chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching). At the time of the report, PRURITUS (itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-177909 (Patient Link).
I was very tired slept 2 days straight,had chills and body aches.  Sharp pains in all part of body (fingers , toes, legs arm) had a recurring headache that would ease after aspirin , or when sleeping. To tired to care. No appetite.  Today is the 17th of March and am feeling like I want to get up, for a shower.
Severe itching both sides of both hands, plus both elbows; BNT162B2 co-administered with other vaccines; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 at the age of 74-years-old via an unspecified route of administration, administered in Arm Right on 27Sep2021 11:45 (Batch/Lot Number: FF2587) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX), via an unspecified route of administration administered in arm left on 27Sep2021 11:45 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunisation; influenza vaccine (FLUZONE), via an unspecified route of administration administered in arm left on 27Sep2021 11:45 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunization. Medical history included known allergies: Penicillin (Penicillin Allergy). Concomitant medication included an unspecified medication. The patient received the first and second doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified dates for covid-19 immunisation. The patient experienced severe itching both sides of both hands, plus both elbows on 27Sep2021 21:00 and BNT162B2 was co-administered with other vaccines on 27Sep2021 11:45. Therapeutic measures were taken as a result of severe itching both sides of both hands, plus both elbows which included Zyrtec and Benadryl. The patient did not recover from Severe itching both sides of both hands, plus both elbows. Prior to the vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination.
This spontaneous report as received from a licensed practical nurse refers to multiple patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies provided. On multiple unspecified dates, the patients were vaccinated with an improperly stored doses of GARDASIL (lot# K007264 with expiration date 02-MAR-2017, dose, anatomical location and route of administration were not reported). It was also reported that the first improperly stored doses were administered on 12-DEC-2014. The reporting nurse stated that the products were exposed to a low temperature of 33 Fahrenheit for an unknown amount of time. there were multiple excursions for these product encompassing various lot numbers (some of which were exhausted). No adverse effects were reported. This is one of several reported received from the same reporter. Additional information is not expected as there was no consent for follow up.
rt deltoid muscle was swollen, red & warm; stiffness w/sl pain; sx lasted 7 days;
rt arm became very noticeably swollen & painful, couldn't put arm down; no redness or swelling noted @ inj site; seen by MD 18MAY95 who did not find any other reason for lump under armpit said was vax related poss 2mo to go away
Excruciating Headaches; Hemorrhoids-externally which never had before and extremely painful; HBP not controlled as normal by meds.
This spontaneous report was received from a physician and refers to a 69-year-old female patient with no drug reactions or allergies. The patient had no pertinent medical history. On 19-JUN-2017, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX injection (exact dose, lot # and expiration date were not reported) for prophylaxis (reported as vaccination). Concomitant therapies included unspecified hypertension medication and unspecified high cholesterol medication. On 22-JUN-2017, the patient experienced golf ball sized (4 by 2.5 inches) lump in her axilla that was tender and hot and tingling on her lips, described by the reporter like the one you get if you have a cold sore. No lab diagnostic studies were performed. The patient sought medical attention by calling the physician. There was no treatment given for the adverse events. The outcome of the adverse events was not recovered/not resolved. No product quality complaint was involved. The relatedness between the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Severe headache; body aches; Chills; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK5730), intramuscular in the left arm on 28Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant. On 29Dec2020, the patient experienced body aches and chills. After 1 week on 05Jan2021, the patient experienced severe headache. The patient has not tested positive for covid post vaccination. The patient did not receive treatment for the events. The events recovered on unspecified date in Jan2021.
having tinnitus, ringing in her ears; It's much worse, harder to hear now; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (having tinnitus, ringing in her ears) and HYPOACUSIS (It's much worse, harder to hear now) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced HYPOACUSIS (It's much worse, harder to hear now). On an unknown date, the patient experienced TINNITUS (having tinnitus, ringing in her ears). At the time of the report, TINNITUS (having tinnitus, ringing in her ears) and HYPOACUSIS (It's much worse, harder to hear now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Patient took ibuprofen on sat 5/15/21 4am and around 1pm due to fever from vaccination. Patient first noticed petechiae on left wrist/hand area when she woke up on sun 5/16/21 6am. Patient stopped by the pharmacy and rph referred her to visit urgent care if PCP closed around 11am since petechiae is associated with ITP ( immune thrombocytopenia) and may require further attention.
No adverse event to report.  Pt. was given incorrect dose-- 0.5mL instead of 0.3mL.
