chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; monovalent dose ages 6-11 administered instead of bivalent booster dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose).    No concomitant medication was provided.  It was reported that 4 patients were supposed to receive the bivalent booster dose instead they were given the monovalent vaccine ages 6-11.  Treatment medication was not provided by the reporter.  This case contains information of 3rd patient out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-661790, US-MODERNATX, INC.-MOD-2022-659987 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661790:Same reporter
Patient received 1st COVID-19 vaccine at a community vaccination clinic. Patient waited for 15min post vaccination. At end of patient waiting period she reported feeling "chest tightness". Was brought to a more private chair for further evaluation. Patient reported feeling anxious about vaccine. She reported feeling "chest tightness" and was pointing to the middle of her chest. Vitals were taken. Blood pressure was 152/102, pulse 89, O2sats 97% Room Air. Patient denied feeling any shortness of breath or difficulty breathing. Due to chest tightness and elevated blood pressure it was advised that patient go to the ED for evaluation. RN offered to call an ambulance to take her to ED. Patient declined ambulance and stated that her husband could drive her. RN advised again that patient go to ED for evaluation of chest tightness and elevated blood pressure. Patient left community clinic with spouse.
Pt reported numbness in both arms and lower back and knees several hours post-vaccination. Husband described "pain and numbness in the fleshy part of her joints" and that it took 3-4 days for the aches and pains to go away. Pt did see her physician the day after vaccination and was told she was ok. Spoke to patient again on 12/22 and she is reporting red swollen hives at the injection site.
Vomiting, stridor onset - 6 hours after vaccination. Projectile x 4. Perioral rash. Resolved after ER visit given albuterol md. at home, ZOFRAN in ER.
At 10:30 AM patient received two shots and stated he felt fine.  He and his mother went to the waiting room and at 10:38, patient fainted and fell, striking forehead on counter.  He had a approx. 5 cm open wound on his forehead, that was bleeding.  911 was called, pressure gauze was applied to wound, legs were elevated, and vitals were assessed. Patient was conscious within seconds. Patient was assessed by a Nurse Practioner until EMS arrived.
Was hallucinating.  Seeing and hearing things without a fever. Was up most of the night.
Pt passed out during administration of covid19 vaccine. Within approx. 15 seconds, pt regained consciousness and was AAOX4 with no obvious distress. Pt was instructed to stay in clinic for 15 to 30 minutes for monitoring. Pt c/o nausea and vomited once while waiting in exam room. Pt denied pain. Pt sat down next to break room in store after leaving clinic and began throwing up. Since pt had left, EMS was notified immediately. Pt did not decide to leave with EMS rather but had a family member pick her up
First dose:    Next day, moderate joint pain in all fingers and wrists. Second dose: August 25/2021.  5 Days post vaccine, blood work showed a spike in my CRP from 4.3 to 6.3 Four months after 2nd vaccine, moderate hip, knee and shin pain
Local swelling, warmth & mild erythema at right upper arm & extending into right axilla
Pt experienced throbbing headache after the Anthrax and typhoid vaccination. The pt was given toradol with improvement of headache within 30 minutes.
