chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Early 3rd dose.; Late 2nd dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 73-year-old female patient who received HAB (Twinrix) (batch number 2PG39) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 02-SEP-2023, the patient received the 3rd dose of Twinrix. On 19-AUG-2023, the patient received the 2nd dose of Twinrix. On 19-AUG-2023, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose.). On 02-SEP-2023, the patient experienced drug dose administration interval too short (Verbatim: Early 3rd dose.). The outcome of the drug dose administration interval too short and drug dose administration interval too long 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: 20-SEP-2023 The reporter did not consent to follow-up. The patient received 3rd dose of Twinrix earlier than recommended interval, which led to shortening of vaccination schedule.  The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Experienced short term memory loss and confusion for about 30 minutes.  I could answer questions about president, etc, but couldn't remember year, date.  Felt like I was in a dream state.  I felt physically fine, no stroke symptoms.  I took my temp and bp and they seemed fine, although bp was a little high because I was stressed about my symptoms.
15 hours after booster dose, muscle aches, neck pain, stuffy nose, arm sore.   extreme fatique around 20 hours, muscle aches continued, post nasal drip 40 hours after dose - mild fatigue, cough, stuffy nose, muscle aches 60 hours after dose - extreme sore through, stuffy nose turned to very runny nose, chest congestion, dry cough, arm not sore anymore 72 hours after does, dry cough and nasal congestions, chest congestion (all milder)
Blood pressure was 178/90 mmHg; Heart rate went up/resting heart rate was 90 beats per minute; This is a spontaneous report from a contactable consumer (patient)  A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Sep2021 (Batch/Lot Number: FD8448) as DOSE 2, SINGLE for covid-19 immunisation  . Age at vaccination :56 years.The patient received the first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for covid-19 immunization (Anatomical Location: left shoulder). There were no concomitant medications and medical history. The clinical course was reported as follows: on 08 Sep2021 he received his second Covid 19 vaccine last Wednesday at around 9:00AM-9:30AM in the morning. His Covid 19 record card says FD8448. He works nights so after he received the vaccine he went home and slept because he had to work that night. He reports probably about 13 hours after he received the vaccine, around 10:00PM-11:00PM that night, he was sitting at his desk at work and his heart rate went up. His resting heart rate was 90 beats per minute. His blood pressure was 178/90 mmHg and it stayed that way for about 3 hours. He left work and was on his way home when he had to stop and call paramedics. The paramedics came to where he was stopped, and the paramedics checked him out. The paramedics put an ice bag on the back of his neck and he sat there for about 15 minutes. His symptoms calmed down enough that he felt safe enough to finish his drive home although his heartrate and blood pressure were still elevated. It probably lasted a total of about 5 hours and after that his heartrate and blood pressure returned to normal. While he was on his way home and if he was feeling bad when he passed by the emergency department close to his house, he would stop. But he didnt have to stop. He arrived home and he sat down and maybe within a couple hours everything was back to what he would call normal.Therapeutic measures were taken as a results of the events.The outcome of the events was recovered.No emergency room/phiscian office visit.Additional information : Vaccination Facility Type :Pharmacy/Drug Store;No prior vaccination within 4 weeks   Follow-up attempts are completed. No further information is expected.
