chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for Covid virus, after being fully vaccinated.; Tested positive for Covid virus, after being fully vaccinated.; This is a spontaneous report from a contactable consumer. This case is for 8th patient of 37 patients. A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN5318), via an unspecified route of administration on 31Jan2021 (age at vaccination 51-year-old) as dose 2, single and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EH9899), via an unspecified route of administration on 10Jan2021 as dose 1, single for covid-19 immunisation. Medical history included ongoing diabetes. The patient's concomitant medications were not reported. The patient experienced tested positive for covid virus, after being fully vaccinated on 22Jul2021. It was reported that, they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. Caller confirms she is calling about the Pfizer Covid 19 vaccine.Caller reclarifies later in report that 15% of the breakthrough cases in her county had the same lot number, EN5318, which was concerning. Caller states, reclarified later in report, she has 37 patients with partial identifiers. The patient underwent lab test which included Covid test was positive on 22Jul2021. The outcome of the event COVID-19 was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 same reporter/drug/event, different patient.
HARD LUMP, 4.5 x4.5 CM, ERYTHEMA HOT SWELLING, T-MAX 37.1.  TREATING PT WITH BACTRIM DOUBLE STRENGTH 1 TABLET PO x 10 DAYS. ICE AND HEAT. AND FU APPT WITH ARNP.
When I went to the doctor because I started having periods on 12/31/2021. My doctor told me it was due to the vaccine. My periods were be a week long and I would have them on and off every two weeks. I have been menopausal since the early 2000s. It wasn't spotting but it was like a regular menstrual cycle that would taper off towards the end of the week.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 11:25 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:25 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 62.82 for dose administered on 20-MAR -2021. No concomitant medications were reported. Batch number 031A21A  underwent temperature excursion on 20-MAR-2021 with temperature 34 and 37 Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 09-MAR-2021 and beyond use date for the vial was reported as 08-APR-2021. Product moved to clinic on 20-MAR-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. Vial was stored on cooler 1 , Excursion duration At 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM : 44, 2 PM : 44, 3 PM: 44, 4 PM: 44 and 5PM: 43. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
101 degrees fever - lasted for 12 hours. Muscle aches, nausea.
2MAR93 diarrhea started about 6 hrs p/immun cont 4MAR93; 5MAR93 no diarrhea since 4MAR93 @ 3PM;
24 hours after 2nd dose in her right arm, developed a rash, itching and splotches. symptoms resolved in 48 hours.
Patient was supposed to get the MMR vaccine.  Pharmacist on duty injected Varicella instead of MMR.  Patient had already received the two doses of Varicella earlier in the year. Patient had no symptoms
TOOK FOUR UNREFRIGERATED DOSES; This spontaneous case (PVX2019-1187) was received from a pharmacist on 13-May-2019. It describes a 37-year-old adult female consumer who "took four unrefrigerated doses". The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003275) for typhoid fever prophylaxis.  Case report: The consumer took four unrefrigerated dose of Vivotif. The first dose was taken on 06-May-2019 and the last dose on 12-May-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took four unrefrigerated doses" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took four unrefrigerated doses" was considered as not applicable.
bronchitis; pneumonia; Initial information received on 30-Dec-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a patient with unknown demographics who had bronchitis and pneumonia while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious bronchitis and pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (bronchitis, pneumonia).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event bronchitis and was Recovered / Resolved on an unknown date for the event pneumonia.; Sender's Comments: Sanofi Company Comment dated 05-Jan-2022: This case involves a patient with unknown demographics who had bronchitis and pneumonia while receiving vaccine INFLUENZA VACCINE.Based upon the reported information, the role of a vaccine cannot be assessed.
1st dose on September 23rd 2021, 2nd wasn't administrated; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 23rd September 2021, batch number:DK23D,Expiry date:8th February 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was 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:30-Mar-2022 Reporter's Comment:The registered pharmacist reported that the patient showed up to the office to get second dose of Twinrix when they realised that more than 6 months had passed since 1st dose, which led to incomplete course of vaccination.  The reporter wanted to know how to proceed. The reporter consented to follow up via fax number as contact number.
Progressive headache. Nausea in evening. Decreased headache on 05/06/2003
Within minutes of receiving vaccination, my tongue began to mildly tingle and itch.  Then my lips were mildly numb and itchy.  The back of my throat had a mild itch.  My ears became very red.  My tongue 23 hours later still feels mildly sensitive on top.
devel fever & had a sz @  home <24hr p/vax;pt was eval by MD & worked up for febrile illness w/ UA, CBC w/diff;sz activity;
Headache with vertigo. Treatment is ibuprofen. Headache is lasting more than 1 week (approximately 10 days). COVID test was negative. No history of headaches lasting more than 1 day until now.
