chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Blood urine, Blood urine present
Clinical narrative: Blood was in his urine after the first shot; The initial case was missing the following minimum criteria: Unidentifiable reporter. Upon receipt of follow-up information on 02Jun2023, this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Lawyer) from legal division. Other Case identifier(s): (court case number).  A 24-year-old male patient received BNT162b2 (BNT162B2), on 27Aug2021 as dose 1, single (Lot number: FD0809) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD URINE PRESENT (non-serious), outcome "unknown", described as "Blood was in his urine after the first shot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that because the patient wanted to take his classes in person, needed to be fully vaccinated. He scheduled his vaccine appointment and received his first shot in Aug (2021) and his second in Sep (2021). His parents said he chose the Pfizer vaccine because it was recently fully approved by the Food & Drug Administration. The patient took two doses of the Pfizer-BioNTech COVID-19 vaccine because the school otherwise barred him from attending in-person classes. After his first dose, the patient experienced complications, which he chose to keep to himself. According to his parents, blood was in his urine after the first shot. His dad described him as healthy/athletic, saying he had no underlying medical conditions. Patient experienced medical symptoms after his first dose of the experimental COVID-19 injection that worsened after received a second dose of the EUA Pfizer-BioNTech COVID-19 injection on 17Sep2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200215072 same patient, different dose and different event.;
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: had a history of sinusitis that "keeps cycling and he can't seem to get rid of it, however it does go away"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 08Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "afib" (unspecified if ongoing); "sinusitis" (unspecified if ongoing). The patient's medical history, reported also as family history included: "parkinsons" (unspecified if ongoing), notes: his wife has Parkinson's and severe scoliosis of 28 years; "severe scoliosis" (unspecified if ongoing), notes: his wife has Parkinson's and severe scoliosis of 28 years. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: AWO173), administration date: 03Aug2021, for COVID-19 immunization, reaction(s): "Unexpected therapeutic effect". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "had a history of sinusitis that "keeps cycling and he can't seem to get rid of it, however it does go away"".  Additional information: Caller provided that his wife (withheld) and himself had two primary, Pfizer Covid-19 shots in 2021 within 3 weeks a part. Caller provided per their vaccination card they received "AWO173 on 03Aug2021 and the second vaccine on 08Sep2021." Caller provided that they never received a booster. Caller is asking if his wife and himself are able eligible to receive the Pfizer Covid-19 bivalent booster?. Caller provided that they are going to be traveling this month and decided that they feel they should get vaccinated. Caller stated that his wife has Parkinson's and severe scoliosis of 28 years. Caller provided that he has afib and has a history of sinusitis that "keeps cycling and he can't seem to get rid of it, however it does go away."   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: She got her last dose on Oct2021 but had a severe allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown Manufacturer), for COVID-19 IMMUNIZATION. The following information was reported: HYPERSENSITIVITY (medically significant), outcome "unknown", described as "She got her last dose on Oct2021 but had a severe allergic reaction".  Additional information: it was reported that the patient completed the primary series since she has 2 doses now. Caller says she got her last dose in Oct2021 but had a severe allergic reaction. Patient is around 40 years old above.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Stem cell transplant
Clinical narrative: underwent a stem cell transplant; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID: (004756).  A 69-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing); "organ transplant" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation; Bnt162b2 (dose 2), for COVID-19 immunisation. The following information was reported: STEM CELL TRANSPLANT (medically significant), outcome "unknown", described as "underwent a stem cell transplant". Therapeutic measures were taken as a result of stem cell transplant. The caller wanted to know the timeframe for a patient, who underwent stem cell surgery, to get a Pfizer bivalent COVID vaccine. Further explained that the patient had his primary series and booster doses of the Pfizer BioNTech COVID-19 vaccine. He then underwent stem cell transplant and got the primary series of the Pfizer BioNTech COVID-19, monovalent vaccine again on 08Mar2023 and 30Mar2023 respectively. The caller asked if all the vaccines prior to the stem cell transplant are invalid. The caller specifically requests information regarding the bivalent Pfizer BioNTech COVID-19 vaccine. The caller also asked if the patient could receive a second dose of Pfizer BioNTech COVID-19 bivalent vaccine 4 months after the first one.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information in the case the reported event STEM CELL TRANSPLANT assessed as unrelated to suspect drug  and more likely related to intercurrent/ underlying medical condition,Linked Report(s) : US-PFIZER INC-202300214458 same patient, different drug, dose and event;US-PFIZER INC-202300214459 same patient, different drug, dose and event;
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Investigation, Pain in extremity
