chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. Date the vial was initially stored in the refrigerator reported as unknown.  Number of doses/vials was reported as 168 doses Dates of administration of vaccine were reported as 10Nov2021 and 11Nov2021  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant follow-up received on 08-Jun-2022. Reporter details was updated.
Around injection site there were 5 bumps that went around site. The bumps were red. C/o pain when pressure is applied.
he received her first Covid 19 vaccination shot and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She reports that her symptoms occurred approximately 10-15 minutes after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal.  Impression: Vasovagal reaction w/ mild allergic reaction to vaccine
SHARP PAIN IN RIGHT HAND; ARM NUMBNESS; This spontaneous report received from a patient concerned a 59-year-old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, drug allergy to prednisone and codeine sulfate. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer)(suspension for injection, route was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination (Dose number in series 1). It was unknown whether the patient had any adverse event with (Dose number in series 1). The patient previously also received adalimumab (Humira) (had to come off due to unbearable pain-medication stopped working). The patient experienced drug allergy when treated with codeine sulfate, and prednisone. It was unknown whether the patient had any adverse event with (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, Unknown, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in NOV-2021 for prophylactic vaccination (Dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included golimumab (Simponi) (solution for injection in pre-filled pen, subcutaneous, batch number: LBS1SME expiry: 31-JAN-2024) 50 mg, 1 time every 28 days) for rheumatoid arthritis, acetylsalicylic acid, folic acid, ibuprofen, macrogol 400/propylene glycol, and methotrexate. On an unspecified date the Patient reported via patient care coordinator to speak with a nurse regarding her concerns with Simponi. The Patient stated that she was unsure if the medication was meeting her treatment expectations due to the last 3-4 weeks the patient had experienced sharp pain in right hand while waking up in morning, up and down arm, numbness, at the time of reporting it was in both arms (Dose number series 2). The Patient stated that all of her symptoms started after receiving the booster covid-19 vaccine ad26.cov2.s booster 3 weeks ago. The Patient had an appointment with her physician on 29-DEC-2021 to discuss her concerns.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp pain in right hand, and arm numbness. This report was non-serious. This case, involving the same patient was linked to 20211232839.
Erythematous maculopapular rash all over the body 2hrs post vaccination. Improved with BENADRYL PO.
The patient had waited their 15 minutes and was setting up their 2nd dose appointment when they fainted. His girlfriend caught him so he didn't hit the floor. By the time I got to him he was sitting up and was alert. I had a code white paged. I sat with him for 10 minutes on the floor then moved him to the chair for another 20 minutes. He didn't state he had issues with shots in the past (as per his consent form but said he hadn't eaten much today), I checked on him every 5 minutes. He stated he was feel better. I informed him that his girlfriend needed to drive home.
lump on the inside of my wrist that was squishy; I Felt A Burning And Stinging Pain In My Left Wrist; Swelling wrist; vomiting; chills; severe body aches; fatigue; slept more than I have in years in one weekend; severe body aches (like I had fever); a baseball size lump formed under my armpit into my left breast; This is a spontaneous report from a contactable consumer.  A 44-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route at Left arm, as dose 1 at a single dose for COVID-19 immunisation on 18Feb2021at 08:30 AM. The patient's medical and Concomitant medications was not reported. The Patients historic vaccine included BNT162B2 (lot no: unknown), dose 1 at Right arm on 28Jan2021 at 08:30 AM. The Patient did not take any other vaccine in four weeks nor other medications in two weeks. Approximately 9:45, patient Felt a Burning and Stinging Pain in Left Wrist, When she Pulled Up Sleeve her Wrist was swollen Up, From There The swelling went down on her wrist but, had a lump on the inside of wrist that was squishy, it has for the most part went away. on Friday a baseball size lump formed under armpit into left breast, the pain was terrible, it ran down my arm into my armpit my chest and shot back thru to her left shoulder blade, ibuprofen just took the edge off and did nothing for the swelling, Cold or Hot packs just seemed to irritate it more than anything. On top of that she had vomiting, chills, severe body aches (like she had fever) and fatigue she had slept more than I have in years in one weekend.no treatment was administered for events. The patient did not have covid prior vaccination nor tested covid post vaccination. The outcome of events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tested positive for COVID after vaccination 12/24/2021. 12/20/2021 was first day of symptoms. I was exposed on Saturday 12/18/2021. In the beginning, my first symptoms were runny nose, sinus congestion, headache and sore throat, and earaches. And then after several days (4 days), I developed a cough, and I was also very tired. I had a fever which was 101. I felt dizziness when I stood up. The next day when I woke up, my chest felt like I had a brick on my chest, it was very heavy. A few days later, I developed a rash on my hands and arms and on my face near the outside of my eyes. There was swelling as well near my eyes. I called the on-call doctor when I got the positive test in the evening, so I had a plan on the weekend. I was told to just treat it as any cold and to go to the ER if I had any difficulty breathing or if things got worse. She also suggested cough syrup and gargling and Tylenol for any pain as well. I also spoke with my doctor today because I haven't been getting any better or worse and she was concerned because I could develop pneumonia, so she prescribed me more prescriptions? albuterol sulfate inhaler 2 puffs 3 times daily, azithromycin 250mg 6 doses, Methylprednisolone 4mg 21 tabs, Benzonatate as needed. For the rash as well, I was also taking Claritin to help with the rash. I had gotten rashes with each of my vaccines, so I took the Claritin to help with those as well.