This spontaneous report was received from an 84 year old male patient referring to himself. The patient's concurrent conditions included Lou Gehrig's disease. The patient's concomitant therapies included TOPROL, AVODART, FLOMAX and riluzole. The patient's historical conditions were not provided. He had no drug reactions/allergies. Approximately in 2010 (also reported as 6 or 7 years ago), the patient was vaccinated with ZOSTAVAX refrigerated vial 19400 plaque-forming unit (PFU) to prevent shingles (dose, route of administration, lot number and expiration date were not reported). On approximately 08-FEB-2017 (reported as about 2 weeks ago), the patient developed a mild case of shingles after receiving the ZOSTAVAX from the physician. The patient reported that he developed an itchy rash on his chest. He received medical attention for shingles at the clinic (without hospitalization), and unspecified treatment was given for the event. Laboratory test were not performed. The outcome of the event was reported as recovering. The causal relationship between the event and ZOSTAVAX was not reported. Additional information has been requested.
the length of time between their first and second doses of the Moderna Covid 19 vaccine was longer than the 42 day window; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the length of time between their first and second doses of the Moderna Covid 19 vaccine was longer than the 42 day window) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the length of time between their first and second doses of the Moderna Covid 19 vaccine was longer than the 42 day window). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the length of time between their first and second doses of the Moderna Covid 19 vaccine was longer than the 42 day window) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Non-significant follow up is added
Within 5 minutes my lips, tip of tongue and front area of the roof of my mouth were numb. At 15 minutes still occurring and when I got up to leave the facility I had tightened in my chest, not a pain, but like a charley horse. That tightness lasted about 15 seconds. About 25 minutes after shot I noticed my hands were very swollen. Went home, rested and within two hours hands were normal and tongue and roof of mouth were back to normal. Lips stopped tingling but within a couple of days I noticed that around my mouth and my cheeks were numb. This is still happening and it comes and goes. I went to the doctor 4/13. I do have the start of a sinus infection so taking a Z PAC now. The numbness seems less but it still comes and goes. I have no pain just numbness and stiffness. I told the doctor the best I can describe it is it feels like what Botox looks like (I have never had Botox or fillers).
This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA (which had a lot # of R003739 and an expiration date of 16-MAR-2019; however, dose, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion on an unknown date: below 32F°/ 0°C (-1.2C) for 21 hours. Reportedly, there had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. Sender's Comments: US-009507513-1807USA006219: US-009507513-1807USA006220: US-009507513-1807USA006221: US-009507513-1807USA000939: US-009507513-1807USA006218.
Severe ringing in ear 4 days after injection. I had ringing in ear prior to injection but the sound is now more intense.
difficulty sleeping; In bed all last week; Joint ache; Metallic taste; A spontaneous report was received from a consumer concerning a 48-years-old, female patient who experienced difficulty sleeping, in bed all last week, joint aches and metallic taste.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 05 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 011L20A] intramuscularly in the left hip for prophylaxis of COVID-19 infection.   On unknown date, the patient was in bed for a week. She experienced joint aches. On 16 Jan 2021, she reported having a metallic taste. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events difficulty sleeping, in bed all last week, joint aches and metallic taste were unknown.
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and MYALGIA (Body aches) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMIN B COMPLEX, BIOTIN and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-406040, MOD-2021-406041 (Patient Link).
5/30/2021 11:04 AM After 4 minutes of receiving vaccine, pt became weak, diaphoretic and fainted. 911 was called. Pt's v/s HR 46,BP80/64. Pt woke up 2 minutes later, able to pronounce name and date of birth and able to drink 3 oz of apple juice. Pt's HR 65 BP 88/58. Transfer of care to ambulance personnel at 11:12. Ambulance record.
Received injection filled out form stating that I had an reaction. Once I received injection my arm I began to itch and hives. It itched all day and began to swell. By 10-7-13. It was very swollen and painful. My arm became numb and tingling along with my fingertips. I also had a large lump under my arm. My pain level was a 9-10 in my arm. On 10-7-13 I went to my doctor's office he sent me up to have an EEG done and to go to an neurologist. At that time my arm was hurting and very swollen. I went back to the doctor on 10-11-13 with severe neck pain and tingling of my arm and hand. My doctor put me on CELEBREX. I went to Occupational Health Department on 10-14-13 to be seen by my jobs Dr. They released me back to work with seeing my Dr, for following visits. On 10-28-13 I went to see my neurologist, I had an EEG done he placed me on gabapentin every 8 hrs. The generic brand for (NEURONTIN). As of right now I have been diagnosed with neuropathy of my left arm. I am still undergoing test. I was fine before the flu injection.
