chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in the injection area; Five days of headaches; chills; aches; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP).  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Sep2021 (Lot number: FF2588) at the age of 33 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEXIPRO; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PANTOPRAZOLE; DICYCLOMINE. The following information was reported: VACCINATION SITE PAIN (hospitalization) with onset 05Sep2021, outcome "recovering", described as "pain in the injection area"; HEADACHE (hospitalization) with onset 05Sep2021, outcome "recovering", described as "Five days of headaches"; CHILLS (hospitalization) with onset 05Sep2021, outcome "recovering", described as "chills"; PAIN (hospitalization) with onset 05Sep2021, outcome "recovering", described as "aches"; FATIGUE (hospitalization) with onset 05Sep2021, outcome "recovering", described as "fatigue". The events "pain in the injection area", "five days of headaches", "chills", "aches" and "fatigue" were evaluated at the physician office visit and emergency room visit. It was unknown if therapeutic measures were taken as a result of vaccination site pain, headache, chills, pain, fatigue.  Additional information included: no covid prior vaccination. The patient had no known allergies and had no days hospitalization.  No follow-up attempts are possible. No further information is expected.
Information has been received from a consumer concerning her 11 year old Caucasian son with no known medical history who on 25AUG1995 was vaccinated in the deltoid with a first 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. There was no illness at the time of vaccination. During the first week of January 2004 the patient developed a full blown case of chickenpox. Unspecified medical attention was sought. There was no treatment required for the adverse event. Subsequently the pt recovered. There was no product quality complaint involved. Follow up information form the physician indicated that the patient was not seen since 05OCT2002. It was reported that the pt has a history of congenital bilateral hydronephrosis and vesicostomy. No further information is expected.
BREAKTHROUGH COVID INFECTION. PT FULLY VACCINATED ON MARCH 11 2021. PT HAD POSITIVE COVID TEST AUG 31 2021
Information has been received from a medical assistant concerning a 26 year old patient with no drug allergies and no pertinent medical history who on 10-NOV-2009 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (LOT# 663452/0671Y). There was no concomitant medication. On 11-NOV-2009 the patient experienced temperature, stuffy nose and "felt like she had a cold". The patient received the second dose of GARDASIL (LOT# 662304/1013Y) late on 23-MAR-2010. There was no lab diagnostic performed. The patient had an office visit for the second dose of GARDASIL. On an unspecified date, the patient recovered from temperature, stuffy nose and "felt like she had a cold". Additional information has been requested.
Patient has developed an itchy rash around one of the vaccines place on right arm (had influenza and MCV) on that arm. Not sure which one. Mother place cool towels and used benadryl cream, but still itchy. No getting worse. No systemic reactions
I had severe pain in my left arm.  It radiated from my shoulder blade all the way down to my fingers.  I had no strength in my thumb or my index finger.  I can't grab anything.  I lost the movement in my hand.  These symptoms have been going on for 2 weeks and 2 days now.  They are getting worse.  I went to the ER.  They gave me a shot and referred me to a neurologist.  I have not seen the neurologist yet.
Headaches on/off (bitemporal). Burning eyes. Vomited one time.
Developed 100-102 T. /w extreme irritability X 4 days resting 20 min/d (nap time) - for 2 days. Exam normal. On day #5 decreases irritability & slowly improving.
Enlarged lymph node in left axilla; started 01/09/21; painful to touch; resolving
Pt received Gardasil and within a minute, pt fainted while sitting on table, fell of and hit her head on a drawer handle, pt began to seize. Called 911, she was stabilized by EMS. 03/05/07-records received from PCP:Five minutes after administration of vaccine episode of eyes rolling back, fell off exam table and struck neck and head on cabinet drawers. Unresponsive to voice with stiffening of all extremities. Event lasted 30 seconds, afterwards alert oriented and recalled speaking to urse prior to event. Glucose 76, O2 sats 99% on RA. BP after episode 99/52, pulse 49. Transported to ER.  03/09/07-records received from facility for DOS 2/16/07-DX:Syncope. Post syncopal seizure.
Generalized convulsive epilepsy; Literature Report.   Information has been received from the authors of a published literature article, title as stated above regarding to a child patient of an unknown gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant therapies.  On an unknown date, the patient was vaccinated with at least the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) to prevent measles (dose, vaccination scheme, route of administration, anatomical injection site, lot number and expiration date were not reported).  On an unknown date, the patient experienced generalised convulsive epilepsy (generalised tonic-clonic seizure). At the time of the report, the outcome of the event was not reported.  The authors considered that the event generalised tonic-clonic seizure was considered to be related to suspect vaccine as this event was considered a rare consequence of routine childhood measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccination.  Upon internal review, the event generalised tonic-clonic seizure was determined to be medically significant.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same reporter (MARRS# 2010USA001144).; Sender's Comments:  US-009507513-2010USA001144:
Bruising and soreness noted next morning2/5/21. Site continued to get darker and reddened and itchy more each day. On 2/8 I contacted my doctor and sent him a photo of my arm and he saw me in his office. He described it as hemorrhagic dermatitis. He didn?t prescribe an antibiotic as he thought it might interfere with vaccine. Prescribed Claritin , ice packs to area and forward daily photos to monitor closely. The injection site is bslow the deltoid.
