chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling and itchy; started 8 days after injection, started to go down 12 days after injection; used benadryl and a bandaid to prevent scratching.
very painful right arm/injection site.  Swelling in armpit of injected arm, looks like  a soft egg-sized lump in right axilla.  very swollen and painful right arm. unable to turn arm or hand. cant eat with right hand can't open any door with right extremity because of pain. right forearm in very bad pain.  cant even type using right hand.
Starting 12 hours after 1st dose, and continuing for additional 6 hours he had difficulty urinating with a weak stream which cleared up after about 6 hours; After 2nd dose, he had high fever that started 12 hours later and continued for about 6 hours; After receiving 1st dose, he had slight soreness in the injected arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (After 2nd dose, he had high fever that started 12 hours later and continued for about 6 hours), MYALGIA (After receiving 1st dose, he had slight soreness in the injected arm) and DYSURIA (Starting 12 hours after 1st dose, and continuing for additional 6 hours he had difficulty urinating with a weak stream which cleared up after about 6 hours) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Enlarged prostate. Concomitant products included SALBUTAMOL SULFATE (INHALERIN) for Asthma.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MYALGIA (After receiving 1st dose, he had slight soreness in the injected arm). On 12-Mar-2021, the patient experienced PYREXIA (After 2nd dose, he had high fever that started 12 hours later and continued for about 6 hours). On an unknown date, the patient experienced DYSURIA (Starting 12 hours after 1st dose, and continuing for additional 6 hours he had difficulty urinating with a weak stream which cleared up after about 6 hours). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PYREXIA (After 2nd dose, he had high fever that started 12 hours later and continued for about 6 hours), MYALGIA (After receiving 1st dose, he had slight soreness in the injected arm) and DYSURIA (Starting 12 hours after 1st dose, and continuing for additional 6 hours he had difficulty urinating with a weak stream which cleared up after about 6 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-064099 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Contact information updated. Non significant.; Sender's Comments:  MOD-2021-064099:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Dec2021 at 14:00 as dose 1, single (Lot number: 330368D), in right arm, on 06Mar2022 at 13:30 as dose 2, single (Lot number: EN6203), in right arm and on 07Mar2022 at 12:00 as dose 3 (booster), single (Lot number: EN6203) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthmatic" (unspecified if ongoing), notes: I become asthmatic when I get respiratory Infections; "and can easily get bronchitis and pneumonia" (unspecified if ongoing), notes: I become asthmatic when I get respiratory Infections, and can easily get bronchitis; "and can easily get bronchitis and pneumonia" (unspecified if ongoing), notes: I become asthmatic when I get respiratory Infections, and can easily get pneumonia.; "Known allergies: Amoxicillin" (unspecified if ongoing), notes: Known allergies: Amoxicillin; "Known allergies: Pollen" (unspecified if ongoing), notes: Known allergies: pollen; "Known allergies: Dust" (unspecified if ongoing), notes: Known allergies: dust; "Known allergies: Animal Dander" (unspecified if ongoing), notes: Known allergies: animal Dander; "Known allergies: Strong smells" (unspecified if ongoing), notes: Known allergies: strong smell; "Known allergies:smoke" (unspecified if ongoing), notes: Known allergies: smoke. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Negative, notes: I tested negative on August 12th and 13th after taking a course of Paxlovid; (13Aug2022) Negative, notes: I tested negative on August 12th and 13th after taking a course of Paxlovid; (20Aug2022) Positive, notes: I tested positive for Covid on August 20th. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks: No. The patient received Paxlovid (Lot number: CD5282) received from 08Aug2022 till 12Aug2022 for treatment of COVID-19.
Pain in right side of right leg upper part of top part of leg. Hard to walk and sleep.
This spontaneous report as received from a patient's friend refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX. No route of administration, dosage information, lot number or expiration date was reported. No other co-suspects or concomitant medications were reported. The reporter stated that her friend who received ZOSTAVAX still developed a mild case of shingles. The outcome of the event was unknown. No further information regarding the adverse event was reported. Additional information is not expected.
Red spot about 2" x 2" that itches and has a hard knot in it.  It does hurt to touch it but the itchiness is more prevalent than my arm hurting.  From what I read, it sounds like "covid arm"
But this time, it is more severe; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (But this time, it is more severe), HEADACHE (Headache) and MYALGIA (Body ache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017821A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (a year ago). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], METOPROLOL, ATORVASTATIN and OLMESARTAN for Heart attack.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced HEADACHE (But this time, it is more severe), HEADACHE (Headache) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, HEADACHE (But this time, it is more severe), HEADACHE (Headache) and MYALGIA (Body ache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-382241 (Patient Link).
