chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT'S DAUGHTER CALLED TO HEALTH DEPARTMENT 4/12/21 TO REPORT THAT THIS PATIENT HAD "STROKE LIKE" SYMPTOMS THAT STARTED 4/10/21, WENT TO ER, HAD CT SCAN AND WORK UP AND WAS DIAGNOSED WITH BELL'S PALSY. SHE IS HAVING FOLLOW UP APPTOINTMENT WITH HER PCP 4/12/2021
Initial information received on 02-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Child patient (age and gender not reported), who was vaccinated with an expired dose of ACT-HIB (expiry date: 28-Jun-2018, batch number, dose, dose in series, route and site of administration were not reported) 02 Aug 2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by sender: none.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 37-year-old female patient (gravida 6, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M208A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage in November 2015, Miscarriage in June 2019 and Miscarriage in August 2020. Concomitant products included ENOXAPARIN SODIUM (LOVENOX HP), PROGESTERONE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Oct-2020 and the estimated date of delivery was 16-Jul-2021. On 12-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  On 12-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound foetal: normal (normal) To view images of fetus when pregnant..     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.   The patient had taken tests relating to the pregnancy which is a genetic test. (Non invasive)
pt recvd vax; exp migraine ha, some sl difficulty breathing, & muscle weakness especially of the upper body x 3 wks;
loud ear ringing within hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 19:00 (Lot number: Fh8030) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allegies: Penicillins" (unspecified if ongoing); "Known allergies: gluten" (unspecified if ongoing), notes: other medical history: gluten snesitivity; "Celiac disease" (unspecified if ongoing); "highblood pressure" (unspecified if ongoing); "demylating disease" (unspecified if ongoing); "Joint and muscle pain" (unspecified if ongoing); "Joint and muscle pain" (unspecified if ongoing); "possibly autoimmune from celiac disease" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE; AMLODIPIN BESYLATE AND BENAZEPRIL HYDROCHLORI. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Er8736, Location of injection: Arm Right, Vaccine Administration Time: 08:00 PM, Duration: 1 day), administration date: 11May2021, when the patient was 47 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0162, Location of injection: Arm Right, Vaccine Administration Time: 08:00 PM), administration date: 19Apr2021, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Nov2021, outcome "not recovered", described as "loud ear ringing within hours". Therapeutic measures were not taken as a result of tinnitus.  Additional information: It was reported that 2 months later still have loud ear ringing especially noticeable after laying down and in the evening and during the day at work less noticeable. The patient had received no other vaccines within 4 weeks prior to COVID vaccine. The patient had not diagnosed with COVID-19 prior vaccination and the patient had not tested to COVID-19 since vaccination.  No follow-up attempts are possible. No further information is expected.
Anxiety; This is a spontaneous report received from a contactable consumer (patient). This patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 03Apr2021 as a single dose for COVID-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL) from an unknown date for arthritis. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported they received their last shot yesterday, their second shot, and they had a neighbor that seemed to know that they had very bad anxiety and that the patient took paracetamol for arthritis which is 125 mg and they took two of those sometimes. The patient stated nobody had told them that they should not take it before or after; the patient stated about their neighbor that she read that patients were not supposed to take paracetamol before or after the shot. The patient inquired if this was going to be a problem with taking this; further stating they thought they could die on the medication. The clinical outcome of anxiety was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
I had the first vaccine almost a year ago. NOTE: The only reason that I delayed my 2nd vaccine is because it was not available.  At that time my reaction was a golf-sized bump on my arm and was very sore for a week and then somewhat sore for another week.  It gradually got better. I felt a little achy, but I didn't think much of it.  This time, I developed a very sore arm almost immediately and felt like I was getting the flu (body aches, gone aches but no sore throat, etc) and by the evening I was chattering, felt like I had a fever, then chills.  This lasted for a few hours. I had a very restless night from the pain and chattering/feeling cold then hot. When I awoke in the morning, I was no longer having the sensation of fever/chills and felt better.  My husband was close to taking me to the ER the night before because I couldn't stop shaking/chattering.  My arm, like the first time around, was even more swollen when I awoke then the day before and I still have some residual discomfort in my right arm, but it is mostly gone now.  NOTE:  I did have shingles when I was approx 27 years old, may have been 28 years old.
This case was reported by a healthcare professional and described the occurrence of injection site blisters in a 25-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included allergic rhinitis and sinusitis. On 23 August 2011 the subject received 1st dose of ENGERIX B (1 ml, unknown route, right arm). On either 23 or 24 August 2011, within 24 hours after vaccination with ENGERIX B, the subject experienced injection site blisters, injection site pruritus and injection site irritation. The subject had a raised blister with pus at the injection site, which was the size of a pencil eraser. The healthcare professional reported that it itched and caused some irritation. At the time of reporting the events were improved.
