chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergy has spread on the ankle and back; hives; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (hives) and HYPERSENSITIVITY (allergy has spread on the ankle and back) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced URTICARIA (hives). On 05-Apr-2021, the patient experienced HYPERSENSITIVITY (allergy has spread on the ankle and back). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Allergy, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) and HYPERSENSITIVITY (allergy has spread on the ankle and back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.   Doctor gave 3 Dexamethasone and Benadryl to treat adverse event.
L clavicular swollen gland, Local site discomfort,  reness, swelling  Narrative:
Severe chills; Headache; Fatigue; Late night stomach cramps; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left  arm on 05Jul2021 at 20:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included supraventricular tachycardia (SVT). The patient had known allergies to iodine, penicillin and shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included propranolol (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0180), via an unspecified route of administration in the left arm on 14Jun2021 at 10:00 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jul2021 at 10:00, about 14 hours after 2nd dose the patient experienced severe chills, headache, fatigue, then late night stomach cramps and then diarrhea. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event severe chills, headache, fatigue, late night stomach cramps and diarrhea were resolving at the time of this report.
Client obtained his first dose and second COVID vaccines (first dose Pfizer COVID vaccine lot: EW0182 on 05/12/2021 and second dose Pfizer COVID vaccine lot: EW0187 on 06/02/2021 both). Client received his Pfizer Booster COVID vaccine lot: FL3197 exp: 06/30/2022 today at 12:02PM.  Ancillary was approached by client's family member. Family member reported that client got vaccinated earlier, feeling dizzy and is lying on the floor. Ancillary then reported it to RN. RN then instructed Ancillary to call the RN Leads. RN and Ancillary approached client and client was sitting in the back seat of the their car drinking water. RN and RN responded as well. Ancillary assisted with translating from another language for client's family members during entire conversation. Client reported that he got vaccinated earlier and that he finished his 15 minutes observation with no issues. Client reported that he felt dizzy 5 minutes ago, which was around 1:14PM, felt anxious and hot, so he took off his shirt and started walking around, he then sat down and laid on the ground. Client denied falling on the ground. Client reported that he did eat earlier at around 10am, but has not been drinking water and that he only had coffee this morning. Client has no medical condition, no known allergies, and is currently taking any medications. Client reported that he's feeling okay now. RN and Co Lead RN educated client to ensure to drink water, rest, on ER precautions and when to contact MD and client verbalized understanding. Client left with family at 1:24PM.
paralyzed; Initial information received on 25-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care.  This case involves an unknown age and gender patient who was paralyzed (paralysis) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease, or risk factor.  The patient medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious event paralyzed (paralysis) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was reported "patient never had a flu shot except the one time my doctor gave me the injection without me knowing it was coming. Patient knew of one reaction and that person was paralyzed. Patient would fall within that 1 percent, whatever measurement they had for negative reactions".   There were no laboratory data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  Information on the batch number was requested.; Sender's Comments: This case involves an unknown age and unknown gender patient who had paralysis after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. There is no further information regarding patient's medical condition at time of vaccination, history and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of a vaccine cannot be assessed.
Staff did not dilute Pfizer vaccine before administration. According to the Pt's received 0.3mL of undiluted Pfizer vaccine.
Chills, fever, fatigue.  Arm is swollen and sore.  Legs are sore.  Have spent the last two days trying to sleep.  Cannot decide if I am hot or cold.
This is spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 04-FEB-2008, the patient was vaccinated with ZOSTAVAX, (lot #, dose, frequency and route of administration not reported). On 23-OCT-2015, the patient was inadvertently administered with the second dose of ZOSTAVAX. No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Pt had imm around 4:30PM. Went home, seemed X 2hrs. Around 8pm became very fussy temp 100.6.  Didn't sleep well that nite. Next day was somewhat lethargic. Fever 101.6  1 Diarrhea stool - pt was sleepy, cranky. Acted same on 2/1/08 appetite down also. Lips blue AM x 2 hrs.
Adverse effect of other bacterial vaccines, init encntr on 2017-11-20.
Information has been received from a physician concerning a female with asthma who was vaccinated with the first dose of Gardasil "a few weeks ago." Subsequently, while at home, the patient developed fever, chills, sweating, difficulty breathing and swelling at the injection site. The patient sought unspecified medical treatment. On an unspecified date, the patient recovered. Additional information has been requested. This is one of two reports received from the same source.
It kind of built up I just noticed it more lately. The chest pain has moved over from my left side to my right. Over the last month and a half I have cut my metoprolol dose in  half and here lately having these chest pains I do not understand as I have been healthy my whole life I am loosing weight as I know this is a factor as well and now I am back to normal weight or almost to where I should be.
concerned about some focal bruising, erythema and soreness at the site of injection (L deltoid). Patient states she did not have any reaction to the first dose aside from some muscle tenderness. Denies fever, chills, seizure, headache, arthralgias, N/V, abdominal pain, diarrhea, urticaria, dyspnea, wheezing.
