chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Positive for COVID; Positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team and product quality group, Program ID: (159558). The reporter is the parent.  A child male patient received BNT162b2 (BNT162B2), on 25May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) 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) all with onset 26May2022, outcome "unknown" and all described as "Positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive, notes: Today he tested positive for COVID.  Question: Report was filed with agency for child as well as for the reporter herself, however the agent notes that the caller does not have any additional questions regarding herself, only the child. Reporter is a consumer calling in regards to her son who received his booster dose of Pfizer dose COVID, yesterday. Today he tested positive for COVID. She is asking does he need to receive another booster dose and also if it is possible due to the booster dose that the patient received. She states her son asked the question and she wanted to follow through with obtaining the information for him. Reporter also notes that she mentioned to the other agent that 1/2 of his class tested positive so she does not think it is a result of the booster. Reporter wants to know if the patient should get another booster dose due to him now testing positive 1 day after having the vaccination or can you get a booster when you are positive. Report was filed with agency for child as well as for the reporter herself, however the agent notes that the reporter does not have any additional questions regarding herself, only the child.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headaches with the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headaches with the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches with the vaccine). At the time of the report, HEADACHE (Headaches with the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown. The reporter stated that she knows of people getting headaches with the vaccine.
3rd dose was administered; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number P7N2H, expiry date 30th January 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2019) and Shingrix (received 2nd dose in April 2020).   On 23rd September 2021, the patient received the 3rd dose of Shingrix. On 23rd September 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter stated that, 3rd dose of Shingrix vaccine was administered to patient, which led to extra dose administered. No additional details provided by caller. The reporter did not consent to follow up.
This case was reported by a healthcare professional and described the occurrence of bruise injection site in a 46-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included TWINRIX (GlaxoSmithKline) given on 15 September 2011. On 15 September 2011 the subject received a dose of BOOSTRIX (.5 ml, unknown route, right arm). On 17 September 2011, 2 days after vaccination with BOOSTRIX, the subject experienced bruise injection site and injection site pain. The bruise was black and blue to purplish and moved down the arm to just above the elbow. TWINRIX was administered in the opposite arm and no event was reported due to TWINRIX. At the time of reporting the events were improved. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX. Follow-up information was received on 13 October 2011. It was reported that the events of injection site bruise and injection site pain began on the day of vaccination, 15 September 2011. The outcome of the events was unknown. The events were considered to be possibly related to BOOSTRIX vaccination.
tired of being tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired of being tired) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 038A21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL and AMLODIPINE for Blood pressure.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired of being tired). At the time of the report, FATIGUE (tired of being tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had the reactions still persisted after the 2nd dose. He said that they didn't get any worse and stayed about the same. No treatment medications were reported.   This case was linked to MOD-2021-230189 (Patient Link).
Sever pain in the injected arm, could not lift arm , radiated into my shoulder. Felt like fire. Also radiated down my arm, and my hand and fingers were numb
fever 102 2NOV97PM;lethargy & irritability on 3NOV97AM;adm to hosp 3 days of amoxicillin;
High rectal temperature of 104.3, rash all over face, stomach and back. Lethargic, lack of appetite, cranky, fever.
chills, fever, sweating, body ache, loss of energy, excessive pain at injection site, loss of balance, fainting, lack of sleep, coughing  Most side effects started within 24 hours of the shot
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (little fever) and CHILLS (chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The patient's past medical history included Blood pressure management. Concurrent medical conditions included Diabetes and Anxiety. Concomitant products included DULOXETINE for Anxiety, AMLODIPINE for Blood pressure management, METFORMIN for Diabetes. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PYREXIA (little fever) and CHILLS (chills). On 23-Jan-2021, PYREXIA (little fever) 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. Concomitant medication included Centrum. On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (route of administration was unknown) 1 dosage form (batch number- 031M20A). The patient did not experience any symptom after second dose. No treatment information were given. This case was linked to MOD-2022-456589 (Patient Link).
threw up twice last night; hasnt been feeling well; He has not been eating or drinking; diarrhea; dizziness; nausea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2020, the patient received Shingrix (intramuscular). On 5th January 2020, 2 days after receiving Shingrix, the patient experienced vomiting, feeling abnormal and appetite lost. In January 2020, the patient experienced diarrhea, dizziness and nausea. On an unknown date, the outcome of the diarrhea was recovered/resolved and the outcome of the dizziness and nausea were not recovered/not resolved and the outcome of the vomiting, feeling abnormal and appetite lost were unknown.   It was unknown if the reporter considered the diarrhea, dizziness, nausea, vomiting, feeling abnormal and appetite lost to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and started experiencing diarrhea, dizziness and nausea. He has continued to feel like that through the weekend. The patient was still feeling dizzy and nauseous. The patient threw up twice last night and he has never thrown up before in his life. The patient has not been eating or drinking since he had not been feeling well.
