chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood pressure again increased; acne outbreak on forehead for the past two weeks; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NASONEX. Vaccination history included: Bnt162b2 (Dose number: 1, Vaccine location: Left arm), administration date: 01Apr2021, when the patient was 40 years old, for COVID-19 Immunisation, reaction(s): "Blood pressure rose", "Light headed". The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 22Apr2021 13:15, outcome "recovered" (2021), described as "blood pressure again increased"; ACNE (non-serious) with onset 22Apr2021 13:15, outcome "unknown", described as "acne outbreak on forehead for the past two weeks". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure increased, acne.   Additional information included: The patient did not receive other vaccine in four weeks. Other medications in two weeks included OTC Nasonex. Second dose: blood pressure again increased, this time within 5 minutes of taking shot, and lasted for 90 minutes. The next day, blood pressure again rose for a few hours in the morning. Returned to normal and hasn't been an issue since. In addition, acne outbreak on forehead for the past two weeks. I don't have a history of high blood pressure, it's always has been in the normal/excellent range. The patient did not receive any treatment for AE. The patient was not diagnosed with Covid-19 prior to vaccination. The patient has not been tested for Covid-19 post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial case retrieved from the scientific literature on 22 September 2011.The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTAP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09246, -09247, -09248, -09249 and 2011-09250. A three-year-old female patient (who was one of triplets) and who had a history of developmental delay, microcephalic, and recurrent CNS infections by unidentified agents which were thought to have been viral, had received an INFLUENZA VACCINE (manufacturer unknown; lot number, route, site and date of administration not reported) when she was 3 years 9 months old. Two weeks later, she presented with CNS symptoms similar to those she had had unassociated with vaccination in the past, including fever. The day following hospitalization, she had a seizure which proceeded to status epilepticus and cardio-respiratory arrest. Respirator therapy was terminated on the following day. Postmortem examination disclosed acute hypoxic-ischemic encephalomyelopathy, noted to have been secondary to status epilepticus. Documents held by sender: None.
immed tingling sensation in rt hand to inj site & then into ear;skin temp variation between hands;
Information has been received from a healthcare worker concerning a patient (age and gender not reported) who was vaccinated on an unspecified date with a dose of varicella virus vaccine live (Oka/Merck). The healthcare worker reported that the patient had breakthrough chickenpox. There was no product quality complaint. Follow-up information from a healthcare worker indicated that no further information about the case was available. "It was something mentioned about someone who had been vaccinated and then gotten chickenpox, no names were mentioned, no dates, just the one fact." Additional information is not expected.
ELEVATED  BP 180 SYS, TINGLING IN FACE , DIZZY, WEAK IN LEGS.
Lips tingling like pins and needles, chest heaviness, coughing, tachycardia, hypertensive, shortness of breath Administered epinephrine dexamethasone, diphenhydramine, famotidine, ondanstron
Complained of metallic taste in mouth and seemed hard to breathe but not anaphylaxis. Had a large red, raised area where shot administered. She was taking BENADRYL and symptoms are subsiding.
Patient complained of having a hard time swallowing, her tongue felt like it was swelling up and so was her throat. Patient was given an Epi-pen injection but it did not help. Paramedics were called, her vitals were normal/fine and was taken to the hospital per patient's request.
At 4 p.m. patient started to have a runny nose and back pain. These resolved by the next morning. While the patient was asleep (midnight to 8 a.m.), she developed itchy, puffy bumps on arms. Patient called the doctor's office on 10/19/18 to see if they could prescribe something to help with symptoms. No one from the office called patient back. Three days after bumps appeared, patient started using Cortisone cream. She used about two rounds of cream, which gave her relief from itching for 1 hour. As of 10/26, bumps have gotten better, but she can still see faint marks of where the bumps were. She still has a bump on her elbow that's about the size of half a marble.
Initial information received on 02-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP (Office staff). This case involves a 4 months old male patient who experienced expired PENTACEL is given, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE for Immunisation; and PREVNAR for Immunisation. On an unknown date, the patient received 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5389AA (expiry date: 17-JUL-2018) via unknown route in left leg. It was a case of actual medication error due to expired vaccine used. It was unknown whether had any adverse event. 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. Documents held by sender: None.
Hospitalized (1.6.22);  COVID-19 positive (1.6.22); fully vaccinated Admitted - 1.6.22;  Discharged - 1.9.22 (s/p remdesivir)  Chief complaint Pneumonia due to COVID-19 virus Assessment/Hospital Course: Patient is a 71 y/o man w/ PMHx of DM, Obesity, OSA, CVA, and multiple other medical issues who is admitted to the Hospital on 01/06/2022 for COVID-19 Pneumonia.  Note from 1.8.22:  Subjective Pt. Seen and evalauted in bed 2519.  Overnight he was up to 3L NC.  He continues to be anxious, but otherwise is doing well. Respiratory Insufficiency with Hypoxia Sepsis COVID-19 Pneumonia -- First day of symptoms 1/2/22 -- Tested positive 1/6/22 -- SoluMedrol 40mg q6hr -- Remdesivir day #2/5 -- Oxygen needs:            - room air at baseline -- CMP and CBC -- CRP and D-dimer -- Lovenox  Patient discharging home with O2. Received final dose of Remdesivir
After receiving the vaccine I had the soreness in my arm and a small  fever of 99. Over the course of the next few weeks I was experiencing severe eye pain which caused me to start losing site in my right eye and also microclots in my eyes, my eye doctor stated that the vaccine was not the cause of my conditions with my eye.  But other than the soreness of my arm where the vaccine was administered and a slight fever I really didn't have any other problems.
4 days after vaccine I got a blotchy rash on lower back, itchy hives. On day 5 I had blotchy itchy hives on neck, part of face, upper and lower back, a spot on buttock cheek. Also have  some itchy spots in under arm area. I took a Loratidine 10mg 24 hour tab to help with itchy hives.
Right lower extremity swelling/pain 4/13/21 Improved swelling of right lower extremity 4/14/21 Heparin 1,000 unit/ml 5,592 units  IV (80 units/kg x 69.9 kg) daily 4/12/21 Eliquis 10 mg po BID 4./14/21 to 4/20/21 Eliquis 5 mg po BID 4/21/21
After 2 days, fever began at 100.4, ranged up to 102.8 for 5 days, headache, dizziness.  Followed fever protocol for secondary adrenal insufficiency, and increased hydrocortisone to 30mg
Noted that pt was 14 yoa, below recommended age.  Mother came for vaccine and signed the  "signature of Parent or Guardian"  on consent form. Mother and pt were provided the FACT SHEET FOR RECIPIENTS AND CAREGIVERS  specific to the Pfizer-Biotech COVID-19 Vaccine. There were no adverse reactions  or symptoms during 15 minute wait period post vaccination.
This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced localized erythema, skin warm and local swelling. On an unknown date, the outcome of the localized erythema, skin warm and local swelling were unknown. It was unknown if the reporter considered the localized erythema, skin warm and local swelling to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter stated that the patient developed a raised, red area on the left deltoid muscle that was warm to touch after their dose of SHINGRIX. The reporter stated that the area was large and was about the size of a baseball. The reporter consented to follow up. The reporter was also the niece of the patient.
A non-serious spontaneous report of child with asthma administered FLUMIST who experienced the following symptoms stomach pain, diarrhea, fever, tiredness, sinus congestion and appetite decreased has been received form a consumer concerning a six-year-old male, subsequent to FLUMIST. The only patient medical history reported was a history of asthma. No concomitant medications were reported. The patient received a single dose of FLUMIST around 31-AUG-2009. The patient received FLUMIST and since receiving the vaccine he has experienced stomach pain, diarrhea, fever, tiredness, sinus congestion and appetite decreased. No outcome was reported for these events.
Patient had significant outbreak of shingles rash within 24 hours of administration of the vaccine cover the upper right arm and down to the T10 dermatone. Patient was started on Valacyclovir greater than 48 hours after administration of vaccine as well as pain medication. He had improvement in his rash but pretty severe neuralagia that was being only modestly improved with the narcotics
Joint pain neck, shoulders, hips, knees; measle like rash anti inflammatory meds given by ER MD;
There was no adverse health effect.  The HPV vaccine was given in error.  A Hepatitis vaccine was supposed to be given.  The error was  caught when it was determined that patient did not have a titer for Hep B.  Upon investigation at the office it was determined that the HPV virus was given in error.
Rash; fevers; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PYREXIA (fevers) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.  Patient had no known allergies.    On 21-Sep-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In September 2023, the patient experienced RASH (Rash), PYREXIA (fevers) and CHILLS (chills). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Rash, Fever and Chills, at an unspecified dose and frequency. On 25-Sep-2023, RASH (Rash) had resolved. At the time of the report, PYREXIA (fevers) and CHILLS (chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: as high 101.0.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient reported side effects such as rash and fevers for about 2-3 days and chills. Rash had cleared, and the fever seems to be going away. Fevers were as high 101.0.  Patient reported that she was taking Aspirin for the symptoms.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 62 years old female patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication received. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ000AB (expiry date: 28-Mar-2019) via unknown route in the left deltoid. It was a case of actual medication error due to Inappropriate age at vaccine administration and overdose. No adverse reaction occurred. 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 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..
First dose on 15Mar2021, 2nd dose on 14Jul2022; Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 2-year-old female patient who received HAV (Havrix) (batch number 5575N, expiry date 19th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (received 1st dose on 15th March 2021).   On 14th July 2022, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 14th July 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long and expired vaccine used. On an unknown date, the outcome of the drug dose administration interval too long and expired vaccine used 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: 31-AUG-2022 Reporter's comment: The nurse reported that a second dose of Havrix was given to the patient and it was already expired. The Vaccine Administration Facility was the same as primary reporter.  The reporter consented to follow up. Additional Supportive Information: The patient received the second dose of Havrix later than the recommended interval which was already expired, which led to lengthening of vaccination schedule and expired vaccine used.
Extreme migraine, nausea/vomiting, fever/chills, fatigue, muscle soreness, aching of joints, sensitivity to light/sounds, and weighted sensation.
Weakness; Redness on right arm more than left 10x10cm began to circle the arm; Fatigue; Myalgia; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (Weakness), ERYTHEMA (Redness on right arm more than left 10x10cm began to circle the arm), FATIGUE (Fatigue) and MYALGIA (Myalgia) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced ASTHENIA (Weakness), ERYTHEMA (Redness on right arm more than left 10x10cm began to circle the arm), FATIGUE (Fatigue) and MYALGIA (Myalgia). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness), ERYTHEMA (Redness on right arm more than left 10x10cm began to circle the arm), FATIGUE (Fatigue) and MYALGIA (Myalgia) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.
Dizziness and weakness, injection site pain, tiredness, headache, muscle pain, chills, fever, nausea, diarrhea
vaccine administered to a 16-year old patient; A spontaneous report was received from a nurse concerning a 16-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine given to a 16-year old patient.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Jan 2021, the Moderna COVID vaccine was given to a 16- year- old patient at their facility. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccine given to a 16-year old patient, was considered resolved on 29 Jan 2021.; Reporter's Comments: This case concerns a 16 year old female who received her first of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.
Severe pain in her back and muscles; Not able to stand uprightly; Stiffness; Took about 40 hours before she got any reliefs; Severe pain in her back and muscles; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Severe pain in her back and muscles), DYSSTASIA (Not able to stand uprightly), MUSCULOSKELETAL STIFFNESS (Stiffness), IMPAIRED HEALING (Took about 40 hours before she got any reliefs) and MYALGIA (Severe pain in her back and muscles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced BACK PAIN (Severe pain in her back and muscles), DYSSTASIA (Not able to stand uprightly), MUSCULOSKELETAL STIFFNESS (Stiffness), IMPAIRED HEALING (Took about 40 hours before she got any reliefs) and MYALGIA (Severe pain in her back and muscles). On 12-Mar-2021, BACK PAIN (Severe pain in her back and muscles), DYSSTASIA (Not able to stand uprightly), MUSCULOSKELETAL STIFFNESS (Stiffness), IMPAIRED HEALING (Took about 40 hours before she got any reliefs) and MYALGIA (Severe pain in her back and muscles) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
severe back pain; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable consumer reported for a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for an Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller was calling on behalf of her neighbour. She said her neighbour was supposed to get the second dose of Vaccine today but was not able to get it because her neighbour was experiencing severe back pain. The outcome of the event was unknown.   Follow-up attempts completed. No further information expected.
Numbness on her feet; Positive for Covid 19; Severe headache; Low grade fever; Chest tightness; Body aches; Sore throat; Congestion; Cough; A spontaneous report was received from female patient who is also a nurse. This case concerns an adult female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore throat, congestion, cough, low grade fever, severe headache, chest tightness, body aches, numbness on her feet, and COVID-19 positive with the use of mRNA-1273.   There was no medical history provided. No relevant concomitant medications were reported.   On 23-Dec-2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 25-Dec-2020 the patient experienced the non-serious events of a sore throat, congestion, and a cough. On 26-Dec-2020 the patient developed a low grade fever, severe headache, chest tightness, and body aches.  On 27-Dec-2020 the patient developed numbness on her feet and tested positive for COVID-19.  Treatment included with paracetamol and and salbuterol.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events of sore throat, congestion, cough, low grade fever, severe headache, chest tightness, body aches, numbness on her feet, and COVID-19 positive was unknown.; Reporter's Comments: This case concerns a female of unknown age, who experienced non-serious unexpected events of sore throat, congestion, cough, chest tightness, body aches, numbness on her feet, and COVID-19  and non-serious expected events of low-grade fever and severe headache. The events began 2 days after the first dose of mRNA-1273 and progressed until she tested positive for COVID-19 at 5 days after mRNA-1273 administration. Treatment included paracetamol and and salbuterol. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.