chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore left arm chills for 15 hours medium high fever for 15 hours - 101.0 to 101.9 degrees F (3/31/21); following that 99.5 degrees on day 2 (4/1/21) took Advil day 1 only (3/31/21)
very painful; arm was sore; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received shingles vaccine over a week ago of reporting date and it was very painful. The patient's arm was sore for days. The patient said he/she would still get the second dose. The patient trusted his/her doctor.
Unwitnessed fall, Scalp laceration, Hypoxia SpO2 87%, COVID, acute pulmonary embolism, Compression fracture of T1 and T2 vertebra. Placed on 5L O2 for hypoxia. Elevated D-dimer. Chest CT showed acute PE. Placed on a heparin infusion.  Plan: IV Decadron 10 mg x 3 days, then 6 mg x 7 days - Tessalon Perles & Robitussin PRN - Heparin infusion ? ID consult for possible Remdesivir
Arm weakness in arm that received injection. Unable to hold light weight items. Feeling of muscle strain. Significant loss of strength in left arm. Situation has persisted through today.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a second dose of VARIVAX (Merck) 0.5 ml SQ. The patient experienced a severe localized reaction (not further specified). Subsequently, the patient recovered from the localized reaction. The patient sought unspecified medical attention. Additional information has been requested.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 06-JUL-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the events herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
4 days after receiving the vaccine in his left arm, my father developed a blood clot in his left arm that required emergency hospitalization and large doses of blood thinners.
Complaining of pain at injection site by 8pm on 10/20.  Severe allergic reaction noticed next morning 8am on 10/21.  Fever, severe hives and rashes all over body, swollen eyes, wheezing.  Rash and fever got worse.  Doctor gave Benadryl at 10am then Steroids that afternoon around 6pm.  Rash and fever got worse, went to ER at 9:30pm.  Rash then covered entire body, fever was 103.  ER Dr. gave him IV of morphine, steroids, benadryl and tagamet (to ease stomach pain from steriods)  Baby refused to eat or drink.  ER DR. gave him fluids in IV.  We were discharged at 2am after the rash was retreating and his fever was back to normal.  Baby has new rash spots on 11/22 but no fever.  He is very pale and still won't eat.  He's on steroids, Tagamet, Benadryl and Tylenol w/ codeine to help him sleep and not itch the rash.
light headed/ Dizziness; Extreme brain fog; Loss of balance (Loss of bal fe); Loss of ability to focus; Vertigo; Difficulty driving; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 09Apr2021 at 13:45 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 13Apr2021 at 08:00, (also reported as almost a week after the shot), the patient experienced dizziness, light headed, extreme brain fog, loss of balance (Loss of bal fe), loss of ability to focus, vertigo and difficulty driving. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, light headed, extreme brain fog, loss of balance, loss of ability to focus, vertigo and difficulty driving was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient reported swelling of the throat after receiving first dose of Pfizer Vaccine. Per protocol, 50mg Diphenhydramine administered IM to Right Upper Quadrant- Gluteal. Lot #6123821 Exp date 03/22. Immediate response to Benadryl, no further medication administration required. Patient discharged 30 minutes post vaccination.
Systolic Hypotension the day after administration of the vaccine. She was on the treadmill when she felt hypotensive. She denied overdose on hypertension medications.
Pt received vaccines at approx 11 this morning. Mom states bumps to body started at 1400 with generalized redness. Returned to clinic at 1500 with redness, rash, and swelling of ears, lips and labia. Benadryl 1 tsp given po at 1615; Epinephrine 0.1 ml given sq at 1620.
fever uncontrollable chills; Malaise; This is a spontaneous report from a contactable consumer, the Patient. A 45-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6208) via an unspecified route of administration in the left arm on 12Mar2021 at 17:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had shellfish and environmental allergies. Concomitant medications included tetracycline hydrochloride (TRICOR), rosuvastatin calcium (CRESTOR), amlodipine (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), and cetirizine hydrochloride (ZYRTEC) all for unknown indication from unknown date. The patient was not enrolled in clinical trial. The patient had not tested positive for COVID-19 since the vaccination. On 20Mar2021 at 18:00 (8 days after vaccination), the patient experienced bedtime, fever, uncontrollable chills and malaise. In the morning the patient felt fine. But the same events reoccurred again 10 days after injection. The patient had COVID-19 virus test on 12Mar2021 and resulted negative. The patient did not receive treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever chills and malaise was not resolved (reoccurred after 10 days of vaccination) at the time of this report.   No follow-up attempts are needed. No further information is expected.
Approx 6 hrs after shot. Pt said nausea, chills, fatigue.
