chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling sick; No energy; Body hurts; Nauseated; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Feeling sick), ASTHENIA (No energy), MYALGIA (Body hurts) and NAUSEA (Nauseated) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient had no known allergies. The patient had no history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination. The patient had tested negative for COVID-19.  Previously administered products included for Product used for unknown indication: Pfizer (Dose:1 Lot number: 101891872) on 19-May-2021, Pfizer (Dose: 2 Lot number: 101891872) on 09-Jun-2021, Pfizer (Dose:3 and First Booster Lot number: 101891872) on 13-Dec-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 04-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling sick), ASTHENIA (No energy), MYALGIA (Body hurts) and NAUSEA (Nauseated). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE (ASPIRIN EXTRA) at a dose of two generic aspirins extra strength. At the time of the report, MALAISE (Feeling sick), ASTHENIA (No energy), MYALGIA (Body hurts) and NAUSEA (Nauseated) was resolving.            No concomitant medications were reported. The patient was feeling adverse events 10 hours after getting the Moderna Booster shot. The adverse events did not cause patient to seek medical care (office visit, urgent care, ER, hospitalized). The patient had not experienced similar events in the past.
just a little bit of soreness; I noticed that my arm was itching a little; there's a red patch about 6 inches long and 2-3 inches wide at the injection site.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 84 year-old female patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single), for covid-19 immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "just a little bit of soreness"; VACCINATION SITE PRURITUS (non-serious) with onset 02Mar2021, outcome "unknown", described as "I noticed that my arm was itching a little"; VACCINATION SITE ERYTHEMA (non-serious) with onset 02Mar2021, outcome "unknown", described as "there's a red patch about 6 inches long and 2-3 inches wide at the injection site."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizzy; Sick in the stomach; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and NAUSEA (Sick in the stomach) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy) and NAUSEA (Sick in the stomach). At the time of the report, DIZZINESS (Dizzy) and NAUSEA (Sick in the stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.
Numbness; itchy throat; tingling in face; trouble swallowing; hives on face and back; This 34- year-old female patient contactable consumer (reported for herself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot En5318), via an unspecified route of administration, on 05Feb2021 at 01:30 PM (at the age of 34-years-old) as a single dose for COVID-19 immunization, in left arm. Historical Vaccine included first dose of BNT162B2 on 15Jan2021 at 10.45 (lot EL1484, expiry 30Apr2021), for COVID-19 immunization and experienced the onset of headache, intense arm pain at the injection site and mild joint pain. The patient's concomitant medications included The medical history included: Asthma, GERD, and obesity. Allergy to Sulfa. Historical Vaccine included first dose of BNT162B2 on 15Jan2021 (lot E63248), for COVID-19 immunization in left arm. The patient's concomitant medications included ALBUTEROL [SALBUTAMOL]. She has had no other vaccines in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Feb2021 13:45, she reported experiencing Numbness, tingling in face, trouble swallowing, itchy throat, hives on face and back. Patient received treatment of 3 doses of Benadryl. The outcome of the events Numbness, tingling in face, trouble swallowing, itchy throat, hives on face and back was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.
Information has been received from an office manager concerning a 12 yr old male pt who on 23Jan96 was vaccinated with a dose of varicella virus vaccine live. On 05Jan06 the pt experienced breakthrough lesions. The pt had 3-4 locations covered with pink, itchy patches on the genital area, chest, face and legs. A serologic test for varicella was performed and the lesions tested sero positive for varicella. The pt also had a mild cough. The case was described as mild breakthrough. There was no quality complaint involved. Additional information has been requested.