Information was received from a Registered Nurse who stated that the refrigerator temperature rose to 16C time of excursion 67 hours (worse case), affecting ROTATEQ (dose, site and duration not reported) "(not supported)". The reporter stated that vaccines had experienced  previous temperature excursion of 14C for 12 hours. Temperature ranged and time frame: 16C for 67 hours and 14C for 12 hours. This is one of several reports received from the same reporter. Additional information is not expected because the registered nurse stated she did not want to receive any further follow up letters.
Information has been received from a physician concerning a 15 year old female with no known drug reaction/allergies or pertinent medical history who was vaccinated with RECOMBIVAX HB. There was no concomitant medication. Subsequently the patient developed a rash. The physician felt that rash may have been related to therapy with RECOMBIVAX HB. The product quality complaint unit was not involved. Additional information has been requested.
Information has been received from a pharmacist referring to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not provided. On approximately 25-NOV-2016 (reported as "about six days ago"), the patient was vaccinated with a dose of ZOSTAVAX, 19400 plaque-forming units (PFU) (0.65 ml, once, route was unknown) for prophylaxis. Following the vaccination, on an unknown date of 2016, the patient experienced an injection site reaction that consisted of ''numbness'' ''peeling flaky skin'' and redness that localized at the injection site. No treatment was given for the adverse events. The patient was seen in the pharmacy for medical attention. The outcome of the events was unknown. Causality was not provided. Additional information is not expected as there was no consent to contact the reporter.
received both doses 4 years ago, shingles is currently recurring/suspected vaccination failure; shingles is currently recurring now about once a month; small clumps of a 5-6 blisters / patch on palm of her hand and on lower back; itch; blisters burn; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (recurrent Shingles prior to any doses of either Shingles vaccine). Previously administered products included Zostavax (received 7 years ago from reporting date).   On 15th February 2018, the patient received the 2nd dose of Shingrix (intramuscular). In December 2017, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister, pruritus and burning sensation. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, pruritus and burning sensation were unknown and the outcome of the shingles and blister were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister, pruritus and burning sensation to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient had received both doses of Shingrix in her right arm approximately 4 years ago from reporting date.  The patient stated that after the 2 doses of Shingrix, she was symptom free of shingles for 4 years, but her shingles was currently recurring now about once a month. The patient described her shingles outbreaks were small clumps of a 5 to 6 blisters that itch and then burn and last a month before healing, before another patch pops up on a different location.  At the time of reporting, the patient had a patch on the palm of her hand and on her lower back near her tailbone. The patient routinely takes acyclovir for outbreaks.  Reporter did not have the lot or expiration date of the Shingrix administered.  She gave consent to contact her or health care professional. The reporter consented to follow up.
Information has been received from a physician assistant concerning a 56 year old male with a history of cold sores who in MAY 2008 was vaccinated with a first dose of ZOSTAVAX vaccine (Oka/Merck) 0.65 ml SQ. Subsequently the patient experienced 2 outbreaks of cold sores. Additional information has been requested.
This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 26th July 2018, the patient received SHINGRIX. On 26th July 2018, less than an hour after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The patient stated that within an hour or so after receiving SHINGRIX, she started to experience severe pain in her arm. The pain was not just at the injection site but down her entire arm. The pain was so intense that she was unable to do anything with her right arm. If the patient needed to use the right arm for something, she had to use her left arm to move the other. The patient was still experiencing pain on the day of reporting but not as intense.
First vaccination 03/09/21 headache within 40 minutes of having shot, fever, chills body aches, nausea for about 3 days.  Second shot 04/06/21 felt fine on day of vaccination however on the next day woke with headache fever chills nausea body aches for Wednesday Thursday, Friday had resolution to fever and arm pain however injection sight still very swollen (larger than hand to include fingers and palm)  and broke out in rash and hives on chest, and left upper and lower arm.   Face and chest area also very red like being badly sunburned.  Called nurse advice line with healthcare provider Tricare- they tried to get me in to see my primary care physician but was unsuccessful.  Nurse advice line sent me to urgent care at above location to have doctor look at rash and hives.