Doctor reports allergic reaction, red streaks going down the arm, raised erythema of lower arm. No reaction at site of injection.
10 days post vax the pt developed chickenpox. Physician described the condition as the worst rash he had seen for someone vaccinated against varicella. The pt was treated with Benadryl and oatmeal baths. The pts sibling reportedly had a similar experience.
Red hives appeared on the back of my legs (hamstrings). They did not itch and they were not painful. Appeared approximately 1 hour after injection and were gone the next morning.
Backache; Headache; Chills; Fever over 100F; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever over 100F) and NAUSEA (Nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021 at 3:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced BACK PAIN (Backache), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever over 100F) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CODEINE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (THERAFLU ALERGIA) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Backache), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever over 100F) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) high units: F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up contains non-significant information (city and state updated).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 11:00 as dose 5 (booster), single (Lot number: Fk9893) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2022 at 10:00 as dose 4 (booster), single (Lot number: Fk9893), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 10Feb2021 as dose 2, single (Lot number: Em9810), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: Ff2590), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa, some antibiotics; "Known allergies: some antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 23Feb2023 to 28Feb2023.
Headache, dizziness, blisters at injection site, itchiness at injection site.
BODY ACHE; FEVER; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 11:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7. On 20-MAR-2021, treatment medications included: paracetamol. On 20-MAR-2021 16:00, the subject experienced headache. On 20-MAR-2021 17:00, the subject experienced chills. On 20-MAR-2021 22:45, the subject experienced fever. On an unspecified date, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 20-MAR-2021, had not recovered from headache, and the outcome of fever and body ache was not reported. This report was non-serious.
Adverse Reaction Notes  Patient reported lightheadedness which subsided after 10 minutes. His vital signs are stable BP 110/65,HR 75,Resp19,02sat 99%.Patient left vaccination site ambulatory in stable condition.
Event occurred at 37 weeks gestation (estimated delivery is July 12, 2021). Severe vomiting and diarrhea accompanied by fever, chills, and body aches. After 16 hours at home, I went to the hospital at the advise of my midwife. I was admitted and given IV fluids immediately.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received first dose of SHINGRIX recently. The caller reported that the patient experienced arm pain that had lasted for a week now after receiving the shot. The caller declined to provide demographics or answer questions for the safety report. The patient had denied permission to contact their physician.
I'm not sure my issues are related to the covid 19 shot.  Had my third shot 8/27/2021 due to compromised immune system.  I felt run down and lethargic.  In mid September I was having lIght headedness and constant urination. Called the Dr - she ordered blood work.  My A!C had jumped from 6.4 to 13.9.  I fell during a dizzy spell and broke my wrist, nose and a toe. On 10/8 i was started on Jardiance and insulin.  I read an article that the vaccine could raise blood sugar - the way I understood the article that it was short lied. I thought I should share my issues.
