chrisvoncsefalvay/vaers-outcomes huggingface dataset:
due to a temperature excursion; the labeled expiration date was short dated to 1/30/2020; No adverse effects reported; a dose of Varivax was administered after the labeled expiration date; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 17-FEB-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number S002396 was verified to be a valid lot number, expiration date reported as 31-JAN-2021, but upon internal validation established as 23-JAN-2021 (dose and route of administration were not provided) for prophylaxis.  It was reported that the labeled expiration date was short dated to 20-JAN-2020 due to a temperature excursion. The patient did not experience any additional adverse effects.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA009697: US-009507513-2005USA009697:
Received vaccine Tuesday at 10:30. Woke up at midnight that evening (Wednesday morning) with fever of 101.5, heart rate in the 140s, body aches, injection site pain,and nausea. Still experiencing these symptoms today, Thursday, at 10 am.
Nausea, Headache, Fatigue, Body Aches, Dizziness, Sore Throat that lasted about a day and a half.
Redness of face, arms, bilateral hand swelling, tingling. Lips tingling.
Pfizer vaccine was dilueted by M.A with 0.8ml NS, rather than reccomended 1.8ml NS- resulting in double odse of vaccine. Mother called by provider and informed of medication error.
The new bi-valent Pfizer/Bion-tech vaccine was given to patient, when he has not had the primary series.  He said he was here for his first booster, and the incorrect vaccine was then entered into the system incorrectly, verified, and administered.  It was discovered after the vaccine was given when he was examining his vaccine record card.  Patient has not complained of any adverse events.
lethargic & pale for 24 hrs, rt deltoid area swollen & red, soreness in rt lower chest on inspiration; lt arm had sl swelling, not red; seen by MD 27AUG & feeling better on 30AUG, arm improved;
Received a booster dose that was past 15 hours of initial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a booster dose that was past 15 hours of initial puncture) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a booster dose that was past 15 hours of initial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a booster dose that was past 15 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication is reported.  No treatment of medication is reported.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) Date and time vial was first punctured: 05Nov2021 7:00 PM and administration of vaccine: 06Nov2021 10:00AM.
4 days after the vaccine my MG flared up. First I spent about 9 days too tired to get up. Droopy eye lids, double vision, too weak to even drive my car and problems swallowing. But then the heavy duty stuff starts. Swollen glands for 4 days with a rash, along with the Myasthenia gravis symptoms. So I think I am on the way to mend 4 days later and my glands re-swelled up and the rash came back. This happened a total of three times. Now I am at the 30 day mark. Vocal cords keep collapsing causing my throat to close when I speak. My one eye wont even open at this point. I am so weak I am teaching the dogs to use the vacuum plus drowning in mucus. Before I took the vaccine I was almost completely off my medication and now I am taking it every three hours.
Sight of injection and surrounding arm became very red, hot, and swollen.  Excessive swelling along both the top of arm and under arm /armpit area of injection. whole top of arm swollen, visible underneath shirt.  Swelling started evening of vaccination. Remained swollen for 4 days before resolved.
3hrs after vaccination, pt had shaking, chills, and vomiting since  (1 month) pt has had arthralgia, fatigue, weakness.
Fatigue; she needed to sleep but could not sleep; Extreme Body Pain; not being able to do normal activities; Headache; Arm Pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2019 16:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th December 2019 19:00, 3 hrs after receiving Shingrix, the patient experienced pain in arm. On 13th December 2019, the patient experienced general body pain, activities of daily living impaired and occipital headache. On 14th December 2019, the patient experienced fatigue and sleeplessness. On 15th December 2019, the outcome of the pain in arm, general body pain and fatigue were resolved with sequelae and the outcome of the activities of daily living impaired and sleeplessness were recovered/resolved. On an unknown date, the outcome of the occipital headache was recovering/resolving.   It was unknown if the reporter considered the pain in arm, general body pain, activities of daily living impaired, occipital headache, fatigue and sleeplessness to be related to Shingrix.  Additional details were provided as follows: On the day of vaccination around 7 to 8 pm, the patient's arm started to hurt. A day post vaccination, the patient had extreme body pain from head to toe and laid out on couch due to not being able to do normal activities and headache.  The patient described headache on the back of her head near her neck that extends to both ears and worsened when bending over as pressure was felt. The following day, the patient still suffered with body pain. Two days post vaccination, the patient had fatigue described as feeling like she needed to sleep but could not sleep. The reporter consented to follow up.
rash since its first appearance even until today.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash since its first appearance even until today.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included Rash both legs (rash on her upper thighs and upper arms) since 31-Dec-2020 and Hypertension since an unknown date. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced RASH (rash since its first appearance even until today.). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (rash since its first appearance even until today.) outcome was unknown.            Reported concomitant medication including blood pressure medication and statin. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash since its first appearance even until today.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included Rash both legs (rash on her upper thighs and upper arms) since 31-Dec-2020 and Hypertension since an unknown date. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced RASH (rash since its first appearance even until today.). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (rash since its first appearance even until today.) outcome was unknown.            Reported concomitant medication including blood pressure medication and statin.