Severely light headed with loss of balance. Unable to walk to car or drive. Lasted about 6-8 hours.  Did not seek medical care.
Hives, Some tightness in chest  Given Benadryl, Prelone 20 mg/kg x 1 and Zantac
Patient developed a warm round rash at the injection site. This developed the following day and was about 3 inches in diameter. She was also slightly feverish the day following the immunization.
Feel awful.  Headache, nausea, muscle pain, emotional for no reason.  (Plus the injection site has a bump and arm is very sore).
Flu symptoms, stomach aches, severe headaches, cough, pain in chest when taking deep breaths, shortness of breath, gall bladder inflamed, high inflammation markers.
recieved 1st dose Moderna 4/1/2021 patient admitted for chest pain and elevated troponin 4/12/2021, non-ST elevated myocardial infarction. Left heart cath performed. Possible coronary vasospasm as cause of chest pain and elevated troponin, although there was no spasm around the catheter on either vessel.  recieved dose 2 of Moderna 4/30/21.  Admitted 6/20/21 for Non-ST elevations MI, chest pain
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever and myalgia. On an unknown date, the outcome of the fever and myalgia were unknown. It was unknown if the reporter considered the fever and myalgia to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The reporter did not know the date of birth of patient.
None for first injection. Second injection started with extreme chills, moved to headache, muscle ache,  weakness.  Lasted 24 hours, mitigated with Tylenol. 10 days  later,  still suffering intermittent fatigue, weakness, inflamed lymph node  near left breast, diarrhea and muscle ache.
Redness at injection site of >2". Temperature of 102F. Seen in ER and dx'd with infection at the site. Treated with cephalexin X 7 days.
Patient developed severe lymph node swelling. Per mother, multiple areas around his head and torso have lymph node swelling that is painful and large. Swelling has remained the same, but the pain has lessened over the last few days.
tested positive after feeling punk. Rx plaxovid. felt better after 2 days. Was running fever of 100.5F on first day. had one half day rebound of fever and malaise on Saturday, 18 Feb. Fine the next day. Tested positive until Feb 21
pt recv vax 27JUN97 & woke up next day w/a bilat rash in the ears;the ear canal was very swollen (unable to examine);pt also had a rash all over body & was very itchy;pt denies chest tightness, breathing problems, or any s/s of anaphylaxis;
The subject received a H1N1 shot in right arm and seasonal flu shot in left arm. She had pain in her right arm beginning on the day of vaccination and neck stiffness for around four days. She also had a tingling sensation in her left hand but not in her fingers. She experienced malaise, fatigue, irritability, abdominal pain, decreased appetite, and muscle pain. She thinks the injection site was probably 4 inches from the tip of shoulder on both sides. Her symptoms relieved without any medical intervention. She does not have any chronic health problem or history of vaccine-related adverse reactions.
fever of 100,4; chills; muscle aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020, the patient received Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced fever, chills and muscle pain. On an unknown date, the outcome of the fever, chills and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills and muscle pain to be related to Shingrix.  Additional details were provided as follows: A day before reporting at 5:30, the patient received Shingrix. On 10th March 2020, the symptoms like fever with chills and muscle pain started. At the time of reporting, the patient had a fever of 100.4 Degree F. The medical assistant informed patient that the majority of solicited local adverse reactions and general adverse events seen with Shingrix had a median duration of 2 to 3 days and recommended patient to speak with your healthcare provider.
received only first dose 2 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-JUN-2022 Reporter's Comments: No lot or expiration date were available. The reporter consented to follow-up. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
I received my second dose of Pfizer vaccine on 1/8/2021. I had titers drawn to check my immunity by the vaccine on 1/30/2021 and they were high. I have tested positive for Covid with a P23 PCR saliva test on 02/09/2021. I have mild symptoms: aches, low grade temp, intermittent cough
This spontaneous report was received from a pharmacist regarding a 31 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 09-JUN-2018, the patient was vaccinated with M-M-R II 0.5mL, subcutaneously in the right upper arm, for prophylaxis, lot# M014902 and 22-MAR-2018 expiration date (strength and frequency were not reported). After the administration it was discovered that the expiration date was 22-MAR-2018. The patient had not experienced any adverse reactions.
no further ae reported; Temp excursion occurred on 11/22/21; This spontaneous report was received from a nurse referring to a 35 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Temperature excursion occurred on 22-NOV-2021. On 10-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the left arm (lot U010398, expiration date 01-APR-2023) (strength and dose were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously in the right arm (lot T034389, expiration date 08-OCT-2022) (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
This spontaneous report was received from a health care worker refers to a patient of unknown age. Patient medical history and current condition was not reported. On an unspecified date since MARCH-2015 the patient administered VARIVAX (Merck) (Lot number and expiry date not provided) of unknown dose which underwent supported temperature excursions due to defrost cycling. No adverse effects reported. Product quality complaint was not reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Seizure-like convulsions, followed by lethargy. Was awakened from sleep with tremors.
