chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Epstein-Barr virus test, HIV test, Hepatitis A virus test, Hepatitis B virus test, Hepatitis C virus test
Clinical narrative: Severe Immune-Mediated Liver Injury Following COVID-19 Vaccination Necessitating Liver Transplantation in a Patient with Cirrhosis; This is a literature report for the following literature source(s):   A 65-year-old male patient received BNT162b2, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "epilepsy" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing); "excessive alcohol use" (unspecified if ongoing), notes: 30+ years. The patient's concomitant medications were not reported. Past drug history included: Levetiracetam for epilepsy; Metoprolol for coronary artery disease; Ramipril; Aspirin; Omeprazole. The following information was reported: IMMUNE-MEDIATED HEPATIC DISORDER (medically significant, life threatening), 10 days after the suspect product(s) administration, outcome "unknown", described as "Severe Immune-Mediated Liver Injury Following COVID-19 Vaccination Necessitating Liver Transplantation in a Patient with Cirrhosis". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 1613; Antimitochondrial antibody: Positive; Antinuclear antibody: Positive; Aspartate aminotransferase: 1786; Blood alkaline phosphatase: 182; Blood creatine: 0.7; 2.6; Blood immunoglobulin G: 1310; Computerized tomogram abdomen: heterogeneous liver with steatosis and mild, notes: nodularity, splenomegaly, ascites, patent vasculature, and no biliary dilation. Liver biopsy: marked portal and lobular inflammation with interface hepatitis and lymphoplasmacytic infiltrates, confluent necrosis with hemorrhage, balloon degeneration, cholestasis and reticulin collapse; Cytomegalovirus test: Negative; Enzyme level test: normal; Epstein-Barr virus test: Negative; Hepatitis A virus test: Negative; Hepatitis B virus test: Negative; Hepatitis C virus test: Negative; HIV test: Negative; International normalised ratio: 2.1; Skin test: 9; Smooth muscle antibody: Positive.  Clinical Information: Reporter reported that Patient was presented with jaundice and ascites on day 10 after first C19V and did not have known liver disease and had normal liver enzymes prior, No family history of autoimmune diseases. Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event immune mediated hepatic disorder and suspect BNT162B2 cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Immune-mediated hepatic disorder, International normalised ratio, Skin test, Smooth muscle antibody
Clinical narrative: Severe Immune-Mediated Liver Injury Following COVID-19 Vaccination Necessitating Liver Transplantation in a Patient with Cirrhosis; This is a literature report for the following literature source(s):   A 65-year-old male patient received BNT162b2, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "epilepsy" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing); "excessive alcohol use" (unspecified if ongoing), notes: 30+ years. The patient's concomitant medications were not reported. Past drug history included: Levetiracetam for epilepsy; Metoprolol for coronary artery disease; Ramipril; Aspirin; Omeprazole. The following information was reported: IMMUNE-MEDIATED HEPATIC DISORDER (medically significant, life threatening), 10 days after the suspect product(s) administration, outcome "unknown", described as "Severe Immune-Mediated Liver Injury Following COVID-19 Vaccination Necessitating Liver Transplantation in a Patient with Cirrhosis". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 1613; Antimitochondrial antibody: Positive; Antinuclear antibody: Positive; Aspartate aminotransferase: 1786; Blood alkaline phosphatase: 182; Blood creatine: 0.7; 2.6; Blood immunoglobulin G: 1310; Computerized tomogram abdomen: heterogeneous liver with steatosis and mild, notes: nodularity, splenomegaly, ascites, patent vasculature, and no biliary dilation. Liver biopsy: marked portal and lobular inflammation with interface hepatitis and lymphoplasmacytic infiltrates, confluent necrosis with hemorrhage, balloon degeneration, cholestasis and reticulin collapse; Cytomegalovirus test: Negative; Enzyme level test: normal; Epstein-Barr virus test: Negative; Hepatitis A virus test: Negative; Hepatitis B virus test: Negative; Hepatitis C virus test: Negative; HIV test: Negative; International normalised ratio: 2.1; Skin test: 9; Smooth muscle antibody: Positive.  Clinical Information: Reporter reported that Patient was presented with jaundice and ascites on day 10 after first C19V and did not have known liver disease and had normal liver enzymes prior, No family history of autoimmune diseases. Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event immune mediated hepatic disorder and suspect BNT162B2 cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick from first 2 shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An adult female patient received 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: ILLNESS (non-serious), outcome "unknown", described as "Sick from first 2 shots".  Additional information: Patient stated that she got so sick from the first 2 shots  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sicker; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An adult female patient received BNT162b2, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I already had Covid" (unspecified if ongoing), notes: I already had Covid. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sicker".  Additional information:  I already had Covid and I got a first vaccine and it made me sicker then actually having Covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Debilitating effects from vaccine and booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster ), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: 2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "Debilitating effects from vaccine and booster"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "Debilitating effects from vaccine and booster". The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "Debilitating effects from vaccine and booster".  