chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable pharmacist.   A 65-year-old female patient received PREVNAR 13 (Lot # N16562, Expire Date Oct2017, NDC number 00005-1971-01), intramuscular at 0.5 ml, single in the left arm on 13Oct2016 for immunisation. The patient medical history was not reported. Concomitant medication included FLUZONE (Lot # UI659AA , Expire Date 29Mar2017), intramuscular at 1DF single in the right arm on 13Oct2016 for immunisation.  On 14Oct2016, the patient experienced severe bruising in the area, swelling, redness, significant pain. No treatment received. The outcome of the events was unknown.
Approximately 1 month after the vaccine, I took my blood pressure and it was elevated. I felt a tightness in my chest and had some anxiety. On 2/7/2022, my blood pressure reading was 152/101 at the highest. My doctor said to take 2 pills of Amlodipine. That made me feel bad so on 2/15/2022, I was taken off Amlodipine and was put on Losartan. The Losartan worked initially but did not bring down my blood pressure enough. I became very anxious. I was also put on Xanax that is to be taken prn. I was put on a 3rd medication Metoprolol 25mg which seems to help control my blood pressure. Before the booster, I always had a good blood pressure reading. My blood pressure is still fluctuating at times. I also have a rapid heartbeat. I had an appointment with a cardiologist 3/11/2022 and he has ordered a heart monitor which I have not received yet.
Information has been received from a registered nurse referring to 12 unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose and route unknown, lot # L036301, expiration date: 20-DEC-2017). No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Dizziness, nausea and near syncope. Gave him alcohol swab to sniff on, had him lay down and gave him water to drink. Monitored vital signs. Patient felt better after 10-15 minutes.
10 days after the first  shot of Pfizer Covid-19 vaccine, around June 4th 2021, patient started to notice accelerated hair loss. A few days later, she noted a bald patch on the right side of her head, behind her ear. Today (June 18) hair loss continues and hair seems to be thinning out. She is stressed out. Not sure what to do and would like some guidance before we get the second shot. Multiple people on VAERS have reported accelerated hair loss post  second shot. Patient had developed Pneumonia last year when she had been diagnosed with covid-19 (around April-May 2020)
Sharp pain in my heart, never experienced before. Quick although painful, subsided quickly. Repeated a few times. Was not doing anything specifically that may have caused this feeling, ie extraneous physical activity or stress.
Patient received Pfizer Covid vaccine 02/12/2021 AND 03/05/2021 admitted  to floor bed Covid positive 08/29/2021
Patient called  with concern that her vaccine was administered too low on her arm, with complaints of redness, swelling and feeling of numbness/tingling down her arm. Later that night she lost all sensation and strength in her arm.  Patient sent photos with site of administration the next day. Site was red and swollen and clearly administered too distally and medial. Patient was advised to reach out to her health care provider to be assessed. Patient stated her health care provider agreed this was incorrect placement but no further treatment or intervention was provided. patient stated it took 3 days to regain sensation and strength . Site took a couple weeks to reduce in redness and swelling. Site is still darker in color, decribed as a "birth mark appearance" with a red spot in the middle at the injection site.
