chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case linked to 2018SA388039 (cluster). This case involves a three years old male patient (98.425 cm and 15.238 kg) who received IPV (VERO) [IPOL] lot N1K921M, expiry date: 14 Nov 2019 via intramuscular route in unknown administration site on 15-Nov-2018 which was exposed max temp of 10 c for three hours one min. The patient's past medical history included Iron deficiency. It was also reported that, the patient had no known drug allergy. The patient's past vaccination(s) included BCG VACCINE. The patient's past medical treatment(s) and family history were not provided. Concomitant medications included 15 mg FERROUS SULPHATE [FERROUS SULFATE] for iron deficiency (PO) on 12 Apr 2018. It was actual medication error due to incorrect product storage. It was reported that the patient received the vaccine which was out of the acceptable temperature range. It was reported that the patient did not experienced any adverse event. It was also reported that, the patient did not need to be revaccinated. 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. Follow up information received on 04-Dec-2018 regarding an unsolicited non-valid non-serious case received from a physician. No new information updated. Follow up information was received on 04-Dec-2018 received from a physician. Patient details, patient history details, concomitant medication, product details were updated and adverse event description updated along with linked case. List of documents held by sender: none.
This was an administration error rather than adverse event.  RN who provided the patient the vaccine first poked patient with empty syringe, then had to draw up an actual dose and re-administer.
No additional AE information; LPN calling for stability data on vaccine that has been administered past expiration date.; This spontaneous report was received from a Licensed Practical Nurse (LPN) referring to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 30-APR-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, (strength, dose, frequency, and route of administration were not provided); which lot # T035721 has been verified to be a valid lot number with expiration date: 15-APR-2022, and was administered as prophylaxis. The reporter was calling for stability data on vaccine that had been administered past the expiration date (expired product administered). When asked about prior temperature excursions, was transferred to the person who was in charge of vaccine storage, and she confirmed that the expired administered vaccine was never stored at a temperature outside of its recommended storage range. No additional adverse event (AE) information. No product quality complaint (PQC) involved.  This is one of several reports received from the same reporter.
After 1 week of receiving the vaccine, I woke up with my arm red, warm, swollen and itchy. It had become that way on the 3rd day but had  resolved. It has now resolved.
side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effect) in a  patient of an unknown age and gender 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 VACCINATION COMPLICATION (side effect). At the time of the report, VACCINATION COMPLICATION (side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Pain and swelling at injection site. Red circular "rash" that is warm to the touch at injection site. Began 8 days after 1st dose. Continues on day 9.
mom states dry cereal & apple juice for breakfast @ 730MA; 3 episodes of vomiting & 2 episodes of diarrhea stools from 8AM until 1030AM;
9 pound weight loss; loss of appetite; loss of energy; can not stand odors; nausea; This case was reported by a consumer via call center representative and described the occurrence of weight loss in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th April 2019, 10 days after receiving Shingrix, the patient experienced nausea, loss of energy and hyperosmia. On 18th April 2019, the patient experienced appetite lost. On an unknown date, the patient experienced weight loss. The patient was treated with ondansetron. On 14th May 2019, the outcome of the appetite lost was recovered/resolved. On an unknown date, the outcome of the weight loss, nausea and loss of energy were not recovered/not resolved and the outcome of the hyperosmia was recovered/resolved.   The reporter considered the weight loss, nausea, appetite lost, loss of energy and hyperosmia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The consumer stated that she received Shingrix and 10 days later developed nausea, loss of energy, and could not stand odors.  On 18th April 2019, 17 days after receiving a dose of shingrix,she lost her appetite. On 23rd April 2019, the patient went to Urgent Care. On 2nd May 2019, the patient visited the physician (MD). On an unknown date, unknown after receiving a dose of shingrix, she lost 9 lbs. The reporter stated that she had a head to stomach computed tomography (CT), endoscopy, gall bladder scan, and numerous blood tests, all results were within normal limits.  She stated that the MDs ruled out everything except for a reaction to the Shingrix vaccine.  The reporter stated that she was treated with two anit-nausea medications. The nausea and lack of energy persist. The loss of appetite resolved and the not being able to stand odor resolved. The reporter consented to follow up. Emergency room visit required. The consumer did not have the vaccine information for this adverse event.      Lab Comments: on unknown date patient had a head to stomach CT, endoscopy, gall bladder scan, and numerous blood tests, all results within normal limits
Information has been received from a RN concerning a 9 yr old white female, with known pre-existing allergies, birth defects, and medical conditions reported, who on 03Feb00 was vaccinated with a first dose of varicella virus vaccine live (route and lot #unk). There was no illness at time of vaccination. There was no concomitant medication. On 23Mar05 the pt experienced rash on trunk, legs, ears, chin. It was also reported that the pt was very itchy, a couple have crusted over, and exposed approx 2 wks ago. Subsequently the pt recovered on 01Apr05. No relevant diagnostics and lab studies were performed. Additional information has been requested.
