chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Heavy metal increased, Investigation
Clinical narrative: high presence of mercury in my body; This spontaneous case was reported by a patient and describes the occurrence of HEAVY METAL INCREASED (high presence of mercury in my body) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine for an unknown indication.    No Medical History information was reported.   In May 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY METAL INCREASED (high presence of mercury in my body). At the time of the report, HEAVY METAL INCREASED (high presence of mercury in my body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: After some testing during travels, patient discovered a high presence of mercury in body.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medication was reported. The patient recently had several booster vaccinations in May 2024 for travel reasons. Following some tests conducted during her travels, she found elevated levels of mercury in her system and was currently investigating possible sources. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2025: Live non-significant follow up received: reference number added.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain, Pain in extremity, Pyrexia
Clinical narrative: aches; painful hands; dizziness; fever; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (aches), PAIN IN EXTREMITY (painful hands), DIZZINESS (dizziness) and PYREXIA (fever) in a 74-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN (aches), PAIN IN EXTREMITY (painful hands), DIZZINESS (dizziness) and PYREXIA (fever). At the time of the report, PAIN (aches), PAIN IN EXTREMITY (painful hands), DIZZINESS (dizziness) and PYREXIA (fever) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       Patient had no medical history, concomitant disease or risk factor.   Concomitant product use was not provided by the reporter.  Patient did not experience any additional symptoms or events.  There were no lab data or results were available.  Treatment information was not provided.  Reporter causality was not reported.
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema
Clinical narrative: Red round mark where the injection site is, it feels like kind of a reddish circle, like a round reddish mark; This is a spontaneous report received from a Consumer or other non HCP.  A male 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: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Red round mark where the injection site is, it feels like kind of a reddish circle, like a round reddish mark".  Additional information: consumer stated, he took it on Wednesday, 6 days ago and you know, no bad reactions. Well now today he noticed back, back like underneath where the injection site was on the triceps. It feels like kind of a reddish circle, like a round reddish mark, you know not a little tiny mark, a big mark which raised my concern level. So, he just went online and did some research and then he would have gone back to his GP who gave him the shot but her office for some reason was closed. So, he went to a emergency care but the guy looked at it and said, sometimes the reactions are delayed but he is not an expert in this vaccine like you are. consumer stated, "Six days later right. It does not itch, there was no pain, it might hurt a little tiny bit but there was no pain. He was not trying to downplay it and just telling you the facts, but it was there, and he did not notice it there prior to today.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Pneumothorax, Pulmonary thrombosis, Swelling
Clinical narrative: left lung collapsed due to a small clot like those from birth control pills; left lung collapsed due to a small clot like those from birth control pills; aphasia; noticed some swelling near her breast underneath the armpit; This is a spontaneous report received from a Nurse from medical information team, Program ID.  A 79-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMOTHORAX (medically significant), PULMONARY THROMBOSIS (medically significant), outcome "unknown" and all described as "left lung collapsed due to a small clot like those from birth control pills"; APHASIA (non-serious), outcome "unknown"; SWELLING (non-serious), outcome "not recovered", described as "noticed some swelling near her breast underneath the armpit". Clinical course: The patient was a retired nurse calling for herself as she took her first covid shot on her left arm and had a reaction and next shot is on her right arm and had the same reaction, and now unable to fit on her coat. The first COVID-19 vaccine she had was some years ago and she had aphasia. Her left lung collapsed due to a small clot like those from birth control pills. Then, a few months later, she noticed some swelling near her breast underneath the armpit. It doesn't go away. Patient was asking if she can get the next shot on her hip or she will do it by herself as she knew how to do it.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events pneumothorax, and pulmonary thrombosis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202500039797 same patient/drug, different event/drug dose.;
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Influenza like illness