This report was from Pfizer, Inc. and was assigned manufacturer report number 2015362785 for PREVNAR 13. This was originally reported by a pharmacist, concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2103 (reported as "2 yrs. Ago"), the patient was vaccinated with PNEUMOVAX 23 (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). On an unknown date, the patient experienced fever, injected area was red and irritated (injection site erythema and injection site irritation), and she had a knot form under her arm (limb discomfort). The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
pt recv vax 16OCT95 & 17FEB96 non-vaccinated devel brother devel chicken pox (WAES96031761);23FEB96 younger brother recv vax & pt devel a chicken pox rash w/approx 100 lesions;the same day brother devel chicken pox (WAES96031270)
On 4/8/02, he had DTAP in left arm. On 4/9/02 PM, mom noticed left arm reaction that was hot to touch, area of reddish-purple raised, area 5" across arm almost going all the way around the arm. Vertically, 3" area of hardness "welt". No fever, no streaking. At 20:00 on 4/9/02, saw doctor and got Benadryl. On 8/16/01, had similar reaction but smaller.
A nurse is reporting an AE on behalf of a patient. The caller states that a pediatric patient received PROQUAD intramuscularly instead of subcutaneously. No additional AE details were provided and no additional AE's were reported. No PQC.; A nurse is reporting an AE on behalf of a patient. The caller states that a pediatric patient received PROQUAD intramuscularly instead of subcutaneously. No additional AE details were provided and no additional AE's were reported. No PQC.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.   On 15-NOV-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status recombinant Human albumin (rHA)) 0.5 ml, lot # W017570, expiration date: 29-NOV-2023 (strength and anatomical location were not provided) administered intramuscularly instead or subcutaneously for prophylaxis (Incorrect route of product administration). There was no additional adverse event (AE) details provided and no additional AE reported.
14 year old was given Pedi Pfizer 5-11 formulation by one of our volunteer vaccinators.  They followed  by giving Pfizer adult in the opposite arm. The patient had no side effects during their post-vaccination observation period.
Both times the vaccine seemed to cause heavy menstrual bleeding which is completely abnormal for me. This time around, after the second dose, I started getting bad cramps the night I received the vaccine and when I went to the bathroom several small blood clots came out. My period was supposed to start on May 5th so it started earlier and I?m a 28 day cycle kind of person.  I was awakened by worse cramps around 5am the morning after on 5/4/21. I had heavy bleeding and some more blood clots. I am not a heavy bleeder normally and I also rarely ever get cramps. This seems to be directly related to receiving the vaccine. I have had regular periods my whole life and haven?t had cramps and heavy bleeding since I was a early adulthood. In addition to the menstrual symptoms I had a pretty bad headache, nausea and significant fatigue following both vaccinations. I also had a slight fever although my body temperature runs lower than average so my fever was not alarmingly high, just higher than usual for me.
Noticed right of 12/15/04 left arm was red. More swelling noted 12/16/04. See pack applied off and on. Redness moved further down arm, will apply ice packs and take Benadryl, will go to MD on 12/18/04 if unimproved.
Shortly after vaccination began to c/o nausea, chills, and a metallic taste, became diaphoretic
Redness, edema, and itching to the left arm approximately 12 hours after administration of vaccine.
Clinician reconstituted vial  with 0.8 instead of 1.8 cc saline
I woke up the morning after the vaccine with: Headache Muscle aches Chills Nausea Weakness Pain at injection site
Patient demonstrates mild cellulitis versus erysipelas of the left anterior thigh secondary to an injection.
No additional AEs or PQC reported; Caller reports a 4th dose of ROTATEQ was administered to a 12 month old.  Dates of administration were 5/28/2021,  7/30/2021, 10/15/2021 and 4/15/2022.  Documented Lot # and Expiration date is from the dose administered on 4/15/2022.  All other lots; Dates of administration were 28-MAY-2021, 30-JUL-2021, 15-OCT-2021; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 28-MAY-2021 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and received additionally doses on 30-JUL-2021, 15-OCT-2021 (inappropriate schedule of product administration) (strength, dose, route of administration, lot number and expiration date were not provided), and on 15-APR-2022, the patient received a forth dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (extra dose administered) 2 milliliter, orally, (lot number 1742083 has been determined to be valid for, expiration date reported and established as 22-SEP-2022) all vaccines were administered as prophylaxis.  No adverse event.