This study case was received from the investigator in a trial on 12 November 2012. A 23 year-old male subject with a history of headaches was found to have six days post vaccination an acute myocardial infarction, subendocardial infarction after the subject had received on 15 September 2012 an injection of ACAM2000 (lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I of 00.18, an abnormal ECG on 21 September 2012 and a normal Echocardiogram on 23 September 2012. Lumbar puncture and MRI of the brain, spinal cord and heart were not available. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
MODERATE TO SEVERE HEADACHES AND RINGING IN THE EARS; MODERATE TO SEVERE HEADACHES AND RINGING IN THE EARS; This is a spontaneous report from a non-contactable other hcp. A 72-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL3248), dose 2 intramuscular, administered in Arm Left on 18Jan2021 08:00 at 2ND DOSE, SINGLE (at the age of 72-year-old) for covid-19 immunisation. Medical history included Allergies: LATEX, allergies: METALS EXCEPT GOLD AND TITANIUM from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination, Patient had not tested positive for COVID-19 since having the vaccine. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Right on 28Dec2021 08:00 (lot number=EL1284) at 1 ST DOSE, SINGLE (at the age of 72-year-old) for covid-19 immunisation. The patient experienced moderate to severe headaches and ringing in the ears on 18Jan2021 16:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jan2021. The outcome of the event was not recovered  No follow-up attempts are possible. No further information is expected.
No adverse event- client reports she only has sore arm, but client was given bivalent dose as her first dose of her primary series.  Per CDC guidance and consultation, client does not need to repeat dose and will receive a dose of monovalent in 21 days for her second dose, but will not need a bivalent booster 2 months following per current guidance.
Patient reported redness and swollenness from shoulder to elbow of left arm. Also experienced itching and flu-like symptoms.
A 13 year old male patient was attacked by bats in September 2003. He received 5 doses total of RabAvert for post-exposure treatment. Treatment started on 9/6/03 through 10/4/03. Following treatment of RabAvert, on approximately 11/13/03, he developed headaches, myalgia, extreme malaise, and muscle aches in his legs to the point of being barely able to walk. The patient was unable to go to school for 1 week because he was so lethargic. He also experienced headaches during the time immediately after the RabAvert injections. Last injection of RabAvert was given was on 10/04/03. (OMIC). Follow-up information received 19 Jan 03: Approximately one month after the last rabies vaccine injection, the patient became listless and unable to walk at times. He was fatigued and also experienced muscle spasms for a period of approximately 2 weeks. The patient also had many headaches that continued until the end of Nov 03. According to the reporter, the patient has recovered from these events.
A few hours after vaccine, began to experience chills. Continued to progress to flu-like symptoms including headache, muscle aches, fatigue, and nausea in addition to initial chills.
I had "covid arm" for the second time. I also had covid arm after my 2nd dose of Moderna to make me be considered fully vaccinated. I am using triamcinolone acetonide ointment that was prescribed to me when I first had covid arm after my 2nd dose.
1 single hive like at site of where injection was given. Noticed on pm of 4/13/10. Mom used BENADRYL cream and CLARITIN. No problems with SOB, tongue swelling etc. Just hive on arm. No other problems.
lt arm approx 3" circular, reddened area w/soreness, states whole lt side is sore;also was nauseated, h/a & had a nose bleed, chills;this MA noticed reddened area & went to MD given rx for med; & use hot/cold packs;
Within 10 minutes of vaccine, employee had complaints of a temporal headache and nausea. Employee had dry heaves with phlegm. Pt. was sent to Occupational Medicine where he was seen.  Employee was unable to return to work on the day of receiving the injection but was to return to work the next day (3/4/2022).  Liquids, rest and tylenol prn.
11 days after COVID-19 vaccine, broke out in hives all over body. Went to urgent care and was told it was Allergic Dermatitis. Given dexamethasone and was prescribed ATARAX hydrochloride. Hives went away within a couple of days.
Dose received: 3; Fever; Chill; Arm pain; Body pain; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.   An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Jan2022 (Lot number: FL3198) as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: ER8731), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: ER8736), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 22Jan2022, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 22Jan2022, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 22Jan2022, outcome "not recovered", described as "Chill"; PAIN IN EXTREMITY (non-serious) with onset 22Jan2022, outcome "not recovered", described as "Arm pain"; PAIN (non-serious) with onset 22Jan2022, outcome "not recovered", described as "Body pain". Therapeutic measures were not taken as a result of pyrexia, chills, pain in extremity and pain.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Received 100mcg dose as her 3rd dose booster rather than 50mcg.
I have a history of Guillain barre and typically after infections or vaccines I get a relapse of symptoms. About 2.5 hours after my injection I noticed numbness starting at the tip of my toes on my left foot. By 5 hours after same on my right. At 24 hours it was up to the base of the toes. Now 2 days after I have numbness to the balls of my feet. I also have numbness around the injection site. Although this is fairly normal for me. Typically lasts about 3-7 days of progression with 1-2 weeks to resolve. So far the pace is spot on for my history. Nothing out of the ordinary.
pt recv vax;about 4-5 wk p/ vax pt c/o pain in her rt side,not better,hosp,dx w/ cancer;mom thinks vax triggered cancer;c/o pharyngitis,v,dec appetite;significant weight dec;pain abd;T 99.3;back pain;pt died from renal cell carcinoma;