chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: had a very rare miscarriage; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). Other Case identifier: 2023NVX-US-000001229 (Novavax).  A female patient (pregnant) received bnt162b2 (BNT162B2), as dose 2, single (batch/lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer biontech covid-19 vaccine (dose 1 (primary series)), for Covid-19 immunization, reaction: "maternal exposure timing unspecified". The mother's vaccination history included: Pfizer biontech covid-19 vaccine (dose 1 (primary series)), for Covid-19 immunization, reaction: "maternal exposure timing unspecified". The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "had a very rare miscarriage". The pregnancy resulted in spontaneous abortion. The fetal outcome is neonatal death. The pregnancy resulted in spontaneous abortion. The fetal outcome is neonatal death. Clinical course: On 26Sep2023, it was reported that a (withheld) patient started treatment on unreported dates with Pfizer BioNTech COVID-19 vaccine primary series for COVID-19 immunisation. It was reported the patient was vaccinated with the primary series when she was pregnant and had a very rare miscarriage.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: Malaise
Clinical narrative: by the next day I was very ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 07Oct2023 as dose 1, 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 NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset 08Oct2023, outcome "unknown", described as "by the next day I was very ill".  Additional information: The patient had the latest Covid shot on the 7th and by the next day the patient was very ill. The patient never had a reaction to the previous shots which were all. Pfizer.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Immunodeficiency
Clinical narrative: immune compromised; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 78-year-old patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune compromised".  The information on the batch/lot number for [RSV VACCINE PROT.SUBUNIT PREF 2V] has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: why his arm has a magnet after having the Pfizer Covid-19 Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "why his arm has a magnet after having the Pfizer Covid-19 Vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pancreatitis
Clinical narrative: pancreatitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: PANCREATITIS (medically significant), outcome "unknown". The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Glossopharyngeal neuralgia, Investigation, Magnetic resonance imaging, Seizure
Clinical narrative: convulsing; glossopharyngeal neuralgia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2 (BNT162B2), on 07Mar2021 as dose 2, 0.3 ml single (Lot number: EN6199, Expiration Date: Jun2021) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (Vaccine: 1st dose Covid-19, Product name/Manufacturer: Pfizer BioNTech, Exp: Jun2021, Lot# EM9810, 0.3 ml), administration date: 07Feb2021, when the patient was 70-year-old, for COVID-19 immunization. The following information was reported: SEIZURE (medically significant) with onset 2021, outcome "unknown", described as "convulsing"; GLOSSOPHARYNGEAL NEURALGIA (non-serious) with onset 2021, outcome "unknown". The events "convulsing" and "glossopharyngeal neuralgia" required physician office visit. Clinical course was as follow: the patient was vaccinated in Feb2021 and Mar2021. A month or so later he started having severe nerve pain in his head, ear and throat. These were events that happened daily once or twice lasting 2-3 minutes - severe pain, coughing, gagging and convulsing. This continued for several months then stopped for a short time. When it started up again he went to his doctor who could not figure it out. He then went to a ear - nose and throat doctor who could not figure it out and ordered a swallowing test and an MRI. The patient had suggested it might be a rare condition call Glassopharngeal neuralgia. Initially the doctor said he doubted it because it was so rare but after the tests he said - maybe. The doctor referred him to a neurologist. At this point he could not even talk as talking would trigger these events and would swallowing etc. The neurologist tested him causing an attack and agreed that it was Glassopharnegeal neuralgia - a very rare condition. When asked if this could be Covid vaccine related he stated "very possibly". He advised the patient not to get any boosters which he had not. The neurologist put the patient on a heavy dose of Gabapentin which he was on for two years. This eventually controlled the convulsions/attacks. Just recently the patient weaned off of the medicine and not having any more attacks.
