chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Dysentery, Dysphagia, Dyspnoea, Pharyngeal swelling
Clinical narrative: causing trouble breathing; trouble breathing and swallowing; intermittent dysentery; exacerbation of his pre-existing dysentery and pre-existing intermittent throat swelling; sore on tongue; scabbed sore on head; scabbed; darkened scabbed area on his head; This serious case was reported by a consumer via call center representative and described the occurrence of dysentery in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included throat swelling (intermittent throat swelling) and dysentery (intermittent dysentery for 3 years).   In OCT-2024, the patient received the 1st dose of Shingrix. On 03-NOV-2024, 4 days after receiving Shingrix, the patient experienced tongue ulceration (Verbatim: sore on tongue), headache (Verbatim: scabbed sore on head), scab (Verbatim: scabbed) and skin discoloration (Verbatim: darkened scabbed area on his head). On an unknown date, the patient experienced dysentery (Verbatim: intermittent dysentery) (serious criteria GSK medically significant), difficulty breathing (Verbatim: causing trouble breathing), swallowing difficult (Verbatim: trouble breathing and swallowing) and condition aggravated (Verbatim: exacerbation of his pre-existing dysentery and pre-existing intermittent throat swelling). The outcome of the dysentery and headache were unknown and the outcome of the tongue ulceration was resolving and the outcome of the difficulty breathing, swallowing difficult, scab, skin discoloration and condition aggravated were not reported.   It was unknown if the reporter considered the dysentery, tongue ulceration, headache, difficulty breathing, swallowing difficult, scab, skin discoloration and condition aggravated to be related to Shingrix.     The company considered the dysentery to be unrelated to Shingrix. It was unknown if the company considered the tongue ulceration, headache, difficulty breathing, swallowing difficult, scab, skin discoloration and condition aggravated to be related to Shingrix.   Additional Information: GSK receipt date: 04-NOV-2024. The patient who stated that he received his first Shingrix dose on either 29th October or 30th October 2024.  He reported that he discovered a darkened scabbed area on his head one day before the reporting date.  He also reported that he noticed a sore on his tongue which was better on the day of reporting.  He also reported exacerbation of his pre-existing dysentery and pre-existing intermittent throat swelling, that caused trouble breathing and swallowing.; Sender's Comments: Dysentery is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Scab, Skin discolouration, Tongue ulceration
Clinical narrative: causing trouble breathing; trouble breathing and swallowing; intermittent dysentery; exacerbation of his pre-existing dysentery and pre-existing intermittent throat swelling; sore on tongue; scabbed sore on head; scabbed; darkened scabbed area on his head; This serious case was reported by a consumer via call center representative and described the occurrence of dysentery in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included throat swelling (intermittent throat swelling) and dysentery (intermittent dysentery for 3 years).   In OCT-2024, the patient received the 1st dose of Shingrix. On 03-NOV-2024, 4 days after receiving Shingrix, the patient experienced tongue ulceration (Verbatim: sore on tongue), headache (Verbatim: scabbed sore on head), scab (Verbatim: scabbed) and skin discoloration (Verbatim: darkened scabbed area on his head). On an unknown date, the patient experienced dysentery (Verbatim: intermittent dysentery) (serious criteria GSK medically significant), difficulty breathing (Verbatim: causing trouble breathing), swallowing difficult (Verbatim: trouble breathing and swallowing) and condition aggravated (Verbatim: exacerbation of his pre-existing dysentery and pre-existing intermittent throat swelling). The outcome of the dysentery and headache were unknown and the outcome of the tongue ulceration was resolving and the outcome of the difficulty breathing, swallowing difficult, scab, skin discoloration and condition aggravated were not reported.   It was unknown if the reporter considered the dysentery, tongue ulceration, headache, difficulty breathing, swallowing difficult, scab, skin discoloration and condition aggravated to be related to Shingrix.     The company considered the dysentery to be unrelated to Shingrix. It was unknown if the company considered the tongue ulceration, headache, difficulty breathing, swallowing difficult, scab, skin discoloration and condition aggravated to be related to Shingrix.   Additional Information: GSK receipt date: 04-NOV-2024. The patient who stated that he received his first Shingrix dose on either 29th October or 30th October 2024.  He reported that he discovered a darkened scabbed area on his head one day before the reporting date.  He also reported that he noticed a sore on his tongue which was better on the day of reporting.  He also reported exacerbation of his pre-existing dysentery and pre-existing intermittent throat swelling, that caused trouble breathing and swallowing.; Sender's Comments: Dysentery is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: COVID19