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with PNEUMOVAX 23 (lot number 669776/0614AA; expired date 27-SEP-2012) (0.5 ml, intramuscular on unknown injection site) on 14-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 14-OCT-2012 the patient was administered an expired dose of PNEUMOVAX 23 expired date 27-SEP-2012. No adverse effect reported. The outcome was unknown. It was unspecified if the patient had sought medical attention. Additional information is not expected.
severe headache; fever/Low grade fever temp of 101 F; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache) and PYREXIA (fever/Low grade fever temp of 101 F) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. J45) for an unknown indication.     No Medical History information was reported.    On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (severe headache) and PYREXIA (fever/Low grade fever temp of 101 F). At the time of the report, HEADACHE (severe headache) and PYREXIA (fever/Low grade fever temp of 101 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 fahrenheit (High) low grade fever down to temp of 101 Fahrenheit..         No concomitant medication were reported.   No treatment drug were reported.   This case was linked to MOD-2022-436119 (Patient Link).
I experienced chest pain, tightness and shortness of breath from 8/12/21-8/16/21.  I continue to have sporadic shortness of breath. I had an extreme flare up of  eczema of both my hands ?all fingers and each palm beginning on 8/12-finally clearing up with use of hydrocortisone.
Patient was administered vaccine that was kept in freezer 2-3 days longer that prescribed 14 days that manufacturer recommends before moving to fridge for 30 days. Manufacturer was contacted and they stated vaccine was still within limits for safety and efficacy and that no further action was needed.
Extreme stomach cramps, diarrhea multiple times a day for 6 days so far.
typical Guillain-Barre syndrome; he could not walk; he cannot play any sport because he cant run/ no control from his waist down; he needed a catheter ,he was not able to pee or poop; he needed a catheter ,he was not able to pee or poop; This is a spontaneous report from a contactable consumer (parent). A 14-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0179; Expiration Date: 31Aug2021; NDC number and UPC number: unknown) via intramuscular on 15May2021 (at the age of 14-years-old) in left arm (shoulder) as a DOSE 1, SINGLE for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0182; Expiration Date: 31Aug2021; NDC number and UPC number: unknown) via intramuscular on 05Jun2021 (at the age of 14-years-old) in left arm (shoulder) as DOSE 2, SINGLE for covid-19 immunization. Medical history included papilloma viral infection from 06May2021 to 06May2021 and bowel movement irregularity from an unknown date and unknown if ongoing. The report was not related to a study or programme. Prior vaccinations (within 4 weeks) included HPV (human papilloma virus) vaccine on 06May2021. Concomitant medication included macrogol 3350 (MIRALAX) as he had trouble going to the bathroom because he didn't had control and had trouble with bowel movement, he started when he left the hospital, so he can get back to his bowel, but he stopped using it couple of days ago as he started to go to the bathroom on his own again. The patient received both doses of Pfizer covid vaccine. He had a serious reaction to the vaccine, he couldn't go to the bathroom on his own, he had no control from his waist down, he needed a catheter as he was not able to pee or poop. He was admitted to the emergency room on 16Jun2021 and spent 3 days in the ICU because he could not walk and move, spent 3 days in out the down rated version, total 6 days in the hospital. He was diagnosed with Guillain-Barre syndrome and he was in the hospital on his birthday in Jun2021 and was doing physical therapy to walk and run again. His mother was trying to deal with the covid compensation because they had work. She and her husband were alone in the hospital. She reported that their medical bills were going to be crazy because they had to go by ambulance from one hospital to other because they were afraid of Guillain-Barre syndrome. The patient didn't have any movement in his legs all the way up to his heart. He was not able to play any sport because he can't run. The patient was discharged from the hospital and was on physical therapy (water therapy). The patient underwent lab tests and procedures which included two MRI, spinal test, and blood work with unknown results in the emergency room as they weren't sure what was going on with him. The patient was treated with IVIG and blood thinner everyday two times a day. The outcome of all the events were unknown.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
Red area in arm; Hard area in arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red area in arm) and INDURATION (Hard area in arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ERYTHEMA (Red area in arm) and INDURATION (Hard area in arm). At the time of the report, ERYTHEMA (Red area in arm) and INDURATION (Hard area in arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication were provided. No Treatment Medications were provided.
This spontaneous report was received from a nurse via a representative referring to a patient of unknown age and gender. The patient's concomitant medication, medical history and drug allergy were not reported. On 07-AUG-2017, the patient received an improperly dose of stored VARIVAX (lot# L048466, expiration date 02-DEC-2017, exact dose and route not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent (MERCK). The vaccine was exposed to temperature excursion of 6 to 14 Fahrenheit (F) for unknown time frame. There was no previous temperature excursion. The data logger was involved. No adverse effect was reported.
This spontaneous report as received from a healthcare worker refers to a male patient of unknown age who was a physician. On an unknown date, the physician had extreme difficulty removing the yellow caps off of the RECOMBIVAX HB vials, to the point where it started to hurt his fingers. The physician always had issues removing the yellow caps and they always seemed to bother his fingers. Product quality issue was reported. The outcome of the event was not reported. The relatedness between the event and the RECOMBIVAX HB was not reported. Additional information has been requested.
