoneal surface disease cancer pain in testes/had cancer cells unknown onset, peritoneal surface disease cancer pain in testes/had cancer cells un-known onset, mass in liver/might be in the colon unknown onset and mass in liver/might be in the colon unknown onset was not provided. AbbVie opinion is that the events of peritoneal surface disease cancer pain in testes/had cancer cells unknown onset, peritoneal surface disease cancer pain in testes/had cancer cells unknown on-set, mass in liver/might be in the colon unknown onset and mass in liver/might be in the colon un-known onset are not assessable.  Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): The reporter's causality for the event(s) of Peritoneal carcinoma, Cancer pain, Large intestine mass, Hepatic mass was Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events malignant peritoneal neoplasm and cancer pain and the suspect drug BNT162B2.
She developed bumps/had these bumps on her knees and elbows and all over; rash on her knees & elbows/there was a rash all over her thighs; They are red and turned purple; They are red and turned purple; headache; nausea; 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 75 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 03Apr2021 (Lot number: ER8733) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, LOT: EN6199, Anatomical location: Left arm), administration date: 11Mar2021, when the patient was 74 years old, for Covid-19 immunization. The following information was reported: MASS (non-serious) with onset 2021, outcome "not recovered", described as "She developed bumps/had these bumps on her knees and elbows and all over"; RASH (non-serious) with onset 2021, outcome "recovered" (2021), described as "rash on her knees & elbows/there was a rash all over her thighs"; ERYTHEMA (non-serious), MACULE (non-serious) all with onset 2021, outcome "not recovered" and all described as "They are red and turned purple"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea". The events "she developed bumps/had these bumps on her knees and elbows and all over", "rash on her knees & elbows/there was a rash all over her thighs", "they are red and turned purple", "they are red and turned purple", "headache" and "nausea" were evaluated at the physician office visit. Therapeutic measures were taken as a result of mass, rash, erythema, macule. No follow-up attempts are possible. No further information is expected.
Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 13-Apr-2022 post 30 days; Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 13-Apr-2022 post 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 13-Apr-2022 post 30 days) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 13-Apr-2022 post 30 days) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 016M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 13-Apr-2022 post 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 13-Apr-2022 post 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 13-Apr-2022 post 30 days) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 13-Apr-2022 post 30 days) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Pharmacist, the vaccine coordinator in their health care facility, reported that they inadvertently administered an expired dose of the Moderna Covid-19 vaccine. Post further investigation of the issue, pharmacist identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. The lot number 084J21A was received and placed in the fridge initially on 11-Jan-2022, which meant that all doses administered more than 30 days after 11-Jan-2022 was not in accordance with the university. The vial did not undergo any temperature excursions.   The patient did not report any adverse reaction to the health care professional knowledge.  No treatment medication was reported.
severe rash all over upper chest, breasts, upper shoulders red, pimply with whiteheads; severe rash all over upper chest, breasts, upper shoulders red, pimply with whiteheads; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 30Mar2021 at 14:00 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date prior to the vaccination and known allergy to penicillin. Concomitant medications included norethisterone acetate, ethinylestradiol, ferrous fumarate (CHARLOTTE 24 FE) 1 daily for birth control from unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 the patient experienced severe rash all over upper chest, breasts, upper shoulders. The rash was not itchy and did not hurt or burn, just red and pimply with whiteheads. The patient underwent lab tests and procedures which included nasal swab for COVID-19 virus test on 06Apr2021 and the results were pending. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event rash and red rash was recovered on an unknown date 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Spotting (light bleeding) for 3 days turned into shedding huge blood clots vaginally from 4/3 - 4/5. I bled though pads in just 5-10 minutes. Clots ranged from the size of a quarter to the size of the palm of my hand. They were very large, very frequent, and very painful. I never experienced this before in my life. The bleeding lasted 12 days total.
Tachycardia (resting heart rate 110-135, walking heart rate 135-150), began 11:00 am day after vaccine, ekg ~5pm with no afib, treated with propanolol, elevated heart rate continues 48 hours Arm pain ~ 5 days Headache ~ 5 days
From telephone call received on 11/02/01, it was reported that a 6 year old male patient received a Fluzone SV '01 -'02 vaccination administered on 10/29/2001. Twenty-four hours after vaccination, the patient developed a local reaction 3' in diameter at the injection site that was red and hot to the touch. Reportedly the reaction resolved and the patient recovered.
Hot flashes, nausea, arm pain from area of vaccine to hand. Initial dizziness started immediately.
