chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning an 80 year old white female with penicillin allergy and no illness at the time of vaccination who at 2:00 pm on 22-AUG-2005 was vaccinated intramuscularly with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P).  On 22-AUG-2005, the patient called the office with complaint of a red arm, swollen, painful arm.  The patient was unable to use affected arm for 2 days due to the pain.  The patient was instructed to use cool compresses to the area and to follow up with office if not better or if symptoms changed.  On 24-AUG-2005, the patient recovered.  Additional information is not expected.
NO ADVERSE EVENTS . I AM REPORTING BECAUSE HE WAS 5 DAYS AWAY FROM HIS 18TH BIRTHDAY. HE GOT MODERNA .25ML IM ON 4-17-22
This spontaneous report was received from a registered nurse who reported that VAQTA, (lot # not reported), was given to multiple unspecified subjects after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported after the vaccine was administered. This is one of several reports from the same reporter source. Additional information has been requested.
Vaccine administered to the child was undiluted.  As of now, patient has not experienced any adverse reactions.
Intense itching, rash, tingling, and numbness came on suddenly beginning in both hands, and moving quickly to arms, feet, torso, and then finally lips and tongue.  Had trouble speaking.  Took two Benadryl.  Then my husband called 911.  Two EMT people took my blood pressure a couple times and exygen level.  Then the attack started to go away, and my pressure returned to normal.  Then the EMT people left our home.
No adverse event. The expiration date was 10-27-21 and it was given on 10-29-21 in error.
Suspect allergic reaction to MCV4/Varivax #2 in series. Patient in office for well visit. Developed asthma, allergic rhinitis, profuse rhinorrhea and urticaria within 5 minutes of vaccinations.  Mother continued home.  Called at 12.35pm stating itchy eyes and coughing. Instructed to return to office.  Upon examination inspiratory wheezing noted, urticaria and profuse rhinorrhea. B/P 93/61, pulse 68 and respirations 18.  Treated with Xopenex 1.25mg neb treatment x 1. Wheezing resolved after treatment.  Sent home with albuterol inhaler,Singulair 10mg tabs, Omnairs nasal spray, Prednisone 10mg tab and Claritin tabs.  Return appointment given 09-21-2008.
This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Got the same symptoms like Dr.) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Got the same symptoms like Dr.). At the time of the report, IMMUNISATION REACTION (Got the same symptoms like Dr.) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient received Pfizer Covid Vaccine - BNT162b2.  The patient got the same symptoms like the physician.   Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2022-584727 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-584727:Dr. case
The evening of shot had low grade temp, temperature continued into second day.  Second day at night temp went up to 102.8.  Third day temp went down to low grade, fourth day temp returned to normal.  Drank plenty of fluids and took Tylenol to lower temperature.  Did experience flu like symptoms - body ache, and weakness.
This initial case was received from a nurse on 22 January 2014. It represents a cluster of "five or six" unidentified patients reported by the same reporter who each experienced H1N1 influenza following administration of FLUZONE (lot number unknown). Five or six patients, ranging in age from 18 to 62 years old, received FLUZONE (lot numbers not reported) in September 2013. In January 2014, approximately four months post-vaccination, the reporter was contacted by the local hospital and informed that the patients had tested positive for H1N1 influenza virus. One patient was briefly hospitalized due to the event. Additional information, including medical history, treatment, and outcome, was not reported. Additional information has been requested.
Headache, foggy brain, nausea, lymph node swelling, entire body aches - that is the worst symptom
PT RECIEVED VACCINE THAT WAS PAST THE BEYOND USE DATE. NO ADVERSE EFFECTS REPORTED.
Swelling rt thigh whole thigh to knee 2 days after flu vaccine no redness on Benadryl and Motrin.
The following morning, top surface of tongue was covered in black spots. Possibly 'hairy black tongue'? Furthermore, nausea and gastric distress began about 10 hours after injection, and persisted through the following day, accompanying the black spots on the tongue.
