chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart attack; underling condition neurologic condition not diagnosed yet but she gets migraines often; pain; dizziness; headache; chest, arm pain; chest, arm pain; fatigue; water retention; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient's medical history was not reported. The patient was taking a lot of concomitant medications (unspecified). The patient reported that she has an underling condition neurologic condition which was not diagnosed yet but she gets migraines often on an unspecified date. It was also reported that patient had extreme episodes of tightness, pain, dizziness, headache, chest, arm pain that led her thought had a heart attack and also extreme fatigue on an unspecified date. She mentioned that she was taking a lot of medicines at the time this happened. The patient also experienced water retention on an unspecified date. She said that if she would know what the vaccine would do to her, she would have not been vaccinated wit the Pfizer vaccine. She wanted to know how does the vaccine work so to know if "it overrides your system to product antibodies." The outcome of all events was unknown.  Follow-up attempts are completed. No further information is expected.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 12-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in right thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes . Digital data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009096:
On 14-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # R004689; expiration date: 29-NOV-2020) or (lot # R006689; expiration date: 29-NOV-2020) (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47 degrees F to 77 degrees F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006252: US-009507513-1809USA006254: US-009507513-1809USA006255: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006258: US-009507513-1809USA006259: US-009507513-1809USA006260: US-009507513-1809USA006261: US-009507513-1809USA006262: US-009507513-1809USA006263: GB-009507513-2011SP027616.
?Pfizer-BioNTech COVID-19 Vaccine EUA nausea vertigo
missed second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.
Within 24 hours, the pt developed an injection site reaction at the site characterized by swelling and redness. The pt recovered.
I have been experiencing swollen lymph nodes under my left armpit and I have noticed that I've developed a bump under my left nipple. The lymph node pain and swelling has been an issue for the past 2 days, and I just noticed the bump under my nipple last night (12/15/2021).
The patient had an anaphylactic reaction. The patient experienced angioedema and could not speak. The patient  presented with difficulty swallowing, shortness of breath, wheezing, and was unable to talk. As a result to the reaction the patient had to be intubated. However, the patient has a  history of excessive anaphylaxis  with multiple intubations.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:39 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:39 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 18.86.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively,8 Am: not provided, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report has been received from a medical assistant concerning a 7 month old patient of unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 28-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dose and dose number were not provided) administered orally for prophylaxis. The lot numbers involved were M043836 and N038804 with expiration date on 17-JUN-2018. It was reported that on an unspecified date, the vaccines were exposed to a temperature between 32 Fahrenheit degrees and 35 Fahrenheit degrees for 72 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported. Lot number N038804 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA001257: US-009507513-1710USA016180.
Moderna COVID-19 Vaccine EUA -- Soreness in armpit and upper right side of chest next to armpit; woke up with sore armpit on 5/1 (2 days after 2nd Moderna shot); pain is gradually getting better and I don't expect to need to see any health professionals.
Rash at the injection site; Itching at the injection site; Redness at the injection site; Throbbing in her left arm from shoulder to hand; A spontaneous report was received from  a consumer concerning a female patient of 75 years of age,who was administered with Moderna's covid-19 vaccine and experienced Throbbing in her left arm from shoulder to hand, Rash , Itching, Redness, and Broken out at the injection site.  Patient's medical history was not provided.No relevant concomitant medications were mentioned.  On 26-JAN-2021,patient received the first of two planned doses of mRNA-1273  vaccine(Lot number:012120A) for prophylaxis of covid-19 infection.  On 28-JAN-2021,the patient experienced throbbing in her left arm from the shoulder to hand.Symptoms ended on 29-JAN-2021.On 03-FEB-2021 the patient experienced a rash,itching, redness and broken out at the injection site.No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not reported.  Outcome for the event Throbbing in the left arm was considered resolved.The events rash, itching, redness and broken out at the injection site were not resolved.
