chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hardness near injection site; sweling at injection site; itchy sensation at injection site; injection site rash; fatigue; soreness near injection site; light headedness; irregular heartbeat; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (light headedness), HEART RATE IRREGULAR (irregular heartbeat), INJECTION SITE INDURATION (hardness near injection site), INJECTION SITE PRURITUS (itchy sensation at injection site) and INJECTION SITE RASH (injection site rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced DIZZINESS (light headedness) and HEART RATE IRREGULAR (irregular heartbeat). On 22-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itchy sensation at injection site), INJECTION SITE RASH (injection site rash), FATIGUE (fatigue) and INJECTION SITE PAIN (soreness near injection site). On 26-Jan-2021, the patient experienced INJECTION SITE INDURATION (hardness near injection site) and INJECTION SITE SWELLING (sweling at injection site). At the time of the report, DIZZINESS (light headedness), HEART RATE IRREGULAR (irregular heartbeat), INJECTION SITE INDURATION (hardness near injection site), INJECTION SITE PRURITUS (itchy sensation at injection site), INJECTION SITE RASH (injection site rash), FATIGUE (fatigue), INJECTION SITE PAIN (soreness near injection site) and INJECTION SITE SWELLING (sweling at injection site) outcome was unknown.        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.   No relevant concomitant medications were reported.      Treatment details include Aleve.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The events of fatigue, injection site-  pain, pruritus-induration, swelling rash, are consistent with the product safety profile
came down with COVID in a week; came down with COVID in a week; This is a spontaneous report from a contactable physician. This physician reported similar events for 4 patients. This is third of four reports. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 immunisation. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient came down with COVID in a week of vaccination. The outcome of the event came down with COVID in a week was unknown. The reporting physician stated that he doesn't think that them getting the vaccine and having COVID is related, he thinks it is a coincidence.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021064977 as same reporter/drug/AE/different patients.
subchorionic hematoma; circumvallate placenta; Velamentous cord insertion; Pregnant patient received first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of SUBCHORIONIC HAEMATOMA (subchorionic hematoma) and ABNORMAL CORD INSERTION (Velamentous cord insertion) in a 39-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pregnancy loss in 2019. Concurrent medical conditions included Hashimoto's thyroiditis since 1999 and Rheumatoid arthritis since 2018.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 09-Aug-2020 and the estimated date of delivery was 21-May-2021. On 22-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received first dose). On an unknown date, the patient experienced SUBCHORIONIC HAEMATOMA (subchorionic hematoma) (seriousness criterion medically significant), PLACENTAL DISORDER (circumvallate placenta) and ABNORMAL CORD INSERTION (Velamentous cord insertion) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 21-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received first dose) had resolved. At the time of the report, SUBCHORIONIC HAEMATOMA (subchorionic hematoma), PLACENTAL DISORDER (circumvallate placenta) and ABNORMAL CORD INSERTION (Velamentous cord insertion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2020, Pregnancy test: positive (Positive) Positive.         No Concomitant medications were provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Significant follow up received, Patient demographics, medical history, previous pregnancy history, maternity medical history, 2nd dose details updated; Sender's Comments: This is a case of product exposure during pregnancy with associated serious AEs of subchorionic hematoma, circumvallate placenta and Velamentous cord insertion. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring of AEs and pregnancy outcome. Events are considered serious as per medical judgment.
They have thousands of deaths, including her mother; This is a spontaneous report from a non-contactable consumer (patient's daughter). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer stated they have thousands of deaths, including her mother (the patient). The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: They have thousands of deaths, including her mother
Within minutes of receiving the injection I experienced waves of dizziness to the point of almost passing out, rapid heartbeat, full body hot flashes, sweating, hand tremors,, dry mouth Observed for 30 min and released with no intervention. Waves of vertigo continued  throughout the day, but are decreasing in frequency but not intensity as days go on. Within an hour of injection psoriasis on left leg flared and was raised, red and extremely itchy through Sunday, 4.11.21. Severe headache through end of day on 4.9.21. Treated allergic symptoms with 10ml Benadryl  every 5 hours for 2 days, Ibuprofen PRN for pain. All symptoms subsided  except for headache and dizziness/vertigo but appears to be decreasing in frequency but not intensity.
