chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 (Lot number: EN6207) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Obsessive-compulsive disorder" (unspecified if ongoing). Concomitant medication(s) included: PAXIL taken for obsessive-compulsive disorder. The following information was reported: DIZZINESS (non-serious) with onset 24Mar2021, outcome "unknown", described as "Dizziness". Therapeutic measures were not taken as a result of dizziness. Additional Information: Patient was wondering, he got the first dose exactly one week ago today and he had no side effects until today, patient noticed one symptom and his job requires to climb up onto trailers and then walk around on trailers and he just noticed today that he had some slight dizziness throughout the day when he was doing that activity and he also do a lot of driving, he did not notice any issues with driving but only when he was climbing up onto trailers which are about 6 feet high off the ground only or get up suddenly from a chair patient noticed dizziness which he never have normally. he was wondering if this is a possible side effect." Consumer stated, he didn't see an expiration date. Consumer stated, he has excellent health.  No follow-up attempts are needed. No further information is expected.
Initial report received from a healthcare professional on 08 December 2008. An adult female patient (age not reported) received a first intramuscular deltoid injection of ADACEL (lot number C3027BA) on 23 September 2008 and the following day, she developed a local reaction described as swelling, fever and sore arm. No diagnostic tests or lab data were performed. The patient received antibiotics and recovered. The patient had previously received an intramuscular left deltoid injection of FLUZONE (lot number U2761AA) on 15 September 2008. No additional details were reported. Follow-up information received 09 February 2009 from a health care professional. ADACEL had been administered in the patient's left deltoid. The injection site swelling was three to four inches across with a hard core at the center. The patient had no illness at the time of vaccination and according to the reporter, the events resolved in approximately 14 days. This patient's case was created as the result of follow-up received for a cluster of six patients. The other five patients were also identified and are recorded in cases 2008-02996, 2008-03924, 2008-03925, 2008-03923 and 2008-03927, all from the same reporter. Documents held by sender: None.
Patient reported pain and numbness in the injected arm/shoulder. Patient also reported itching throughout the body.
He tested positive for the flu on 11/26/22. He was sick for about a week with a fever, cough, congestion, and body aches. He was not prescribed medications, but he was taking over-the-counter MOTRIN and TYLENOL. He is feeling better, but still has a lingering cough and stuffy nose.
localized rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (localized rash) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (localized rash). At the time of the report, RASH (localized rash) 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 provided by Reporter.
Patient states she feels nauseous after receiving vaccine and developed a headache.  b/p 144/76,p-83, R 18, 02 sat 99% Temp 96.1.  After observing patient for 20 minutes patient c/o sever left sided abd pain and was taken to ED for further evaluation
Patient developed a big knot, size of a baseball at the injection site. The whole arm was swollen and red starting day ! after injection. Patient received antibiotics from his PCP two days after injection. Swelling is subsiding as of day 5.
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In 2010, the patient was inoculated with ZOSTAVAX (dose, route, and lot # were not provided) at a medical center for routine adult health maintenance and for the long-term prevention. It was mentioned that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015, the patient was treated in a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. At the time of the report, the outcome of the aforementioned adverse events was unknown. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related.
Rash Onset a couple of weeks ago, back and abd itchy rash Right arm back side rash First thing he noticed was his forehead, he made an appt with dermatology Explained to pt it would be harmless to treat for scabies and may be very helpful Has had both of the Moderna COVID vaccines with public health, 1st dose February 9th, 2021 right arm (lot # 043L20A) and 2nd dose, March 9th 2021, left arm (lot # 002A21A). Rash developed February 20th, 2021 and persisted despite benadryl, topical benadryl cream and hydrocortisone cream.  It got worse after the second vaccine If he eats any spicy food it will make the rash worse pt states he told the nurses at health department and they replied that it is common after the Moderna vaccine and that there was nothing they could do. Physical exam Skin: Papular rash, some areas excoriated, involving bilateral arms, chest, abdomen, and back. Some areas of linear papules on back of right upper arm just above the elbow. Some variation of color on the skin base, some pink and some greyispurple areas. Pt did not note this. The left lateral ankle has a well healed surgical scar. There is a rough looking dry rash approx 10x12cm patch. Base is dry and red. Some silver scaling appearance. Also, papular flesh colored lesions across forehead.
