chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccine was maintained at proper refrigeration temperatures, but for longer than 31 days.  7/29/21 was day 31 at refrigeration temps and vaccine was given on 8/5/21.  No adverse events have been reported by patient.  Error discovered on 8/16/21
Vaccine was given that was 24 hours after vial was initially punctured but kept in the fridge.  Biotech was contacted and they recommended no more than 2 Moderna vaccinations and to use our professional judgement.  We decided since the vaccine was kept in the fridge, not to revaccinate at this time.
pt bled after the vaccine.  I applied pressure with a cotton ball and the bleeding stopped.  The patient left the counseling room and her father returned a few minutes later saying that she had turned white.  I met the patient at the higi machine where she was breathing and talking but was saying she felt out of it and was thirsty.  The father thinks she fainted at some point.
Arm sore for a week   Hurt into chest   Felt extremely fatigued for about 5 days.  Ran fever over 100 for 2 days.  Felt fine after 5 days.
Pt verbalized prior history of dizziness with vaccinations. Pt felt dizzy upon vaccination. BP: 92/66 Pulse: 51 O2Sat: 99 No temp was taken. Nurse on Site, and doctor were made aware of the incident. Pt was released and left under no distress.
Pt tested positive for COVID on 10/29/2021.  Pt presented with generalized malase, fatigue, nausea and abdominal discomfort. Pt febrile.  While attempting to ambulate today had a syncopal versus near syncopal episode where his legs gave out and he could not move. Patient could not get up off the floor. D dimer 1085. As patient not hypoxic, will hold decadron.  Continue lovenox, and not in need of remdesivir. Discharged home.
A report has been received from a Health Professional concerning a 10 year old, male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 23-DEC-2014. The reporter stated that they accidentally administered an expired FLUMIST Quadrivalent  dose to patient on 23-DEC-2014. FLUMIST Quadrivalent was discontinued on 20-DEC-2014. The outcome of the event of accidentally administered expired FLUMIST Quadrivalent is unknown. The report was considered to be non-serious.
The pt experienced redness, pain, induration at the site where the HIB was given. redness began the same day increased after the follow 48 hours. No fever was experienced.
I developed off and on heart palpitations shortly after my second injection. They have remained constant and have not abated. They do not seem too serious but I do get anxious when my heart palpitates and has an irregular heartbeat. It usually goes away after a minute or two. But it does happen every couple of times. So, it is relatively frequent.
Patient came to ED with complaints of generalized weakness, headache, and shortness of breath.  Patient was admitted to hospital with Covid and treated with remdesivir.
Client was given adult dose of Hep A vaccine instead of pediatric dose. Clients mother was notified and will be assessing for signs/symptoms of adverse reactions.
Information has been received from a registered nurse concerning a 5 year old Caucasian female with no known drug allergies with a food allergy (unspecified), milk allergy, eczema and asthma who on 02 APR 1997 was vaccinated with varicella virus vaccine live (lot #621071/1552D) subcutaneously in the left thigh. At the time of vaccination, the patient had otitis media that was treated with amoxicillin. On 21 JUN 2001, the patient presented with a vesicular rash with distribution all over her body with small number of lesions. No other symptoms were noted. In follow up, the registered nurse reported that on 21 JUN 2001, the patient presented with a small amount of lesions, complained of erythematous papulopustular, vesicular, pruritic, exanthem on groin area, bilateral trunk, on abdomen, scattered patter, afebrile. In follow up, the registered nurse reported that the patient recovered on 26 JUN 2001. The registered nurse also reported on anther patient who had an experience following vaccination with varicella virus vaccine live (WAES #01062324). No further information is available.
Right eye became bloodshot, later became blurry. I washed my eye with sterile solution. It became much worse over the weekend. I saw Dr on 10/17/2011. He diagnosed a severe case of shingles in my right eye. Dr treated me every day for the week. My eye was administered antibiotic on 10/17 and taped shut. My eye was very painful and my vision blurry. I was prescribed antiviral oral medication and antibiotic eye drops. On 10/18 the bandage was removed and I continued antiviral oral medication and antibiotic eye drops. My vision was blurry for @ 3 weeks.