Symptoms: Osteopenia, Osteoporosis
Clinical narrative: OSTEOPOROSIS -2.5 IN SPINE; OSTEOPENIA IN FEMUR; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported (Dose no in series: 1), administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. Inbound call from consumer stating in 2019 her bone density was perfect, in 2021 she had the shot, and in 2024 the repeat test now shows osteoporosis -2.5 in spine and osteopenia in femur (Dose no in series: 1) with no family history.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the osteoporosis and osteopenia was not reported. This report was non-serious.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Rotator cuff syndrome, Sinus disorder
Clinical narrative: tendinitis of his left shoulder; sinus issues; The caller shares that he also contracted COVID in July2024 despite receiving the boosters / fatigue; This spontaneous case was reported by a patient and describes the occurrence of ROTATOR CUFF SYNDROME (tendinitis of his left shoulder), SINUS DISORDER (sinus issues) and COVID-19 (The caller shares that he also contracted COVID in July2024 despite receiving the boosters / fatigue) in a 79-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In July 2024, the patient experienced COVID-19 (The caller shares that he also contracted COVID in July2024 despite receiving the boosters / fatigue). On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (tendinitis of his left shoulder) and SINUS DISORDER (sinus issues). In 2024, COVID-19 (The caller shares that he also contracted COVID in July2024 despite receiving the boosters / fatigue) had resolved. At the time of the report, ROTATOR CUFF SYNDROME (tendinitis of his left shoulder) and SINUS DISORDER (sinus issues) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient had tendinitis of his left shoulder and was asking if it was okay to receive the vaccine or would it aggravate the inflammation on his left shoulder. The reporter stated he would receive a plasma injection in his right arm to address the tendinitis.  The reporter shared that he also contracted COVID in Jul-2024 despite receiving the boosters. The reporter confirmed that his doses were from Moderna and had 5 or 6 doses. The reporter stated that his COVID-19 symptoms lasted for 2 weeks. He described his experience as ugly stuff and elaborated that his symptoms were fatigue and sinus issues. However, the reporter highlighted fatigue was his main issue.  Reporter causality was not reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Tinnitus
Clinical narrative: Migraines and tinnitus seem to be more frequent; Migraines and tinnitus seem to be more frequent; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 05Nov2024, this case now contains all required information to be considered valid.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "vaginal" (unspecified if ongoing); "vitamin D3" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "headaches" (unspecified if ongoing); "accident", start date: 2010, stop date: 2010, notes: caused partially compressed or collapsed hip; feels two legs are different lengths affecting balance; "aura symptoms" (unspecified if ongoing); "tinnitus, ringing" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3; TIROSINT taken for hypothyroidism, autoimmune thyroiditis, autoimmune disorder (ongoing). The patient also took other concomitant therapy. Vaccination history included: Bnt162b2 (Dose number: 1, Single), for Covid-19 immunization, reaction(s): "migraines", "tinnitus". The following information was reported: MIGRAINE (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "Migraines and tinnitus seem to be more frequent".  Additional information: It was reported that patient was also taking vaginal cream for an unspecified indication.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400144077 Same patient, different dose/event;US-PFIZER INC-202400295403 Same patient/event, different dose;
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: Sore arm; drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) in a 28-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Asthma - since childhood ADHD Patient was diagnosed with Covid 19.  The patient's past medical history included COVID-19 on 25-Apr-2023 and ADHD. Previously administered products included for No adverse effect: TDAP on 05-Nov-2024. Past adverse reactions to the above products included Product used for unknown indication with TDAP. Concurrent medical conditions included Asthma. Concomitant products included Paracetamol (Tylenol) for an unknown indication.    On 05-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 05-Nov-2024, the patient experienced PAIN IN EXTREMITY (Sore arm) and MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy). On 05-Nov-2024, PAIN IN EXTREMITY (Sore arm) and MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) had resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Patient was 31 weeks, 4 days pregnant at the time of vaccine administration. No treatment medications were reported.