Received 2nd shot on 2/5/2021 at 5:20pm. Was fine until I woke up at 5:30am on 2/6/2021 for work. I experienced extreme aching joints (especially in my neck and back), muscle aches (especially on back), fatigue, exhaustion, headache and chills
Pt recvd vax & w/in 15 min started swelling around eyes devel rash patches on neck down to chest; c/o abd became listless & wanted to go to sleep; Taken to ER;
Soreness, fatigue, nauseous, diarrhea, missed two days of school so far
Pt fainted, but she was awake, we lifted her leg for about 10 minutes and drank some water, sat down for about 5 minutes, then got fainted again ( still conscious and awake) , then again laid back on the floor by the pharmacist and able to talk and relax, 911 was called (after her second incident) they checked her vitals, all were normal , pt stayed in the store for about 1 and 1/2 hours and was well before left for home.
After receiving the second dose of the Shingrix vaccine, the patient started feeling unwell that night. The next morning he was experiencing shortness of breath, fatigue, fever, chills, and overall malaise. At home he used duonebs and Tylenol to help with symptoms. The patient's daughter called his primary care physicians office who instructed her to take him to the local ED because he was experiencing shortness of breath. Upon follow up on 8/28, patient reported that he did not go to ED for symptoms, and that symptoms lasted for 5-6 days before resolving. He had raised his home oxygen from 2L to 4L. All symptoms had resolved completely after 6 days. He had no current complaints at the time of follow up.
pneumonia; Arm soreness; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on (27Feb2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (daughter) via a Pfizer Sponsored Program. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 30Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On unspecified dates in Jan2021 the patient experienced pneumonia and arm soreness. It was reported that the patient had been diagnosed with pneumonia and had arm soreness after the first dose on 30Jan2021. The second dose was scheduled for today, 27Feb2021. The clinical outcomes of the events pneumonia and arm soreness were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Approx. 15 min. after vaccination, pt began to complain of his hears were burning. Parents brought him back to clinic immediately. Pt had generalized rash upon return. Rash resolved with IM Benadryl.
neck injury; A report was received from a consumer concerning a patient who was participating in the mRNA-1273  Program and experienced neck injury.  The patient's medical history, as provided by the reporter, included heart issues. No relevant concomitant medications were reported.   On 23 Dec 2020, approximately 3 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 26 Dec 2020, the patient had a neck injury. Treatment for the event included a 4 mg dose of methylprednisolone from 6x/day on day one, 5x/day on day 2, 4x/day on day 3, and 2x/day on day 4.  Action taken with mRNA-1273 in response to the event was not reported.  The event, neck injury, was considered resolved on 29 Dec 2020.   The reporter did not provide an assessment for the event, neck injury.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
No adverse event; Vaccine administered after beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date).    No concomitant medication information was reported.  The vaccine was received at the clinic on 07-Jun-2022.  The vaccine beyond use date was reported as 07-Jul-2022.  No treatment information was provided.
On 09/05/2005 had tactile fever, on 09/06/2005 had fever 100.2 and rash starting on face, rest of body.
10/19/22 Reaction started approximately 15minutes to half hour after given. Tingling and numbness in fingers and toes. Upper and lower limbs started shaking.  Felt nausea and ready to vomit. Blood pressure elevated and felt hot.  Denied throat or lips swelling. 10/19/22 Taken to Dr. and PA. Full assessment completed. Was able to drive and go home.  Instructed if any difficulties with heart or breathing to go to the ER. 10/19/22 At home started stuttering. 10/20/22 Taken to the Hospital ER. Medical treatment provided in ER
Significant red rash on neck and upper chest, with some less noticable rash on upper back and shoulders/upper arms. Lasting an hour so far, not particularly itchy but I can feel it especially on the left side
This is a spontaneous report from a contactable prescribing physician (MD) for a patient enrolled in Pfizer-sponsored program, this report is regarding an event reported in the patient's past medical history. A currently 60-year-old patient of an unspecified gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (MANUFACTURER UNKNOWN), tetanus vaccine (MANUFACTURER UNKNOWN), and influenza vaccine (FLU); all vaccines were given via unspecified route on unspecified dates at single doses for immunization; and clarithromycin (MANUFACTURER UNKNOWN) and erythromycin ethylsuccinate (E-MYCIN); both were taken via an unspecified route of administration from unspecified dates at unknown doses for unspecified indications. Medical history included allergy to penicillin (PCN) and allergy to Sulfa drugs. The patient's concomitant medications were not reported. On unknown dates, the patient experienced drug allergy to clarithromycin, e-mycin, flu vaccine, pneumonia vaccine, and tetanus. The action taken in response to the event for the vaccines was not applicable, and for clarithromycin and erythromycin ethylsuccinate was unknown. The clinical outcome for the event was unknown. Pfizer is a Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report in cases where another Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
Pt vaccinated with DTP developed fever 101.5-102.5 lasting more than 5 days.