Moderate  pain and swelling  pain in right shoulder at injection site.   Extreme tiredness, Fever (100), chills,  headache
Fever, Nausea Vomiting, fatigue Narrative: Low grade fever, fatigue, nausea, brain fog stared on day of vaccine, continued the next day. Taking Tylenol OTC.
17 days post vax, the pt developed a red rash on scalp and face. The next day the rash had spread to trunk. Papules appeared "reddish purple". Temperature was 99.4. Swelling of hands, feet, and perineal area. Treated with Benadryl and Albuterol breathing treatment as a preventive measure.
Patient scheduled for Pfizer dose #2. Upon entering room MA confirmed patients name/DOB/Pfizer #2 the patient answered all questions. Patient was asked for her vaccine card, stated she washed it in her pants. MA proceeded to draw up Pfizer, while another MA created the patient a new vaccine card. MA administered vaccine, while the other MA was creating card upon looking up the vaccine information for the patients first dose. MA realized the patient received Moderna 3 wks prior, MA immediately consulted with a provider.  We discussed the anticipated side effects for both mRNA vaccines and there are no additional concerns regarding getting mixed mRNA vaccine series. We also discussed for her to sign up for Vsafe and that PCC will be submitting a VAERS report. In addition I will be having a conversation with Public health to see if additional recommendations are needed at this time. Patient felt more assured at the end of the conversation and all questions answered.
Patient received the Pfizer vaccine. Patient left to sit in out waiting room after vaccine. Patient's mother informed in a few minutes that the patient was not feeling well. She stated that the patient felt hot. I grabbed an ice pack on my way out to her. I put the ice pack behind her neck. Patient passed out within a minute of me getting to the patient. She came back to quickly and stated that she was having a hard time seeing and hearing. She then again passes out. At this point I made the decision to call 911. I delegated to my tech to call 911.  She called 911.  I asked my other tech to come help me thinking the patient my have needed to be lower to the ground. The patient again regained consciousness.  At this point I asked tech to call our Store Director and inform them. I also asked that she get me a water for the patient. The patient was feeling better and drank some water. She then again passes out. This time we were struggling to get her to regain consciousness. I used sternal rubs to help the patient regain consciousness. I was having a hard time finding her pulse. This lasted for a minute or two and then she stared responding. Right then EMS arrived and took over. I gave them the information I had and they took her vitals. EMS decided that she was stable and could go home to be monitored by mom. I did call the Mother the next morning to check on the patient. The patient did well last night and was feeling good this morning.
This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 64-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site itching. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site itching were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient had local reaction included injection site area was very red and itchy with mild swelling about 6 to 8 inches in diameter.
Mom called on 10/21 and reported that patient experienced a patchy, red rash on the palms of her hands following administration of the flu shot.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 23-NOV-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Patient was given both the Meningococcal and HPV vaccine. Within several minutes he passed out and had a seizure. Seizure lasted approximately 1-1.5 minutes. He lost consciousness and awareness, was rigid and shaking, not coherent and unable to control body. Once he seizure stopped he was dizzy, had a headache that was localized to the right side, the same side as the arm that got the shot. Headache went away by morning, but is left feeling tired and slightly dizzy.
Pt came to clinic and dr ordered tetanus shot.  I administed infanrix instead of the adult adacelle.  Patient was not hared at time of vaccination.
Patient came to get menectra vaccine but was administered expired vaccine, after  it was realized that the vaccine was expired , the patient contacted and no adverse effects were reported.
OBJECTIVE Physical Exam EXTREMITIES: R arm: large red indurated area over mid upper arm over tricep muscle.  Gardasil injection site was cephaled to the affected area. Duration 72 hours. Treatment: Ice to affected area and Ibuprofen 400 mg every 4-6 hours as needed for discomfort.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 39-year-old male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On 20 July 2006, 19 August 2006 and 26 January 2007 the subject received 1st dose, 2nd dose and 3rd dose of Engerix B (20 mcg, intramuscular, right and left deltoids).  On 11 April 2007, 75 days after the 3rd vaccination with Engerix B, the subject had a titer drawn which was negative for immunity against hepatitis B.  At the time of reporting the outcome of the event was unspecified.  This case was reported by the same reporter in junction with another case of a subject not responding to therapy, case ID A0655093A.