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: a patient getting more than one dose, administered in 2023 and then administered in 2024; arm soreness; This is a spontaneous report received from a Pharmacist from medical information team.  A 73-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 16Sep2024 as dose 2, 0.5 ml single (Lot number: HC3598, Expiration Date: 31May2025) at the age of 73 years, in right arm for immunisation, Device Lot Number: HC3598, Device Expiration Date: 31May2025. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE, on 16Sep2024; BNT162B2 OMICRON (KP.2) taken for immunisation, on 12Sep2024 as dose 1, single. Vaccination history included: abrysvo (DOSE 1, SINGLE), administration date: 11Dec2023, for Immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Sep2024, outcome "recovered", described as "arm soreness"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "a patient getting more than one dose, administered in 2023 and then administered in 2024". Therapeutic measures were not taken as a result of incorrect dose administered.  Additional information: NDC number of Abrysvo: 00069034401. The patient had was he actually got a high dose flu shot on the same day on the right arm also and then within the past 4 weeks, he did get a Pfizer covid shot.  The high dose flu shot was also administered on 16Sep2024 and the manufacturer is Sanofi Pasteur; the Pfizer covid vaccine was administered to the patient on 12Sep2024. No treatment required for the reported event. The second Abrysvo was a mistake and the patient thought he had to find a secondary shot and did not realize that it was only the one time and he thought it was every year that you get it. The patient had not reported a reaction so far and had not had a reaction so far. The medication error occurred when the product was administered to the patient. The error was not noticed and intercepted before the product was supplied to the patient. Inadvertent human error was considered to be responsible for the medication error. The patient experience any adverse event as a consequence of the error including arm soreness. The reporter contacted the patient again, spoke to patient on 11Oct2024, arm soreness resolved, no issues.   Follow-up (01Nov2024): Follow-up attempts are completed.  Follow-up (05Nov2024): This is a spontaneous follow-up report received from a Pharmacist. Updated information: historical vaccine (BNT162B2 OMICRON (KP.2) deleted), concomitant vaccine (added flu vaccine, BNT162B2 OMICRON (KP.2)), new event (arm soreness), details for medication error.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: Reconstituting the vaccine, the top that was on the syringe which contains the diluent broke off and it's made the vaccine spread all over the counter vaccine was not administered to any patient; The initial case was missing the following minimum criteria: No adverse event (Product complaint only). Upon receipt of follow-up information on 30Oct2024, this case now contains all required information to be considered valid (reportable determination)  This is a spontaneous report received from a Pharmacist from product quality group, Program ID: .  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), (Lot number: KC7884, Expiration Date: 30Sep2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), outcome "unknown", described as "Reconstituting the vaccine, the top that was on the syringe which contains the diluent broke off and it's made the vaccine spread all over the counter vaccine was not administered to any patient". The action taken for rsv vaccine prot.subunit pref 2v was unknown.  Additional information: A pharmacist was calling about RSV vaccine which was Abrysvo. The reporter said that as she was reconstituting the vaccine, the top that was on the syringe which contained the diluent broke off and made the vaccine spread all over the counter. The reporter also said that the sample of the product was available to be returned.   Causality for "reconstituting the vaccine, the top that was on the syringe which contains the diluent broke off and it's made the vaccine spread all over the counter vaccine was not administered to any patient" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out/Lost consciousness; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Nov2024 at 10:00 as dose 1, single (Lot number: 020F) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, start date: 05Oct2024, stop date: 05Oct2024. Vaccination history included: Moderna covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Manufacturer: Moderna), for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer: Moderna), for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer: Moderna), for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE, Manufacturer: Moderna), for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 1, SINGLE, Manufacturer: Moderna), for Covid-19 Immunization. The patient had no known allergies. The patient had no other medical history.   The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 02Nov2024 at 10:02, outcome "recovered" (02Nov2024), described as "passed out/Lost consciousness". Therapeutic measures were taken as a result of loss of consciousness. It was reported that patient lost consciousness/passed out within minutes of receiving the booster. Paramedics were called "blood pressure/blood sugar" (as reported). This was the first dose of Pfizer (vaccine dose number: 6). All others were Moderna.   