Age: 45.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Moderate pain at injection site; Mild fatigue; Mild body aches; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 45 years old female patient who experienced moderate pain at injection site, mild fatigue and mild body aches after receiving vaccines Pfizer Biontech COVID-19 vaccine and Influenza Quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Oct-2023, the patient received an unknown dose of suspect Influenza Quadrival A-B vaccine suspension for injection of lot UT8155JA (strength and expiry: unknown) via intramuscular route in the left arm as annual flu vaccine (influenza immunization).On the same date, the patient received an unknown dose of suspect Pfizer Biontech COVID-19 vaccine not produced by Sanofi Pasteur of lot Fj1611 (formulation, strength and expiry: not reported) via intramuscular route in the left arm as prophylactic vaccination (immunization).  On 09-Oct-2023, the patient developed moderate pain at injection site (injection site pain) (latency: 5 mins) following the administration of Influenza Quadrival A-B vaccine and Pfizer Biontech COVID-19 vaccine.  On 09-Oct-2023, the patient developed mild fatigue (fatigue) and mild body aches (pain) (latency: 8 hours) following the administration of Influenza Quadrival A-B vaccine and Pfizer Biontech COVID-19 vaccine.  No lab data was reported.  Action taken was not applicable.  No corrective treatment was received for all events.  At time of reporting, the outcome was Recovering / Resolving for all events.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administration of vaccine that expired with no reported adverse event; Initial information received on 05-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of unknown age and demographics who was administered expired Influenza Quadrival A-B High Dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-Oct-2023, the patient received an unknown expired dose of suspect Influenza Quadrival A-B High Dose HV vaccine of lot UJ773AA and expiry: 30-Jun-2022 (formulation and strength: not reported) via unknown route in unknown administration site for influenza, with no reported adverse event (expired product administered) (latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was 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 and Regulatory Authority 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: No adverse event, Product preparation issue
Clinical narrative: patient was administered Pentacel from two different lot, pentacel vials were placed in dispensing machine incorrectly and lots were not put together with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient where patient was administered diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] from two different lot, pentacel vials were placed in dispensing machine incorrectly and lots were not put together 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 lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (wrong technique in product usage process). Information on the batch number was requested.  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: 9.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: separate administration of the PENTACEL components with no reported adverse event; Initial information received from on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2023SA312759.  This case involves 9 years old male patient who had separate administration of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] components with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Heparin [Heparin Sodium]; measles vaccine, mumps vaccine, rubella vaccine (MMR) for immunisation; and varicella zoster vaccine (Varicella Vaccine) for Immunisation.  On 09-Oct-2023, the patient received a standard dose 1 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml (lot UJ869AA, expiry date- 23-MAR-2024) via intramuscular route in the right deltoid for Immunization.  On 09-OCT-2023 the patient had separate administration of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine components with no reported adverse event (single component of a two-component product administered) (latency- same day).  Reportedly, patient was administered with the Hib component. Nurse wanted to know if the dose given would be valid. Nurse mentioned that she was not sure if the Hib part was reconstituted with 0.4mL saline solution. Caller reported that no adverse reactions were experienced by the patient.  Action taken was 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.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was given PENTACEL without reconstitution with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was given diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] without reconstitution 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 strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for immunization and patient was given pentacel without reconstitution with no reported adverse event (product preparation error) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient was given pentacel without reconstitution 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: M
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received a duplicate dose of MENQUADFI, Boostrix (Tdap), and HPVwith no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 12-year-old male patient received a duplicate dose of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi], boostrix (tdap), and hpvwith no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for Prophylactic vaccination; and HPV vaccine for Prophylactic vaccination.  On 12-Sep-2023, the patient received a dose 1 of 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (strength: unknown) (lot: U7903AA, expiry date: 31-Dec-2025) via intramuscular route in the right deltoid for immunization.   On 06-Oct-2023 he also received a dose 2 of 0.5 ml dose of the same vaccine (lot: U7903AA) via intramuscular route in the right deltoid for immunization and patient received a duplicate dose of menquadfi, boostrix (tdap), and hpvwith no reported adverse event (extra dose administered) (latency: 24 days) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.  It was unknown if any lab data/Test results available.  Action taken with meningococcal vaccine (Menquadfi) was 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.