Shot given 9/29/14. Noticed redness, left thigh swollen an warm on 10/1/14. Child seen in office on 10/2/14 because area gotten larger. Treated with ORAPRED. F/u on 10/3/14 child doing better -getting smaller.
10 days after injection pain recurred in left arm followed by itching and rash then 2 days of fatigue on 1/29 (approx 3 weeks post injection) i developed numbness and neuropathic pain on the right side of my face and scalp and was diagnosed with shingles
Vaccinations Hep A and Dtap given at 4pm 10/9/07 running fever 101.6 and left arm where DTaP given sore
1st 2 doses: sick for 3 days; headache was tolerable; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (1st 2 doses: sick for 3 days) and HEADACHE (headache was tolerable) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction NOS (Allergic to almost everything (did not specify)). Concomitant products included RIVAROXABAN (XARELTO) and LEVOTHYROXINE for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ILLNESS (1st 2 doses: sick for 3 days) and HEADACHE (headache was tolerable). In January 2021, ILLNESS (1st 2 doses: sick for 3 days) had resolved. At the time of the report, HEADACHE (headache was tolerable) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient concomitant medication include Supplements and Cholesterol medication. No treatment information provided for dose 1.   This case was linked to MOD-2021-317412 (Patient Link).
Patient was given wrong vaccine.  She was to receive a HPV but was given Prevnar20.
prolonged crying episode 5-6 hrs; parent stated jerking motion by pt while sleeping, warm to touch, but temp not taken; APAP given p/immun;
Post vax the injection site has erythema, swelling and is tender. The site has remained swollen and tender for 3 days.
Patient presented in Employee Health Services c/o intense itching and feeling like she was wheezing. BP 154/83, HR 101, RR 24. Taken to ER by wheelchair with 2 lpm O2. According to records patient received: BENADRYL 25mg IV, Albuterol Nebulizer, TOPROL XL 100 mg po, MEDROL 4 mg tab po, EPIPEN 0.3/0.3ml IM, SOLU-MEDROL 125mg IV, and PEPCID 20 mg IV. Discharged home with MEDROL DOSEPAK and EPIPEN. Also instructed to continue BENADRYL po.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Joint Pain-Severe, Additional Details: Pt presented to pharmacy where received COVID-19 vaccine on 5/18/21, 5 days after vaccine was administered and 3 days after pt states symptoms began. States he "can hardly walk", complains of severe persistent pain in R hip, as well as chest and groin pain that has gone away. Pt wanted to be seen by NP, but NP was unable to see him. Pt states that he has no primary healthcare provider.
Information has been received from a physician concerning a 36 year old female patient who on 25-JAN-2011 was vaccinated with a dose of PNEUMOVAX 23 (Expire date and route not reported). On 26-JAN-2011 at 14:00, the patient developed a fever of 104 to 105 degrees farenheit. The patient returned to the clinic on 28-JAN-2011 and was experiencing body chills. It was also documented that the patient had a local reaction at the injection site that was 10x10 centimeters. Patient was given an intravenous bolus for dehydration as well as intravenous fluids and SOLUMEDROL as well. On an unspecified date, a flu test was performed and result was negative. Therapy with PNEUMOVAX 23 was discontinued. At the time of the report, patient had improved after stopping therapy (also reported as unspecified present status). Follow up information has been received from a Registered Nurse, concerning a 36 year old female Registered Nurse with no known allergies, asthma, gastrooesophageal reflux disease (GERD) and hypothiroid no known drug allergies and no illness at the time of vaccination, who on 25-JAN-2011 in the morning was vaccinated intramuscularly in the right deltoid with the first dose of PNEUMOVAX 23. Concomitant therapy included a dose of ADACEL (Lot #C3518AA) administered on 25-JAN-2010 in the morning, intramuscularly on the left deltoid. The nurse reported that on the next day (on 26-JAN-2011) at 13:00, patient started having body aches, then temperature raised to 105 farenheit degrees, severe body aches, local reaction noted to right arm, redness, pain, swelling (10 x 10). Ran temperature for 48 hours. On an unspecified date, patient had 2 flu swab test performed and results were negative. On an unspecified date, patient had fluid bolus at clinic and was given 80 mg of intravenous SOLUMEDROL. At the time of the report, patient had recovered from severe body aches, temperature raised to 105 farenheit degrees, local reaction noted to right arm, redness, pain and swelling. The events required medical/surgical intervention. Additional information has been requested.
