chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had two part shot got shingles/suspected vaccination failure; got the shingles; awful pain very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had two part shot got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got the shingles) and pain (Verbatim: awful pain very painful). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2023 This case was reported by a patient via interactive digital media. The patient had two part shingles shots in 2018. The patient was in his/her third month with this awful pain at the time of reporting. The reporter thought he/she was safe from getting the shingles but he/she got the shingles and it was very painful. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, almost 101 F; This non-serious case was reported by a consumer and described the occurrence of fever in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-APR-2023, the patient received the 2nd dose of Shingrix. On 12-APR-2023, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever, almost 101 F). The outcome of the fever was not resolved.   The reporter considered the fever to be related to Shingrix.   The company considered the fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-APR-2023 The case was reported by patient's brother. The temperature was almost 101 degree F. The case had been linked to US2020AMR218334 and US2020AMR218281,reported by the same reporter, for a different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR218334:same reporter US-GLAXOSMITHKLINE-US2020AMR218281:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Impaired work ability, Muscle spasms
Clinical narrative: Severe body aches, extreme pain; Bad headaches/ severe headaches; Dizziness; Chills; Muscle spasm; Nausea; I had to call off work; This non-serious case was reported by a consumer and described the occurrence of general body pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included trouble falling asleep. Concomitant products included zolpidem. Family history included guillain barre syndrome (grandmother became incapacitated when she got the swine flu in 70s.).   On 12-APR-2023, the patient received Shingrix. On 12-APR-2023, less than a day after receiving Shingrix, the patient experienced general body pain (Verbatim: Severe body aches, extreme pain) and headache (Verbatim: Bad headaches/ severe headaches). In APR-2023, the patient experienced dizziness (Verbatim: Dizziness), chills (Verbatim: Chills), muscle spasm (Verbatim: Muscle spasm), nausea (Verbatim: Nausea) and impaired work ability (Verbatim: I had to call off work). The outcome of the general body pain and headache were not resolved and the outcome of the dizziness, chills, muscle spasm, nausea and impaired work ability were not reported.   It was unknown if the reporter considered the general body pain, headache, dizziness, chills, muscle spasm, nausea and impaired work ability to be related to Shingrix.     It was unknown if the company considered the general body pain, headache, dizziness, chills, muscle spasm, nausea and impaired work ability to be related to Shingrix.   Additional Information: GSK receipt date:13-APR-2023 This case was submitted by the online direct entry reporting system.  This report was submitted by site: Public Reporting Selected. The patient was the reporter. The reporter's grandmother had guille barre syndrome and became incapacitated when she got the swine flu shot in the 70's. (Severe body aches, bad headaches )  The symptoms were not treated. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Severe body aches, extreme pain; Bad headaches/ severe headaches; Dizziness; Chills; Muscle spasm; Nausea; I had to call off work; This non-serious case was reported by a consumer and described the occurrence of general body pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included trouble falling asleep. Concomitant products included zolpidem. Family history included guillain barre syndrome (grandmother became incapacitated when she got the swine flu in 70s.).   On 12-APR-2023, the patient received Shingrix. On 12-APR-2023, less than a day after receiving Shingrix, the patient experienced general body pain (Verbatim: Severe body aches, extreme pain) and headache (Verbatim: Bad headaches/ severe headaches). In APR-2023, the patient experienced dizziness (Verbatim: Dizziness), chills (Verbatim: Chills), muscle spasm (Verbatim: Muscle spasm), nausea (Verbatim: Nausea) and impaired work ability (Verbatim: I had to call off work). The outcome of the general body pain and headache were not resolved and the outcome of the dizziness, chills, muscle spasm, nausea and impaired work ability were not reported.   It was unknown if the reporter considered the general body pain, headache, dizziness, chills, muscle spasm, nausea and impaired work ability to be related to Shingrix.     It was unknown if the company considered the general body pain, headache, dizziness, chills, muscle spasm, nausea and impaired work ability to be related to Shingrix.   Additional Information: GSK receipt date:13-APR-2023 This case was submitted by the online direct entry reporting system.  This report was submitted by site: Public Reporting Selected. The patient was the reporter. The reporter's grandmother had guille barre syndrome and became incapacitated when she got the swine flu shot in the 70's. (Severe body aches, bad headaches )  The symptoms were not treated. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Pain in extremity
