chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oxygen saturation, Pain in extremity, SARS-CoV-2 test
Clinical narrative: She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine; She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine; She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine), HEADACHE (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine) and FATIGUE (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine) in a 76-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (very mild, symptoms: runny nose and dry cough. COVID-19 test was positive, date: unknown) in December 2021. Concurrent medical conditions included High cholesterol and Overactive bladder. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR OD) for High cholesterol.    On 09-Oct-2022, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine), HEADACHE (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine) and FATIGUE (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine). At the time of the report, PAIN IN EXTREMITY (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine), HEADACHE (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine) and FATIGUE (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: not below 96. On an unknown date, SARS-CoV-2 test: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was reported as Crestor on Z tab. Other Moderna covid-19 vaccination details were as follows: patient received first dose on 01Jan2021 (lot number: 014F21A), second dose on 28Jan2021, third dose on 09Apr2022 (lot number: 001M21A) and fifth dose on 19-Sep-2023 (lot number: 3030342). Treatment information was not provided.   This case was linked to MOD-2023-741466, MOD-2023-742199 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No adverse event; Both formulations are pre-filled syringes. HCP accidentally picked up 2 Moderna COVID-19 pre-filled syringes and administered to the patient (Lot# 203E234 & Exp. Date: 27MAR2024).; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Both formulations are pre-filled syringes. HCP accidentally picked up 2 Moderna COVID-19 pre-filled syringes and administered to the patient (Lot# 203E234 & Exp. Date: 27MAR2024).) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 203E234) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ACCIDENTAL OVERDOSE (Both formulations are pre-filled syringes. HCP accidentally picked up 2 Moderna COVID-19 pre-filled syringes and administered to the patient (Lot# 203E234 & Exp. Date: 27MAR2024).). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Both formulations are pre-filled syringes. HCP accidentally picked up 2 Moderna COVID-19 pre-filled syringes and administered to the patient (Lot# 203E234 & Exp. Date: 27MAR2024).) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Both formulations are pre-filled syringes. HCP accidentally picked up 2 Moderna COVID-19 pre-filled syringes and administered to the patient (Lot# 203E234 &amp; Exp. Date: 27MAR2024).).    HCP accidentally picked up 2 Moderna COVID-19 pre-filled syringes and administered to the patient. She does not know how many previous COVID-19 vaccine the patient received previously.  She did not received the FLU Vaccine.  Reporter states that the patient refused to get the FLU shot after the mistake was communicated to her. Pharmacist observed the patient post vaccination and patient was fine. Concomitant medications were not reported.  No treatment information was provided by the reporter.
Age: 82.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Peripheral swelling, Pruritus
Clinical narrative: intially sore; itchy; large swollen area on the her left arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN (intially sore), PRURITUS (itchy) and PERIPHERAL SWELLING (large swollen area on the her left arm) in an 82-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057965) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: pfizer (Dose 1, Lot-ELN263) on 26-Jan-2021, Pfizer (Dose 2, Lot-EN6201) on 11-Feb-2021, Pfizer (Dose 3, Lot-FC3180) on 30-Aug-2021, Pfizer (Dose 4, Lot-FKN891) on 17-Feb-2022, Pfizer (Dose 5, Lot-BJ5342) on 21-Sep-2022, Pfizer (Dose 6 and Lot-GJ6743) on 29-Mar-2023. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer, Pfizer, Pfizer and pfizer. Concurrent medical conditions included Celiac disease.    On 22-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (intially sore), PRURITUS (itchy) and PERIPHERAL SWELLING (large swollen area on the her left arm). The patient was treated with CORTISONE in September 2023 at an unspecified dose and frequency. At the time of the report, PAIN (intially sore), PRURITUS (itchy) and PERIPHERAL SWELLING (large swollen area on the her left arm) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Within less than 24 hours of vaccination there was a large swollen area on her left arm. It got progressively worse measuring about 5 by 4 inches.