vaccine given to 4months old infant with no reported adverse event; Initial information received on 28-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional via Media Information (under the reference 00832918).  This case involves a 4 months old male patient whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] given (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) (Lot number and expiration date not provided) for Prophylactic vaccination.  On 26-Oct-2021, the patient received a dose of suspect FLUZONE QUADRIVALENT (0.5 ml, once, total, Solution for injection, lot UT7378KA and expiration date: 30-Jun-2022) via intramuscular route in the right thigh for Prophylactic vaccination.  It was an actual medication error due to Inappropriate age at vaccine administration (same day latency).  It was reported "Caller states that the nurse in question is not available today and that they are not sure why this vaccine was given to a 4 month old. Caller asked if there was any information available as far as what side effects to be looking for or any precautions that should be taken so that they could inform the patients parents."  At time of reporting, the outcome was unknown for the reported 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 the 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.
Patient went to restroom shortly after receiving both the moderna booster and flu vaccine, had to sit down, and was complaining of severe rectal pain. Paramedics were called and patient's symptoms eventually went away. Patient did not end up going with paramedics to the hospital and went home instead.
Patient reported having redness and swelling for a few days after getting Fluzone HD vaccination. Large area of bruising appeared afterward on the deltoid muscle around the injection site. Bruising did not subsided 7 days after vaccination, though it appears more purplish. She has no fever or flu like symptoms. She is otherwise alert without fever, without pain, and without flu like symptoms.
Narrative: Timing ERROR only, 2nd dose given too  soon (16 days) after 1st dose
This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported.  It was  unspecified whether the patients had sought any medical attention. There was no product quality complaint involved.   Follow up information has been received from office manager, who stated she may call back for fax information as it become available. Also, reported that M-M-R II was not mentioned in the original call, but did experience a temperature excursion. No further information was available at that time.   Follow up information as received from a  healthcare processional refers to a 15 months old patient. On 25-JUN-2014 the patient ws vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # J013907, expiration date 30-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of the several reports from the same source.  Additional information has been requested.
Error by vaccine administration nurse, 0.2 mL given by nurse on 3/2/21 at clinic. Client was called at 4:22 pm and did not answer. Voicemail explaining situation with call back number was left.
mom described redness & swelling @ inject site & considerable crying; states that pt quit crying abruptly, stared off into space, shook a little bit, then cried some more;
Information has been received from a physician concerning her daughter who was vaccinated with the first  doses of Gardasil. Subsequently the patient experienced joint pain the following day on both occasions. Unspecified medical attention was sought. The physician indicated that each time the pain went away after one day. No product quality complaint was involved.
chills, headache, severe body aches, diarrhea, throwing up and nausea
Hospitalization: 3/4/2023 - 3/9/2023 (5 days) Presentation to the ED: shortness of breath COVID + date: 3/4/23 Treatment: remdesivir, steroids Discharge to: home.  012M20A 1/28/2021 002A21A 3/1/2021
vomiting, diarrhea, fever, headaches, huge red mark tht became sore and itchy
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 35-year-old female patient received BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing), notes: Hashimoto's disease; "Osteopenia" (unspecified if ongoing), notes: Osteopenia. Concomitant medication(s) included: SYNTHROID taken for autoimmune thyroiditis; VITAMIN D [COLECALCIFEROL] taken for osteopenia; CALCIUM taken for osteopenia. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Dec2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: COVID 19 Treatment, patient took Paxlovid. As nurse stated that "It was the Pfizer (Pfizer COVID-19 Vaccine)." Nurse stated that the last one, Pfizer FJ6120. There is a date but that is not the expiration date. When asked if it was the Pfizer Bivalent COVID-19 Vaccine or Pfizer COVID-19 Vaccine, Nurse stated, "she was not sure. She thought it was just the Pfizer one (Further not clarified, hence suspect captured as Pfizer COVID-19 Vaccine and captured as conservatively)." When asked if the nurse missed the second booster shot, Nurse stated, "Yes that she didn't took the second booster." She took Vitamins as prescribed because she had Osteopenia, Vitamin D and Calcium. Regarding lab data she was not sure. She had one last month and she was not sure what time exactly. In last 2 weeks and another one on December 2.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Multiple recurrent episodes of supraventricular tachycardia noted on 09/28/2021, 10/22/2021, 12/15/2021, 02/21/2022, 03/09/2022 x 3 episodes
Head ache, muscle aches, very sore at site of injection, chills and fever, redness and soreness at arm pit opposite injection site.