Additional information: Will not get any further vaccinations due to horrible effects from having Covid in 2020 & then with each vaccine & booster the debilitating effects lasted for 2-3 weeks (original Covid lasted 2 months for patient)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: broke out in hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4912695 (RA).  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (ongoing); "Allergic to eucalyptus" (ongoing), notes: If exposed she breaks out in a rash, gets bright red and flaming hot; "rash" (unspecified if ongoing); "gets bright red" (unspecified if ongoing); "gets flaming hot" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset Jun2021, outcome "unknown", described as "broke out in hives".  Additional information: She found out she was allergic to the Pfizer covid vaccine when she broke out in hives in Jun2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little bit of sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-MODERNATX-MOC20230519000021 (RA).  A 71-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension but controlled with meds" (unspecified if ongoing), notes: Hypertension but controlled with meds. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a little bit of sore arm".  Additional information: Reporter stated that he had his 6th shot last 09May2023, lot number 016H22A. He had the 1st 4 (Pfizer) and the last 2 were Moderna. He states that he had no reaction after his previous shots except for "a little bit of sore arm". But the last dose of the Moderna which he had 8 days ago, in about 7 hours he had a reaction. He stated it was nothing significant - "little chills, fever, achy and my arm hurt, and he expected that and it was okay because he know that his body was working". After a day or two almost all of them went away except for a low grade fever. It's been 8 days and he still has fever which was a little less high than it used to be.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 1.25
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received expired Pentacel vaccine,with no reported adverse event; Initial information received on 22-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who had received expired pentacel vaccine,with no reported adverse event after receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [pentacel (vero)].  The patient had no medical history, concomitant disease or risk factor   On 12-May-2023, the patient received a unknown dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection, lot UJ664AA via unknown route, strength, expiration date in unknown administration site for Prophylactic vaccination(Immunisation).  On 12-May-2023 the patient developed a non-serious received expired pentacel vaccine,with no reported adverse event (expired product administered) (latency: same day).  Patient did not experience any additional symptoms/events  There were no lab data/results available.  Action taken was not applicable.  Outcome: Unknown for the event received expired pentacel vaccine,with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: F
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: accidentally administered an extra booster dose with no reported adverse event; Initial information received on 16-May-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 12 years old female patient who was accidentally administered an extra booster dose of meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-May-2023, the patient accidentally received an extra Booster dose (0.5 mL) of suspect meningococcal A-C-Y-W135 (T conj) vaccine (Strength = Normal), solution for injection (batch number: U7447AC; expiry date: 20-Sep-2024) via intramuscular route in unknown administration site for Immunization with no reported adverse event (Extra dose administered ) (same day latency).  It was reported, She wanted to know if it was safe and what will be the next dosing schedule. The latest schedule of administered vaccine did not populate in their system and that is why she accidentally administered an extra booster dose. Prior to giving the extra dose, the last dose was in 4April2022.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event accidentally administered an extra booster dose with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired PENTACEL was administered to a patient with no reported adverse event; Initial information received on 17-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom experienced expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml dose once (1X) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection, (lot UJ640AAA; Expiry Date: 28-JAN-2023)  via unknown route in unknown administration site for Immunization.  On an unknown date the it was reported that an expired pentacel was administered to a patient with no reported adverse event (expired product administered) (latency: on same day).  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: vaccine was administered 13 days expired with no reported adverse event; Initial information was received on 18-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and gender patient to whom diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] was administered 13 days expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-May-2023, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot UJ662AA, expiry date: 04-May-2023), strength, was unknown) via unknown route in unknown administration site for Immunization.  On 17-May-2023 the patient was administered 13 days expired with no reported adverse event (expired product administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: U
Vaccine: MEN