Clinical narrative: severe headaches; made her feel like she had the flu; sick; This is a spontaneous report received from a Nurse from medical information team.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing), notes: diagnosed at least 15 years ago. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (medically significant) with onset 19Jan2021, outcome "recovered" (20Jan2021), described as "sick"; HEADACHE (non-serious), outcome "recovered", described as "severe headaches"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "made her feel like she had the flu". Clinical course: The patient informed that she had both of Pfizer's Covid vaccines in the past and they made her very sick for several days. She informed that the doctor was not involved. Her symptoms occurred the day after she received the injections. The second dose made her sicker than the first. With both of them, she had a reaction and clarified that she had severe headaches, and it made her feel like she had the flu. The first shot she was sick for 2 days and with the 2nd shot she was sick in bed for 4 days. She has completely recovered from this. The event very sick was reported as serious as other medically important condition. The reporter relatedness of drug to reaction/events was yes.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: Based on the close temporal relationship, the association between the event sick with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202500039829 same reporter/patient/events, different dose;
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Investigation, Laboratory test, Menstrual disorder, Postural orthostatic tachycardia syndrome
Clinical narrative: Dysautonomia; Postural orthostatic tachycardia syndrome; Small fiber neuropathy; Changes in my menstrual cycle with abnormal bleeding; von Willebrand factor high; This is a spontaneous report received from a Consumer or other non HCP.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: EN6203) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO taken for depression, anxiety. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EL9267), administration date: 17Mar2021, when the patient was 34-year-old, for COVID-19 immunization. The following information was reported: AUTONOMIC NERVOUS SYSTEM IMBALANCE (medically significant), outcome "unknown", described as "Dysautonomia"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown"; SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "Small fiber neuropathy"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Changes in my menstrual cycle with abnormal bleeding"; VON WILLEBRAND'S FACTOR MULTIMERS ABNORMAL (non-serious), outcome "unknown", described as "von Willebrand factor high". The patient underwent the following laboratory tests and procedures: factor eight assay: (2021) high; Lab work: (unspecified date) Unknown results, notes: Yes a lot of it actually; Von Willebrand's factor antigen test: (2021) high, notes: von Willebrand factor activity is high. Therapeutic measures were taken as a result of autonomic nervous system imbalance.  Clinical course: Consumer stated, that she developed the disorder Dysautonomia, Pots postural orthostatic tachycardia syndrome, also developed small fiber neurotherapy and She experienced some changes in menstrual cycle with abnormal bleeding, those she thinks are the most distinguishable right now."Consumer stated, "I am not prior to this but my doctors have put me on IVIG on this and I am also taking Lexapro for anxiety and depression."Consumer stated, "So right now it is finding that I have the factor for von Willebrand, factor is coming back high and if we go back to 2021 I have elevated sedimentation rates. The von Willebrand factor antigen is high, the factor eight assay is high and the von Willebrand factor activity is high."
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Small fibre neuropathy, Von Willebrand's factor antigen test, Von Willebrand's factor multimers abnormal
Clinical narrative: Dysautonomia; Postural orthostatic tachycardia syndrome; Small fiber neuropathy; Changes in my menstrual cycle with abnormal bleeding; von Willebrand factor high; This is a spontaneous report received from a Consumer or other non HCP.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: EN6203) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO taken for depression, anxiety. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EL9267), administration date: 17Mar2021, when the patient was 34-year-old, for COVID-19 immunization. The following information was reported: AUTONOMIC NERVOUS SYSTEM IMBALANCE (medically significant), outcome "unknown", described as "Dysautonomia"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown"; SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "Small fiber neuropathy"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Changes in my menstrual cycle with abnormal bleeding"; VON WILLEBRAND'S FACTOR MULTIMERS ABNORMAL (non-serious), outcome "unknown", described as "von Willebrand factor high". The patient underwent the following laboratory tests and procedures: factor eight assay: (2021) high; Lab work: (unspecified date) Unknown results, notes: Yes a lot of it actually; Von Willebrand's factor antigen test: (2021) high, notes: von Willebrand factor activity is high. Therapeutic measures were taken as a result of autonomic nervous system imbalance.  Clinical course: Consumer stated, that she developed the disorder Dysautonomia, Pots postural orthostatic tachycardia syndrome, also developed small fiber neurotherapy and She experienced some changes in menstrual cycle with abnormal bleeding, those she thinks are the most distinguishable right now."Consumer stated, "I am not prior to this but my doctors have put me on IVIG on this and I am also taking Lexapro for anxiety and depression."Consumer stated, "So right now it is finding that I have the factor for von Willebrand, factor is coming back high and if we go back to 2021 I have elevated sedimentation rates. The von Willebrand factor antigen is high, the factor eight assay is high and the von Willebrand factor activity is high."