COVID arm. Injection site got itchy and swollen and warm to the touch 7 days later. Felt like a mosquito bite welted. Lasted 3 days until it went completely away.
Began having chills, aches and nausea a few hours after receiving the vaccine. The side effects were strong enough to keep me in bed for two days.
administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date.; No AEs were reported; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date) and NO ADVERSE EVENT (No AEs were reported) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) 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. On 06-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date.) and NO ADVERSE EVENT (No AEs were reported). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date.) and NO ADVERSE EVENT (No AEs were reported) outcome was unknown.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No AEs were reported) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date).    No concomitant medications were reported. No treatment medications were reported.  Patient identifiers for patient number 2 were documented in this case
Itching and hives on body one day after. Took Benadryl. Symptoms have continued to present.
2nd year in a row where 2-3 days after FLUMIST vaccination my child complained of hands & feet tingling, pain in legs & armpits. Lost all ability to walk for 3 days. Could be Guillain-Barre syndrome.
about 20m after receiving routine 1 yr shots(MMR, Varivax, Hep a), in the car on the way home, baby began screaming , arching, grabbing at her face..extrememely agitated..called office.gave benadryl and was directed to ER..en route she improved and subsequently was normal.  Mom was very frightened by the intensity of this reaction.Child had tested positive on skin tests for egg allergy ( test done becaues of eczema);no hx of rash, swelling, diff breathing.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection (lot # L023232, expiry date 27-FEB-2017). There were no concomitant therapies reported. The medical assistant stated that the doses of the vaccines were exposed to a temperature excursion for a cumulative time of 2.5 hours (2 hours 27 minutes) at a temperature of -0.1 degrees Celsius. There was no previous temperature excursion involved. No adverse effect was reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pts wife called at 11:50 on 10/20/11 to report pt had high fever and chills at approx 12 hrs after at 11:50 temp was 99 degrees F.
bottom lip on the left side swelled very large; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6204) via an unspecified route of administration in the left arm on 16Mar2021 at 10:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included High blood pressure, anxiety/depression, high triglycerides and makeup tattooing on lips (permanent makeup). Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), drospirenone, ethinylestradiol (GIANVI), levothyroxine (MANUFACTURER UNKNOWN), duloxetine hydrochloride (DULOX) used for unknown indication from an unspecified date received within 2 weeks of vaccination. The patient was allergic to sulfa based antibiotics. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 at 20:00 on 5th day after vaccination, the patient had a swelling on her bottom lip on the left side swelled, was very large. The patient reported that it was not painful but it was just uncomfortable. The adverse event did not result in a visit to the doctors or other healthcare professional office/ clinic visit and emergency room/ department or urgent care. Therapeutic measures were taken as a result of event which included treatment with prednisone and Benadryl. The clinical outcome of the event swollen lips was recovered after 24 hours on an unknown date.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a consumer (patient's mother) refers to a 17 year old female patient with thalassemia and no drug reactions or allergies. Concomitant medications were not specified by the reporter. On 24-SEP-2013 the patient was vaccinated with GARDASIL (lot number, expiration date, dose and strength were not reported) intramuscularly. On 25-SEP-2013 the patient developed flu, trouble breathing, fever, shakes and shivers. The patient went to the emergency room. On 26-SEP-2013 the patient recovered from the events. The patient sought medical attention - went to the emergency room at hospital, the patient was not hospitalized. The relatedness between the events and GARDASIL was not reported. Additional information is expected.
Redness and warmth to right deltoid. Erythema site, diameter 15 x 11cm. Mild induration, without tenderness, streaking or lymphadenopathy.
mom states pt started crying 30 mins p/vax on 18SEP92 & cont to cry for 6 hrs & unable to get pt to calm down; took pt to ER this next day & was told to receive DT only next visit;
Woke up at 10:30pm freezing, chills   Checked temp at 2:00am =101.9 po  Also developed a headache (moderate)  Morning of 12/30/20 noted red flat rash on both forearms and front torso, which faded during day. Slightly present at this time. No itching.