Please note the following if from the Urgent Care physician who treated the patient. He mistakenly identified the patient as receiving the zoster vaccine but in fact received the pneumococcal 23 vaccine: HPI: 69 male presents c/o developing achy right shoulder pain shortly after getting an injection at the site where he had a zoster vaccination yesterday and a mild headache took aspirin which helped a little. Not worst headache of life. Denies dizziness, visual change, dyspnea, wheeze, throat/lip swelling, weakness, numbness, tingling, redness/streaking, nausea, vomiting, abdominal/back pain, chest pain, palpitations, or other complaints. Myalgia and headache pain at injection site. Acetaminophen 325 mg prn.
Headache, Myalgia, Arthralgia, fatigue, swollen glands around neck and eyes. Narrative:
slight headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced slight headache for 5 minutes on unspecified date. The outcome of the event was resolved on unspecified date.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
FATIGUE; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 04-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210427380 and 20210421641.
Fever 102.4, malaise, severe pain in joints, decreased ROM in right arm , tender to touch at injection site with swelling,  Slowed responses in general and delayed swallowing.  I felt pretty awful,  which persisted into the next day with fever down to 100.4 but otherwise about the same
PATIENT STATED HAD SOME DIZZINESS DAY OF SHOT 1. WE DISCUSSED AND WE AGREED TO GO AHEAD AND CLOSELY MONITOR FOR USUAL 15 MINUTES.  10 MINUTES AFTER ADMINISTERING SHOT 2, PATIENT LOOKED UNWELL AND WAS SLOUCHING FORWARD.  I HELPED HIM TO LARGER BENCH WITH MORE ROOM.  HE WAS FLUSHED AND HOT.   HE REPORTED FEELING DIZZY.   HIS BREATHING WAS NORMAL. I GOT HIM COLD PACK AND WATER.  HE REMAINED SEATED FOR ABOUT 30 MINUTES, DRANK MORE WATER AND EVENTUALLY FELT BETTER AND LEFT.
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient's medical history and concurrent condition included rheumatoid arthritis (chronic condition). On an unspecified date in July-2013, the patient was vaccinated with ZOSTAVAX vial dry SD (dosage, frequency, lot number not provided). Concomitant therapies included methotrexate. About 10 days later approximately on an unspecified date in July-2013, the patient was diagnosed with chicken pox. The patient experienced disseminated rash on her thighs, waists, breasts and forehead. The physician stated that the patient had came in for an office visit last week (approximately in 2015) and complained that since taking ZOSTAVAX, she noticed that she has been persistently getting cold sore on her lips. The patient sought medical attention, had visited office and the patient was treated with acyclovir and LYRICA. The outcome of events and causality assessment were unknown. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. Additional information has been requested.
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 years old female patient who received 0.5 ml of vaccine IPOL (lot N1K921M, 14-Nov-2019) via unknown route in unknown administration site on 10-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage (temperature excursion). It was reported that the refrigerator was out of range for 2 hours and 57 minutes with a maximum temperature of 57.1 F. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. This case is linked to AER# 2018SA285833 (same reporter) and AER# 2018SA286128 (same reporter).
Started getting rash on top of both hands that lasted for months; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Started getting rash on top of both hands that lasted for months) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 040A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced RASH (Started getting rash on top of both hands that lasted for months). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 UNK. At the time of the report, RASH (Started getting rash on top of both hands that lasted for months) 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.   Treatment medication include Steroid cream.     This case was linked to MOD-2021-235140 (Patient Link).
Initial report received on 18 March 2008 from an investigator participating in the above-mentioned trial under the reference number MTA37. A ten-month-old female subject experienced a febrile seizure 5 days after receiving an intramuscular right thigh injection of Menactra (lot number U010253) on 13 March 2008. On the evening of 17 March 2008, the subject's mother noted that she felt warm to the touch. The following morning the subject awoke crying and, according to her mother, felt warm (temperature not reported). She was treated with Motrin, and shortly afterwards had an episode of vomiting. She subsequently turned "limp and unresponsive" for approximately 15 minutes; no cyanosis or upward rolling of eyes was noted. The subject presented to the investigator's clinic for medical evaluation, and her temperature at the time was noted to be 102.6 degrees Fahrenheit. She was treated with a tepid sponge bath, and after 15 minutes her temperature had decreased to 99.9 degrees Fahrenheit. Laboratory testing was performed, including CBC, urine culture and sensitivity, and blood cultures (results not provided). She was treated with Tylenol and observed for two hours, at which time her temperature was noted at 99.3 degrees Fahrenheit. The event was considered to be resolved on 18 March 2008. The subject had no history of convulsions or seizures, and no concomitant medications were reported. She recovered, and continued on the trial. According to the investigator, the event was related to the study vaccine.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old male patient who received SHINGRIX. On 26th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced fever and shivering. On 26th March 2018, the patient experienced headache and pain in arm. On an unknown date, the outcome of the fever, headache, pain in arm and shivering were unknown. The reporter considered the fever, headache, pain in arm and shivering to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. In the morning the patient received the SHINGRIX on an unknown arm. When the patient came home after receiving the vaccination he reported having a headache and a sore arm. Around 12:00 midnight, the patient began to experience a fever and shivering. The reporter was unable to provided additional details and did not know in which arm the vaccine was administered.