A few days after receiving my first Madonna shot injection I started developing a fixed drug eruption in the middle of my forehead.
30 min/p shot->shaking, violent chills, tachycardia-140/min. T 102.No skin rxn-no dizziness,no local rxn.Now has rash on hands.Pt OK the next day & was seen by MD on 26Jun.
approx 18 mos p/ recv vax pt devel fever & chickenpox-like rash w/25-30 lesions all over body.
Patient has a quarter-sized red area at the injection site that is warm to touch. There is also significant bruising in a 3-4 inch area surrounding the red area. Physician advised Diphenhydramine and to apply ice.
sick to her stomach; feeling dizzy; she's really really sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A female patient received first dose of  bnt162b2 (BNT162B2, Batch/Lot number: unknown) administration date 25Feb2021 as DOSE 1, SINGLE dose for covid-19 immunization. Relevant medical history included: "gall bladder trouble" (unspecified if ongoing); "mental illness" (unspecified if ongoing); "emphysema" (unspecified if ongoing); "asthma" (unspecified if ongoing); "heavy smoker" (unspecified if ongoing). Concomitant medication(s) included: HALDOL. The following information was reported: GASTRIC DISORDER (non-serious), outcome "unknown", described as "sick to her stomach"; DIZZINESS (non-serious), outcome "unknown", described as "feeling dizzy"; ILLNESS (non-serious), outcome "unknown", described as "she's really sick". Therapeutic measures were taken as a result of gastric disorder, dizziness, illness.  Additional Information: Caller stated she was asking questions regarding her daughter medical conditions. Caller stated her daughter received her first Pfizer COVID-19 vaccination on last Thursday (25FEB2021). Caller reported that her daughter is a heavy smoker. Caller mentioned that her daughter had other underlying medical conditions. Caller stated her daughter has emphysema and asthma. Caller reported to that her daughter has a mental condition. Caller stated her daughter is on Haldol. Caller reported that her daughter has taken Dramamine secondary to feeling dizzy and sick to her stomach after taking the vaccine. Caller implied she was really sick. Due to these symptoms, caller stated that they were hesitant of her taking the second vaccination. Caller stated her daughter had gall bladder trouble. Caller asked will this vaccine effect the gall bladder. Caller asked was there any information regarding her daughter medical conditions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Slight nausea and about 2:00 am -woke up with an excruciating headache - worse when I was lying down. Sensitivity to lights. Fatigue throughout the day as well. I called clinic at 8:00 am (where I work, too) - spoke with a nurse through triage. They told me to rest and that I should stay on schedule for my second dose (didn't think it was from vaccine). Told me I could take 600 mg Ibuprofen about noon that day and finally started getting relief from headache. I did take another Ibuprofen when I went to bed. On the 13th,I was back to 100%. I don't usually get migraines - it was really weird because I felt worse when I was lying down.
Patient was supposed to get Moderna Bivalent but received Moderna Non-Bivalent Booster.
Fever, chills, severe brain fog, shortness of breath. Resting heart rate skyrocketed from 69-71 to 87 after the vaccine. I can't get my heart rate down. Severe fatigue. brain fog for weeks. The same thing happened with the first shot except I was much sicker. Tested negative for COVID both times. Out of work for weeks in a pandemic. Would not have gotten vaccinated had I known it was going to be this bad.
Extremely heavy menstrual period since my 1st dose.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 at 15:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 22Apr2021 at 15:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to antibiotics since an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 the patient experienced extremely heavy menstrual period since her 1st dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken for the event. The clinical outcome of the event extremely heavy menstrual period since her 1st dose was unknown at the time of this report.
Patient experienced difficulty breathing and had no detectable pulse within 5 minutes after receiving both immunizations.  Epinephrine 0.3mg was administered, dose was repeated 2 additional times every 5 minutes until paramedic arrived. Patient did not lose consciousness. Patient was given oxygen and transported to hospital for evaluation.
