chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable other hcp. A 52-years-old male patient received second vaccination dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302, expiration date not reported), via intramuscular, administered in left arm on 30Jan2021 08:30 (at the age of 52-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received first vaccination dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302), via intramuscular, administered in left arm on 09Jan2021 09:00 AM (at the age of 52-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Patient did not receive any other vaccine within 4 weeks. On unspecified date in 2021, 24/48 hours after the second shot, patient experienced major headache, sore and achy all over, fever around 100 and little nauseous. Patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was tested for COVID-19 (Aegis) nasal swab which showed negative on 29Jan2021 and on 01Feb2021, patient tested sars-cov-2 test with pending result. Patient did not receive treatment for the adverse event. Reporter assessed the case as non-serious with no seriousness criteria (results in death/ life threatening/ caused/prolonged hospitalization/ Disabling/Incapacitating/ Congenital anomaly/birth defect). At the time of report, patient was recovering from all the events. Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a pharmacist via a company representative and refers to a 21-year-old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 12-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly or subcutaneously in the arm (dose, lot# and expiration date were not provided). Other suspect therapies included FLUARIX, also reported as FLUVARIX in the same arm. On 13-AUG-2017 (also reported as next day), the patient had a reaction on large area of arm from the shoulder to the elbow that is red, tender, hot and swollen. The patient went to urgent care and was told that there was no infection and to treat it with cool packs. The outcome of the events was unknown. The relatedness between the event and suspect therapies was not provided. Additional information is not expected, since there was no consent for contact.
This spontaneous report was received from a Registered Nurse and refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # K023328, expiration date: 23-JUN-2015 (dose, route and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Third dose of hepatitis B was given too early.  1st dose given on 1/17/19 2nd dose given on 3/5/19 3rd dose given on 5/1/19  There had to be 16 weeks between dose one and dose three, but the third dose was given at 14 weeks and 6 days.   Reviewed the Agency information that was printed back on 4/30/19. The Agency information said that the the accelerated date for hepatitis B is 4/30/19, which is incorrect. The right accelerated date was 5/9/19. Confirmed that the Agency was having a bug in their system around Spring/Summer of 2019 and was forecasting wrong accelerated and recommended dates for third dose of hepatitis B vaccine.  RN called the mother and explained what happened. Mother verbalized understanding and agreed to have the patient redo the third dose of hepatitis B on 11/7/19 to ensure immunity.    No adverse reaction has happened from this incident.
felt dizzy followed by stiffing of the extremities w/a little jerking & paleness which lasted about 3-5minutes;
This spontaneous report as received from a physician via field representative, refers to a 12 months old infant. On 20-OCT-2014, the patient was vaccinated with VARIVAX (Merck) 1 shot with lot # K003420 (expiry date not reported) in the left thigh as vaccine. Other suspect therapies included Influenza virus vaccine (reported as unspecified flu vaccine) (strength, dose, route of administration, anatomical location, indication, lot # and expiration date not reported) received a route the same time. No concomitant medication was reported. On an unknown date in 2014, the patient experienced varicella-like blister after the vaccination. The outcome and causality of the event was unknown for VARIVAX (Merck) and Influenza virus vaccine (unspecified). No laboratory studies were performed. The reaction was reported to the office on 04-NOV-2014. A product quality complaint (PQC) was not involved. Additional information has been requested.
Intestinal pain and vomiting starting 27 hours after shot, lasting for 6 hours and then lessening. Constipation for a week after.
Mr. called the Monday, October 4th complaining of severe shoulder pain and the inability to move his right arm.  He explained that the shot was given about one inch beneath his should and that it has hurt since that time..  He was unable to sleep the night before due to the pain.  I recommended that he visit his PCP to have his shoulder examined.  His PCP gave him Prednisone, which he purchased at our pharmacy.