Sex: M
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: after got the shot, hasn't for a long time, has no need for asthma medicine anymore/very good for asthma; after got the shot, hasn't for a long time, has no need for asthma medicine anymore; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "after got the shot, hasn't for a long time, has no need for asthma medicine anymore".  Additional information: Calling to let know caller got the COVID-19 shot from Pfizer two times and caller was suffering with asthma for a long time, many years, for 15 or 18 years. Confirmed asthma was prior to caller getting any of the Pfizer COVID-19 shots. After caller got the shot, hasn't for a long time, has no need for asthma medicine anymore. Usually by Spring time caller was not even able to go outside, after got the shot for the last 3 years feeling good. Confirmed both doses were the Pfizer COVID-19 shot. 1st dose: Date: Unknown, doesn't remember, in Spring time, but does not have card at time of call to provide information. Patient received 2nd dose, about 6 months later.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: got the Pfizer COVID-19 shot, patient was feeling a lot better. Confirmed had asthma prior to getting the Pfizer COVID-19 shot; got the Pfizer COVID-19 shot, patient was feeling a lot better. Confirmed had asthma prior to getting the Pfizer COVID-19 shot; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "hospitalized" (unspecified if ongoing), notes: every month. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 omicron (kp.2) (DOSE 1, SINGLE), for Covid 19 immunization, reaction(s): "was suffering from asthma, after got the Pfizer COVID-19 shot, is feeling a lot better", "was suffering from asthma, after got the Pfizer COVID-19 shot, is feeling a lot better". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown" and all described as "got the Pfizer COVID-19 shot, patient was feeling a lot better. Confirmed had asthma prior to getting the Pfizer COVID-19 shot".  Additional information: Caller's friend, marked as patient, also was suffering from asthma, and caller's friend used to get hospitalized every month. After caller's friend got the Pfizer COVID-19 shot, caller's friend is feeling a lot better. Confirmed had asthma prior to getting the Pfizer COVID-19 shot. Caller stated Pfizer had the best reputation, and then caller got the second shot because was very good for asthma, which was the same for caller's friend who was worse.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Pain in extremity
Clinical narrative: received the Prevnar vaccine and he was actually fine and he just said that he had soreness in arm; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 66-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single, in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "received the Prevnar vaccine and he was actually fine and he just said that he had soreness in arm".  Additional information: The reporter was now asking for Prevnar 20. The reporter mentioned that her husband got the Pfizer Prevnar shot through (redacted) and was fine but has a wonderful immune system and allergic to nothing. The reporter informed that she was considering the same shot for her son.
