chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed full body rash.  Her face, neck, and chest were red. Her Thighs were hot. She went to the emergency room that evening where she received benadryl, pepcid, and a steroid. She has received vaccines cultivated in eggs before with not problems.
Information has been received from a registered nurse concerning a 9 to 10 year old male who on an unspecified date was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed "swelling the size of a grapefruit on his thigh". Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Given H1N1, .25cc (NOVARTIS) IM to 6 month old. No side effects at this time.
ARM ALL THE WAY DOWN TO BELOW ELBOW WAS SLIGHTLY SWOLLEN AND RED.  LOOKED LIKE A BURN AND APPEARS THAT THE PORES ARE OPEN.  PATIENT ICED IT DAY AFTER VACCINATION.  SLIGHTLY SORE BUT NO REAL PAIN.  48 HOURS LATER IS STILL RED BUT IMPROVING.
4 days of painful erythema at injection site; first day also had shaking chills; first 2 days felt febrile.
After receiving the vaccine, my mom experienced multiple side effects that were explicitly described on  the website. She experienced a smal hard knot at her left arm at the injection site which started to spread down to involve her upper left arm. The area became red, warm, painful. It was also very itchy. She developed fatigue, nausea, and loss of appetite. The day after the vaccine, she had a fever and developed chills for 10 minutes. She also had diffuse body aches.
I waited for 30 and 45 mins after the vaccine.  I started to have shortness of breath.  I took my inhaler, and it didn?t work.  It?s kind of subsided but did not work.  The next day I still had shortness of breath.  I also began to vomit.  I also had a headache.  I also was still having shortness of breath.  I also had a postnasal drip.  Not sever but notable.
Patient experienced redness around site of injection, that redness continued to spread, we found out on 11/24/13 because she came in with a prescription for Bactrim. She was told to see if the spreading of redness subsided by 11/27/13 and to let her physician know if it didn't. She said it was painful.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 20-OCT-2014 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # H014029, expiry date: 07-SEP-2014, dose, units, route of administration, anatomical location were not reported). The reporter stated that the dose of RECOMBIVAX HB had never been exposed to a temperature out of the recommended storage range. No adverse effects reported. Additional information has been requested.
headache; sore arm at injection site; severe shortness of breath; skin on her entire left palm was peeling; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (severe shortness of breath), SKIN EXFOLIATION (skin on her entire left palm was peeling), VACCINATION SITE PAIN (sore arm at injection site) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetic. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LISINOPRIL, METFORMIN, GLIPIZIDE, PIOGLITAZONE HYDROCHLORIDE (ACTOS), EZETIMIBE (ZETIA), FAMOTIDINE and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.    On 04-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore arm at injection site). In March 2021, the patient experienced DYSPNOEA (severe shortness of breath). March 2021, the patient experienced SKIN EXFOLIATION (skin on her entire left palm was peeling). On an unknown date, the patient experienced HEADACHE (headache). In March 2021, DYSPNOEA (severe shortness of breath) had resolved. At the time of the report, SKIN EXFOLIATION (skin on her entire left palm was peeling), VACCINATION SITE PAIN (sore arm at injection site) and HEADACHE (headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Oxygen saturation: 95 (Inconclusive) 95.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       At 10:00 AM the patient felt almost normal from barely breathing, but did end up borrowing her neighbors pulse oximeter where she saw that was at 95%. The patient stated that on the right arm a little spot that was smaller than a pencil eraser that was starting to peel. The patient stated that she did not  know how many layers peeled off but it did not hurt or bleed, and it was just her palm.  No treatment information was provided.
5 days after injection in the evening, left side of base of neck felt tender and lump could be felt. Day 6, in the morning, visible swelling could be seen on left side base of neck where it meets the shoulder. Tenderness was still present throughout the day and by the evening around 6pm earache right side started to present itself.  400mg ibuprofen taken at 8:30pm for earache. 1230am 1000mg of Tylenol taken for same earache. Day 7-6:00am , swelling and hardness at sight of injection (left arm), earache gone, lymph node still swollen left side of neck . Felt very lethargic and lightheaded throughout day and some itchiness around injection site. By the early evening of day 7, large red swelling like welts appeared and was itchy around and down injection site. Area was also tender and sore. Benadryl taken at 9pm along with 600mg Ibuprofen. Day 8, redness and swelling still present but no longer itchy. Energy level back to normal. Headache present at 2pm, 1000mg tylenol taken. By 4pm, headache is gone. Some itchiness has returned to left arm, swelling still present.
Pt. received Pfizer COVID vaccine.  10 minutes post-injection, complained on "itchy throat", indicates difficulty swallowing and tongue numbness.  No difficulty breathing.  Pt. transported to ED, treated, and discharged with resolution.
