chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got the shots and still get it; still get it; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shots and still get it) (serious criteria GSK medically significant) and shingles (Verbatim: still get it). 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 and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 12-Mar-2023 The patient got the shots and he/she still got it. The follow-up would not possible as no contact details were available This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Starting on Wednesday, Sept 8, I started having burning eyes and nose started burning, too. On the Sunday before, I had sneezing, about three times. I had a light headache that felt like a sinus headache but when I took my allergy pill it didn't go away when I took it at onset (this was Wednesday). Thursday-Friday, no headache but still had burning eyes and burning nose. On Sunday, I began to had to keep clearing my throat, not a cough but just had to keep clearing my throat. On the following Monday, 13th, I went to the doctor. They gave me a steroid shot and they prescribed some antibiotics and then they told me to get some OTC medications for coughs that wouldn't affect my high blood pressure because I was draining a lot. After doing the steroid shot, I started to feel good but that lasted for only a short period. Through that whole week, I would start feeling better but the cough wouldn't go away. But I found out that the medication I was taking for coughing would just quiet it down for a break for the cough and so I needed to take it for every four hours the moment I could take it otherwise I was coughing every few minutes. I had it all for a week and a half.
Info has been received from an RN concerning a 9 year old female who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt experienced breakthrough. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that the pt's brother developed breakthrough after vaccination with varicella virus vaccine live. No additional info is expected.
I received the Pfizer Bivalent booster on 10/08/2022. On 11/12/2022, I began to feel extremely achy and tired as the day progressed, which is really unusual for me. I also developed a fever of 101 and began coughing and having a runny nose. I took a home antigen test and got a positive result. On 11/13/2022, I went to an urgent care clinic and underwent testing that confirmed the positive result I had received the day before. I was prescribed PAXLOVID. For the first couple of weeks that I was ill, I had a fever, body aches, fatigue, and coughing. My nose alternated between being stuffy and being runny. I also slept a lot during this period. I found the PAXLOVID helpful, because after I had taken it for 5 days, my symptoms started to improve. I took OTC TUSSIN to treat my cough, and it also helped. On 12/12/2022, I took a home test and got a negative result. My case of COVID-19 was quite long, and I was out of work for about a month. At the time of this writing, I feel fine and have no residual symptoms.
Patient asymptomatic; An 11 year old was mistakenly given Pedvax Hib instead of meningococcal vaccine; An 11 year old was mistakenly given Pedvax Hib instead of meningococcal vaccine; the medication error resulted from similarities in the Pedvax Hib carton and the carton of the meningococcal vaccine; This spontaneous report was received from a pharmacist referring to an 11-year-old female patient. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, or previous drugs reactions/allergies was provided.  On 27-OCT-2011, the patient received the first immunization for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (administered dose, vaccination scheme, route and anatomical location of vaccination, lot number and expiration date were not reported). On 01-SEP-2021, an haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number S030970 has been verified to be valid, expiration date reported and validated as 14-APR-2022) was inadvertently administered to the patient who was supposed to be getting a meningococcal vaccine (wrong product administered). The vaccine was administered intramuscularly in the right deltoid (dose number, administered dose and vaccination scheme were unknown by the reporter) as prophylaxis. The patient was over the recommended age for the vaccine (product administered to patient of inappropriate age) and was currently asymptomatic (no adverse event). The reporter also stated that the medication error resulted from similarities in the haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) carton and the carton of the meningococcal vaccine (product packaging confusion).
Patient received 2nd dose of Moderna vaccine on 03-23-2021. 1st dose provided on 03-01-2021
This case was reported by a consumer via sales rep and described the occurrence of injection site rash in a 55-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included shingles. Concomitant products included Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site rash and blistery rash. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the injection site rash was unknown and the outcome of the blistery rash was recovered/resolved. It was unknown if the reporter considered the injection site rash and blistery rash to be related to Shingrix. Additional details were provided as follows: The patient experienced shingles twice previously but presented on different dermatome first at 48 and second case 3 years later. In late April or early May 2018, the patient received 2nd dose of Shingrix. The day after receiving Shingrix, the patient experienced rash at injection site as well as blistery rash on opposite arm (primarily forearm). The patient received antivirals right away and the rash lasted about a week. The reporter was agree to follow up from GlaxoSmithKline.
