chrisvoncsefalvay/vaers-outcomes huggingface dataset:
neck felt sore on the side of injection; Metallic taste; numbness in back of mouth; lump feeling in throat; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste), HYPOAESTHESIA ORAL (numbness in back of mouth), SENSATION OF FOREIGN BODY (lump feeling in throat), OROPHARYNGEAL PAIN (sore throat) and NECK PAIN (neck felt sore on the side of injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 8025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to vaccine. Concomitant products included LOSARTAN POTASSIUM (COZAAR), ALDOSTERONE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DYSGEUSIA (Metallic taste), HYPOAESTHESIA ORAL (numbness in back of mouth), SENSATION OF FOREIGN BODY (lump feeling in throat) and OROPHARYNGEAL PAIN (sore throat). On 03-Mar-2021, the patient experienced NECK PAIN (neck felt sore on the side of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. On 02-Mar-2021, DYSGEUSIA (Metallic taste), HYPOAESTHESIA ORAL (numbness in back of mouth), SENSATION OF FOREIGN BODY (lump feeling in throat) and OROPHARYNGEAL PAIN (sore throat) had resolved. At the time of the report, NECK PAIN (neck felt sore on the side of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Nose bleed on March 3, 2021.  Rested all day after with pressure on nose.  Unusual event for me.
Patient was experiencing aches and chills prior to arrival, did not inform pharmacy staff or note on form.  After receiving vaccinations, chills worsened and patient began running a fever of greater than 100 degrees.  Later that evening hives began to form on trunk and progressively got worse until patient's entire back was completely covered in a rash. Patient's wife also noted slightly higher HR of 94 bpm (normal for patient is 60 bpm).  Next morning (11/28), in addition to fever and hives,  patient was described as dizzy, weak and confused by wife, who called the pharmacy.  Recommended they go to the ER immediately.
SORE THROAT AND NASAL CONGESTION APPROX 24 HRS AFTER RECEIVING VACCINE. SYMPTOMS LASTED APPROX 48 HRS
Pt vaccinated with diarrhea, fever, injectin site pain, nausea, sorethroat, aches, congestion.
Information has been received on 04-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age and her spouse. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 22-AUG-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, on or about 10-SEP-2016, the patient presented to a physician with complaints of a painful, itchy rash, along with other symptoms. The patient was evaluated and diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Infant nursing on left breast in semi-reclined position. His whole body began trembling with small jerky movements. Attempted to stimulate by calling name and stroked but no response (eyes were closed during episode). Stopped nursing. Entire event lasted 15-30 seconds, then he started nursing again.
3/7/2021 7:00 AM - Experiencing weakness, fatigue, chills, nausea, chest pain upon inhaling, rashes on other parts of the body.   3/8/2021 Experiencing sore throat, weakness, fatigue, headache, migraine, dizziness, brain fog, nausea, decrease in appetite, and rashes on other parts of the body.
Breakthrough case of COVID, I had a very sore throat, running nose, pretty serious cause which caused like spasms in my throat, I was having episodes of coughing where I could not stop coughing, and very fatigue. Still have a bit of shortness of breathe and a little cough but everything is back to normal.
Patient was given wrong covid booster schedule (5-11yo) when pt should have been given on the 12+ vaccine. Error was reviewed with staff and education was conducted. Vaccine workflow was redesigned to ready reviewed with the staff ? 5-11  years olds may not go to the toddler area, even with a sibling  ? New signs placed in both Pfizer & Moderna room with ?Birthday must be on or after this date in _______ (appropriate year)?  ? Registration is not to partially fill out white cards for 5-11 year olds
Immediately following administration of vaccines, client became pale, hot, and dizzy. BP 74/40. Had client place head between knees, cold pack applied to back of neck, juice given. 10 minutes later BP 90/72, HR 62. Client escorted by RN to another room to rest and have another juice. Health aid remained with client. BP 118/78 15 minutes later. Client felt fine, color back in face, no longer hot or dizzy. Client driven home by her friend.
A minute after getting the shot, I felt dizzy and faint. I after telling the person I was with that I felt as if I were going to pass out, I did pass out. It was difficult to breathe. It was roughly 5-10 minutes before I came to with paramedics surrounding me. I still felt faint and dizzy when I came to. I was sweating and my whole body felt like it was fuzzy and vibrating. After 10minutes of being awake, I finally felt better.
Shock-like pain in shoulder, neck, head, and chest lasting 1-2 minutes, occurring multiple times per day. Also c/o cramping pain in stomach. Symptoms developed approx 1 week after vaccines were administered.
