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 a 76-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, 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 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Vial did not undergo temperature excursion. Total of 173 doses were given from LOT 070H21A. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live non significant follow up. No new clinically significant information received.
shoulder is still sore; Legs hurt, in the morning time both legs hurt when getting up; when wakes up every morning joints, just hurting all over; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration in Arm Left on 27Mar2021 17:00 (age at vaccination: 78 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination. The patient medical history and patient's concomitant medications were not reported. The patient experienced shoulder is still sore on an unspecified date with outcome of unknown, legs hurt, in the morning time both legs hurt when getting up on an unspecified date with outcome of unknown, when wakes up every morning joints, just hurting all over on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of shoulder is still sore, legs hurt, in the morning time both legs hurt when getting up, when wakes up every morning joints, just hurting all over was Tramadol 50mg. Relevant tests were reported as none The outcome of the events arthralgia, pain in extremity was unknown.  No follow-up attempts are needed. No further information is expected.
Couldn't get out her seat; Diarrhea; Very weak; Chills; Swollen and sore at injection site; Swollen and sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (Couldn't get out her seat), DIARRHOEA (Diarrhea), ASTHENIA (Very weak), CHILLS (Chills) and VACCINATION SITE SWELLING (Swollen and sore at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced DYSSTASIA (Couldn't get out her seat), DIARRHOEA (Diarrhea), ASTHENIA (Very weak), CHILLS (Chills), VACCINATION SITE SWELLING (Swollen and sore at injection site) and VACCINATION SITE PAIN (Swollen and sore at injection site). At the time of the report, DYSSTASIA (Couldn't get out her seat), DIARRHOEA (Diarrhea), ASTHENIA (Very weak), CHILLS (Chills), VACCINATION SITE SWELLING (Swollen and sore at injection site) and VACCINATION SITE PAIN (Swollen and sore at injection site) had not resolved.            No concomitant medications were reported.  No treatment medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
12 hours after shot, experienced nausea and headache and sore arm; next day, feverish with headache, along with sore arm; all symptoms resolved except for sore arm by three days except for new symptom, itchy rash at site of injection and continued soreness of arm.
Left leg positive for erythematous area, positive tenderness, & positive nodule. Lt. leg red @ injection site. Child uncooperative. Not able to take measurements for erythema.
Large hive (~4 inches in diameter) at injection site, heated pink and itchy.  Hives down right arm, splotchy.  Fever (~101 consistently), muscle aches  took benadryl, tylenol, advil and topical anti-itch cream.
Post vax, the pt developed a sunburn-like rash that covers the entire body as well as fatigue. Symptoms lasted 2 days then disappeared. Pt was in bed for one full day due to symptoms.
Fever 102 degrees F large local reaction (8 x 8 cm) with lymphangitic streaking to (L) axilla.
Got the flu vaccine, around 11 pm I woke up with severe stomach cramps that feel as if I had been kicked multiple times. Difficulty moving because of pain. Gurgling stomach. I took gas-x and nexium for pain and pain has not subsided as of 8 am the next day. Still in extreme pain.
The effects began with pain and inflammation in my right foot on July 4th. The pain and inflammation later escalated to my right arm, and thus I could not move them much. I visited a clinic on July 6th to no avail, and was referred to the hospital for testing. I visited a Medical Center on July 8th and received blood tests, x-rays, and ultrasounds. The tests all came back clear. I was prescribed naproxen for the inflammation. The next day, July 9th, my left foot was then inflamed and painful. I visited another physician on July 13th for a second opinion, and was prescribed furosemide as they had told me I had edema in my feet. On the evening of July 14th, I had begun to get a sharp pain in my right hip and thigh. The pain soon escalated well into midnight (July 15), and at that point, I could no longer move without a shooting pain that was unbearable. I visited the Hospital the same day, and again received multiple tests, including blood, ultrasound, and x-rays. I was there until the next day, and was given an anti-inflammatory shot, and was told to continue to take the naproxen for the rest of the dosage. As of today, July 29th, my swelling and pain have mostly gone down in my feet and arm, but I continue to have flare-ups of pain in the joints, and I now have pain and inflammation in my right knee. Any sort of joint inflammation was rare for me before I was vaccinated.
She mentioned that she was just diagnosed with COVID yesterday; She mentioned that she was just diagnosed with COVID yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 20Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date 30Jan2021 (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "She mentioned that she was just diagnosed with COVID yesterday". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive, notes: she was just diagnosed with COVID. The lot number for bnt162b2 was not provided and will be requested during follow up.
