chrisvoncsefalvay/vaers-outcomes huggingface dataset:
big red patch on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (big red patch on her left arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced ERYTHEMA (big red patch on her left arm). At the time of the report, ERYTHEMA (big red patch on her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.    This case was linked.   Reporter did not allow further contact
On day 10, developed red, raised, itchy rash on shoulder of injection site. Approximately, 3" x 4". Treated with topical hydrocortisone cream. Resolved by day 12.
COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            No concomitant medications were reported.  It was reported two weeks ago patient got the latest strain of Covid. Patient boosted in October, but that booster did not save patient and two weeks later patient was still battling symptoms, which was gradually diminishing with time and neither of patient was well yet.  No treatment medications were reported.
On 08/12/2017, mother noticed patient's right bicep was swollen, red, hot, and painful to touch. She initiated ibuprofen and BENADRYL every 4 to 6 hours and hydrocortisone cream. Notified RN at Health Department at 3:15 PM on 08/12/2017. Patient iced right arm off and on for 15 minutes at a time, every few hours over the weekend. Patient reports a headache on 08/12/2017. Mother marked redness and swelling with a marker on 08/12/2017 at 8:45 PM; redness extended from 15.5 cm at acromion and extended down arm, and 14 cm across at widest point. On 08/14/2017, mother brought patient to health department to have arm assessed and VAERS filled out. Patient complains of arm itching and being painful to touch. Redness and swelling have receded from the line marked by mother on 08/12. Right bicep measures 24.5 cm around, 4.5 cm from acromion. Redness extends 12 cm down arm and is 12 cm across at widest point. In comparison, left bicep measures 23.0 cm from acromion.
It has come to my knowledge that the nurse vaccinated a child under 12 years old.  No adverse effects have been reported.
Patient's third (booster) dose of Pfizer vaccine was given early, only 3 months after his second dose. This was an error in administration. There were no other known complications or adverse effects, beyond the anticipated immune response, experienced from this early administration. Concrete steps are being taken to prevent similar errors in the future.
severe ticcing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A child male patient received bnt162b2 (BNT162B2), administration date 20Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TIC (non-serious) with onset Dec2021, outcome "unknown", described as "severe ticcing". The event "severe ticcing" was evaluated at the physician office visit. Additional information: The patient received the first shot of the Covid vaccine on 20Dec2021. Within two days, he began having what they now know was severe ticcing. The first pediatrician they saw said he should not get the second shot. The second pediatrician they saw said he should still get the second shot. They were referred to a neurologist who will be doing an EEG next week. She said he should get the second shot as well.   The lot number for bnt162b2 was not provided and will be requested during follow up.
A report has been received from a Pharmacist concerning a 53 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. Concomitant medications included Simvastatin. FLUMIST QUADRIVALENT (Intranasal) started on 14-Dec-2013. The Pharmacist reported that they inadvertently administered FLUMIST QUADRIVALENT to person over 49 on 14-Dec-2013. The outcome of the event of inadvertently administered FLUMIST QUADRIVALENT to person over 49 is unknown. The report was considered to be non-serious.
She got her vaccine, she had a little stinging at the injection site and soreness but nothing else on the day of the vaccine.  She had blurriness of the eyes and high blood sugar to 245 which your normal is 79-100 fasting.   She takes her insulin at bedtime, and drank a lot of water so that she did not over medicate herself.  Her sugars are still a little elevated but are slowly getting back to normal. She would like some kind of information out there that people with underlying medical conditions can go to a website and find out that this may be some sort of reaction so that they are informed and don't panic. She has been informing people that she knows that are diabetics.  Her brother is a diabetic as well and she informed him and he had some reactions and would have liked to have known if there were reactions so that he could be more at ease, as well as others so they can calm down with this information and not get over reactive.
LA sore since injection. 11/16 LA was red about 4 in in diameter w/induration. 11/17 slight redness 3" x 1" w/ 1" induration > saw MD 11/17. Left arm: Tdap
01/15/22 presents to Birth Center Triage for "contractions" "SVD (spontaneous vaginal delivery)".  No significant PMH.
This spontaneous report was received from a registered nurse regarding a 16 month old patient unknown gender. The patients' medical history, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of M-M-R II  lot # N024696, expiration date 07-APR-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 9 to 25  (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA000142:
Arm pain at injection site and muscle ache in the injection arm.  Next morning woke up in pain of 4 out of 10.  Whole arm hurts.  Pain goes from forearm to neck on the side where received injection.