Narrative: COVID infection following COVID vaccine series 03/09, Pfizer, dose #1 03/30, Pfizer, dose #2 10/15, Pfizer, dose #3 08/11 09/18 COVID swab, result: detected NON-FACILITY 09/17 ESR 4 09/18 COVID swab, result: detected 09/18 pt cc: exposure: unknown 09/19 clinically resolved
Hospitalized for COVID 19 and diverticulitis, abdominal pain no COVID infection symptoms Remdesivir x t days, dexamethasone x 10 days.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age. Concurrent conditions and medical history of the patient were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored doses of GARDASIL (lot# K007264, expiry date 02-MAR-2017; lot# K007828, expiry date 02-MAR-2017, lot# K009482, expiry date 06-MAR-2017; lot# K010215, expiry date 05-MAY-2017, lot# K010574, expiry date 08-APR-2017; lot# K011562, expiry date 08-APR-2017, lot# K023432, expiry date 08-JUN-2016) (dose, route unspecified). Concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
About three hours after receiving the shot I had arm pain around the injection site. About nine hours after receiving the shot I had a low grade fever, chills, a headache and body aches. These symptoms persisted for about 12 hours. I took Motrin and Tylenol and the symptoms improved.
HEART DAMAGE; This spontaneous report received from a patient via a company representative via a social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced heart damage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart damage was not reported. This report was non-serious.
Information has been received from a mother concerning her 14 month old daughter with no allergies and not medical history, who in "September 2004", was vaccinated with 0.5 ml of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. There was no concomitant medication. The mother reported that "soon after receiving the shot", her daughter became sick for "about 2 weeks", which was described as nausea, fever and a case of the measles. It was reported that the adverse events improved and the patient recovered. There were no laboratory studies completed. There was no product quality complaint reported. Follow up information was received from a physician concerning a 14 month old female with a milk intolerance and a history of allergy testing on 07/01/05, in an allergists office, who on 08/19/04 at 13:58 PM was vaccinated subcutaneously in the right leg with a first 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot # 648461/1306N). Concomitant vaccine therapy administered on 08/19/04 at 13:58 PM included a fourth dose of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (Daptacel) (lot # C169AA) administered in the left leg and a second dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (Lot # 648823/0240P) administered in the left leg. It was noted the patient was not ill at the time of vaccination and had not had averse events following prior vaccination. The physician reported that on 08/27/04, the patient experienced fever and swollen glands in the neck. On 09/22/2004, the patient's fever continued, she had irritability, was not sleeping, had congestion, cough and a mouth blister. On 09/24/004, she developed a rash, fever continued and pruritus. Follow up information reported that the patient was seen again on 09/23/04 for fever. It was mentioned that the patient had possible hand, foot and mouth virus. It was noted that the patient recovered on an unspecified date. The patient sought unspecified medical attention. Additional information has been requested.
PAINFUL INJECTION SITE/ARM WEAKNESS LASTING GREATER THAN 1 WEEK
Patient received 2nd dose of SHINGRIX 2/1/19 and called the pharmacy 2/2/19 with complaints of red sore egg-sized spot at the site of injection.
Initial unsolicited report received from a physician on 20 August 2015. An 11-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of MENACTRA (batch number U4847BA) and a dose of ADACEL (batch number C4697AA, expiration date 19 February 2017) (dose, route and site of administration was not reported for vaccines) on an unspecified date. On an unspecified date after vaccination, the patient fainted. Patient was sent to the hospital for precautionary measures and to be monitored. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of event was unknown. Documents held by sender: none.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with the ZOSTAVAX vaccine at a hospital as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In-2016, the patient was treated at a hospital for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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 will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient came in 7 days after receiving 2nd Moderna COVID-19 complaining of excruciating neck pain.  She received this dose at 11:15 am 6/3/2021 and by that evening was experiencing chills, fever, nausea, swelling and pain in right arm in injection site.  The fever and chills subsided in a few days but the pain travelled up to her neck.  I called her primary care provider, and his office will reach out to her as she wants to be seen on 6/10/2021 by her primary care doctor.
I noticed blurred vision the next week while I was at work.  I went optometrist the beginning of the year 1/2/23 to see what was going on and they sent me to ER to rule out stroke and retinal artery inclusion.  ER did MRI and ekg ruled out stroke on 1/2/23.  Ophthalmologist looked at eye on 1/3/2023 and diagnosed retinal vein occlusion.  Vision is still blurred as of 01/16/2023 and return visit to Dr. is scheduled for 01/17/2023 - Dr.
PATIENT CALLED THE PHARMACY AND REPORTED A RASH ON THE ARM THAT SHE RECIEVED THE VACCINATION. SHE WAS COUNSELED THAT THIS IS A COMMON SIDE EFFECT, AND TO TRY A ANTIHISTAMINE TO HELP RELIEVE THE REACTION. THE NEXT DAY I FOLLOWED UP WITH PATIENT AND SHE SAID THAT THE RASH WAS BEGINNING TO DISAPEAR.
