chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle aches; 0.5mL 2nd booster instead of 0.25mL; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches) and ACCIDENTAL OVERDOSE (0.5mL 2nd booster instead of 0.25mL) 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.   In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced MYALGIA (muscle aches) and ACCIDENTAL OVERDOSE (0.5mL 2nd booster instead of 0.25mL). At the time of the report, MYALGIA (muscle aches) and ACCIDENTAL OVERDOSE (0.5mL 2nd booster instead of 0.25mL) outcome was unknown.            No Concomitant medications were provided.  Patient was at high risk but not immunocompromised.  It was reported that the patient had primary series Jan 2021 and 1st booster in August then recently received 0.5mL.  No treatment medications were provided.   This case was linked to MOD-2022-536492 (Patient Link).   Reporter did not allow further contact
This spontaneous report was received from a healthcare professional referring to a 14 months old female patient. Information about the patient's medical history and concurrent conditions was not reported. On 09-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Headache, fever 101.6, body aches, chills, joint pain, nausea, injection site pain and dizzness
Intermitent shoulder pain; Intermitent shoulder stiffness; Very painful; Pain at injection site/intermitent sharp stabbing pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th July 2022, several minutes after receiving Shingrix, the patient experienced injection site pain. On 11th August 2022, the patient experienced shoulder pain, stiffness shoulder and pain. On an unknown date, the outcome of the injection site pain, shoulder pain, stiffness shoulder and pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, shoulder pain, stiffness shoulder and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-AUG-2022 and 15-AUG-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received Shingrix vaccine. the reporter stated that after minutes of received vaccine patient experienced injection site pain. On 11 August 2022 the patient experienced sharp stabbing pain at injection site, Shoulder pain and shoulder stiffness. The sharp stabbing pain at injection site, Shoulder pain and shoulder stiffness was intermittent and lasts for few seconds but these are unresolved. The reporter stated that the patient had recurrence of a weird side effects with the Shingrix vaccine and it was very painful. The reporter declined date of birth and the batch number and expiration date was unknown. The reporter consented to follow up. Additional supportive information: The case US2022119079 was identified as duplicate of case US2022119045. All future correspondence would be added in case US2022119079, which stands as case of record for this patient and the case US2022119045 would be deleted.
Lip blistering; Severe headache; body aches; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration on the left arm on 19Jan2021 at a single dose for COVID-19 immunization. Medical history included high blood pressure and allergies penicillin. The patient is not pregnant. Concomitant medication included felodipine and losartan. The patient received the first dose of BNT162B2 on 30Dec2020 06:30, lot number: EL1283 for COVID-19 immunization. The patient experienced lip blistering, severe headache and body aches on 20Jan2021 15:00. The outcome of the event was not recovered.
Medical Assistant accidentally administered Fluzone High Dose to a 54 year old patient, no AE; Medical Assistant accidentally administered Fluzone High Dose to a 54 year old patient, no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked with 2019SA295846, 2019SA295847, 2019SA295848, 2019SA295849, 2019SA295850 and 2019SA295851 (same reporter).  This case involves a 54 years old male patient who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Prefilled Syringe, lot UJ285AA, expiry date: 02-Jun-2020) via intramuscular route in the right arm.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of reporting, no adverse event was reported.  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.
Extreme fatigue, muscle aches, weakness. Sudden onset, accompanied by a 100.4 F fever, teeth chattering chills, and pounding headache.
First shot caused significant fatigue and amplified joint issues. The second dose caused even more fatigue and I could not move because my joints hurt so bad. About 4 days ago, I started getting a rash on my injection arm and now my whole body is itch with a rash. Joint issues still seem to be amplified. I have been taking Tylenol Arthritis as well as Advil and will soon be taking Benadryl.
On 08/30/2021 patient experienced chest pain, it lasted 20 minutes was left sided and described as throbbing, the pain did not radiate, denied diaphoresis, dyspnea and palpitations, was not aggravated by exertion. History of pericarditis 11 years ago.   VS-BP110/70, HR70, RR17, O2 sat 98%, weight 236, height 6.0ft
The patient experienced presyncope, nausea, and blacked out for about 20 minutes 2 hours after receiving the vaccine.