Increased erythema and warmth to right anterior thigh, approximately 8 cm x 12 cm wide. Ambulates without difficulty, denies discomfort.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "muscular dystrophy" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "skin cancer" (unspecified if ongoing); "allergy: Avocado" (unspecified if ongoing); "allergy: tree nuts" (unspecified if ongoing); "allergy: nickel" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  Additional information: It was unknown if patient received other medication in 2weeks. Anti-viral details: product=COVID 19 Treatment, brand: Paxlovid, treatment start date=09Jun2022, treatment stop date: 13Jun2022, indication: Treatment of COVID-19. Return of symptoms 5 days after my last dose of paxlovid.  Follow-up attempts are completed. No further information is expected.
My lymph nodes under my right arm swelled up when I got my first shot. That lasted about a week and then it went away on its own. I took pain medication to help with the pain.  Then when I got my second shot I developed a rash and swelling around the injection site. I took Tylenol for the pain and used and ice pack to help with the swelling.
following day lower belly pains started. see medical tests and I relate this issue directly to the vaxx. Pain, blood tests revield staff infection
MILD NAUSEA FOR 3 DAYS; MILD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced mild nausea for 3 days, and mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild nausea for 3 days, and mild headache. This report was non-serious.
In July 2021, I was having atrial fibrillation and tiredness. I was also out of breath and my jaw and chest would hurt when I walked fast. My doctor referred me to a cardiologist. The cardiologist did an EKG, ECG, and a stress test. He diagnosed me with congestive heart failure.  He prescribed me metoprolol 50mg and Entresto.
Rash on injection site; Headache and had to sleep early; Low grade fever (100.3°); Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on injection site), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache and had to sleep early), PYREXIA (Low grade fever (100.3°)) and CHILLS (Chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Sinus allergy was reported.). Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (MIGRAINE [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Migraine.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache and had to sleep early), PYREXIA (Low grade fever (100.3°)) and CHILLS (Chills). On 11-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash on injection site). At the time of the report, VACCINATION SITE RASH (Rash on injection site) and HEADACHE (Headache and had to sleep early) outcome was unknown and PAIN IN EXTREMITY (Sore arm), PYREXIA (Low grade fever (100.3°)) and CHILLS (Chills) had resolved.        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.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up contains no new information
A spontaneous report has been received from a Health Professional concerning a female patient, who has been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported that the patient has been administered expired FLUMIST Quadrivalent. The outcome of the event of patient has been administered expired FLUMIST Quadrivalent is unknown. The report was considered to be non-serious.
101.6 fever for 2 1/2 days; headache; joint and muscle pain; joint and muscle pain; stiff, sore neck; chills; sweating; fatigue; restlessness; lack of appetite; injection site pain; swelling in left armpit; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old female patient (non-pregnant) received second dose of bnt162b2 (Pfizer COVID-19 Vaccine, formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 16Feb2021 10:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included Hay fever, known allergies to Sulfa, Penicillin. The patient's concomitant medications were not reported. Patient previously took cefalexin (KEFLEX) and had drug allergy. The patient received first dose of historical vaccine, bnt162b2 (Lot: EN5318, product: COVID19, brand: Pfizer) in left arm on 26Jan2021 10:30 for covid-19 immunisation. The patient experienced 101.6 fever for 2 1/2 days, headache, joint and muscle pain, stiff, sore neck, chills, sweating, fatigue, restlessness, lack of appetite, injection site pain, swelling in left armpit on 16Feb2021 around 19:30 and lasted until Friday (19Feb2021) 3 days later with slight injection site pain and slight neck and underarm pain still lingering. Remained in bed all Wednesday, Thursday and some of Friday. The patient underwent lab tests and procedures which included body temperature: 101.6 fever for 2 1/2 days on 16Feb2021, sars-cov-2 test via Nasal Swab the Rapid and PCR: negative on 03Feb2021. The Clinical outcome of all the events was recovered on 19Feb2021.  Information about lot/Batch number has been requested.
Patient one week later had aseptic meningitis.  LP showed elevated glucose, protein, monocytic lymphocytosis.  Recovered after 2-3 days with antivirals and antibiotics
I started to cry; for 1 week I had depression; general sadness for 1 week; back aches; nausea; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration on 22Feb2021 11:45 (at the age of 72-year-old) as dose 1, single for covid-19 immunisation.  Medical history included lung neoplasm malignant from an unknown date and unknown if ongoing Remission 9 years, known allergies- Highly sensitive to many drugs. No concomitant medications were taken. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. On 22Feb2021, twenty minutes after vaccination, patient started to cry, for 1 week patient had depression, general sadness for 1 week, back aches, nausea. No treatment was taken as a result of events. The outcome of the events were recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Headache, swollen muscles, dizziness, blindness, sweating, flushing, feeling dehydrated, weakness, muscle fatigue, eye soreness, sore neck.
Parent states that patient developed recurrent vomiting and non-bloody diarrhea for 10 days following administration of above vaccines.
mild headache; fever; pain at the injection site; felt very tired; felt like if her heart warmed up and burning sensation in her left side of the neck and face; This is a spontaneous report from a contactable other healthcare professional, the patient.  A female patient of unspecified age (57; units: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, administered in Left arm on 15Jan2021 as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. The patient received the injection on her left side, she was kept for half an hour and then on the same day (on 15Jan2021), she had a mild headache and slept. On unspecified dates in 2021, she had a reaction to the vaccine, had a mild reaction with first one, she felt like if her heart warmed up and a burning sensation in her left side of the neck and face, she also had fever, pain at the injection site and felt very tired. The outcome for the events was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
see above....chills lasted for months until hot weather started, headaches still on going taking asprin each morning, weak and getting weaker, fatigue use to walk 6 or 7 miles 4 or 5 times a week now 2 or 3 miles twice a week and feeling tired
No additional adverse events reported; V ARlV AX is not valid since it was administered too close to another live vaccine/administered MMR II on 15Feb2021 and V ARlV AX on 02Mar2021; This spontaneous report was received from a nurse (also reported as patient's mother) and refers to a patient (a child) of unknown age and gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 15-FEB-2021, the patient was vaccinated with measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 1 dose, lot # S032826, expiry date 16-OCT-2021, for prophylaxis (formulation, concentration, dose number, route of administration, frequency were not reported). On 02-MAR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 1 dose, lot # T027301, expiry date 12-AUG-2022, for prophylaxis (formulation, concentration, dose number, route of administration, frequency were not reported). The vaccination with varicella virus vaccine live (oka/merck) (VARIVAX) was reported as not valid since the vaccine was administered too close to another live vaccine. No additional adverse event was reported. No product quality complaint (PQC) was involved.
Patient reported to the ER on Feb. 16th  with onset of right-sided facial droop today about 1400.  Patient has no other weakness symptoms, bilateral extremity strength is equal. No  forehead sparing on facial droop along with some tenderness and rhinorrhea.  Symptoms are consistent with a Bell's palsy. Patient recently had Covid which  fits with viral syndrome causing Bell palsy. Discharged with valacyclovir and  prednisone burst. Follow-up and strict return precautions to the ED were  discussed and patient verbalized understanding.
No adverse effects reported; Nurse reported that an expired dose of MMR II was inadvertently administered to patient; This spontaneous report was received from a other health professional refers to a patient of unknown age and gender. On 15-AUG-2017 the patient was vaccinated with an expired dose of M-M-R II (HSA) lot # L027432 and expiration date of  22-JUL-2017, 0.5 ml subcutaneous for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT).  No adverse effects reported.
About 60-90 minutes post injection he began to feel bad. Voice became very raspy, felt weak, felt like someone was chocking him. Extremely diaphoretic, felt very hot, had to remove shirt. Felt SOB, Called 911 with EMT response. BP 220/160, declined transport to ED, went home with family. BL more stable by 2100 that day. Day after shot blood sugar elevated at 220, normally 150/180.ALso vomiting clear fluids. Still not feeling well 4 days later, feels like  "in another world", feels weak at times. Feels dizzy. Has and "eerie" feeling. Feels "equilibrium is off". Took Benadryl on 2/20. Has some disorientation "forgot what he was doing" at one point. Cramps in bilateral legs, both thighs and calves. Has headaches, migraine like at 3am without an elevated BP. Encouraged to see PCP, has appointment with physician on 3/2
Four hours after vaccine client felt flushed, sweating, itching, hives on upper torso. SOB (hyperventilating) HR 126. 911 called. IV started 02 Meds?- SOB resolved with reassurance. Transported to hospital ER. Was hospitalized. Returned to work in 2 days with no after affect.
Tdap - from state stock/ Meningococcal - from private stock:  Nausea, Headache, sore throat, dizziness, shortness of breath, chest tightness, then developed fever and chills the next day. She reported it on 8/2/11.  I told her to go to PCP or ER.  She said it was getting better so she did not go. Called back on 8/3/11 and said she was "fine now."
Pt recvd 2nd dose of Hep B vax on 21JUL92 & was told that was unable to donate blood because tested pos for Hep C antibody; No further details were provided;
Fever of 104 1/2; extreme fussiness, blotchy red rash on chest & upper stomach (probably irritant rash); pt given Ceclor;
Headaches; Case reference number MOD-2021-020252 is a spontaneous case report sent by a Non-Health Professional on 22-FEB-2021 00:00:00. .  On 1feb2021,  the patient was administered the second dose of  Moderna COVID-19 Vaccine for COVID-19 vaccination. The patient developed Headache.   The patient was treated with Excederin1500 daily.   The eventual diagnosis made on was Headache.  Follow-up required.   The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship.   Terse Narrative (narratives and signal review) Brief 3 line summary of above for listing: Report Source- Non-Health Professional,  Age-  ,  Sex-  ,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- Headaches - Unknown.