Clinical narrative: Slightly sore arm; This non-serious case was reported by a nurse and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of cellulitis (1st dose received on May 2022 from lot number 42CM4 and expiry date 11th June 2023, refer linked case US2023AMR039736). Concurrent medical conditions included hypothyroidism, hypertension, anxiety, depression, migraine and allergic reaction to wasp sting (Yellow jacket allergy).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Slightly sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR039736   Additional Information: GSK Receipt Date: 11-APR-2023 The reporter reported that the patient received second dose and did not experienced any other issue other n a slightly sore arm. The reporter did consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR039736:Same reporter
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Expired Hiberix administered; This non-serious case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a infant patient who received Hib (Hiberix) (expiry date 23-MAR-2023) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Expired Hiberix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-APR-2023 The patient received one dose of expired vaccine Hiberix, which was 3rd dose of the series. Patient received a dose of Hiberix, which was expired on 23rd April 2023, which led to expired vaccine used. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: worst case of shingles; still suffering in pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles (Verbatim: worst case of shingles) and pain (Verbatim: still suffering in pain). The outcome of the shingles was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Apr-2023 This case was reported by a patient's wife via interactive digital media. On the next day of vaccination, the patient woke with the worst case of shingles. It had been 17 months; umpteen treatments and he was still suffering in pain.  The pain was excruciating. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Dosing schedule was interrupted by a year; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Dosing schedule was interrupted by a year). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The health care professional (HCP) stated they may had a patient who had a dose interruption with the vaccine Shingrix. Limited information was available as HCP refused to answer questions such as dates and demographics.  The HCP stated that the a possible patients dosing schedule was interrupted by a year. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Due to limited information, the case was processed conservatively for incomplete course of vaccination.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Wrong technique in product usage process
Clinical narrative: The patient got a shingles shot and pneumonia at the same time in the same arm; The pain was awful for about 3 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine (unknown arm) and PNEUMOCOCCAL VACCINE (unknown arm). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: The pain was awful for about 3 days) and wrong technique in product usage process (Verbatim: The patient got a shingles shot and pneumonia at the same time in the same arm). The outcome of the injection site pain was resolved (duration 3 days) and the outcome of the wrong technique in product usage process was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-MAR-2023 The case was received from the patient via interactive digital media. The patient got a shingles shot and pneumonia at the same time in the same arm, oh what a mistake. The follow-up could not be possible as no contact details were available. The patient got a shingles shot and pneumonia at the same time in the same arm, which led to wrong technique in product usage process.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: tired; sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm) and tiredness (Verbatim: tired). The outcome of the pain in arm was recovered/resolved (duration 1 day) and the outcome of the tiredness was not reported.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and tiredness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-Mar-2023 The case was received form the patient via interactive digital media. The patient stated that shingles, vaccination did not gave him or her anything but sore arm for a day and might be a little tired the next day. The patient stated that thanks for pointing out his or her previous comment was not too clear he or she fixed it. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise
Clinical narrative: His reaction really made him feel bad; He did not feel well for a day; This non-serious case was reported by a physician via sales rep and described the occurrence of feeling unwell in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: He did not feel well for a day) and feeling bad (Verbatim: His reaction really made him feel bad). The outcome of the feeling unwell was resolved (duration 1 day) and the outcome of the feeling bad was not reported.   It was unknown if the reporter considered the feeling unwell and feeling bad to be related to Shingrix.     It was unknown if the company considered the feeling unwell and feeling bad to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR056717   Additional Information: GSK Receipt Date: 06-APR-2023 The patient self-reported this case (over age 50). The patient took preventative Shingrix vaccine. The patient reported that after his vaccine he did not felt well for a day and that his reaction really made him feel bad. The sales representative did not know if the reaction was to both shot 1 and 2 or one or the other. This case was linked with case US2023AMR056717, reported by same reporter.