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Myalgia
Clinical narrative: pain in the shoulder for 2 days now; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in the shoulder for 2 days now) and MYALGIA (muscle aches) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 27-Sep-2023, the patient experienced ARTHRALGIA (pain in the shoulder for 2 days now) and MYALGIA (muscle aches). At the time of the report, ARTHRALGIA (pain in the shoulder for 2 days now) had resolved and MYALGIA (muscle aches) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that patient and his brother had 6 Moderna shots. On 27SEP2023, patient only had pain in the shoulder for 2 days and muscle aches.  Treatment information was not reported.   This case was linked to MOD-2022-647145, MOD-2021-015968, MOD-2022-647146 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Feeling cold, Headache, Heart rate increased, Nasopharyngitis
Clinical narrative: her temperature, it was 99.8 close to 100.; cold; Spinning; On the night of 25Sep2023, she complained that she was cold, her head was hurting, and saying my head is bothering me; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), VERTIGO (Spinning), HEADACHE (On the night of 25Sep2023, she complained that she was cold, her head was hurting, and saying my head is bothering me) and PYREXIA (her temperature, it was 99.8 close to 100.) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 205E23A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccines (she had normal reactions and like arm hurting and fever.). Past adverse reactions to the above products included No adverse event with Pfizer vaccines. Concurrent medical conditions included AFib. Concomitant products included METOPROLOL and FLECAINIDE for an unknown indication.    On 25-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced NASOPHARYNGITIS (cold), VERTIGO (Spinning) and HEADACHE (On the night of 25Sep2023, she complained that she was cold, her head was hurting, and saying my head is bothering me). On an unknown date, the patient experienced PYREXIA (her temperature, it was 99.8 close to 100.). At the time of the report, NASOPHARYNGITIS (cold) and VERTIGO (Spinning) had not resolved and HEADACHE (On the night of 25Sep2023, she complained that she was cold, her head was hurting, and saying my head is bothering me) and PYREXIA (her temperature, it was 99.8 close to 100.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 close to 100..     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient's heart was running faster but this time it was hurting. She went to sleep and the next morning she couldn't eat as before and not drinking as much, there is a difference in thirst, and she complained. On 26Sep2023, in night after eating, she wanted to vomit, but didn't.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-742507 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742507:Husband Case (same reporter different patient)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: her temperature, it was 99.8 close to 100.; cold; Spinning; On the night of 25Sep2023, she complained that she was cold, her head was hurting, and saying my head is bothering me; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), VERTIGO (Spinning), HEADACHE (On the night of 25Sep2023, she complained that she was cold, her head was hurting, and saying my head is bothering me) and PYREXIA (her temperature, it was 99.8 close to 100.) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 205E23A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccines (she had normal reactions and like arm hurting and fever.). Past adverse reactions to the above products included No adverse event with Pfizer vaccines. Concurrent medical conditions included AFib. Concomitant products included METOPROLOL and FLECAINIDE for an unknown indication.    On 25-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced NASOPHARYNGITIS (cold), VERTIGO (Spinning) and HEADACHE (On the night of 25Sep2023, she complained that she was cold, her head was hurting, and saying my head is bothering me). On an unknown date, the patient experienced PYREXIA (her temperature, it was 99.8 close to 100.). At the time of the report, NASOPHARYNGITIS (cold) and VERTIGO (Spinning) had not resolved and HEADACHE (On the night of 25Sep2023, she complained that she was cold, her head was hurting, and saying my head is bothering me) and PYREXIA (her temperature, it was 99.8 close to 100.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 close to 100..     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient's heart was running faster but this time it was hurting. She went to sleep and the next morning she couldn't eat as before and not drinking as much, there is a difference in thirst, and she complained. On 26Sep2023, in night after eating, she wanted to vomit, but didn't.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-742507 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742507:Husband Case (same reporter different patient)
Sex: M
Vaccine: UNK
Symptoms: Tremor
Clinical narrative: shake or can call it tremble; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shake or can call it tremble) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 26-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced TREMOR (shake or can call it tremble). At the time of the report, TREMOR (shake or can call it tremble) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient states that he had all Moderna vaccines with no reactions.  A night before a day of reporting, patient received the new vaccine and when he was inside, he was shaking or can call it tremble when it was a little cool or the air was on. When patient went outside, the shaking or trembling stopped and never had that before. Patient did not have chills or any other reactions.  No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: got a Prevnar 20 syringe out of the box and tried to remove the cap on the end of the syringe and the end of the syringe broke off making the syringe unusable; The initial case was missing the following minimum criteria due to no adverse event reported. Upon receipt of follow-up information on 12Sep2023, 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) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GN2778, Expiration Date: Sep2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MALFUNCTION (non-serious), outcome "unknown", described as "got a Prevnar 20 syringe out of the box and tried to remove the cap on the end of the syringe and the end of the syringe broke off making the syringe unusable".  The reporter considered "got a prevnar 20 syringe out of the box and tried to remove the cap on the end of the syringe and the end of the syringe broke off making the syringe unusable" not related to pneumococcal 20-val conj vac (dipht crm197 protein). Causality for "got a prevnar 20 syringe out of the box and tried to remove the cap on the end of the syringe and the end of the syringe broke off making the syringe unusable" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein) (malfunction).  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.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: rash and redness and it is every where on her. It started just on her arms but now it is all over; rash and redness and it is every where on her. It started just on her arms but now it is all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72-year-old female patient (unknown if pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown (booster), single (Lot number: HG4633) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: I take medicine for diabetes; "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, manufacturer: Johnson & Johnson), for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, manufacturer: Moderna), for COVID-19 immunisation; Comirnaty (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: RASH (medically significant), ERYTHEMA (medically significant), outcome "unknown" and all described as "rash and redness and it is every where on her. It started just on her arms but now it is all over". The patient underwent the following laboratory tests and procedures: Weight: about 200 pounds. Therapeutic measures were taken as a result of rash, erythema.  Additional information: The patient asked about what they are calling Covid arm. She have been reading about it online and she got this Pfizer Vaccine last Friday and she have this Covid arm that looks like rash but it was everywhere from her neck down to her knees and it started out with just her arm and then her forearms and then next day on her neck and then on chest, stomach and in her legs it just kept adding and she was just wondering. Patient discovered it after administration of the Pfizer COVID-19 vaccine "covid arm" and looked it up online. She had rash and redness and it was every where on her. It started just on her arms but now it is all over. She was wondering if that was unusual and would like to know what recommendation of something topical to put on it or med she can take by mouth. She used Benadryl but did not know if there was something better to use. She mentioned what more importantly is at what point does this become a concern. She wanted to know if it was something unusual and how does she know when it gets to the point that she needs to go have somebody look at it. Patient took Benadryl as treatment.  She stated she only took 2 tablets, she did not take any medication before, she took Benadryl afterwards.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 73.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Arthralgia, Aspiration bursa abnormal, Bursitis, Culture negative, Erythema
Clinical narrative: Three hours after the injections, severe pain started at the injection site.  The pain was rated at 10/10 and did not respond to OTC analgesics or hydrocodone.  After phone consultation with my PCP at about 10:30 PM, I had my wife take me to a local ED.
