chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; Information has been received from a lawyer, regarding a case in ligitation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On an unknown date in 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Patient received Moderna vaccine from a different pharmacy when she wasnt in the approved age of 18 years old so we administered the second dose so they are finished with the series as a requirement for school.
Initial misuse report received from a healthcare professional on 17 May 2013. A child received only DTaP/IPV component of PENTACEL and was not given the ActHIB component. No adverse event was reported. List of documents held by sender: none.
Patient presented to the clinic stating she was needing a COVID booster shot.  Patient was given a Pfizer Bivalent booster shot 0.3ml. When going to enter vaccination into system it was noticed that this was patients first COVID vaccination and not a booster shot.
In the beginning of June when she sat up she couldn't see. Everything was completely blacked out. It lasted about 10mins her vision came back and every since then her vision has been blurry. She couldn't walk or go anywhere without help. She had to get a caregiver. She also had tiredness, word recognition lost, unable to read & write. She has suffered memory issues and balance issues.  She has had hearing loss, peeling of the skin and within the last 3 weeks she has had a sensory of sensitive of the skin when being touched.  She has been to several doctor.
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes mellitus.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (fatigue). On 25-Mar-2021, FATIGUE (fatigue) had resolved. Not Provided      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.   Concomitant medications are not provided by the reporter. No treatment drugs are not provided by reporter.
This report was received from a person and was assigned manufacturer report number US201011004024. An unknown number of young girls on an unspecified date were vaccinated with a dose of GARDASIL (Lot # not provided) on an unspecified date. It was reported that the patients experienced bad reactions to GARDASIL. The reporter stated that they had had bad reactions that were like autoimmune disorders as a result of treatment with GARDASIL. Some of the patients had experienced pancreatitis. "It was like the body turned around and attacked itself, almost like an allergic reaction." The reporter said that the physician thought that the patients may have lupus or other autoimmune disorder. She also stated that the patient's were also complaining of joint-muscle pain and neurological system problems. At the time of this report, the patient's outcome was unknown. This was originally reported by a lawyer. This is one of several reports received from the same source. Upon internal review, pancreatitis was considered to be an other important medical event. Attempts to obtain additional identifying information to distinguish the individual patients mentioned in this report has been unsuccessful.
This spontaneous report as received from a nurse refers to a 10 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 21-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Dizziness, sweating, light headedness (45 minutes after vaccine); fainting (1 hour after vaccine);  low grade fever, body aches (12 hours after vaccine)
little bit of shortness of breath; fever; head is hurting; soreness of arm; This spontaneous case was reported by an other caregiver and describes the occurrence of PAIN IN EXTREMITY (soreness of arm), DYSPNOEA (little bit of shortness of breath), PYREXIA (fever) and HEADACHE (head is hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high and Blood cholesterol abnormal.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness of arm). On 13-Apr-2021, the patient experienced DYSPNOEA (little bit of shortness of breath), PYREXIA (fever) and HEADACHE (head is hurting). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache and Fever, at an unspecified dose and frequency. On 13-Apr-2021, PAIN IN EXTREMITY (soreness of arm) had resolved. At the time of the report, DYSPNOEA (little bit of shortness of breath), PYREXIA (fever) and HEADACHE (head is hurting) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was Not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications were reported.
Pt went to bed with a headache and woke up the next AM with a 103 fever. Her vaginal area was really swollen and painful. She also had some dysuria.
high pitched screaming, convuls, lifeless, very cold reaction started 2hrs or so p/shot; took to MD few days later had ear infect & probable bronchitis; was prescribed Rondec & amoxicillian; next day pt died;
pt recvd 2nd dose of vax;1aug95 exp tingling at inj site which radiated to hand;devel redness&swelling of bicep & medial upper arm to the antecubital fossa;ecchymosis & exquisite tenderness to touch;few varicella lesions on arms,legs,body
Breathing problems/she still has breathing problems; She still has tachycardia; She didn't receive the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing problems/she still has breathing problems), TACHYCARDIA (She still has tachycardia) and PRODUCT DOSE OMISSION ISSUE (She didn't receive the 2nd dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (LUTERA) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Breathing problems/she still has breathing problems), TACHYCARDIA (She still has tachycardia) and PRODUCT DOSE OMISSION ISSUE (She didn't receive the 2nd dose). At the time of the report, DYSPNOEA (Breathing problems/she still has breathing problems) and TACHYCARDIA (She still has tachycardia) had not resolved and PRODUCT DOSE OMISSION ISSUE (She didn't receive the 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 antibody test: positive (Positive) tested positive twice for Covid-19. On an unknown date, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided by the reporter.
Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Warm Transferred from Moderna Customer Care Case No.00135704. HCP reported on 02Apr2021 that they had power outage on 02Apr2021 and vials were in Freezer and Refrigerator where Temperature dropped to : Frozen Vaccine 47Minutes -13.79 C Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses Lot no 027B21A 100 doses Lot no 030B21A 100 doses Lot No 02B21A 140 doses HCP said that 63 doses were administered to 63 Patients. She provided all requested information of patients who received the effected Vaccine.   This case was linked to MOD21-068792, MOD21-068791, MOD21-068620, MOD21-068645, MOD21-068696, MOD21-068788, MOD21-068703, MOD21-068705, MOD21-068707, MOD21-068709, MOD21-068711, MOD21-068713, MOD21-068716, MOD21-068786, MOD21-068717, MOD21-068718, MOD21-068718, MOD21-068721, MOD21-068722, MOD21-068723, MOD21-068724, MOD21-068727, MOD21-068729, MOD21-068731, MOD21-068732, MOD21-068733, MOD21-068734, MOD21-068735, MOD21-068736, MOD21-068738, MOD21-068785, MOD21-068739, MOD21-068768, MOD21-068769, MOD21-068770, MOD21-068771, MOD21-068772, MOD21-068773, MOD21-068774, MOD21-068775, MOD21-068776, MOD21-068778, MOD21-068780, MOD21-068781, MOD21-068782, MOD21-068783, MOD21-068784 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-068792: MOD21-068791: MOD21-068620: MOD21-068645: MOD21-068696: MOD21-068788: MOD21-068703: MOD21-068705: MOD21-068707: MOD21-068709: MOD21-068711: MOD21-068713: MOD21-068716: MOD21-068786: MOD21-068717: MOD21-068718: MOD21-068718: MOD21-068721: MOD21-068722: MOD21-068723: MOD21-068724: MOD21-068727: MOD21-068729: MOD21-068731: MOD21-068732: MOD21-068733: MOD21-068734: MOD21-068735: MOD21-068736: MOD21-068738: MOD21-068785: MOD21-068739: MOD21-068768: MOD21-068769: MOD21-068770: MOD21-068771: MOD21-068772: MOD21-068773: MOD21-068774: MOD21-068775: MOD21-068776: MOD21-068778: MOD21-068780: MOD21-068781: MOD21-068782: MOD21-068783: MOD21-068784:
Head Ache Nauseated Fever/Chills Body Aches/Fatigue Extreme pain in both hands/Arthritis like pain/trouble holding on to a cup, would drop from my hand, would have to use 2 hands
Start having Arthritis pain in feet and fingers on 05/17/19 and symptoms gotten worse after second shot.
Approximately 5 minutes post vaccine administration, pt reported shortness of breath and chest tightness. Vital signs remained stable BP 100/65, O2 sat 97%, HR 80-100, respirations easy and unlabored.  Pt also experienced nausea without vomiting, and possible tightness in the throat, and numbness in the left arm. No swelling, no redness, no rash. EMS was called, EKG showed NSR, pt was transported to the hospital via EMS
Have started to constantly smell cigarettes; The smell has led to me being nauseous and vomiting; My doctor drew a blood panel but didn't find any cause.
From initial information received from a pharmacist regarding an adverse event occurring, it was reported that the pharmacy dispensed a dose of Menomune A/C/Y/W-135 to the pt's grandmother. The vaccine was left out of refrigeration for five days and was then administered to a male pt by his grandmother on an unspecified date. The pt now complains of a fever, muscle aches and joint pain. No specifics were provided regarding the pt's age, the lot number, route, site or vaccination date of the product administered or the onset date of the adverse events. The pt's recovery status is currently unk. From additional information received on 25Oct04, it was reported that the pt is an 18 year old male. The responsible physician's name was also provided. Per the reporter the case was reviewed and there is no additional information at this time. The pt's recovery status was not reported.
Itching, pain Rash (observed in office 8/23/19, erythematous, vesicular lesions in dermatomal pattern on right side of back, right torso/breast
Severe tremors or twitches in the muscles that control my left eyeball. I began to experience this condition only after my COVID-19 booster shot (3rd COVID-19 shot).
This case was reported by a nurse via call center representative and described the occurrence of chills in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 3rd September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 12 hrs after receiving SHINGRIX, the patient experienced chills, pain in arm, pain, facial flushing and swelling of feet. In September 2018, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the pain, facial flushing and swelling of feet were recovering/resolving. It was unknown if the reporter considered the chills, pain in arm, pain, facial flushing and swelling of feet to be related to SHINGRIX. Additional details were reported as follows: The reporting nurse was the patient who received a dose of SHINGRIX in right arm. The patient reported that about 12 hours after the vaccination with SHINGRIX, she awoke with shaking chills which lasted about 10 minutes. The patient did not have a fever. On 5th September 2018, after 60 hours, the patient noted right axillary area tenderness. The next evening, the patient noted that her upper arm was tender to the touch. The events subsequently progressed to her lower arm being tender. The patient also began experiencing achiness, flushing of her face, and puffy feet. The axillary and arm tenderness lasted for approximately three days and it was resolving. The symptoms related to the achiness, flushing, and puffy feet were unchanged. The patient called back and stated that she changed her mind and did not want her physician to be contacted.
