chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to an unknown number of newborn patients of unknown age and gender. Medical history and concurrent conditions were not reported. Between 18-OCT-2013 to 11-NOV-2013, the patients were vaccinated with RECOMBIVAX HB. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The medical assistant reported that an unknown number of newborn patients were administered RECOMBIVAX HB, between 18-OCT-2013 to 11-NOV-2013, that had been improperly stored. No adverse effects reported. Additional information has been requested.
pt recvd vax; inject area became red swollen & itched a lot; redness 3-4 inches in size;
Fever, chills, soreness of injection site, rash near injection site, fatigue, weakness
Patient receivrd HPV immunization and within 10 minutes became very faint, pale and weak and had near syncopal episode while exiting the waiting room. Was returned back to the patient room, laid down and applied cool compress to face. Was assessed by nurse and Dr. Patient remained supine for about 15 minutes until feeling better. Was able to ambulate out of office without help accomanied by father.
it could potentially be his Parkinsons; he started to shake and now is still shaking; he can't concentrate; he doesn't think right; cannot talk right; he has a hard time moving, he moves so slowly; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old (age at time of vaccination) male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in Arm right, on 14Apr2021, as a single dose for COVID-19 immunization at clinic. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in Arm right, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history included ongoing Parkinson's from 2010. He did not know about family history of having Parkinson's. Concomitant medications were not reported. The patient did not receive any vaccine within 4 weeks prior to vaccination. The patient reported that after two vaccines on an unknown date in Apr2021, he started to shake and now was still shaking. He was wondering why he was shaking so hard. He said it could potentially be his Parkinson's and asked what he should do. Mailing and email address declined. Primary care doctor's address, telephone number, and email address declined. The patient stated the doctor was not in. Shaking was noticed after the second dose. It was improved, but he didn't like it. He could not concentrate, he didn't think right, and could not talk right. When asked to provide information from vaccine card, the patient stated he had a hard time moving, he moved so slowly and had card but could not find it. He also could not recall date of first vaccine, but both doses were given to right arm. Time the vaccination was given: 10:14:2020, was the time that second dose was received. Time was documented as provided, and confirmed, by caller. He had first one and was given another 3 weeks to come back. He was waiting for his doctor and stated he had Parkinson's, diagnosed in 2010. There was no product complaint to report. Outcome of the event he started to shake and now is still shaking was recovering and for all other events, it was unknown.  Communication: Caller had a thick accent- details were as provided by caller with clarifying attempts.  Information about lot/batch number has been requested.
She got her vaccine, she looked it up on database and it appears to be an autoimmune response to the vaccine.  She had fatigue, joint and muscle pain and overall malaise.  The worst of it is the joint and muscle pain, which is particularly bad when she gets up in the morning.  During the day it seems to alleviate, however, the fatigue does not go away.  Along with the fatigue is depression, which still continues today.  She did not go to her doctor as she did not know how serious it was until she did some research on it, and thought that her symptoms were due to over exercising, which she stopped for 5 days which did not alleviate the condition.    According to the research there is an 11% chance of getting an autoimmune reaction that can resolve or become permanent and feels that the people receiving the vaccine should  know that so that they can weigh the risks of the vaccine.
Information has been received from a registered nurse concerning an 8 year old female who, at 2 years old, was vaccinated with a dose of varicella virus vaccine live. On 01DEC2003 it was reported that the patient "recently" developed 10-15 varicella breakthrough lesions. It was reported that she was exposed to the wild type varicella at school and that there had been an "outbreak of wild virus of varicella" in the school district. No testing was done. It was unknown if medical attention was sought. No product quality complaint was involved. It was also reported that the patient's brother and female cousin was vaccinated with a dose of varicella virus vaccine live and also developed varicella breakthrough lesions. It was also reported that 12-14 children were vaccinated with a dose of varicella virus vaccine and developed varicella. The nurse also reported that she did not keep separate charts and that she was unable to answer the questions asked. No further information is expected.
had Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had Covid) in an elderly male patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     Patient has medical history of having a pacemaker.     On 11-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had Covid). At the time of the report, COVID-19 (had Covid) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient reported he was seniors and had their previous vaccines all Moderna and had Covid 2 times within the last three years. He reported he just got back from a cruise and have Covid now. His question was for the new Covid vaccine coming out, how long do they have to wait to get the vaccine since they have covid now and going on another cruise in December.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745076 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745076:Wife case
I started having pain 2-3 hours after receiving the vaccine. I started having convulsions late at night from 12:15AM-12:45AM. I put my symptoms in my app, for the hospital, and my doctor called me and told me to go to the hospital. I went to the hospital and had my appointment. They did a detailed check-up and  did not find anything wrong. My doctor told me that if I have these episodes anymore, then I need to contact her and go to the hospital. I have not had any other episodes except for that night.
Patient stated that her arm was sore and that she has limited range of motion. She stated that she had to go to the doctor from the pain.
The above patient was given Bexsero Men B vaccine instead of Men-ACYW there is no adverse reaction, no harm to patient.  Parent, provider and supervisor all notified of incident.
vomiting, increased heart rate, headache, stomach pain, muscle aches, numbness in lower limbs,
My mother received the Jansen vaccination on April 6, 2021.  2 days post vaccination she had 2 asthma attack at work. That following Friday she was not able to attend work due to shortness of breath.  Saturday morning she cold not inhale and  couldn?t stop coughing. She was then attempted to be taken to urgent care, but upon arrival she was coughing up blood and was instructed to go straight to the hospital.  At the hospital upon test being done she was admitted to the covid unit and diagnosed with pneumonia due to covid 19 virus, bilateral pulmonary embolism in both lungs. She is now home in quarantine taking blood thinners for the next three months and unable to work.
Body ache/ soreness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache/ soreness) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced PAIN (Body ache/ soreness) and FATIGUE (Tiredness). At the time of the report, PAIN (Body ache/ soreness) and FATIGUE (Tiredness) outcome was unknown. Not Provided          Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Patient was expecting to receive a COVID booster only, She was given a flu shot in addition to the covid vaccine. Records indicated she was due for the influenza shot and she signed up for both the flu and Covid vaccines. On her vaccine questionnaire form she did indicate that she already received the flu shot. We did not catch that and gave her the flu shot in which she already received from another provider. It is unknown which manufacturer of flu shot she received from the other provider.
Information has been received from a nurse concerning a 22 year old female who on 21-APR-2008 was vaccinated with the first dose of GARDASIL and on 23-APR-2008 developed back spasms. The patient's father called the office stating his daughter was off from work for 1 week due to the back spasms. The patient stated that she was not going to continue the GARDASIL series. At time of report, the patient was not having any problems. Back spasms were considered to be disabling. Additional information is not expected.
Pain at the injection site in conjunction with a large knot on my right deltoid muscle.  This was followed by a rash and bruising the next day, 4/2/2021.  On 4/4/2021, the swelling in the deltoid muscle is still present, the pain has gradually gotten better, but still tender to the touch.  The rash and bruising continue to be present as well.   I have been using ice to relieve the swelling and Tylenol to ease the pain.
This spontaneous report as received from a nurse refers to an 11 year old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. The patient began vomiting directly after being administered the first dose in the GARDASIL 9 series. The patient's mother reported that, the patient "vomits a lot before she goes to school". The patient's mother reported the vomiting was "anxiety driven". The patient did not receive treatment for the events, on an unknown date. The outcome of vomiting and anxiety was unknown, at the time of the report. The patient had not sought medical attention, post visit. No product quality complaint was involved. The relationship between the events and GARDASIL 9 was not provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13May2022 as dose 4 (booster), single (Lot number: 057M21A) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose  2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild seasonal allergies (rhinitis)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Apr2023) Negative; (15Apr2023) Positive, notes: tested (strongly) positive again on 15Apr2023; (20Apr2023) Positive, notes: (20Apr2023), still testing (faint-to-moderate) positive.  Clinical information: Tested negative on 11Apr2023 after increasingly faint readings (one week after starting Paxlovid course); tested (strongly) positive again on 15Apr2023. As of today (20Apr2023), still testing (faint-to-moderate) positive. (All testing using at-home antigen tests.) Symptoms since rebound positive test were minor to nonexistent (congestion and mild fatigue, could have been due to allergies and lack of sleep from worry about the positive test). Other medication in 2weeks.