Breakthrough case admission after three vaccines Moderna 3/4/21 Lot# 029A21A;  Moderna 4/1/21 Lot# 28A21A;  Moderna 11/30/21 Lot# 058H21A
Fever; Nauseous; Terrible migraine; Fatigue; Chills; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 08May2021 at 08:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included herpes simplex virus (HSV2), asthma. The patient was allergic to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included Goli ACV (MANUFACTURER UNKNOWN), aciclovir (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and ibuporfen (ADVIL); all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in right arm on 11Apr2021 (at the age of 55-years-old) at 08:45 as a single dose for COVID-19 immunisation. On 08May2021 at 20:00, the patient experienced fever, nauseous, terrible migraine, fatigue and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events fever, nauseous, terrible migraine, fatigue and chills. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, nauseous, terrible migraine, fatigue and chills were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
chills; fevers; This is a spontaneous report from a contactable consumer (parent). This consumer reported same events for two patients. This is the first of two reports. A male patient of an unspecified age received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced chills and fevers on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021168417 Same reporter, drug, event; different patient
This spontaneous report was received from a pharmacist, concerning to a patient of unknown age and gender. The patient pertinent medical history, drug reactions/allergies were not provided. On 05-DEC-2013, the patient was vaccinated with an expired dose of PNEUMOVAX23 (Lot # 1947AA, expiry date on 20-OCT-2013) (route and dose not reported). Co-suspect therapy and concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Lightheadedness, after first vaccine; Weakness, after first vaccine; Felt like she ran a marathon, after first vaccine; Stomach upset, after first vaccine; Bad stomach pains, after first vaccine; This is a spontaneous report from a contactable consumer (patient herself).   A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number: unknown, expiry date: unknown), via unspecified route of administration on an unspecified date as DOSE 1, SINGLE for Covid-19 immunisation. She got her vaccine at her doctor's office. Patient s medical history and concomitant medications were not reported. Patient stated she got her first dose 3 weeks ago and was due for her second shot today. She asked if the second shot will make her react in the same way, when she got her first shot. Patient stated that after the first shot, she had light headedness, weakness, felt like she ran a marathon, stomach upset and bad stomach pains on an unspecified date. These effects lasted for over a week. She wanted to know whether her doctor could answer her question. Patient was due for her vaccination today (The consumer might miss her dose) and she want to know about will it make her feel the way she felt when she got the 1st one.The outcome of the events was recovered.   Information on the lot/batch number has been requested.
Patient was to receive injectable Flu Vaccine and the age was over looked.  Patient recieved FluMist at age 50. Patient has had no Current symptoms.
SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer through other manufacturer (Pfizer Inc.) concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy, and drug allergy (fosomax and arthrotec). The patient received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, dose 1, was administered on 10-MAR-2021 to left arm for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included levothyroxine sodium (Synthroid).  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received 2 doses (second and third dose) of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 017F21A, expiry: unknown) administered on 02-NOV-2021 to left arm and (form of admin, route of admin were not reported, batch number: 005M21A, expiry: unknown), administered on 20-APR-2022 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with 2 doses (second and third dose) of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2). The patient also received fourth dose with Non-company suspect vaccine Moderna covid-19 vaccine, (elasomeran), (Dose number in series 3), (form of admin, route of admin were not reported, batch number: AS7162B, expiry: unknown) dose was not reported, administered on 20-SEP-2022 to left arm for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 3). On an unspecified date in 2023, the patient experienced suspected covid-19 infection (Dose number in series 3). The patient started taking treatment with non-company drug Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported from 27-SEP-2023 to 01-OCT-2023 for suspected covid-19 infection. On 07-OCT-2023, after 5 days of last dose with treatment with Paxlovid, the patient experienced covid-19 rebound (suspected covid-19 infection) (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (Dose number in series 2), and elasomeran (Dose number in series 3) was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Two minutes post . vaccination Pt reponed neck pain. Pain level 5 out of 10. V/S taken BP 152/74 HR 95 Spo2 93 o/o RP 18. Patient observed for an additional 15 minutes. Prior to discharge v/s retaken BP 136/79, HR 86 Spo2 96o/o. Patient reponed pain level  2 out of 10
I had a headache and sore throat, my temperature moved to a second degree above normal (99), chest cold. I email my doctor and tell me to take TYLENOL for the fever and MUCINEX for the chest cold. I took it for 7-10 days. I was fever but I still have cough for 3 weeks. I still have flame. I have allergy season. I took the home test, and it was positive. I have COVID.
Pt was given pneumococcal vaccine booster sub q left upper arm at 10:28 am on 03/02/10. Came to health center on 3/4/10 at 3pm. With left red swollen elbow. Pt went to pilates class this AM. Elbow appeared normal to pt before class.