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, Vaccination error
Clinical narrative: Patient received a third Havrix dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 4-year-old female patient who received HAV (Havrix) (batch number CN3G5, expiry date 19-NOV-2023) for prophylaxis.   On 11-APR-2023, the patient received the 3rd dose of Havrix. On 11-APR-2023, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: Patient received a third Havrix dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 18-MAR-2023 The reporter reported that by mistakenly patient received third dose of Havrix vaccine. The reporter wanted to know safety information regarding this situation. The reporter stated that the patient also received an extra dose of hepatitis B vaccine from Merck. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received extra dose of Havrix vaccine in error, which led to extra dose administered.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: Soreness at injection site; Leg soreness; Hip soreness on both sides; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-APR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 11-APR-2023, several hours after receiving Shingrix, the patient experienced injection site pain (Verbatim: Soreness at injection site). In APR-2023, the patient experienced leg pain (Verbatim: Leg soreness) and pain in hip (Verbatim: Hip soreness on both sides). The outcome of the injection site pain, leg pain and pain in hip were not resolved.   It was unknown if the reporter considered the injection site pain, leg pain and pain in hip to be related to Shingrix.     It was unknown if the company considered the injection site pain, leg pain and pain in hip to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-APR-2023 The patient reported that she received 1st dose of Shingrix and a few hours later experienced leg and hip soreness on both sides and soreness at injection site.  Referred to HCP phone number and shingrix website offered. The reporter did not consent to follow-up.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given 20 days after 1st; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 18-year-old female patient who received HBV (Engerix B) (batch number 25K3M, expiry date 02-JUN-2024) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 11-APR-2023, the patient received the 2nd dose of Engerix B. On 11-APR-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose given 20 days after 1st). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 13-APR-2023 The reporter informed that a patient received the 2nd dose of Engerix B 20 days after the first dose. The patient received 2nd dose of Engerix B earlier than the recommended interval, which led to shortening of vaccinations schedule.  Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2019, never got the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in 2019, never got the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter was the patient who stated she never got the second dose.  No other information provided. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired Boostrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 575HC, expiry date 28-FEB-2023) for prophylaxis.   On 14-APR-2023, the patient received Boostrix. On 14-APR-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired Boostrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-APR-2023 The reporter called to report an expired dose of Boostrix was administered to a patient. The reporter consented to follow up via email. The reporter called to report an expired dose of Boostrix was administered to a patient, which led to expired vaccine used.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This solicited report received from a consumer via social media, concerned a female of unspecified age of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in APR-2023, the patient experienced blood clots, and was hospitalized. Duration of hospitalization and discharge information were not reported. It was reported as "Just last week I had my sister hospitalized for blood clots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and blood clots was related.  This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20230434716.; Sender's Comments: V0: 20230433876- blood clots. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered related.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Oral discomfort, Suspected COVID-19
Clinical narrative: EXTREME BITTER TASTE; BURNING IN MOUTH; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: unspecified drug allergy, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient was previously treated with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 8-APR-2021 at left arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1)  The patient received second covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 16-DEC-2021 at left arm for covid-19 prophylaxis. Age at time of vaccination 66 years old. Concomitant medications included prednisone, and zolpidem.  On unspecified date in APR-2023, the patient experienced suspected covid-19 infection (Dose number in series 2) and received non-company suspect drug Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin were not reported, batch number: GG4631 expiry: UNKNOWN) dose and frequency were not reported, administered from 11-APR-2023 to 12-APR-2023 for covid-19 treatment.  On 11-APR-2023 at 19:00, the patient experienced extreme bitter taste and burning in mouth (Dose number in series 2), lasts for approximately 10 hours. Patient was taking other medications within 2 weeks of starting COVID-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from extreme bitter taste, and burning in mouth, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.            No concomitant medications were reported. It was reported that the patient had a heart attack that was occurred four days after the second dose of Moderna COVID-19 vaccine. No treatment medications were reported.   