01/23  sat  left arm soreness and left axillary intensified pain/  was so uncomfortable/feel like crying for intensified pain on Sunday  and had no pain relief after Tylenol 1000mg  and  Children's Motrin 15ml
After dose two, platelet count was much lower than normal; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Apr2021 09:30 (Lot number: EW0162) at the age of 60 years as dose 2, single and intramuscular, administered in arm left, administration date 27Mar2021 09:00 (Lot number: ER8734) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: Hypothyroidism; "arthritis" (unspecified if ongoing); "obesity" (ongoing), notes: Obesity: Yes, Onset date: ongoing, Treatment required: No. Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); EXCEDRIN PM; EUTHYROX taken for hypothyroidism (ongoing). The following information was reported: PLATELET COUNT DECREASED (non-serious) with onset 18May2021, outcome "not recovered", described as "After dose two, platelet count was much lower than normal". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of platelet count decreased.  Additional information: If other vaccine in four weeks: No. if covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: Sensitivities only - not allergic. Vaccine facility type: Pharmacy or Drug store. Patient received 1st Pfizer vaccine on 27Mar2021, had received 2nd Pfizer covid vaccine on 17Apr2021; had annual blood work completed on 18May2021 and noted to have a low platelet count; recheck of platelet count on 18Jun2021 and result was lower than previous. Patient contributed this to prior Covid-19 vaccination; but was not a publicized side effect. After dose two, platelet count was much lower than normal on routine lab draw. I suspected vaccine may be contributing factor. ABD ultrasound was done & negative. Platelets eventually returned to my baseline. I had platelets drawn right before dose 3 and they were 150K (ref range 150k-399k and where I usually run). 3 weeks later platelets down to 126k.  Follow-up attempts are completed. No further information is expected.
No strength in my legs. Went from walking 80-100 miles a week to not being able to walk a mile. I get exhausted easily. When I push myself to much I feel my body racing much like a car that?s idling.  I constantly feel like I ran a marathon yesterday. My primary care dr sent me to a neurologist and a cardiologist but the tests reveal nothing. My condition is worsening slightly every day
c/o sore neck and back, nausea and sweating 7/10. 7/11 - some better, still no fever, cont. to have nausea and sweating. 7/12 feels better.
A nurse reported the occurrence of an injection site reaction in a 26 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The patient had no relevant medical history, concurrent conditions, concurrent medications, or concurrent vaccinations. The patient had no adverse events following previous vaccinations. The patient received his fourth dose of Infanrix (lot DTPA610A2) in the left deltoid on 9/29/03. Two days later, on 10/01/03, he developed an injection site reaction characterized by redness, swelling, warmth, and itching. The swelling and redness extended from the shoulder to the elbow, and the area was uncomfortable. left arm circumference was 21cm; right arm was 16.5cm. The events resolved on 10/8/03. The nurse considered the events to be probably related to vaccination with Infanrix.
immediately headache,  chest pain, arm pain followed by sore throat and felt sick 3 days  10/1 stabbing left arm pain, left leg cramp and left upper side  chest pain
Information has been received from a physician concerning a 12 year old female patient with no pertinent medical history and no drug reactions/allergies, who on 08-JUN-2010 was vaccinated with the first dose of GARDASIL (Lot # 662304/1013Y). Concomitant therapy included VAQTA (Lot # 667827/0416Z), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and MENACTRA. On 09-JUN-2010 the patient experienced severe stomach ache, constipation, pain on the right side and joint pain after receiving GARDASIL. The patient went to ER and the final diagnosis was mesenteric adenitis with post infectious arthritis and was hospitalized. The patient had some blood tests performed (results not provided). At the time of the report, the patient's arthritis continued and the outcome for mesenteric adenitis was unknown. The physician said that experience was considered to be disabling as it had kept the patient from participating in sports. Additional information has been requested.
