chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient has received one polio vaccine prior to the administration of QUADRACEL.with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from nurse via Global Medical Information (GMI) (Reference number- 00699306) and transmitted to Sanofi on 27-Jul-2021.  This case involved 5-year-old and unknown gender patient has received one polio vaccine prior to the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (extra dose administered)  The patient's past vaccination(s) included Pentacel at 18 months old for prophylactic vaccination.  Relevant medical history, medical treatment(s) concomitant medication and family history were not provided.   On an unknown date, the patient has received one polio vaccine prior to the administration of dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination (extra dose administered)  It was reported that, "Nurse called in regard to a patient that is due to be vaccinated for Tetanus and Polio. The patient has had one dose of QUADRACEL. The nurse would like to know if the patient can get an additional dose of QUADRACEL to satisfy this requirement? This information is limited due to possible AE (adverse event) identified after the call disconnected. Unknown reason for off schedule administration. Possible delay in dose. Nurse called in regard to a 5-year-old patient that is due to be vaccinated for Tetanus and Polio".  This was an actual medication error case due to extra dose administered (latency: same day)  At the time of reporting no adverse event  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.  There will be no information available on the batch number for this case.
Following vaccination of her covid booster, patient called the clinic and said that she had a reaction within 30 minutes of leaving the clinic and had to use her epi pen.   Reported feeling arm numbness, chest pain and tongue numbness and said she had called the local emergency room that instructed her to use her epi pen.   We encouraged her to follow up with her provider on her reaction.   Patient stated she felt fine within an hour of vaccination and during additional follow up call on 6/29/22 , reported she still felt normal but did not go  to the emergency room or doctor in person for follow up care.   She did receive her regular allergy injection at her regular doctor on 6/28/22, the day following her injection with no adverse events reported.     Discussed that she should talk to her provider about her reaction and that next time she receives a vaccination, in particular a covid vaccination she should check "yes" on the screening form about a history of allergic reactions that require an epi pen so that the clinic is aware and that she should be monitored  for at least 30 minutes following vaccination.     At the time she received her booster injection on 6/27 she had checked no on the screening form.
Severe attack of shivering, followed by increased pulse rate - 70 to 120, loss of stability, stiffness in joints, tiredness, loss of apatite. Treated with extended sleep.  Stiffness lasted 20 hr and was treated with Ibuprofen
Sever shortness of breath - resulted in trip to urgent care for blood test and then ER for CT following blood test results
10/30 evening  Swollen glands under chin on on back of neck 10/31 afternoon  Glands still swollen.  Eyes watering. 11/1  morning  Glands still swollen.  Eyes watering. 11/2  morning  Glands still swollen & painful.  Eyes watering copiously and sticky.  Rash (small red dots) on entire trunk.  Left knee stiff and numb. 11/2 afternoon  Rash spread to arms. 11/2  evening  Swollen glands almost back to normal.  Rash gone.  Knee still stiff. 11/3  morning  Left knee still stiff, but better than yesterday.  Right knee also stiff.  Eyes and glands back to normal.  No rash.
This spontaneous report was received from a medical assistant and refers to a 11-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history. On 05-DEC-2018, the patient mistakenly received a dose of LIQUID PEDVAXHIB injection, via intramuscular route, lot number: R013569, expiration date on: 18-MAR-2021 (strength, dose number, anatomical location, and indication, were not reported) instead of the "scheduled Meningococcal Vaccine".
I had itching and rash on arm that grew to cover most of the upper part of my right arm. It was very red and hot rash.  I had very similar reaction to the first vaccine shot, which was done in the left arm in March. I filed that adverse reaction as well.
had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month/ no adverse event; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant).  This case is linked to cases 2019SA166192, 2019SA164978, 2019SA166194, 2019SA166195 and 2019SA166196, same reporter.  This case involves a 28 years old patient (gender unknown) who received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given.   On 07-Jun-2019, the patient received once a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6101AA, expiry date 23-Oct-2020 via intramuscular route in the left thigh.  It was an actual medication error due to incorrect product storage.  It was reported that had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  List of documents held by sender: none.
Pt reported dizziness to vaccinator at vaccination chair. Pt given water and orange juice. Patient advised to wait for further observation. Pt reassessed at approx. 1550. Pt had unlabored respirations and denied itchiness/rashes.  At approx. 1551, pt left facility to mother with unlabored respirations and steady gait.
Pt recvd vax & exp inject site reaction; pt vaxed 28FEB92 & 6MAR reported erythema the size of a quarter w/warmth & tenderness @ inject site;
Hematuria noted about 1 1/2 days after receiving the first COVID vaccine.  No treatment, pushed fluids and cleared up.
Moderate to severe fatigue and flu-like symptoms - including body aches, loss of appetite and severe headache 72hrs post-injection.  Hard 2" lump at injection site 72hrs post injection with swelling, itching and redness at the injection site. Administering MD's office has been notified.