Headache, Myalgia, Sore, swelling, redness at site, swollen gland, fever for 21 days Narrative:  Other Relevant History:
her left arm (same side as vaccine was given) feels like a "dead arm/cannot touch it without pain; a quarter sized rash (left arm)/rash increased to a size of her palm; intense red (left arm); really itchy (left arm); extreme tiredness; lung pain, "like needed to clear my throat"; she felt nauseous, "like she was going to puke"; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (lung pain, "like needed to clear my throat"), NAUSEA (she felt nauseous, "like she was going to puke"), VACCINATION SITE PAIN (her left arm (same side as vaccine was given) feels like a "dead arm/cannot touch it without pain), VACCINATION SITE RASH (a quarter sized rash (left arm)/rash increased to a size of her palm) and VACCINATION SITE ERYTHEMA (intense red (left arm)) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021 at 1:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced NAUSEA (she felt nauseous, "like she was going to puke"). On 08-Nov-2021, the patient experienced PULMONARY PAIN (lung pain, "like needed to clear my throat"). On an unknown date, the patient experienced VACCINATION SITE PAIN (her left arm (same side as vaccine was given) feels like a "dead arm/cannot touch it without pain), VACCINATION SITE RASH (a quarter sized rash (left arm)/rash increased to a size of her palm), VACCINATION SITE ERYTHEMA (intense red (left arm)), VACCINATION SITE PRURITUS (really itchy (left arm)) and FATIGUE (extreme tiredness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PULMONARY PAIN (lung pain, "like needed to clear my throat"), NAUSEA (she felt nauseous, "like she was going to puke"), VACCINATION SITE PAIN (her left arm (same side as vaccine was given) feels like a "dead arm/cannot touch it without pain), VACCINATION SITE RASH (a quarter sized rash (left arm)/rash increased to a size of her palm), VACCINATION SITE ERYTHEMA (intense red (left arm)), VACCINATION SITE PRURITUS (really itchy (left arm)) and FATIGUE (extreme tiredness) outcome was unknown.            Patient reported concomitant medication: Birth control  Patient reported she had extreme tiredness and did not experience these symptoms with the first two doses.  Patient reported treatment with Tylenol, Ibuprofen and Benadryl but none worked.
Next day after vaccine administered, developed an area of redness, warmth, swelling at the injection site. Worsened over a period of a couple days & increased in size. Resolved for a few days. Then symptoms returned.
One blister (red with raised center, fluid filled)developed on my arm two days after vaccination.  It itched before it developed and while it was present, but the next day it was flat, but still red and did not itch.  The blister never opened.  Now it is the 4th day after the shot, and the red spot remains.
Pain in my arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included paracetamol (TYLENOL). consumer stated, "I was pain in my arm in 2021 but I was wondering that with the second dose I heard that you feel worse " Consumer further stated, "I had pain a little bit just the day afterwards. My concern is, can I take Tylenol within 24 hours of getting the shot" The outcome of the event was unknown.  Information about lot/batch number has been requested.
went to MD 18NOV; sore throat 15NOV progressive; very red, inflammed throat;  poss strep, cultured not strep; viral infect;
Chest pains started the night of vaccine and lasted for 2 days and on 12/05/2022 the symptoms were resolved. Mom mentioned there was no need for Doctor visit as they were aware of the potential side effect of this vaccine and the symptoms were mild.
By next morning arm was red about the size of a quarter and sensitive to the touch and warm to the touch as well as Body aches, fatigue and joint pain. Later in the afternoon the red area around injection site started getting larger and itchy that was Sunday as my injection was given Saturday morning Monday still suffered from fatigue bodyaches and joint pain as well as redness on arm and itchiness the temperature of the site or the injection site was very warm too touch. By Tuesday the bodyaches and joint pain have begun to subside the arm is still painful to touch the redness is still extremely large around the site there?s still a knot at site of injection and it still itches but has mildly improved from day before.
Within minutes had tightness in chest, dizziness, HA, rapid pulse 11/05/15 dizziness/rapid pulse lasted 26 hours, upper arm swollen lasted 2 weeks, pain in arm lasted several weeks chest tight headache continued, round of prednisone then methyiprednisoXopenexlone helped some, Xopenex inhaler did not help, continued mild chest tightness.
pt exp 4 afebrile sz w/in 24 hr of vax & was hospitalized for 48 hr & sent home on
Pt. complained of discomfort when Tdap administered. Discomfort became pain and continued. Six days after administration, Pt still complaining of pain but deined any inflammation. Pt. saw doctor and was told that the administration needle could have hit a nerve or burst a bursa.
Information has been received from a registered nurse concerning a 8 year old female who on 10/15/96 in the evening was vaccinated SC in the left side with a first dose of varicella virus vaccine live (lot # 617265/0566D). There was no illness at the time of vaccination. On 5/15/04 (previously reported as 5/17/04), the patient presented with a chicken pox rash described as more than 50 lesions over her entire body, papular and scabbed over her extremities, back and trunk. No other symptoms were reported. See below for diagnostic laboratory tests. No treatment was required. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information is not expected.
received the 1st dose / in 2018 and is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No symptoms reported. The pharmacist did not have the exact date of vaccination for 1st dose. The reporter consented to follow up.
severe pain @ the site of inj & throughout the entire shoulder & arm for 2 dasy;no swelling or fever;