36-48 hours, post vax, pt had acute gastroenteritis. Symptoms began with vomiting and diarrhea and lasted 7-10 days. Episode #2 lead to dehydration requiring IV hydration in the ER. Vaccines given on 10/6/00, 11/20/00 and on 1/11/01 was also given MMR II and Varivax.
Raised, red welt on arm after 4-5 days. Hot, itchy.
Diarhhea 4 hours after shot Vomiting starting 12 hours after shot both continued until 24 hours after shot fatigue and aches for 72 hours  note 22 weeks pregnant
No adverse event; 4 month old patient getting 1 dose of GARDASIL 9 in error; This spontaneous report was received from a licensed practical nurse concerning a 4-month-old patient. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 25-AUG-2020, the patient was vaccinated with by error with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S023476 was internally confirmed as valid for with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date 26-03-2022) 1 dosage form for prophylaxis (strength, route, anatomical site of administration and vaccination schedule were not reported). The patient did not experienced any adverse event. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S023476; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability.
Mild throat swelling, able to swallow, no respiratory distress. Stable, released from vaccination site.
Flu vaccine given on 10/15/14 - itching and redness after vaccine. Examined in office again 10/17 and had urticarial patch to left deltoid 25 cm x 15 cm.
EE states she received Covid vaccine on Wednesday 1/27/21. She had to call off work on Thursday (1/28/21) due to headache, general body aches and nausea. Came back to work today (1/29/21) and came to EH with c/o uppder body aches, intermittent headaches and a rash to back, chest and bilateral underarms. EE afebrile at this time. EE medicated with Benadryl PO, as per standing order.
Severe nausea, fever, chills. Patient fainted while dry heaving in bathroom. Large amount of swelling at injection site. Patient was scared, but recovered by next morning.
PATIENT RECEIVED MORE THAN THE RECOMMENDED DOSES OF THE COVID-19 VACCINE. JANSSEN WAS ADMINISTERED ON 4/12/2021 AND PFIZER WAS ADMINISTERED ON 4/15/2021 AND 5/6/2021. OUTCOME, SYMPTOMS, AND TREATMENT UNKNOWN.
Patient stated that the PREVNAR 13 inject hurt and there was a small bump where it was injected into her deltoid muscle of the left arm. She bled through her bandaid and down her arm and onto the floor. She felt a little warm and lighted headed. She remained seated for about 45 minutes and drank water. She stated that she felt fine and went ahead and went home.
Information has been received on 13-APR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 06-APR-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did function as intended, and the patient subsequently suffered severe complications the same day she was vaccinated. Shortly after being vaccinated on or about 06-APR-2016, the patient was treated at a family health care and was diagnosed with Ramsay Hunt Syndrome. The patient has been prescribed valacyclovir hydrochloride (VALTREX) and gabapentin for management of her zoster virus related injuries and complications. As a direct and proximate result of the ZOSTAVAX, 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. Upon internal review, Ramsay Hunt Syndrome was considered to be medically significant. Additional information has been requested.
bumps on her skin; itchy rash; hives on her body; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 17th September 2021, 16 days after receiving Shingrix, the patient experienced itchy rash and hives. On 4th October 2021, the patient experienced local swelling. On an unknown date, the outcome of the itchy rash was not recovered/not resolved and the outcome of the hives and local swelling were unknown.   It was unknown if the reporter considered the itchy rash, hives and local swelling to be related to Shingrix.  Additional details provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine in right arm and experienced itchy rash that looks like hives on her body. The reporter stated that the rash comes and goes, 33 days after receiving Shingrix, the rash was itchier and there were more bumps on her skin. The patient reported that she had an appointment with the dermatologist today (on day of reporting). The patient did not give permission to contact healthcare professional. The reporter did not consent to follow-up.
Fever ranging from 100.3 to 100.7 over 19 hours. Lose of appetite, body aches and headache.