chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up and had a rash on her torso, arms and legs and about an hour later developed into hives. That night she got appendicitis and was admitted into the hospital for surgery. She had not been sick nor eaten anything different, nor taken any medications. The only thing different was the 2nd covid vaccine given the week before.  She had no issues with the first dose of the covid vaccine. I had to give her Benadryl for 5 days to keep the allergy under control. After 5 days it went away.  I don?t know if the appendicitis was coincidental or related to the vaccine either. She had no symptoms prior to the evening of Aug 2nd when the pain began.
pain, redness, extensive swelling and feels like a hard bunch right near where the Tdap shot was given on my arm and its still there
tested positive for the COVID-19 infection; tested positive for the COVID-19 infection; This is a spontaneous report from a contactable consumer (patient's mother).  A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified it was reported that the mother received the second dose of the vaccine 3 weeks ago on 31Jan, last week (17Feb or 18th) her daughter (who was 33 years old) tested positive for the COVID-19 infection, the mother calling has not presented any symptoms apart from "feeling like coming down" for a short period of time, she was not sure if the vaccine was working, doctors have suggested that her daughter should isolate, caller wanted to know if there was any studies on how patients who received the second dose of the vaccine react to the exposure of the virus. She has been in contact with her daughter for 5 days, caller has been tested for the infection and she resulted negative. Caller received the second dose of the BNT162B2 vaccine and wanted to know how to participate as part of the clinical trials of the vaccine. Outcome of the events were unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Developed a rash on the chest, neck and back; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On an unknown date, 1 day after receiving Shingrix, the patient experienced rash (Verbatim: Developed a rash on the chest, neck and back). The outcome of the rash was resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.   It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-MAY-2023 The reporter was patient. The patient received Shingrix and one day later developed a rash on the chest, neck and back.  Nothing else was reported.  The reporter consented to follow up with physician.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Right numbness on the right side of my face , an  hour and a half after vaccine was administered.    Numb areas are:  Lower Right Neck Behind my right ear on my head My right cheek My right Gums Side of right eye near temple Top right side of forehead
NauseaVomiting CHILLS, FATIGUE, NAUSEA, COUGH, RUNNY NOSE, CONGESTION, HOT FLASHES Narrative:
Condition aggravated; past 42 days between doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (past 42 days between doses) and CONDITION AGGRAVATED (Condition aggravated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (past 42 days between doses). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated). At the time of the report, PRODUCT DOSE OMISSION ISSUE (past 42 days between doses) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. /unknown.  Concomitant product use was not provided/unknown by the reporter.
Extreme itchiness at site of injection. Moderate to extreme cold symptoms of headaches, sinus congestion, sore throat, barking cough, extreme exhaustion. No fever. No physician treatment sought. Treated with over-the-counter meds. No subsequent illnesses after receiving the flu shot in the past.
Information has been received from an office worker concerning a 44 year old (reported as 45 year old) female with asthma, aspergillosis, penicillin allergy, tetracycline allergy, azithromycin allergy, COMPAZINE hypersensitivity and REGLAN hypersensitivity who on 17-AUG-2009 was vaccinated with the first dose of PNEUMOVAX 23 (lot # reported as 08743X). On 26-AUG-2009 the patient experienced redness and swelling in her arm which was also hot to touch. The patient also experienced soreness and was unable to lift her arm. At the time of the report, the patient recovered on an unspecified date. Follow up information has been received from the office worker and medical records concerning a 44 year old (previous reported as 45 year old) female with asthma, penicillin allergy, allergic reaction to antibiotics, drug hypersensitivity, sleep apnoea, bronchopulmonary aspergillosis allergic, rhinitis allergic, oedema, cough, liver disorder, overweight, no social history (smoking, alcohol, drug use and caffeine) and anxiety disorder and a history of colitis, liver fatty, metabolic syndrome, migraine, supraventricular tachycardia, oesophageal reflux, candidiasis, caesarean section, cholecystectomy, intestinal adhesions, psoriatic arthritis, gastritis and gastrointestinal erosion who on 3:00 pm on 17-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot # 662263/0743X) in her left arm. Concomitant therapy included AMBIEN, ZANTAC, ZITHROMAX, CIPRO, BACTRIM DS TABLETS, Epi EZ Pen, ZOFRAN, albuterol, ALVESCO, SYMBICORT, XOPENEX, lidocaine, PROAIR HFA, hydrochlorothiazide, HYCODAN and KAPIDEX. On 24-AUG-2009 the patient experienced a local reaction to the vaccine. Her left arm was sore, red, swollen and hot to touch. She was unable to lift her arm. There was no temperature noted. At the time of the report, the patient recovered on 28-AUG-2009. No further information is available.