Headache; Low grade fever; Upper body pain; Enlarged axillary lymph node-left; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) on 06May2022 at 17:00 as dose 3 (booster), single (Lot number: FM9992), at the age of 35 years in left arm for COVID-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Known allergies: yes. The patient had received unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: FC3184; Anatomical location: Left arm), administration date: 06Sep2021, when the patient was 35 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: FF2589; Anatomical location: Left arm), administration date: 27Sep2021, when the patient was 35 years old, for COVID-19 immunisation.  The following information was reported: HEADACHE (non-serious) with onset 07May2022 at 11:00, outcome "recovered" (an unknown date in May2022); PYREXIA (non-serious) with onset 07May2022 at 11:00, outcome "recovered" (an unknown date in May2022), described as "Low grade fever"; PAIN (non-serious) with onset 07May2022 at 11:00, outcome "recovered" (an unknown date in May2022), described as "Upper body pain"; LYMPHADENOPATHY (non-serious) with onset 07May2022 at 11:00, outcome "recovered" (an unknown date in May2022), described as "Enlarged axillary lymph node-left". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive other vaccines within four weeks prior to 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 doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a male physician of unknown age via company representative and referred to a physician himself. No pertinent medical history, drug reactions or allergies were reported. On an unknown date (reported as an awhile ago), the patient was vaccinated with ZOSTAVX (lot #, expiration date, strength, dose and frequency were not reported) via. No concomitant medications were reported.The reported stated that approximately on 30-JAN-2014 (reported as about 5 weeks ago), he got shingles and he had chronic pain in his leg. The pain in his leg was a level 10, except if he put topical medication on the leg, then the pain level was a 4. The outcome of events was unknown at the time of the report. The relatedness between ZOSTAVAX and events shingles and chronic pain in his leg was not reported. Additional information has been requested.
pt recv vax; devel fever, tremors, and irritability; to MD w/ low grade fever; no further details known at time of report;
Patient admitted for recurrent pancreatitis, subsequently tested positive for COVID-19.  Is currently asymptomatic for COVID-19 symptoms.
24-48 hrs after vaccination, developed severe bilateral excrutiatingly painful axillary lymphadanopathy that persisted for 1wk requiring opiates for pain control. Also developed fevers to 102 F, and diffuse myalgias, arthralgias.
patient was administered a dose of Pediarix on 25Jul2023, instead of a plain DTaP dose.  Therefore the patient received extra IPV and Hepatitis b dosing; received extra IPV and Hepatitis b dosing.; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number HS4F9, expiry date 11-APR-2025) for prophylaxis.   Previously administered products included DTaP (recent dose prior to this dose was on 15th November 2022).   On 25-JUL-2023, the patient received Pediarix. On 25-JUL-2023, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: patient was administered a dose of Pediarix on 25Jul2023, instead of a plain DTaP dose.  Therefore the patient received extra IPV and Hepatitis b dosing) and extra dose administered (Verbatim: received extra IPV and Hepatitis b dosing.). The outcome of the wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Aug-2023 Doctor reported that a patient was administered a dose of Pediarix instead of a plain DTaP dose.   Therefore the patient received extra IPV and Hepatitis b dosing.   The Pediarix was the patient's fourth dose of IPV, DTaP, and Hepatitis B.   The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The patient received a dose of Pediarix as fourth dose of IPV, DTaP, and Hepatitis B instead of a plain DTaP, which led to wrong vaccine administered and extra dose administered.
On November 25th I started with some nasal and sinus soreness, but no runny nose or congestion. It moved down to my throat where I just had a really sore throat. I also developed some hives but I develop hives very easily. On Monday I just so happened to have an ENT appointment, and he looked at my throat and stated it was probably some type of virus. I was tested for COVID-19, Flu, and RSV. Negative for all of them. They gave me a steroid to help, and then my son ended up getting sick. About a week later we both went to urgent care because I had developed a cough. They prescribed some penicillin to take along with the steroid. It didn't feel like the cough was coming from my chest, it felt like drainage was coming from my head. My son tested positive for flu at that time, and ended up giving him half of my steroids, so I didn't finish that regiment. I kept coughing and coughing but wasn't coughing anything up, but it just felt like something was stuck in my throat and I couldn't get it up and it made me start choking. I was in bed for about a week. Finally a clear mucus started coming up but it was so thick I couldn't get it out and it was choking me and giving me massive headaches. I went to ER several times and they gave me a cough medicine and fentanyl several times, at one point I could barely walk and they still discharged. I was just coughing constantly and my head was banging and I was losing my balance and became confused. We called 911 and I was later diagnosed with two brain bleeds and a hypertensive emergency. I was in ICU for 3 days and they worked on getting my blood pressure down, and then I was in hospital for 6 more days. Doctor's were in and out but I was heavily medicated but I know they discussed possible surgeries, stroke, and aneurisms, but none of that is on my chart. When I went back to my Parkinson's neurologist, he said it could possibly have been a burst blood vessel.