Sudden onset of shortness of breath, chest tightness and coughing.  His usual rescue  inhaler didn't help symptoms.  Up all night long.  Unable to lay down as it made his breathing worse.   The next day, he did a nebulizer treatment and that helped his symptoms.   Unfortunately, he has had an acute asthma attacks nearly every day since.  Starting 1 week ago, symptoms have gradually improved.  He is still having to use his nebulizer, but not as often, as his usual inhalers have not been ineffective.
Welted rash around site of shot. Occurred 2-3 x's /wk for the first month after shot, mostly after working out. Currently is taking medication for rash that is possibly related to vaccination.
Patient was complaining about tingling and numbness in left leg and abdomen. Numbness decreased after 40 minutes, patient released
schedule today as her 2nd Pediatric dose; one person tested COVID positive; they need to quarantine for 10 days; I told him not to send him in today; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program (159558).  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Lot number: FL0007) 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: EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "schedule today as her 2nd Pediatric dose; one person tested COVID positive; they need to quarantine for 10 days; I told him not to send him in today".  Additional information- Transferring agent stated that, They have a caller on other line, she is a pharmacist, who has a patient who is supposed to get the 2nd dose today but the patient's school send them home since another kid tested positive (Further clarifications unknown) but the patient is not showing any symptoms. When asked if Pharmacist wants to report or had medical query, Pharmacist stated, the dad calling us her daughter, his daughter has schedule today as her 2nd Pediatric dose, its been three week so today was her 2nd dose however today she was send home from school, her school he thought its like whole classroom or something either whole classroom or the whole school he was not sure like one person tested COVID positive (Further clarifications unknown) and so they send them home and they need to quarantine for 10 days, he said that she doesn't have any sign of the symptoms (Further clarifications unknown).
I got an audiogram, CT to make sure that I am okay. I am taking an advil whenever I have a headache. I have been instructed to seek a neurologist and get an MRI.
Flu like symptoms, HA, sore throat, muscle aches, runny nose, dizziness, chills, felt feverish-but no fever noted.
diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/swollen glands; swollen injection site; tired; mouth ulcers; extreme nerve pain; This is a spontaneous report from a contactable consumer.   A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 08Apr2021 15:00 (Batch/Lot number was not reported) at single dose (at the age of 47 years old) for COVID-19 immunisation.  Medical history included "if covid prior vaccination: Yes". Concomitant medications included potassium, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cetirizine and chlorthalidone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 for COVID-19 immunisation. The patient reported, "fever, muscle aches, headache, throwing up, chills, swollen lymph nodes, swollen injection site, tired. After chills, fever, throwing up, mouth ulcers. On day 7 I have extreme nerve pain, swollen glands, and paralysis on left side of face. Went to DR and they diagnosed with Bells Palsy. Left side of face does not move at all", 09Apr2021 09:00. The patient received no treatment. The outcome of bells palsy, extreme nerve pain, mouth ulcers and swollen lymph nodes/ swollen glands were not recovered and other events was recovering.   Information about lot/batch number has been requested.
The patient was unable to move for 4 days starting the evening of the dose. He had to call his daughter to help him get dressed. The symptoms resolved without lasting effects or medical intervention.
Flu-like symptoms beginning at 1:30 am with no fever, and vomiting at 4:30 am. Both arms were hot and anything that touched them felt like sandpaper, and a fever begins at 5:30 am and goes up past 100° at 9 am. Fever finally reduced and feeling back to normal by 7 pm that same day.
Evening of vaccine. Went to bed as normal. Awoke stiff, blue and eyes rolling into back of her head. Lasted 2". Went to ED by ambulance. By the time at ED noted to have fever. Thought to have febrile seizure due to vaccines.
Pt came for covid vaccine. He started panicking once he saw the syringe. I tried as much as I can to calm him down before administering the vaccine. after the injection, he complained of feeling nauseous and he needed drinking water. I stepped out to get the water, coming back and saw him on the floor. He seemed disoriented at first, he started answering my questions coherently. I helped him to a sitting position and activated cold white because he was complaining of head hurt because he hit the head on the floor when he fell. Ambulance was called and he was checked out and released.