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old patient received BNT162b2 (BNT162B2), in Apr2020 as dose 1, single (Lot number: FL3198) for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "cataracts are forming over the last few years" (ongoing); "Penicillin allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "tetracycline allergy" (unspecified if ongoing); "latex allergy" (unspecified if ongoing); "allergies" (unspecified if ongoing); "deaf/profound hearing loss" (ongoing), notes: 50+ years; "Wore oticon 380P hearing aids" (ongoing). Concomitant medication(s) included: LEVOXYL taken for thyroid disorder; CLARITIN [CLARITHROMYCIN]. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500021060 same patient/product/event; different dose;
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: sore arm; inappropriate schedule of vaccine administered; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 2, single (Lot number: EP6955) for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "cataracts are forming over the last few years" (ongoing); "Penicillin allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "tetracycline allergy" (unspecified if ongoing); "latex allergy" (unspecified if ongoing); "allergies" (unspecified if ongoing); "deaf/profound hearing loss" (ongoing), notes: 50+ years; "Wore oticon 380P hearing aids" (ongoing). Concomitant medication(s) included: LEVOXYL taken for thyroid disorder; CLARITIN [CLARITHROMYCIN]. Vaccination history included: Biontech (dose 1; lot: FL3198), administration date: Apr2020, for covid-19 immunization, reaction(s): "sore arm". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Mar2021, outcome "unknown", described as "inappropriate schedule of vaccine administered"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500021060 same patient/product/event; different dose;
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old patient received BNT162b2 (BNT162B2), on 19Apr2021 as dose 3 (booster), single (Lot number: EW0162), for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "cataracts are forming over the last few years" (ongoing); "Penicillin allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "tetracycline allergy" (unspecified if ongoing); "latex allergy" (unspecified if ongoing); "allergies" (unspecified if ongoing); "deaf/profound hearing loss" (ongoing), notes: 50+ years; "Wore oticon 380P hearing aids" (ongoing). Concomitant medication(s) included: LEVOXYL taken for thyroid disorder; CLARITIN [CLARITHROMYCIN]. Vaccination history included: BNT162b2 (Dose 2; Lot: EP6955), administration date: 27Mar2021, for covid-19 immunization, reaction(s): "sore arm"; Biontech (dose 1; lot: FL3198), administration date: Apr2020, for covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500021060 same patient/product/event; different dose;
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Lot number: GH9703) for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "cataracts are forming over the last few years" (ongoing); "Penicillin allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "tetracycline allergy" (unspecified if ongoing); "latex allergy" (unspecified if ongoing); "allergies" (unspecified if ongoing); "deaf/profound hearing loss" (ongoing), notes: 50+ years; "Wore oticon 380P hearing aids" (ongoing). Concomitant medication(s) included: LEVOXYL taken for thyroid disorder; CLARITIN [CLARITHROMYCIN]. Vaccination history included: BNT162b2 (Dose 2; Lot: EP6955), administration date: 27Mar2021, for covid-19 immunization, reaction(s): "sore arm"; BNT162b2 (Dose 3; lot: EW0162), administration date: 19Apr2021, for covid-19 immunization, reaction(s): "sore arm"; Biontech (dose 1; lot: FL3198), administration date: Apr2020, for covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500021060 same patient/product/event; different dose;
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Lot number: HD9876) for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "cataracts are forming over the last few years" (ongoing); "Penicillin allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "tetracycline allergy" (unspecified if ongoing); "latex allergy" (unspecified if ongoing); "allergies" (unspecified if ongoing); "deaf/profound hearing loss" (ongoing), notes: 50+ years; "Wore oticon 380P hearing aids" (ongoing). Concomitant medication(s) included: LEVOXYL taken for thyroid disorder; CLARITIN [CLARITHROMYCIN]. Vaccination history included: BNT162b2 (Dose 2; Lot: EP6955), administration date: 27Mar2021, for covid-19 immunization, reaction(s): "sore arm"; BNT162b2 (Dose 3; lot: EW0162), administration date: 19Apr2021, for covid-19 immunization, reaction(s): "sore arm"; bivalent (Dose 4; lot: GH9703), administration date: 12Oct2022, for covid-19 immunization, reaction(s): "sore arm"; Biontech (dose 1; lot: FL3198), administration date: Apr2020, for covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500021060 same patient/product/event; different dose;
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: arm swelling; itching; redness; pain; hot to the touch; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A 59-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 09Jan2025 as dose 1, single (Lot number: HP7365) at the age of 59 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 14Jan2025, outcome "recovered" (18Jan2025), described as "arm swelling"; FEELING HOT (non-serious) with onset 14Jan2025, outcome "recovered" (18Jan2025), described as "hot to the touch"; PRURITUS (non-serious) with onset 14Jan2025, outcome "recovered" (18Jan2025), described as "itching"; PAIN (non-serious) with onset 14Jan2025, outcome "recovered" (18Jan2025); ERYTHEMA (non-serious) with onset 14Jan2025, outcome "recovered" (18Jan2025), described as "redness". It was unknown if therapeutic measures were taken as a result of peripheral swelling, pruritus, erythema, pain, feeling hot.  Additional information: The vaccine was administered in the upper deltoid. The patient did not receive any other vaccines on the same date and within 4 weeks prior to pneumococcal 20-val conj vac (dipht crm197 protein).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Epilepsy, Seizure
Clinical narrative: seizures / epilepsy; seizures / epilepsy; This is a spontaneous report received from a Consumer or other non HCP.  A 27-year-old female patient received BNT162b2 (BNT162B2), on 18May2021 as dose 2, single (Lot number: EW0183) at the age of 27 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE taken for anxiety. Vaccination history included: BNT162b2 (Dose 1, Single, Intramuscular, Batch number: EV0175, in the AM), administration date: 27Apr2021, when the patient was 27-year-old, for Covid-19 Immunization, reaction(s): "Seizures", "Epilepsy". The following information was reported: SEIZURE (disability) with onset 19May2021, outcome "not recovered", EPILEPSY (disability), outcome "unknown" and all described as "seizures / epilepsy". The event "seizures / epilepsy" required physician office visit. Therapeutic measures were taken as a result of epilepsy, seizure which included Keppra 3000 mg, Lamictal 200mg, Vimpat 400mg, Onfi 40 mg.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400161429 Same patient, product and event different dose;
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had a mild case; I had a mild case; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "immunocompromised" (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 "unknown" and all described as "I had a mild case".  Clinical course: The reporter stated that he was a healthcare worker, who has asthma, and the Pfizer COVID vaccine prevented hospitalization when caught COVID. Had a mild case, and strongly believe that  may have died without the vaccine. Withheld is a former drug addict, and he lacks medical and science education and training. Please fight and stand up for immunocompromised people like me.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Influenza like illness
Clinical narrative: sick; it made her feel like she had the flu; headaches; This is a spontaneous report received from a Nurse from medical information team.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing), notes: Diagnosed at least 15 years ago. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 18Jan2021, when the patient was 50-year-old, for Covid-19 immunization, reaction(s): "headaches", "it made her feel like she had the flu", "sick". The following information was reported: HEADACHE (non-serious) with onset 09Feb2021, outcome "recovered", described as "headaches"; INFLUENZA LIKE ILLNESS (non-serious) with onset 09Feb2021, outcome "recovered", described as "it made her feel like she had the flu"; ILLNESS (medically significant) with onset 09Feb2021, outcome "recovered" (12Feb2021), described as "sick". The second dose made her sicker than the first. The event sick was reported as serious as other medically important condition. The reporter relatedness of drug to reaction/events was yes.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Given the compatible time association, the reasonable possibility that the reported events are related to BNT162b2 (BNT162B2) administration cannot be excluded. This case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.,Linked Report(s) : US-PFIZER INC-202500039043 same reporter/patient/event, different dose;