Aching muscle, pain at some joints, 99.5 fever, minor headache, excessive gas and diarrhea
Nausea; Shakes; Muscle cramps; Aches; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), TREMOR (Shakes), MUSCLE SPASMS (Muscle cramps) and MYALGIA (Aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced NAUSEA (Nausea), TREMOR (Shakes), MUSCLE SPASMS (Muscle cramps) and MYALGIA (Aches). At the time of the report, NAUSEA (Nausea), TREMOR (Shakes), MUSCLE SPASMS (Muscle cramps) and MYALGIA (Aches) outcome was unknown.            No Concomitant medications were reported. No Treatment medications were reported.
GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT TEMPERATURE EXCURSION ISSUE (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 04821A) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT TEMPERATURE EXCURSION ISSUE (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT TEMPERATURE EXCURSION ISSUE (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and PRODUCT TEMPERATURE EXCURSION ISSUE (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact.
BODY ACHES; STOMACH A LITTLE OFF; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAR-2021 11:45 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAR-2021 22:00, the subject experienced body aches. On 21-MAR-2021 22:00, the subject experienced stomach a little off. On 21-MAR-2021 22:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body aches, and stomach a little off. This report was non-serious.
Daily headaches continue since second vaccine.  Significant change in mood and concentration/depression from aproximately 1-2 wks post vaccine,
Subsequent to receiving vax the pt developed an injection site bump and itching. Pt was treated with Benadryl.  Two days later the pt developed a papular rash on her arms, legs and trunk as well as aching in joints, general fatigue and weakness in the right arm. The pt had approximately 11 lesions which persisted. The pt is using anti itch cream.
Rash that looks almost like a chemical burn under arms around the armpit area and lower part of chest under breasts, also at top bend of one leg. Itching and burning rash. Started evening of 3/26 and has not gone away. Taking Benadryl and Pepcid per a nurse?s suggestion.
Headache; Muscle pain; Tiredness; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), via an unspecified route of administration on 12Jan2021 14:00 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, muscle pain and tiredness in Jan2021. The outcome of events was unknown.    Information about lot/batch number has been requested.
pt recvd vax on 18NOV92 & the next day had a fever of 100 to 103.4, malaise, fatigue, muscle aches & pains, diarrhea, migraine h/a & bronchitis w/bilateral crackles & cough; 5 wks later pt lost 28 lbs; dx viral illness;
Fever ranging 100 to 104 degrees x 48 hours so far, vomiting on 11/02/12, body aches, diarrhea, 4 red spots on left arm. Currently ongoing.
7 days after the first shot I developed a rash on both shoulders. I am still having itching on both upper arms. 3 days After the second shot I experienced swollen gums. This went away approximately 2.5 days later.
Body aches, chills, fatigue, headache treated with acetaminophen and ibuprofen over the course of 19 hours (so far) - acetaminophen helped somewhat, but I had to add on ibuprofen a few hours later with much more relief
The day I got the vaccine, that evening, my neck and back locked up. The next day, Friday, my neck and my back hurt most of the day. About 24 hours later, I felt really bad. I went and laid down. It felt like there were bamboo shoots in every joint in by body. It was incredibly painful. I woke up about 7pm and had a fever. That night my fever hit 102. On Saturday, I rested all day. Felt terrible. 102 fever. I still had bamboo shoots with my fever. Also, incredibly painful-on Saturday and Sunday. Also on Sunday, I noticed that my eyelids were starting to swell. On Monday, my fever was better but my eyes were worse. I have double vision and pain behind my eyeballs. So, I called my doctor and my eye doctor. On Monday afternoon, I had a phone appointment with my doctor. I was told to take Pepcid and Allegra for an inflammatory reaction. on Tuesday morning, I went to the eye doctor. He said behind my eye, I had inflammation and edema. He gave me some drops to put in my eye.
After first dose, patient was instructed to take 50 mg of diphenhydramine 30 minutes prior to her dose of vaccine and also take 2 puffs of albuterol immediately before the vaccine. The patient did as instructed, but approximately 15 minutes after the vaccine dose the patient experienced bronchospasm and coughing, and states her tongue was itching. She received 0.5 mg epinephrine and was transported to the ED for observation and treatment. The patient received a 10 mg dose of dexamethasone at 1916.
Information has been received from a nurse, via a company representative, concerning a female patient, who on 24-APR-2007 was vaccinated with a dose of Gardasil (Lot #657617/0384U). Concomitant therapy may have included VARIVAX, MMR II and VAQTA. The nurse reported that "after receiving Gardasil, the patient nearly passed out and was lightheaded." The nurse confirmed that the patient had recovered on the same day, 24-APR-2007. The patient sought unspecified medical attention. Additional information has been requested.