I had Moderna for the initial 2 dose vaccination, this was my booster. Just soreness at injection site on 9 and 10 Dec, woke up on 11 Dec with soreness in armpit of same arm as injection. Visibly swollen and tender when touched. My sister had the same thing happen, said it went away in a few days. She also had Moderna and then a Pfizer booster.
This spontaneous report as received from an immunization coordinator via a company representative, refers to a 17 year old female patient. No medical history or concurrent conditions were provided. On 15-APR-2014, the patient was vaccinated with GARDASIL INJ (dose, route and lot number not provided). No co-suspect or concomitant therapies were provided. The reporter stated that on the same visit, on 15-APR-2014, the patient received 2 doses of GARDASIL in different arms. No adverse effects were reported. Additional information has been requested.
6/4/21 Severe chest pains, left side and under breast, left shoulder and arm Unable to take a normal breath without pain Dizziness, very tired Left leg below knee, ankle, foot and toes swollen... toes like sausages 6/25/21 Sudden Sensorineural Hearing Loss in both ears... One second I could hear, the next only minimal hearing remains . Did not respond to steroid treatment by ENT or further steroid treatment over the next month. Permanent hearing loss.
This spontaneous report was received from a medical assistant regarding a multiple unspecified number of patient of unknown age and gender. The patients' medical history, concurrent condition, drug allergies or concomitant medications were not reported. On 06-JAN-2017, 23-JAN-2017, 30-JAN-2017 and 10-FEB-2017, patients were vaccinated with improperly stored doses GARDASIL 9 injection (strength and dose were not reported) (lot # L040054, expiration date 26-DEC-2017) for prophylaxis. According to the reporter, on 01-MAR-2017, GARDASIL 9 doses were exposed to 32 degrees Fahrenheit (F) for 166 hours. No adverse effects were reported. It was unspecified if a digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010647: US-009507513-1704USA005264: US-009507513-1704USA005262:
The arm with Shingrix experienced from shoulder down arm to elbow swelling, redness. She had a fever and GI upset
Rash appeared on trunk and is on and off; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash appeared on trunk and is on and off) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced RASH (Rash appeared on trunk and is on and off). At the time of the report, RASH (Rash appeared on trunk and is on and off) had not resolved.            No concomitant medications were provided.  No treatment information provided.
Patient was receiving booster dose of Moderna and was given 0.5ml instead of the recommended dose 0.25ml.  No adverse reactions reported at this time.
Little chill; Sore arm; This is a spontaneous report from a contactable consumer (patient), from a Pfizer-sponsored program.  A female patient of an unspecified age (Age: 71 Units: Unknown, as reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history included allergy to penicillin. Concomitant medications were not reported. It was reported that, patient reports a little chill and sore arm, she fell asleep and woke up the next day feeling fine. Also, reports an allergy to penicillin. Patient would like to know whether antibiotics would diminish the effects of the dose of the covid vaccine, whether participants in the clinical trial for the covid vaccine were allowed to take antibiotics, whether people with an allergy to penicillin are able to take the covid vaccine. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Second dose 2 years apart form first; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th October 2019).   On 27th September 2021, the patient received the 2nd dose of Shingrix. On 27th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix later than the recommended dosing interval, which led to lengthening of vaccination schedule. The patient was not immunocompromised. No lot numbers available at the moment of the call. The patient did not consent to follow up.
Patient had a sore arm then became tingly underneath the next day. She said after the pins and needles stopped her whole are turned black and blue from the shoulder to the elbow.
A father brought his three children in to get flu shots and the technician failed to verify with the father and the consent form which vaccine the children were here to get and processed Pfizer Pediatric Covid-19 instead of the Flu vaccine.  The pharmacist brought the family into the counseling room and was distracted and failed to verify which vaccine the children were getting and administered the Pfizer Covid-19 Pediatric vaccine.  Upon giving the father the vaccine dose card it was discovered that the incorrect vaccine was given.
I tested positive for Covid-19 on January 14, 2023 I experienced sore throat, cough, tired, I was prescribed a steroid for my symptoms.