Information has been received from a healthcare worker concerning a female who on 26-SEP-2008 was vaccinated with PNEUMOVAX 23 (lot #658074/0961U) 0.5 mL/one dose IM. On 26-SEP-2008 after receiving the dose of PNEUMOVAX 23, the patient experienced swelling, pain, cellulitis and fever. The swelling, cellulitis and pain were experienced in the arm of PNEUMOVAX 23 vaccine administration. The healthcare worker reported that the patient was seen in the practice. At the time of reporting the patient had not recovered from swelling, pain, cellulitis and fever. No further information was provided. This is one of two reports received from the same source. Additional information has been requested.
No AE/PQC; MMR-II was inadvertently administered after a supported temp excursion; This spontaneous report was received from the Medical Assistant, and refers to a patient of unknown age, and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 22-MAR-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant Human albumin) subcutaneous injection, lot #U039906, verified to be valid (after internal review), expiration date: 16-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was inadvertently administered after a supported temp excursion: 9.1 C for 4 hours and 54 minutes. There was no previous temperature excursion (discrepancy, as HCP called back to report multiple excursions on different dates). No adverse event was reported.
Information has been received from a registered dietician concerning a male patient between the age of 5 and 6 who in July 2010, was vaccinated with a dose of MMR II. In July 2010, the patient experienced "flu-like symptoms" after receiving the vaccine. It was unknown if the patient had sought medical attention. Additional information has been requested.
Stuff/sore neck started on October 5th, 2021.  After a week, a headache began in the back of my neck into the back of my head.  On October 5th, I began to have gastrointestinal issues.  Alternating constipation and diarrhea lasted about 5 days.   I've had muscle aches all over my body, but since I have fibromyalgia I am not certain the muscle pain isn't due to the COVID vaccine or my fibromyalgia.  But, the neck pain has gotten quite bad the past 5 days.   Taking tramadol 50mg as needed.
8/1/2022 - ER visit #1, Pulmonary Embolism, 3-month treatment with Xarelto starter pack 12/12/2022 - ER visit #2, Pulmonary Embolism, Xarelto prescription for life 1/11/2023 - ER visit #3, Musculoskeletal Pain (PE resolved) 4/24/2023 - Sudden discoordination and stiffness when walking 5/2/2023 - ER visit #4, Gait Issues, CT ruled out stroke 6/10/2023 - Sudden thrusting of head back and forth, Valium 5mg prescribed 3x/day as needed 6/22/2023 - Target rash on back, negative Lyme but completed Doxycyline 2x/day for 3 weeks
Patient was given Pfizer dose that was not diluted. The error was notice immediately, and reported to the parents. Parents were educated on signs and symptoms to watch for requiring the error. Contacted the parents no response, and left a voice message to return our call requiring  any signs and symptoms that may have occur. We have not heard back from the parents.
Pt stated he had headache and felt weak. Pt lied down, vitals taken BP 118/67; retaken 129/80. Apple juice x2 given. Pt stated he longer had headache & was not weak.
Site: Pain at Injection Site-Severe, Additional Details: patient states pain from injection site did not go away for 4 days. was out of work for 2 days. patient was adviced to see a doctor as this is not normal.
Information has been received from a medical assistant concerning an unspecified adult patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history of the patient was unknown. On 15-FEB-2019, the patient inadvertently received one pediatric formulation dose of VAQTA (strength 25/0.5 (unit was not provided), 0.5 ml once, lot # and expiration date were unknown) intramuscularly for prophylaxis instead of the intended adult formulation dose of VAQTA (strength, dose, lot # and expiration date were not reported). This was confirmed as medication error and not product confusion. No adverse effects was reported.
Immunization given in early afternoon and by evening patient noticed pronounced redness and swelling 2-3 inches from injection site and soreness. By the following day, redness had increased and she called the pharmacy. Pharmacist recommended Tylenol and ice and patient complied. Withing 48 hours, symptoms had subsided.
Instant nodule appeared - small amount of blood - used cotton to wipe. Area turned red and swelled up. Rechecked in 15 minutes. Still swollen. Some soreness in arm. Printed inj. site rxn paper to tell to use ice and NSAID. Rechecked following Monday - she took ADVIL and had a half dollar bruise.
This spontaneous case reported by a consumer, describes the occurrence of injection site pain (her right arm at injection site is sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 047B21A) for COVID-19 immunization. No medical history reported. On Apr 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 16, 2021, patient experienced injection site pain (her right arm at injection site is sore). At the time of the report, injection site pain (her right arm at injection site is sore): unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided. She called inquiring what type of treatment can she use to relieve the soreness. She wants relief before it gets any worse.