Chills, nausea, vomiting, severe arm pain, malaise, fatigue, dizziness, lightheaded, and fainting . Symptoms started at midnight 12/30/20
Myalgias; She was nursing her infant; She was nursing her infant; This is a spontaneous report from a contactable other health professional (patient). This other health professional reported for herself and her infant. This is mother report. A 37-year-old non-pregnant female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 11Jan2021 at 18:15 at single dose in left arm for covid-19 immunization. Medical history included hypothyroid, and known allergies: penicillin. Concomitant medication included levothyroxine, biotin, ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), ergocalciferol (VIT D), lactobacillus acidophilus (PROBIO). The patient previously received the first dose bnt162b2 (lot number: EK5730) on 22Dec2020 at 06:15 pm in right arm for covid-19 immunization. The patient experienced myalgias on 12Jan2021 at 11:00. Event details: The patient experienced myalgias 16 hours after receiving the 2nd vaccine. She was nursing her infant and the infant developed fever for 3 days without any other symptoms following her vaccination. The patient did not received treatment for event myalgias. The patient did not have COVID prior vaccination, and have not been tested for COVID post vaccination. The outcome of the event myalgias was resolved in Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051876 infant case
Soaked in sweat; Headache; Shooting pains through body; Shivering uncontrollably; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sweating in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 03-MAR-2023, the patient received the 2nd dose of Shingles vaccine. On 04-MAR-2023, 1 days after receiving Shingles vaccine, the patient experienced sweating (Verbatim: Soaked in sweat), headache (Verbatim: Headache), general body pain (Verbatim: Shooting pains through body) and shivering (Verbatim: Shivering uncontrollably). On 04-MAR-2023, the outcome of the sweating, headache, general body pain and shivering were recovered/resolved.   It was unknown if the reporter considered the sweating, headache, general body pain and shivering to be related to Shingles vaccine.   It was unknown if the company considered the sweating, headache, general body pain and shivering to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-Mar-2023 This case was reported by a patient via interactive digital media. The reporter stated that he/she just got his/her shingles dose the day before reporting in the morning.  At midnight last night, he/she was soaked in sweat and shivering uncontrollably with a headache and shooting pains going through his/her body. Less than a day after receiving shingles vaccine, the patient experienced sweating, headache, general body pain and shivering.  The patient was glad that was all done and over with. The follow up would not possible as no contact details were available.
Patient received his first dose of Moderna vaccine on Thursday, March 4, 2021.  He reports noticing his stomach itching on Friday, March 5, 2021.  He reports onset of hives Monday, March 8, 2021 in the late afternoon/early evening.  He phoned his PCP who did a telehealth visit on 3/8/21 and prescribed a steroid dose pack and instructed him to take Benadryl as needed.  He reports the hives were on his trunk, both arms, hands chest and legs. Reports the hives lasted 1 1/2 - 2 weeks.
She was given the vaccine on 5/25/2022 at 11:36 am, and only had a sore arm that day.  On 5/26/2022 at 7:00 am she developed a circular swollen area that felt hard to the touch at the vaccination site.  The diameter is roughly 2-3 inches.  She also has 2 red streaks in the area, with one being around 2 inches long and the other about an inch.  She denies fever, itching or body aches.  She will follow up with her physician's office to see if they think it is a localized reaction and to rule out infection.
Day 2 - rash on arm w/ big red circle, Day 3 - took CLARITIN, Day 4 - rash on arm started to fade, broke out w/ rash on chin/fingers, muscle of arm really sure and radiated toward back. Day 5 - breaking out w/rash on both legs inside where knee caps are. Day 6 - Pt went to ER, more dots on arms, fingers, but rash at injection site much better. No new meds taken or treatment. Day 8 - better.
pt recvd vax & w/in 12hrs exp a flu-like illness w/fever,nausea & vomiting;addl exp redness,swelling,& edema inj site;sx lasted approx 2 days;
About a week after I received the initial Moderna injection,  a red ring developed around the injection site - like a bad sunburn.  Then the red area kept enlarging until it became the size of my hand.  The red area was hot to the touch and the arm was slightly swollen.  After a few days, the redness began to subside and now there is only a slight shadow where the redness was.
got the shots and still got shingles/Suspected Vaccination Failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shots and still got shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles shots and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  The follow up would not possible as no contact details were available.
w/in 15-20 mins p/inject, pt had swollen eyes, tearing, red-sneezing-face became red; no dyspnea, itched all over;
I had sinus congestion, low grade fever, fatigue, scratchy throat, sinus congestion and post nasal drip. I had been exposed to COVID-19, so I used my home COVID-19 test, once my test came back positive I called my doctor. He prescribed PAXLOVID, I took the five course and felt better, then had a rebound case of COVID-19. I have recovered and have no long COVID-19 symptoms.