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a vaccine she was not due for.  Moderna Covid-19 12+ was administered for the 2nd time this season. Patient was actually due for a PCV20 vaccine.  Patient did not report any adverse reaction.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Antinuclear antibody, Arthralgia, Blood lactic acid, Brain fog
Clinical narrative: Fever 103 for several Mos.  Whole body turned bright red.  Shortness of breath and chest pain.  Digestion shut down for several Mos, losing 20 lbs, got down to 88 lbs.  Body aches and severe joint pain.  Hair fell out.  Extreme brain fog.  Skin rashes.  Exertional intolerance.  Fatigue.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Colonoscopy, Computerised tomogram abdomen, Dyspepsia, Dyspnoea
Clinical narrative: Fever 103 for several Mos.  Whole body turned bright red.  Shortness of breath and chest pain.  Digestion shut down for several Mos, losing 20 lbs, got down to 88 lbs.  Body aches and severe joint pain.  Hair fell out.  Extreme brain fog.  Skin rashes.  Exertional intolerance.  Fatigue.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Erythema, Exercise tolerance decreased, Fatigue, Full blood count
Clinical narrative: Fever 103 for several Mos.  Whole body turned bright red.  Shortness of breath and chest pain.  Digestion shut down for several Mos, losing 20 lbs, got down to 88 lbs.  Body aches and severe joint pain.  Hair fell out.  Extreme brain fog.  Skin rashes.  Exertional intolerance.  Fatigue.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Haematology test, Metabolic function test, Pain, Pyrexia, Rash
Clinical narrative: Fever 103 for several Mos.  Whole body turned bright red.  Shortness of breath and chest pain.  Digestion shut down for several Mos, losing 20 lbs, got down to 88 lbs.  Body aches and severe joint pain.  Hair fell out.  Extreme brain fog.  Skin rashes.  Exertional intolerance.  Fatigue.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor, Weight decreased, X-ray of pelvis and hip
Clinical narrative: Fever 103 for several Mos.  Whole body turned bright red.  Shortness of breath and chest pain.  Digestion shut down for several Mos, losing 20 lbs, got down to 88 lbs.  Body aches and severe joint pain.  Hair fell out.  Extreme brain fog.  Skin rashes.  Exertional intolerance.  Fatigue.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events/problems reported by patient.  Patient came in to get "second" dose and it was discovered that the last dose was actually the patient's third dose of Shingrix.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Chest discomfort, Chest pain, Dizziness, Dyspnoea, Hot flush
Clinical narrative: Adverse events included: hot flash, trouble breathing, chest pain/ tightness, injection site burning, light headedness.  Pt called her MD for recommendation during onset of symptoms.  While seating in the vaccine area, patient was given water,  glucose tablet.  Then patient felt ok and left the pharmacy ~ 11:28 am. Pharmacy tried to contact patient after 3 times, leaving voicemail but with no response.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain
Clinical narrative: Adverse events included: hot flash, trouble breathing, chest pain/ tightness, injection site burning, light headedness.  Pt called her MD for recommendation during onset of symptoms.  While seating in the vaccine area, patient was given water,  glucose tablet.  Then patient felt ok and left the pharmacy ~ 11:28 am. Pharmacy tried to contact patient after 3 times, leaving voicemail but with no response.
Age: 5.0
Sex: M
Vaccine: HEPA, IPV
Symptoms: Breath holding, Musculoskeletal stiffness, Staring
Clinical narrative: Patient's body was very stiff, and he had a blank stare right after receiving havrix and ipv vaccines, he was seen by a doctor right after who attested that he is fine.  Mother told us after the event that child has breath holding spells and that happen many times before.