General weakness in the arm to the point that you can't even lift 20% of what you could previously lift with ease; left shoulder is more fragile in general; Useless arm syndrome; lifting capacity diminished significantly; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a (RA). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was also reported that, fAfter first and second dose Pfizer Covid 19 Vaccine, the caller had left arm useless syndrome the day after receiving the first dose Pfizer Covid 19 Vaccine for four days. The caller's left arm shut down and the caller couldn't lift anything. He was also enquiring if he got the booster dose, would he experience useless arm syndrome again.  The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "General weakness in the arm to the point that you can't even lift 20% of what you could previously lift with ease"; LIMB DISCOMFORT (non-serious), outcome "recovered", described as "Useless arm syndrome"; MOVEMENT DISORDER (non-serious), outcome "recovered", described as "lifting capacity diminished significantly"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "left shoulder is more fragile in general".  The day after receiving first dose vaccine had useless arm syndrome: The caller clarifies the day after receiving the first dose Pfizer Covid 19 Vaccine the caller had useless arm syndrome. The caller clarifies anywhere from, the average was about 4 days the caller had useless arm syndrome. The caller states it was not that he was not able to lift anything, that would imply the caller was able to lift zero. The caller's lifting capacity diminished significantly. Straight up and down the caller can lift 85% to 80% of half the caller's body weight with the caller's right arm. The caller's left shoulder is more fragile in general and can't do everything.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
muscle spasms in the chest; chest pain that was severe, dull, in the middle of the chest; experienced the pain at the back as well; body temperature dropping; coldness; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (body temperature dropping), FEELING COLD (coldness), CHEST PAIN (chest pain that was severe, dull, in the middle of the chest), BACK PAIN (experienced the pain at the back as well) and MUSCLE SPASMS (muscle spasms in the chest) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Herpes virus infection.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced BODY TEMPERATURE DECREASED (body temperature dropping) and FEELING COLD (coldness). On 01-Apr-2021, the patient experienced CHEST PAIN (chest pain that was severe, dull, in the middle of the chest) and BACK PAIN (experienced the pain at the back as well). On 02-Apr-2021, the patient experienced MUSCLE SPASMS (muscle spasms in the chest). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 31-Mar-2021 for Chest pain, at an unspecified dose and frequency. On 02-Apr-2021, CHEST PAIN (chest pain that was severe, dull, in the middle of the chest) had resolved. On 06-Apr-2021, MUSCLE SPASMS (muscle spasms in the chest) had resolved. At the time of the report, BODY TEMPERATURE DECREASED (body temperature dropping), FEELING COLD (coldness) and BACK PAIN (experienced the pain at the back as well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) EKG of the chest was normal.         No concomitant medications was reported. The patient  sought medical attention from primary care physician who referred her to a physical therapist. She had an EKG done, and the primary physician said everything was fine. through the discussion with the primary care physician, the cause was possibly due to the Moderna Vaccine.   This case was linked to MOD-2021-372919 (Patient Link).
Fever (100.5), body aches, chills, headache, fatigue; Fever (100.5), body aches, chills, headache, fatigue; Fever (100.5), body aches, chills, headache, fatigue; Fever (100.5), body aches, chills, headache, fatigue; Fever (100.5), body aches, chills, headache, fatigue; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the left arm on 18Jan2021 (at the age of 22-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included prior Covid. Concomitant medications included ethinylestradiol/etonogestrel (NUVARING) and cetirizine hydrochloride (ZYRTEC). The patient had no known allergies. Historical vaccine included BNT162B2 on 28Dec2020 in left arm, dose number 1. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. On 19Jan2021 at 03:00, the patient experienced fever (100.5), body aches, chills, headache, and fatigue. No treatment was provided for the events fever, body aches, chills, headache, and fatigue. The outcome of the events fever, body aches, chills, headache, and fatigue was recovering. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 10NOV95 & 30JAN98 pt felt warm but had no fever;mom states the child was broken out all over, pale & did not feel good;
had chicken pox type rash & fever up to 102 10 days p/vax;
Patient passed out and also had seizure like symptoms including muscle stiffness and shaking with minor convulsions, blue lips, and eye twitching behind eyelid. Patient also had trouble breathing during episode. Seizure like symptoms lasted approximately 15 seconds. EMS was called. Patient recovered fully and walked out of store under own power. She denied further evaluation by EMS and plans to follow up with doctor.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 53-year-old female patient who received SHINGRIX. Concomitant products included PREVACID, WELLBUTRIN, fluticasone propionate, ADVAIR, ADDERALL, Albuterol, estradiol, Glaucoma Eye Drops, KLONOPIN, metoprolol, topiramate and TRINTELLIX. On 9th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 9th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, migraine and nausea. On an unknown date, the outcome of the injection site swelling, injection site erythema, migraine and nausea were not recovered/not resolved. The reporter considered the injection site swelling, injection site erythema, migraine and nausea to be related to SHINGRIX. Additional details were reported as follows: The reporter was very kind and understanding and informed, not like he could do much about my migraines. The patient's concomitant medication included FLEXERIL. The patient received SHINGRIX on left arm. The patient experienced migraine, redness and swelling at injection site and nausea. The reporter just wanted to make sure that was not and did not need to go to the hospital or anything like that, that I was not having an overreaction. So the patient was very good.