The caller reported that her cousin was administered the HPV vaccine while pregnant.; No additional AE/PQC reported.; This spontaneous prospective pregnancy report was received from a patient's cousin concerning to a female patient of unknown age. The patient's medical history, current conditions, previous drug reactions/allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (reported as HPV vaccine) administered for prophylaxis (strength, dosage, lot number, expiration date, vaccination scheme frequency, route of administration and anatomical site of application were not provided) while pregnant (exposure during pregnancy).   The last menstrual period (LMP) and the estimated date of delivery (EDD) were not reported. No demographics were gathered for the patient or the reporter; therefore, no letter would be sent. The pregnancy outcome was lost to F/U. The fetal outcome was unknown. No additional adverse event was reported (no adverse event).
Patient rolled over on arm around 5am and was in extreme pain. She felt like her muscle was going to burst. Went to ER and was admitted. No temp, swelling, bruising, etc.
This spontaneous report was received from a nurse refers to a 4 year old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 29-JUL-2015, the patient was vaccinated with improperly stored VARIVAX (lot # K016129, exp. date: 23-SEP-2016) (dose, strength, route and frequency were not reported). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recvd 3 doses of Engerix-B, 3rd dose given 21NOV90; 19FEB91 titers indicated no seroprotection p/3 doses; 4th dose given 7MAY91;
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient had a localized reaction  with redness swellin and warmth to the touch  patient went to urgent care and was given an antibiotic and steriod to treat
This is a spontaneous report from a contactable consumer. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration (age at vaccination 40 years) on 05Apr2021 as a single dose in arm for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. On 06Apr2021, the patient experienced a big ball of a lump under her armpit of the arm at the vaccination site. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of big ball of a lump under armpit was unknown. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Updated age at Vaccination and updated event code from "Lymphadenopathy " to "vaccination site mass"
sinus congestion; hard time breathing; low grade fever; flare up of lymph edema in her legs; Condition aggravated; Not feeling well / Really sick; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included shingles (prior shingles outbreak) and sjogren's disease. Concurrent medical conditions included lymphedema (lymph edema in both legs).   On 7th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 7th February 2020, 4 hrs after receiving Shingrix, the patient experienced malaise. On 8th February 2020, the patient experienced sinus congestion, difficulty breathing, fever, lymphedema and condition aggravated. On 9th February 2020, the outcome of the malaise, difficulty breathing and fever were recovered/resolved. On an unknown date, the outcome of the sinus congestion, lymphedema and condition aggravated were not recovered/not resolved.   It was unknown if the reporter considered the malaise, sinus congestion, difficulty breathing, fever, lymphedema and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and started not feeling well then later that day feeling sick.  She stated that she woke up with sinus congestion, hard time breathing, low grade fever, and a flare up of lymph edema in her legs. She states at this time she still has sinus congestion and the lymph edema has not resolved.  The reporter consented to follow up. The reporter did not have vaccine information for this adverse event. This case linked with US2020025208, reported by same reporter.
Full body rash started ~10 days after the first dosage of the Moderna Vaccine, beginning in the mid section (thighs and lower stomach) on the first day and then spreading to the legs, chest/back and arms over the course of 2 more days.  Treatment- appointments with primary care and a dermatologist, Prednisone and Lexette were prescribe to treat the rash.  Rash has subsided 95% in the following 7-10 days.
Starting on the day of the vaccine (2nd dose)- I felt "a warm, chemical and electrical sensation" in my chest a few hours after the vaccine. The next morning, I was unable to have a bowel movement, when usually I am very regular.  I was not able to have a bowel movement for a couple of days.  I felt very constipated and would try to force myself to have a bowel movement.  I ate more fiber and fiber pills and drink more water, which was uneffective.  I  was finally able to have a bowel movement but it took a lot of force and would push the point of exhaustion and almost passing out. On 2/19/2021, I decided to seek medical care for my constipation, stomach cramps, fatigue, difficulty concentrating and shortness of breath. The doctor diagnosed me with Covid long hauler (I had a previous covid infection in 11/2020).  I was prescribe probotics (for constipation) and  rest for 2 months.  I am still feeling fatigue and having heart palpitations. They order ECG(normal) and blood work (normal).
On Tuesday 1/12/16 developed itchiness and redness at site, redness spread and became swollen half of upper arm involved tried OTC hydrocortisone.
Vaccine recipient stated she felt hot in her chest and face upon parking after her vaccination was given. She stated she didn't quite feel light headed or dizzy but she felt weak. Vitals were taken and within normal ranges. VR was given a longer observation time and was given water. Upon 30 minutes of observation she stated she felt better and safe enough to leave.