Because last one i took nearlykilled me; This case was reported by a consumer via market research programs and described the occurrence of near death experience in a patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   On an unknown date, the patient received Hz/su + AS01B. On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to Hz/su + AS01B.   Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's Comments: The patient self-reported the case via market research programs. The patient reported that, last one dose of Shingrix, nearly killed him/her
hearing organ music/when she takes her hearing aids out/its the same organ song; This spontaneous case was reported by a patient and describes the occurrence of HYPERACUSIS (hearing organ music/when she takes her hearing aids out/its the same organ song) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A. and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced HYPERACUSIS (hearing organ music/when she takes her hearing aids out/its the same organ song). At the time of the report, HYPERACUSIS (hearing organ music/when she takes her hearing aids out/its the same organ song) outcome was unknown. Not Provided          Concomitant medication included unspecified high blood pressure medication and cholesterol medication.  Treatment information was not provided.  Action taken with mRNA-1273 was not applicable
Vaccines 5/2/12 & on 5/4/12 started with muscle fatigue at night (PM) & on 5/5/12 - Fever around 100 - & joint achiness - cloudy thought process & decrease in appetite - see in office on 5/7/12 - still had fever 5/9/12 so lab work done - & fever was gone on 5/14/12 per mom treating now.
arm was sore; fibromalagi; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program.  A female patient of an unspecified age received first dose of bnt162b2, via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had the first dose of the Covid vaccine she did not have problems except her arm was sore. She did have fibromalagi. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No rash or erythema.  Patient states they had arm pain near injection site radiating to breast area.  Happened within one week of getting vaccine and persisting now for two weeks after.
Within 30-minutes of vaccination, the patient returned to the vaccine clinic to report her face becoming hot, her cheeks being red, and a headache. EMS evaluated patient on-site. Patient was hypertensive (206/96). EMS transported patient to Emergency Department for further evaluation. In ED, patient was still hypertensive, but in no acute distress. Per patient, she was taken off losartan by PCP in September secondary to hyperkalemia. ED physician administered losartan and Tylenol. Patient was discharged with HTN, HA, and vaccine reaction.
problems with the head; about concerning the side effect; Problem with the same arm; temperature over of a 100°F, temperature and had 100.1°F; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (problems with the head), VACCINATION COMPLICATION (about concerning the side effect), VACCINATION SITE REACTION (Problem with the same arm) and PYREXIA (temperature over of a 100°F, temperature and had 100.1°F) 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.   In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (problems with the head), VACCINATION COMPLICATION (about concerning the side effect), VACCINATION SITE REACTION (Problem with the same arm) and PYREXIA (temperature over of a 100°F, temperature and had 100.1°F). At the time of the report, HEAD DISCOMFORT (problems with the head), VACCINATION COMPLICATION (about concerning the side effect), VACCINATION SITE REACTION (Problem with the same arm) and PYREXIA (temperature over of a 100°F, temperature and had 100.1°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Body temperature: 100 (High) 100°F and 100.1 (High) 100.1°F.         No concomitant medications were reported. No treatment medications were reported. Reporter left an incomplete phone number.
enlarged lymph nodes; left ear pain; white patches on tongue; itching on arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (enlarged lymph nodes), EAR PAIN (left ear pain), TONGUE DISCOLOURATION (white patches on tongue) and INJECTION SITE PRURITUS (itching on arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Keflex, sulfa and cipro.).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching on arm). On 09-Feb-2021, the patient experienced LYMPHADENOPATHY (enlarged lymph nodes), EAR PAIN (left ear pain) and TONGUE DISCOLOURATION (white patches on tongue). On 29-Jan-2021, INJECTION SITE PRURITUS (itching on arm) had resolved. At the time of the report, LYMPHADENOPATHY (enlarged lymph nodes), EAR PAIN (left ear pain) and TONGUE DISCOLOURATION (white patches on tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medications were reported. Treatment medication taken was Tylenol.
fever to 105.9 approx 12hrs p/vax;inconsolable crying;swollen, red, tender 4cm x 5cm x2cm area of induration @ the site
sore arm for first shot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm for first shot) in a 57-year-old male patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (sore arm for first shot). At the time of the report, INJECTION SITE PAIN (sore arm for first shot) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081725 (E2B Linked Report). This case was linked to MOD-2021-052313 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081725:Cross linked; Dose 1
Information has been received from a 22 year old female with sulfonamide allergy to an unspecified pertussis vaccine and a history of kidney stone and other kidney problems who in January 2008, was vaccinated with the first dose of GARDASIL (lot#, dose and route not reported).  Concomitant therapy included YAZ and ZOLOFT.  In January 2008, after first dose of GARDASIL the patient reported that the injection site was very swollen and painful for approximately 4 weeks.  She noted that after the second dose of GARDASIL (lot #, date, dose and route not reported) the injection site became swollen and painful.  The patient also noted that 5-6 hours after vaccination she developed a fever, began vomiting, and proceeded to feel nauseous and sick for approximately 3 weeks.  At the time of the report, the patient reported that she no longer felt sick; however the injection site was still swollen and painful.  Unspecified medical attention was sought.  No further information was available.  Additional information is not expected.
