chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the administration of an expired RECOMBIV AX HB; the nurse administered a fourth dose today since the last dose the patient received "did not count".; he patient was given the third dose too early/The nurse states that the third dose should have been administered after 24 months; he patient was given the third dose too early/The nurse states that the third dose should have been administered after 24 months; This spontaneous report was received from a nurse referring to a 10 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/ allergies and concomitant medication were not reported.  On 30-MAR-2011, at 1 day old, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, strength, frequency, route, lot# and expiration date unknown) for prophylaxis. On 05-MAY-2011, at 5 weeks old, the patient was vaccinated with the second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, strength, frequency, route, lot# and expiration date unknown) for prophylaxis. On 08-SEP-2011, the patient was vaccinated with the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, strength, frequency, route, lot# and expiration date unknown) for prophylaxis. The reporter stated that the third dose should have been administered after 24 months (inappropriate schedule of product administration and circumstance or information capable of leading to medication error). Then on 15-JUN-2021 (also reported today), the patient was vaccinated with the fourth dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (0.5 ml, once, lot# R028384, expiration date 08-JUN-2021; route unknow) for prophylaxis (Extra dose administered). The administrated Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) was expired (Expired product administered).
redness/swelling at injection site, intermittent up  103, chills, cough, diarrhea, joint pain, frontal headache, light sensitivity, diarrhea
Information has been received from a registered nurse concerning unknown number of patients who on an unknown dates were vaccinated with doses of RECOMBIVAX HB (doses, routes and lot numbers not reported) which were stored at lower than recommended temperatures on multiple occasions. No adverse effect reported. This is one of several reports received from the same source. Attempts are being made to obtain additional information to distinguish individual patients mentioned in this report. All telephone attempts to obtain follow-up information have been unsuccessful. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination/therapy, dose number (if applicable), lot number (if applicable), date of event, recovery status, healthcare provider name and contact information. Additional information has been requested.
Left arm blotched tender red right away. Swelling started and top of arm and extended to hand by 3-20-2023. Returned to Dr & was told to wrap and elevate. I have been putting heat and ice.
TOOK UNREFRIGERATED DOSES; This spontaneous case report (PVX2019-1979) was received from a pharmacist on 31-Jul-2019. It described an adult female consumer who "took unrefrigerated doses" (PT: Product storage error). The consumer was receiving Vivotif for an unknown indication.  Case report: The Vivotif was dispensed on 23-Jul-2019 and the first dose was taken within hours of dispensing. The consumer took all doses of Vivotif, but did not store it in the refrigerator.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Fever, Malaise, Chronic hives on flanks, arms and sacrum and angioedema on lips, swollen tongue, difficulty breathing.  Hives and angioedema are recurrent.
PT WAS RUNNING A TEMP OF 102.0 WITH A RUNNY NOSE AND COUGH. PT WAS SEEN ON 09/26/2010 FOR RUNNING FEVER.
Red rash on face, neck, chest and arm; difficulty swallowing; This is a spontaneous report from a contactable nurse (patient). A 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ELO140) intramuscular on 26Dec2020 18:30 (06:30 PM) at a single dose on the right arm as COVID-19 vaccine. Medical history included previously diagnosed with COVID-19 prior to vaccination. The patient had no known allergies to medications, food, or other products. There were no concomitant medications. The patient had adverse events of red rash on face, neck, chest and arm; and difficulty swallowing, both on 26Dec2020 19:00 (07:00 PM) assessed as non-serious. It did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. There was no treatment for the events. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). He had no other vaccine within four weeks prior to the COVID vaccine, no other medications within two weeks of vaccination. He did not have Covid tested post vaccination. The outcome of the events was recovered on Dec2020.
I had my first vaccine (Moderna, V00120) on February 26. About a week after,  I started feeling paresthesia, numbness in the right side of my body, specifically in the right leg and arm, and I started having difficulties walking.  Since the symptoms persisted, I went to the Dr. on March 23. I told him that I thought my symptom were out of the blue and I linked them to the vaccine, so I was visiting him to see if I should put my second vaccine in those circumstances, few days after. Doctor said that there was no relation between nerve damage and the vaccine and he recommended me to put it.  He sent me test thinking that could be multiple esclerosis. I did my brain MRI on Thursday 25 and on Friday March 26 I put my second dose.  About a week after the second dose my symptoms  were dramatically aggravated. I first started experiencing  a sudden fatigue that didn't even allow me to hold the cellphone or a spoon and I had to lie down. I couldn't hold my 8 months daughter because I felt such a strong weakness. This fatigue didn't allow me to work. This happened few days in a raw for few hours. On April 8th I started to feel needles and strong neuropathic pain that I had never experience in my whole life. On April 9th in the evening I had a massive crisis. I started to feel a sudden  having a lot of cold, starting shivering and then chattering teeth and strong headache. (Same reaction I had 12 hours after putting the second dose of the vaccine).  I had to lie down in bed and my husband had to cover me with a jumper and eiderdown, but I still was cold. I couldn't stop shivering. Then I had difficulty swallowing. And the worst part started when I felt all over my body an intense pins and needles, burning, electricity, very profoundly and spread all over in a very intense way., I thought I was dying. I started panicking, I didn't have control over my body. I had difficulty breathing and such a weakness that didn't make me speak because I couldn't stop chattering my teeth. Was the worst life experience ever until that moment. The situation lasted about 90 minutes and then went away. The next day, Sunday April 10th, I spent the whole day in bed to rest, but at night time I experienced the same crisis as the night before. It started with the sudden cold as well.  After that I didn't have more crises but the pins and needles pain remains and it made it difficult to sleep because of the pain and discomfort and I wonder if I would have it my entire life. I returned to the doctor. To a different one specialized in multiple esclerosis. Brain MRI came out negative but it was done one day before the second dose, so we cannot be sure. I did 3 MRI of my whole spine and some muscular tests to check the response of the nerves. They also took 8 tubes of blood. We are waiting for the results but doctor think is Guillain Barrel syndrome. She thinks I am suffering peripheral neuropathy.