Clinical narrative: a little fatigue; her arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6202) at the age of 78 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing), notes: I take blood pressure pill losartan; "reflux" (unspecified if ongoing); "overweight" (unspecified if ongoing), notes: I am overweight. Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; OMEPRAZOLE taken for gastrooesophageal reflux disease. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "a little fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm was sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She stated she received the first two shots, no problem, the only major thing was a little fatigue and her arm was sore. No investigations performed. She was taking a bunch of Vitamin supplements. Route of administration: Consumer stated, "They were all given as shot, is that what you are asking?". In the arm or shoulder, the part above her elbow.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300214685 same patient, different drug, dose and event;US-PFIZER INC-202300214684 same patient and drug, different dose and event;US-PFIZER INC-202300214683 same patient and drug, different dose and event;US-PFIZER INC-202300214682 same patient and drug, different dose and similar event;
Sex: M
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: Her husband in particular has had a few inflammatory responses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient 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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; but unknown manufacturer), for Covid-19 Immunization. The following information was reported: INFLAMMATION (non-serious), outcome "unknown", described as "Her husband in particular has had a few inflammatory responses". Additional information: Reporter stated that the people that she knew are clearly nervous getting the bivalent, given what she had experienced, but everyone responded differently. Her husband (patient) in particular has had a few inflammatory responses, not anywhere like this but a hip flare or something.Caller stated that she's wondering if inflammation is reported after the vaccine. Its a big question for her family. Both her and her husband (patient) had both experienced it. She had a tear in her hip that she had surgically repaired and one of vaccines, one of the times she got a booster set off a flare in her hip. Her husband (patient) had the same experience with his knees. She was just wondering if it was anecdotal or if that's something there is data on. Knock on wood, neither of her or her husband have had Covid. It made to wonder if the side effects are worse than the disease but they really don't want to get it, especially with long Covid.  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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: a little fatigue; her arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 2, single (Lot number: EN6206) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing); "reflux" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; OMEPRAZOLE taken for gastrooesophageal reflux disease. Vaccination history included: BNT162b2 (Dose 1, single, Lot#: EN6202), administration date: 28Feb2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "a little fatigue", "her arm was sore".  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "a little fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm was sore".  Additional information: She stated she received the first two shots, no problem, the only major thing was a little fatigue, and her arm was sore. No investigations were performed. She was taking a bunch of Vitamin supplements. Route of administration: she stated, "They were all given as shot, is that what you are asking?". In the arm or shoulder, the part above her elbow.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300214238 same patient and drug, different dose and similar event;
Age: 70.0
Sex: M
Vaccine: PNC20
Symptoms: Illness, Pyrexia
Clinical narrative: Several fever, several hours after the Prevnar (Prevnar 20); developed a fever 99.3 to 100.3 up until last night though I received Prevnar (Prevnar 20); Several illness; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 02Jun2023 as dose number unknown, 0.5ml single (Batch/Lot number: unknown) at the age of 70 years intramuscular, in left deltoid for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 02Jun2023, outcome "recovered" (05Jun2023), described as "Several fever, several hours after the Prevnar (Prevnar 20); developed a fever 99.3 to 100.3 up until last night though I received Prevnar (Prevnar 20)"; ILLNESS (non-serious) with onset 02Jun2023, outcome "unknown", described as "Several illness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, illness. Additional information: Reporter stated, "Several illness, several hours after the administration of Prevnar 20." Paraphrased the concern: Reporter stated, "Several fever, several hours after the Prevnar (Prevnar 20). I developed a fever 99.3 to 100.3 up until last night though I received Prevnar (Prevnar 20) on Friday, 02Jun2023, as of last night I had a fever of 100.3." The patient went to the urgent care and was given Tylenol, 650 milligrams, PRN, as needed. The patient's condition improved today. The patient's fever stopped on 05Jun2023.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: Sore arm; Did not feel 100 percent but felt ok; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9263) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "MS", start date: Aug1998 (ongoing), notes: MS; "Immunosupressed" (unspecified if ongoing), notes: has an underlying condition and is immune suppressed. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; MALAISE (non-serious), outcome "unknown", described as "Did not feel 100 percent but felt ok".  