This spontaneous report was received from the Vaccine Coordinator referring to a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 14-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Patient also has Moderate to large pericardial effusion; Patient has moderate left pleural effusion with associated atelectasis at the left lung; Patient has moderate left pleural effusion with associated atelectasis at the left lung; This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. A 52-year-old male patient received bnt162b2, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient has moderate to large pericardial effusion, moderate left pleural effusion with associated atelectasis at the left lung on an unspecified date. Event took place after use of product. Outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate
Resident tested positive for COVID on 01/06/2021. Resident received monoclonal antibody treatment on 01/09/2021.
tenderness in her arm; red patch at the injection site; This is a spontaneous report from a contactable consumer (patient) via a medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated her arm did not bother her much just tenderness in her arm. 10 days after the vaccine, on 26Jan2021, the patient developed a red patch at the injection site and wanted to know if this symptom has been reported this many days after the vaccine. The patient wanted to know if she should get the second dose of the vaccine after she experienced a red patch around the injection site 10 days after the first dose of the PFIZER-BIONTECH COVID-19 VACCINE. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Vaccine was given to patient 1 day shy of 16th birthday. No adverse events reported by the patient or patient's parents post-vaccination after a call was made to them.
This spontaneous report as received from a physician refers to a 11-week-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant drugs were not provided. On an unknown date, the patient inadvertently received a dose of PNEUMOVAX 23 lot # R012713, expiration date: 03-AUG-2019 (exact dose and route of administration were not provided), for prophylaxis, instead of PREVNAR. There were no adverse effects reported.
Stiff Neck--began  3-2-04 Achiness Prescribed Skelaxin 3-15--04 through present parathesias of feet, hands, neck, abdomen (also weakness)--doctor visits, 3-23-04, 3-29-04, 4-7-04---er visit 3-31-04  Rx--neurontin, davocet, tramodol
Patient diagnosed with Behcet's Syndrome.  Behcet's Syndrome symptoms began 6 weeks after 2nd moderna vaccination.
Swelling in left armpit and neck, low grade fever, nauseous, fatigue,, migraine
trembling uncontrollably; freezing; felt like every muscle in my body had seized; I couldn't move; 103.5°fever / I'm still running a 101°fever; tremendous amount of pain; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.  A 28-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, in Arm Right on 18May2021 at 15:00 (at the age of 28-year-old), as dose 2, single for COVID-19 immunization. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 27Apr2021 at 15:00 (at the age of 28-year-old), in Arm Right, as dose 1, single for COVID-19 immunization. Patients did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination reported as not applicable. Patient had not diagnosed with COVID-19 prior to vaccination and patient had not been tested for COVID-19 since the vaccination. Covid prior to the vaccination reported as no. patient had no known allergies. On 19May2021 05:00, patient experienced trembling uncontrollably and freezing. Patient felt like every muscle in my body had seized and she couldn't move. Patient was running a 103.5-degree fever. patient was still running a 101degree fever and patient body, while now able to move. Patient had tremendous amount of pain. The patient underwent lab tests and procedures which included on 19May2021 body temperature: 103.5 fahrenheit, I was running a 103.5 degree fever, body temperature: 101 fahrenheit on 19May2021 It is now 5:30pm, I'm still running a 101 degree fever. Patient did not received any treatment as a result of AE. The clinical outcome of the events was unknown.  Follow-up (16Jul2021): This follow-up is being submitted to notify that the lot/batch number not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Needle inserted in left arm muscle hit a nerve that made that muscle clench involuntarily. Tightness subsided gradually until around 3 PM when the whole arm clenched/tightened in the same arm, making movement impossible or painful, depending on what she tried to do. About 1 hour later (4 PM), she had an onset of visual disturbances that precede a faint. She put her head down but the visual disturbances did not subside. She became nauseous and crawled to the sofa, where she lay for approximately 2 hours, after which time visual disturbances and nausea started to subside. She was then able to call her doctor and was told to call 9-1-1. When the medics arrived, they checked her vital signs, which were okay. She refused to go to the hospital, although she felt weak and shaky. The tight, sore muscles in the injection arm continued to bother her but gradually improved over several days. By the date of this report (6/23/16), there is residual soreness in the muscle at the site of injection.
Redness, warmth to injection site; 5x6cm area of redness, warmth on left deltoid when seen by EOH on 12/21/2020.
arm pain is vomit induding / The pain is so overwhelming; It constantly feels like my elbow and arm is being hammered on by a mallet.; I can't sleep; I can't concentrate; I can't think straight; drug ineffective; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ibuprofen unknown for pain.   On 7th October 2020, the patient received Shingrix. In October 2020, the patient started ibuprofen at an unknown dose and frequency. In October 2020, less than 2 weeks after receiving Shingrix and not applicable after starting ibuprofen, the patient experienced pain in arm, pain in elbow, sleep disturbance, concentration loss, abnormal thinking and drug ineffective. The patient was treated with ibuprofen, paracetamol (Tylenol), non-drug therapy (Ice Pack (No Medication)) and non-drug therapy (Hot Compresses). The action taken with ibuprofen was unknown. On an unknown date, the outcome of the pain in arm, pain in elbow, sleep disturbance, concentration loss, abnormal thinking and drug ineffective were unknown.   It was unknown if the reporter considered the pain in arm, pain in elbow, sleep disturbance, concentration loss and abnormal thinking to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The arm pain was vomit inducing. It constantly feels like elbow and arm was being hammered on by a mallet.  The patient cannot think straight, cannot sleep, cannot concentrate.  The pain was so overwhelming. The patient taken tylenol, ibuprofen, oil, rubbed oil on my arm, taken gummies, and have taken other pain medication. Nothing has helped.  The patient has iced to the arm, put heat on it, wrapped it, did some stretching, rested it nothing has even begun to this pain. The patient has been going through this pain for over 10 days. This side effect was so painful, so sad.