Company Comment: This is a spontaneous case concerning an adult male patient (unknown age) and no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI of Myocardial infarction. The event occurred approximately 4 days after the second dose of mRNA-1273 vaccine. Clinical course, supportive diagnostic procedures and treatment were not provided. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Ear pain, Exposure to SARS-CoV-2, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I was exposed to COVID-19 on March 17, 2023. My symptoms include scratchy throat, sniffles, and an earache. My symptoms got worse. I took a COVID-19 test at home on March 21, 2023. The result was positive. I called my doctor. I was seen that morning. My doctor prescribed Paxlovid. I took the 5-day pill regimen. They symptoms eased on day three, and I tested negative for COVID-19 on the sixth day. I've felt fine ever since.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Throat irritation
Clinical narrative: I was exposed to COVID-19 on March 17, 2023. My symptoms include scratchy throat, sniffles, and an earache. My symptoms got worse. I took a COVID-19 test at home on March 21, 2023. The result was positive. I called my doctor. I was seen that morning. My doctor prescribed Paxlovid. I took the 5-day pill regimen. They symptoms eased on day three, and I tested negative for COVID-19 on the sixth day. I've felt fine ever since.
Age: 43.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient received one vial of the two vial Menveo vaccine. Unknown which vial patient received. Patient reports swollen, hot, red, and very itchy reaction at the injection site. MD recommended she take benadryl at night before bed and Zyrtec during the day and ibuprofen for the pain and swelling and to go to urgent care if this does not improve over the next few days.
Age: 43.0
Sex: F
Vaccine: MNQ
Symptoms: Swelling
Clinical narrative: Patient received one vial of the two vial Menveo vaccine. Unknown which vial patient received. Patient reports swollen, hot, red, and very itchy reaction at the injection site. MD recommended she take benadryl at night before bed and Zyrtec during the day and ibuprofen for the pain and swelling and to go to urgent care if this does not improve over the next few days.
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 20.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A Bivalent booster vaccination that was 6 days past use date. The use by date was 4/8/2023. The vaccine was administered 4/13/2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A Bivalent booster vaccination that was 6 days past use date. The use by date was 4/8/2023. The vaccine was administered 4/13/2023.) and NO ADVERSE EVENT (No adverse event) in a 20-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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-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 13-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 (A Bivalent booster vaccination that was 6 days past use date. The use by date was 4/8/2023. The vaccine was administered 4/13/2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A Bivalent booster vaccination that was 6 days past use date. The use by date was 4/8/2023. The vaccine was administered 4/13/2023.) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (A Bivalent booster vaccination that was 6 days past use date. The use by date was 4/8/2023. The vaccine was administered 4/13/2023.).    Concomitant medications were not reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reporter stated that her facility administered a Bivalent booster vaccination that was 6 days past use date. The use by date was 08-Apr-2023. The vaccine was administered 13-Apr-2023. No report from patient and no reported symptoms.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-719718 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2023: Live follow up received. Updated patient details, event verbatim and narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719718:1st adult patient
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Frustration tolerance decreased, Injected limb mobility decreased, Injection site pain, Pain in extremity, Skin warm
Clinical narrative: The morning after I got the immunization, I awoke to s sore arm, it also felt warm to the touch. I took some Tylenol and my other daily meds. the pain eased up some, but came back when the medicine wore off. I thought the pain would gradually go away. It did not. 11-17-22,  I went to a regularly schedualed appointment with my Rheumatoligist. I told her about my arm and she wrote me a script for Diclofenac Sodium 1% Gel and suggested that I try it a couple times a day. It has eased the pain some, but it comes right back. 12-20-22, I returned to Dr for a schuedualed three month follow-up, I tood him about my arm still hurting and he ordered an X Ray of my right shoulder. I told him that it wasn't my shoulder that was hurting,  I had the X Ray of my shoulder done that day and recieved a card from Dr,  on 1-7-23. the card stated no acute shoulder injury and no Arthritis.  I had told him that the pain was around where the injection was given and not in my shoulder, so the X RAY results were not surprising to me. On 3-27-23 I went to see Dr. for a regularly schedualed three month follow up. The nurse, ( I don't know her last name) who gave me the flu vaccine last September, was in that day, it was the first time I had seen her since. She Looked at my are and said it looked fine to her  { mind you this was over six months after the vaccine was given to me }        i reminded her that I had had on a top with tight sleeves and how she had tugged and pulled on my shirt to get it up far enough to give me the shot. I told her it was like I had had a turniquet on my arm. at that, she didn't have anything else to say to me and when the Doctor came in he did his rutine exam and didn't want to discuss my arm he did say that maybe it would just go away.I am still experiencing pain and mobility issues in my arm. This has all been quite frusterating for me !!
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: X-ray limb normal
Clinical narrative: The morning after I got the immunization, I awoke to s sore arm, it also felt warm to the touch. I took some Tylenol and my other daily meds. the pain eased up some, but came back when the medicine wore off. I thought the pain would gradually go away. It did not. 11-17-22,  I went to a regularly schedualed appointment with my Rheumatoligist. I told her about my arm and she wrote me a script for Diclofenac Sodium 1% Gel and suggested that I try it a couple times a day. It has eased the pain some, but it comes right back. 12-20-22, I returned to Dr for a schuedualed three month follow-up, I tood him about my arm still hurting and he ordered an X Ray of my right shoulder. I told him that it wasn't my shoulder that was hurting,  I had the X Ray of my shoulder done that day and recieved a card from Dr,  on 1-7-23. the card stated no acute shoulder injury and no Arthritis.  I had told him that the pain was around where the injection was given and not in my shoulder, so the X RAY results were not surprising to me. On 3-27-23 I went to see Dr. for a regularly schedualed three month follow up. The nurse, ( I don't know her last name) who gave me the flu vaccine last September, was in that day, it was the first time I had seen her since. She Looked at my are and said it looked fine to her  { mind you this was over six months after the vaccine was given to me }        i reminded her that I had had on a top with tight sleeves and how she had tugged and pulled on my shirt to get it up far enough to give me the shot. I told her it was like I had had a turniquet on my arm. at that, she didn't have anything else to say to me and when the Doctor came in he did his rutine exam and didn't want to discuss my arm he did say that maybe it would just go away.I am still experiencing pain and mobility issues in my arm. This has all been quite frusterating for me !!
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Fall, Head injury, Skin laceration, Suture insertion, Syncope
Clinical narrative: Patient was seen for his 2nd dose of Meningococcal B.  After receiving the vaccine he fainted and fell off the table hitting his head on he ground. Do to the fall he was then transported to the ER where he received 3 stiches on his laceration about his eyebrow.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Rash
Clinical narrative: rash
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Blood test, Inflammation, Localised infection, Peripheral swelling
Clinical narrative: PATIENTS LEFT ARM BECAME INFLAMED AND STARTED TO SWELL THE MORNING AFTER THE VACCINE.  PATINET STATES SWELLING INCREASED OVER THE NEXT FEW DAYS.  SHE SAW DR ON 04/18/23.  DOCTOR THINKS THE ARM IS INFECTED OR POSSIBLE CELLUCITIS.  STARTED ANTIBIOTIC TREATMENT. PATIENT STATES THAT ARM IS SLOWLY GETTING BETTER.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: NO ADVERSE EVENT WAS NOTED.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angiopathy, Arthralgia, Arthritis, Autoimmune disorder, Blood donation
Clinical narrative: For about three months I have been having joint pain and inflammation and pain in my bones. I was donating plasma and during my 12th donation I just had this feeling that something inside of me that kind of blew up and it spread throughout the inside of me. It was this tingling sensation and it just spread throughout me. After my donation and I thought maybe it was something from my donation and maybe it was something from that. I went to go donate again and they said that I could no longer donate, and I needed to reach out to my health care provider and that my viral load is very high, but they could not disclose the information and I had to reach out to my health care provider. I could not see the doctor for two months and I was so sick I was in so much pain in my bones they ached, my fingers and my joints, my head felt like it was three times its sizes there was also this ringing in my ears. I had pink welts on my torso, I had a pink rash and broken blood vessels on my arms and legs as well, I have this feeling of a sunburn on my skin, and bugs that are crawling under my skin. I have a rapid pulse very randomly when I have not been doing something that would cause it to be high. I finally followed up with my health care provider and we did more testing and everything came back negative. I was sent to my PCP who has me going to a neurologist to follow-up. The thing that we have come up this far is that it is an auto immune disease or fibromyalgia. I am seeing a rheumatologist as well.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bone pain, Burning sensation, Feeling abnormal, Fibromyalgia, Formication