Age: 1.75
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Colitis ulcerative, Colonoscopy, Diarrhoea
Clinical narrative: Child started showing signs of extreme diarrhea--frequency and intensity at the beginning of 2023.  After consultation and tests with GI specialist, was diagnosed with ulcerative colitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Axillary pain, Chills, Injection site erythema, Oedema peripheral, Pain
Clinical narrative: Per ED note: patient received a combo shot (Tdap/polio) on Friday and afterwards the injection site was red. On Saturday was complaining of soreness and today mother noted a painful bump to the L axilla with swelling extending to the L chest. per parent also with fever and chills. a similar thing happened with Kinrix and MMRV at prior administration. Patient was discharged from ED symptoms self resolved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Per ED note: patient received a combo shot (Tdap/polio) on Friday and afterwards the injection site was red. On Saturday was complaining of soreness and today mother noted a painful bump to the L axilla with swelling extending to the L chest. per parent also with fever and chills. a similar thing happened with Kinrix and MMRV at prior administration. Patient was discharged from ED symptoms self resolved.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic dilatation, Arthralgia, Biopsy peripheral nerve, Bladder dysfunction, Blindness transient
Clinical narrative: Horrific chest pain, paralysis of leg, vasculitis, aortic dialation, dilated left ventricular of heart, muscle weakness,  overwelming fatigue, temporary loss of vision, joint and muscle pain, blood pooling in hands and feet,  blood clotting, extreme loss of cognitive function, inability to exercise. Shortness of breath, kidney stones, edema, chronic dehydration, bladder dysfunction, lung nodules, pots
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Cognitive disorder, Computerised tomogram, Dehydration
Clinical narrative: Horrific chest pain, paralysis of leg, vasculitis, aortic dialation, dilated left ventricular of heart, muscle weakness,  overwelming fatigue, temporary loss of vision, joint and muscle pain, blood pooling in hands and feet,  blood clotting, extreme loss of cognitive function, inability to exercise. Shortness of breath, kidney stones, edema, chronic dehydration, bladder dysfunction, lung nodules, pots
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Exercise tolerance decreased, Fatigue, Left ventricular dilatation, Magnetic resonance imaging
Clinical narrative: Horrific chest pain, paralysis of leg, vasculitis, aortic dialation, dilated left ventricular of heart, muscle weakness,  overwelming fatigue, temporary loss of vision, joint and muscle pain, blood pooling in hands and feet,  blood clotting, extreme loss of cognitive function, inability to exercise. Shortness of breath, kidney stones, edema, chronic dehydration, bladder dysfunction, lung nodules, pots
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Monoplegia, Muscular weakness, Myalgia, Nephrolithiasis, Oedema
Clinical narrative: Horrific chest pain, paralysis of leg, vasculitis, aortic dialation, dilated left ventricular of heart, muscle weakness,  overwelming fatigue, temporary loss of vision, joint and muscle pain, blood pooling in hands and feet,  blood clotting, extreme loss of cognitive function, inability to exercise. Shortness of breath, kidney stones, edema, chronic dehydration, bladder dysfunction, lung nodules, pots
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Poor peripheral circulation, Postural orthostatic tachycardia syndrome, Pulmonary mass, Thrombosis, Tilt table test
Clinical narrative: Horrific chest pain, paralysis of leg, vasculitis, aortic dialation, dilated left ventricular of heart, muscle weakness,  overwelming fatigue, temporary loss of vision, joint and muscle pain, blood pooling in hands and feet,  blood clotting, extreme loss of cognitive function, inability to exercise. Shortness of breath, kidney stones, edema, chronic dehydration, bladder dysfunction, lung nodules, pots
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vasculitis
Clinical narrative: Horrific chest pain, paralysis of leg, vasculitis, aortic dialation, dilated left ventricular of heart, muscle weakness,  overwelming fatigue, temporary loss of vision, joint and muscle pain, blood pooling in hands and feet,  blood clotting, extreme loss of cognitive function, inability to exercise. Shortness of breath, kidney stones, edema, chronic dehydration, bladder dysfunction, lung nodules, pots
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Malaise, Pyrexia, Vomiting
Clinical narrative: Patient states she was sick for 10 days after receiving the shot with fever and vomiting. She states she contracted cellulitis approx 4-5 days after the shot.
Age: 58.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Disorientation, Dizziness, Migraine, Pain, Photophobia
Clinical narrative: Dizziness, disorientation, body aches onset approximately 1230 AM 2/21/25; migraine with severe light sensitivity onset approximately 345 AM 2/21/25; fever onset approximately 9 AM 2/21/25. AA symptoms continuing through the time of this report 739 PM 2/21/25. All times are PST.