Patient reports two days after immunization she broke out in small, slightly itchy blisters on arms, face, upper legs, and buttocks which resolved without treatment in seven days.
pt recv vax;mom reported pt rolled eyes back,foaming at the mouth & convulsed 4 times;
Lightheadedness, tachycardia. Treated by supine positioning and water. Initial BP 145/70, 117/76 after resolution. HR 90
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown. On an unknown date, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 for prophylaxis, lot # N024384 and expiration date 12-SEP-2019 or lot# N024384 and expiration date 18-MAY-2019 (dose, strength, route of administration, and frequency were unknown). On an unknown date, the vaccines experienced product storage error of 31°F or colder (26F) 15 cycles for 30 days. The vaccines had no previous temperature excursions. Data logger was involved.
mild headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "recovered" (29Apr2021), described as "mild headache". Therapeutic measures were taken as a result of headache.  Additional information: It was reported that 13 hours after vaccination he had a mild headache. Patient took 2 naproxen (ALEVE) 14 hours after vaccination between 01:00 -02:00. It was reported that it cleared up and was now feeling normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna Covid-019 vaccine that was given after the expiration date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-019 vaccine that was given after the expiration date) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-019 vaccine that was given after the expiration date). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-019 vaccine that was given after the expiration date) had resolved.            No concomitant medications were provided. No treatment medications were reported.  Date of administration of vaccine: 24Oct2021 - 27Oct2021.
Not feeling well; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced MALAISE (Not feeling well) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, MALAISE (Not feeling well) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 70-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced allergic reaction and product supply issue. On an unknown date, the outcome of the allergic reaction and product supply issue were unknown. The reporter considered the allergic reaction to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose of SHINGRIX. The case was reported by the patient's husband who informed that they were looking for the second dose of SHINGRIX since the first dose had been more than 6 months. No local sources claimed to have received it. The reporter inquired when his wife would get the second dose of SHINGRIX. The reporter stated that his wife had experienced an allergic reaction (facial) with the 1st dose of SHINGRIX and suspected a connection. This case was linked with the case US2019GSK044468, reported for patient's husband.
The symptoms that I have experienced like a knot in my neck and it swells when I feel sick and in my groin area where the femur meets the pubic bone I felt a knot there as well. I had several urinary tract infections as well my doctor stated my urine s overloaded with red and white blood cells. X-rays showed a herniated disc in my lower lumbar are close to my sacrum and signs of early bone degeneration.
16 month old patient needing catch up shots presented up to date on Hep B but needing DTaP and IPV. Provider asked nurse what combo vaccines were available for patient. Nurse replied KINRIX. Provider did not confirm appropriate age for KINRIX and ordered KINRIX. Nurse administered KINRIX. Patient should have either gotten PEDIARIX and an extra dose of Hep B or separate DTaP and IPV shots given age. No adverse reaction was noted. Our pharmacist called company that manufactures KINRIX and confirmed that KINRIX can count as dose of both DTaP and IPV for child. Parent was notified. It would be nice to see KINRIX approved for a wider age range. Age of patient at time of event: 16 months 20 days.
Started around midnight getting nauseous - lasted throughout the night, in the morning had a headache, felt feverish, weak, stayed in bed slept on and off until 8:30 pm; in the evening had stomach ache. July 2nd still have stomach ache, felt weak - this afternoon at a  store I actually somehow dropped a glass bottle of water which shattered all over the floor.
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 30-JUN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23-10PK 0.5 ml SD PFS LLokwTip (lot number L040181, with an expiration date of 18-AUG-2017 (route and anatomical location were not reported), that was improperly stored. On an unspecified date, the PNEUMOVAX 23 vaccine had a temperature excursion. The highest temperature excursion was of 47 Fahrenheit (F), (8.333333333 Celsius degrees) for a total of 24 hours. No adverse effects were reported. The vaccine storage criteria and the type of the excursion were reported as refrigerator (R), and the vaccine status was reported as "in excursion". Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Erythematous, raised rash surrounding PCV13 injection site on (R) thigh. Swelling approximately 2in x 2in. Mild tenderness. No fever.
Insomnia; Weakness and lethargy - very marked; Fever - 102; Headache; Neck stiffness.
High Fever 104 degrees, very stuffy nose, muscle aches, cough. Ibuprofen every 5 hours for 5 days.
