chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weakness in legs; Loses ability to walk at random times; Pain in legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "Weakness in legs"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "Loses ability to walk at random times"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Pain in legs". The events "weakness in legs", "loses ability to walk at random times" and "pain in legs" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscular weakness, gait disturbance, pain in extremity.  Additional information: She has had tons of tests but no one can tell what is wrong. Unknown If covid prior and post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dose administered on April 26 by Pharmacy at clinic. First symptoms of Covid appeared on April 29. I thought it was a cold with runny nose, post-nasal drip, fatigue, no fever. Runny nose lingered for several weeks. Not sure when conjunctivitis symptoms first appeared because complicated by fact that I'd had eyelid surgery on April 6. Eye lids were swollen and eyes irritated from drops and ointments having to apply several times daily. Conjunctivitis diagnosed at Immediate Care - and antibiotic eye drops began on May 20. Infection resolved by May 23 when I saw my eyelid surgeon for 6-week post-op visit. She took me off antibiotics and now on 3x daily eye drops, Refresh PM eye ointment in pm and Lumify in am. Irritation subsiding, but not yet fully resolved (see #20 below).
Pt states her arm was sore from the time of injection, but she developed a pruritic rash that radiated from her shoulder to her elbow over the course of the weekend. She took APAP and Benadryl with mild relief from itching and inflammation. Pt came to pharmacy on Monday with rash with erythemia, edema, and c/o pruritis. Pt was going to MD to have them look at it, but was not given any medication to treat.
Triggered IBS flare of severe diarrhea for 2 days.  Patient reports the same flare up occurred last year with H1N1 vaccine.
Fever up to 104F, asthma attacks, back to back, requiring treatment every 4 hours. Knot in left leg with soreness and redness and swelling. Applied warm soaks to leg. Tylenol was given for fever and albuterol nebs for asthma.
Fever got up to 102.7F at its highest, still have 100F today. Chills on and off, severe fatigue, some nausea, headache on and off, whole body hurts. I do not have an appetite.
a doctor said they are finding that some people are getting a rash from the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a doctor said they are finding that some people are getting a rash from the booster shot) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (a doctor said they are finding that some people are getting a rash from the booster shot). At the time of the report, RASH (a doctor said they are finding that some people are getting a rash from the booster shot) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Expired vial of Moderna vaccine used to give the 2nd dose of Moderna vaccine - first dose given on 09/20/2021 Lot number 048c21a- product expired on 10/13/2021 . Manufacture expiration date is 11/09/2021  and product removed from freezer on 09/13/2021
Information has been received from a physician concerning a patient with "allergy to malprotein" who was vaccinated PO with the first 2.0 ml dose of Rotateq (not lot# provided). One to two days after vaccination, the patient experienced a "malprotein allergy." The patient also experienced severe diarrhea and was hospitalized (length of stay unknown). The outcome was unknown. It was noted that the patient was not immunized in the specialist's office. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Undetermined Category II SIDS, WCC 3/9/06 PE exam WNL.
Lymphadenopathy and congestive heart failure.  Emergency surgery to drain fluid from around the heart.  Fluid was analyzed and cancer cells detected.  Stage 4 cancer diagnosed 9/9/2021.  Chemotherapy ongoing.
silver dollar size welt, nausea, h/a, fever, arm still has welt, redness 26AUG93;
This patient was admitted to Hospital, and subsequently transferred  with acute coronary syndrome and cardiogenic shock two days after receiving a COVID-19 vaccination. He died of complications of acute coronary syndrome on April 17, 2021.
Dizzy; Don't feel right; Headache; This is a spontaneous report from a contactable consumer (Patient's Caregiver).   A 27-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown, expiration date: unknown), via an unspecified route of administration on 20Aug2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included COVID 19. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown, expiration date: unknown), via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. Patient received second COVID Vaccine today (on the day of this report). Right after he had it, he felt little dizzy and he had a headache. He was 'in bed' right now and he was like he don't feel right and he was getting a headache, he was dizzy. Reporter checked him, he don't have any hives, nothing like that 'some skin' bites (Not clarified) but nothing from you. Reporter was asking is it normal and she can give him something. At the time of this report event outcome was unknown.
Was completely fine the first day, only experienced  soreness in right arm where i had got the shot. The next day I noticed my body was achy, nothing too terrible, but there was some discomfort as well as feeling like my energy was completely depleted. By the evening the aches became terrible and I had also had chills badly. I had at some dinner, was fine at the time, woke up mid night and was extremely nauseous and ended up throwing up. By the middle of the night I had woke up completely drenched in sweat. Next day after I am fine, but still slightly achy.
Rash all over the body; itchy rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash all over the body) and RASH (Rash all over the body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (itchy rash all over the body) and RASH (Rash all over the body). At the time of the report, RASH PRURITIC (itchy rash all over the body) and RASH (Rash all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported. No treatment information provided.