Information has been received from a medical assistant concerning multiple patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unspecified dates, the patients were vaccinated with PROQUAD (lot # M034692 with expiration date: 24-JAN-2018 and lot #: L046509 with expiration date: 17-MAY-2017) (dose, dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 5°F but less than 14 °F for 48 hours and at temperature greater than 14°F but less than 46°F for 72 hours without any previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000247: US-009507513-1702USA000248:
Sore neck was reported as worsened; Sore neck; sore arm; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), intramuscular, administered in Arm Left on 17Feb2021 12:08 (Batch/Lot Number: EM9809; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included stiff neck. There were no concomitant medications. The caller explains the arm soreness developed on 17Feb2021 after she got home from receiving the vaccine. She couldn't sleep on her left side, which she is used to doing that. She hasn't slept on her left side still. Right now, where the needle went is a little sore, but her arm is okay. Her neck just hurts. The caller states her neck started to get sore probably last night while she was sleeping. She had a little bit of sore neck yesterday (18Feb2021) and last night. But, she woke up this morning and it was worse. She could move her neck and everything up until this morning. The outcome of the events sore arm was reported as recovering. The outcome of the event Sore neck was reported as not recovered. The outcome of the event Sore neck was reported as worsened was reported as unknown.
low grade fever / fever around 100; fatigue; intermittent  headache; feel foggy, my head feels a little foggy, strange feeling in my head just a little out of it; Arm pain near injection; some upset stomach; diarrhea; This is a spontaneous report from a contactable female consumer (patient).  A 39-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right on 22Feb2021 13:00 (Batch/Lot Number: EL9267) as single dose at the age of 39-year-old for COVID-19 immunisation, 24 days apart from dose 1.  Medical history included hypothyroidism subsequent to radioactive thyroid ablation for hyperthyroidism. No known allergies. No COVID prior vaccination. Concomitant medication(s) included levothyroxine sodium (manufacturer unknown) at 125 mcg taken for an unspecified indication, start and stop date were not reported taken for many years. Vaccine history included bnt162b2 (BNT162B2), dose 1 in arm right on 29Jan2021 14:00 (Batch/Lot Number: EL9265) as single dose for COVID-19 immunisation and experienced arm pain on 29Jan2021 resolved within a day or two. Patient was not pregnant at the time of vaccination. On 22Feb2021 20:00 (also reported as about 24hours after 2nd shot) the patient experienced low grade fever / fever around 100 F, fatigue, intermittent headache, feel foggy/spacey feeling in my head, her head felt a little foggy, strange feeling in her head just a little out of it, arm pain near injection, some upset stomach, diarrhea. She was having continued side effects several days after her vaccine. No treatment received (she was not miserable or anything). COVID was not tested post vaccination. The outcome of arm pain recovered resolved within a day or two in Feb2021, of all events was not recovered.  No follow-up attempts are needed. No further information is expected.
Depression, angry, rash, lost memory, joint pain, fever, anxiety.  Major depression, peptic ulcer disease, nonerosive gastritis of the antrum and the body of stomach, small hiatal hernia, H phylir positive. Pain in joint involving shoulder regions, subacromial shoulder injection, neuralgia of the nighth cranial nerve.  Records received-11/17/06-DX: Major depression, peptic ulcer disease, nonerosive gastritis of the antrum and the body of stomach, small hiatal hernia, H phylir positive. Pain in joint involving shoulder regions, subacromial shoulder injection, neuralgia of the nighth cranial nerve.
Patient presented to clinic for Janssen booster vaccine. Inadvertently administered 0.5mL undiluted pediatric Pfizer vaccine. Called the regional immunization consultant and Pfizer company for guidance for how to proceed.
Headache, Myalgia, Arthralgia, NauseaVomiting, right arm pain at injection site Narrative:
Pt complained that he "can't breathe" & dizziness. Hx of COPD & DM. BP 143/90; HR 120; RR30. Provider at bedside & given water & crackers. BP after 10 min 157/100; HR 120; RR 36. Taken by wheelchair to car, stable & released from vaccination site
pt recvd vax 01DEC95 & 7DEC95 pt devel a varicella like rash w/6 to 10 bumps 1 to 2 millimeters each;9DEC95 & 10DEC95 the pt devel a fever of 103.4 & 102;also devel vomiting;
19JUN98 chickenpox like blister began today;pt has 2 on arm, 2 on legs, 1-2 on back, 2 on chin, 1 chest welt like bumps no itch;no other s/s illness;no fever, no s/s of adverse rxn @ inj site;
Information has been received from a registered nurse referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 09-FEB-2016 the patient was vaccinated with improperly stored VARIVX (Merck) (dose and route not reported, lot # L034372, expired date: 08-SEP-2017). The vaccine exposed to 6.9F for 34 minutes. No previous excursions. Concomitant therapy was not reported. No adverse effects. This is one of the two reports from the same reporter. Additional information has been requested.