No follow-up attempts are possible.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6201), in arm, on 15Mar2021 as dose 2, single (Lot number: EN6207), in arm and on 12Jan2022 as dose 3 (booster), single (Lot number: FD7218) at the age of 74 years, in arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Allergic to dander, cat, dogs, horse, pigs" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Tetanus- equine-horse-serum origin, for Immunisation, reaction(s): "chills", "Temporary high fever". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The clinical course was reported as follows: The patient presented COVID-19 in early Jan-Jul 2022 (as reported). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (2022) positive, notes: Early Jan2022-Jul2022.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Tinnitus
Clinical narrative: migraines and tinnitus seem to be more frequent; migraines and tinnitus seem to be more frequent; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune disease" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "vaginal" (unspecified if ongoing); "vitamin D3" (unspecified if ongoing); "tinnitus, ringing", start date: 2017 (unspecified if ongoing); "accident", start date: 2010 (unspecified if ongoing); "Migraine", start date: 2017 (unspecified if ongoing); "aura symptoms", start date: 2017 (unspecified if ongoing); "headaches" (unspecified if ongoing); "partially compressed or collapsed hip", start date: 2010 (unspecified if ongoing); "feels two legs are different lengths affecting balance", start date: 2010 (unspecified if ongoing); "feels two legs are different lengths affecting balance", start date: 2010 (unspecified if ongoing); "screws put in femur" (unspecified if ongoing); "vestibular migraine" (unspecified if ongoing). Concomitant medication(s) included: TIROSINT taken for hypothyroidism, autoimmune thyroiditis, autoimmune disorder (ongoing); VITAMIN D3. The patient also took other concomitant therapy. The following information was reported: MIGRAINE (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "migraines and tinnitus seem to be more frequent".  Additional information: The patient started taking TIROSINT probably 2019 or 2020. Clarified takes Tirosint for hypothyroidism, clarified Hashimoto's thyroiditis, autoimmune disease. Concomitant medications also included thyroid medication and vaginal cream. The patient did get migraines, gets various aura symptoms, had tinnitus, ringing, since 2017, after bad migraine, since started taking all of the COVID vaccines migraines and tinnitus seem to be more frequent. The patient's migraines, headaches were not severe, aura symptoms, some doctors say, like ENT and neurologist, sometimes gets migraine, had light shows with migraines. Headaches were really least significant, if strong moderate headache, takes two aspirins. When getting a headache, tinnitus starts, part of migraine symptoms. When in hospital for observation, the patient was said to have vestibular migraine. The accident that the caller had dating from 2010, caused partially compressed or collapsed hip, because of that feels two legs were different lengths affecting balance.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400144077 Same patient, different dose/event;US-PFIZER INC-2021058557 Same patient/event, different dose;US-PFIZER INC-202400295404 same patient/events, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Blood test, Computerised tomogram, Magnetic resonance imaging, Migraine
Clinical narrative: migraines and tinnitus seem to be more frequent; migraines and tinnitus seem to be more frequent; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "tinnitus, ringing", start date: 2017 (unspecified if ongoing); "migraines, gets various aura symptoms", start date: 2017 (unspecified if ongoing); "headache" (unspecified if ongoing); "accident", start date: 2010 (unspecified if ongoing); "partially compressed or collapsed hip", start date: 2010 (unspecified if ongoing), notes: because of accident caller had dating from 2010, caused partially compressed or collapsed hip; "feels two legs are different lengths affecting balance", start date: 2010 (unspecified if ongoing). Concomitant medication(s) included: TIROSINT taken for hypothyroidism, autoimmune thyroiditis (ongoing); VITAMIN D3. The patient also took other concomitant therapy. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated"; Bnt162b2 (SINGLE, DOSE 2), for COVID-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated". The following information was reported: MIGRAINE (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "migraines and tinnitus seem to be more frequent". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Does get migraines, gets various aura symptoms, has tinnitus, ringing, since 2017, after bad migraine, since started taking all of the COVID vaccines migraines and tinnitus seem to be more frequent. But has never had what happened to caller. Concomitant products: Takes very few medications, nothing changed in terms of medications. Takes thyroid medication and vaginal cream and vitamin D3, that is all. Clarified takes Tirosint for hypothyroidism, clarified Hashimoto's thyroiditis, autoimmune disease.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400144077 same patient, different dose/events;US-PFIZER INC-202400295403 same patient/events, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Spinal X-ray, Tinnitus, X-ray of pelvis and hip