Pt recvd vax 14DEC93 & reaction occurred 23DEC92; red dot on face 24DEC93; evening chest & back noted covered w/rash approx 14 days p/MMR was given; fever devel 4 days prior to rash;
Sleeping often; Convergence insufficiency; Difficulty seeing; Soreness; Body ache; Intense pain in her arm; severe headache; Exhausted; chills; Severe migraine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Severe migraine), INSOMNIA (Sleeping often), BINOCULAR EYE MOVEMENT DISORDER (Convergence insufficiency), VISUAL IMPAIRMENT (Difficulty seeing) and PAIN (Soreness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cataract extraction in 2011. Concurrent medical conditions included Hypothyroidism since 1944, Hypertension since 1980, Penicillin allergy, Allergy to antibiotic (Vancomycin), Food allergy (Crab) and Food allergy (Shrimp).   On 21-Feb-2021 at 12:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021 at 7:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced MIGRAINE (Severe migraine), PAIN (Soreness), PAIN (Body ache), PAIN IN EXTREMITY (Intense pain in her arm), HEADACHE (severe headache), FATIGUE (Exhausted) and CHILLS (chills). On an unknown date, the patient experienced INSOMNIA (Sleeping often), BINOCULAR EYE MOVEMENT DISORDER (Convergence insufficiency) and VISUAL IMPAIRMENT (Difficulty seeing). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-May-2021, MIGRAINE (Severe migraine) had resolved with sequelae. At the time of the report, INSOMNIA (Sleeping often), BINOCULAR EYE MOVEMENT DISORDER (Convergence insufficiency), VISUAL IMPAIRMENT (Difficulty seeing), PAIN (Soreness), PAIN (Body ache), PAIN IN EXTREMITY (Intense pain in her arm), HEADACHE (severe headache), FATIGUE (Exhausted) and CHILLS (chills) outcome was unknown.            Other treatment medication included a nasal spray. Concomitant drug used by the patient is CULTRELLE as a probiotic.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up received and it contains updated medical history, allergies, product details, concomitant medications, treatment medications and events.
Severe pain, fever.  Patient went to emergency room. Was seen by primary care 3 days later, still has pain. Was told that the needle may have entered the bursa in her shoulder.
Case number PHEH2015US024815 is an initial spontaneous report received from a other health care professional (medical assistant) on 23 Nov 2015. This report refers to a 11 years old female patient. Medical history and concomitant medications were not reported. This patient under the age of 18 year was vaccinated with FLUCELVAX (batch number: 173991), at a dose of 0.5 ml intramuscularly in deltoid on 23 Nov 2015 at 14:59. It was reported that, the patient was accidently administered FLUCELVAX. No adverse event were reported following the inadvertent administration. Follow up done 1 week after vaccine administration showed no adverse reaction. Follow up received from other healthcare professions (medical assistant) on 01 Feb 2016: Added patient demographics (age and weight), FLUCELVAX details (dose, site of application and time of administration), added event (the patient was accidently given FLUCELVAX) and reporters comments were updated.
Patient was administered a dose of the Moderna COVID 19 vaccine that was beyond 12 hours post punctured.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose of the Moderna COVID 19 vaccine that was beyond 12 hours post punctured.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose of the Moderna COVID 19 vaccine that was beyond 12 hours post punctured.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose of the Moderna COVID 19 vaccine that was beyond 12 hours post punctured.) outcome was unknown.        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.   No concomitant medication was reported. No treatment medication was reported.
11/3/09 Within 45 sec-1 min-burning sensation in throat and nose, 5 min later-headache (whole head) dizziness. 7 hours later-swollen lymph nodes both sides of neck, general swelling back of neck. Dizziness resolving and headache. ADVIL (2) taken. Chills and skin warm to touch.  11/4/09 Woke up next AM with feeling that throat was constricted, difficult to swallow, swollen tongue.  Lymph nodes in neck still swollen, small amt shortness of breath.  Chills and cotinued skin warm to touch.  ADVIL taken again feeling tired.  11/5/09 All symptoms above continue.  Contacted MD- BENADRYL and TYLENOL ordered x1.  Suggested pt recontact MD and ask how to continue taking BENADRYL.  Pt. reports only had 1 inactivated flu shot last year.  Allergic to Sulfa drugs.
no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 21-APR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter. ; Sender's Comments:  US-009507513-2106USA007355:
Systemic: Numbness on right arm-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Patient says received Johnson covid shot 4/29/21 on left arm then on 5/25/21 his right arm felt numb.
This case was reported by a nurse and described the occurrence of arm swelling in a 55-year-old female patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix). The patient's past medical history included allergy to morphine, aspirin allergy, chronic portal hypertension, hepatitis C, intolerance to acetaminophen and penicillin allergy. On 17 February 2004, the patient received the first dose of Twinrix in her left arm (lot HAB239A4). At an unspecified time following the administration of Twinrix, on 17 February 2004, the patient experienced swelling and soreness of the "entire arm", and an injection site reaction described as "black and blue around the injection site". Approximately one week later, on 23 February 2004, the events resolved. On 16 March 2004, the patient received the second dose of Twinrix in her right arm (lot HAB222A6). The expiration date of this lot of Twinrix is 25 January 2004. The nurse noted that, within one hour of the second dose of Twinrix, the patient did not have "any adverse reactions to the injection site." The nurse considered the events to probably be related to vaccination with Twinrix.
Dermatographia since booster. Worst where clothing is bunched up, relieved with antihistamines, pruritus all over body, hives wherever I itch.