Approx 2 weeks after vaccination 10/6/16 felt numbness in left hand and fingers, later at night same feeling in right hand, next morning both feet and then up to knees, difficult standing and walking. Fell down on 10/17 went to hospital dia with GBS. In hospital for 5 weeks.
Hands and fingers swelling; episodic nighttime finger pain; This non-serious case was reported by a consumer and described the occurrence of hand swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included lisinopril, cetirizine, vitamins nos (Vitamins) and calcium.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hand swelling (Verbatim: Hands and fingers swelling) and pain in fingers (Verbatim: episodic nighttime finger pain). The patient was treated with ambiguous medication nos (Neurontin (Nos)) and ibuprofen. The outcome of the hand swelling and pain in fingers were not reported.   It was unknown if the reporter considered the hand swelling and pain in fingers to be related to Shingrix.     It was unknown if the company considered the hand swelling and pain in fingers to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-May-2023 The patient experienced hands and fingers swelling, episodic nighttime finger pain. These symptoms were treated with Neurontin, ice packs, ibuprofen.
Administered 0.5ml instead of the 0.25ml dose. Patient is not aware of the error and never reported any side effects or adverse reactions.
Discomfort with area reddened and swollen, as well as hives.   Area effected from below elbow to shoulder.  No breathing problems noted.
1. numbness tingling  pain down right arm to 4th and 5th fingers, pain with movement, difficulty moving arm. 2. Chest pains, SOB 3. Light sensitivity, unable to look at lights, migraine that never went away, seeing neurology still because of this, pain in eyes 4. Joint pains 5. Numbness tingling pain, tightness in left leg after 2nd dose given in Left arm 6. Recent dx of polyarthritis 1 year after COVID vaccines
Pt recv vax on 1/12/98; on 3/29/99 pt exp chicken pox, fever      (x2 day), runny nose
10/12/2003: Went to ER for left arm swelling, redness and blisters, area of redness 4.5 inch tall x 3.5 inch.  Referred to MD. Advised Benadryl, Tylenol, ice compresses and wrap in gauze.
Pt experienced pain running up and down left arm. Also burning sensation was felt. The pt had red streaks under side of arm, swelling and pain in arm pit.
Information has been received from a registered nurse concerning a female who on 12-JUN-2008 was vaccinate with ZOSTAVAX vaccine (Oka/Merck) (lot#: 659409/0409X).  13-JUN-2008 the patient developed redness and a blister at  the injection site. The patient was treated wit ROCEPHIN and as of 19-JUN-2008 she was recovering. The patient was seen at the physicians office. Additional information has been requested.
Injection site swelling; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Injection site swelling".  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
COVID vaccine causing her arm, hand and face to go numb; COVID vaccine causing her arm, hand and face to go numb; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer (manufacturer control number: UNT-2021-006890). A 40-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included ongoing pulmonary arterial hypertension. Co-suspect medication was treprostinil sodium (TYVASO) via inhalation route at 60-120 ug (10-20 breaths), four times a day for pulmonary arterial hypertension from 29Jun2018, Concomitant medications bosentan (TRACLEER) and tadalafil (ADCIRCA). The patient was admitted to the hospital (in Apr2021) with possible adverse event from COVID vaccine causing her arm, hand and face to go numb on 13Apr2021. The action taken with treprostinil was unknown. The clinical outcomes of the "COVID vaccine causing her arm, hand and face to go numb" were unknown.  Case Description: This case is a spontaneous report received on 14Apr2021, from a consumer via (pharmacy name). This 40-year-old, 125-lb, female patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A), on 29Jun2018 for primary pulmonary arterial hypertension. The current dose was reported as 60-120 ug (10-20 breaths), four times a day (QID) (off label use), via inhalation (IH) route. On 13Apr2021, the patient experienced the event term of COVID vaccine causing her arm, hand and face to go numb (hypoaesthesia, hospitalized).  Co-suspect included coronavirus disease (COVID-19) vaccine. Concomitant medications included Tracleer (bosentan) and Adcirca (tadalafil). Relevant medical history included primary pulmonary arterial hypertension. On 13Apr2021, 2 years, 9 months, and 16 days after initiating IH Tyvaso, the patient was admitted to the hospital with possible adverse event from COVID vaccine causing her arm, hand and face to go numb. Action taken with IH Tyvaso was not reported for the event of hypoaesthesia. Action taken with Covid-19 vaccine was not applicable for the event of hypoaesthesia. At the time of reporting, the outcome of hypoaesthesia and off label use was unknown. The reporter did not provide causality for the event of hypoaesthesia.   Case Comment: The company has assessed the serious adverse event of hypoaesthesia as not related to IH treprostinil and TD-300/A device. The event was likely post vaccination with COVID vaccine.  Pfizer is a marketing authorization holder of BNT162b2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162b2 has submitted the same report to the regulatory authorities.  No follow-up attempts are possible. Information about BNT162b2 vaccine lot/batch number cannot be obtained.
the vaccine has cured his insomnia starting after the first dose.his sleep is a lot deeper than it has been in 40 years, he wakes up with crust in his eyes.; he sleeps a short amount of time and wakes up in 3 hours totally refreshed; after getting his first Pfizer Covid 19 Vaccine Shot he started to get high blood pressure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: EP8727) at the age of 58 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: HYPERTENSION (non-serious) with onset Apr2021, outcome "unknown", described as "after getting his first Pfizer Covid 19 Vaccine Shot he started to get high blood pressure"; ENERGY INCREASED (non-serious) with onset Apr2021, outcome "unknown", described as "he sleeps a short amount of time and wakes up in 3 hours totally refreshed"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 04Apr2022, outcome "unknown", described as "the vaccine has cured his insomnia starting after the first dose.his sleep is a lot deeper than it has been in 40 years, he wakes up with crust in his eyes.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: 329. Therapeutic measures were taken as a result of hypertension.  Additional information: The reporter was calling to let Pfizer know that after getting his first Pfizer Covid 19 Vaccine Shot he started to get high blood pressure and he also experienced high blood pressure after his second and after his booster his blood pressure skyrocketed. Caller clarified that after his first Vaccine he did not bother checking his blood pressure, so he did not know whether or not his blood pressure was elevated. Caller stated the vaccine has cured his insomnia starting after the first dose. Caller stated Pfizer has discover so many things by accident.  He had found that his sleep was a lot deeper than it has been in 40 years, he woke up with crust in his eyes. Caller stated it was beyond what he has had in 40 years, he slept a short amount of time and woke up in 3 hours totally refreshed. Treatment included he stated he got put on a blood pressure medication for almost a year now.  No follow-up attempts are possible. No further information is expected.
Information has been received from a certified medical assistant concerning an 85 year old male who on Apr 15 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 646711/1180N). Subsequently, on Apr 17 2004, the patient returned to the office complaining of myalgia and nausea. the patient was advised to use ice and acetaminophen (Tylenol). Unspecified medical attention was sought. No product quality complaint involved. It was also reported that another patient had similar symptoms (WAES0406USA01890). Additional information has been requested.
General fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (General fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Goiter and Radioactive iodine therapy (For goiter). Concurrent medical conditions included Latex allergy, Drug allergy (Zantac) and Penicillin allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATENOLOL and LISINOPRIL for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced FATIGUE (General fatigue). At the time of the report, FATIGUE (General fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter. After receiving two injections , the patient cannot keep thyroid level normal. Patient  had an x-ray of right hand and an ENG (Electronystagmography)was done - ENG showed carpal tunnel the tests were ordered by her primary care physician. she was referred to a neurologist.   This case was linked to MOD-2021-386040 (Patient Link).
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) 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.   Reporter stated that, It was unknown if the doses were first, second or third doses for the patients. 10 patients were administered the dose on 09Sep2021, 20 patients on 16Sep2021, 11 patients on 30Sep2021, 9 patients on 07Oct2021, 10 patients on 08Oct2021 and 20 patients on 11Oct2021.  No concomitant medications were reported. No treatment medications were provided.
I received the first dose of the Pfizer covid-19 vaccine on Friday night at 8:30 pm. At around 10 pm I felt like my body was going into shock: waves of numbness and cold washing over me repeatedly, and felt like my body and heart were relaxing too much, and I would go into shock at any moment. I was very close to asking my husband to take me to the hospital. After about 30 minutes it subsided however around midnight I was feeling what I can only describe as heart zings where I felt like the electrical system around my heart was giving me electric zaps throughout my body. I did not have any headache or nausea, but just continues to feel like my body could go into shock or stop functioning at any moment. It did not settle down enough to rest until 2 am.  I have never had this type of reaction to a vaccine since I was 2 months old, not even when given multiple shots at once during basic training.   When I contacted my provider the following morning I was told that this reaction could be normal. As I stated above I have never had this type of reaction before. This was far from normal.  I was still feeling weak and drained  from the shock to my system and my body felt off, but otherwise the shocks had subsided. I did have swelling along my left arm, and an acne bump appeared near the immunization site.   My provider said they would not be filing an adverse reaction report for me, even though I had provided all of the information regarding my extreme reaction to the vaccine.
Patient received both flu and pneumonia vaccines on the same day/same arm. She called two days later complaining of swelling, redness, tenderness to her elbow. She took diphenhydramine with no relief then physician prescribed KEFLEX in case of infection.
Reports sensation of tingling and puffiness of lips starting about 2 hours after immunization, which was still present the next morning.  She did not visualize any change in her lips, and did not tell anyone about the reaction until it was time for her 2nd dose.  She had previously tested positive for COVID in September and was not given a 2nd dose.
Instant arm redness to elbow, swelling, pain. Next day severe abdominal pain for 1 week, 2 days radiating into chest with shortness of breath. 1 week of bilateral leg pain consistent with restless leg symptoms. Right heel pain feeling like gout for 3 days, multiple loose/liquid stools daily for 4 days.
LIMITED USE OF LEFT ARM; SORE LEFT ARM; MALAISE; INJECTION SITE REDNESS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced arm tenderness. On 11-APR-2021, the subject experienced limited use of left arm. On 11-APR-2021, the subject experienced injection site redness. On 11-APR-2021, the subject experienced malaise. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the fatigue, sore arm, arm tenderness, limited use of left arm, injection site redness, malaise and headache was not reported. This report was non-serious.
bad bruise from a intramuscular injection in the past; Initial information regarding this valid unsolicited non-serious case from nurse and transmitted to on 08-Oct-2020.  This case involved an elderly patient who experienced bad bruise from intermuscular injection in the past (Vaccination site bruising), while the patient received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant drug was not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Lot number and expiration date unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious bad bruise from a intramuscular injection in the past (Vaccination site bruising), (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting the outcome of the event was unknown.
Vomiting. Mild fever. Headache within 24 hrs. Several others in the class, girls and boys.
I have been having continous headaches and also tightening of my chest that feels like if I have a weight on my chest in the middle of my chest.
The vial was initially stored in refrigerator on 20-Apr-2022/Vaccine administered on 24-May-2022; Patient was given expired (4 days expired) Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-Apr-2022/Vaccine administered on 24-May-2022) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K212A, 042L20A, 013M20A and 011F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-Apr-2022/Vaccine administered on 24-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-Apr-2022/Vaccine administered on 24-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was taken out of freezer on 20-Apr-2022 and out of freezer expiration date was 20-May-2022.  The vial did not undergo any temperature excursion.  No treatment medications were reported.