Fever/ running temperature; felt worn out; Generally feeling like crap; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the first dose of BNT162B2  on unspecified date for COVID-19 immunisation. The patient got the second shot of the Pfizer COVID Vaccine yesterday, 18Jan2021. On unspecified date in Jan2021, he had a running temperature and felt worn out. He had a fever and was generally feeling like crap. The temperature was almost gone. He was sure that it's a side effect. He was calling to see if he can take Advil for the fever or not. He wanted to make sure that it would not interfere with the vaccine. He says that yesterday, last night was more intense. It was almost like it was gone, but he still has a little fever. The patient asked if he can use antipyretics after vaccination with the Pfizer-BioNTech COVID-19 vaccine and how long can the symptoms last. The outcome of the event fever/ running temperature was recovering and unknown for the other events.  Information about lot/batch number has been requested.
severe cramping along with explosive diarrhea.  started 2 days after shot.  continues today.  weight lost of 15 pounds since
pt recv vax 24FEB98 & began s&s;25FEB c/o rash & sl difficulty swallowing;seen in EDT & given DPh & steroids;
Dizziness. Sweating. Paleness. Weakness. Nausea. Shakiness. Labored breathing. Symptoms started immediately and lasted for 4 hours. Administered BENADRYL.
After receiving flu vaccine within 18 hours left arm site became red, inflamed, hard, tender to touch, cellulitis, started on antibiotics.
6 weeks after getting her  Johnson and Johnson vaccine she developed decreased appetite, weight loss, and fatigue.  She had a follow up in June and requested thyroid labs to be drawn which showed evidence of hyperthyroidism.
Paxlovid indication=Treatment of COVID-19; Paxlovid indication=Treatment of COVID-19; 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 16Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 21Oct2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 29Mar2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid indication=Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
asthma attack; lost voice; problems breathing; coughing; This case was reported by a consumer via patient support programs and described the occurrence of asthmatic attack in a female patient who received umeclidinium bromide (Incruse Ellipta) inhalation powder (batch number Unknown, expiry date unknown) for product used for unknown indication.   On an unknown date, the patient started Incruse Ellipta (inhaled) 62.5 µg at an unknown dose and frequency. On an unknown date, an unknown time after starting Incruse Ellipta, the patient experienced asthmatic attack and loss of voice. The action taken with Incruse Ellipta was unknown. On an unknown date, the outcome of the asthmatic attack and loss of voice were unknown.   It was unknown if the reporter considered the asthmatic attack and loss of voice to be related to Incruse Ellipta.  Additional details: This case was reported by a consumer via GSK patient assistance programs on 7th June 2019. The patient started Incruse Ellipta about 5 years. Reporter stated that, "patient stated that she had an asthma attack and lost voice. No further details given."  On follow-up it was determined the initial receipt date was 6th June 2019 which is earlier than initial as 7th June 2019.  Backend earlier receipt date correction; significant FU flags ticked to ensure reports schedule from corrected initial receipt date. Follow-up information was received via GSK patient assistance program on 6th June 2019. Ventolin and Shingrix as suspect and breathing problems and coughing as events were added. Reporter stated that, "patient stated that she is having problems breathing and has lost her voice due to continuous coughing."
The side effects that both my husband and I experienced lasted about 2 days.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (The side effects that both my husband and I experienced lasted about 2 days.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had medical challenges.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced IMMUNISATION REACTION (The side effects that both my husband and I experienced lasted about 2 days.). At the time of the report, IMMUNISATION REACTION (The side effects that both my husband and I experienced lasted about 2 days.) had resolved.            No concomitant medications were reported.  The patient was a senior and stated that they received 3 doses of Moderna COVID-19 vaccine so far, 2 primary and 1 booster dose. The patient's third and last Moderna shot was in Oct-2021, 9 months ago. The patient and their husband experienced the side effects which lasted about 2 days and they got over it. It was also reported that patient was still working.  No treatment information was provided by the reporter.   This case was linked to -MOD-2022-607724 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2022: Live Follow-up received contains non significant information: Reporter phone number was added.; Sender's Comments:  -MOD-2022-607724:Crosslinked (Husband case) (Same Reporter)
red hot rash appeared 1 week after received vaccine. it was slightly itchy. Rash grew slightly on 2nd day but decreased in redness, still hot. Third day size and redness decreased as well as temperature. 4th day gone.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 05-JAN-2016, the patient was inoculated with the ZOSTAVAX vaccine at a clinic as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 30-JAN-2016, the patient was treated at a clinic for a rash diagnosed as herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient reports experiencing pain in shoulder and armpit, numbness/tingling of arm and fingertips. Has been treated with a prednisone taper but symptoms returned when finished with taper. Has appointment and nerve test scheduled with physician for further evalution.
Left eye is swollen and skin around the entire orbital socket, including eyelids, is tender and itchy
The next day, post vax, pt had non-stop crying for hours x 4 days, no appetite x 4 days and child's temperature was not taken. He would not take in fluids x 4 days, picking at arms, legs and head. Saw a physician on 5/19/00 and was prescribed Benadryl and Tylenol.
Reported a temperature of 101.4 at 6pm (5 hours after immunization) did not take any medications, seek treatment, and was fever free the next morning. Reported to work the next day feeling better and ready for work.
Eye irritation began 5/13/2021. Noticed mouth droop with facial paralysis on the left side next morning. Rushed to ER (thought I was having a stroke).  Diagnosed with Bell's Palsy on 5/14/2021 in Dept. Followed up with appt to eye doctor 5/17/2021; scheduled appt with Rheumatologist 5/25/2021
Patient says rash developed about 20 minutes after immunizations were given. Hives to face, back, trunk, arms, upper thigh. No respiratory distress. Oral BENADRYL was given and rash faded after 20-30 minutes. (record attached)
Inadvertently administered Moderna vaccine to person less than age 18.  As per CDC recommendation will administer Moderna as the second dose.  This should be noted as off-label use because Moderna vaccine is not authorized in this group.  Second dose Moderna Vaccine is scheduled for May 12, 2021.
5/14/22 home tested + for covid-19, mild sx-cough & mild fever, received paxlovid, resolved 6/14 71y.o. female presented for planned robot hernia repair. Intraoperative course uneventful, patient recovered well.
chills with 2nd shot.; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (1st dose received on an unknown date, refer case US2021AMR067988).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chills. On an unknown date, the outcome of the chills was unknown.   It was unknown if the reporter considered the chills to be related to Shingles vaccine.  Additional details were provided as follows: The reporter reported for himself or herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had chills with 2nd shot of Shingles vaccine. The patient was glad to get the vaccine. The follow-up would not possible as no contact details were available.
Information has been received from a pharmacist referring to a 61 year old female patient with cardiac issues, high cholesterol and unspecified gastrointestinal issues. The patient did not have drug reactions/allergies. On 13-JUL-2015 the patient was vaccinated with (Oka/Merck) ZOSTAVAX, (lot # was reported as L015416, expire date 03-JUL-2016, dose, dose # and strength not provided), subdermal) in the left arm for vaccination. The patient took several unspecified concomitant medications. On 16-JUL-2015 the patient felt sick, achey and feverish and had abdominal cramping. On 19-JUL-2015 the patient began vomiting. No lab diagnostics studies were performed. The reporter stated that the patient came into the pharmacy on 22-JUL-2015 and reported that her symptoms had resolved although she was still a bit achey. The outcome of felt sick and feverish abdominal cramping and vomiting was reported as recovered/resolved on an unspecified date in July 2015. The outcome of felt achey was reported as recovering/resolving. This is one of several reports received from the same reporter. Additional information has been requested.
Four weeks after the vaccine I was getting unexplained dizziness. I am not sure if it is Vertigo. I thought maybe it was my blood pressure being low but the doctor confirmed that the reading was normal for me. It was happening every day for the first week and then nothing the following week.  I was unable to work because I needed to lay down when the dizziness happens. It is still coming back after eight weeks but it is not often, maybe twice a week. It is hard to drive when it is happening. It comes on me all of a sudden when I am sitting down working.
irregular menstrual bleeding 2 1/2 days after receiving covid 19 moderna vaccine, cramping, constipation, nausea, no appetite
Immunization given outside the expiration date, patient did not have any symptoms or reaction of any kind.
Cellulitis of the right thigh with erythema, edema with tenderness over an area of 8cmx10cm.
vision loss; other zoster-related conditions; other zoster-related conditions; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by health providers for vision loss and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event vision loss and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, vision loss was determined to be medically significant.
Few hours after shot became very tired and weak feeling by end of night I could barely left arms. By morning I was in full flare-up pain was awful vomiting fever very tired it has continued for 3 days now and will not stop I cannot sleep from the pain or bare to be touched. I was ok before the shot. I called a online telemedicine that insurance has and the doctor said after listening to everything and seeing me that I had had an adverse reaction to the vaccine and a fibromyalgia flare-up due to the vaccine.
So on May 4, 2021 I started getting chronic hives.  They have continued since daily.  When I ended up getting the delta variant on August 17, 2021, my hives were incessant while infected with Covid 19.  Which leads me to believe the hives were originally caused by the vaccine and then worsened when getting covid.  I had urticaria.
Information has been received from a RN concerning an 58 yr old male with asthma who on 05Dec05 was vaccinated IM into the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 650330/0748P). Concomitant therapy given into the other arm included a dose of influenza virus vaccine (unspecified) (no reaction noted). That night, the pt experienced an injection site reaction described as pain with tenderness, swelling and redness. On 06Dec05, the pt was seen in the doctor's office. The pt was treated with cephalexin (Keflex). Two days later, the pt's symptoms completely resolved. No product quality complaint was involved. Additional information is not expected.