Mother reports that child had hives on her arm and small bumps near the injection site (LD mother wanted this event reported
Started out with gastritis issues developed vomiting diarreaha runny nose and extreme fatigue. Congestion, mucus and fever. Prescribed Paxlovid subsided within a week then rebounded symptoms subsided after 3 weeks.  Still experiencing fatigue.
L arm became edematous. Red and hot last night. Pt c/o pain also and fever.
Pt was found dead in crib at 6am. Mild URI symptoms x 1-22 days. had been started on Pediatex (antihistamine only) on 12/29/2005 and was given 1st set of shots.3/20/06 Received autopsy report which revealed COD as complications from multiple congenital anomalies & abnormalities/ss
His left eye looks like it is bleeding on the inside of the eye; Inside the eye with pus; A spontaneous report was received from a consumer concerning a 68 years old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and his left eye looks like it was bleeding on the inside of the eye with pus.  The patient's medical history included cancer. He received his chemo shot (Lupron) last Tuesday. Relevant concomitant medications included candesartan and aspirin 81 mg.  On 01 Mar 2021, the patient received the first of the two planned doses of mRNA-1273 (Batch No: 025A21A) in right arm for prophylaxis of COVID-19 infection.   On 03 Mar 2021, 3 days after vaccination the patient's left eye looks like it was bleeding on the inside of the eye with pus.   Treatment details was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of his left eye looks like it was bleeding on the inside of the eye with pus was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
About a week ago: frontal and occipital head pain, lightheadedness, syncope for seconds, right calf pain, shortness of breath
Severe Hematuria, about 18 hours after vaccine. Severe chills about 12 hours after vaccine. Nausea, headaches, body and flank pain, severe fatigue lasting 5 days from vaccine. Hospitalization 2 days after due to Hematuria .
Broke out in a rash between my legs, that ran down my inner thighs and on my wrists and hands; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration, in Left arm in Mar2021 at 13:45 (at the age of 42-years-old) at single dose for COVID-19 immunization. Medical history was reported as none. Patient had no allergies to medications, food or other products. The patient did not receive concomitant medications. The patient was not pregnant at the time of vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient broke out in a rash between legs, that ran down inner thighs and on wrists and hands after the first dose on 16Mar2021. The event resulted in doctor or other healthcare professional office/clinic visit. Steroid treatment was received for the event. The outcome of the event was not recovered. It was also reported the patient received first dose of unspecified Pfizer vaccine in left arm in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a licensed practical nurse refers to a 5 patients of unknown age and gender. On an unknown date in 2012 the patients were vaccinated with a dose of RECOMBIVAX HB (dose, route not reported) (lot # 671326/1522AA, exp date 21-APR-2014) which was stored in a refrigerator reading 36-46F, but in a section of the refrigerator with intermittent excursion to 30 F since 11-JUN-2012. No adverse effect reported. Follow-up information has been received from the nurse reporting that patient #5 was a 8 month old female who on 16-JUL-2012 was vaccinated with the dose of RECOMBIVAX HB. The reporter also noted that the patient would be re-vaccinated at her next visit. This is one of several reports received from the same source. No further information is available.
1st dose 25nov2020, 2nd ot yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix shot  (received 1st shot on 25th November 2020 intramuscularly of batch number 4z43X and expiry date 22nd February 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 12-Jan-2023 Reporter's comment: The retail pharmacist failed to ask for the patient's date of birth and reporter if GlaxoSmithKline safety could follow-up with her. The vaccine administration facility was the same as primary reporter. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd shot of Shingrix, which led to incomplete course of vaccination. The vaers details were reported for 1st Shingrix shot.
Had small red area immediately after injection but by evening the redness extended to elbow and around back of arm. In the morning  of Dec 17 arm was more tender and had red streaks, and  she had chest pain on left side.
pt recv vax 2JAN97 & 7JAN97 pt exp dry, frequent croupy cough for 3 days & a fever of 101;
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 10-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius(C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013091: US-009507513-1701USA013090: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082:
Breakthrough case admission after 4 vaccines Pfizer 2/24/21 Lot# EN6202; Pfizer 3/17/21 Lot# Er8727;  Pfizer 11/12/21 Lot# 30135BA;  8/1/22 Moderna Lot# 037A22B
Right arm injection site red/blotchy. Arm swelled. Hot to touch. Swelling spread to forearm over night less than 24 hours from onset of symptoms.  Infection seen. Treated with antibiotics and allergy medications. Steroids. 1 week follow up
Vaccine was picked up from state department on 12/07/2021 to be stored in fridge and used by 01/07/2022. Patient received this dose four days past the vaccine usage date. Patient reported no known symptoms.