"COVID arm" - redness about 2 inch in the diameter, swelling like she just got a shot; "COVID arm" - redness about 2 inch in the diameter, swelling like she just got a shot; sore injection site; tingling arm; tingling in the lips and her tongue; This is a spontaneous report received from a contactable consumer from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm, administration date 17Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PARAESTHESIA ORAL (non-serious) with onset 17Feb2021, outcome "recovered" (Feb2021), described as "tingling in the lips and her tongue"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 28Feb2021, outcome "unknown" and all described as ""COVID arm" - redness about 2 inch in the diameter, swelling like she just got a shot"; VACCINATION SITE PAIN (non-serious) with onset 28Feb2021, outcome "unknown", described as "sore injection site"; PARAESTHESIA (non-serious) with onset 28Feb2021, outcome "unknown", described as "tingling arm".  Additional information: The patient's age was reported as 78 (unit unspecified). The patient said she had breast cancer and can use only one arm for shots and she read on the CDC site that the arm needed to be rotated for the second dose. She was wondering if it's safe to receive the 2nd dose of the vaccine on 10Mar. The patient also said her sister also got tingling after the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 17-JAN-2009, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 29-SEP-2015, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with a 2nd dose of GARDASIL (Lot #, dose/frequency, route and duration were unspecified) on 26-NOV-2012 with the GARDASIL that was exposed to an unspecified high temperature excursion. No further information provided regarding the date that therapy started. No adverse effects were reported. The outcome was unknown. Additional information has been requested.
ipol at Max/low temperature reached: 48.9F for 38 minutes with no reported adverse event; Max/low temperature reached: 48.9F was administered to the patient with no reported adverse event; Initial information received on 08-Sep-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient, for whom ipol at max/low temperature reached: 48.9f for 38 minutes with no reported adverse event and max/low temperature reached: 48.9f was administered to the patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the suspect IPV (VERO), Suspension for injection lot V1B891M, expiry: 27-Sep-2023 via unknown route in unknown administration site for immunization (strength, dose: unknown), max/low temperature reached: 48.9f was administered to the patient with no reported adverse event (poor quality product administered) (latency same4 day).  On an unknown date ipol at max/low temperature reached: 48.9f for 38 minutes with no reported adverse event (product storage error) (unknown latency).  This situation is due to human error.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events poor quality product administered and product storage error  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 the Directive 2001/83/EC 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.
Started off with no reaction.  After an hour started to feel stiffness in the injection arm.  Woke up to vomiting, then for the next 30 hours continued with Chills, vomiting, lose of appetite, fever, sweats (wake up covered in sweat), extreme fatigue, muscle pain, diarrhea.  Sleep was very difficult would wake up every hour on the hour with heat coming from back of neck and / or head.
PATIENT NOTICED SYMPTOMS BEGAN THE SATURDAY AFTER HER VACCINATION ON THURSDAY.  SHE HAD EXTREME SWINGS IN BLOOD SUGAR FOR 9 DAYS.  SHE WAS EXTREMELY DIZZY FOR 3 DAYS AND ACTUALLY BLACKED OUT.   SHE KEPT A CLOSE WATCH ON HER BLOOD SUGAR AND SYMPTOMS WENT AWAY AFTER 9 DAYS.  I FOUND OUT ABOUT THIS WHEN SHE CAME IN FOR HER 2ND SHOT ON MAY 6.
The morning following the shot, I started having chills, body aches, headache, and a some dizziness. The injection site felt like someone had hit it with a baseball bat. I was exhausted and slept all day. I was hungry but couldn?t finish anything I tried to eat. I took some Tylenol which seemed to help a bit with the headache. By about 10 pm, I was back to normal. The following day (2 days post-vaccine), I was still a bit low energy and had a headache. The vaccine site was only sore when touched.
Patient complained of itchy, scratchy throat and what felt like a swollen epiglottis about 15 minutes after vaccine.  She was administered 50mg of diphenhydramine orally.  She stated that symptoms were slowly getting worse, so she was observed in clinic for a while.  The clinic felt she was ok to go home about 15-30 minutes after arriving at clinic (about 45 minutes to 1 hour after vaccine).  Of note, she opted to get the Janssen vaccine as her booster as she had previously experienced more significant epiglottis swelling after her second Moderna vaccine in April 2021
Patient has a red and swollen rash on left arm that is hot to the touch. Patient has been taking tylenol and using a pain cream for pain and discomfort. She is concerned the rash would not go away.
Pt came in today 04/19 and has injection site reaction that is red and still painful. It has been 6 days since her vaccination. She said it feels painful and it feels like she has a lump at the bottom of her arm pit that has developed. I told her that might be her lymph nodes being enlarged since it was the same site as the vaccination site.  I told her that could happen because sometimes if a pt gets a mammogram, the cdc is recommending to postpone in 4 weeks from now because of enlarged lymp nodes being  mistaken for something else. I told her if her symptoms get worse then to let me know and to let her doctor know. I also told her I would fill out a form.