Experienced persistent pain in medial deltoid muscles. Paralysis, lack of mobility in left arm, lasting as recovering with severe diminishment 30 days after onset.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Apologized to patient about her experience and advised patient to see her physician
Information has been received from a physician concerning a 23 year old white female who on 09-OCT-2007 was vaccinated intramuscularly, into the left deltoid, with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #657872/0515U). Illness at the time of vaccination included a urinary tract infection. Concomitant therapy included nitrofurantoin (MACROBID) and ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN). On 09-OCT-2007, in th evening, the patient experienced nausea, left arm pain and weakness. At the time of the report, the patient's outcome was unknown. No further information is available.
9/17/2021 Fever (100.9 - 101.5) chills, dry cough and fatigue. I also lost my sense of smell for about a week. I was seen at Urgent care and had a Covid test performed on 9/20/2021 - results were positive for COVID-19. I contacted my MD the same day via telehealth visit and was scheduled to receive the monoclonal antibody. My symptoms continued for a total of 7 days from onset. I received the monoclonal antibody at Hospital ER on 9/23/2021. My symptoms resolved within 24 hours of receiving the AB. (NOTE: My husband was diagnosed 2 weeks prior with Covid-19. He too had both Pfizer vaccines and the booster and had breakthrough covid). His only symptom was loss of smell.
covid vaccine breakthrough case  dose 1 1/28/21 Pfizer EL9261 dose 2 2/18/21  Pfizer EL9265
tiredness; Chills; Right arm terrible sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In DEC-2022, the patient received the 1st dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced tiredness (Verbatim: tiredness), chills (Verbatim: Chills) and pain in arm (Verbatim: Right arm terrible sore). The outcome of the tiredness, chills and pain in arm were recovered/resolved.   It was unknown if the reporter considered the tiredness, chills and pain in arm to be related to Shingrix.     It was unknown if the company considered the tiredness, chills and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-Mar-2023 The reporter was the patient who stated she received first dose of Shingrix vaccine in December 2022, then she developed tiredness, chills and right arm was terrible sore.  Timing of events was not specified by patient.  Symptoms did not last very long.  The reporter consented to follow up.
This spontaneous report as received from patient's father concerning his son, a 15 year old male patient. Patient's concurrent conditions and relevant medical history was not reported. Approximately on an unknown date in February 2014 (also reported as March 2014), patient was vaccinated with first dose of GARDASIL (lot number, dose, frequency and route unspecified) for prevention of HPV infection. Approximately on an unknown date in August 2014 (reported as 2 and half months ago from 17-OCT-2014), the patient was vaccinated second dose of GARDASIL (lot number, dose, frequency and route unspecified) for prevention of HPV infection. Concomitant medications were not reported. On an unknown date in 2014 the patient experienced severe skin dermatitis and small red bumps after the first dose of GARDASIL. The reporter stated that initially the red bumps were only present on the hands, but now it was spreading throughout entire body and legs as well. The reporter also stated that itching was the real issue for the patient. On an unspecified date the patient has since developed the MRSA infection. The patient also has had fever when there was an infection present. The patient has also been diagnosed with Eczema. Patient has undergone full blood screening and metabolic lab test but results were not reported. The patient sought medical attention and had seen several doctors such as pediatric, dermatologist and primary cause physicians during this period. The patient has received various therapy treatments CORTISONE, Steroid based prescription creams, and over the counter topical creams without success (dose and manufacturers unspecified). The third dose of GARDASIL was not given yet. The outcome of the events was reported as not recovered/not resolved. The causality of the events with GARDASIL was not reported. Additional information has been requested.