Age: 58.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Pyrexia
Clinical narrative: Dizziness, disorientation, body aches onset approximately 1230 AM 2/21/25; migraine with severe light sensitivity onset approximately 345 AM 2/21/25; fever onset approximately 9 AM 2/21/25. AA symptoms continuing through the time of this report 739 PM 2/21/25. All times are PST.
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: Blepharospasm, Computerised tomogram normal, Electroencephalogram normal, Eye movement disorder, Gaze palsy
Clinical narrative: Within 2 days of his first dose of flu shot, patient began demonstrating random eye rolling/fluttering and would also tilt his head up and have an upward gaze. There was nothing in particular that onset these episodes. They were very sporadic, lasting only a few minutes, but could be hours apart or minutes apart. We told our doctor and he asked to see patient to evaluate. We showed 2 videos as evidence. Doctor spoke with neurologists at the University Hospital and they asked to see the videos. I emailed them and they called to say they wanted to do and EEG, so we went 2 days later for the scan and evaluation.
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: Posture abnormal, Streptococcus test negative
Clinical narrative: Within 2 days of his first dose of flu shot, patient began demonstrating random eye rolling/fluttering and would also tilt his head up and have an upward gaze. There was nothing in particular that onset these episodes. They were very sporadic, lasting only a few minutes, but could be hours apart or minutes apart. We told our doctor and he asked to see patient to evaluate. We showed 2 videos as evidence. Doctor spoke with neurologists at the University Hospital and they asked to see the videos. I emailed them and they called to say they wanted to do and EEG, so we went 2 days later for the scan and evaluation.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pruritus, Rash, Somnolence
Clinical narrative: SEVERE ITCHING & RASH up & down bottom-third of spine, can feel raised little spots / bumps on skin up & down spine. SOME, LESSER ITCHING & RASH along bottom edge(s) of rib cage, front, right & left sides. BEGAN WITHIN 48 HRS of vaccination. CURRENTLY, 8 DAYS SINCE VACCINATION, with no relief. OTHER, VERY MILD SYMPTOMS: pain at injection site for a few days, nothing extreme.  EXTREME FATIGUE & SLEEPINESS, onset approximately 6-8 hrs after vaccination and lasting 48+ hours. Recommended on 02/21/2025 by pharmacist to try OTC products for itching and if itching & rash still present on 02/24/2025, to contact PCP.
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Blepharospasm, Computerised tomogram normal, Gaze palsy, Posture abnormal
Clinical narrative: The day after his 2nd dose of the flue shot vaccine, patient experienced similar seizure like activity as he did after his first dose 2 months prior. This time, however, he was throwing his head back with more force, he was sticking his tongue out (new compared to last time), eyes would roll back and eyelids flutter. He would have his head tipped back so far, it would cause him to lose his balance. These episodes lasted for a few seconds, and were happened much more frequently than they did the first time, so we decided to go to the ER.
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: Seizure like phenomena, Streptococcus test negative
Clinical narrative: The day after his 2nd dose of the flue shot vaccine, patient experienced similar seizure like activity as he did after his first dose 2 months prior. This time, however, he was throwing his head back with more force, he was sticking his tongue out (new compared to last time), eyes would roll back and eyelids flutter. He would have his head tipped back so far, it would cause him to lose his balance. These episodes lasted for a few seconds, and were happened much more frequently than they did the first time, so we decided to go to the ER.
Age: 28.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area around the site of the Varicella injection, red, swollen approximate size of a grapefruit, warm to touch. No itching. Patient states she had taken Benadryl, elevated left arm and ice to the area the evening of 2/19/25. Patient was going to continue the Benadryl, ice and elevate and if not better in 24-36 hrs, going to see HCP.
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Had a rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced rash (Verbatim: Had a rash). The outcome of the rash was not reported.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-FEB-2025 This case was reported by a patient via interactive digital media. Patient had a rash that appeared 2 days after the vaccine. The patient wanted to know was it safe to have 2nd vaccine.