Headache; Nausea; Dizziness; Fever; Muscle Aches; Diarrhea; Pain in lymph nodes; pain in arm of the injection (left arm); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jan-2021 and was forwarded to Moderna on 20-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ( ) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date for Adverse event, at a dose of 220 mg x2 tabs.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        she gave consent for safety to contact her or her healthcare provider if additional information is needed. and the out come was unknown so the follow up necessary
I had no reaction to the vaccine. In March 2022, I started coughing in the middle of the night. Probably due to an allergy or cold and eventually it cleared up. My doctor referred me to an allergist, and I was tested for several things. I was diagnosed with encephalitis asthma. I have been tested for COVID-19 numerous times and they were negative. I clear my throat a lot throughout the day.
Vaccine given to 17 year old; A spontaneous report  was received from a health care professional (Nurse) concerning 17-years old male patient who got mRNA-1273 vaccine at the inappropriate age.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On 20 Feb 2021, the patient received first dose of mRNA-1273 (Batch number: 023M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  The reporter reported that the patient is completely fine and has no symptoms.  Action taken with the drug in response to the event was not applicable.  The outcome of the event was considered as recovered on 20 Feb 2021.; Reporter's Comments: This case concerns a 17-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Pt c/o bilateral arm itching within three min of vaccination. Within 5 min  pt stated itching was almost gone. Pt observed for 30 min. VS wnl. Pt given instructions when to call MD and when to go toER
Information has been received from a registered nurse concerning a 21 year old female with no drug allergies and no medical history, who on 14-MAY-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot# 657621/0387U).  Concomitant therapy included ORTHO TRI-CYCLEN.  Several weeks after the first dose, on 23-JUL-2007 the patient developed a generalized rash.  On 30-JUL-2007 the patient was vaccinated in the left deltoid with a second dose of GARDASIL (Lot# 658490/0802U).  No laboratory diagnostics were performed.  The patient sought unspecified medical attention.  At the time of the report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 9/17/2007. Additional information is not expected.
Rapidly progressive arm pain and swelling which soon became very severe. Unable to move arm at all due to pain and swelling. Initially called physician's office at 3pm and advised by nurse to take ibuprofen and apply ice followed by heat. Called again and paged physician around 8:30pm to report marked progression of swelling and pain. Advised to take Benadryl 50mg and plan to see MD the following day. Evaluated 12/13 12:30pm confirming findings as described. Upper arm circumferentially swollen, exquisitely tender and hot. Unable to move upper arm due to pain. Treated with course of prednisone.
"COVID arm" red, itchy, large rash that appeared 8 days after first dose of Moderna. Feels swollen and feels like there is a hard lump under the skin at the injection site.  Photo available upon request.
Diarrhea; Headaches; Fever; This is a spontaneous report from a contactable physician. A 68-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, rheumatoid arthritis and coronary artery disease. The patient had no known allergies. Concomitant medications taken within two weeks included hydroxychloroquine (MANUFACTURER UNKNOWN), methotrexate (MANUFACTURER UNKNOWN), linagliptin (TRADJENTA), pantoprazole (MANUFACTURER UNKNOWN), diltiazem (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN), isosorbide (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), folic acid (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN), all from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 12:00, the patient experienced diarrhea, headaches and fever. Therapeutic measures were taken as a result of the adverse events which included treatment with imodium, tylenol from unknown date. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event diarrhea, headaches and fever was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 14 year old female who on 07-MAR-2007 was vaccinated with the first dose of 0.5ml of Gardasil IM. During the same visit, the patient was vaccinated with hepatitis A vaccine (inactive) (duration and dose not reported). The patient returned to the office 4 hours after her appointment complaining of dizziness. The patient was monitored for 1 hour. During that time, the patient recovered from dizziness and was sent home. No lab testing was performed. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/13/2007.  In follow-up, it was reported there were no further details to provide.  Additional information is not expected.
PATIENT DEVELOP 4" AREA OF ERYTHEM AND INDUATION AT SITES OF VACCINE(BOTH THIGHS).  PATIENT WAS TREATED WITH NSAID.
This spontaneous report was received from a nurse refers to a 5 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 01-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M044397, expiry date: 20-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054.
Mouth and tongue numb; bitter taste; soreness; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Mouth and tongue numb), DYSGEUSIA (bitter taste), PAIN (soreness) and NAUSEA (nauseated) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included EZETIMIBE, AMLODIPINE, LISINOPRIL, GLIMEPIRIDE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN (soreness) and NAUSEA (nauseated). On 12-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (Mouth and tongue numb) and DYSGEUSIA (bitter taste). On 11-Feb-2021, PAIN (soreness) had resolved. At the time of the report, HYPOAESTHESIA ORAL (Mouth and tongue numb), DYSGEUSIA (bitter taste) and NAUSEA (nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took no treatment for symptoms.