Clinical narrative: migraines and tinnitus seem to be more frequent; migraines and tinnitus seem to be more frequent; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "tinnitus, ringing", start date: 2017 (unspecified if ongoing); "migraines, gets various aura symptoms", start date: 2017 (unspecified if ongoing); "headache" (unspecified if ongoing); "accident", start date: 2010 (unspecified if ongoing); "partially compressed or collapsed hip", start date: 2010 (unspecified if ongoing), notes: because of accident caller had dating from 2010, caused partially compressed or collapsed hip; "feels two legs are different lengths affecting balance", start date: 2010 (unspecified if ongoing). Concomitant medication(s) included: TIROSINT taken for hypothyroidism, autoimmune thyroiditis (ongoing); VITAMIN D3. The patient also took other concomitant therapy. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated"; Bnt162b2 (SINGLE, DOSE 2), for COVID-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated". The following information was reported: MIGRAINE (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "migraines and tinnitus seem to be more frequent". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Does get migraines, gets various aura symptoms, has tinnitus, ringing, since 2017, after bad migraine, since started taking all of the COVID vaccines migraines and tinnitus seem to be more frequent. But has never had what happened to caller. Concomitant products: Takes very few medications, nothing changed in terms of medications. Takes thyroid medication and vaginal cream and vitamin D3, that is all. Clarified takes Tirosint for hypothyroidism, clarified Hashimoto's thyroiditis, autoimmune disease.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400144077 same patient, different dose/events;US-PFIZER INC-202400295403 same patient/events, different dose;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Blood test, Computerised tomogram, Magnetic resonance imaging, Migraine
Clinical narrative: migraines and tinnitus seem to be more frequent; migraines and tinnitus seem to be more frequent; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "accident", start date: 2010 (unspecified if ongoing); "partially compressed or collapsed hip" (unspecified if ongoing), notes: because of that feels two legs are different lengths affecting balance; "vestibular migraine", start date: 2017 (unspecified if ongoing); "tinnitus", start date: 2017 (unspecified if ongoing); "headache" (unspecified if ongoing). Concomitant medication(s) included: TIROSINT taken for hypothyroidism, autoimmune thyroiditis, autoimmune disorder (ongoing); VITAMIN D3. The patient also took other concomitant therapy. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated". The following information was reported: MIGRAINE (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "migraines and tinnitus seem to be more frequent". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient started taking TIROSINT probably 2019 or 2020. Concomitant medications also included thyroid medication and vaginal cream. The patient did get migraines, gets various aura symptoms, had tinnitus, ringing, since 2017, after bad migraine, since started taking all of the COVID vaccines migraines and tinnitus seem to be more frequent. The patient's migraines, headaches were not severe, aura symptoms, some doctors say, like ENT and neurologist, sometimes gets migraine, had light shows with migraines. Headaches were really least significant, if strong moderate headache, takes two aspirins. When getting a headache, tinnitus starts, part of migraine symptoms. When in hospital for observation, the patient was said to have vestibular migraine.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400144077 Same patient, different Dose/event;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal X-ray, Tinnitus, X-ray of pelvis and hip
Clinical narrative: migraines and tinnitus seem to be more frequent; migraines and tinnitus seem to be more frequent; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "accident", start date: 2010 (unspecified if ongoing); "partially compressed or collapsed hip" (unspecified if ongoing), notes: because of that feels two legs are different lengths affecting balance; "vestibular migraine", start date: 2017 (unspecified if ongoing); "tinnitus", start date: 2017 (unspecified if ongoing); "headache" (unspecified if ongoing). Concomitant medication(s) included: TIROSINT taken for hypothyroidism, autoimmune thyroiditis, autoimmune disorder (ongoing); VITAMIN D3. The patient also took other concomitant therapy. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated". The following information was reported: MIGRAINE (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "migraines and tinnitus seem to be more frequent". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient started taking TIROSINT probably 2019 or 2020. Concomitant medications also included thyroid medication and vaginal cream. The patient did get migraines, gets various aura symptoms, had tinnitus, ringing, since 2017, after bad migraine, since started taking all of the COVID vaccines migraines and tinnitus seem to be more frequent. The patient's migraines, headaches were not severe, aura symptoms, some doctors say, like ENT and neurologist, sometimes gets migraine, had light shows with migraines. Headaches were really least significant, if strong moderate headache, takes two aspirins. When getting a headache, tinnitus starts, part of migraine symptoms. When in hospital for observation, the patient was said to have vestibular migraine.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400144077 Same patient, different Dose/event;
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Tinnitus
Clinical narrative: migraines and tinnitus seem to be more frequent; migraines and tinnitus seem to be more frequent; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "Vaginal" (unspecified if ongoing); "Vitamin d3" (unspecified if ongoing); "headaches" (unspecified if ongoing); "accident", start date: 2010 (unspecified if ongoing); "partially compressed or collapsed hip", start date: 2010 (unspecified if ongoing), notes: because of accident caller had dating from 2010, caused partially compressed or collapsed hip; "feels two legs are different lengths affecting balance" (unspecified if ongoing); "Tinnitus, ringing", start date: 2017 (unspecified if ongoing); "migraines, gets various aura symptoms", start date: 2017 (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3; TIROSINT taken for hypothyroidism, autoimmune thyroiditis, autoimmune disorder. The patient also took other concomitant therapy. Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 08Sep2022, for Covid-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated"; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "Migraine aggravated", "Tinnitus aggravated".  The following information was reported: MIGRAINE (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "migraines and tinnitus seem to be more frequent".  Additional information: Does get migraines, gets various aura symptoms, has tinnitus, ringing, since 2017, after bad migraine, since started taking all of the COVID vaccines migraines and tinnitus seem to be more frequent. But has never had what happened to caller. Concomitant products: Takes very few medications, nothing changed in terms of medications. Takes thyroid medication and vaginal cream and vitamin D3, that is all. Clarified takes Tirosint for hypothyroidism, clarified Hashimoto's thyroiditis, autoimmune disease.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400144077 Same patient, different Dose/event;
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Feels like there was a heater next to patient leg all the time like a burning sensation just on the right side of leg; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Nov2024 at 02:35 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: BURNING SENSATION (non-serious) with onset Nov2024, outcome "not recovered", described as "Feels like there was a heater next to patient leg all the time like a burning sensation just on the right side of leg". Therapeutic measures were taken as a result of burning sensation.  Additional information: It was reported that patient just want to let someone know that patient got my, patient do not know what COVID shot this was. patient just got a COVID shot on Monday, and patient had a reaction. So, his wife was nurse, and patient asked her like so, his right side of butt, on his leg. It feels like there was a heater next to patient leg all the time. like it was just the, it was like a burning sensation just on the right side of his leg. patient never had it with all the other COVID shots and then patient got this one. So, patient just letting them know that, if anyone else calls it, patient do not know. It does not hurt, it was just annoying. Patient just letting you know, like patient do not, like this phone number comes up if you got side effects. So, patient just letting somebody know that it could be a side effect that no one knows about yet, because patient just got the shot on Monday. If it does not go away in a week or two. Then patient will go get a look at it but right now, patient just going to leave it as it was and hopefully this just goes away. No other Conditions were reported. Because patient got all the other shots. Patient just took some Tylenol and some Aleve. No prior vaccination within 4 weeks. Patient just took some Tylenol and some Aleve. The Tylenol probably 500 milligrams.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Near death experience