Pt. c/o severe abdominal pain, nausea, and vomiting within 4-7 days of receiving Hepatitis B vaccination.  Pt. went to E.R. 4 days after first dose given on 09/25/07.  Symptoms occurred again 8 days after receiving 2nd dose on 10/30/07.  Pt. states less severe, no E.R. visit, F/U with PCP.  PCP felt that symptoms were coincidental after dose 1 & 2 of HBV.  Symptoms occurred again 7 days after receiving 3rd dose on 03/25/08.  Less severe than after previous two doses.  No E.R. visit.  Did miss work for day.
No adverse reaction; reporting as vaccine lot number was expired ( 02/2020) and not noticed until after administered by medical assistant.
Later in the evening after receiving vaccine, patient was  watching BMP on activity tracker - fluctuating  between 55bmp then would shoot up to 79 while patient was attempting to go to bed. Patient states she, " felt as my heart was racing and was having a panic attack." Lasted about 2 hours.
Horrible headache and body aches; fever; nausea; chills Has lasted two days so far
Pt reports he has a rash that started on his abdomen and back. Within 1-2 hours spread to include some of his chest, possibly some on his inner arm bicep area (these later resolved) and also on his feet, ankles and up to his mid-calf area on both feet and legs. He reports he doesn't have any signs of fever, chills, itching, pain, discomfort. He feels "ok". Rash is described as small red dots that look like "hair follicles" but are not raised. I encouraged him to take some Benadryl and monitor closely. If sx worsen or rash spreads more, he should see Dr. ASAP. If he continues to feel okay and sx don't worsen we will monitor closely until Friday when he already has a Dr. apt scheduled.
Dose 1 Moderna within 15 minutes of dose: Vertigo, high blood pressure (>200/90), fatigue. subsequent 2 days, fever, nausea, body aches, fatigue. Treated at home with fluids and rest. Dose 2 Moderna within 15 minutes of dose: Vertigo, high blood pressure. Treated by paramedics at scene with fluids. Subsequent 3 days, fever nausea, body aches, fatigue. Recovered at home. Dose 3 Pfizer within 15 minutes of dose: Vertigo, high blood pressure, extreme fatigue, difficulty speaking. Could not sit up or walk. Treated at scene by paramedics and transported to ER. Given fluids and oxygen, released after 3 hours.
unconsolable > 3 hrs p/vax until next AM; MD tactile  fever;
Developed a slight headache and then horrible body aches and temperature later in the night. Had a slight cough. I tested positive and called my doctor and received PAXLOVID. Finished 5 days of medication and started feeling better by the 3rd day. I tested negative on the 5th day but tested positive again on day 7.
Extreme vertigo 5 days after 2nd shot. I have noob once a year in August and it lasts about a week .this episode in February lasted until July and took lots of PT to retrain my balance.
This case was reported by a consumer and described the occurrence of tiredness in a 6-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Previous vaccination included PEDIARIX (GlaxoSmithKline) given on 27 March 2009. Concurrent vaccination included Haemophilus influenza type b vaccine (manufacturer unspecified) given on 13 April 2009 and (non-gsk) PREVNAR (manufacturer unspecified) given on 13 April 2009. Concurrent medications included Multivitamins. On 13 April 2009 at 15:00 the subject mistakenly received 3rd dose of PEDIARIX (route unknown, right thigh) after only receiving his 2nd dose 17 days ago (drug dose administration interval too short). On 13 April 2009, 5 hours after vacciantion with PEDIARIX, the subject experienced tiredness. At the time of reporting the event was unresolved.
Patient came into pharmacy a week later stating that she had a swollen spot after shot and a scar is now on her arm.
Called mother to explain that patient was too young to receive the COVID 19 Pfizer vaccine (13 years old). Mother reported no adverse reactions on 2/2/21 at 8:07pm, one day after the vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. Many patients have complained of significant arm pain after receiving SHINGRIX. No additional details was provided. No information was provided. This case has been linked to the case US2019034286, reported by same reporter.
Diarrhea, NauseaVomiting, arm pain, chest tightness Narrative:
PATIENT'S ARM WAS ITCHING AND SHE NOTICED A LARGE RED RASH AROUND INJECTION SITE THAT WAS WARM TO THE TOUCH. THE AREA WAS SWOLLEN AND EVENTUALLY HER ENTIRE ARM SWELLED.
Headache; Nausea; Covid-19; Coughing; Sore throat; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19), COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Body aches) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history was not reported .  Concomitant products included ABATACEPT (ORENCIA) for Rheumatoid arthritis.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced COVID-19 (Covid-19), COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Body aches) and CHILLS (Chills). On an unknown date, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19), COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a RN concerning a 71 year old male with allergies to horse serum and tetanus who on 29OCT2003, at 09:00, was vaccinated IM in the right deltoid with the first dose of pneumococcal 23v polysaccharide vaccine. Illness at the time of vaccination included Helicobacter pylori gastritis and Hepatitis C. The RN reported that on 30OCT2003, at 11:00, the patient developed redness and an area of induration at the injection site. The pt was evaluated at the clinic, but no lab/diagnostic tests were performed. On approximately 01NOV2003, 2-3 days after onset, the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Patient called next morning to state her neck glands (lymph node) swollen felt hard and she put warm compress on it. Reported swelling went down and resolved. Denies fever, chills, denies short of breath or any other symptoms.
(R) thigh red, swollen, warm to touch. Remind mother to continue rubbing area and apply ice pack or cold compress 22 degrees for 24 degrees then warm pack. TO call if get worse or redness, swelling worsen.
56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
chills, hot flashes, constant pressure h/a, HA diminishes but is not completely relieved by APAP; profuse sweating, neck ache, nausea;
Initial information from a consumer with follow up information from a secretary at a physician's office, concerning a 24 year old female with warts and no known drug allergies who on 24-AUG-2008 was vaccinated with the first dose of GARDASIL (lot# 660553/0070X), 0.5 ml, I.M. and on 16-OCT-2008 was vaccinated with the second dose of GARDASIL (lot# 660612/0229X) 0.5 ml, I.M. Concomitant therapy included ALDARA for warts and "kapara" 500 mg daily. The patient had been off the birth control pill since January 2009. The physician noted in the chart for the 09-SEP-2009 visit, "The patient reported new onset of seizures since starting GARDASIL". Upon internal review seizures were considered to be an other important medical event. The health care professional contacted during telephone follow-up could not supply the following information: date of event, recovery status, hospital name (if applicable), primary practitioner contact information. Additional information has been requested.  9/28/09 PCP medical records received DOS 8/24/08 to 9/18/09. Patient experienced new onset seizure after Gardasil. Genital warts resolved. Reports Augmentin allergy. Oral contraception. 12/7/2009 and 12/14/2009 ED records for 7/28-7/29/2009 and neuro f/up visit for 7/31/2009. Patient with c/o's confusion, biting the tongue, short term memory loss, headache and difficulty with speech after waking today. Patient had a similiar incident 4/2009 but did not seek tx. Neuro consult in hospital, started on Keppra. Dc Dx seizure disorder/Epilepsy
While sitting in chair in observation area after vaccine was talking on phone to friends and suddenly felt very weak with tachycardia to the 120s, SOB, pre-syncopal, very lightheaded.  Weakness.   No chest pain or tightness.  Waved to the staff,. wanted to lay flat.  They raised my legs and as there was no stretcher available.  Felt heart racing and a sense of doom.  HR settled down after about 3-5 mins.  Tried to stand so staff could get orthostatic BP but could not support my weight.  Remained under observation by the staff for about 45 min.  symptoms improved. Was directed to go to ED for evaluation.   My husband picked me up.
arm was a litter tender; experienced a large area of redness; skin was hot; Vaccination site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a litter tender), ERYTHEMA (experienced a large area of redness), SKIN WARM (skin was hot) and VACCINATION SITE PAIN (Vaccination site tenderness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was a litter tender), ERYTHEMA (experienced a large area of redness), SKIN WARM (skin was hot) and VACCINATION SITE PAIN (Vaccination site tenderness). At the time of the report, PAIN IN EXTREMITY (arm was a litter tender), ERYTHEMA (experienced a large area of redness), SKIN WARM (skin was hot) and VACCINATION SITE PAIN (Vaccination site tenderness) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.  No treatment medication was reported.
Employee experienced a generalized rash to arm and chest/breast area several hours after receiving the 2nd dose of COVID19 vaccine PFIZER. Employee subsequently tested positive for COVID-19 on 01/20/22 and experienced same rash.
Adult dose of Hepatitis A given (1440elu) instead of Pediatric dose of Hepatitis A (720 elu)
left Arm pit lymph node swollen/pain.  Called Primary care for appointment, scheduled for 4/1/2021.