This is a spontaneous report from a contactable consumer. A 74-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6198), via an unspecified route of administration, in left arm, on Mar 3, 2021, at 16:30, single dose for COVID-19 immunisation. Medical history included benign prostatic hyperplasia. Concomitant medication included Terazosin 5 mg and Finasteride 5 mg. Patient received the 1st dose of BNT162B2, via an unspecified route of administration, left arm, on Feb 10, 2021, at 16:30 (batch/lot number: EN6201), single dose, for COVID-19 immunisation. The patient tested for COVID-19 since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On Mar 4, 2021, at 07:00, patient experienced extreme pain in upper left shoulder area; increasing intensity, from 2nd shot through 8th day afterwards. Day 1 only slight pain. Days 2-3, no pain at all. Days 4-8, pain increased, each day. Patient did not receive any treatment for the events. At the time of this report, the outcome: not recovered. Follow-up attempts completed. No further information expected.
patient who received an extra dose of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 87-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7Z07L, expiry date 09-DEC-2023) for prophylaxis.   Previously administered products included boostrix (on 19th September 2023 received 1st dose.).   On 31-OCT-2023, the patient received the 2nd dose of Boostrix. On 31-OCT-2023, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: patient who received an extra dose of Boostrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 01-NOV-2023 An HCP requests data on potential adverse effects or risks to patient who received an extra dose of Boostrix which led to extra dose administered. The reporter Consented to follow up.
Seizure. lasted 8 seconds. Went to ER> was discharged with normal EKG but told to follow up for EEG with Neuro
Information has been received from a health professional concerning a 21 year old female patient who on 10-AUG-2009 was vaccinated with the second dose of GARDASIL (Lot: 661953/1130X) in the left deltoid at 2:30 pm. On 12-AUG-2009, the patient reported to the physician's office that she has had soreness at the injection site, nausea, dizziness and clamminess every morning since she got GARDASIL. At the time of the report, the patient's status was unknown. Additional information has been requested.
about 12 hours after the injection this past Sunday, I experienced body chills, headache, and fever ( 101.8) unable to sleep, seemed to get better the next morning , then occurred again that afternoon. I recovered that evening and felt better the following day. I also experience the same symptoms when I received my first Moderna vacation on 3/14/21. I did have Covid at the end of December 2020.
Information has been received from a licensed practical nurse for the pregnancy registry for GARDASIL concerning an 18 year old female with no pertinent medical history and no known drug allergies, who on 20-JAN-2009 and 20-MAR-2009 was vaccinated with first dose (dose and route not reported, lot number 661703/0651X) and second dose (dose and route not reported, lot number 661766/0652X) respectively of GARDASIL. The licensed practical nurse reported that the patient was three to four months pregnant when she received the first dose of GARDASIL. The reporter stated "pregnancy is normal to date". Lab test performed included urine pregnancy test. The patient was seen in the office. Follow up information has been received from a licensed practical nurse concerning the patient with a history of varicella and no known drug allergies, who on 20-JAN-2009 was vaccinated intramuscularly (IM) in the left deltoid with first dose of GARDASIL (dose not reported, lot number 661703/0651X). Concomitant therapy included ADACEL (lot number C773AA), MENACTRA (lot number U2734AA) and EMERFLU (lot number U2840AA). Subsequently on 20-MAR-2009, the patient was vaccinated IM with second dose of GARDASIL (lot number 661766/0652X). The licensed practical nurse stated that patient's LMP varied per visit so it cannot be estimated. She suggested contacting the patient's obstetrician to obtain the estimated LMP. Follow up information was received from a health professional which reported that on an unspecified date at 34 weeks of gestation, the patient delivered a normal infant with no congenital anomalies due to premature rupture of membranes. The baby's experienced is captured in WAES 0904USA00268B1. Additional information is not expected.
This is a spontaneous report from a Pfizer-sponsored program. A contactable patient (consumer), of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Jul 29, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient got the first dose on Jul 29, 2021 in the afternoon. Afterwards, she experienced blurry eyesight on Jul 29, 2021. The patient asked if she would need to go to hospital. While doing a warm transfer and talking to the agent, both lines disconnected.  Customer and/or medical inquiry was forwarded or referred. Reason for no lot number: Complainant hung up abruptly/transfer incomplete. Call back done however it was unsuccessful. Hence further probing could not be done. Thus, limited information available. The outcome of the events reported: unknown. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up.
This case was reported by a consumer via call center representative and described the occurrence of meningitis-like reaction in a female patient who received HAVRIX (batch number 37RY4, expiry date 3rd March 2021) for prophylaxis. In September 2018, the patient received HAVRIX. On an unknown date, 1 day after receiving HAVRIX, the patient experienced meningitis-like reaction (serious criteria disability), seizure (serious criteria GSK medically significant), stroke (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), headache, weakness, general body pain, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction. On an unknown date, the outcome of the meningitis-like reaction, seizure, stroke, passed out, headache, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction were unknown and the outcome of the weakness was recovered/resolved and the outcome of the general body pain was not recovered/not resolved. It was unknown if the reporter considered the meningitis-like reaction, seizure, stroke, passed out, headache, weakness, general body pain, joint pain, abdominal pain, nausea, tremor, eye rolling, inflammatory reaction and allergic reaction to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine in the end of September 2018. The day after vaccination at night, the patient woke up with a severe headache, weakness and pain in her low back, arms, legs. She could barely get out of bed. All her joints were in severe pain. Then she had 4 sharp pains in the left side of my abdomen. The patient had severe nausea. She had an immediate need to have a bowel movement and throw up. But she did not throw up. The patient did have a small bowel movement. She started feeling like she was going away. She tried to keep talking to her husband. He got her to sit on the side of the bed. At that point the patient started shaking uncontrollably, her eyes rolled back in her head and she felt back on the bed passed out briefly. Her husband pulled her up and forced some water. This brought her back. The patient's husband thought that, she was having a seizure or a stroke. She stayed in bed and was terrified that this was going to continue to repeat. The pain in her low back, legs, neck, arms continues. The severe weakness lasted for 3 weeks. The patient did not have the flu or any sign of a cold prior to or since. The patient's neurosurgeon diagnosed it as a mini Meningitis severe inflammatory allergic reaction that attacked her nervous system. Since then she went through many test. CT scan, MRI, brain scan and an ultra sound on my arteries in her neck. Before this happened she had no low back pain, weakness, headaches or any of the symptoms, she now suffer on a daily basis.  The patient wanted to know what could be done to help her. Lab Comments: Lab test was done on an unknown date.