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: MENQUADFI administered to patient which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; MENQUADFI administered to patient which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA157122(CLUSTER), 2023SA157726(CLUSTER), 2023SA157696(CLUSTER), 2023SA157752(CLUSTER), 2023SA157746(CLUSTER), 2023SA156938(CLUSTER), 2023SA157755(CLUSTER) and 2023SA157696(CLUSTER).  This case involves a 18 years old patient of unknown gender who was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-May-2023, the patient received a dose of 0.5 ml (dose 2) of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (Solution for injection) (lot: U7576AB; expiry date: 28-FEB-2025) via intramuscular route in the left arm for Immunization.  On 08-May-2023, the patient was administered menquadfi which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day).  It was reported, "Nurse says that the excursion was caused by additional gel packs being placed in the refrigerator. She asked for appropriate follow-up. The vaccines had been transported due to power outage and then cold packs were put into refrigerator and apparently made the refrigerator temperature drop."   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: Hib part of the PENTACEL vaccine was diluted with VAQTA, a Hepatitis A Vaccine (with no reported adverse event); Initial information received on 18-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves  patient with unknown demographics and is reported hib part of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was diluted with hepatitis A Vaccine inact [vaqta], a hepatitis A vaccine (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection and Vaqta not produced by Sanofi Pasteur strength, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) and hib part of the pentacel vaccine was diluted with vaqta, a hepatitis A vaccine (with no reported adverse event) (product preparation error) on the same day.Information on the batch number was requested.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event hib part of the pentacel vaccine was diluted with vaqta, a hepatitis a vaccine (with no reported adverse event).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 60 years patient received expired ACT-HIB with no reported adverse event; Initial information was received on 19-May-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 60 years old male patient who received expired hib (prp/t) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-May-2023, the patient received 0.5 ml, total dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection (lot UJ738AA, expiry date:29-Apr-2023) of unknown strength via intramuscular route in the left deltoid for prophylactic vaccination (Immunization).  On 17-May-2023 the patient received expired act-hib with no reported adverse event (expired product administered) (Latency:same day) following the administration of hib (prp/t) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUC3
Symptoms: Anaphylactic reaction, Immediate post-injection reaction
Clinical narrative: Anaphylaxis immediately after administration of the Flucelvax; This spontaneous case was received on 18-May-2023 from a physician (reference number: SEQW23-01397) and concerned a patient of unreported age and gender.  The patient's medical history and concomitant medications were not reported.   On an unspecified day in Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for prevention of influenza disease. The batch number was not reported.  On the same day, immediately after receiving influenza vaccine, the patient experienced anaphylaxis.  The outcome of the event was not reported.   The reporter did not provide causality assessment.  The event of 'anaphylaxis' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A patient of unreported age or gender experienced anaphylaxis immediately after vaccination with influenza vaccine. Information regarding the underlying medical history and concomitant medications has not been provided. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related based on suggestive temporal relationship. Limited information precludes assessment of Collaboration criteria for anaphylaxis.; Sender's Comments: A patient of unreported age or gender experienced anaphylaxis immediately after vaccination with influenza vaccine. Information regarding the underlying medical history and concomitant medications has not been provided. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related based on suggestive temporal relationship. Limited information precludes assessment of Collaboration criteria for anaphylaxis.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Condition aggravated, Injection site pain, Muscle strain
Clinical narrative: Between 03/04/2021 and 09/30/22 I had 7 vaccinations in my left shoulder -- 5 Covid vaccinations and 2 Shingles vaccinations.  After the second of the shingles vaccination (the fifth vaccination overall), I developed severe, excruciating pain in my left shoulder. That vaccine was 3/24/2022; I went to the emergency room in 3/28/2022 with 10/10 pain. This pain event lasted about 8 hours and was diagnosed as "Trapezius Strain."  I subsequently had two more Covid boosters in the same shoulder, followed by more severe shoulder pain events. In 2023, the pain has now become chronic and debilitating.  I don't know if this pain is related to the vaccines or not -- that is why I am reporting it. History of vaccinations in left shoulder, and the development of severe left shoulder pain:  3/4/21 Covid Moderna  4/1/21 Covid Moderna 10/22/21 Covid Booster Moderna 12/7/21 Zoster Shingrex 3/24/22 Zoster Shingrex  (First Pain Event becomes severe 3/28/21 -- ER visit) 5/19/22 Covid Booster Moderna (Intermittent severe left shoulder pain events 10/10 pain) 9/30/22 Covid Booster Pfizer (Intermittent severe left shoulder pain events, 10/10 pain) 2023 (Severe left shoulder pain become chronic. Pain becomes debilitating several times per week.)
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, X-ray
Clinical narrative: Between 03/04/2021 and 09/30/22 I had 7 vaccinations in my left shoulder -- 5 Covid vaccinations and 2 Shingles vaccinations.  After the second of the shingles vaccination (the fifth vaccination overall), I developed severe, excruciating pain in my left shoulder. That vaccine was 3/24/2022; I went to the emergency room in 3/28/2022 with 10/10 pain. This pain event lasted about 8 hours and was diagnosed as "Trapezius Strain."  I subsequently had two more Covid boosters in the same shoulder, followed by more severe shoulder pain events. In 2023, the pain has now become chronic and debilitating.  I don't know if this pain is related to the vaccines or not -- that is why I am reporting it. History of vaccinations in left shoulder, and the development of severe left shoulder pain:  3/4/21 Covid Moderna  4/1/21 Covid Moderna 10/22/21 Covid Booster Moderna 12/7/21 Zoster Shingrex 3/24/22 Zoster Shingrex  (First Pain Event becomes severe 3/28/21 -- ER visit) 5/19/22 Covid Booster Moderna (Intermittent severe left shoulder pain events 10/10 pain) 9/30/22 Covid Booster Pfizer (Intermittent severe left shoulder pain events, 10/10 pain) 2023 (Severe left shoulder pain become chronic. Pain becomes debilitating several times per week.)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Dizziness, Gait disturbance, Headache, Laboratory test normal
Clinical narrative: Dizzy/ Light headed/ she almost fell a couple of times; Stumbling/ Walking from side to side; Headache; Nausea; Room spinning; Elevated Blood Pressure; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 15-MAY-2023 17:00, the patient received the 1st dose of Shingrix. On 15-MAY-2023, 3 hrs after receiving Shingrix, the patient experienced dizziness (Verbatim: Dizzy/ Light headed/ she almost fell a couple of times). In MAY-2023, the patient experienced gait disturbance (Verbatim: Stumbling/ Walking from side to side), headache (Verbatim: Headache), nausea (Verbatim: Nausea), increased blood pressure (Verbatim: Elevated Blood Pressure) and spinning sensation (Verbatim: Room spinning). The outcome of the dizziness, gait disturbance, headache, nausea, increased blood pressure and spinning sensation were resolving.   It was unknown if the reporter considered the dizziness, gait disturbance, headache, nausea, increased blood pressure and spinning sensation to be related to Shingrix.     It was unknown if the company considered the dizziness, gait disturbance, headache, nausea, increased blood pressure and spinning sensation to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-MAY-2023 The patient self-reported this case. The patient reported that she received 1st dose on Monday at 5 pm and within 3 hours of vaccination she began to feel light headed, and dizzy. When the patient got up, she began to stumble, walking from side to side. She also began to experience a headache and later became nauseated. The patient stated that almost fell a couple of times.  The patient's blood pressure was usually 90/60, but her blood pressure rose to 145/105.  The patient felt the room began spinning.  The patient subsequently went to the emergency room (ER), where they ran tests, but results were negative, and nothing was found.  At the time of reporting, the patient felt much better. The patient stated that some of the nurses in the emergency room told her that they have been seeing a lot of patients come to the adverse event with similar symptoms as this patient after having the Shingrix vaccine.  The reporter consented to follow up with health care professional (pharmacy).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vertigo
Clinical narrative: Dizzy/ Light headed/ she almost fell a couple of times; Stumbling/ Walking from side to side; Headache; Nausea; Room spinning; Elevated Blood Pressure; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 15-MAY-2023 17:00, the patient received the 1st dose of Shingrix. On 15-MAY-2023, 3 hrs after receiving Shingrix, the patient experienced dizziness (Verbatim: Dizzy/ Light headed/ she almost fell a couple of times). In MAY-2023, the patient experienced gait disturbance (Verbatim: Stumbling/ Walking from side to side), headache (Verbatim: Headache), nausea (Verbatim: Nausea), increased blood pressure (Verbatim: Elevated Blood Pressure) and spinning sensation (Verbatim: Room spinning). The outcome of the dizziness, gait disturbance, headache, nausea, increased blood pressure and spinning sensation were resolving.   It was unknown if the reporter considered the dizziness, gait disturbance, headache, nausea, increased blood pressure and spinning sensation to be related to Shingrix.     