Patient presented to the ED via ambulance with fever, nausea, vomiting. Patient noted to have 103 degree temperature at home. Patients heart rate was elevated in the 110s. Patient has rigors.  Fever increased while at hospital. Patient admitted to the hospital for sepsis. Started on numerous antibiotics, fluid boluses.
I was painting my garage and remember it being quite an effort. The next day was 07/04/2022 and I was feeling flu like symptoms: aches, pains, headache, and fatigue. I had some people over for dinner and I remember just not feeling well. The following day, I couldn't even get out of bed. I took an at home COVID-19 test and it was positive. My wife called our doctor who prescribed Paxlovid but advised that I not begin taking it until the next morning. I began taking it on 07/06/2022 and took it until 07/10/2022. The day after beginning the Paxlovid, I began to feel noticeably better but did experience some diarrhea. By 07/08/2022, I was feeling much better and was up and around. Basically within 48 hours of beginning the Paxlovid, I was better.
Confirmed Breakthrough  COVID-19 (Moderna) 1 95 Years 02/06/2021 Hospital Moderna 007M20A   COVID-19 (Moderna) 2 95 Years 1 Month 03/09/2021 Hospital Moderna 023M20A
104 degree-rectal for 4 days. Acute conjunctivitis for 10 days. Dry cough for 10 days. 1 episode of acute muscle spasm lasting a few seconds, followed by trembling for 30 minutes.
10/1/2022 - Patient given Pfizer-BioNTech COVID-19 Vaccine first dose  2y <5y: 0.2mL drawn from vial prior to dilution and given to patient. Contact mother to report this error. Mother reports patient is doing fine 38 minutes post administration. Mother was advised about increase risk of side effects and given return to clinic/ER precautions.
Fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter asked how long will fever last after second dose of Shingrix.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 17-OCT-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of the several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Excessive chills (freezing) & 102.4°F fever lasting all day. Fever broke around 5 pm & chills stopped.
Onset March 27 or 28th. Scattered red rash-itchy. Topical ointment-per mom. DX. per Dr. Varicella/ cellulitis
left arm paresthesia and tingling; Left arm numbness; difficult to bend over and do something with the arm; Nerve pain starts from her shoulder and extends down the left arm; A spontaneous report was received from a consumer concerning a 67-year old female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced lleft arm paresthesia, numbness and tingling and the nerve pain which starts from her shoulder and extends down the left arm and difficulty to bend over and do something with the arm.  The patient's medical history was provided as arthritis in lower back. Relevant concomitant medications reported was Robaxin.  Allergies reported included penicillin and Alpha-gal syndrome.  28-Dec-2020, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 026L20A) for prophylaxis of COVID-19 infection.  On an unknown date, five days after the first dose the patient experienced left arm paresthesia,numbness and tingling and the nerve pain which starts from her shoulder and extends down the left arm and difficulty to bend over and do something with the arm.  No Laboratory details provided but scheduled MRI of the cervical spine on 29-JAN-2021.  The treatment taken was reported as Gabapentin which was prescribed by primary HCP.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the experienced left arm paresthesia, numbness and tingling, nerve pain starts from shoulder and extends down the left arm and difficulty to bend over and do something with the arm  is not resolved.
Redness, pruritus and induration 8cm X 7cm. Treated with Prelone and Augmentin.
I had been having tachycardias one month prior to vaccination and made appointment with cardiologist for echocardiogram. My appointment happened to be one week AFTER vaccination.