Patient called later in the day after she received the Flu shot in our office (approx 16:00) and reported a metallic taste in her mouth almost immediately after receiving then dizziness and tongue feeling "thick".
Hands started swelling and it will go up some and then down; Elbow started swelling and now my knee is hurting; Sore throat; I want to sleep a lot; I have to take nap during the day and this is unusual for me; Elbow started swelling and now my knee is hurting; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hands started swelling and it will go up some and then down, elbow started swelling and now my knee is hurting, sore throat, i want to sleep a lot; i have to take nap during the day and this is unusual for me, elbow started swelling and now my knee is hurting on an unspecified date. Clinical course was re-ported as I got the injection 2 weeks ago and about 4 days later my hands started swelling and it will go up some and then down and I have been putting Voltaren lotion (Treatment) on it and about 5 days ago my elbow started swelling and now my knee is hurting but it isn't started swelling yet and I wondered if this is a side effect of the things, I checked on it. I have a sore throat and tiredness. I want to sleep a lot. It makes me (incomplete sentence), during the day I run down, and I have to take nap during the day, and this is unusual for me. We are scheduled to get our next one in one week from today and I wonder if this a side effect or is it going to continue, get worse or not. The clinical outcome of the event was unknown. Therapeutic measures were taken as a result of hands started swelling and it will go up some and then down.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On 3/20/00, had almond-sized lump at injection site on right upper arm with some discomfort with movement of arm. On 3/27/00, had lump size of tennis ball and very tender and hot. Treating with ibuprofen, Keflex and applying ice. Saw family physician. Ultrasound-no fluid noted. On 3/30/00, physician dx: extravasation into subcutaneous tissues, improvement noted.
Pt had a red circle around the injection site that seemed slightly raised and that was 3 to 4 inches in diameter.
Infuenza shot was given on 10/15/2010 at aprox 8:45AM.  On 10/16/2010 at aprox 7:30AM pt. started itching and hives developed.  10/17/2010  itching intensified and she took Benadryl 50mg at aprox 10:30am and 7:00pm on 10/17/2010.
Heart arrhythmias; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Lot number: FK9895; also reported as FR9895) at the age of 50 years, in right arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; COVID-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; COVID-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ARRHYTHMIA (medically significant) with onset May2022, outcome "not recovered", described as "Heart arrhythmias". Clinical course: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies. Therapeutic measures were not taken as a result of arrhythmia.
High fever, EXTREME body aches, malaise, fatigue, headache, dizziness? for over a week
6 days after the vaccine I had a pain in my right side under my ribcage  Went to the emergency room and was diagnosed with a pulmonary embolism
One of them mentioned that their PCP only gave their children one shot of GARDASIL 9 and did not give the second dose. The PCP indicated that the vaccine was out of stock. They eventually went to a pharmacy to get their child the second dose; One of them mentioned that their PCP only gave their children one shot of GARDASIL 9 and did not give the second dose. The PCP indicated that the vaccine was out of stock. They eventually went to a pharmacy to get their child the second dose; PCP indicated that the vaccine was out of stock; No additional adverse effects reported; This spontaneous report was received from consumers via company representative, referring to a child of unknown age and gender (also reported as "children" and "unspecified patients": conflicting information). The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (route of administration, anatomical location, lot number and expiration dates were not reported).  On an unknown date, the reporters took the patient at a subsequent visit, however did not received the second dose, as the vaccine was not available because it was out of stock (product availability issue). It was reported that eventually they went to a pharmacy to get the second dose (circumstance or information capable of leading to medication error and inappropriate schedule of product administration). No additional adverse effects reported.
Chills, sweats, bone aches, muscle fasiculations, itching with mild rash, diarrhea
Per mother, patient complains of fever last night of 103.6F. Today temp. is 101.9F.  Patient taking Tylenol as directed with some relief.
was vaccinated without incident or reaction. After she left, we realized that she was not old enough as she is 17 years, 10months old.