Clinical narrative: going to die; felt very unwell; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-776050 (Moderna).  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "felt very unwell". The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "going to die"; MALAISE (non-serious), outcome "unknown", described as "felt very unwell". Clinical Course: The inquiry was received from a patient who stated that had 2 vaccinations with Biontec and the 3rd with Moderna. The patient informed that after the Biontec vaccinations, felt very unwell. After the 2nd, thought was going to die. The patient stated that everything got better only after the Moderna vaccination.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400144913 same reporter/patient/vaccine, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: it really got me sick; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 67-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (The first one the patient got was 14Jan2021 that was the first shot the patient ever got and it was bad (intent: side effects)), administration date: 14Jan2021, when the patient was 63-year-old, for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "it really got me sick".  Additional information: The patient stated, "The first time, I didn't pay attention but then it got worse every time I would take the shot and it would make me need to stay home [...] last time, it really got me sick, I was in bed [...]". The first one the patient got was 14Jan2021 that was the first shot the patient ever got and it was bad (intent: side effects). It was not as bad as it was this last weekend (latest vaccine received by the patient), but it was there.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: I had an anaphylaxis reaction to shots 2 and 3 of the Pfizer vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization; Bnt162b2 (Dose 2, Single), administration date: 2021, for COVID-19 immunization, reaction(s): "I had an anaphylaxis reaction to shots 2 and 3 of the Pfizer vaccine". The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "I had an anaphylaxis reaction to shots 2 and 3 of the Pfizer vaccine". Clinical course: Patient had two Pfizer vaccines plus one booster but then was told that patient cannot get the (withheld) vaccine booster at a (withheld) vaccination site in 2021. Patient had an anaphylaxis reaction to shots 2 and 3 of the Pfizer vaccine. It had been since 2021 that patient hadn't been vaccinated against Covid 19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400145469 same patient/product/event, different dose (dose 2);
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Loss of consciousness, Paralysis
Clinical narrative: she felt she was becoming paralyzed; woke up unconscious; took her 45 minutes to have to strength to get up; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV24-00738 (Novavax).  A 32-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: 2020, stop date: 2020, notes: I have had COVID in 2020; "asthma" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "severe gastroparesis" (unspecified if ongoing); "syncope" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Flu shot (do pretty good with flu shots), for Immunisation. The following information was reported: PARALYSIS (medically significant), outcome "unknown", described as "she felt she was becoming paralyzed"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "woke up unconscious"; ASTHENIA (medically significant), outcome "unknown", described as "took her 45 minutes to have to strength to get up". The events "she felt she was becoming paralyzed", "woke up unconscious" and "took her 45 minutes to have to strength to get up" required physician office visit.  Clinical course: During the height of the pandemic, the patient got the second dose of Pfizer and made her "deathly sick". The patient stated she had to go to the hospital as she felt she was becoming paralyzed and woke up unconscious on her bathroom floor not remembering how she got there, it took her 45 minutes to have to strength to get up. The patient said it was horrific and she has been using a mask in every public place since then. She doesn't want to get boosted with mRNA and her doctor recommended her getting a vaccine that is not mRNA. The patient wants to make sure her body can handle this, her doctor thinks so because it does not have the mRNA.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt very unwell; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-776050 (Moderna).  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "felt very unwell".  Additional information: The inquiry was received from a patient who stated that had 2 vaccinations with Biontec and the 3rd with Moderna. The patient informed that after the Biontec vaccinations, felt very unwell. After the 2nd, thought was going to die. The patient stated that everything got better only after the Moderna vaccination.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400296418 same reporter/patient, different dose number/AE;
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: I had an anaphylaxis reaction to shots 2 and 3 of the Pfizer vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "I had an anaphylaxis reaction to shots 2 and 3 of the Pfizer vaccine". Clinical course: It had been since 2021 that patient hadn't been vaccinated against Covid 19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400297404 same patient/product/events, different dose;