Employee c/o itching to local site 7:05 AM. At 7:10 AM c/o throat itching. 720 A - Dr. ER - tx with prednisone.
17 years old patient received a dose of Flublok with no adverse event; Initial information regarding this valid unsolicited non-serious case was received from pharmacist and transmitted to Sanofi on 09-Oct-2020.  This case involved a 17-year-old male patient received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number and expiration date were not reported) via unknown route in unknown administration site (Product administered to patient of inappropriate age) for prophylactic vaccination on 08-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant drug was not reported.  This was an actual medication error case as 17 years old patient received a dose of Flublok (Latency: Same day).  At the time of reporting, the patient did not experience any adverse event.  There will be no information available on the batch number for this case.  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.
Patient had mild hypotension, decreased oral intake, somnolence starting 3 days after vaccination and death 5 days after administration. He did have advanced dementia and was hospice eligible based on history of aspiration pneumonia.
After receiving the vaccine dose 1 injection, I experienced a red, itchy rash around the injection site. The rash appeared 2 days after the first dose was administered.  Rash lasted around 6-7 days.  I took Tylenol, Benadryl, and used an Aveeno itch reducing lotion.  Rash is now fully healed.
Received the 4th dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 4th dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 019B21A, 048B21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 4th dose). On 30-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 4th dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Shingles-like rash primarily on the sides of my torso from lower hips up to shoulders with a few spots on my chest.; look like red hives about 3/4 to 1.5 inches across; white headed blister with mild pain and itch; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8743) via an unspecified route of administration in the left arm on 29Mar2021 at 08:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks. The patient had no known allergies. On 14Apr2021, the patient experienced shingles-like rash primarily on the sides of his torso from lower hips up to shoulders with a few spots on his chest, looked like red hives about 3/4 to 1.5 inches across and then developed a white-headed blister with mild pain and itch. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shingles-like rash primarily on the sides of torso from lower hips up to shoulders with a few spots on chest, red hives about 3/4 to 1.5 inches across and white-headed blister with mild pain and itch was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
vaccine was administered to patient after a temperature excursion of minus 1.25 degree Celcius, no AE; Initial information was received on 03-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA203126, 2020SA202350, 2020SA202831, 2020SA202832, 2020SA202232, 2020SA203422, 2020SA203423 and 2020SA207050 (same reporter).  This case involves a 15 month old female patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number KG4M7 and expiration date 06-Feb-2022) via an unknown route in the left arm for prophylactic vaccination on 31-Jul-2020 after a temperature excursion of minus 1.25 degree Celsius (product storage error).  The patient's medical history, past vaccination and family history were not provided.  The patient was concomitantly vaccinated with a dose of PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) on 31-Jul-2020 for prophylactic vaccination.   This was an actual medication error case due to product storage error temperature too low.  It was reported that, the refrigerator got too cold many times due to possible batteries issues, got to frozen temperatures several times, with a minimum of minus 1.25 degree Celsius.  No adverse event was reported at the time of reporting.  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.
Patient was admitted to the Hospital on 10/31/2021 for COVID related symptoms. This is considered a breakthrough case.
fever, chills, blocked ears, tiredness, stomach pain, loss of appetite continuing as of 5pm April 13
Went to vaccinate my children. Found out my record was not complete and I don?t know if I was vaccinated with the bivalent booster or not.   On 10/17, I went in for a COVID-19 bivalent booster and a flu shot. They were busy and I forgot about the flu shot and only received one shot that day. I didn?t realize it until my Dr appointment when I requested a flu shot. She told me I already had a flu shot at Pharmacy. I told her I only received one shot that day (one band-aid). She gave me another flu shot  as we both assumed it was a COVID shot.   When I accessed my records, I saw the flu shot at Pharmacy was properly filled in, but the bivalent booster was flagging.   I want to know if I was boosted or not.
5am woke up shivering like I had a fever. On and off all day but got better with ibuprofen. Resolved within 24 hours Sore arm at injection site and in armpit area
I had a weeks worth of worsening congestion and cough when I went in and lots of sinus pressure and green mucus. I was given Augmentin to treat.
Given pneumovax only with no problems within 30 minutes. 1 1/2 hours, later, upper left arm with increased aching, fatigue, red and splotchy rash around shot site and itching. At home she took aspirin. Next AM she was still sore and under arm pit, had dizziness and trouble with vertigo, laying down. Slightly improved that day.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe