chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered an expired Daptacel vaccine / no AE; Initial information received on 11-Mar-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 21 months old female patient who was vaccinated expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot number C5367AA (Expiry date 30-Jan-2020) via unknown route in the left thigh on 11-Mar-2020 for Prophylactic vaccination.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB), HEPATITIS A VACCINE (HEPATITIS A) and INFLUENZA VACCINE (INFLUENZA).  It was an actual medication error case due to expired vaccine used.  At a time of reporting no adverse event 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.
Pt. states after receiving the Shingrix 2nd dose 07/12/2021, started experiencing pain, swollen at injection site, woke up with fever (101.2) 07/13/2021. Continuing after taking Tylenol reading (99.8), weakness, slight headache, stomach pain, arm currently experiencing an itchiness' at injection site.
PATIENT RECEIVED IMMUNIZATION ON 8/19/2016. SHE STATED THAT HER ARM WAS SORE ON 8/20/2016, SHE NOTICED THAT IT WAS RED AND WARM TO THE TOUCH ON 8/21/2016 AND SHE CAME BACK INTO THE PHARMACY ON 8/22/2016 TO SEE IF SHE SHOULD SEEK TREATMENT. SHE DID GO TO A CLINIC WHERE SHE WAS TREATED FOR INJECTION SITE ABSCESS.
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB for prophylaxis. On an unknown date the patient experienced inappropriate schedule of drug administration and no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to RECOMBIVAX HB.
Rash on arm of the injection site,  swollen tongue, and severe migrane headaches since date of last vaccination
On approximately 02/01/2023, he began having ear infections and colds. His ears hurt and he had coughing, runny nose, and mild fever. We went to the doctor for two sick visits and were prescribed a different antibiotic each time. As far as we  know, he has recovered. He is in preschool.
Gave patient  vaccine that was expired 07/13 and we gave it to her 07/15. Patient hasn't called in regards to a reaction.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 25th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd December 2018, 7 days after receiving SHINGRIX, the patient experienced muscle pain. In December 2018, the patient experienced pain in arm and impingement syndrome. The patient was treated with FLEXERIL (NOS) and (non-proprietary) Cortisone Shot. On an unknown date, the outcome of the pain in arm, muscle pain and impingement syndrome were unknown. The reporter considered the pain in arm, muscle pain and impingement syndrome to be probably related to SHINGRIX. Additional details were provided as follows: The patient experienced sore arm for several weeks. Less than a week after receiving SHINGRIX, the patient experienced pain in arm and impingement syndrome. The patient developed pain in his trapezius muscle and was seen by orthopedist and diagnosed with an impingement syndrome that might be related to injection that made it into the bursa of his shoulder. The patient was receiving cortisone shots and physical therapy to treat the issue. The reporter did not give consent to follow up. Emergency room visit required.
Flu like symptoms; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were provided.  Treatment information was not provided.   This case was linked to MOD-2021-378310 (Patient Link).
redness and swollen upper arm starting on day of immunization and lasted for 5 days. Treatment: Tylenol and compress with cold water.
Call received from patient reporting she received flu vaccine in right deltoid. Felt fine after and exercised later in the day. Started to feel the area get warm and painful spreading into neck and chest area on the same side. Advised to apply cold compress to vaccine site and to take an ibuprofen. Local reaction likely from exertion and exercise with vasodilatation. On 11/13, Check-in call to patient. States that she had a fever till about midnight last night and had a bit of a fever this morning but does feel better today. Said the warmth and pain in her neck and chest area is still there, but now it is more sore and not as painful as last night. She is just taking ibuprofen now for the pain/fever. Has never had a reaction to any vaccine before. Says that she believes it was from exercising after receiving the vaccine, as symptoms started very suddenly upon exercising. Advised patient to call if symptoms get worse.
On day vaccine was given, vaccinated left arm (site of vaccination) became very painful that night, next day site became very itchy and later that day rash started and spread to down to my elbow. I applied hydrocortisone cream 1% and took CLARITIN but rash persisted so switched after 2 days to TOPICORT 0.25% cream BID and rash disappeared in 5 days.
Headache, high fever (102.5 with Tylenol), violent chills/body shaking, difficulty swallowing, extreme fatigue.
Information has been received from the below mentioned literature article regarding 40 patients. The study used a retrospective electronic database chart review of all patients 18 years of age or older at a tertiary care. This review was approved by the Review Board School of Medicine. Subjects met inclusion criteria if they had a visit at the allergy-immunology clinic between 2002 and 2009, received an International Classification of Diseases, Ninth Revision (ICD-9) diagnosis of Chronic rhinosinusitis (CRS), and underwent evaluation for immunodeficiency by assessment of quantitative serum immunoglobulin levels and pneumococcal antibody titers pre- and post immunization with a PPV. The treating physician made the decision to evaluate the individual patient with CRS for immunodeficiency. All subjects had normal IgG levels (>550 mg/dL). Subjects were included if they had a sinus CT scan documenting CRS and met criteria for CRS as defined by nationally recognized consensus statements. The presence of nasal polyposis was determined by rhinoscopy or surgical pathology specimens, and subjects were subsequently classified as chronic rhinosinusitis without nasal polyps (CRSsNP) or chronic rhinosinusitis with nasal polyps (CRSwNP). Atrophy was determined in all subjects via skin testing to pollens, dust mite, pets, molds, and cockroach using Hollister-Stier extracts. Asthma diagnosis and severity was determined in accordance with the 2007 NAEPP expert panel report 3 guidelines using % FEV1 values. Subjects were excluded if they had common variable immunodeficiency, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome, primary ciliary dyskinesia, cystic fibrosis, malignancy, IgA deficiency, or any acquired immunodeficiencies  (eg, HIV/AIDS or secondary to medications such as chemotherapy). Evaluation of subjects characteristics, antipneumococcal antibody titers, and serum Ig levels was performed via Analysis of variance (ANOVA) with post hoc Tukey analysis. Analogous chi-square tests were used to compare percentage for categorical variables. Data are expressed as mean with standard deviation. A P-value less than 0.05 were considered statistically significant; such results have been marked with an asterisk in the table in which they appear. Total number of patients were 239. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (manufacturer unknown) (dose, anatomical location and lot number was unknown). On an unknown date, the patients experienced specific antibody deficiency (had less than 50% of the pneunococcal serotypes greater than or equal to 1.3 mg/ml after PPV immunization). The outcome of the event was unknown. The author considered the event to be related to PNEUMOVAX 23. A copy of published article was attached as further documentation of the patients' experience. This is one of the several reports received from the same literature article. Additional information has been requested.
I had my IUD placed in June 2019 and my menstrual periods (which were very regular prior to insertion) stopped shortly after insertion. Approximately 2 months after receiving the Pfizer COVID-19 vaccine in March 2021, I started getting very irregular/heavy spotting randomly throughout the month and I have been since. It comes and goes but after speaking with a few friends who also have IUD?s they said the same thing happened to them after receiving their COVID-19 vaccine (all from Pfizer as well). I'm not against the vaccine but I think this should be reported as it is obviously effecting the reproductive system in some way.
Became ill in afternoon after receiving Hep B vaccine symptoms headache, sore throate, nausea.
This spontaneous report as received via social media from an unspecified reporter, who obtained the information from the articles published on a web page, refers to many female patients of unknown age. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated  with unknown doses of GARDASIL (lot #, expiry date, route and site of administration were not reported). Concomitant medications were not reported. On unknown dates, many of patients died. The reason of death was not reported. The reporter considered the events to be related to GARDASIL (it was reported that "vaccine which has killed many women"). This is one of two reports received from the same reporter. Additional information has been requested.
When I caught COVID-19 I stared with a scratchy throat that lasted for a week. I had no fever. After a week the sore throat became very intense. I had white pus on my throat. I had heavy chest congestion and a lot of mucus that lasted for about another week. It gradually started to get better. I also had some fatigue. On 5/16/2022 my doctor prescribed me an antibiotic just in case I had strep throat.
Patient c/o right axilla area burns, tender, swollen started this am 6/16/2010. Seen by nurse practitioner with no visible erythema at site of injection, no warmth, and no edema. Noted right axilla with visible edema.
Patient admitted for ETOH intoxication, unresponsive on arrival, found to be covid and Influenza positive. ICU admit.  Valium for alcohol withdrawal, IVF, seizure precautions.
Patient complained of a burning sensation in arm after influenza vaccination. He remained sitting near the pharmacy for observation, and within a few minutes complained of nausea, abdominal cramping, and a need to go to the bathroom. He became pale, and began sweating heavily, then lost consciousness. His breathing became labored, and then stopped. We called 911 and I administered an Epi-pen. He began to breathe again after the epinephrine injection, and regained consciousness. Patient continued to complain of nausea, dizziness, and exhaustion. EMT's arrived and patient was transported to ER. Patient was released from the ER later the same afternoon and was well enough to stop by the pharmacy later the same day to pick up his personal items left behind by emergency services.
dizzy spells; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy spells) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy spells). At the time of the report, DIZZINESS (dizzy spells) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-346520 (Patient Link).
Palpitation, arterial blood pressure, confusion, concertation head pressure, vibration, palpitation, and ringing in the ear, anxiety, back pain, leg numbness.
First COVID vaccine Moderna. Second COVID vaccine Pfizer. Third COVID vaccine Pfizer. Incorrect medication given on second dose.
Woke up with extreme pain in my lower back; lesser pain in various joints. I could barely walk.   I have had back pain before, this was different. At first I assumed it was coincidence, but later after my wife had me check the 'side-effects' of moderna shots, decided it was more likely the shot (I had no problem except shoulder pain with the first shot).   This lasted for several days - fortunately I had the weekend, and then hobbling around at work all I had to do was say that I'd had the second Covid shot and everybody gave me enough flex to do my job slowly and gingerly. It was Thursday or Friday before I was able to get around with a semblance of normalcy, and nearly as many days before I was back to normal.  I've had back problems before, including debilitating like this - but this was different - just pain.  I went to the chiropracter twice - he immediately recognized that I was walking bent over sideways, and that it was muscle rather than actual vertebra, as I've had in the past. The first visit made things feel better for a few minutes, but I was still walking bent sideways. The second visit was during the time I was getting better, and definiately helped more.  Note, I don't know if this is cause (shot 2) & effect (joint & muscle pain). I doubt it was just correlation, but I'll grant the possibility. More likely, my opinion is that the shot caused something, which made things worse than they would've been. Just over a month, hence not required, but included in case the time between shots is significant - doubt it, but included anyway.
COVID BUT NO SYMPTOMS; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (COVID BUT NO SYMPTOMS) and CHILLS (Chills) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No known allergies.  No relevant medical history.    On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) Booster dose. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ASYMPTOMATIC COVID-19 (COVID BUT NO SYMPTOMS) and CHILLS (Chills). At the time of the report, ASYMPTOMATIC COVID-19 (COVID BUT NO SYMPTOMS) and CHILLS (Chills) had resolved.     Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of COVID but no symptoms and chills with Skyrizi (Risankizumab) was no reasonable possibility.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Thaw date: 4/5/2022; given on 4/15/2022.
At 4:48 PM the patient started complaining of feeling "lightheaded", soft speech, diaphoretic, pulse deep, BP 90-80/50. He was removed from the chair and layed supine, "voices distant". Heart rate 70, BP 100/50, at 4:55 PM, BP 130/80, heart rate 78; at 5:00 PM, BP 130/88, heart rate 68 up in chair at 5:15 PM; BP 130/80 at 5:30 PM.
Patient received a second flu shot for 2021. Patient received first flu shot in October 2021.
were exposed to 30.2F for about 1h; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2021, the patient received FluLaval Tetra 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix, Menveo, Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Havrix, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix, Menveo, Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Havrix, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, had a freezing temperature excursion that affected their vaccines. The vaccines were exposed to 30.2 Fahrenheit for about 1hour and the reporter did not know if the vaccines were administered after that excursion. The reporter consented to follow up.
chills, fatigue, muscle/body aches, no appetite (general flu like symptoms); symptoms lasted for about 10-12 hours
I experienced a shingles outbreak again, had chills, sore arm, headache, fatigue, and my eye started bothering me and tearing up badly. I went to see my doctor who diagnosed shingles in my eye, prescribed steroid eye drops and antibiotics. This lasted for 2 weeks, and I have a scar on my eye from this event.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source.; Sender's Comments: US-009507513-1801USA005992:
High fever (103+) over 4 days (expected). Loss of appetite and severe sleep disruptions for 21 days which began within 2 hours of receiving MMR vaccine.
given pentacel to a patient using only the liquid component, without the hib component with no reported adverse event; Initial information received on 19-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 months old male patient who was given only the liquid component of diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)], without the HIB component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitants: None  On 19-Jul-2023, the patient received 0.5 mL dose 2 of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(vero)/ HIB (PRP/T) vaccine, suspension for injection (Strength: standard) (Batch number: UJ8778AA; Expiry date: 22-Mar-2024) via intramuscular route in the left thigh for Immunization only the liquid component was given, without the hib component with no reported adverse event (product preparation error) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event product preparation error.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.