I worked out one day and I had not worked out for a while. I had muscle fatigue all over that started on the second day and it got worse on the third day. I had a headache and took Tylenol and I developed a slight cough. The next day, I was extremely fatigued, and I could barely move I was so tired and sore. I took an at home test and it was positive, and I went to the Urgent Care to get tested. I tested Positive for COVID-19 on 01/09/2022. The next day I was very tired with tiredness, chills and coughing. I felt better on the fourth day. My head felt fuzzy and I had trouble focusing. I had no loss of taste or smell that was noticeable. I was fully recovered but I still had little energy and my brain fog lingered until a full week after it started.
Sugar below was 65; injection site was black; she was shaky; injection site was swollen; injection site was painful; This spontaneous case was reported by a consumer and describes the occurrence of HYPOGLYCAEMIA (Sugar below was 65), VACCINATION SITE DISCOLOURATION (injection site was black), TREMOR (she was shaky), VACCINATION SITE SWELLING (injection site was swollen) and VACCINATION SITE PAIN (injection site was painful) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced HYPOGLYCAEMIA (Sugar below was 65), VACCINATION SITE DISCOLOURATION (injection site was black), TREMOR (she was shaky), VACCINATION SITE SWELLING (injection site was swollen) and VACCINATION SITE PAIN (injection site was painful). On 15-Jan-2021, HYPOGLYCAEMIA (Sugar below was 65) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (injection site was black), TREMOR (she was shaky), VACCINATION SITE SWELLING (injection site was swollen) and VACCINATION SITE PAIN (injection site was painful) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Blood glucose: 65 (Low) Blood glucose decreased and 125 (Inconclusive) Blood glucose elevated to 125 after taking cookies and milk.         Concomitant and Treatment drugs were not provided   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow-up received on 13-Apr-2021: Updated event outcome and dose 2 of mRNA-1273 vaccine. On 02-Jul-2021: Follow up received on 2-JUL-2021 TCR attached patient denies further follow up consent; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be ruled out.
Guillain-Barre Syndrome, weakness in legs, fall at home. Per F/U 3/23/01: The final dx was Gullain-Barre Syndrome which was made by a Neurologist. Within 4 weeks prior to the dx, the pt had cold symptoms. Per F/U 4/3/01: Pt is able to get up with moderate assistance. Gait is quite ataxic. In therapy, the pt made excellent progress. By the time of discharge, he was ambulating several hundred feet independently with a walker. Medications at discharge: Flomax 0.4mg po daily; multi-vitamins 1 po daily; Furosemide 20mg po daily; Coumadin 2mg po daily; Lanoxin 0.25mg po daily, Clorazepate 3/75mg po tid prn. The pt had received a routine flu injection and seemed to have no difficulty. About a week later, he developed upper respiratory tract infection symptoms. One or 2 weeks later, he developed some difficulty walking and weakness in the legs and ataxia and sensory dysfunction.
grandma stated that on the 2nd & red day p/vax pt became weak w/poor response, was taken to MD;
I got up on 12/28/2023 and I felt bad. I didn't sleep well and I got up extra early that morning. I was achy and hurting. I took my temperature and it was around 101. I had some nausea but I took some medication to help with that. I decided later to call in and get PAXLOVID. It ran its course in just a few days. I didn't have much appetite. The aching and hurting got me the most. When I called the doctor, they told me to stay away from people. January first would have been my 5th day, but I did 10 days for quarantine. My husband also had COVID-19 but worse than me. He had to end up going to the doctor for follow up after an emergency room visit. Mine was not as bad as his. I did also notice a lot of thin spots in my hair after the infection. The whole month of January felt like a blur.
Lip swelling + diffuse pruritus 1st dose, diffuse hives and lip swelling 2nd dose
STARTED PERIODS X 2; THROBBING ARM (CARPAL TUNNEL  AREA); STOMACH PAINS; CHILLS; TENDER BREASTS; EMOTIONAL; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced tender breasts. On 08-APR-2021, the subject experienced emotional. On 08-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced stomach pains. On 10-APR-2021, the subject experienced started periods x 2. On 10-APR-2021, the subject experienced throbbing arm (carpal tunnel area). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pains on 12-APR-2021, and chills on 08-APR-2021, was recovering from tender breasts, and the outcome of emotional, throbbing arm (carpal tunnel area) and started periods x 2 was not reported. This report was non-serious.
Patient given second dose of COVID-19 vaccine at 10:16 am.  Vial being stored in refrigerator had DO NOT USE BEYOND date of 10/14/21 at 0700 am.  Manufacturer (Pfizer) contacted and stated that they have off-label studies showing physical properties of vaccine are unchanged for 32 days.  Medical director consulted and does not advise re-administering vaccine.
Gave pt vaccine. As I was pulling needle out of deltoid muscle pt looked at me and stated she felt like she was going to pass out. As she said that pt dropped her head and went limp in chair. Put pt in Trendleberg position and paged doctor. Stat overheard and got cold rag. Mom was by patient side entire time. Pt then woke up emotional and fine and stated she had not eaten that morning. Pt hung around office. Color came back in face and pt was able to walk out of office with mother. Pt called next day to doctor and they said she was fine.
Flu-like symptoms, especially dizziness ;  feeling very lightheaded, close to passing out.  Had to lay down on the  floor to avoid passing out.  Resolved with oral fluids over about 12 hours
my arm hurt so bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm hurt so bad) in a patient of an unknown age and gender 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 PAIN IN EXTREMITY (my arm hurt so bad). At the time of the report, PAIN IN EXTREMITY (my arm hurt so bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt received an extra booster of Pfizer vaccine (total of 4 doses despite not being immunocompromised)
headache; vomiting; soreness at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 (Lot number: FA6780) at the age of 12 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 1, Lot number: ER8731, Vaccine Location: Left arm), administration date: 23Jul2021, when the patient was 12 years old, for COVID-19 immunisation, reaction(s): "1st vaccine with a temperature excursion", "1st vaccine with a temperature excursion". The following information was reported: HEADACHE (non-serious) with onset 14Aug2021, outcome "recovered", described as "headache"; VOMITING (non-serious) with onset 14Aug2021, outcome "recovered", described as "vomiting"; VACCINATION SITE PAIN (non-serious) with onset 14Aug2021, outcome "recovered", described as "soreness at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, vomiting, vaccination site pain.  Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had been tested for COVID-19. It was reported that the vaccine administered was kept in the freezer too long.    No follow-up attempts are possible. No further information is expected.
passed out/She was out; she later told him that he was a big blue octopus and she couldn't understand anything that he was saying; her face was drooping a bit; twitching of the arms/legs; she couldn't understand anything that he was saying; fell over in the chair; This is a spontaneous report from a contactable consumer received via Medical Information Team. A 15-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced twitching of the arms/legs and passed out. The reported stated that: he took his niece (patient) to get a COVID vaccine shot. When she got the shot, she was fine. He was holding her hand and everything, she sat there for the wait period and were waiting for 10 minutes. Suddenly, she fell over in the chair, her legs were twitching, her arms were twitching a bit and her face was drooping a bit. She was out. He quickly ran over there by her and shook her, not violently, but just like waking someone up. He shook her and was calling out her name and telling her that he loved her if she could hear him and come to. After a while she started coming to and he put his hand in front of her and moved it back and forth and she had no movement in her eyes or anything. He asked her after she started coming back to if she could see his hand, she later told him that he was a big blue octopus and she couldn't understand anything that he was saying. The patient outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. states after receiving the 2nd Phizer dose 02/22/2021, ER visit 06/18/2021 due to abdominal pain, slight fever, suffering from 5 kidney stones. Surgical efforts due to blockage from kidney stones. Outpatient surgery.
Information has been received from a pharmacist concerning a female patient who on an unknown date, was vaccinated with a complete HepB series (manufacturer unspecified). On an unknown date, the patient had a negative hepatitis B antibody titer after having receiving a complete HepB series (manufacturer unspecified). Lab diagnostic studies performed included hepatitis B antibody titer with a negative result. At the time of the report, the outcome was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
spotting consisting of dark brown discharge; extreme dryness when she attempted to insert a tampon; hot, hot sweating at night; flashes/hot, hot sweating at night; constant peeing; did not get her monthly period; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (did not get her monthly period), NIGHT SWEATS (hot, hot sweating at night), HOT FLUSH (flashes/hot, hot sweating at night), POLLAKIURIA (constant peeing) and INTERMENSTRUAL BLEEDING (spotting consisting of dark brown discharge) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MENSTRUATION DELAYED (did not get her monthly period). In May 2021, the patient experienced NIGHT SWEATS (hot, hot sweating at night), HOT FLUSH (flashes/hot, hot sweating at night) and POLLAKIURIA (constant peeing). In August 2021, the patient experienced INTERMENSTRUAL BLEEDING (spotting consisting of dark brown discharge) and VULVOVAGINAL DRYNESS (extreme dryness when she attempted to insert a tampon). At the time of the report, MENSTRUATION DELAYED (did not get her monthly period) was resolving and NIGHT SWEATS (hot, hot sweating at night), HOT FLUSH (flashes/hot, hot sweating at night), POLLAKIURIA (constant peeing), INTERMENSTRUAL BLEEDING (spotting consisting of dark brown discharge) and VULVOVAGINAL DRYNESS (extreme dryness when she attempted to insert a tampon) outcome was unknown.            No concomitant medications were reported. No treatment information was provided
This spontaneous report as received from a registered nurse via company representative refers to a 16 year old female patient. On an unknown date, the patient was vaccinated with a second dose of GARDASIL,(lot number, expiry date was not reported and route was intramuscular). Concomitant medications were not reported. On an unknown date, the patient noticed a painless pea size lump in her arm after the patient received the second dose. The outcome of painless pea size lump in her arm was unknown. The patient sought medical attention. Additional information has been requested.