Additional information: Indication as Reported by the Primary Source: has an underlying condition and was immune suppressed. She was concerned about health information and how this will be shared and was calling about the newest Pfizer bivalent vaccine and had a very severe reaction to it and ended up going to the emergency room twice and has been diagnosed with acute pericarditis with fluid around her heart and has no other cause of that and it was directly related to the timing of when she got the vaccine. She knows that has been reported in young men and teenage boys but it has not been reported in her cohorts so she called her pharmacy and they directed her to call Pfizer. All the vaccines she received were Pfizer and the 1st dose was administered on 25Jan2021 with EL9263 and her card has no expiry dates or NDC to provide; For the prior dose of the Pfizer vaccine she had on 14Mar2022, all other doses prior to that one she had the typical sore arm for 48 hours and did not feel 100 percent but felt ok and had nothing major Indication for the Pfizer Vaccine: she has an underlying condition and was immune suppressed and every time she has an opportunity to get this she has been advised she should have it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300215077 Same product, patient, different event, different dose;US-PFIZER INC-202300215226 Same product, patient, same event, different dose;US-PFIZER INC-202300215227 Same product, patient, same event, different dose;US-PFIZER INC-202300214232 Same product, patient, different event, different dose;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: typical sore arm; did not feel 100 percent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose 2, single (Lot number: EN6201) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "MS", start date: Aug1998 (ongoing), notes: MS; "Immunosupressed" (unspecified if ongoing), notes: has an underlying condition and is immune suppressed. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single), administration date: 25Jan2021, when the patient was 68-year-old, for COVID-19 Immunization, reaction(s): "typical sore arm", "did not feel 100 percent".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "typical sore arm"; MALAISE (non-serious), outcome "unknown", described as "did not feel 100 percent".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300215077 Same product, patient, different event, different dose;US-PFIZER INC-202300215225 Same product, patient, same event, different dose;US-PFIZER INC-202300215227 Same product, patient, same event, different dose;US-PFIZER INC-202300214232 Same product, patient, different event, different dose;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: did not feel 100 percent; typical sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), on 06Sep2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "MS", start date: Aug1998 (ongoing); "immune suppressed" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Lot: EL9263), administration date: 25Jan2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "typical sore arm", "did not feel 100 percent"; BNT162b2 (Dose 2, Single, Lot: EN6201), administration date: 15Feb2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "typical sore arm", "did not feel 100 percent".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "typical sore arm"; MALAISE (non-serious), outcome "unknown", described as "did not feel 100 percent".  Additional information: The patient had a typical sore arm for 48 hours and did not feel 100 percent but felt ok and had nothing major.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300215077 Same product, patient, different event, different dose;US-PFIZER INC-202300215225 Same product, patient, same event, different dose;US-PFIZER INC-202300215226 Same product, patient, same event, different dose;US-PFIZER INC-202300214232 Same product, patient, different event, different dose;
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EL8982), in left arm, on 01Apr2021 as dose 2, single (Lot number: EL898), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 26 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 17Sep2022 as dose 5 (booster), single (Lot number: A57145B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "eczema" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Peanut allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29May2023, outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29May2023, outcome "not recovered", described as "Interchange of vaccine products ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2023) Positive, notes: I tested daily with Floflex rapid antigen tests throughout my illness; (05Jun2023) Negative. Therapeutic measures were taken as a result of events, the patient received paxlovid from 22May2023 to 03Jun2023.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had a mild case of COVID-19; had a mild case of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had a mild case of COVID-19".  Clinical course: Patient received a COVID-19 monovalent booster (manufacturer not specified) and had a mild case of COVID-19 "sometime afterwards". Also reported a heart attack following their second Pfizer vaccine shot (Reporter was unsure if this was referring to primary series or booster).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 5 (booster), single (Lot number: GH9702), 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: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (03Jun2023) Positive, notes: Had faint positive line for three days after completion of 5-day Paxlovid series; (04Jun2023) Positive, notes: Had faint positive line for three days after completion of 5-day Paxlovid series; (05Jun2023) Positive, notes: Had faint positive line for three days after completion of 5-day Paxlovid series; (06Jun2023) Positive, notes: Positive line on day 4 after completing Paxlovid series. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).
Sex: F
Vaccine: PNC20
Symptoms: Pain, Urticaria
Clinical narrative: experienced hives all over her body; experienced pain for a total of 48 hours with no relief; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), 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: URTICARIA (non-serious), outcome "unknown", described as "experienced hives all over her body"; PAIN (non-serious), outcome "recovered", described as "experienced pain for a total of 48 hours with no relief". Additional information: Patient experienced hives all over her body 48 hours post vaccination with Prevnar. Patient also experienced pain for a total of 48 hours with no relief.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Obesity
Clinical narrative: Obesity; This is a spontaneous report received from contactable reporter(s) (Nurse).  An 11-year-old male patient received BNT162b2 (BNT162B2), on 02Aug2022 as dose 2 (orange cap), single (Lot number: FL8095) at the age of 11 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1 (Orange cap), Anatomical site of injection: unknown, Route of administration: Intramuscular, Batch/Lot number: FL8094), administration date: 12Jul2022, when the patient was 11-year-old, for COVID-19 immunization.  The following information was reported: OBESITY (non-serious) with onset 08Sep2022, outcome "not recovered".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300102420 Same patient, different vaccine dose and different event.;
Sex: U
Vaccine: PPV
Symptoms: Drug hypersensitivity, Rash
Clinical narrative: Drug Allergies: Yes; Pneumococcal vaccine (Rash); This is a spontaneous report received from a contactable reporter(s) (Physician).  An 82-year-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), 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: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Drug Allergies: Yes"; RASH (non-serious), outcome "unknown", described as "Pneumococcal vaccine (Rash)".  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administer an expired adacel with no reported adverse event; Initial information received on 06-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 year old female patient and reporter reported that an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] administered 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 MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI)  and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Prophylactic vaccination.  On 06-Jun-2023, the patient received a dose 1 at a dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE suspension for injection (Strength: Standard and expiry date: 10-May-2023, lot C5882AA) via intramuscular route in unknown administration site for Immunization and administer an expired vaccine 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 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: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event.  Received 2nd Prevnar 13 . 1st Prevnar 13 was given on 9/23/2018
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15
Symptoms: Agitation, Pruritus, Urticaria
Clinical narrative: Mom called office after leaving office. Child was given vaccines around 12:30pm. When giving child a bottle around 2pm mom noticed that child was beginning to develop hives.  By the time he finished the bottle he as broken out from head to toe. Mom noted that child was very itchy and agitated. Mom laid child down for a nap and made sure he was in a cool room without clothes on. Mom has been observing child and has noted child has not had any trouble breathing at this time. Mom called office and sent pictures to the office for review. Child has eczema and already had a mild rash. Mom was given okay to use liquid Benadryl at  dose per provider of 2 ml every 6 hours prn. Mom to keep a close eye on child and if swelling spreads, especially to face/mouth, or any trouble breathing develops mom was instructed to take child to the ER.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: none
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Back pain, Brain fog, Condition aggravated, Diarrhoea, Fatigue
Clinical narrative: Late in the evening I had trouble sleeping as the arm was sore. Unable to do anything for about 2 weeks. I experienced extreme fatigue. I just slept close to 24 hours a day for 2 weeks. Arm was swollen. Back Pain flared up as well. Saw doctor and he gave me some prednisone, a topical cream, and something for diarrhea. Follow up with Doc, reupped the diarrhea medications and to come back in things get worse. Symptoms have become less, but I still have fatigue and brain fog.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Hypersomnia, Loss of personal independence in daily activities, Pain in extremity, Peripheral swelling, Sleep disorder
Clinical narrative: Late in the evening I had trouble sleeping as the arm was sore. Unable to do anything for about 2 weeks. I experienced extreme fatigue. I just slept close to 24 hours a day for 2 weeks. Arm was swollen. Back Pain flared up as well. Saw doctor and he gave me some prednisone, a topical cream, and something for diarrhea. Follow up with Doc, reupped the diarrhea medications and to come back in things get worse. Symptoms have become less, but I still have fatigue and brain fog.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient was admitted to hospital with GBS
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: Tinnitus
Age: 1.0
Sex: M
Vaccine: COVID19, HIBV, MMR, PNC13, VARCEL
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: no side effects noted per mom
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Laboratory test normal
Clinical narrative: My first Covid shot was 2/21 and my second Covid shot was 3/21. In April of 2021, I started having chills and sweats. I would go through 5 to 10 shirts a day. Starting in November of 2022 the chills got worse and I refer to them as freezing chills. I have to take 2 to 3 hot showers a day just to get my core temperature up. So I have been having a serious problem with chills and sweats for 2 years and 2 months.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Incorrect product formulation administered, Pain in extremity, Product preparation error
Clinical narrative: Wrong formulation of vaccine given.  Staff thought she grabbed the single dose vial of Pfizer for 12 year old and over, but had actually grabbed Pfizer vaccine for 6month to 4 year old.  Vaccine was given undiluted.  Patient notified of error pt c/o headache and arm pain.  Pt and daughter also advised they could go to the ER if needed.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: Patient think that she is getting a Varicella vaccine instead of a shingrix
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation error
Clinical narrative: Pt given the wrong formulation.  Staff thought she was giving the Pfizer for 12 y/o and over but actually gave the Pfizer 6 month-4 y/o undiluted.  Patient notified, no adverse reactions reported
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: Patient think that she should be getting  Varicella vaccine instead of the shingrix
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Emotional distress, Tinnitus
Clinical narrative: Within less than a month of the vaccines I developed ringing in the ears that continues to this day.  It is very disturbing.
Age: 91.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient received the second dose of flu vaccine within the same season.
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Received the second dose of flu vaccine within the same season.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash, Urticaria
Clinical narrative: Rash/hives which started in right arm, spread to both arms, chest, then back, legs. Swollen fingers.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Myalgia
Clinical narrative: Inflamation & muscle pain that continues 6 months after Injection on (L) UE.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Haematemesis, Respiration abnormal
Clinical narrative: After two days of second Moderna vaccine my blood aresion was pretty low and I start to vomited pure blood badly. I start to have diseas after 1 hour that I got this vaccine very tired, not breathing normal. I am vomiting, diaradh, etc. & November went in emergency care Hospital.
Age: 0.83
Sex: F
Vaccine: COVID19-2
Symptoms: Dyskinesia, Fatigue
Clinical narrative: A few hrs. post vaccine parents noticed quick head movement that was not normal for patient, parents thought at first it may have been water in ear  as patient was in the bath. But both parents had noticed similar abnormal head movement tilt to one side, 3 to 4 quick head tilts. No muscle stiffness or decreased muscle tone. No eyes staring or rolling back, no LOC. SHE was holding a chewing on toy during movement. She is cruising, standing. patient seemed a little more tired this morning. No head movements when sleeping.
Age: 1.75
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Dyskinesia, Rapid eye movements sleep abnormal, Unresponsive to stimuli
Clinical narrative: Foster mom heard patient moving middle of the night in his crib. When she checked on him he was doing rapid movement with his body and foster dad noticed his eyes moving rapidly, wasn't responding to his name, not waking up - lasted about 30 seconds, EMS called, patient was then acting fine by the time paramedics arrived. Patient seen in office for follow up 1/18/22
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: On the 4th day after vaccination I began having a pain in my left knee which lasted over a week. During that time I began having a hip joint pain, which lasted over 4 weeks.  few days after the knee pain I got a sharp pain in my left big toe for 24 hours, then a throbbing pain above my right ankle which lasted about a week.  After over 4 weeks all my pain was gone and no other issues continued.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event on patient; temperature excursion; This spontaneous report was received from an office manager referring to a 12-year-old male patient. The patient had none pre-existing physician-diagnosed allergies, birth defects and medical conditions. Information of concomitant medications was not reported.  On 28-DEC-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (1 dosage form (1 dose); strength, route and anatomical location were unknown) (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023, lot #1775827, expiration date: 27-JUN-2024, lot #U032681, expiration date: 26-OCT-2023, lot #1780876, expiration date: 09-NOV-2023, and lot #W009829, expiration date: 19-OCT-2024; it was not specified which one was received by the patient) for prophylaxis at private doctor's office/hospital by the ordering physician. The vaccine was purchased with public funds and the vaccine-device was purchased with private funds. The vaccine experienced temperature excursion on 09-SEP-2022 for 8 minutes and on 16-SEP-2022 for 5 minutes (product storage error). Excursions were not noted until after the fact due to employee error of cleaning data logger more than once a day. This medication error occurred in the process of storage in clinical practice. This report was called because of a data logger.  No adverse event and no issues were on patient (no adverse event). The patient had no illness at time of vaccination. The patient did not die.   This was one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a patient of unspecified age or gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 16-MAY-2023, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (0.5 milliliter (mL), once, lot# X004813, expiration date 28-JUL-2024, strength, route and anatomical location were unknown) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions at 46.74 degree Fahrenheit (F) for 2 minutes (product storage error). There were no previous temperature excursions. No additional adverse events were reported (no adverse event), and no further information was provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events reported.; Caller reports that improperly stored vaccines were administered.; This spontaneous report was received from an administrator referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-MAR-2023, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA), 1 time dose, lot #3397T1, expiration date on 30-NOV-2023 (dose, dose number, route of administration, and anatomical location were not provided), administered for prophylaxis. Lot number 3397T1 is an invalid lot number for hepatitis a vaccine, inactivated (VAQTA).    It was reported that on an unspecified date, the vaccine was exposed to a temperature of -40 degrees Fahrenheit (F) for 70 hours and 5 minutes. There was no previous temperature excursion. No other adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE occurred; an expired dose was administered to the patient; This spontaneous report was received from a licensed practical nurse referring to a patient of unspecified age or gender. The patient's concurrent conditions, concomitant medications, pertinent medical history, drug reactions or allergies were not informed.   On 15-MAY-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status recombinant human albumin (rHA)) (M-M-R II) injection (1 dosage form (1 dose), lot# U014655, expiration date 07-MAY-2023, strength, route and anatomical location were unknown) for prophylaxis (expired product administered). No other adverse event was occurred (no adverse event), and the product did not have any temperature excursions prior to administration.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Accidental exposure to product
Clinical narrative: No Additional AE/PQC; the product possibly did go onto the patient's leg; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-MAY-2023, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). They were intended to receive a dose of dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (0.5 milliliter) (strength, lot #, expiry date not provided) but it was spilled on the floor because the patient moved. HCP did not believe any of the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was injected and stated that only the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was injected. While on the Phone with the HCP, it was mentioned that the product possibly did go onto the patient's leg (Accidental exposure while administering drug).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion. Exact date of administration not provided. Patient is asymptomatic. No additional AE. No PQC. Names of vaccines involved (including lot/exp) VARIVAX W02; No additional AE; This spontaneous report has been received from nurse referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.    On an unknown date, the was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W025274 that had been verified to be a valid lot number with expiration date 10-AUG-2024, administered for prophylaxis (strength, vaccination scheme, route of administration and anatomical site of application were not provided) (product storage error), which had a temperature excursion of 24.4 F for 5 hours 51 minutes 0 seconds. No additional adverse event reported and there was no a previous temperature excursion.
Age: 22.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient has not had any side effects. No additional AE; Patient accidently received a dose of PROQUAD instead of MMR; Proquad administered to a 22-year-old patient; This spontaneous report has been received from a nurse, concerning a 22-year-old female patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 06-JUN-2023, the patient accidently received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1 dose, as prophylaxis (exact dose, lot number, expiration date, route of administration, and anatomical location were not provided) instead of measles, mumps and rubella (MMR) vaccine (Wrong product administered) (Product administered to patient of inappropriate age). She did not had any side effects nor additional adverse events (AEs).
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported; Patient received a dose of the RECOMBIVAX HB vaccine that was improperly stored; This spontaneous report has been received from a healthcare professional, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 18-MAY-2023, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (lot number W012032 has been verified to be valid, expiration date reported and confirmed as 19-NOV-2023), as prophylaxis (exact dose, route of administration, and anatomical location were not provided) (Product storage error). No additional adverse event (AE) nor product quality complaint (PQC) were reported.  This is one of multiple reports received from the same reporter. ; Sender's Comments:  US-009507513-2306USA003052: US-009507513-2306USA003084:
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: had recently gotten over covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had recently gotten over covid) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced COVID-19 (had recently gotten over covid). At the time of the report, COVID-19 (had recently gotten over covid) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the patient had gotten over covid recently 2 months ago after receiving the vaccine in September of last year and wanted to know when the patient could receive an additional vaccine. No treatment medication was reported.   Reporter did not allow further contact