MMR 2/18/2004. Body aches, fever 8 days later some fatigue for 2 days. No URI symptoms. Rash 1 degree of  face/neck papular and confluent. No vesicles began on 2/28/04 with increased confluence of 3/1/04. Mild itch only feels well by 2/28/04 except for rash.
PATIENT PRESENTED FOR EXAM. PATIENT/DAUGHTER COMPLETED FORMS NOT STATING PATIENT WAS ON ANTI-REJECTION MEDICATIONS AND WAS BEING FOLLOWED FOR A RENAL TRANSPLANT. PT RECEIVED MMR PER PROTOCOL. TO DATE PATIENT HAS NOT HAD ANY REACTION. PATIENT'S TRANSPLANT DOCTOR HAS BEEN CONTACTED AND IS ADJUSTING MEDICATION AND FOLLOWING PATIENT. PATIENT HAS BEEN SEEN ON OUR CLINIC 01/25/21 AND HAS NO SYMPTOMS OR FINDINGS.
Fatigue; Headache; Chills; Fever; Sore arm; This is a spontaneous report from a contactable consumer (Patient). A 74 (units unspecified) female patient of an unspecified age received bnt162b2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration on 22Apr2021 as dose 1, single and bnt162b2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration on 13May2021 as dose 2, single for COVID-19 immunization. Medical history included blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medications included olmesartan taken for blood pressure measurement, start and stop date were not reported (dose was not clarified. Reporter think it was 40-25 mg). After the first and second dose the patient experienced fatigue, headache, chills, fever and sore arm on unspecified date in Apr2021. Reporter wanted to report it, but she wanted to report it to someone who was going to have records with CDC, and she guess that you don't have that. You do not report to CDC. Pfizer does not report the side effects to the CDC. Lab tests was not provided, but reporter saw her doctor after all this. Patient did not receive any treatment for events. Reporter stated that she was not having any problems (not clarified further). The outcome of the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.  Follow-Up (21Jul2021): Follow-up attempts are completed. No further information is expected.
A spontaneous report was received from a consumer, who was a 63-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dry mouth, pain at vaccination site, swelling and redness at the vaccination site that travelled up to her neck, heat, headache and fatigue. The patient's medical history, as provided by the reporter, included immune disorders. Concomitant products reported included ascorbic acid, gentiana lutea root, primula spp. flower, rumex acetosa, sambucus nigra flower and verbena officinalis herb, valaciclovir hydrochloride, rosuvastatin calcium and hormone replacement therapy. On 14 Feb 2021, the patient received second dose of mRNA-1273 (Lot number: 010M20A) intramuscularly for prophylaxis of COVID-19 infection. On 14 Feb 2021, immediately following administration, the patient experienced dry mouth sensation and pain at the vaccination site. On 15-Feb-2021, a day after receiving the second dose of vaccine, the patient experienced some swelling and redness at the vaccination site that extended to her neck following which the patient felt vaccination site heat. On 17 Feb 2021, three days after receiving the vaccine, the patient experienced headache and some fatigue. Treatment of the events included Tylenol and application of ice pack. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, dry mouth, pain, swelling and redness at the vaccination site that travelled up to her neck, heat, headache, fatigue, were considered unknown on 18 Feb 2021; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded