chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given a vaccine Tuesday morning 1037am (8/28/18). Patient also picked up and started a MEDROL DOSE Pak. On Wednesday night patient experienced acid reflux (very severely) and measured her blood pressure which was at 200/95. Currently Thursday BP at 124/85.
patient was given Kinrix as recommended for catch up schedule for school, upon further investigation polio component will not be recognized as it was to soon, doctor seeing pt and pediatrician notified who state will not harm patient but will not be recognized- will need in 6 months, (mom) notified who was not noted to be upset- made aware of immunization schedule
Pt developed temp 103-104, no appetite, vomiting, (may be teething) slight cold, dx by MD tonsillitis.
Pfizer Covid-19 vaccine EUA. Pt. had covid 19 in November of 2020. side effected she experienced starting the day after her first vaccine included chills, deep muscle and joint pain, prostration and fatigue as well as the reappearance of symptoms from her 2017 stroke such as loss of voice (vocal cord and facial weakness) for 4 to 5 days and reduced fine motor control in her hand. she didn't experience headache, fever, or rash.
tested positive for Covid after being double vaccinated; tested positive for Covid after being double vaccinated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 16 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation.  The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid after being double vaccinated". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: positive. The clinical course of events was as follows: I learned of another individual who tested positive for Covid after being double vaccinated. Her name is # and she is sixteen years old. Her mother's contact information is below. Her mother informed me Friday evening and I confirmed today that withheld had been vaccinated by Pfizer. The lot number for bnt162b2 was not provided and will be requested during follow up.
Pharmacist said that they have 5 refrigerated vials that went the beyond use date of 8July2021; second dose given was beyond the use date (BUD) of 8July2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (second dose given was beyond the use date (BUD) of 8July2021) and PRODUCT STORAGE ERROR (Pharmacist said that they have 5 refrigerated vials that went the beyond use date of 8July2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (second dose given was beyond the use date (BUD) of 8July2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Pharmacist said that they have 5 refrigerated vials that went the beyond use date of 8July2021). On 09-Jul-2021, EXPIRED PRODUCT ADMINISTERED (second dose given was beyond the use date (BUD) of 8July2021) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Pharmacist said that they have 5 refrigerated vials that went the beyond use date of 8July2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were reported. Pharmacist said that 1 vial was used and 4 patients received a dose from a vial today 9-July-2021 and that was beyond the use date of 8- July-2021. Pharmacist said that the 4 other vials are still sealed, unused and for disposal. The pharmacist said that the patients are not yet aware of the concern. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Live follow-up information received on 12-JUL-2021 contains non-significant information. On 20-Jul-2021: Follow up received and the event outcome has been updated from unknown to resolved with respect to initial document.; Sender's Comments: Causality for events Expired product administered and Product storage error is not applicable.
Dizziness; "Tender headaches; Chills; Body aches; Patient due for B12 injection this month; Sore arm after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after second dose), ANAEMIA VITAMIN B12 DEFICIENCY (Patient due for B12 injection this month), DIZZINESS (Dizziness), HEADACHE ("Tender headaches) and CHILLS (Chills) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MECOBALAMIN (B12 RAPID SHOT), ACETYLSALICYLIC ACID (ASPIRIN KENT [ACETYLSALICYLIC ACID]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm after second dose). On 01-Apr-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE ("Tender headaches), CHILLS (Chills) and MYALGIA (Body aches). In April 2021, the patient experienced ANAEMIA VITAMIN B12 DEFICIENCY (Patient due for B12 injection this month). At the time of the report, PAIN IN EXTREMITY (Sore arm after second dose), ANAEMIA VITAMIN B12 DEFICIENCY (Patient due for B12 injection this month), DIZZINESS (Dizziness), HEADACHE ("Tender headaches), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.            Concomitant medicines include low dose aspirin, multivitamin, B12 shot once a month. Treatment included pain reliever, acetaminophen.   This case was linked to US-MODERNATX, INC.-MOD-2021-069267 (E2B Linked Report). This case was linked to MOD-2021-069267 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069267:2nd dose
Severe stiffness and pain in upper neck/base of skull.  Severe headaches.  Blurred vision.  No treatment.
Pt had history of anaphylaxis related to bee stings. We asked if he had ever had a reaction to another vaccine and he said no. Pt came up saying he wasn't feeling well during the observation period, within about 5-10 minutes after receiving the vaccination. He look very pale and clammy. I asked if he was ok and he shook his head. Tried to grab a chair for him and he started to collapse. With some help I was able to get him to the ground without injury. We called 911 and I grabbed an epipen. I tried to assess the patient, and he was unable to tell me if he was having any trouble breathing or if his lips/mouth/tongue was swelling. He was conscious but couldn't speak coherently. I administered the epipen to his right lateral thigh due to his history of anaphylaxis with bee stings. We were able to lay him down while waiting for the ambulance. His color started to return and he was able to respond to questions, but was still slightly confused. He did tell me at this point that he has had similar reactions after vaccines and blood work. The paramedics arrived and took the patients vitals and took him to the hospital.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 04-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Fever stated on 3/26/11 T 102-104. Reevaluated 3/29/11. Had fever that morning but afebrile in office. Pimple like rash on chest, back, a few on his neck and groin area. Incidentally, older sister got Varicella vaccine that day.
severe headache and vomiting starting about 18-20 hrs after immunization, given 500ml NS bolus and Zofran by ER
Information has been received through the pregnancy registry from a registered nurse for VARIVAX (Merck) concerning a 20 year old female with no pertinent medical history and drug allergy who on 25-MAR-2008 was vaccinated subcutaneously with VARIVAX (Merck) 0.5 ml (Lot number 659072/1469U) (site not reported). Concomitant therapy included ORTHO TRI-CYCLEN LO. The patient's "urine human chorionic gonadotropin (hCG) level was negative". On 01-APR-2008 the patient fainted on the bus and was seen in the emergency room where it was discovered that she was pregnant. The patient sought medical attention. She was then seen on 15-APR-2008 at the clinic. The reporter mentioned that the patient was planning to terminate the pregnancy (for personal reasons, not related to the vaccine) and was assisted in making the appointment. But to the reporter's knowledge the pregnancy has not been terminated. The reporter mentioned that the patient has been been seen since 15-APR-2008 and probably would not been seen at this clinic again since she has been terminated from the program that she was a part of at the clinical building. Follow up information was received. The patient was no longer receiving care at this center. The reporter did not have any further information regarding health care professional contact information for this patient, for prenatal care or otherwise. The reporter had tried to contact the patient herself several times, unsuccessfully. This case had been lost follow-up.
This spontaneous report was received from a certified nursing assistant referring to a multiple unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (lot #, dose, route of administration and frequency were not reported). No adverse effects reported. Concomitant medications were unspecified. This is one of several reports from the same source. Additional information has been requested.
Arm was Sore; Swelling; Redness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was Sore), SWELLING (Swelling), ERYTHEMA (Redness) and PYREXIA (Fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced VACCINATION SITE PAIN (Arm was Sore), SWELLING (Swelling), ERYTHEMA (Redness) and PYREXIA (Fever). At the time of the report, VACCINATION SITE PAIN (Arm was Sore), SWELLING (Swelling), ERYTHEMA (Redness) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were provided   This case was linked to MODERNATX, INC.-MOD-2021-138400 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-138400:Patient who called - their case
Fever, extreme body aches all over, mild tenderness at injection site but severe tenderness under arms in glands, severe chills - could not get warm.
Fever, headache, nausea vomiting, problems breathing, swollen red itchy arms.
Left arm pit pain Extreme Hypersensitivity all over body, skin burning, blistering and peeling, extreme teeth sensitivity, brain feels swollen hurts.
Adverse events: Severe chills, fever, fatigue, muscle aches, joint pain, dizziness, injection site pain Treatment: Acetaminophen, ice applied to injection site, rest/sleep Duration: chills lasted about 2 hours, fever lasted about 24 hours, muscle/joint pain lasted about 24 hours, injection site pain lasted about 48 hours
Patient came in for first Pfizer dose and he was given Pfizer Bivalent dose.  Patient waited the 15 minuets and had no adverse reaction. Patient was called 2 hours after and still had no reaction to the vaccine.
This spontaneous report was received from a healthcare worker refers to a 12 months old patient of unknown gender. On 07-NOV-2014, patient was vaccinated with an improperly stored dose of M-M-R II (lot# J016232, Expiry: 19-DEC-2015, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
I woke up Friday 2/12 morning very dizzy. The dizziness subsided. Later Friday afternoon, I had severe dizziness and was vomiting when I got up. I went to Clinic Saturday 2/13, for being unbalanced and weak, but not so dizzy. Sunday 2/14 I was extremely weak with low blood pressure and fast heart rate.  Monday  2/15, in the morning,  my left arm started hurting, swelling, was feverish, red, itchy and I had a rash at the injection site. I went to my doctor on 2/19 and he stated that maybe I should not get the 2nd vaccine shot. He stated that he was not certain that everything that happened was a result of the vaccine, but that he couldn't say that it wasn't.
This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Syncope in waiting room. Fell and hit her head on chair in waiting room ~ 5 min after receiving vaccines. Possibly hit head on seat cushion or possibly on chair arm. Was tx with rest, juice, + crackers. No c/o head pain, no contusion or bruising noted.
fever 103, all over body aches, all over joint pain, sore throat, ear ache left side, chills, complete body/muscle weakness, left side lymph node swelling, 0 appetite, absolute fatigue and pain for 2 days. on third day left arm, injection sight is still very heavy feeling, sore, and hard to move. Lymph nodes are still sore to the touch even clothing, and an over all feeling of weakness.
Headache/light headache; Fever; swollen on the right arm where they put the injection, very swollen and also red and hot; swollen on the right arm where they put the injection, very swollen and also red and hot; swollen on the right arm where they put the injection, very swollen and also red and hot; This is a spontaneous report from a contactable consumer (patient) via medical information team. A patient of unspecified age and gender received BNT162B2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 18Aug2021 (Lot Number: EW0173, Expiry date not reported) as dose 1, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Headache (also reported as  light headache), fever and swollen on the right arm where they put the injection and it was very swollen and also red and hot. The patient was treated with Advil 200mg each, for every 8 hours. The outcome for the events was not reported.
2 days after vaccine administration and she developed a painful pruritic rash on the right upper back and since then she has continued to develop similar rashes on different parts of her body lasting for up to 2 weeks.
At injection site - hotness; Skin hardness at injection site; Extreme pain at injection site; Redness at injection site that has spread; This is a spontaneous case from, initially received from other health professional via agency (case ID: SEQ19-04875) on 16-Oct-2019, concerning a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100112490, expiration date: 11-Jun-2020, route of administration and anatomical location: not reported] for an influenza prophylaxis.  On an unknown date, after vaccination, the patient experienced hotness, extreme pain, skin hardness at injection site and redness at injection site that had spread.   On 24-Sep-2019, the reporter stated that the patient was doing well.  The outcome of all the events was recovered, on an unspecified date.  The reporter did not provide seriousness and causality assessment.  The case is linked to 201905307, 201905318, 201905319, 201905320, 201950321, 201905322, 201905323, 201905324 and 201905325 due to same reporter.  Follow up received from other health professional via agency (SEQ19-05499) on 24-Oct-2019: The reporter stated that all vaccine recipients were doing well. The outcome of all events updated to 'Recovered/resolved'. Narrative amended accordingly.  Company Comment: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
pt recvd vax & following the vax pt's cry immed escalated into screaming, followed by flushing of the face w/in 1 min; approx 1-2 min p/the face flushed; became extremely flushed; scream for about 7-8 minutes; pt pale; cyanosis; wheezing;
Feeling bad; diarrhea; throwing up; stiffness; tired; This case was reported by a consumer via call center representative and described the occurrence of stiffness in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3-4 months ago and had redness at the injection site,refer case US2019AMR142864).   On 22nd July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 23rd July 2019, 1 days after receiving Shingrix, the patient experienced stiffness and tiredness. On 27th July 2019, the patient experienced diarrhea and vomiting. On 3rd August 2019, the patient experienced feeling bad. On an unknown date, the outcome of the stiffness, tiredness and vomiting were recovered/resolved and the outcome of the diarrhea and feeling bad were not recovered/not resolved.   It was unknown if the reporter considered the stiffness, tiredness, diarrhea, vomiting and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and the next day of reporting he was stiff and tired but he was fine.The patient got up and he had diarrhea and was throwing up on and then it all stopped. The patient started to feel bad again with diarrhea and it was currently not resolved. The reporter consented to follow up. There is discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovered with sequel). This is 1 of the 2 cases reported by the same reporter.
Rash noted at trunk w/extension to (L) upper extremity; (+) low grade temp (Tmax < 102).
Mother and two sons came to receive vaccines. The sons received their vaccines first, mother went last. Patient  completed the consent form and marked that there was no history of chronic conditions, fainting, or seizures. Upon speaking to the mother before her vaccination, she stated that she was very scared of vaccines and needles. We spoke through the vaccine and administered with no issues. The mother and sons were sitting waiting for the 15 minute period when the two sons came to the window and stated that their mom said her arm "felt hot." I immediately grabbed two ice packs and went outside to her. She was leaning back in the chair with her eyes closed but was responsive. I placed one ice pack on her chest and the other behind her head. At this point, the mother began seizing. I asked the boys if this had happened before and they stated that yes, she had a history of seizures. This lasted for approximately 5-10 seconds. The mother came to again and laid with her head back. She too stated that she had a history of seizures. But not after a vaccine before, but that she thinks that the heat in her arm and the pain got to her. She remained sitting for another 15-20 minutes with the ice packs with her feet in the chairs and the fans on her before her husband arrived and she stated that she felt comfortable leaving.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown multiple dates, the patient were vaccinated with improperly stored dose of PNEUMOVAX 23 (lot # L024132, expiry date: 21-JAN-2017, dose and route were not reported). The doses were stored under temperature of 60 F for 3 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Day 8 - upper Right arm began feeling warm.  Upon inspection, two warm erythemic areas that grew over the next couple of days.  Area felt hard, achy similar to the feeling post a vaccine injection.  Self improving; however, continuing feelings of heat and erythemic areas noted 3/20/2021.  No real rash.   Have a regular MD appointment scheduled for 3/23/2023, will have her check if the symptoms are still present.
Pt with H/O LABs presented with B/L LE DVT's 3 days after receiving vaccine, while he was therapeutic on warfarin.
Had Covid in December, the day after receiving the vaccine around 11AM  I developed chills and my shoulder/arm was sore and achy this morning made it up to my neck I started experiencing chills.
Myocarditis Patient presented w/ chest pain X 2 days. ECG w/ ST elevations, no depressions, PR depressions.  Echo showed small amount of pericardial fluid.  Troponin positive.