Arm was sore after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore after first dose) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore after first dose). At the time of the report, PAIN IN EXTREMITY (Arm was sore after first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-228969 (Patient Link).
Patient got shingles vaccine on July 8, 2020.  The next day she began with headaches, the following day low-grade fever, and for 6 days after she had a temperature up to 102.  Bad headaches, fatigue, neck pain, back pain.  Fevers stopped on July 16, 2020.  Patient was sent to emergency room for evaluation on 7/14/2020 at Medical Center.
This spontaneous report was received from a registered nurse refers to a male patient of unknown age. On 13-JUN-2008 the patient was vaccinated with VARIVAX (dose strength was not reported) dose 2, subcutaneous. And on 27-AUG-1999 patient received dose 1 of VARIVAX. No concomitant medication was reported. Nurse reported that patient has negative titers after receiving 2 doses of VARIVAX. It was reported that patient sought medical attention and visited the office. There was no product quality complaint involved. The outcome of patient has negative titers after receiving 2 doses of VARIVAX was reported as not resolved. The relatedness between the VARIVAX and event was unknown. Additional information has been requested.
I've been suffering from vaginal bleeding for 3 months. It started 10 days after my first dose.   After 2 months of bleeding, I have seen a primary physician and a gynecologist. I was told to take birth control, i took it for a month  but the bleeding didn't stop. The bleeding would occasionally stop only if I take 3 birth control pills. On top of that, I would randomly get a excruciating sharp pain in the lower abdomen area.
HEART PAIN; SHORTNESS OF BREATH; VERY SICK; This spontaneous report received from a consumer via company representative through social media (social media) concerned a female of unspecified age, race and ethnic origin. 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, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced heart pain, shortness of breath, and very sick. It was reported as, "This is all very nice but it is not the whole store. My wife is a nurse. Her work forced her to get a shot. She chose the vaccine on a Monday. Within 24 hours she became VERY sick. By Thursday I thought I was going to have to take her to the hospital. She began to recover but could started to have heart issues that lasted a month. Which included a great deal of heart pain and shortness of breath. Symptoms lasted a little longer than a month. Be aware that there is potential side effects which can be quite severe. None of these covid drugs, no matter who makes the drug, have been fully tested, and no one knows the long term impact. But studies and other places looking at side effects do not look promising". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart pain, and shortness of breath, and was recovering from very sick. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221125875-Heart pain. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Exp tinny taste 15-20 mins p/1st dose; no local or systemic sx; 2nd dose recvd w/no problem; w/in 5 mins of 3rd dose had same taste sensation; resolved w/no other sx; 20NOV92 f/u vax administered on 1OCT92, 7OCT92 & 21OCT92; all w/same lot
hearing issues; fibromyalgia; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was 64 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about 06-DEC-2012, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by a healthcare provider for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: hearing issues and fibromyalgia. The outcome of the events was not provided. The reporter considered the events of hypoacusis and fibromylagia to be related to zoster vaccine live (ZOSTAVAX).
A few hour after the injection I experienced  sharp pains  in my neck , numbness and tingling in the left facial cheek (similar to a shot of Novocaine wearing of after dental work)and  headaches. I am still having the feeling in my left facial cheek and the headaches sill come and go but not as often
He is complaining that his body/legs hurt. He is very lethargic. His fever is around 102.
w/in 12hr of vax pt devel burning & itching of feet;progressed to edema & petechia;dx w/vasculitis secondary to reaction by HBV by both allergist & vascular surgeon;steroid rx is responding well;
Stiff swollen neck, swollen lymph glands in neck and headache. As of 12/30/2021 symptoms still ongoing. Patient had a neck X-ray and CT scan.
Patient received influenza vaccine 10.2.14. on 10.3.14 at 0800. patient noticed (R) neck swelling above right clavicle, measuring 6cm x 4cm in diameter. Was seen at Health Services and referred to PCP who dx as influenza vaccine reaction. Today reports 90% resolved.