Patient stated that she had discomfort in her arm immediately following injection. She was reassessed by management  approximately 20 minutes later and was still having discomfort.  Upon waking 10/5/2020 she stated that she was still having discomfort and noticed redness and swelling at the injection site. Around 10 pm she noticed that the redness was also in her upper shoulder and the pain had spread to that area. She stated that her temperature was 99, she took 1 extra strength Tylenol for pain and the temperature.   On 10/06/2020 , there was no fever in the am.  She was assessed by staff. Staff noted that there is swelling, redness, and heat coming from the injection site. There is redness in the upper shoulder. She stated she is a level 7 pain when palpated and stated that there is itching and burning at the site.  CMD contacted.
PATIENT RECEIVED MORE THAN THE RECOMMENDED DOSES OF COVID-19 VACCINE. THE PFIZER SERIES WAS ADMINISTERED ON 3/15/2021 AND 4/5/2021, THEN THE MODERNA SERIES WAS ADMINISTERED ON 4/24/2021 AND 5/22/2021.
Very strong chills for 6 hours around bedtime... bad headache...it has been about 24 hours, still have headache, left arm very sore.
I had no reactions to the vaccine. When I caught COVID I started off with a really bad cough. Then it turned into a sore throat. I was sneezing a lot. I had a severe pain on the middle of my lower back not located on the spine. I had fatigue. When I would stand up, I would feel exhausted. I felt bad for 3 days. My COVID symptoms weren't severe just mild. The back pain was on and off. The back pain and fatigue lasted for about 3 or 4 weeks, and they were not every day. The most difficult part was being isolated. I had pounding headaches that were at a 3 or 4 out of 10. A couple of times they would be at a 6 or 7 out of 10. I never lost my smell, appetite, or taste. I never got body aches either.
1 day p/vax#2, pustules on arms, legs, buttocks - later scabbed over;also happened again p/vax#3
This spontaneous report as received from a physician refers to a female patient of unknown age. No information about medical history, concurrent conditions were reported. The physician reported that patient completed ROTATEQ suspension 2, (route dose strength not reported) series on 23-DEC-2014. No concomitant therapy was reported. Approximately on 27-DEC-3014 (reported as within 4 days after vaccination), the patient developed colicky abdominal pains (hospitalization). Ultrasound(unknown date) revealed possible intussusception (hospitalization). The reporter stated that patient was admitted to unspecified hospital of one day on an unknown date and released to home on an unknown date. The patient was treated for the event in acute care for 24 hours. The outcome of patient developed colicky abdominal pains and possible intussusception was reported as recovering. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
soreness in his arm and chills last night; soreness in his arm and chills last night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "soreness in his arm and chills last night". Additional information: the patient received the RSV vaccine yesterday and wants to know how often he should get it.  He has soreness in his arm and chills last night, but it wasn't too bad.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022; receiving doses after its beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The patient was administered with second booster dose.  Number of doses/vials were 6 doses from the same vial. On 16-Jun-2022, the vial was initially stored in the refrigerator and the patient received dose from the same vial lot.  The vial did not undergo any temperature excursions.  No treatment information was provided.
This spontaneous report as received from a female consumer of unknown age reporting on herself. In 2009 reported 4 years ago, the patient was vaccinated with ZOSTAVAX, injection in arm, (route, lot number and exp.date not reported). The patient could not spell what other medicines she was taking concomitantly. In March 2013 the patient came down with shingles after having had the vaccine. There was unspecified treatment given for the adverse event. The outcome of event was unknown. Additional information has been requested.
Arm hurts; Shortness of breath; I can hardly breathe; Heart is beating like so fast; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16May2021 11:00 (Batch/Lot number was not reported) as 1st dose, single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm hurts, shortness of breath and heart was beating like so fast on 16May2021. The outcome of the events was unknown.  The patient just wanted to know if it was normal because she never had and it was her first time having the vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient is fully vaccinated and was hospitalized due to Covid. Case was symptomatic as of 8/2/21 with fever, loss of taste/smell, fatigue, nausea, and abdominal pain that he is still experiencing. Last Monday 8/2/21 case went to urgent care and was given medication. He got worse the next week on 8/9/21 which is when he went to Hospital because they thought he had a stomach virus and stayed there and still has not been discharged.
No adverse event(s) to report.  Vaccine was given to a a 17 year old due to incorrect calculation of age by staff.
Swollen painful tender pea sized left Supraclavicular lymph nodes about 1? in length. The injection was on my left arm. It?s still there. This happened 6 days after injection. I?m assuming this must be related to injection but have not seemed medical attention for professional opinion yet.
Right arm, broken out in pinkish/purply area; under arm blotchy reddish/pink; right arm noticably larger (swollen) than left arm; no c/o pain or discomfort; warm to touch (parent has pictures, taking to Dr. for chart); had no trouble moving the arm; "back to normal on Saturday morning"; ROM is normal currently