Clinical narrative: For about three months I have been having joint pain and inflammation and pain in my bones. I was donating plasma and during my 12th donation I just had this feeling that something inside of me that kind of blew up and it spread throughout the inside of me. It was this tingling sensation and it just spread throughout me. After my donation and I thought maybe it was something from my donation and maybe it was something from that. I went to go donate again and they said that I could no longer donate, and I needed to reach out to my health care provider and that my viral load is very high, but they could not disclose the information and I had to reach out to my health care provider. I could not see the doctor for two months and I was so sick I was in so much pain in my bones they ached, my fingers and my joints, my head felt like it was three times its sizes there was also this ringing in my ears. I had pink welts on my torso, I had a pink rash and broken blood vessels on my arms and legs as well, I have this feeling of a sunburn on my skin, and bugs that are crawling under my skin. I have a rapid pulse very randomly when I have not been doing something that would cause it to be high. I finally followed up with my health care provider and we did more testing and everything came back negative. I was sent to my PCP who has me going to a neurologist to follow-up. The thing that we have come up this far is that it is an auto immune disease or fibromyalgia. I am seeing a rheumatologist as well.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Heart rate increased, Laboratory test, Malaise, Paraesthesia, Rash erythematous
Clinical narrative: For about three months I have been having joint pain and inflammation and pain in my bones. I was donating plasma and during my 12th donation I just had this feeling that something inside of me that kind of blew up and it spread throughout the inside of me. It was this tingling sensation and it just spread throughout me. After my donation and I thought maybe it was something from my donation and maybe it was something from that. I went to go donate again and they said that I could no longer donate, and I needed to reach out to my health care provider and that my viral load is very high, but they could not disclose the information and I had to reach out to my health care provider. I could not see the doctor for two months and I was so sick I was in so much pain in my bones they ached, my fingers and my joints, my head felt like it was three times its sizes there was also this ringing in my ears. I had pink welts on my torso, I had a pink rash and broken blood vessels on my arms and legs as well, I have this feeling of a sunburn on my skin, and bugs that are crawling under my skin. I have a rapid pulse very randomly when I have not been doing something that would cause it to be high. I finally followed up with my health care provider and we did more testing and everything came back negative. I was sent to my PCP who has me going to a neurologist to follow-up. The thing that we have come up this far is that it is an auto immune disease or fibromyalgia. I am seeing a rheumatologist as well.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus, Urticaria, Viral load increased
Clinical narrative: For about three months I have been having joint pain and inflammation and pain in my bones. I was donating plasma and during my 12th donation I just had this feeling that something inside of me that kind of blew up and it spread throughout the inside of me. It was this tingling sensation and it just spread throughout me. After my donation and I thought maybe it was something from my donation and maybe it was something from that. I went to go donate again and they said that I could no longer donate, and I needed to reach out to my health care provider and that my viral load is very high, but they could not disclose the information and I had to reach out to my health care provider. I could not see the doctor for two months and I was so sick I was in so much pain in my bones they ached, my fingers and my joints, my head felt like it was three times its sizes there was also this ringing in my ears. I had pink welts on my torso, I had a pink rash and broken blood vessels on my arms and legs as well, I have this feeling of a sunburn on my skin, and bugs that are crawling under my skin. I have a rapid pulse very randomly when I have not been doing something that would cause it to be high. I finally followed up with my health care provider and we did more testing and everything came back negative. I was sent to my PCP who has me going to a neurologist to follow-up. The thing that we have come up this far is that it is an auto immune disease or fibromyalgia. I am seeing a rheumatologist as well.