S/sx unconscious, stop breathing. Tx EPIPEN (0.3mg) inj x1.
15-month old received Quadracel and not the prescribed Daptacel with no reported adverse event; Initial information received on 12-Nov-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a 15-month-old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and not the prescribed DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to wrong product administered [Latency: on the same day].  It was reported "Caller said that when she put the QUADRACEL in the Florida shots, it shows that the polio counts as a dose and the dtap counts a dose, but she wants to double check that the QUADRACEL is okay or if they need to revaccinate with DAPTACEL".  At time of reporting, the outcome was unknown for the event.  At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.  There will be no information available on the batch number for this case.
The following morning after I got my second COVID shot, I experienced extreme nausea, sweating, high-fever, weakness in my legs, lack on night vision (everything was unusually dark), light headedness, trouble hearing, extreme ringing in both of my ears, and trouble balancing. I felt like I was blacking out. I was treated by laying back in bed and I felt much better after about 20 minutes.  4 days later on May 26th at about 3:00 am, I experienced severe diarrhea (15-20) bouts for an entire day, I vomited 3 times by 9:00 am, severe dehydration, sweating, nausea, and stomach cramps. I was treated with 2 full bags of Iv's and nausea medication.
9:30 Developed dizziness after left office - hadn't eaten breakfast prior to injection - Mom got her breakfast.  Went back to Middle School started getting shaky, wrist pain and then throat felt funny and she had trouble swallowing.  School nurse called hospital staff - staff recommended AMC ED - was seen in ED and given Benadryl 25mg IM at 11.
Zostavax was the vaccine given, it is not in the list of vaccines below. Patient stated she was very off balance the next morning.  She stayed in bed all day Thursday.  Friday, Sat., and Sunday she was "off balance"  Used a cane to help her get around.  Pt. did not feel like it was vertigo.  She said she staggered around.  By Monday she was better and has not reported any more problems
Localized reaction around the injection site. Red, warm to touch, rash like. Patient also stated feeling under the weather and achy
Started with a headache on 2/08/21. On 2/09/21 I woke in the middle of the night freezing, chills and body aches. I took Asa 162mg, Tylenol 325mg and Ibuprophen at approximately 11:30am. I took the same medication at 10:30am 2/09/21. At approximately 4:00pm on 2/09/21 I had a fever of 100.3, cold and body aches. At this time 5:59pm I'm feeling better. I called in ill to work do to this sickness.
24 hours after flu vaccine pt reported mild erythema with no induration and hot to touch, site aprox 4x4 radius. Site was marked and re-evaluated next day with increased site spreading of erythema and hot to touch.
14 hours following the vaccine I woke up with flu like symptoms: chills, body aches, headache, tiredness, which lasted about 9 hours. I believe it was from the shingles vaccine and not the flu shot due to this being my 3rd year having a flu shot with no side effects. The 2nd day after the shingles vaccine I developed a rash on the arm of the injection witch lasted about a day.
Developed distal joint pain, subjective fevers/dysautonomia, tachycardia at rest, and palpitations around 1 week after my second vaccine. 6 months later developed new brain fog, tremors, paresthesias, and muscle fasciculations. This has now been going on for 8 months. I am currently being evaluated for suspected autoimmune small fiber neuropathy.
Continuous and followed by blows between palpitations in the heart, loss of sleep, exhaustion in the events and cough followed. Visit the Clinic of cardiovascular. They did a blood sample and EKG and everything was negative. They gave me an appointment for many studies in March. I need help sooner and I am looking for a cardiologist to see me sooner because these events are very frequent and constant and I haven't been able to sleep. Today, January 19, I had an episode of bleeding in my left leg and I woke up with a swollen left eye and throbbing in my head at night. I need help before March 11 which is the appointment.
low fever (100), headache, and fatigue the following day, lasted about 8 hours
Approx 12 hours post vaccination sx's started. Fever, body aches, (L) axillary swelling, (L) arm swelling elbow to shoulder, headache. Tx: cool compresses and TYLENOL.
Area is red swollen and warm to the touch. Sensitive for patient. Has continued to get worse over the past 5 days. Did not improve with cold therapy.