Initial information received on 05-Oct-2018 regarding an unsolicited valid serious case received from a other health professional. This case is linked to cases 2018SA279494 and 2018SA279814 (same reporter). This case involves a male patient (patient 01) who experienced cellulitis and reactions between the injection site and elbow, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history and concomitant medications were not provided. On  03-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ004AB (expiry date: 30-Mar-2019) via intramuscular route in unknown administration site. On an unknown date, The patient developed a serious cellulitis following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. On an unknown date, The patient developed a non-serious reactions between the injection site and elbow (local reaction) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included no lab test reported.) Final diagnosis was reactions vaccination site reaction and cellulitis. The patient was treated with amoxicillin sodium, clavulanate potassium (augmentin [amoxicillin sodium;clavulanate potassium]) for Cellulitis. The patient outcome is reported as Recovering / Resolving for both events. list of documents held : none; Sender's Comments: This case involves a male patient who presented with cellulitis. Time to onset is not known. There is, however, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
0.25 mL administered as first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (0.25 mL administered as first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (0.25 mL administered as first dose). At the time of the report, ACCIDENTAL UNDERDOSE (0.25 mL administered as first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided.  The patient received second dose  of 0.5mL 28 days later of first dose. No symptoms reported.  No treatment information was provided.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A female patient of an unspecified age (reported age: over 65, unit: unknown) and ethnicity received PREVNAR 13 via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced weakness for a few days on an unspecified date after the injection of PREVNAR 13. Outcome of the event was unknown. Information on batch and lot numbers has been requested.
Information has been received from a 50 year old female patient who received two doses of "pediatric chicken pox" VARIVAX, WAES #0708USA02982 and one dose of ZOSTAVAX for the treatment of sacral and left hip "herpetic pain". The patient reported that she experienced improvement of her pain after the immunizations. Additional information has been requested.
Mandatory EUA Reporting - Patient received Moderna COVID-19 vaccine on 1/4. She was living with someone who was diagnosed with COVID-19 on 1/11. Patient was tested on 1/11 and was negative for COVID-19. Then about 4-5 days later developed symptoms and tested positive. She was admitted to hospital on 1/20/2021 to medical floor, transferred to ICU on 1/27, and died on 2/5/2021.
On March 10th I felt pain in my right armpit for 36 hours and the lymph nodes were swollen in my armpit.  On the evening of March 10th I felt tired and unwell similar to having the flu.  The next morning the flu like symptoms were gone
Initial unsolicited report received from a non-healthcare professional on 30 March 2015 and Follow-up information received from non-healthcare professional on 19 June 2015. A male patient (age not reported), whose medical history was reported as diarrhea, tiredness and concomitant medication was not reported, had received a dose of INFLUENZA VACCINE (batch number, dose of vaccine, route and site of vaccination were not reported) on an unspecified date. It was reported that, diarrhea and tiredness which was illness at time of vaccination were not related to Flu vaccine. On an unspecified date, patient had Allergies: Flu vaccine. Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none.
This spontaneous report was received from a physician refers to a 10 year old female patient. The patient had no pertinent medical history. On an unknown date, the patient was vaccinated with a dose of 0.5 ml GARDASIL, (lot number, expiration date was not reported, route intramuscular). Concomitant medications were not reported. On 05-JAN-2013, the patient experienced fever and stated that the fever was not quantified. On 05-JAN-2013, the patient had many vomiting at day 18 of dose 1. The outcome of the events were unknown at the time of this report. Additional information has been requested.
Fourteen days post vax, this pt experienced pain in the joints of both feet and the knuckle of one thumb. No further information is available.
Case number PHEH2015US022483, is an initial spontaneous report received from a pharmacist on 30 Oct 2015. This report refers to a 32-year-old female patient. Medical history was not reported. Concomitant medication was not reported. It was reported that FLUVIRIN (batch number: 1515001) form multi dose vial (MDV) was administered intramuscularly to the expectant patient on 30 Oct 2015. Final outcome, seriousness and causality was not reported.
I had a severe headache. I had sore throat, coughing, running nose, and sneezing. I also had fatigue and brain fog. I had some shortness of breath. These symptoms lasted for about 10 or 11 days. I tested positive for Covid19 on Nov 22nd.
Nauseous for 2 days after; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Apr2021 at 14:30 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, latex allergy, allergy to bananas, cucumber and seasonal allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC), ethinylestradiol; drospirenone (YASMIN 28), amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL), colecalciferol (VITAMIN D 3) and d-mannose (MANUFACTURER UNKNOWN); all taken from an unknown date for unknown indications. The patient previously took the first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 12Mar2021 at 15:15 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. 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 COVID-19 vaccination. On 07Apr2021 at 00:00, the patient reported that she felt nauseous for 2 days after and experienced diarrhea. 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. The clinical outcome of the event nauseous for 2 days after was resolved on 09Apr2021 at 00:00 and the clinical outcome of the event diarrhea was resolved on an unspecified date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.