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pt. received a second bivalent booster dose before it was authorized.  The dose given beyond its beyond use date.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Nasal congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had runny nose, stuffy nose, I did not have fever at all, I had a persistent cough. It was not moist cough. On 03/2/2023 I took a PCR COVID-19 test at an urgent care and the results were positive.  I had a telehealth visit with urgent care on 03/3/2023 and was prescribed Paxlovid.  I started Paxlovid on 3/3/2023 and continued that for the 5 days. I also received a cough medicine, Benzonatate. I could take it as much as 3 times a day. Within a couple of days, I was significantly better the cough persisted for at least 10 day and it got better and better.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Nausea, Oropharyngeal pain
Clinical narrative: Fever, chills, body aches, fatigue, sore throat, dizziness, naseua for over 1 week following vaccine
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, fatigue, sore throat, dizziness, naseua for over 1 week following vaccine
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: none COVID 19 VACCINE EXPIRED 11/22/2022 GIVEN 12/1/2022
Age: 0.42
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient's parent called the clinic and stated that 5 hours after the patient received the Heb B Vaccine the patient started to develop a fever and vomiting.  Advised parent to take the patient to the ER. Followed up with parent, and parent stated that the patient was given medication in the ER and was told to monitor situation. Parent stated that patient started to stabilize after ER Visit.  Parent stated that adverse reaction lasted for about 30 hours in total.
Age: 58.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Chest X-ray normal, Computerised tomogram thorax, Cough, Productive cough, Sleep disorder
Clinical narrative: I began having a persistent cough in January 2023. It became productive after a few weeks. The phlegm was kind of green, so I thought I must have an infection, so I called my PCP on 1/23/2023 and saw him in person on 1/24/2023. I underwent a chest X-ray, and I was put on Advair and prednisone. No anomalies were detected in the X-ray. After I started the Advair and prednisone, the productive cough continued, but I felt better and was able to sleep better at night. I felt like the medications were masking the underlying issue, though. On 1/26/2023, my PCP ordered a CT scan, which I underwent on 2/3/2023. The CT scan results were fairly inconclusive, though the radiologist thought they showed minor scarring of the lungs, which the pulmonologist thought later was an overread. The pulmonologist now thinks that the symptoms may be indicative of seasonal allergies and/or latent asthma. I am currently taking fluticasone and an albuterol inhaler, ipratropium bromide, and OTC decongestant with guaifenesin and dextromethorphan (as needed). My cough is now much milder, but it is still present.
Age: 58.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Sputum discoloured
Clinical narrative: I began having a persistent cough in January 2023. It became productive after a few weeks. The phlegm was kind of green, so I thought I must have an infection, so I called my PCP on 1/23/2023 and saw him in person on 1/24/2023. I underwent a chest X-ray, and I was put on Advair and prednisone. No anomalies were detected in the X-ray. After I started the Advair and prednisone, the productive cough continued, but I felt better and was able to sleep better at night. I felt like the medications were masking the underlying issue, though. On 1/26/2023, my PCP ordered a CT scan, which I underwent on 2/3/2023. The CT scan results were fairly inconclusive, though the radiologist thought they showed minor scarring of the lungs, which the pulmonologist thought later was an overread. The pulmonologist now thinks that the symptoms may be indicative of seasonal allergies and/or latent asthma. I am currently taking fluticasone and an albuterol inhaler, ipratropium bromide, and OTC decongestant with guaifenesin and dextromethorphan (as needed). My cough is now much milder, but it is still present.