Last week she started having a sore arm on the arm where they gave the injection (left); a slight headache; 1st dose 30Jul2021 / 2nd dose 10Sep2021; pain on her arm and everything; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on her arm and everything), VACCINATION SITE PAIN (Last week she started having a sore arm on the arm where they gave the injection (left)), HEADACHE (a slight headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 30Jul2021 / 2nd dose 10Sep2021) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced PAIN IN EXTREMITY (pain on her arm and everything) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 30Jul2021 / 2nd dose 10Sep2021). In December 2021, the patient experienced VACCINATION SITE PAIN (Last week she started having a sore arm on the arm where they gave the injection (left)) and HEADACHE (a slight headache). On 10-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 30Jul2021 / 2nd dose 10Sep2021) had resolved. At the time of the report, PAIN IN EXTREMITY (pain on her arm and everything) had resolved and VACCINATION SITE PAIN (Last week she started having a sore arm on the arm where they gave the injection (left)) and HEADACHE (a slight headache) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided.
RASH TO BODY x3 DAYS AFTER GETTING VACCINES. PRESCRIBED PRELONE, BENADRYL, AND HYDROCORTISONE CREAM.
Nausea, Vomiting, chills started on 5/25/22. Treatment includes: ST/PT consult, IV zosyn and monitoring in hospital.
The vial was moved from freezer to refrigerator on 27-Feb-2023 with BUD as 29-Mar-2023 was administered to patient after 29-Mar-2023; No adverse event; Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023), PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator on 27-Feb-2023 with BUD as 29-Mar-2023 was administered to patient after 29-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 45-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     It was reported that there were no information about previous COVID-19 vaccination doses.     On 07-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator on 27-Feb-2023 with BUD as 29-Mar-2023 was administered to patient after 29-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023), PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator on 27-Feb-2023 with BUD as 29-Mar-2023 was administered to patient after 29-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023) and PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator on 27-Feb-2023 with BUD as 29-Mar-2023 was administered to patient after 29-Mar-2023).    Dosage text for suspect product was reported as additional booster.  Concomitant drugs were not reported.  It was reported that the Moderna 6 years plus booster vaccine was administered past its use by date of 29-Mar-2023.  Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2023: Live follow up received, updated patient's name, vaccine expiry date, vial storage condition and event product storage error was added.
chills, fever, muscle aches p/4th dose; no rash no resp problems; opossum behaving aggressively; shot animal & splattered tissue all over; some got into open cut;
After 3-4h of the vaccine, patient suffered intermediate headache, 1st dose of Tylenol 750mg PO was given, symptom partially resolved. 15h after, patient had chills followed by high fever, another dose of Tylenol 750mg PO and naproxen 60mg PO were given, 2 hours later, fever and chills resolved. Continuously having fatigue, dizziness, nausea, diarrhea, myalgia, arthralgia for 1-2 days. Lymphadenopathy was felt but unable to touch any swelling lymph nodes in left axillary area. All of symptoms were resolved after 3-4 days. Due to a possible exposure notice, got COVID-19 tested on 12/23/2020, both rapid antigen test and RT-PCR were negative.
Booster dose: Headache, chills, injection site pain, fatigue, weakness, bellyache, decreased appetite
Left side of face is numb, increases with nasal congestions, below cheek and above eye but vision is not affected at this time, no noticeable facial droop.  So far cannot tell by looking at face.  started out feeling like "tingly after seeing the dentist" then turned to numb and progressed to the eye. now eye is numb.
Pain in left arm where I received the shot. Pain when I lift my arm. Pain still persists now (11/16/2010)
Vaccine mixed with incorrect diluent (sterile water instead of normal saline). Pt informed of error and offered revaccination. Pt reports no adverse effects.
This spontaneous report as received from a medical assistant referred to a patient of unknown age. The patient was vaccinated with dose 2 of GARDASIL late on 22-MAY-2012. The first dose of GARDASIL was given at another provider's office. No other co-suspects were reported. No concomitant medications were reported. The patient was not experienced any known symptoms. No treatment information was reported. Additional information has been requested.
No other AE; the dose of ROTATEQ was administered today and expired on 4/1/2021; This spontaneous report as received from Medical Assistant regarding to a 2 month old female patient. Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 13-APR-2021, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S024843 with expiration date 01-APR-2021, 1 dosage form, orally for prophylaxis (expired product administered). There was no adverse event.
Flu like sysmptom including ringing in ears, headache, fatigue and fever.  Covid arm with lesion approximately 4" in diameter with fever and itching.
Patient received Pfizer Covid 28 days after Moderna Covidvaccine.  Patient should have received Moderna Covid vaccine for 2nd shot in the series