constipated throat; did not allow him to swallow; swelling in the heel and foot of the right leg; stronger rush" in the chest; severe headache; body aches; stomach pain,; bone pain; his sciatica "was activated"; also affected his blood pressure; This is a spontaneous report from a contactable consumer (patient himself).  A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation, he mentioned that when he received the first dose, he manifested a small rush and fatigue for two days. On an unspecified date, the patient suffered from a constipated throat that did not allow him to swallow and swelling in the heel and foot of the right leg. The patient received both doses of the vaccine (he does not remember when). He mentioned that when he received the first dose, he manifested a small rush and fatigue for two days, when he received the second dose he presented a stronger rush in the chest, he had to take Benadryl, he had a severe headache, body aches similar to when he has flu, he presented stomach pain, bone pain, his sciatica was activated and the vaccine also affected his blood pressure. The reporter consider the seriousness as non-serious. The patient underwent lab tests and procedures which included blood pressure measurement: affected, the vaccine also affected his blood pressure on an unspecified date. The clinical outcome for the events was unknown.  No follow-up attempts needed. No further information expected.
FEVER, CHILLS, SHAKINESS, NAUSEA BODY ACHES DIARRHEA RESTLESS, DIFFICULTY SLEEPING SWELLING AT INJECTION SITE
Soon after flu vaccine, evolved swelling and pain of deltoid - pain radiates at times to hand persisted for 2 days - went to outpatient facility. Came to my office 4 days later; swelling lessened.
I received 2 dose on 1/26 at 8:40 a.m.  About 4:30 p.m. I start feeling a throbbing pain at injection site. I around home about 6:00 p.m. immediately I start having chills, fever, muscle ache , nausea , and  headaches. I could not sleep all night I was back and forth with chills and fever up to 102 for two days. On third day I felt better but headache and nausea linger still.
With in 6 hours a sore arm from shoulder to elbow with  a large Angioedema under the skin protruding about the size of a soft ball.  Edema slowly reduced to subcutaneous.  Starting on 1/9/2021- a quarter size red Angioedema visible topically  with a tennis ball size edema.  On 1/10/2021 site is enlarged to the size of a half dollar. Currently tracking the size.
Varicella rash- onset 08/23/2002 am. Pt did have fever x T day on 08/15/2002. Vaccine was given 08/09/2002
Moderna COVID-19 Vaccine EUA: patient presents to emergency department with congitive decline and persistent abnormal movements for six months. Patient admitted, administered steroids for possible autoimmune etiology, initiated tetrabenazine for chorea, and discharged home in good condition with family and follow-up in place.
He had a complete personality change. The very obvious changes lasted 1 1/2 weeks. No smiles, very fussy! He was very smiley and happy prior to vaccinations.
Fever 101.5 for 24 hours  (First dose, in 2019, experienced red, hot, swelling of arm, 3 days after vaccination.)
This spontaneous case reported by an other healthcare professional, describes the occurrence of product storage error (vaccine administered after more than 30 days in the refrigerator), and administered expired product (vaccine administered after more than 30 days in the refrigerator) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 009C21A) for COVID-19 immunization. No medical history reported. On Jun 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Aug 6, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Aug 6, 2021, patient experienced product storage error (vaccine administered after more than 30 days in the refrigerator), and administered expired product (vaccine administered after more than 30 days in the refrigerator). At the time of the report, product storage error (vaccine administered after more than 30 days in the refrigerator), and administered expired product (vaccine administered after more than 30 days in the refrigerator): resolved. The reporter did not provide any causality assessments, or concomitant medication. Patient did not experience any symptoms after receiving the vaccine, and has not received any treatments.