Patient was unaware of pregnancy on the day of flu shot. Patient received the regular flu vaccine and not the preservative free. Nurse asked if patient is pregnant or planning to be pregnant. Patient responded with no. Regular QIV flu vaccine was given with no adverse effects noted. At a later time the patient went to her primary doctor for a checkup and found out she miscarried. She tried to think back to the possibility of being pregnant when receiving the flu shot, and remembered that she received the regular vaccine and not the preservative free vaccine. Patient was given information about the vaccines and had no previous reactions to regular QIV vaccine before. She was worried that due to the preservative she miscarried. Education was provided. Writer spoke with patient and patient understood information provided. No further follow up was done on behalf of writer.
Headache started day of vaccine and persisted to the next day. Body aches started the day after around noon and face felt really hot. I do not have a fever.
Moderna booster administered too early. 2nd dose given 10/26/2021. No adverse effects noted in observation period.
Product storage error; no adverse event; the vaccine was expired by 3 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the vaccine was expired by 3 days), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (the vaccine was expired by 3 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (the vaccine was expired by 3 days), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (the vaccine was expired by 3 days) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant products reported.  Health care professional stated that she just a client the vaccine on 15 Feb 2023 and when she went to put it in the system it showed that the vaccine was expired by 3 days. No adverse events were reported.  No treatment products reported.
Osteopenia in hands; lumbar spine; right hip; monocloxial gammapothy (pre-cursor to bone marrow cancer). All happened since series of shots. Patient now in cancer center.
Pt received PNEUMOVAX 9-23-11, noticed swelling, pain, erythema (R) upper arm came into ED to be evaluated.
I gave a flu shot to a child who had not yet turned 6 months old. Was born on 4/30/2016 and I gave the shot on 10/13/2016.
Generalized itching, hives over entire body, swollen eyes, lightheaded and dizzy, SOB on (2 separate events).
Headache, Myalgia, Fever, ErythemaMultiform, red spots on injection site, low grade fever,chills,sweating Narrative:  employee pulled out of work due to feeling fatigued, advised to rest
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unspecified age and gender. Since 25-JUL-2015 (exact dates unspecified), the patients were vaccinated with doses of ROTATEQ suspension 2 (lot number: K011948, expiry date: 07-JUN-2016; lot number: K020181, expiry date: 24-JUN-2016) (dose, route and site of administration not reported) which were exposed to temperature outside of the recommended range. No adverse experience was reported. The outcome of incorrect storage was unknown. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.
Mild dizziness/lightheadedness after first dose, which became severe after second vaccine.  Specifically not vertigo.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-APR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003078.
Left thigh with 12cm x 8.5 cm area of erythema, tenderness, swelling.
Immediately after immunization dime sized hive noticed directly below injection site. Gave hcild 12.5mg po liq Benadryl-after 20 min. decreased in size of hive.
I had a skin flair, and then my doctor proscribed Vitamin D. I had a little fever. 100.5. I had a flair of joint pain in my toes. I took a home Covid test. One of my toes is still hurting.
6days p/vax pt ran fever, was lethargic & unresponsive. 8 days later pt devel a rash over her body.
15APR91, 630PM red spots started in diaper area mom gave child bath & rash spread to arms, legs few on neck, face & back; 16APR91 rhinitis present; Seen by MD stated rash due to allergic rxn to food;
positive for covid; two shots in may; This case was reported by a consumer via interactive digital media and described the occurrence of covid-19 in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included Herpes zoster (Shingles vaccine).   In May 2021, the patient received the 2nd dose of Shingles vaccine. In May 2021, unknown after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too short. On 24th September 2021, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's family member. The age at vaccination was not applicable for this report. The reporter stated that the patients received 2 Shingles shots in May 2021 and on the day of reporting whole family (patients) was positive for covid. The patients received 2nd dose early than the recommended time interval, which led to shortening of vaccination schedule. The follow-up would not possible as no contact details were available. This case was linked with case US2021AMR202899 and US2021AMR202898, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202899:same reporter US-GLAXOSMITHKLINE-US2021AMR202898:same reporter
She had an on and off fever after that up until May.; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 67-year-old at the time of vaccination), via an unspecified route of administration on 23Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced she had an on and off fever after that up until May. Reported that she went to infectious disease doctors and ran test, CT scan, blood works, X-rays. She already discussed this concern with her HCP and said she might need to get the 1st shot again, then she also spoke with her Pharmacist and said she needs to get the 2nd dose. The patient underwent lab tests and procedures which included blood test, CT Scan, x-ray all with unknown results. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Very high fever (~103 F). The temperature would only drop to 100 F and would not subside after.
I started having a sore throat a couple days after the vaccine, and I was worried because I was around my in laws at the time. I was tired and started coughing and did my best not to be close to others. I thought it was COVID-19 again but it was mimicking the same symptoms I had before and I did a COVID-19 test and it was positive again. I went to the Dr. and they gave me 3 shots, and antibiotics with a Z-PAK. No one else tested positive that I was around. I am still taking FEBRAX for my symptoms.
Patient given an IM flu shot on 1-9-13. Patient's arm has been painful & swollen since the evening of 1-9-13. She saw her doctor on 1-11-13 & was given cefadroxil in case of secondary infection pharmacy will follow up with patient next week.
Injection site soreness (1 hour afterward, lasting through the following day and night), muscle soreness and pain (3 hours afterward, worse the next day, abated the evening of 1/21), slight vertigo (1 hour afterward, laying about 2 hours)
Patient developd worsening congestion and new weakness, fatigue, shakiness days 1-6 after vaccine administration.   Patient was evaluated at healthcare facility on 3/15/21 with elevated blood pressure of 200-246/80-90 and sent to emergency room via 911/EMS activation.   HR 99-108, Pulse ox 94-97% room air.  BP 200-246/80-90
sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore right injection site arm). At the time of the report, VACCINATION SITE PAIN (sore right injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported Treatment medication were not reported    This case was linked to MOD-2021-306220 (Patient Link).
Blurry, loss of vision; numbness in arms & legs, extreme fatigue, loss of feeling in face
Information has been received from a 60 year old male with hypertension, kidney stones, high cholesterol, tinnitus and reactions to amoxicillin and BIAXIN, who on 20-JUN-2008 was vaccinated with a first dose of ZOSTOAVAX, IM, instead of subcutaneously. Concomitant therapy included BENICAR, spironolactone, UROCIT-K, CENTRUM SILVER, calcium (unspecified), magnesium (unspecified), omega-3 marine triglycerides, chondroitin sulfate sodium (+) glucosamine sulfate, simvastatin (manufacturer unknown), TRICOR, LEXAPRO and XANAX. The patient reported that about one-two weeks after receiving the vaccination (approximately 27-JUN-2008), he had persistent itching, slight pain, swelling, redness and a lot of tenderness and inflammation at the injection site just below his left shoulder. He though "it might be shingles," especially because his father had shingles. The lesion was 4 inches by 3 inches, but the shingles-looking area looked to be smaller than a quarter but bigger than a nickel. He still has sensitivity to clothing and a small, round redness about the size of a dime. The patient did not seek medical attention. At the time of reporting, the patient was recovered from the persistent itching, slight pain, swelling, redness and tenderness and inflammation at the injection site. The patient reported he recovered about 10 days later on approximately 09-JUL-2008. No labs or diagnostic studies were performed. This is one of two reports from the same source. Additional information has been requested.
6:00 pt began crying & screaming,cont to scream & cry unconsolably until 10:30/11:00;mom noted no other problems or sx during this past vax time period
This case was reported by a physician, via a GSK representative, and described the occurrence of fever in "multiple" subjects of unspecified age and gender who were vaccinated with PEDIARIX (GlaxoSmithKline). On unspecified dates the subjects received unspecified dose of PEDIARIX (.5 ml, unknown route and site). On unspecified dates, at an unspecified time after vaccination with PEDIARIX, the subjects experienced fever. The outcome of the event was unknown. The physician also reported an infant subject who experienced high fever following vaccination with PEDIARIX. See case ID A1042992A for details.
Pt experienced swelling of upper lip morning after vaccine. Pt took BENADRYL and reported a decrease in swelling. The day after that, both lips were swollen and has an ulcer on her upper frenulum under her upper lip. Pt reports continued swollen lips along with redness and pain on the lips inside the mouth. Pt is trying to get an appt with her physician. Incident was reported to us on 5/21/13 in the afternoon when the pt presented to our office.
rashes all over the body due to poison ivy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATITIS CONTACT (non-serious) with onset 26Apr2021, outcome "unknown", described as "rashes all over the body due to poison ivy". The event "rashes all over the body due to poison ivy" was evaluated at the physician office visit. Therapeutic measures were taken as a result of dermatitis contact. Additional information: The patient received loratadine (CLARITIN) as treatment for the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme pain in arm. Back of forearm. (Not at injection site). Also front of and back of lower arm. Elbow. Tingling of arm do to pinky and ring finger. Family physician Dr. prescribed Prednisone 10 mg for 8 days (decreasing dosage).
Erythematous, indurated, pruritic, painful plaque measuring 5 x 4 cm to (L) deltoid to site of vaccine admin. Tingling sensation no subjective swelling to tongue.
Patient reports signs/symptoms of: slight cough, one episode of diarrhea, soreness at the vaccination site, nausea, fatigue, decreased appetite, decreased activity, and right, lower back pain. I recommend: increasing fluids, alternating acetaminophen and ibuprofen every three hours, a heating pad for the back pain. Outcome is yet to be determined as she was just seen today for symptoms.