Redness, swelling, had lump in area of L upper deltoid, redness and bump have gone away, but still small area of hard bump inside muscle area where immunization was administered. Today redness is gone, hard skin.
swollen lymph nodes (lymphadenopathy) in left arm pit (arm of injection), swollen breast area,, lump in arm pit; sore
Immediately after Pt received second vaccine:  Twinrix, Her head went forward towards knees. Pt was returned to sitting position and regained awareness. States she had not eaten all day- (late afternoon)
following the administration of 1st vax, that evening pt cried unconsolably for 3 hrs; pt was taken to ER where was observed for an hr & given some pain reliever & sent home w/mom;
I had fatigue and tiredness. Also, my lymph nodes in my left arm became swollen and sore. It hurts to move my arm around a little bit, but I was still able to perform normal task. I went to see a certified lymphatic RN. She did a drainage lymphatic treatment. I see her once a month. I no longer have any more pain in my arm.
?Vaccine arm? - raised red rash covering the injection site, accompanied by soreness in the shoulder.
adult dose of Havrix instead of the pediatric dose; adult dose of Havrix instead of the pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 7-year-old female patient who received HAV (Havrix adult) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device injection syringe for prophylaxis.   On 10th September 2021, the patient received the 2nd dose of Havrix adult and hepatitis A vaccine pre-filled syringe device. On 10th September 2021, unknown after receiving Havrix adult and hepatitis A vaccine pre-filled syringe device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a AMAS (unspecified). Health care professional reported that the patient received adult dose of Havrix instead of pediatric dose, which led to overdose, and adult product administered to child. The reporter consented to follow up. This case had been linked with US2021080764, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021080764:Same reporter
Fever 101.4, chills, extreme fatigue, slightly nauseous, leg cramping at night. This lasted 2 full days.
Immediate burning down my left arm to finger tips lasting 3 hrs after injection. Experienced massive headaches for 4 months after injection, requiring self dosing up to 1G of Tylenol q 6hrs each day to control. Current nerve pain in extremities.
Weakness; Stomach cramps; Severe vomiting; Joint pain; Injection arm (right arm) is very painful; Severe headache; High fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), ABDOMINAL PAIN UPPER (Stomach cramps), VOMITING (Severe vomiting), ARTHRALGIA (Joint pain) and VACCINATION SITE PAIN (Injection arm (right arm) is very painful) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from February 2020 to March 2020, Lung disorder NOS from February 2020 to March 2020 and Tendon repair. Concurrent medical conditions included Asthma and Oxygen saturation low (currently receiving breathing treatment).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced ASTHENIA (Weakness), ABDOMINAL PAIN UPPER (Stomach cramps), VOMITING (Severe vomiting), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (Injection arm (right arm) is very painful), HEADACHE (Severe headache) and PYREXIA (High fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness), ABDOMINAL PAIN UPPER (Stomach cramps), VOMITING (Severe vomiting), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (Injection arm (right arm) is very painful), HEADACHE (Severe headache) and PYREXIA (High fever) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable   This case was linked to MOD-2021-074897 (Patient Link).
This spontaneous report as received from a Health care worker refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-NOV-2015, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # K010442 EXP date: 22-JUL-2016) (dose, route, therapy type not reported). No adverse symptoms were reported. This case is one of two reports received from the same reporter. Additional information has been requested.
2-4 hours after receiving Anthrax vaccine, pt felt severe pains in neck and trapezius muscles. Could not turn head more than 30 degrees left or right. Symptoms/pains and soreness went away after 3 weeks.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 71 years intramuscular, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "obese" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; SIMVASTATIN. Past drug history included: Tetracycline, reaction(s): "known allergies: tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (12Jun2022) Unknown results, notes: rebound covid symptoms after completed 5 day dual medications. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had other medication in 2weeks. COVID 19 Treatment. Treatment start date: 04Jun2022 and stop date: 08Jun2022. Lot number: 0069-1085-30. On 10Jun2022, rebound covid symptoms after completeed 5 day dual medications.   Investigational results: As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the One and Done business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details: PR ID (CR): 7278594. Product-Description (CR): Compound bnt 162 covid-19 vaccine suspension for intramuscular 2ml vial x 1 adult 10 x 2.25ml multidose. Lot (CR): FJ6369  Conclusion of Previously Completed Investigation. The complaint for covid-19 vaccine was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FP FJ6369 (SF: FJ6287). A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. It was concluded that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. PR ID of Previously Completed Inv: 6780093. PR Link (Previously Investigated CR): 6768751.
SORE LYMPH NODE; This spontaneous report received from a patient via a company representative concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On JUL-2021, the subject experienced sore lymph node. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore lymph node was not reported. This report was non-serious.
tongue swelling, upper exteremity splotchyness, c/o mild difficulty breathing; treated with epi 0.3mg, Pepcid 20mg, Benadryl 50mg, transported to Hospital per EMS