Oxygen saturation dropped from 98% to 68% within 1 hour of administration of vaccine and 90% 14 hours later. In previously stable baby.
I had continued headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 10:30 (Lot number: EN0158) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy: avocado, melon/cantelope" (unspecified if ongoing), notes: Allergy: avocado, melon/cantelope; "Allergy: raw spinach, eggplant, zucchini" (unspecified if ongoing), notes: Allergy: raw spinach, eggplant, zucchini; "Allergy: dill" (unspecified if ongoing), notes: Allergy: dill. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8721, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 19Mar2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "I had continued headaches". The event "i had continued headaches" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of headache.  Additional information: Facility the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
The patient seemed stable and was not experiencing any acute adverse events within the 30 minutes she was being observed post vaccination.
After getting the flu shot, my arm swelled up, was very warm to touch, red and very painful. I also experience vomiting and diarrhea. Injected on the 20th - swollen next; diarrhea & vomiting started the evening, chills during night (no ) lasted 24 hours. Staff did not lose work.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE HYPOXIA
A report has been received from a Pharmacist concerning a patient of unknown gender, who received nasal FLUMIST Quadrivalent, 0.2 milliliters. Pharmacist administering the vaccines had noticed that when administering the first half of the dose to a patient, there has been dribbling of liquid out of the nostril of the patient, but upon delivery the second half of the vaccine dose to the patient in the other nostril, there has been less dribbling of liquid after administration. It was unknown whether the patients were receiving the full dose of vaccine. Also reported product quality complaint. Action taken with FLUMIST Quadrivalent was unknown. The outcome of when administering first half of dose to patient there has been dribbling of liquid out of nostril of patient, but upon delivering second half of vaccine dose in other nostril there has been less dribbling of liquid after administration, unknown whether the patients are receiving the full dose of vaccine and product quality complaint was unknown. The report was considered to be non-serious by company physician.
Information has been received from a health professional concerning a 5 yr old white male child with no medical history, who on 10Jul01 was vaccinated IM in the left arm with the first dose of varicella virus vaccine live (Lot 638490/1900K). Concomitant vaccinations given on the same day included: the first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 638605/0252L) given IM in the right arm and the second dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) (lot479792) given in the left arm. It was unk if there was illness at the time of vaccination. On 17Dec05 the pt developed a fever and on 19Dec05 red bumps appeared. The pt continued breaking out with lesions on his belly, back and legs through 21Dec05, when the pt's mother called the office. Breakthrough chickenpox diagnosed. No lab or diagnostic tests were performed. The child stated that these both itch and hurt. Subsequently, the pt recovered from breakthrough varicella. The RN also reported that two of the pt's siblings developed adverse events following vaccine administrator (WAES numbers: 0601USA03298 and 0601USA03299). Additional information is not expected.
Fever increased 105 within 24 hours and febrile seizure x 2 within 24 hours.
pt recv vax 21OCT96 & 23OCT96 pt devel swelling & heat in arm from elbow to the inj site & exp pain in arm pit;
This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 66-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included hepatitis C (previously diagnosed) and neuropathy (in 2015). Previously administered products included Unspecified medication with an associated reaction of paraesthesia (in 2015, three years ago, she was diagnosed with neuropathy from a neurologist within eight hours after receiving another medication and she experienced needles and pins but the side effects resolved). Concurrent medical conditions included drug hypersensitivity (according to her rheumatologist). In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a month after receiving SHINGRIX, the patient experienced influenza like illness. On an unknown date, the outcome of the influenza like illness was recovered/resolved. It was unknown if the reporter considered the influenza like illness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination could be 65 or 66 years. The patient had 3 glucose tests in the past 3 years that came back in the normal range. Three years before the reporting date, she was diagnosed with neuropathy from a neurologist within eight hours after receiving another medication and she experienced needles and pins but the side effects resolved. After receiving 1st dose of SHINGRIX, the patient felt like she had the flu and she was in bed for one week. The patient claimed that she was very thin and active. The patient refused to answer any questions regarding her experience. The patient had denied permission to contact their physician. For tolerance to next dose, refer case US2018164372.
I started to feel light headed extreme fatigue and slept all the time. When I drink water I got a metallic taste. I started to get more tired. Last Saturday 04-30-2022, I was light headed, temperature was 99.0F and the next morning I was fine. I bought couple COVID-19 tests, both were negative. I got at home UTI test and it was negative. I called the doctor because my temperature was 100.6F in the evening and she sent me to get tested for strep and Flu A and both were negative. I also have allergies. The tiredness is not as bad today, fever is gone, color of sinus drainage is lightened and I will be going to work today. I am still on antibiotics Amoxicillin for ten days.