Pt recvd vax & 2 hrs later pt's leg was swollen to the size of a nickel & had a sl fever; pt then developed sl diarrhea & was taken to ER-dehydration; pt vomited; appeared to be in colic-like pain; breathing was rapid & fever 104; bluish
Information has been received from a physician concerning a 64 year old female who on approximately 01-FEB-2011 (early February 2011) was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (Merck) (lot# not reported). Second suspect therapy included LIPITOR. On approximately 01-FEB-2011 (early February 2011), the patient experienced "muscle spasms in her chest on the right side after receiving ZOSTAVAX (Merck). The doctor did say her dosage of LIPITOR was increased the same day but it was not clear whether this had anything to do with the adverse event. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Additional information has been requested.
broke out w/varicella 19 days p/vax;erythemic vesicles lesions on trunk, back & upper arms;
Pt had swelling and noted redness at injection site also reported fevers and body aches 24hrs after injection. Pt seen 48 hrs after injection treated with antibiotic for cellulitis. Pt seen again in office 5 days after injection area much improved no redness or swelling noted.
Patient was given KINRIX. 3/17/15 at 8:12 am spoke with mother. She reports patient had "a little fever" last night but no other symptoms or reaction.
First night of symptoms, about 8 hours after the shot, I experienced familiar symptoms to the second vaccine (e.g., fever, chills, body aches, headache). I began experiencing new symptoms I hadn't had before. I was nauseous. I went to reach for nausea medicine and experienced rapid increase in heart rate and became dizzy. This subsided after a minute. That night, I experienced what I assumed was heartburn that woke me from sleep approximately every 2 hours. Even with antacid, the heartburn did not subside. Throughout the next full day, I experienced the same symptoms which I determined as chest pain and tightness, not heartburn. I made an appointment for the following morning, 48 hours after the shot.
2 days after receiving my 2nd Covid booster, I noticed a pronounced change in left eye vision. My eyeglass prescription has been relatively stable for 5+ years so this sudden change was surprising. I've since seen my Optometrist who did a comprehensive exam. During that exam, a Cornea scan revealed an area of increased height/axial curvature in my left eye. My Dr says that this change in cornea topography would explain the vision change I've had.   It has now been 3 weeks since the initial vision change with no improvement. Besides the Covid vaccine, I had no changes in medication, health, lifestyle, or other vaccines in the period leading up to the vision change.
This spontaneous report as received from a pharmacist refers to a 68 years old female patient with asthma and allergy sulfas who on 13-NOV-2012 was vaccinated with a dose of PNEUMOVAX23 (lot number, dose, route and indication were not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient developed itching at the injection site of PNEUMOVAX23 vaccination. No treatment information was reported. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered from the adverse event. The relatedness for the adverse event was unknown for PNEUMOVAX 23. Additional information has been requested.
On Friday, 06/25/2010 patient reports she started to feel lethargic. On Saturday afternoon she had chills and fever of 103.8. She began to alternate taking Tylenol and Motrin every 4 hrs. She wasn't able to sleep, had muscle aches and chills. By Sunday fever was 102.4 and she felt awful. She was drinking fluids but on Monday morning went to the  ER .She had a negative chest x-ray, her blood and urine tests were negative. She reports that she had a swollen node in her left armpit. She was given a liter of IV fluids, her fever was 101.7 and she was almost discharged when her fever spiked. She was given more Motrin and discharged when her fever was lower. She said she was in the ER for approx. 5 hrs. When she left she was still quite fatigued. She said she had missed work from 6/28 through 7/02. She felt much better by 7/03.
When attempting to administer vaccine into left deltoid, plunger failed to work and no vaccine administered. New syringe obtained, vaccine given with no incident or complication
SLEEP APNEA ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT, UNSPECIFIED VEIN ACUTE HYPOXEMIC RESPIRATORY FAILURE
Beginning the evening of the 8th day after receiving the vaccine my arm began to feel sore and tender in the area of the injection. Upon waking on the 9th day after the vaccination, the arm was red, warm, tender to touch, sore and itchy in a roundish area at the injection site. This has now continued for two days without resolving.