Fever, chills, severe headache and joint pain. Felt tired and fatigued. This occurred after both injections but was considerably worse after the second.  Headache has continued to be constant since the vaccine. I have also experienced heavy periods, and horrible cramps. Before the vaccine I almost had no period whatsoever. I didn?t have cramps at all. In my 20s I did have cramps and heavier periods. Since the vaccine the cramps have been so bad they wake me up at night. I also am experiencing a lot of bleeding for a longer duration. This is absolutely abnormal for me. I had an ablation three years ago so seldom had any period. If I did it would be very light brown spotting. Not enough to even wear a pad. So, this is highly unusual.
Carpal Tunnel increased greatly in severity with burning pain radiating to elbow & armpit Swelling & pain in hands & feet. Chills Sore arm for 48 Hrs.
VAXELIS was administered to a patient after experiencing a supported TE. HBP did not know the exact date of administration, between 8/18/2023 & 8/30/2023.No side effects reported.TE: 59.2 F,Time :7 hrs, 56 min,Previous TE:48.7F for 48 min,33.4F 10hrs; This spontaneous safety report, with reference number  (Case ID #: 02462671) was received by the partner on 30-AUG-2023 and forwarded to company on 31-AUG-2023, from a Physician.    This case was considered non-valid due to no patient identifiers (Temperature excursion only).  Due to the nature of the event, the causality between the event "VAXELIS was administered to a patient after experiencing a supported TE. HBP did not know the exact date of administration, between 8/18/2023 & 8/30/2023.No side effects reported.TE: 59.2 F,Time :7 hrs, 56 min,Previous TE:48.7F for 48 min,33.4F 10hrs" and Vaxelis was not applicable.  Significant Follow-up information was received by the partner on 14-SEP-2023 and forwarded to company on 14-SEP-2023, from a health care professional. This case is maintained as non-serious.  Patient identifiers were received; therefore, the case is considered to be valid.  Due to the nature of the event, the causality between the event "VAXELIS was administered to a patient after experiencing a supported TE. HBP did not know the exact date of administration, between 8/18/2023 & 8/30/2023.No side effects reported.TE: 59.2 F,Time :7 hrs, 56 min,Previous TE:48.7F for 48 min,33.4F 10hrs" and Vaxelis was not applicable.  Further information is not expected.
Pt was administered Varicella at ROA. Pt developed swelling at site of injection. No fever, sleeps well and eating well. Warm to touch, painful. 2x3 in diameter.
Approximately two weeks following her vaccine, my mother suffered from a bout of transient global amnesia, as eventually diagnosed by her family doctor. All of a sudden one evening, she lost any and all orientation to time. My father and I rushed her to the hospital for fear she was suffering from a stroke. She could not remember what day it was, what she had done that day, conversations we had the day before and she kept repeating herself in 3-minute loops. About 6 hours after the initial onset and while still in the ER,  she regained all orientation however she does not remember what happened to her or what she did or said during this period of time.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection (strength, dose and route not provided). No adverse event was reported. The outcome of event was not reported. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A 73-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at left arm on 2015 at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, after the use of product, the patient experienced severe swelling in left arm. The outcome of the event was unknown.
multiple cold sored on my mouth; staph infection; Shingles; This is a spontaneous report from a contactable nurse (patient).  A 55-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 17:00 (Batch/Lot Number: EM9810) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included HTN, Bilat PE's(9y ago), chronic sinusitis/bronchitis and allergies to Contrast Dye. Concomitant medication included colecalciferol (RX D) taken for an unspecified indication, start and stop date were not reported. Patient previously took BNT162B2 (lot number: em3247) in Jan2021 as dose 1 administered in the right arm for Covid-19 immunization. On 22Mar2021 at 13:00, 6 weeks after the second Covid vaccine, patient developed shingles, and required Rx medication. On 11Jul2021, 21 weeks after the second Covid vaccine, she developed a staph infection in several places of her body requiring Rx medication. On 31Jul2021, 24 weeks after the second Covid vaccine, she developed multiple cold sores on my mouth, requiring prescription Zovirax and Valtrex. The outcome of events was reported as not recovered.  Follow-up attempts are completed. The following information on the batch number has been obtained.