Age: 86.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Radiating pain, into the back; Radiating pain, up and down in his arm; Radiating pain, shoulder; This spontaneous case was received on 04-Oct-2023 from other healthcare professional (pharmacist) and concerned an 86-year-old, male patient.   The patient's medical history and concomitant medications were unknown.   On an unspecified date in 2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose reported as '0.5', route of administration and anatomical location: not reported) for prevention of influenza disease, as reported. The batch number reported was 371626 and expiry date 30-Jun-2024.   On an unspecified date in 2023, after receiving Fluad Quadrivalent vaccine, the patient experienced radiating pain, up and down in his arm and into the back and shoulder.  At the time of initial reporting, the outcome of the events 'Pain in arm', 'Back pain', and 'Shoulder pain' was unknown.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  This case is linked with the case 202304562 (the same reporter).  Company comment: On an unspecified date, an unknown amount of time after receiving Fluad Quadrivalent, an 86-year-old patient experienced pain in his arm, back and shoulder. Due to unclear temporal relationship, causal role of the suspect vaccine is unassessable for the events of pain in arm, back pain and arthralgia.; Sender's Comments: On an unspecified date, an unknown amount of time after receiving Fluad Quadrivalent, an 86-year-old patient experienced pain in his arm, back and shoulder. Due to unclear temporal relationship, causal role of the suspect vaccine is unassessable for the events of pain in arm, back pain and arthralgia.
Age: 31.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Chest discomfort, Fatigue, Feeding disorder, Migraine, Nausea
Clinical narrative: The evening of 10/15, I experienced arm pain and had a migraine. The next morning, I was fatigued, had a sore arm, feeling of tightness in the chest, whole body aches, and nausea that was severe enough that I was unable to eat all day. All these symptoms continued throughout the day, and in the afternoon (about 24 hours after being vaccinated), I began to vomit. Though I felt better after, the nausea persisted for the rest of the evening.
Age: 31.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: The evening of 10/15, I experienced arm pain and had a migraine. The next morning, I was fatigued, had a sore arm, feeling of tightness in the chest, whole body aches, and nausea that was severe enough that I was unable to eat all day. All these symptoms continued throughout the day, and in the afternoon (about 24 hours after being vaccinated), I began to vomit. Though I felt better after, the nausea persisted for the rest of the evening.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness
Clinical narrative: Dizzy & Lightheaded  when walking  2-3 days so far after getting vaccinated
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Dyskinesia, Facial paralysis, Hypoacusis, Therapeutic response unexpected
Clinical narrative: PATIENT CAME IN 10/16/23 TO INFORM US PATIENT EXPERIENCE PARALYSIS ON LEFT SIDE OF FACE 2-3 DAYS AFTER RECEIVING COMIRNATY ON 10/6/2023.  PATIENT COMPLAINED OF REDUCED HEARING, NO PROBLEM WITH VISION, PROBLEM WITH CONTROLLING MOUTH MUSCLES. HE ALSO NOTED THAT NORMALLY HE FEELS PAIN IN LOWER EXTREMETIES (BOTH FEET AND BOTH HANDS) BUT NO LONGER HAVE PAIN. HE BELIEVES IT'S NEUROLOGICAL EFFECTS.  I ADVISED HIM TO IMMEDIATELY SEE A DOCTOR WHICH HE HAS NOT.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Electric shock sensation, Herpes zoster, Pain, Pain in extremity, Urticaria
Clinical narrative: The day following the injection, I started getting sharp shooting electrical pain in my right arm (NOT the injection arm).  And then about 11pm on the following day (27 hours following the injection), I started forming hive clusters on my right arm. The hives were on my entire arm but they were especially focused on the front and back of my elbow.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient's second dose was delayed due to insurance issues and the patient traveling; No additional AE/PQC reported; the patient was 46 years old when she received the 2nd dose of the GARDASIL 9 vaccine; This spontaneous report has been received from a pharmacist and refers to a 46-year-old female patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date in April 2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection and received the second dose at 46-year-old on 11-OCT-2023 (product administered to patient of inappropriate age) after being delayed due to patient's insurance issues (insurance issue) and traveling. Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). No adverse events reported for this patient.