4/21- 12pm throat and chest very tight and hard to breathe. Dizziness and problem reading  and understanding words on work computer. Laid down in bed to try to rest for several hours. 730pm - Sat down in warm bathtub water.  4/22 - No issue 4/23 - 830am Chest and tight again and hard to breathe,  Visit to Urgent Care at 10am.   Several tests ran. 6pm- Researched severe symptoms of Pfizer and see to get Benadryl medicine for allergic reactions.
Information has been received from a registered nurse concerning a patient who was vaccinated with GARDASIL. The patient shortly thereafter came down with genital warts. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008. Follow-up information from the registered nurse indicated that there were doctors and nurses in her community who have told patient's that there "have been outbreaks of genital warts after receiving GARDASIL". Attempts to verify the existence of an identifiable patient and reporter have been unsuccessful. This report no longer meets criteria for submission to the FDA as identifiable patients have not been validated.
This spontaneous report was received from a female pharmacist of unknown age is also the patient. Patient's concurrent conditions included contact dermatitis. On an unknown date the patient was vaccinated with a dose of hepatitis A vaccine (manufacturer unknown) (dose, route, lot# and expiration date were not reported). On an unknown date the patient experienced swelling at the injection site. The outcome of the event was reported as recovered/resolved (date unknown). Relatedness between the event and hepatitis A vaccine (manufacturer unknown) was not provided. This case is linked to MARRS# 1410USA014200 (same patient link). Additional information has been requested.
On 11-26-10 Patient passed out. Was taken by ambulance to hospital for overnite stay. On 12-20-11 while driving a vehicle patient passed out. Was taken by ambulance to hospital for overnite stay. Many tests have been done as to the cause & no conclusion.
all the patients who received a vaccine which was more than 30 days in the refrigerator; all the patients who received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (all the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (all the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (all the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant drug was not reported.  HCP has provided demographics for all the patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021). For this patient, the number of days that have passed were 26.
I had my 1st shot 8 months ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 8 months before reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report.  The patient had not received the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The patient wanted to know was it too late to get the second dose. The follow-up would not be possible as no contact details were available.
Patient developed facial flushing, hives on neck and c/o itching throat about 15 minutes after receiving vaccine.    She was given 50mg of diphenhydramine.  She was monitored for another 30 minutes with improvement in her symptoms.  She had no shortness of breath.  She states hives resolved completely over the course of a couple hours  on the day of vaccine.  She had fully recovered upon telephone contact 24 hours later.   She was advised to get an allergy evaluation before receiving 2nd vaccine dose.
Dose administered outside protocol.   Not currently eligible for 4th shot based on age.   I mis-understood the guidelines
Presented with AMS, fever and SOB.  Dx with Covid PNA.  Treated with O2, abx, steroids, zinc and vit c. PMH of of CAD-chronic on medical management, HTN, HLD, chronic back pain presented to ED via EMS for fever, short of breath. Found to have COVID pneumonia. treated overnight with Vit C, Vit D, Zinc, ASA. O2 weaned off. Patient ambulated and O2 sats remained 97%. Patient's other Medical issues remained stable during hospitalization and required minimal or no interventions. discharged to home
Pt. had scaly rash develop around lips, on chest, on upper eye lids and below eyes. Lips were painful with some swelling. Rash resolving after finishing last dose of vaccine.
Left arm swollen, red, hot, painful. Used cool compress, ibuprofen to relieve. Contact PCP if continues to worsen. Received cephalexin 500 QID on 10-5-16.
Rash developed around injection site, fever as high as 102 degrees, rash developed all over body as well, chills, nausea.