medical assistant gave it on 18Nov2020 without reading the chart with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Global Medical Information (GMI) (Reference number- 00377633) and transmitted to Sanofi on 01-Dec-2020.  This case involved a 6 year old male patient for whom it was reported that medical assistant gave 15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] on 18-Nov-2020 without reading the chart with no adverse event (expired product administered) lot number not reported, indication: prophylactic vaccination.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was a actual medication error  due to expired product administered.  On an unknown date, Nurse practitioner stated that she ordered the 15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE for the male child with initials as BS, but she was not there that day and another medical assistant gave 15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE on 18-Nov-2020 at a dose of 0.5 mL once at a standard strength without reading the chart (Lot number C55532AA Expiration date: 09-Oct-2020 via an unknown route in an unknown administration site for prophylactic vaccination) (expired product administered).  It was also reported that he was overdue for his vaccines.    At the time of this 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 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.
Received flu shot 9/23/10 - 10am. Noticed symptoms of swelling of lips, hands, face, ears on 9/24/10 -9pm continued to get worse, went to Urgent Care and received prednisone, ZANTAC and BENADRYL. Confirmed allergy on 10/1/10 by pt's MD.
Local large (7 in x 5.5 in) local erythema, warmth, tense swelling of arm where injections given. Systemic headache.
Expired 3rd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product  was not provided by the reporter.  No treatment information was provided.
Pt was found unresponsive and not breathing by mother approximately 6 hours after receiving vaccinations. Pt was transferred to hospital at 5:30pm via ambulance and was expired at 6:20pm. Unknown at this time cause of death.
This spontaneous report as received from a Nurse practitioner via a company representative refers to a female patient of unknown age. The patient's medical history included varicella. The patient was vaccinated with VARIVAX (Merck). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced injection area reaction that resembled a charlie horse above the elbow after receiving VARIVAX. The patient's entire upper arm was inflamed in red. No treatment information was reported. The outcome of injection area reaction was reported as recovered/resolved. The relatedness for injection area reaction is unknown for VARIVAX (Merck). Additional information has been requested.
On 8th day after shot, injection site became very sore, hit and swollen. Now day 9, swelling has increased and soreness is persistent.
Covid vaccine monitoring documentation. PT admission  1/23/22 ? 1/27/22. COVID-19 vaccine, 0.5 mL (JANSSEN) 03/11/2021 1802068.
Symptoms: Fever, malaise, chills, night sweats, slight cough, some shortness of breath, palpitations, watery diarrhea, decreased appetite, nausea, toothache, earache, body aches, headache, weakness.  Developed hives 4 days after those symptoms. Treatments used: Bedrest, Tylenol, Advil, Pepto Bismol, prednisone, cephalexin, halobetasol cream
Information has been received from a nurse practitioner concerning unspecified number of patients of unknown age and gender. Patient's medical history and concurrent conditions were not reported. Between 06-APR-2015 and 30-APR-2015, unspecified  number of patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (dose, lot # and route were not reported). No adverse effects were reported. Follow up information has been received from a receptionist during a phone call on 02-JUN-2015. The reporter could not supply patient identifiers, lot numbers or dates of vaccination. Follow up information was received on 15-JUN-2015 from a nurse practitioner. The reporter provided the names, dates and lot numbers with expiration dates of the patients who received (Oka/Merck) VARIVAX which was incorrectly stored. A total of 22 patients received the improperly stored vaccine between the dates of 06-APR-2015 and 30-APR-2015. ON 28-APR-2015, a male patient of unknown age received (Oka/Merck) VARIVAX (lot number K108963, expiration date 15-OCT-2016. The vaccine was reported as improperly stored. No adverse event was reported. Follow up information was received on 16-JUN-2015 from a nurse practitioner. Multiple patients received the (Oka/Merck) VARIVAX vaccine which was exposed to higher than normal temperature. All vaccines were completed before the date required by the manufacturer. As of 16-JUN-2015, no vaccines were left from the event. Additional information has been requested.