PATIENT RECEIVED THE VACCINE AND APPEARED PERFECTLY FINE, NO COMPLAINTS OF PAIN AT INJECTION SITE, DIZZINESS, OR ANY OTHER ADVERSE EFFECT. PATIENT WAS ASKED TO REMAIN IN OBSERVATION AREA FOR STANDARD 15 MINUTES OBSERVATION. APPROXIMATELY 5-10 MINUTES AFTER RECEIVING VACCINE, PATIENT WAS LOOKING AT HIS PHONE AND SUDDENLY LOST CONSCIOUSNESS CAUSING HIM TO FALL OUT OF THE CHAIR HE WAS SITTING IN. HE WAS QUICKLY ASSESSED AND FOUND TO HAVE WOUND ON HIS FOREHEAD AND NOSE. HE DID NOT KNOW HOW HE GOT TO THE FLOOR. HE SIMPLY REMEMBERS "BEING ON TIK-TOK AND THEN BEING STARTLED THAT HE WAS AWOKEN ON THE FLOOR". PATIENT WAS CLEANED UP AND BANDAGED WHILE EMT WAS EN ROUTE. PATIENT WAS DISORIENTED AT FIRST, UNABLE TO EXPLAIN WHAT HAPPENED/HOW IT HAPPENED. AFTER 2-3 MINUTES HIS COGNITION CLEARED AND HE WAS ABLE TO SPEAK WITH THE PARAMEDICS WHO ARRIVED. THE PARAMEDICS RAN A ECG, BLOOD GLUCOSE TEST, AND COGNITION TEST. PATIENT WAS RELEASED UNDER HIS OWN POWER TO HIS SIGNIFICANT OTHER. HE WAS BEING TAKEN TO URGENT CARE AND BOTH HE AND HIS PARTNER WERE GIVEN INSTRUCTION ON WARNING SIGNS AND WHEN TO ALERT MEDICAL PROFESSIONALS.
Blood pressure got to 194/97; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure got to 194/97) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Mar-1954, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure got to 194/97). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure got to 194/97) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 194/97.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
New, red Rash on my Right side (ribs area), about 3" x 9". Part of rash emitted pus when touched. Also. having aching pain where Rash located, as well as on my back. My wife, a retired ICU nurse, said it absolutely looked like Shingles/Herpes Zoster. Two days later, Rash spread Horizontally to Middle of my chest and to my spine (right side). Pain increased to 3 to4 on 1~10 scale.
Bruise around injection site, pain in arm where immunization occurred, pain radiated down past elbow. Patient reported not being able to move her arm around without experiencing extreme pain. She took ibuprofen the evening of the immunization to help minimize symptoms. 1 week later there is a dime size bruise/rash at infection site that patient reports to still be painful
classic covid pneumonia; positive covid PCR; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (positive covid PCR) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive covid PCR) (seriousness criterion hospitalization). The patient was hospitalized on 26-Jan-2021 due to COVID-19 PNEUMONIA and SARS-COV-2 TEST POSITIVE. At the time of the report, SARS-COV-2 TEST POSITIVE (positive covid PCR) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin G: (Negative) Negative. On an unknown date, Blood immunoglobulin M: (Negative) Negative.     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.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Upon internal review on 16-Sep-2022 non-significant corrections performed to update case received from field.; Reporter's Comments: This case concerns a male patient, an infectious disease MD, who experienced a serious event of COVID-19 pneumonia and SARS-Cov-2 test positive after receiving first dose of mRNA-1273 (Lot# 039K20A). Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273.
mixing vials for quite a few patients to make up missing parts; A spontaneous report was received on 10 FEB 2021 from a pharmacist concerning patient of unspecified age and gender, who received Moderna's COVID-19 vaccine.  Patients' medical history was not provided. No relevant concomitant medications were reported.  On 27 JAN 2021, patient received their one of two planned doses of mRNA-1273(Lot/ batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 27 JAN 2021, when patient received the vaccine, the reporter stated that her office has been mixing vials of Moderna's COVID-19 vaccine for quite a few patients to make up missing parts. She wanted to know, was it efficient to open a different vial and get parts missing for an already punctured vial to administer. Treatment for the event was not provided.  Action taken with the other dose of mRNA-1273 in response to the event was not reported.  The outcome of the event, mixing vials for quite a few patients to make up parts, was considered recovered/resolved on 27 JAN 2021.; Reporter's Comments: This report refers to a case of "Interchange of vaccine products" for mRNA-1273, lot # unknown,  with no associated Adverse Events.