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; HCP called to report a TE with PROQUAD. Improperly stored. TE case reference 02490108. No adverse effects reported; This spontaneous report has been received from a medical assistant and refers to a 5-year-old patient of unknown gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the was vaccinated with a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, at a dose of 0.5 milliliter (ml) that had suffered a temperature excursion prior to being administered (product storage error) (lot number w029555 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), with an expiration date established as 14-MAR-2024), administered for prophylaxis (strength, and anatomical site of administration were not provided). No adverse events were reported for this patient.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/No PQC; HCP called to report a TE with VARIVAX.  Improperly stored.; This spontaneous report has been received from a medical assistant and refers to a 13-year-old patient of unknown gender.  The patient's pertinent medical history , other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 22-SEP-2023, the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 milliliter, that had suffered a temperature excursion (product storage error) (lot number W018825 varicella virus vaccine live (oka/merck) (VARIVAX), with an expiration date established as 14-JUN-2024), administered for prophylaxis (strength, and anatomical site of administration were not provided). No adverse events were reported for this patient.  This is one of several reports from the same reporter.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Headache, Myalgia, Pyrexia, Rash
Clinical narrative: Caller has not had very much of an appetite; muscle aches all over; little rash on the lower left arm; low grade fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Caller has not had very much of an appetite), MYALGIA (muscle aches all over), RASH (little rash on the lower left arm), PYREXIA (low grade fever) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031278) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Dose Number: 5 and Batch/Lot No: 062D22A) on 21-Oct-2022; for Drug use for unknown indication: CALCIUM (Vitamins like Calcium) and VITAMINS NOS (Vitamins like Calcium). Past adverse reactions to the above products included No adverse event with CALCIUM, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) and VITAMINS NOS.    On 08-Oct-2023 at 12:30 PM, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 08-Oct-2023, the patient experienced DECREASED APPETITE (Caller has not had very much of an appetite), MYALGIA (muscle aches all over), RASH (little rash on the lower left arm), PYREXIA (low grade fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Caller has not had very much of an appetite), MYALGIA (muscle aches all over), RASH (little rash on the lower left arm), PYREXIA (low grade fever) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Oct-2023, Body temperature: around 100.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-745657 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745657:same patient, different dose
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got flu A; Initial information received on 06-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient with unknown age and demographics who got flu A after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (formulation, strength, lot number and expiry: not reported) via unknown route in unknown administration site for Flu B (influenza immunization). Information on the batch number was requested.  On an unknown date, the patient got flu A (influenza) (unknown latency) following the administration of Influenza vaccine.  Reportedly, got flu shot for flu B! Got flu A!! Couple years ago sick as crap.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got flu A).  At time of reporting, the outcome was Unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported.; Nurse calling to report adverse event regarding an administration of an expired dose of MMR II.  Nurse stated that the MMR II dose had a labeled lot / expiry of U031359 10/7/2023, and the dose was inadvertently administered on 10/11/2023.  Nurse conf; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 11-OCT-2023, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 ml / two dose series, lot #U031359, expiration date: 07-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 07-OCT-2023, Nurse called to report adverse event regarding an administration of an expired dose of MMR II.  Nurse stated that the MMR II dose had a labeled lot / expiry of U031359 07-OCT-2023, and the dose was inadvertently administered on 11-OCT-2023. Nurse confirmed this was the patient's first dose in the series, and that the patient has not reported any medical concerns or symptoms due to being administered the expired dose of MMR II. No additional information provided regarding this adverse event. Nurse consents to correspondence regarding this adverse event. Case number provided. No additional AE/PQC reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Improperly stored of PROQUAD; This spontaneous report was received from a medical assistant referring to a 1-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapy were not reported.   On 11-AUG-2023, the patient was vaccinated with the improperly stored (temperature excursion [TE]) measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection 0.5 mL (lot# W029555, expiration date: 14-MAR-2024; dose number, anatomical location and route of administration not reported) as prophylaxis (product storage error). No adverse effects were reported. There was no additional adverse event (no adverse event).  This is one of several reports received from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she never got the second dose; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27-MAR-2019). Additional patient notes included was not immunocompromised.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she never got the second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-OCT-2023 The patient was over 50 years, and she never got the second dose. The reporter consented to follow up via fax to Doctor's office. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: She has not yet received her second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of in August of 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: She has not yet received her second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-OCT-2023 The patient self-reported this case. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Inflammation, Myalgia, Pyrexia
Clinical narrative: inflammatory reaction; fever; chills; myalgia; arthralgia; This spontaneous case was reported by a patient and describes the occurrence of INFLAMMATION (inflammatory reaction), PYREXIA (fever), CHILLS (chills), MYALGIA (myalgia) and ARTHRALGIA (arthralgia) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 016B22A) for COVID-19 prophylaxis.     Patient did not report any medical history or condition. He said he has nothing that would be related to his reactions.     On 15-Jul-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammatory reaction), PYREXIA (fever), CHILLS (chills), MYALGIA (myalgia) and ARTHRALGIA (arthralgia). At the time of the report, INFLAMMATION (inflammatory reaction), PYREXIA (fever), CHILLS (chills), MYALGIA (myalgia) and ARTHRALGIA (arthralgia) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  Patient took 1st dose 07-Mar-2021 with the lot number 003A21A, 2nd dose 05-Apr-2021 with the lot number 032B21A and 3rd dose 27-Nov-2021 with the lot number 036C21A.  He stated he never had any reaction to any other vaccine except inflammatory reaction, fever, chills, myalgia, and arthralgia.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745277, MOD-2023-745287 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745277:Monovalent Dose MOD-2023-745287:Bivalent dose
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache
Clinical narrative: feeling terrible/feeling crappy/feeling tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling terrible/feeling crappy/feeling tired) and HEADACHE (headache) in an 84-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031279) for COVID-19 vaccination.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:afib on a "bunch of pills".  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine ( 1st dose: 24-Feb2021, lot number: 023M20A  2nd dose: 24-Mar-2021, lot number:048A21A  3rd dose: 01-Dec-2021, no lot number  4th dose: 02-Nov-2022, no lot number  5th dose: 10-Oct-2023 and lot number:3031279). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine. Concurrent medical conditions included AFib.    On 10-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 11-Oct-2023, the patient experienced FATIGUE (feeling terrible/feeling crappy/feeling tired) and HEADACHE (headache). At the time of the report, FATIGUE (feeling terrible/feeling crappy/feeling tired) and HEADACHE (headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient did not think that it was nothing serious but have feeling crappy.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-745353 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745353:Wife case
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Very strong tinnitus and fluctuating hearing loss.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: No reaction on previous exposure to drug, Rash, Urticaria
Clinical narrative: hive type rash appeared on body next day, legs, stomach, chest.  did not really notice rash till showering next day, and removing clothes because it was not itching.   thought it must be reaction to moderna booster ( had no reaction to previous 3 pfizer doses.    had a few prednsione 10mg left over from previous bee string 2 years prior.  took 20mg saturday am,  2 days after shot, rash seemed to go away several hours later, but came back sunday, took last 2  tablets, sunday am,  same thing rash seemed to go away, monday rash returned, went to er clinic, got steriod shot and rx for prednisone taping course,  rash went away again, this is tuesday am and rash has returned, so starting 2 days of prednisone regimen.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Blister, Pruritus
Clinical narrative: About 15 minutes after the injection. A few of my body parts started to itch  and little blistery pimples appeared. It is day three right now, and I still have this little blustery  itching pimples.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Productive cough, Throat tightness
Clinical narrative: Ten minutes after receiving Flu vaccine, began to cough, copious amounts of mucous, tightness in her throat.
Age: 21.0
Sex: M
Vaccine: MENB, MNQ, TDAP
Symptoms: Arthralgia, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: As per patient, arm soreness started next day. Which developed into weakness/soreness from hand to shoulder. Patient was unable to pick arm up above head.  History obtained by pt and ED f/u  Patient has not f/u w/ our office.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Peripheral swelling, Urticaria
Clinical narrative: Two days post administration developed swelling if eyes, hands and feet. Third day post administration, developed hives. Saw PCP for worsening of hives on 10/10/23 and a covering up on 10/11/23. Was given a RX for Prednisone (5 day) on 10/10/23. On 10/11/23 was advised to add ZYRTEC OTC BID and PEPCID OTC once daily. Hives were resolved on 10/12/23.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 35.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient reported for a nurse visit to receive Prevnar 20 to complete the pneumococcal vaccine series due to the patient having previously received a dose of Prevnar 13.  The nurse administered the wrong vaccine by giving the patient another dose of Prevnar 13. Patient reported no adverse effects from the first or second dose of Prevnar 13.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Pediatric 5 - 11 year old dose given in error.  Pt had no significant reactions
Age: 65.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Hypoaesthesia, Peripheral coldness
Clinical narrative: Cold and numb fingers
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Periorbital swelling, Rash, Rash pruritic, Urticaria
Clinical narrative: I developed a red itchy rash that spread across my scalp, face, ears, neck, back, shoulders, chest, stomach, arms and legs.  I took a methyprednisolone pack, benedryl, zyrtec and famotadine, which had very limited success.  I went to the ER on 10/16, as recommended by my doctor because my face was covered with hives (looked like sunburn) and my eyes were puffy and starting to close.  The ER treated me with iv benadryl and steroids.  The rash improved after this treatment but remain to this day, approximately 1 week after vaccination.  I continue on the benadryl, zyrtec and famotadine.  I will finish the steroid pack tomorrow.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture, Atrial fibrillation, Bacteraemia, Bifidobacterium infection, Biopsy liver abnormal
Clinical narrative: Patient is a 63 y.o. female with a history of IDDM2 on U-500, Afib on Eliquis, chronic systolic CHF, ESRD on HD, and multiple recent hospital admists 8/11-8/21/23 for acute CHF and started on HD, 8/23-9/2/23 for R ankle fracture s/p ORIF and 9/15-9/20/23 for hypoglycemia and discharged home with HHC. She presented to hospital 9/23/2023 with 1 day history of fever, dyspnea and cough and was found to have COVID 19. Course complicated by Bifidobacterium bacteremia.    1. COVID 19: 1 day history of fever, productive cough and shortness of breath.  COVID-19 positive on admit.  Chest x-ray on admit nonacute.  Patient on baseline oxygen requirement.  ID followed, remdesivir thru 9/29/23.  2. Bifidobacterium bacteremia: 1/2 bottle from 9/23/23. Started on unasyn 9/25/23. Repeat blood cx 9/25/23, negative so far. ID followed, recommended CT Ab/pelvis which was non acute, and Unasyn continued thru 9/29/23. 3. Nausea, diarrhea, Bloody stools: C diff neg. Eliquis held, restarted 9/29/23. Zofran, PPI ordered. GI followed, OP colonoscopy.  4. Thrombocytopenia: Platelets normal at baseline.  Platelets 142 on admit.  Likely due to above.  monitored, stable. 5. Demand ischemia, Elevated troponin: Troponin 69 on admit.  Repeat troponin stable.  EKG on admit nonacute.  No further work-up 6. COPD with chronic respiratory failure: On 2 to 3 L nasal cannula at baseline.  No evidence of exacerbation.  Continue home inhalers.  Continue home oxygen 7. ESRD: Follows with Dr. (nephrology).  On HD Monday Wednesday and Friday.  Consulted nephrology for ESRD while inpatient 8. Chronic systolic CHF: Follows with Dr. (MC).  TTE 3/23 with EF of 40%.  Volume management per HD. 9. Paroxysmal atrial fibrillation: Eliquis held dt bloody BM, restarted. no longer on beta-blocker due to hypotension 10. IDDM2: Follows with Dr. (endocrinology).  On U-500 at home.  Recent hospitalization for hypoglycemia and insulin adjusted.  Continued home U-500.  Endocrine followed, adjusted regimen as below.  11. Anemia of chronic disease: Baseline hemoglobin 8-9.  Hemoglobin 7.9 on admit. Stable.  12. Chronic liver disease: Follows with Dr. (GI).  S/p biopsy 5/20/2022 with perisinusoidal fibrosis.  Continue home lactulose and Xifaxan. 13. Recent right ankle fracture: S/p ORIF 8/24/2023 by Dr. (ortho). 14. Chronic pain: NaRx reviewed on admit.  Continued home medications 15. Obesity: BMI 37
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture negative, COVID-19, Cardiac failure congestive, Chest X-ray normal, Clostridium test
Clinical narrative: Patient is a 63 y.o. female with a history of IDDM2 on U-500, Afib on Eliquis, chronic systolic CHF, ESRD on HD, and multiple recent hospital admists 8/11-8/21/23 for acute CHF and started on HD, 8/23-9/2/23 for R ankle fracture s/p ORIF and 9/15-9/20/23 for hypoglycemia and discharged home with HHC. She presented to hospital 9/23/2023 with 1 day history of fever, dyspnea and cough and was found to have COVID 19. Course complicated by Bifidobacterium bacteremia.    1. COVID 19: 1 day history of fever, productive cough and shortness of breath.  COVID-19 positive on admit.  Chest x-ray on admit nonacute.  Patient on baseline oxygen requirement.  ID followed, remdesivir thru 9/29/23.  2. Bifidobacterium bacteremia: 1/2 bottle from 9/23/23. Started on unasyn 9/25/23. Repeat blood cx 9/25/23, negative so far. ID followed, recommended CT Ab/pelvis which was non acute, and Unasyn continued thru 9/29/23. 3. Nausea, diarrhea, Bloody stools: C diff neg. Eliquis held, restarted 9/29/23. Zofran, PPI ordered. GI followed, OP colonoscopy.  4. Thrombocytopenia: Platelets normal at baseline.  Platelets 142 on admit.  Likely due to above.  monitored, stable. 5. Demand ischemia, Elevated troponin: Troponin 69 on admit.  Repeat troponin stable.  EKG on admit nonacute.  No further work-up 6. COPD with chronic respiratory failure: On 2 to 3 L nasal cannula at baseline.  No evidence of exacerbation.  Continue home inhalers.  Continue home oxygen 7. ESRD: Follows with Dr. (nephrology).  On HD Monday Wednesday and Friday.  Consulted nephrology for ESRD while inpatient 8. Chronic systolic CHF: Follows with Dr. (MC).  TTE 3/23 with EF of 40%.  Volume management per HD. 9. Paroxysmal atrial fibrillation: Eliquis held dt bloody BM, restarted. no longer on beta-blocker due to hypotension 10. IDDM2: Follows with Dr. (endocrinology).  On U-500 at home.  Recent hospitalization for hypoglycemia and insulin adjusted.  Continued home U-500.  Endocrine followed, adjusted regimen as below.  11. Anemia of chronic disease: Baseline hemoglobin 8-9.  Hemoglobin 7.9 on admit. Stable.  12. Chronic liver disease: Follows with Dr. (GI).  S/p biopsy 5/20/2022 with perisinusoidal fibrosis.  Continue home lactulose and Xifaxan. 13. Recent right ankle fracture: S/p ORIF 8/24/2023 by Dr. (ortho). 14. Chronic pain: NaRx reviewed on admit.  Continued home medications 15. Obesity: BMI 37