chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Injection of expired; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Injection of expired". Additional information: vaccine readmissions. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 13:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 17Mar2023 to 21Mar2023 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose Number: 4/Moderna; Dose number: 3/Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL0140), on 18Feb2021 as dose 2, single (Lot number: EL9261), in left arm and on 11Oct2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Apr2022 as dose 4 (booster), single (Lot number: 049L21A), in left arm and on 29Oct2022 as dose 5 (booster), single (Lot number: 014H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Type II Diabetes" (unspecified if ongoing); "known allergies: Wool" (unspecified if ongoing); "known allergies: trees" (unspecified if ongoing); "known allergies: grass" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Apr2022, outcome "unknown", described as "Dose Number: 4/Moderna; Dose number: 3/Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Mar2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Mar2023) Positive, notes: home test. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose Number: 4 / moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: EW0158), in left arm, on 04May2021 as dose 2, single (Lot number: EW0173), in left arm and on 04Nov2021 as dose 3 (booster), single (Lot number: FD0809), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23May2022 as dose 4 (booster), single (Lot number: 037A22B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight (210 pounds, 5'10")" (unspecified if ongoing), notes: Other medical history: Overweight (210 pounds, 5'10"); "complex sleep apnea" (unspecified if ongoing), notes: Other medical history: complex sleep apnea. The patient's concomitant medications were not reported.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23May2022, outcome "unknown", described as "Dose Number: 4 / moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) 5'10", notes: Overweight (210 pounds, 5'10"); SARS-CoV-2 test: (06Apr2023) Negative, notes: Tested negative on 06Apr and 07Apr on home test; (07Apr2023) Negative, notes: Tested negative on 06Apr and 07Apr on home test; (10Apr2023) Positive, notes: Symptoms resumed on 10Apr and tested positive on home test; Weight: (unspecified date) Overweight, notes: Overweight (210 pounds, 5'10"). Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose Number: 4 / moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: EW0158), in left arm, on 04May2021 as dose 2, single (Lot number: EW0173), in left arm and on 04Nov2021 as dose 3 (booster), single (Lot number: FD0809), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23May2022 as dose 4 (booster), single (Lot number: 037A22B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight (210 pounds, 5'10")" (unspecified if ongoing), notes: Other medical history: Overweight (210 pounds, 5'10"); "complex sleep apnea" (unspecified if ongoing), notes: Other medical history: complex sleep apnea. The patient's concomitant medications were not reported.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23May2022, outcome "unknown", described as "Dose Number: 4 / moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) 5'10", notes: Overweight (210 pounds, 5'10"); SARS-CoV-2 test: (06Apr2023) Negative, notes: Tested negative on 06Apr and 07Apr on home test; (07Apr2023) Negative, notes: Tested negative on 06Apr and 07Apr on home test; (10Apr2023) Positive, notes: Symptoms resumed on 10Apr and tested positive on home test; Weight: (unspecified date) Overweight, notes: Overweight (210 pounds, 5'10"). Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team and product quality group.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) and 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: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: Reporter on behalf of his wife who took doses of Pfizer Covid-19 vaccine and tested positive for Covid-19 virus. His wife was given a prescription for Paxlovid and not taken it yet since his wife weighs 80 lbs which was 8 lbs less than the required weight to take Paxlovid. his wife still tested positive after taking 4 doses of the Pfizer Covid-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events drug ineffective, Covid-19 and the suspect  product BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 at 12:00 as dose 1, single (Lot number: EN6205), in left arm, on 06Apr2021 at 12:00 as dose 2, single (Lot number: EN8727), in left arm and on 02Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FF2593) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PTSD" (unspecified if ongoing); "Liver disease" (unspecified if ongoing); "Gall bladder disease" (unspecified if ongoing); "Sensitivity to Flagyl" (unspecified if ongoing); "Sensitivity to Cipro" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; XANAX; BUSPAR. The following information was reported: COVID-19 (medically significant) with onset 13Jul2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 13Jul2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148415 same patient/SD (dose 3), different AE.;
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Pulmonary embolism
Clinical narrative: Patient had a PE after taking booster Comirnaty; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Nonvalvular Atrial Fibrillation (NVAF)" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for NVAF. Patient didn't miss a dose. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: PULMONARY EMBOLISM (non-serious), outcome "unknown", described as "Patient had a PE after taking booster Comirnaty"; CHEST PAIN (non-serious), outcome "unknown".  Additional information: patient had a PE (Pulmonary Embolism) after taking booster Comirnaty. She was having chest pain so she went to ER (Emergency Room). 2 weeks prior to shot, she had testing done and no DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) showed on scans until having Bivalent. Provider stated that she read an article stating that they are starting to see more DVT (Deep Vein Thrombosis) and PEs (Pulmonary Embolism) after having Comirnaty booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 3 days after first shot in right arm rash developed on upper arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "3 days after first shot in right arm rash developed on upper arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Haemorrhagic stroke
Clinical narrative: hemorrhagic stroke; 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 (BNT162B2), on 15Aug2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series completed, unknown manufacturer), for COVID-19 immunisation. The following information was reported: HAEMORRHAGIC STROKE (medically significant) with onset 22Dec2022, outcome "unknown", described as "hemorrhagic stroke".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid 3 times; Covid 3 times; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 3 times". Additional information: the patient got Covid 3 times after using Pfizer product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: patient being administered PENTACEL after the liquid and lyophilized components were not properly reconstituted together and some of the lyophilized vaccine component was still left in the vial after administration with no reported adverse event; patient being administered PENTACEL after the liquid and lyophilized components were not properly reconstituted together and some of the lyophilized vaccine component was still left in the vial after administration with no reported adverse event; Initial information received on 10-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] after the liquid and lyophilized components were not properly reconstituted together and some of the lyophilized vaccine component was still left in the vial after administration 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 pneumococcal vaccine conj 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 10-Apr-2023, the patient was administered 0.5ml  dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength; not reported) (lot UJ668AA; Expiry Date: 13-May-2023) via unknown route in the right vastus lateralis (Rt thigh) for Immunization after the liquid and lyophilized components were not properly reconstituted together and some of the lyophilized vaccine component was still left in the vial after administration with no reported adverse event (product preparation issue) (incorrect dose administered) (latency; on same day).  It was reported that she reconstituted the liquid component (DTAP-IPV) of vaccine with the powder component (lyophilized ACTHIB vaccine) and after they were mixed it was some powder component still stuck to the bottom of the vial once she withdrew the vaccine into a syringe. It was hard to dissolve the powder into the solution even after shaking for about 1 minute and tapping on her hand. The vaccine was administered to a patient.  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 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: 11.0
Sex: F
Vaccine: TD
Symptoms: No adverse event, Wrong product administered
Clinical narrative: tennivac vaccine was administered to a patient accidently as the patient was supposed to receive the tdap with no reported adverse event; Initial information received on 10-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient and it was reported diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] vaccine was administered to a patient accidently as the patient was supposed to receive the tdap 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 HPV vaccine VLP RL1 4V (yeast) (Gardasil) and meningococcal vaccine A/C/Y/W CONJ (CRM197) (Menveo) both for Prophylactic vaccination.  On 05-Apr-2023, diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] vaccine suspension for injection (batch/lot number: U7189AA; expiry date: 30-Sep-2023; strength: standard; dose:0.5 mL) was administered to the patient accidently via intramuscular route in the right deltoid for immunization as the patient was supposed to receive the tdap with no reported adverse event (wrong product administered) (latency: same day).  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: 7.0
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: extra dose administered with no reported AE; Initial information received on 11-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA113854.  This case involves a 7 years old male patient who was administered an extra dose of 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 21-Jun-2022, the patient received 0.5 ml  of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot number: UJ635AAA; Expiry date: 30-NOV-2022) (Strength: Standard; Frequency: utr) via intramuscular route in unknown administration site for immunisation.  On 21-Jun-2022 the patient was administered an extra dose of HIB (PRP/T) VACCINE with no reported adverse event (extra dose administered) (Latency: same day).  It was reported, Nurse has questions on how to proceed. She states the PENTACEL components were all given separately and an extra dose was given by accident. Call transferred. The nurse states that their clinic did not receive the immunization records on a new patient until after extra doses of DAPTACEL, IPOL, and ACTHIB were given in error. Extra dose of ACTHIB given on 21Jun2022. The nurse asks if these are valid doses or should they be reinjected. The HCP asks if the patient will experience any AE's as a result of this  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event extra dose administered with no reported ae.  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: 7.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: extra dose of IPOL given in error with no reported adverse event; Initial information received on 11-Apr-2023 regarding an unsolicited valid non-serious case received via nurse. GMI number: 01570626  This case involves 7 years old male patient who experienced extra dose of ipol (IPV (VERO)) given in error with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2023SA113922 and 01570409.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunization.  On an unknown date, the patient received extra dose of suspect IPV (VERO) at dose 0.5ml frequency unknown (lot: U1A452M, expiry date: 20-Feb-2023) via subcutaneous route in unknown administration site for Immunization given in error with no reported adverse event (extra dose administered) at same day latency.  It was reported that "Nurse has questions on how to proceed. She states the PENTACEL components were all given separately, and an extra dose was given by accident. The nurse states that their clinic did not receive the immunization records on a new patient until after extra doses of DAPTACEL, IPOL, and ACTHIB were given in error. Extra dose of ACTHIB given on 21Jun2022. Clarified as NOT PENTACEL as all 3 vaccines (DAPTACEL, IPOL, and ACTHIB) were given on separated dates and as separate injections. The nurse asks if these are valid doses or should they be reinjected. The HCP inquired if the patient would experience any adverse event because of this."   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event extra dose administered.    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: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACTHIB was accidentally given to a patient with no reported adverse event; Initial information received on 11-Apr-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 1 years old female patient and it was reported that expired HIB (PRP/T) vaccine [ACT-HIB] was accidentally given to a patient 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel); pneumococcal vaccine CONJ 7V (CRM197) (Prevnar); and hepatitis A vaccine INACT (Vaqta) all for Immunisation.  On 11-Apr-2023, an expired dose of HIB (PRP/T) vaccine [ACT-HIB] powder and solvent for solution for injection (batch: UJ671ABA; expiry date: 07-Apr-2023; dose: 0.5 mL; strength: standard) was accidentally given to a patient via intramuscular route in the left thigh for immunization with no reported adverse event (expired product administered) (latency: same day).  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: 66.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Muscle spasms
Clinical narrative: Severe shoulder stiffness. Shoulder froze on third day and still stiff after 2 weeks. Hurts to move the arm. Constant feeling of muscle pull/spasm. Doctor prescribed Ibuprofen 400 mg  since last Friday 3/7. Since 4/14 he prescribed 600mg three times a day. he Prescribed exercise for the left arm and apply  Heat pad. It has not helped a bit.  I was perfectly OK until I got this vaccine. My fear is permanent pain, restricted arm motion and stiffness spreading to other joints or muscles.
Age: 66.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Fear, Muscle spasms, Muscle strain, Musculoskeletal stiffness, Pain
Clinical narrative: Severe shoulder stiffness. Shoulder froze on third day and still stiff after 2 weeks. Hurts to move the arm. Constant feeling of muscle pull/spasm. Doctor prescribed Ibuprofen 400 mg  since last Friday 3/7. Since 4/14 he prescribed 600mg three times a day. he Prescribed exercise for the left arm and apply  Heat pad. It has not helped a bit.  I was perfectly OK until I got this vaccine. My fear is permanent pain, restricted arm motion and stiffness spreading to other joints or muscles.
Age: 66.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Periarthritis
Clinical narrative: Severe shoulder stiffness. Shoulder froze on third day and still stiff after 2 weeks. Hurts to move the arm. Constant feeling of muscle pull/spasm. Doctor prescribed Ibuprofen 400 mg  since last Friday 3/7. Since 4/14 he prescribed 600mg three times a day. he Prescribed exercise for the left arm and apply  Heat pad. It has not helped a bit.  I was perfectly OK until I got this vaccine. My fear is permanent pain, restricted arm motion and stiffness spreading to other joints or muscles.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation reaction, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: COVID Arm  Rash, stiff lump, pain/soreness and intense itching at injection site Single hive appeared on thumb with itching Joint pain similar to arthritis, mainly in left wrist  Feeling hot to touch wrist and injection lump  Palms and soles itching first night  Intense body aches   Benadryl 2x  Ibuprofen 800mg 1x
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth, Joint warmth, Musculoskeletal stiffness, Pain
Clinical narrative: COVID Arm  Rash, stiff lump, pain/soreness and intense itching at injection site Single hive appeared on thumb with itching Joint pain similar to arthritis, mainly in left wrist  Feeling hot to touch wrist and injection lump  Palms and soles itching first night  Intense body aches   Benadryl 2x  Ibuprofen 800mg 1x
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: COVID Arm  Rash, stiff lump, pain/soreness and intense itching at injection site Single hive appeared on thumb with itching Joint pain similar to arthritis, mainly in left wrist  Feeling hot to touch wrist and injection lump  Palms and soles itching first night  Intense body aches   Benadryl 2x  Ibuprofen 800mg 1x
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; HCP called to report a TE with PNEUMOVAX 23 PFS.; This spontaneous report was received from a consumer and refers to a 68-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-MAR-2023, the patient was vaccinated with an improper stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) at a dose of 0.5 ml, lot #W027449, expiration date: 25-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) following a temperature excursion of 46.7F (47F) for 72 hours 0 minutes 0 seconds discovered upon looking at the data logs (product storage error). Data logger recorded a 46.7F temp on 03-MAR-2023, and did not record again until logging a 43F temperature on 06-MAR-2023, worst case scenario of 46.7F was used for the full 72 hours. No additional adverse event was reported.  This is one from several cases from the same reporter. ; Sender's Comments:  US-009507513-2304USA002650: US-009507513-2304USA002667: US-009507513-2304USA002750: US-009507513-2304USA002694: US-009507513-2304USA002746:
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered at inappropriate site
Clinical narrative: Dose administered in left thigh instead of deltoid; This non-serious case was reported by a other health professional via call center representative and described the occurrence of vaccine administered at inappropriate site in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5AY2NJ, expiry date 10-JUN-2024) for prophylaxis.   On 08-MAR-2023, the patient received Kinrix (left thigh). On 08-MAR-2023, an unknown time after receiving Kinrix, the patient experienced vaccine administered at inappropriate site (Verbatim: Dose administered in left thigh instead of deltoid). The outcome of the vaccine administered at inappropriate site 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: 06-APR-2023 The reporter was medical assistant. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The Kinrix was given on left thigh instead of the deltoid, which led to vaccine administered at inappropriate site.
Age: 73.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: expired dose of ACTHIB was administered to a patient with no reported adverse event; Initial information received on 11-Apr-2023 regarding an unsolicited valid non-serious case received via registered nurse. GMI number: 01570546.  This case involves 73 years old male patient to whom expired dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] was administered to a patient 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 PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination; MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for Prophylactic vaccination; MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) for Prophylactic vaccination; and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Prophylactic vaccination.   On 11-Apr-2023, the patient was administered expired first dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection at dose 0.5ml once (powder lot: UJ633AA, expiry date: 30-Jan-2023) via intramuscular route in the right deltoid for Immunization with no reported adverse event (expired product administered) at same day latency.  It was reported that Caller confirmed that an expired dose of ACTHIB was administered to a patient. The diluent was within the correct date, but the powder portion had expired 30JAN2023. Caller would like to know how to proceed. This is reported as a medication error due to the inappropriate administration of an expired product to a patient.    Action taken: Not applicable.  No corrective treatment was received for the event.  At time of reporting, the outcome was Unknown for the event expired product administered.    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: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, No reaction on previous exposure to drug, Pain in extremity, Peripheral swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Complains of pain in left hand with slight swelling near palm closest to pointer finger after second dose. States that she did not feel anything after the first vaccine. Vaccine administration, technique, and volume properly verified.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Electric shock sensation, Hypoaesthesia, Laboratory test, Neuropathy peripheral
Clinical narrative: In March of 2021 I had a first Moderna vaccine, in a while - second. Last week I got a 4th booster. All of them were Moderna.  Soon after the first vaccine, I started to feel burning in my soles. Situation slowly but steadily worsened. By now, I have a strong case of peripheral neuropathy up to the middle of my  lower legs and some in my hands. Most of the feeling is lost. Tingling and light shockwaves in the lower legs are constant.  I am not a diabetic, drinker or smoker.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: In March of 2021 I had a first Moderna vaccine, in a while - second. Last week I got a 4th booster. All of them were Moderna.  Soon after the first vaccine, I started to feel burning in my soles. Situation slowly but steadily worsened. By now, I have a strong case of peripheral neuropathy up to the middle of my  lower legs and some in my hands. Most of the feeling is lost. Tingling and light shockwaves in the lower legs are constant.  I am not a diabetic, drinker or smoker.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines PFizer 4/28/21 Lot# BW0153 ; Pfizer 5/23/21 Lot# EW0176
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines ; Moderna 2/12/21 Lot# 015M20A;  Moderna 3/12/21 Lot# 040A21A;  Moderna 10/5/21 Lot# 049C21A
Age: 13.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Vaccine was inadvertently given to patient after it was not properly stored under the conditions recommended by manufacturer.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Arthritis, Osteoarthritis, Pain, X-ray limb abnormal
Clinical narrative: My problem started in November when I would get up to walk, when I would start to walk my right knee gave me a lot of pain. After a few weeks my left knee started to give me the same pain so I made an appointment to see the doctor they referred me to get some x-rays and after the x-rays I was referred to an Orthopedic doctor. The Orthopedic doctor gave me a cortisone shot in both knees and she prescribed the medication meloxicam and Diclofenac Sodium Topical. I was also sent to rehabilitative therapy and my condition improved.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Pfizer 1/20/21 Lot# El3249;  Pfizer 2/11/21 lot# EM9810;  Pfizer 10/29/21 Lot# 320308D;  Moderna 7/7/22 Lot# 014B22A
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 4/22/21 Lot# 030A21A;  Moderna 5/20/21 Lot# 022B21A;  Moderna 12/23/21 Lot# 033H21A
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Feeling abnormal, Malaise, Mastication disorder, Oral pain
Clinical narrative: I started feeling off and tired that afternoon. Then the next day I didn't feel too well the whole day. I started feeling feverish and by afternoon I was running a temperature of 101 degrees. On Friday I started feeling better Friday night. I had fever congestion, and mouth pain. It was difficult to eat or chew.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I started feeling off and tired that afternoon. Then the next day I didn't feel too well the whole day. I started feeling feverish and by afternoon I was running a temperature of 101 degrees. On Friday I started feeling better Friday night. I had fever congestion, and mouth pain. It was difficult to eat or chew.
Age: 15.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Vaccine was inadvertently given to patient after it was not properly stored under the conditions recommended by manufacturer.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 3/4/21 Lot# 030A21A;  Moderna 4/5/21 Lot# 025B21A
Age: 41.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Cough, Diarrhoea, Feeling abnormal, Headache
Clinical narrative: I had a fever, headache and just didn't feel for about three days after receiving the vaccine. I tested positive for COVID-19 on 03/22/2023. I had nausea, extreme body aches, diarrhea and fever. I called my doctor for advice. I decided not to take PAXLOVID and treat my symptoms with over-the-counter medication. As of today, I still have a cough.
Age: 41.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Nausea, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I had a fever, headache and just didn't feel for about three days after receiving the vaccine. I tested positive for COVID-19 on 03/22/2023. I had nausea, extreme body aches, diarrhea and fever. I called my doctor for advice. I decided not to take PAXLOVID and treat my symptoms with over-the-counter medication. As of today, I still have a cough.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines  Pfizer 2/19/21 Lot# En6200;  Pfizer 3/12/21 Lot# EN6207;  Pfizer 10/03/2021 Lot# FF2588;  Pfizer 4/24/22 Lot# FJ4989
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 3/3/21 Lot# 030A21A;  Moderna 3/31/21 Lot# 018B21A
Age: 17.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Vaccine was inadvertently given to patient after it was not properly stored under the conditions recommended by manufacturer.  No symptoms present. Dose will not count and will have to be repeated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: On December 17 I woke up feeling poorly. I took a home Covid test and it was positive. On Monday morning I went to clinic to have that result confirmed. It was confirmed that I had Covid. I use some over the counter, cold and flu preparation?s. The symptoms were primarily headache, fatigue, nausea. I didn?t really have any fever this go around. I had Covid last December and it was much worse.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: On December 17 I woke up feeling poorly. I took a home Covid test and it was positive. On Monday morning I went to clinic to have that result confirmed. It was confirmed that I had Covid. I use some over the counter, cold and flu preparation?s. The symptoms were primarily headache, fatigue, nausea. I didn?t really have any fever this go around. I had Covid last December and it was much worse.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines  Janssen 4/10/21 Lot# 041A;  Moderna 12/19/21 Lot# 068H21A
Age: 0.33
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Vaccine was inadvertently given to patient after it was not properly stored under the conditions recommended by manufacturer. No symptoms present. Dose will not count and will have to be repeated.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Headache, Nausea
Clinical narrative: I had COVID-19 on 01/17/2023. I was prescribed Paxlovid medication and took this for five days. I had severe headache, fever of 102 degrees, shaking chills, nausea and a bad cough.  I did have a home COVID-19 test on 01/18/2023.  The Paxlovid helped me a lot started to feel better after my first day.  I have recovered from my COVID-19 symptoms.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test positive, Tremor
Clinical narrative: I had COVID-19 on 01/17/2023. I was prescribed Paxlovid medication and took this for five days. I had severe headache, fever of 102 degrees, shaking chills, nausea and a bad cough.  I did have a home COVID-19 test on 01/18/2023.  The Paxlovid helped me a lot started to feel better after my first day.  I have recovered from my COVID-19 symptoms.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Bacterial test negative, Chest X-ray normal, Chills, Dyspnoea
Clinical narrative: I woke up with chills, very cold that day, I could not breath, my lungs were very painful, pain on all my joints, my eyes were sensitive to the sun. No fever or any other symptoms coughing (no cough, no running nose).  On the 2nd day the chills were gone, but I still had a lot of trouble in breathing, joints still hurt, and the lung hurt. On the 4th day I went to the doctor, and they took chest Xray, the Xray did not showed anything, I thought it was a virus and not a bacteria, they took a nose swab and throat swab, and they did a culture for bacteria and not for a virus. One week later the pain on my joints were gone, I still had difficulty breathing, but it was getting better, after 2 weeks the pain on the lungs were gone. They did not give me any prescription.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling cold, Photophobia, Pulmonary pain
Clinical narrative: I woke up with chills, very cold that day, I could not breath, my lungs were very painful, pain on all my joints, my eyes were sensitive to the sun. No fever or any other symptoms coughing (no cough, no running nose).  On the 2nd day the chills were gone, but I still had a lot of trouble in breathing, joints still hurt, and the lung hurt. On the 4th day I went to the doctor, and they took chest Xray, the Xray did not showed anything, I thought it was a virus and not a bacteria, they took a nose swab and throat swab, and they did a culture for bacteria and not for a virus. One week later the pain on my joints were gone, I still had difficulty breathing, but it was getting better, after 2 weeks the pain on the lungs were gone. They did not give me any prescription.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Impaired work ability, Influenza virus test negative, Pain, Productive cough
Clinical narrative: Fever and body aches, congestion were most of the symptoms, with a slight cough. I tried to take care of it at home using airborne, and Tylenol, trying to treat it like a cold but finally realized I needed to see a doctor. I tried to see my PCP on 11/9 but wasn't able to, so I had to go to the ER to try and get some medicine. They gave me dicyclomine for 7 days. On the last day the symptoms started coming back, specifically the fever came back and I felt "zapped". I was able to get in to see the NP at my PCP's office and they gave me a different antibiotic to take, Amoxicillin Clav; which made me feel a whole lot better, along with some Mucinex. The second time I did end up having to take off two days work. I'm thinking all of this is related to my allergies because I'm still congested a few months later and still coughing up some yellow phlegm.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Respiratory syncytial virus test negative, Respiratory tract congestion, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Fever and body aches, congestion were most of the symptoms, with a slight cough. I tried to take care of it at home using airborne, and Tylenol, trying to treat it like a cold but finally realized I needed to see a doctor. I tried to see my PCP on 11/9 but wasn't able to, so I had to go to the ER to try and get some medicine. They gave me dicyclomine for 7 days. On the last day the symptoms started coming back, specifically the fever came back and I felt "zapped". I was able to get in to see the NP at my PCP's office and they gave me a different antibiotic to take, Amoxicillin Clav; which made me feel a whole lot better, along with some Mucinex. The second time I did end up having to take off two days work. I'm thinking all of this is related to my allergies because I'm still congested a few months later and still coughing up some yellow phlegm.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Muscle spasms, Muscle tightness, Musculoskeletal discomfort, Nervous system disorder
Clinical narrative: I had pain from my left shoulder that was going down my left arm. It was treated like muscle spasm or tension that was irritating the nerve. I went to see the doctor within a day or two. The doctor did an x-ray and prescribed muscle relaxants. I also alternated between heat and cold to relax the shoulder. Within the last 2 weeks I went to a chiropractor to get my neck adjusted also as my neck was bothering me. That has also helped with the symptoms.