It was unknown if the company considered the dizziness, gait disturbance, headache, nausea, increased blood pressure and spinning sensation to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-MAY-2023 The patient self-reported this case. The patient reported that she received 1st dose on Monday at 5 pm and within 3 hours of vaccination she began to feel light headed, and dizzy. When the patient got up, she began to stumble, walking from side to side. She also began to experience a headache and later became nauseated. The patient stated that almost fell a couple of times.  The patient's blood pressure was usually 90/60, but her blood pressure rose to 145/105.  The patient felt the room began spinning.  The patient subsequently went to the emergency room (ER), where they ran tests, but results were negative, and nothing was found.  At the time of reporting, the patient felt much better. The patient stated that some of the nurses in the emergency room told her that they have been seeing a lot of patients come to the adverse event with similar symptoms as this patient after having the Shingrix vaccine.  The reporter consented to follow up with health care professional (pharmacy).
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Near death experience
Clinical narrative: I was going to die; This serious case was reported by a consumer via market research programs and described the occurrence of near death experience in a elderly female patient who received Flu unspecified (Flu vaccine unspecified) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Flu vaccine unspecified and COVID-19 VACCINE. On an unknown date, less than 2 years after receiving Flu vaccine unspecified, the patient experienced near death experience (Verbatim: I was going to die) (serious criteria GSK medically significant and life threatening). The outcome of the near death experience was not reported.   It was unknown if the reporter considered the near death experience to be related to Flu vaccine unspecified.   It was unknown if the company considered the near death experience to be related to Flu vaccine unspecified.   Additional Information: GSK Receipt Date: 18-MAY-2023 The case was reported by a consumer via market research programs. The reporter received flu vaccine and covid vaccine together, after vaccination she experienced terrible and she thought that she was going to die. The reporter reported that she did not receive vaccine last year and she would not ever do it again. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: They stated that they did not feel well for 3 days after the vaccine but was fine after; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (They stated that they did not feel well for 3 days after the vaccine but was fine after) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (They stated that they did not feel well for 3 days after the vaccine but was fine after). At the time of the report, MALAISE (They stated that they did not feel well for 3 days after the vaccine but was fine after) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   1 patient involved. They had the 1st 2 vaccines in early 2021 and then the 3rd one at the end of 2021. They did not feel well for 3 days after the vaccine but was fine after. They did not indicate which dose they had this reaction to. Concomitant medication not reported. Treatment medication not reported.   Reporter did not allow further contact
Sex: U
Vaccine: MENB, MNQ
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: Feverish.; Felt Crummy; This non-serious case was reported by a other health professional via call center representative and described the occurrence of fever in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Bexsero and Menveo. On an unknown date, an unknown time after receiving Bexsero and Menveo, the patient experienced fever (Verbatim: Feverish.) and feeling abnormal (Verbatim: Felt Crummy). The outcome of the fever and feeling abnormal were unknown.   It was unknown if the reporter considered the fever and feeling abnormal to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo.     It was unknown if the company considered the fever and feeling abnormal to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:18-MAY-2023 The nurse at the Health Department, indicated they use Menveo and Bexsero. They used to administer both doses on them same day, however, they had since stopped doing that because they had a few/ handful of patients whose parents called back to report that their child (the patient) had experienced "feeling crummy". Sales Representative asked nurse to elaborate on feeling crummy and asked about being feverish and she said yes.  No further information was known about the gender or amount of patients. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received dose two of Twinrix late; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old male patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 19-MAY-2023, the patient received the 2nd dose of Twinrix. On 19-MAY-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: The patient received dose two of Twinrix late). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-May-2023 The reporter consented to follow up. The reporter did not provide lot number and expiration date for dose two. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient through other manufacturer (Pfizer Inc.) concerned a 47 year old , female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination and had no history of past drug. The patient stated that she was no taking other medication or products within 2 weeks of starting covid-19 treatment (Paxlovid). The patient received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 42A21A expiry: UNKNOWN) dose was not reported,1 total was administered on 05-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 5 decade old. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received second dose of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin, and were not reported, batch number: 067F21A expiry: UNKNOWN) dose was not reported, administered on 22-NOV-2021 for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 2).   On an unspecified date, the patient experienced suspected covid-19 infection (Dose number in series 2) The patient started taking treatment with non-company suspect drug Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported from 26-APR-2023 to 30-APR-2023 for covid-19 treatment.  On 14-MAY-2023, the patient again experienced covid-19 (covid-19 rebound infection) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: It had been refrigerated but past the recommended time; No adverse event; Administered a vaccine that was drawn 21 hours prior./Dose was given on 19MAY2023 8:45 AM after being initially punctured on 18MAY2023 11:13 AM; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a vaccine that was drawn 21 hours prior./Dose was given on 19MAY2023 8:45 AM after being initially punctured on 18MAY2023 11:13 AM), PRODUCT STORAGE ERROR (It had been refrigerated but past the recommended time) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-May-2023 at 8:45 AM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-May-2023 at 8:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a vaccine that was drawn 21 hours prior./Dose was given on 19MAY2023 8:45 AM after being initially punctured on 18MAY2023 11:13 AM). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (It had been refrigerated but past the recommended time) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a vaccine that was drawn 21 hours prior./Dose was given on 19MAY2023 8:45 AM after being initially punctured on 18MAY2023 11:13 AM), PRODUCT STORAGE ERROR (It had been refrigerated but past the recommended time) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered a vaccine that was drawn 21 hours prior./Dose was given on 19MAY2023 8:45 AM after being initially punctured on 18MAY2023 11:13 AM) and PRODUCT STORAGE ERROR (It had been refrigerated but past the recommended time).    No concomitant medication information was provided.   Patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient didn't report any symptoms.  Treatment medication information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2023: Follow-up received, updated patient demographics and suspect drug information.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Dry mouth, Flushing, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: 20 minutes after the vaccine patient passed out for a few seconds, felt cotton mouth and flushed skin. Had water, rested for 30 minutes near the pharmacy and left walking by herself
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: 20 minutes after the vaccine patient passed out for a few seconds, felt cotton mouth and flushed skin. Had water, rested for 30 minutes near the pharmacy and left walking by herself
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Confusional state, Dizziness, Flushing, Hyperhidrosis, Loss of consciousness
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainted soon as needle was removed from arm. Laied patient down. Patient gained consciousness. Had technician call EMS. Dad laied down with patient then she vomited. Lost and gain consciousness before paramedics arrived. She was taken out on a stretcher
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainted soon as needle was removed from arm. Laied patient down. Patient gained consciousness. Had technician call EMS. Dad laied down with patient then she vomited. Lost and gain consciousness before paramedics arrived. She was taken out on a stretcher
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Anticoagulant therapy, Arthralgia, Infection, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: blood  clot-Severe, Systemic: Joint Pain-Medium, Additional Details: Patient went to ER, diagnosised with clot and infection. Given antibiotics and xarelto.  patient still having pain/uncomfortable in left arm. Tried to submit prior site not working