About 9 hours later, I had diarrhea. 14 hours later, I had a temperature of 99.5. 28 hours later, I had a fever of 99.1.
soreness in the armpits area; experienced soreness at the injection site; This is a spontaneous report from a contactable consumer (patient) A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported) via an unspecified route of administration on an unspecified date in Mar2021 as single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported.  The patient experienced soreness at the injection site in Mar2021 and on 18Mar2021 had soreness in the armpits area. Patient wanted to know if they suggest taking Tylenol for it and wanted to know what area blood clot will show up.The outcome of the events was unknown.No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse concerning a 39-year-old female who in 1995 (12 years ago) was vaccinated with 2 doses of varicella virus vaccine live (Oka/Merck) and now has negative titers. The patient sought medical attention via a phone call with the physician. A product quality complaint was not involved. Additional information has been requested.
pt recvd vax;mac pap erythematous pruritic rash 1 day p/ vax;
Red Rash below injection site.   Itchy.   Rash lasted about 5 days.
Breakthrough COVID infection. Patient is a 45 yo M who reported to the ED on 1/14 for weakness and abdominal pain x 1 day. He also missed his dialysis because he didn't feel good. Pt. denied any other symptoms. ED workup included EKG showing sinus tachycardia, CT Abd/Pelvis showed bibasilar tree-in-bud and confluet opacities, concerning for infective bronchiolitis and bronchopneumonia. Lactic acid 2.5, Creatinine 12.73. Pt given IV Abx, IV steroids, IV fluids and received immediate dialysis.
I was completely Healthy I had ate and drank water, I went to get vaccine in my left arm. I got the shot and sat down to wait the 15mins, left arm starting tingling then going numb, I felt a warm sensation going across my chest then my right arm started tingling . I started feeling hot and so I put my hair up and then I was waking up on the floor i had passed out my blood pressure was low and they couldn?t get my pulse. I could not move my whole body was tingly and numb and my hands and fingers went stiff and I could not move them from that position. I haven?t had issues with my blood pressure before it?s usually textbook and my bp was 70/50. The first responder tried to sit me up and I almost passed out again I was taken to the hospital on the way I was given an ekg and saline. I still could not move , my body was heavy and my throat was starting to feel like it was closing it was hard to breathe. At the hospital I was given more saline and blood was taken I could not stand for about 4 hours and my blood pressure was still very low. When my bp got up they sent me home. I was very tired and achy. The next day 9/17/21 I was still very drained and weak I also had 2 nosebleeds ( never really had for no reason )  and I felt really bad , headache and a little dizzy. I have a follow up appointment with my primary In a few days.
Patient experienced tingling within 15minutes of getting the vaccine, went away shortly after but came back a few days after along with heart palpitations which both come and go.
8/31/03: rash bilateral groin/itchy. 9/2/03: Trouble sleeping/rash to back. Received med, took only 3 dosages out of 4 required.
HYPOTENSION 4/17/2023 PSEUDARTHROSIS AFTER SPINAL FUSION
Tetanus Vaccine administer on 02/19/2022 at 13:14. Pt reporting reactions began on 02/20/2022 at 18:00 which includes flu like symptoms, left upper arm with redness and swelling at site of injection measuring 1.5 x 2.25 inches with skin intact and no drainage.  Pt's temperature noted at 99.7 degrees Fahrenheit on 02/21/22 at 6:36 PM. Pt counseled on application of cold compress for swelling, the importance of seeking emergency treatment in the event of an anaphylaxis reaction, Medical Staff follow up and Medical Director review of adverse event. Pt verbalized understanding, denies respiratory distress or any other complications at this time and departed the facility in stable condition.
Patient experienced chest pain and shortness of breath. Visit to emergency room ruled out cardiac event. Patient subsequently developed redness and soreness at injection site. The area of the injection site reaction was approximately 4 inches in diameter.
Patient was given expired vaccine. Patient did not report any adverse effects from vaccine. Patient will be coming back to be revaccinated.