Admitted with Afib/RVR and Covid PNA.  Negative Covid test on 7/29.  Reports was fully vaccinated.  Required O2 by nasal cannula. Treated with remdesivir, steroids, zinc, vit c and d.  Home
the patient was administered improperly stored VARIVAX; This spontaneous report was received from a registered nurse and refers to a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 07-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # T002848, expiration date 23-JAN-2022, site and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine underwent a temperature excursion of -14 degrees Celsius (C) to 10 degrees C (-12.1 degrees C) for 3 hours and -9 degrees C to 8 degrees C (-7.5 degrees C) for 8 hours 30 minutes (multiple excursion). There was no previous temperature excursion. Data logger was involved.
Arm was red and slightly swollen. The red area itched. The redness appeared where the vaccine was injected. It was about 2 inches by 6 inches down my arm.
Inflammation arm/face/ left hand; Hand pain more intense; Vertigo; This is a spontaneous report from a Non-contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL9263) via an intramuscular route of administration in upper right arm on 02Feb2021 at 13:30 as 1st dose, single for covid-19 immunization. Patient medical history included Diabetes from 1993 and its ongoing, Cancer from Jul2017 to Nov2018 and done Chemo, lumpectomy, Radiation, Inflammation in both wrists hands (7 incisions in left hand) on 30May2020, both knees completely replaced (8Oct + 18Nov). Both knees, however right knee collapsed & it had to be redone same day time. Family history included High blood pressure, diabetes, inflammation (back and knees) and stroke. Patients concomitant medications included hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN) from 2019 and its ongoing for pain and diclofenac sodium from 2020 and its ongoing for inflammation, take 3 meds for blood pressure, cancer med, diabetes med, HBP med, depression med and cholesterol med. The patient previously took second dose of shingles vaccine on 11Jan2021 for immunization. On 03Feb2021, patient experienced vertigo, vertigo remained on and off, inflammation of arm, face and left hand. Hand pain was more intense. Patient took second dose BNT162b2 on 24Feb2021 (Lot No: EN6200) and experienced fatigue. The patient underwent lab tests and procedures which included Blood pressure measurement: 137/70 mmhg on Dec2020 and HbA1C (Glycosylated haemoglobin): 6.9 on Nov2020. Serious criteria for event Inflammation arm/face/ left hand was reported and hand pain more intense as important medical event and for vertigo it was persistent /significant disability/incapacity. The events did not require any treatment. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
pt recvd vax; 1 day later, devel swollen glands in the neck & underarm area;
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received covid vaccine, approximately 10 minutes after patient slumped foward in chair then fell out of the chair and struck there face on an unkown object, blacked eye and chipped patients tooth. I went to the pharmacist rushed to patient's side made sure they were awake, asked technician to call 911, assisted patient back in the chair. Had technician stay with patient got him a water and waited for paramedics to arrive. The paramedics determined patient could leave.
Swelling, redness, pain, firmness and itchiness at injection site, add well as body aches and chills, one week after shot. Aches and chills dissipated after about 12-15 hours, injection site symptoms lasted about 2 days longer.
Immediately after vaccine administration, patient lost consciousness and collapsed in chair. Epi and O2 were administered. Patient recovered and was able to sit up after several minutes.  Patient was observed at the vaccination site for ~1 hour, and then transported to the ED for evaluation.
I (the pharmacist) was giving the vaccine and noticed that the syringe was leaking where the needle screws into the syringe.  I was confident that the amount was significant (drops were even on the patient's arm); so, I was confident that the patient did not receive enough vaccine.  I got a new vial, prepared it and re-administered the vaccine without any more issues.
This case was reported by a healthcare professional and described the occurrence of cellulitis in an 11-year-old female subject who was vaccinated with Boostrix, GlaxoSmithKline, Havrix, GlaxoSmithKline, and Menactra, Sanofi Pasteur for prophylaxis. The subject's medical history included allergy to Keflex and egg allergy. There were no concurrent medications. On 13 September 2007 the subject received the second dose of Boostrix (unknown), a booster dose of Havrix (unknown), and a booster dose of Menactra (unknown). On 13 September 2007, one of the three vaccines that the subject received was inadvertantly administered via the incorrect route (subcutaneous). It was noted that the person who administered the vaccines did not document the injection site of each vaccine. On 13 September 2007, the same day that she was vaccinated with Boostrix, Havrix and Menactra, the subject experienced tissue cellulitis. This case was assessed as medically serious by GSK. The subject was treated with Augmentin. At the time of reporting the outcome of the events was unspecified.
This spontaneous report as received from a registered nurse concerning an unspecified number of patients who on unknown dates received an unspecified number of doses of VARIVAX (merck) that were possible stored improperly. The electronic freezer temperature monitor was unable to produce freeze temperature range. No adverse events were reported. Additional information has been requested.