No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions.  Vaccines were administered to unknown patients on unknown dates.  No additional information provided.  No additional AEs or PQC reported.       ?    Names of vaccines involved (in; This spontaneous report has been received from a medical assistant, concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.  On unknown dates, the patients were vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin) (PROQUAD) subcutaneous injection as prophylaxis (lot number W026316 has been verified to be valid; expiration date reported and established as 18-FEB-2024), and varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection as prophylaxis (lot number W021740 has been verified to be valid; expiration date reported and established as 10-JUL-2024) (doses, frequencies, vaccination schemes, routes of administrations, and anatomical locations were not provided). The administered doses of the vaccines were stored at a temperature of 1.1 degrees Celsius (C), during a time frame of 16 hours and 21 minutes. There was not a previous temperature excursion reported. There was no adverse effect reported.   This was a non-valid case due to the lack of patient's identifiers.  Follow up information has been received from the medical assistant on 11-JAN-2023 and 12-JAN-2023.   The medical assistant reported there were 8 patients who received vaccines after the temperature excursion occurred. One of them was a 12 month old male patient with no illness at time of vaccination. The patient had no siblings. On 02-JAN-2023, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M R II) (lot # W023072 exp date 05-APR-2024, dose not reported) subcutaneously in the left leg at a private hospital.   The medical assistant reported that the freezer door was left ajar.  This is one of several reports received from the same source.  This case was previously considered non valid, but upon receipt of FU is considered valid due to patient identifiers were provided.; Sender's Comments:  US-009507513-2302USA001034: US-009507513-2302USA001035: US-009507513-2302USA001036: US-009507513-2302USA001037: US-009507513-2302USA001038: US-009507513-2302USA001039: US-009507513-2302USA001040:
Headache; Internal shaking when lie down.; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ENG206) in the right arm via an unspecified route on 06Mar2021 at 14:45 as a single dose (at the age of 61-year-old) for COVID-19 immunisation. The patients past drug history included allergy to sulfur. The patient did not receive any vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included multi vitamins (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), crestor (MANUFACTURER UNKNOWN), RAPFLO all for unknown indications from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Mar2021, the patient had SARS CoV-2 test via rapid nasal swab and resulted negative. On 11Mar2021 at 07:00 am (5 days after vaccination), the patient had headache started with internal shaking when patient lied down. Therapeutic measures were taken as resulted events and included treatment with muscle relaxer. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of events headache and internal shaking was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Started off with a fever on 05/29/2014 and then developed into vomiting on 06/01/2014; he is currently unable to hold any liquid down and we may need to go the the ER in the next day or two.
has not received another dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose in February 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: has not received another dose yet).  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: 3-Oct-2023 The pharmacist reported that the patient had not receive another dose yet. The reporter declined follow up, did not have any patient information. Did not consent to follow-up. Till the time of reporting, the patient did not receive second dose of Twinrix, which led to incomplete course of vaccination.
My son developed a severe rash resembling measles within 3 days after receiving the vaccine that started on his face. By day 5, His body was completely covered from head to toe with what looked like the chicken pox or measles. He has had severe pain and itching with this rash. The rash and itching is still present. Four days after the rash started he was presenting with fevers over 103° F. We brought him to urgent care, they ruled out hand foot and mouth and gave him an antibiotic due to his rash looking like an infection was starting. They told us to follow up with our regular doctor.  We weren't able to see our normal doctor so we saw the next available one 2 days after urgent care visit. This doctor did no tests, and said it was scabies. We then went to a holistic nutritionist to get a second opinion and they said it was absolutely not scabies and did cold laser treatment on his body. They thought it was fully related to the vaccines. My son has been in daycare and around his siblings with no one getting any of the signs and symptoms he presented with. After that we got in to our regular doctor (at the beginning of October), at this point the rash was so severe my son was itching chunks of skin off his body. Up to this point, we tried, coconut oil, antibiotics, creams, lotions, anti-itch, BENADRYL. At this appointment he was prescribed another antibiotic. 3 days later his head was seeping pus, and we were sent to the hospital. He was tested for many things and given IV antibiotics and topical steroids but still did not have any answers to what it was and did not get better. After 5 days we were discharged home still with rash present. We continued with BACTRIM at home for 10 days. The hospital used ATARAX to help itching, this did not help relieve the symptoms. We followed up with his primary after that and he said there wasn't much he could do for him we just had to wait it out. On December 12th, 2018 we went to a holistic doctor. He said it was eczema most likely caused by vaccinations.