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 23-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
The upper arm is itchy; Soreness in the arm; a red area which became larger; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (The upper arm is itchy), PAIN IN EXTREMITY (Soreness in the arm) and VACCINATION SITE ERYTHEMA (a red area which became larger) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006MR0A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (The upper arm is itchy), PAIN IN EXTREMITY (Soreness in the arm) and VACCINATION SITE ERYTHEMA (a red area which became larger). At the time of the report, PRURITUS (The upper arm is itchy), PAIN IN EXTREMITY (Soreness in the arm) and VACCINATION SITE ERYTHEMA (a red area which became larger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
When given the injection, I immediately had pain go down my arm for a few seconds and subsided quickly. By that afternoon my entire upper arm ached. I had pain in my arm that was severe when I raised my arm or adducted my arm. I took ADVIL. I could not sleep due to the pain and my shoulder was stiff in the evenings. I increased to taking 2 ADVIL at bedtime and changed my position for sleeping which helped slightly. I did not feel it was getting any better so on 11/30/2015 I went to the doctor. I was told it was not from the shot (why did it start with the shot?). I was told I had arthritis and a frozen shoulder and given exercises to do. I had an X-ray on 12/1/2015 to check for arthritis. I tried the exercises on 12/1/2015 - doing the exercises did not hurt but the pain in my upper arm became very intense after an hour and later that day, pain shot down my arm again. I stopped doing the exercises. I continued taking ADVIL and avoided adducting my arm or raising it. I waited for the doctor's call about the X-ray which I never got. My arm gradually improved. By January I stopped taking the ADVIL. I still had pain with adduction - so I had pain occasionally when driving as I turn using a hand over hand method. Today in Feb. that pain is gone. I still have pain when dancing when my arm is raised and adducts while I turn. I also have a weakness in that arm when I get a gallon jug out of the refrigerator. I always get a yearly flu shot and never had problems before.
pt recv ax 1AUG95 & 17DEC96 2 wk p/vax pt exp 10 spots which reporter originally though were but bites & itching;
attempted to kill herself; acting differently; This is a spontaneous report from a Pfizer Sponsored Program . A contactable consumer (patient's parent) reported a female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization this morning (03Feb2021). Medical history included: autism, depression and anxiety. Concomitant medication was not reported. The patient experienced acting differently and she attempted to kill herself after the first dose of the vaccine today (03Feb2021). Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.  Information on Lot/batch number has been requested.
Breaking out in hives all over body and super itchy. Have taken over the counter Benadryl around the clock but it has yet to clear itself up.
Leftside of tongue, Leftside of lips, Left ear, Left side of the  face-numbness, no tingling. resolved after 30 minutes.
11/16/2022 at work stomach began to get sick around 6PM threw up; chills and fever during night woke at 3AM 11/17/2022 threw up and contained blood quarantine for 2 days 11/17/2022 normal temperature returned; liquid diet; diarrhea later afternoon and light dizziness. 11/19/2022 lightheadedness went to see doctor; blood test unable to be performed sent to ER; transported to local hospital stayed overnight, 11/20/2022 saw gastrointestinal doctor hemoglobin dropped endoscopy was performed was discharged that day.
Case number PHEH2014US008762 is an initial spontaneous report from the nurse received on 29 Apr 2014 with a follow-up received on 24 Jun 2014. This report refers to an 11-years-old male child. He did not have any relevant medical history. Concomitant medications were not reported. On 29 Apr 2014 at 2.00 pm, the child was vaccinated intramuscularly with only MenCYW-135, the liquid component of MENVEO (batch number: M13015) and did not receive Men A lyophilized conjugate. It was reported that the child did not experience any adverse event following this administration error (inappropriate preparation of medication). Mother was advised about the error and was given information regarding the rarity of Mena. Mother was given option to revaccinate now or later, if the child left the country. Mother stated that she would wait for the booster dose at 16 years of age unless there would be a foreign travel (which was not likely). Follow-up received from the nurse on 24 Jun 2014: Updated patient demographics, medical history, time of vaccination and comment from mother.
headache; ringing in ear; upset stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date Mar2021 (Batch/Lot number: unknown) at the age of 55 years 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: HEADACHE (non-serious) with onset Mar2021, outcome "recovering", described as "headache"; TINNITUS (non-serious) with onset Mar2021, outcome "recovering", described as "ringing in ear"; ABDOMINAL DISCOMFORT (non-serious) with onset Mar2021, outcome "recovering", described as "upset stomach". Additional information: Clinical course: The patient experienced headache, ringing in ear, and upset stomach on the evening of first BNT162B2 vaccine. Felt better by morning.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hospitalization: 7/22/22 - 8/14/22 (23 DAYS) Presentation to the ED: PATIENT WAS HOSPITALIZED D/T ABDOMINAL SURGERY. COVID-19 + date: 7/22/22; PATIENT STATES SHE TESTED POSITIVE INITALLY 3 WEEKS PRIOR TO THE CONFIRMED TEST WHILE HOSPITALIZED. Treatment: NONE. Discharge to: HOME.
Patient lost consciousness after receiving a vaccine and appeared to be having a tonic-clonic type seizure. Paramedics were called and arrived on scene. Patient regained consciousness and was evaluated by the paramedics. His blood glucose levels were tested and upon pricking the finger to draw blood the same event of losing consciousness/seizing occured. Patient was monitored and regained consciousness. He was then cleared by EMTs before leaving the pharmacy on his own.