coughing up thick mucus; Mucus Sinus; headaches; tight breathing; Body aches; Arm  hurts; couldn't sleep bc arm hurts that much; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DEFICIT (couldn't sleep bc arm hurts that much) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Arthritis.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SLEEP DEFICIT (couldn't sleep bc arm hurts that much). At the time of the report, SLEEP DEFICIT (couldn't sleep bc arm hurts that much) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-032094 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-032094:Linked, Same reporter,case of daughter
Patient states she received her second COVID vaccine Moderna on 2/22/2021; presented to hospital and admitted with history of weakness starting 3/3/2021; diagnosed with  Guillian Barre Syndrome sensory >motor variant resulting in progressive weakness and inpatient hospitalization;
she has experienced issues with restriction of motion in her left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown, ), for COVID-19 immunization, reaction(s): "She has experienced issues with restriction of motion in her left arm"; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown, ), for COVID-19 immunization, reaction(s): "She has experienced issues with restriction of motion in her left arm". The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "she has experienced issues with restriction of motion in her left arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201368440 same patient/drug/event, different dose;
Ongoing Hospitalization: Transferred from Medical Center for COVID pneumonia and hypoxia. Began having symptoms 9/2. Tested positive 9/3, continued having shortness of breath. 9/7 worsening chills, fever and shortness of breath with some pain when breathing in his upper chest. Given Rocephin, azithromycin, dexamethasone, lovenox, high flow oxygen.
This study case was received from the investigator on 22 February 2012. A subject (age, date of birth and gender not reported) had received an injection of ACAM2000 (lot number, route, site and date not reported). The subject was diagnosed with other, chest pain on 02 August 2011. Medical history was not reported. No further information was available at the time of the report. 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.
This case was reported in a literature article and described the occurrence of uveitis in a 1-year-old male subject who was vaccinated with HEPATITIS B vaccine (manufacturer unspecified). On an unspecified date the subject received unspecified dose of HEPATITIS B vaccine (unknown). At an unspecified time after vaccination with HEPATITIS B vaccine, the subject experienced uveitis, arthritis and injection site reaction. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after Hepatitis B vaccine 1982 and 2009. It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of Hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic Hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the Hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
A report has been received from a consumer via Health Authority (VAERS), concerning an 18 year old male patient. The patient's medical history included upper respiratory tract infection. Concomitant medications included MMR vaccine, Tdap, hepatitis A vaccine, hepatitis B vaccine, varicella virus vaccine, meningococcal polysaccharide and BCG vaccine. On 22-Sep-2008, the patient started receiving FLUMIST (intranasal). On 06-Oct-2008, the patient experienced fever. He also developed chills, congestion, runny nose, sore throat, nausea and productive cough. The patient was diagnosed with upper respiratory infection. On 15-Oct-2008, numbness of feet, hands and mouth developed. Polyneuropathy idiopathic progressive was diagnosed. The patient also experienced tingling in feet bilaterally and in both hands and roof of mouth, weakness in lower extremities while trying to go upstairs. On 16-Oct-2008, the patient developed progressive neurologic symptoms consistent with Guillain-Barre syndrome with respiratory failure requiring ventilator support. The patient was stable. On 20-Oct-2008, the patient was in rehabilitation center. Neuro symptoms were not progressing. On unknown dates, aphonia and dysphagia developed. Acute sensory motor neuro deficit developed. Respiratory ventilator, subsequent tracheostomy, IVIG and plasmapheresis were performed. The patient developed orchitis. Tachycardia, hypertension, haemolysis and hyperbilirubinaemia developed. On an unspecified date, the patient was on a ventilation complicated by aspiration pneumonia. The action taken with FLUMIST was unknown. The outcome of the events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis, hyperbilirubinaemia and Guillain-Barre syndrome was unknown. The reporter considered the event of Guillain-Barre syndrome as serious due to hospitalization. The events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis and hyperbilirubinaemia have been identified by the company physician from the source documents and added as serious adverse events due to hospitalization. Laboratory values and diagnostic test details are available.