04/05/2003 am:  Woke up complained of a "fever blister".  On 04/07/2003 pm: noticed 3 "red spots" on right arm.  Also soreness in right arm.  Advised to take Tylenol and apply cold compresses to right today.
vertigo and dizziness; vertigo and dizziness; Vomiting; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 28Jan2021 (Lot number: EL9262) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "UTI" (unspecified if ongoing). Concomitant medication(s) included: MACROBID [CLARITHROMYCIN] taken for urinary tract infection. Vaccination history included: Bnt162b2 (Batch/lot number: EL3246 , Dosage text: First dose), for COVID-19 immunisation. The following information was reported: VERTIGO (non-serious), DIZZINESS (non-serious) all with onset 06Mar2021, outcome "recovered" (09Mar2021) and all described as "vertigo and dizziness"; VOMITING (non-serious) with onset 06Mar2021, outcome "recovered" (09Mar2021), described as "Vomiting"; HEADACHE (non-serious) with onset 06Mar2021, outcome "recovering", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 11-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Patient received vaccine at approximately 2 PM on 10/1/13. By 6 PM her arm became red, painful, and swollen from the site of injection to her elbow. She took TYLENOL to help with pain.
COVID 19 Treatment/Tested positive of 16Jun2022; COVID 19 Treatment/Tested positive of 16Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), on 18Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 27Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: RESTASIS, start date: 10Mar2022, stop date: 16Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment/Tested positive of 16Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (16Jun2022) Positive; (29Jun2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: the patient tested positive of 16Jun2021 Mild flu like symptoms. Began Paxlovid when T went to 102. Negative Ag home test for 3 days after completing Paxlovid 5-day course. Tested positive again on 29Jun2022. Mild symptoms. But extreme fatigue and still positive with fatigue to date. Adverse events start date reported as 29Jun2022 (as reported). Adverse events start time reported as 10:00 (as reported). Adverse was not resulted in emergency room or physician office visit.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
3/21/07 Afebrile, Rash on face: looks like rhino derm more than shingles". Treated 1% HC cream and f/up next wk.
redness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness in injection site) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness in injection site). On 22-Mar-2021, VACCINATION SITE ERYTHEMA (redness in injection site) had resolved. Not Provided          Concomitant Medication includes: Blood Pressure Medication  No treatment medications were reported.   This case was linked to MOD-2021-211833 (Patient Link).
Patient given vaccine about 4:30 pm, some pain in arm, otherwise ok until about 1:30 am awoke with numbness and tingling in her legs, severe headache, and abdominal pain.  She also developed tingling and numbness in the arms and face.  No visable swelling or redness at injection site.  Mother treated her with ibuprofen and bedrest.  Symptoms resolved after about 24 hrs.
Erythema Multiforme, Edema of Hands and Feet, Polyarthritis, Serum sickness treated with Prednisone and Benadryl
The patient received Pediatric Pfizer 0.3ml dose diluted with 1.8ml of Sodium Chloride.
Symptoms in first 48 hours: Bad persistent headache in first 48 hours after vaccine; red skin rash on chest, stomach, back, neck, and face; experienced body feeling very hot and cold multiple times over first 48 hours; the point of administration (my left deltoid) is painful up to my shoulder and I cannot raise my left arm without feeling a lot of pain.  Treatment: took Tylenol twice in first 48 hours.  I am reporting as at Friday Dec 3 at 9pm (~52 hrs later). I still have a persistent headache and bad rash all over in the above-noted parts of my body. The rash has not improved and is still very red. The skin feels very warm where I have a rash. I am still unable to raise my left arm without a lot of pain.  This was my booster Pfizer dose. I experienced similar symptoms after my second Pfizer dose, but the headache and rash were both such worse this time.
Moderate case of COVID. Symptoms hit fast and hard at 2:00am on 10/17/2022. (Severe sore throat, head ache, congestion.).    Performed home covid test at 8am.  Tested POSITIVE.  Symptoms worsened thru the day. (Body chills, body aches, weakness, labored breathing.).    Called primary care doctor and got Paxlovid.   Started paxlovid 10/17/2022 evening.    Improved overnight, after 1 dose of  Paxlovid.    Today is day 4 of taking Paxlovid and symptoms have vanished.   I will continue taking Paxlovid for the last day tomorrow.
The patient received her Moderna Covid vaccine and a couple of days later she had shortness of breath and was brought to the hospital a couple of days later. They found multiple blood clots in her lungs. The hospital discharged her too early and she had to go back, They told her to get her second dose on her regular scheduled date.
pt recvd vax had syncopal episode-tonic clonic sz lasting seconds no postictal period; vomited x 1;
The plunger on the FLUMIST malfunctioned and didn't allow for 50/50 distribution in each nostril. The FLUMIST rep was notified and lot # shared.
10SEP93 a couple hrs p/vax started w/high pitchted cry, unusual cry, unable to sleep well; taken to ER: