chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Having difficulty getting pregnant; This is a spontaneous report from a contactable consumer (patient's father). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medication were not reported. On an unspecified date, the reporter mentioned that her daughter was having difficulty getting pregnant and thus had an IVF (in-vitro fertilization). Reporter daughter had the first dose of the Pfizer-BioNTech COVID-19 Vaccine and was waiting for their second dose. The patient's father expressed concern for her daughter and asked if the vaccine could affect the DNA. The report was non serious. Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Moderna Covid-19 vaccine EUA Soreness at the injection site, body aches, chills, fatigue Treated effectively with ibuprofen
arm has been itchy n the area where she received the vaccine; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PRURITUS (arm has been itchy n the area where she received the vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included EZETIMIBE for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 24-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (arm has been itchy n the area where she received the vaccine). At the time of the report, PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PRURITUS (arm has been itchy n the area where she received the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.   Reporter did not allow further contact
I did not have an adverse reaction to the vaccine. I test positive for COVID-19 on 05/19/2022. I had both the home test and PCR test. I had no symptoms.  I also had COVID-19 in December 2020.
After 6 hours, I couldn't move my arm at all. It was stuck at 90 for 3 days. It has been 16 days and I have tendinitis, which I did not have previously, and have never had prior to receiving the covid vaccine. I believe the shot was infected into my bursa instead of the muscle, resulting in SIRVA. I can't go to the doctor for a true diagnosis because I am unemployed and have no health insurance. However, I worked as an orthopedic technician and have a BS in Exercise Science. I know tendinitis when I have it.
Felt fatigue 6 hours after shot and went to sleep for two hours. I started running a temp of 102 10 hours after shot.  I started throwing up about 12 hours after shot until about sixteen hours after shot. I had hot and cold chills and would wake up with night sweats for about 40 hours after shot. Had a pounding headache also for about 24 hours after shot. Was thirsty for about 12 to 16 hours just couldn?t drink due to having to throw up. Still have hot and cold chills and feel weak and have no appetite now 45 hours after the shot. Only been able to eat soup since the shot.
I did have a reaction to a vaccination/huge reaction; nerve pain in right arm; Parsonage Turner; This is a spontaneous report from a contactable consumer (patient). A female patient (age: 65, unit: unknown) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at right arm on an unspecified date at single dose for immunization; influenza vaccine, via an unspecified route of administration at left arm on an unspecified date at unspecified dose and frequency for immunization. Concomitant medications and past drug/medical history were not reported. Patient reported she did have a reaction to a vaccination when she turned 65. She got a pneumonia shot in right arm, she didn't know the name of the pneumonia vaccine. She also got a double flu vaccine in left arm, with a huge reaction. Her nerve pain in right arm started about 2 months after this (dates not specified). Doctors did two nerve conduction studies and multiple MRIs. Patient was put on pregabalin (LYRICA) by one of doctors for pain down right arm. She did not have a firm diagnosis. One possible diagnosis was Parsonage Turner. The patient's outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Around 9:00 am EST on Saturday, April 17 - vomiting, fever, chills, fatigue, loss of appetite.  Lasted all day.  Took a nap around 11:00 am for about an hour.  Took another nap around 4:00 pm.  Took another nap around 10:00 pm; had chills and fever.  When he woke up, blanket drenched in sweat.  He went to bed - still not eating anything.  Slept until  next day (Sunday, April 18) until about 10:00 am EST.  Feels fine now.
Patient received Polio instead of HIB  No treatment advised at this time.  Patient to come at age 4 for revaccination.
I had body aches, knee joints were hurting, temp 100F, chills, shaking, exhausted like I was hit by a truck. Later that evening my temp went to 102F, after that I was sleeping 10 hours a day, no appetite, nausea, vomiting, diarrhea, 9lbs in 9 days, back was killing me, alternated hot and cold compress. One morning I woke up and my tongue was like a rock, I was so dehydrated. Fever for 5 days, took Tylenol and it would just break it down to 100F. Went to COVID and flu on the 12/29 got positive for COVID on 12/31/20. Yesterday I felt hot and flushed and was sweating profusely, other than that no other symptoms. ( I received the second dose on 01/13/21)
Passed out a few seconds. Syncope - for a few minutes --> 1 hour - patient also didn't eat breakfast that day and said had this reaction after injections before - Felt better after sitting awhile and having orange juice and peanut butter crackers.
ATE A VERY SMALL PIECE OF GRAPE AFTER TAKING VIVOTIF; This spontaneous case report was received from a consumer (PVX2019-697) on 21-Mar-2019. It described a 36-year-old female consumer who "ate a very small piece of grape after taking Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer ate a very small piece of a grape after taking last dose of Vivotif on 21-Mar-2019.  The action taken with Vivotif with respect to the event "ate a very small piece of grape after taking Vivotif" was not applicable.  The clinical outcome of the event "ate a very small piece of grape after taking Vivotif" was unknown.  Company's Comment: The causality of the event "ate a very small piece of grape after taking Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "ate a very small piece of grape after taking Vivotif" was considered as not applicable.
Can I have very bad flu like symptoms even 3 days after getting a 2 nd shingles shot?; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: This case was reported b patient himself or herself. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had very bad flu like symptoms.
Numbness/tingling in my ring and pinky finger in the left hand.  It started just a few hours after my first vaccine and has remained persistent since that time.  Some days it can be more prominent than others but has generally remained consistent since the time of the vaccine.
1 week after receiving second dose started noticing blurred vision, numbness in right arm, heaviness in bilateral legs along with increased tripping over feet, extreme fatigue, brain fog.
Pt developed chest pains and other signs of pericarditis including a pericardial friction rub, hospitalized
I have Long COVID; I have Long COVID; I have Long COVID; moderna vaccine in 2021/ Pfizer booster in November of 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Nov2021, outcome "unknown", described as "moderna vaccine in 2021/ Pfizer booster in November of 2021"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown" and all described as "I have Long COVID". Clinical course: Patient had a very harsh and long lasting reaction to the moderna vaccine in 2021. Patient took a Pfizer booster in Nov2021. Patient was only ill for a week and understand that the Pfizer vaccine was not as strong as the moderna. Patient had Long COVID and do not want to be ill for months like was with the moderna vaccine.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
I received my Covid-19 vaccine on 01/24/2022. On the evening of 10/09/2022 I started having horrible diarrhea. The next day's I experienced ear pain, sore throat fever and shortage of breath. On 10/12/2022 I tested positive for Covid-19 and contacted my doctor. I was not prescribed medication for Covid. Symptoms lasted about 2 weeks. After about 2 month I had Covid again with continuing on going symptoms of coughing, fever, brain fog, sore throat, ear pain, diarrhea, and  congestion
No symptoms reported. No further AE details; Temperature: 70F Date of excursion: 3/2/2023; Lot Number: W0252273, Expiration Date: 6/2/2023.; This spontaneous report was received from a pharmacist, referring to a 10-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were not reported.  On 12-JUN-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml), once (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number was reported as W0252273, but upon internal validation was updated to W025273, expiration date reported as 02-JUN-2023, but upon internal validation was established as 10-AUG-2024) as prophylaxis, which also experienced a temperature excursion (expired product administered and product storage error).  The vaccine experienced a temperature excursion of 70 degrees Fahrenheit (F) for 9 minutes on 02-MAR-2023.  This is one of several reports received from the same reporter.
Pt c/o (L) upper arm pain origination at vaccination site, extending down to elbow. Erythema, edema of (L) upper arm within 24 hrs, subjective fever, pain with movement of extremity.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-JUL-2012, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
I thought I was getting my cold back, I had a sore throat, I took a nap, I had chills, shivering, I could not get warm, sneezing, slight headache, slight fever for two days. I took a home COVID-19 test late on March 15, 2023, it came back positive. Since it was close to midnight, I called my doctor the next day to let her know I tested positive for COVID-19. She did suggest Coricidin and prescribed the Paxlovid that I decided against taking after reading the side effects. I still have a bit of stuffiness, but I am much better.
29 yo Female reported after last vaccine hives that resolved next day with Benadryl and single brief dizziness described as insignificant before vaccine.  Upon walking to the bathroom during the 30 minute wait time, escort noted patient appeared to be in need of assistance so he offered her a chair. Upon sitting, she slumped against him so he asked for medical assistance. EMS called. On the ground patient was unresponsive with shallow breathing; neck was hard to move but attributed to her large bun. Stethoscope used to hear breath sounds as nurse reported she was breathing but did not appear to be strong breaths. Pulse ox 96% or higher with BP appropriate, HR in 90s.  She awoke to sternal rub, nurse asked her if she had difficulty breathing after noting her jaw was rigid and unable to open. Patient indicated yes to difficult breathing so epinephrine was given.  ~ 30 seconds after epinephrine patient alert and breathing deeply, began to respond to questions.  After reporting breathing was still moderately difficulty (a few minutes later), epinephrine second dose given. Patient transport via EMS.
Patient's wife reported that after the shot, patient's left arm is sore. after 2 hours, he can't lift up his left arm.  The arm is not swollen or red. Patient started taking Naproxen on 8/20/19 but has not been resolved.  He started doing hot compresses twice for 20-30 minutes at the time of reporting at 11:00 AM 8/21/19
slight puffiness at the injection site; soreness at the injection site/tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (slight puffiness at the injection site) and VACCINATION SITE PAIN (soreness at the injection site/tenderness at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013821A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-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 13-Mar-2021, the patient experienced VACCINATION SITE SWELLING (slight puffiness at the injection site) and VACCINATION SITE PAIN (soreness at the injection site/tenderness at the injection site). At the time of the report, VACCINATION SITE SWELLING (slight puffiness at the injection site) and VACCINATION SITE PAIN (soreness at the injection site/tenderness at the injection site) outcome was unknown.            No Concomitant medications were provided. No Treatments were provided.
Mom called clinic 28OCT91 states since Friday had not been eating, afebrile, & coughing,  had sought advice from clinic who said see MD-MD felt immun was culprit & advised Dimetapp cough syrup; dx bronchitis 1OCT91;
12/16/09: Patient complains of muscle weakness to right side of his face, slight drooping noted, unable to blink right eye. Having trouble chewing on right side. States he began noticing this the morning after receiving both the seasonal and H1N1 flu vaccines. Possible Bell's Palsy.
Dose 1 given 2/25/2021 Moderna Lot #002A21A Pt had a cardiac arrest at her assisted living facility and was brought to the hospital. Patient died in the emergency room on 1/10/2022. Not a covid illness related death
acute myocardial infarction; He was found by his secretary unconscious; feeling unwell; This is a spontaneous report from a contactable nurse.  A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), intramuscular in the left arm on 19Jan2021 (at 68-years-old) as a single dose for COVID-19 immunization.   Medical history included blood cholesterol of 200 (not further specified).  The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included irbesartan (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 19Jan2020 at 08:00, after the vaccine, that patient was at work and was feeling unwell and the patient was found by his secretary unconscious. An ambulance was called. The patient's blood pressure was 79/38 and electrocardiogram showed acute myocardial infarction. He underwent one stent placement with the remaining arteries normal. He was also started on ticagrelor (BRILINTA), metoprolol (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). The patient immediately improved and was feeling well and resumed exercise. The clinical outcomes of the unconscious, acute myocardial infarction, and feeling unwell were recovering. The events required emergency room visit and were assessed as serious for requiring hospitalization for 2 days and being life-threatening.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: There is not a reasonable possibility that reported events acute myocardial infarction, unconsciousness and feeling unwell are related to BNT162B2.  The events are more likely intercurrent medical condition for this elderly patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Left upper arm began to hurt a few hours after the injection. Then my muscles in the upper arm and across the upper back began to ache . My skin was sensitive in the same area. I felt like I had the flu . The muscles continued to hurt down my back and into my legs the following day. I had a headache and waves of chills. I did go to work the next day but felt terrible. No fever. After work I went home and went to bed and slept till the next morning and woke feeling better. Left arm still tender.
A nurse reported that a 42 year old female received an injection of Pnu-Imune 23 on 4/20/01. On 4/21/01, she developed an injection site reaction characterized by redness, swelling and heat. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23, lot 472209.
20 hours after injection temperature started to rise. 23-24 hours after injection loss of sensation and tingling in finger tips left arm, lasted about 45 minutes. 26 hours after injection fever topped at 102.4 30 hours after injection starting to feel better again. 42 hours after injection fully recovered, only slight headache left, that lasted all day
The first thing I noticed was some tightness in my chest and fatigue. That has persisted since the middle of January. I then started having upset stomach and nausea daily. I have had blood work, chest xray, EKG. I have been able to manage the upset stomach and nausea with acid reducing medication recently. If I don?t take the acid reducing medication, I still experience the nausea.  The fatigue persists. My rheumatologist did blood work and discovered I had no antibodies from the vaccine.
Patient developed severe R facial neuropathic pain (V3 distribution) approximately 2 weeks after receiving vaccination.  Mild improvement with VALTREX.  No lesions ever developed.  After 2 weeks symptoms began to gradually resolve.
Off label use; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label use) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 04-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced OFF LABEL USE (Off label use). At the time of the report, OFF LABEL USE (Off label use) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-318424 (Patient Link).
This spontaneous report as received from an administrator refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of PNEUMOVAX 23 (intramuscularly, lot # L040178, expiration date 18-AUG-2017; dose was not reported) for prophylaxis. No adverse effects were reported. The vaccines were stored in the temperature between 0 degrees Celsius to 2 degrees Celsius for 24 hours and in the temperature range of above 8 degrees Celsius but below 25 degrees Celsius for 26 hours and for 14 hours and 10 minutes. The call was made because of a data logger. Additional information has been requested.
Information has been received from a licensed practical nurse concerning an 18 month old female with no pertinent medical history and no drug reactions/allergies who on 18, Jan 2007 was vaccinated SC in the left arm with a first dose of PROQUAD (Merck) (lot# 655842/1330F). There was no concomitant mediation. It was noted that the child has been crying since she was vaccinated. The child was given TYLENOL and was scheduled to be evaluated by the physician on 19, Jan 2007. There were no lab diagnostic studies performed. Unspecified medical attention was sought. The outcome was not recovered. There was no product quality complaint. Additional information has been requested. There were no adverse events following prior vaccinations of the patient.  Follow up infromation indicated that on 19-JAN-2007, the patient was thought to be having pain at the injection site, she was fussy and irritable. This resolved with TYLENOL and MOTRIN over "2 days". On approximately 05-FEB-2007, two weeks later, the patient had a couple of episodes of staring with tight fists. The reporter was not sure if it was normal behaviour. There was no follow up from the parents. No additional information is expected.