only DTaP-IPV portion of Pentacel was inadvertently administered to twin male patients on 04Jun2019/no AE; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 6 months old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that only Dtap-IPV portion of Pentacel was inadvertently administered to twin male patients on 04jun2019/no AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  On 04-Jun-2019, the patient received 1st dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ104AA and expiry date: 13-Oct-2020 via intramuscular route in the left thigh.  It was a case of actual medication error due to inappropriate reconstitution technique.  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 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.
Patient got covid pfizer bivalent booster on 10/7/22. On 10/9/22 she suffered a massive stroke.
L thigh swollen, red and painful. Patient advised to take Benadryl, ice area and given rx for Keflex 250mg/ 5ml 1 tsp x 7 d. (DTAP site)
On the next day after my vaccine, 02/21/2021, I started having more issues with my lymph nodes, they were already swollen from the 1st dose of Moderna. My lymph nodes started aching and they felt hot. At 09:00 AM I had a bad headache, and I took so ibuprofen. By noon I had to walk a little way, like a block, and I noticed I was having trouble breathing. By 04:00 PM when I came home from work, I had muscle fatigue and weakness. I was tired enough that I took a nap. By the morning of 02/22/2021, @ 9:00 AM, I started having severe gastrointestinal pain, I had diarrhea, I had gut pain. I treated that with ibuprofen, 2 bd. I had no fever. By nighttime on 02/22/2021, I was having joint pain, I had insomnia that night, I slept for like an hour that night. I took the next 2 days off of work. I had muscle pain and weakness, painful lymph nodes, severe joint pain, headache, gastrointestinal distress, abdominal cramping, fatigue and insomnia. Those symptoms lasted through 02/26/2021. I also had high blood pressure it was 170/90 and high blood sugars. Most of these symptoms lasted for like 6 weeks. Only the insomnia went away, and I was able to sleep. On 04/27/2021 - I went to see my doctor, my BP was still high, she asked me to track my blood pressure, my BP was 200/100 on awakening. She tweaked my medication, she raised my Losartan, from 50 mg to 100 mg. I started having tachycardia when I would stand. And bradycardia when I would lay down. Para thyroid is functioning correctly but there is 1 inch mass pressing on my vagus nerve, that controls autonomic function. So, I'm experiencing suppress autonomic function: low oxygen, persistent heart palpitations, tachycardia, and bradycardia, I have been bed ridden since June 20, 2021 The swelling of the lymph nodes were still present in my ultrasound and mammogram a month ago.
Fever: Spiking; Onset: Today; Duration: Acute; Severity: Severe. Pt developed breath holding spell and spiked fever after adminstration of vaccines. Pt passed out, became limp for several seconds with color change of paleness, not cyanotic. Then was unresponsive for several more seconds and then remained lethargic for next 20 minutes and was taken by ambulance to ER. Pt's was 101.3, TYLENOL given 5:57 pm. Pulse ox on rm air was 97%, but pt remained very pale and was given oxygen at 2 liters. 8/10/2010 Here for folow-up from ER. Patient seen in our office on 08/05/10. Had vaccines that day, held his breath for a prolonged period of time and then passed out. There is no history of prior breath hold spells of patient or family members. Mom and dad state fever had developed that day (08/05) and lasted for a few days. On 08/08, fever resolved and patient awoke from a nap with a rash on his face, belly, neck. Rash is fading. Parents states he is doing better. Normal activity level today. Eating normally.
Pain and redness, slight edema around injection site on bilateral upper arms. 9 blisters on right upper arm on 9-12-07. Mother states she will take client to the emergency room today to be evaluated by physician. (9-12-07).