Age: 73.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Inflammatory marker increased, Injection site pain, Joint swelling, Laboratory test, Magnetic resonance imaging abnormal
Clinical narrative: Three hours after the injections, severe pain started at the injection site.  The pain was rated at 10/10 and did not respond to OTC analgesics or hydrocodone.  After phone consultation with my PCP at about 10:30 PM, I had my wife take me to a local ED.
Age: 73.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Magnetic resonance imaging joint, Musculoskeletal stiffness, Pain, Skin warm, Tenderness
Clinical narrative: Three hours after the injections, severe pain started at the injection site.  The pain was rated at 10/10 and did not respond to OTC analgesics or hydrocodone.  After phone consultation with my PCP at about 10:30 PM, I had my wife take me to a local ED.
Age: 73.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Ultrasound joint abnormal, X-ray normal
Clinical narrative: Three hours after the injections, severe pain started at the injection site.  The pain was rated at 10/10 and did not respond to OTC analgesics or hydrocodone.  After phone consultation with my PCP at about 10:30 PM, I had my wife take me to a local ED.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: redness and raised temperature at injection site.  Recommended ice pack and tylenol as needed.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Blood glucose, Hyperhidrosis, Joint injury, Pallor, Syncope
Clinical narrative: The following day after giving vaccine, child was at school running from building to building on playground equipment. At end of recess when heading in for lunch, he hit knee hard against a piece of equipment.  When he was about to go into the school, his vision turned yellow, became pale and very sweaty  then  fainted.  Teacher was able  to  catch him.  EMS and parent called,  Evaluated at school. Mother called and reported incident to clinic at 2:10 pm.  She requested incident be reported to VAERS.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Xanthopsia
Clinical narrative: The following day after giving vaccine, child was at school running from building to building on playground equipment. At end of recess when heading in for lunch, he hit knee hard against a piece of equipment.  When he was about to go into the school, his vision turned yellow, became pale and very sweaty  then  fainted.  Teacher was able  to  catch him.  EMS and parent called,  Evaluated at school. Mother called and reported incident to clinic at 2:10 pm.  She requested incident be reported to VAERS.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: none
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapporved storage unit
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine stored in unapproved storage unit.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapporved storage unit
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: As soon as vaccine was administered, patient's arm swelled up at injection site. Injection site got red and bumpy. Ice was applied and injection site swelling decreased slightly after 15 minutes but still present when patient departed the pharmacy.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Flushing
Clinical narrative: PATIENT HAD A HISTAMINE REACTION POST DOSE. PATIENT TURNED RED AND FLUSHED. RESPONDED TO DIPHENHYDRAMINE.
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on body, beginning 4 days after vaccine was given. Hives would appear and disappear over body (i.e. would occur on back and then one hour later, would not be on his back but would be on his arms/shoulders). Child reported it was itchy, was given allergy medicine for itch. No other symptoms.
Age: 64.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: PT STATED SHE HAD ITCHING, A LITTLE PAIN, SWELLING AND BRUISING AROUND INJECTION SITE ON LEFT DELTOID. PT STATED THAT IT STOPPED HURTING UNLESS SHE PRESSES ON IT.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Contracted covid; Contracted covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, in Jan2023 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown) and in Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Sep2023, outcome "not recovered" and all described as "Contracted covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Sep2023) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: No any other vaccine was given in four weeks. No covid prior vaccination: No. Known allergies: No.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown since unable to locate or read the details) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid treatment).   No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: a patient that had their vaccination 8 days and was now testing positive; a patient that had their vaccination 8 days and was now testing positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "a patient that had their vaccination 8 days and was now testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course was as follows: a nurse called to say that she had a patient who had their vaccination 8 days and was now testing positive.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive COVID test on 26Sep2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 09:15 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 19Sep2023 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FINASTERIDE. The following information was reported: COVID-19 (non-serious) with onset 25Sep2023 at 05:30, outcome "recovering", described as "Positive COVID test on 26Sep2023". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Other medications in two weeks: Finasteride 1 mg. AE treatment: Over the counter cold/flu medications If covid prior vaccination: No.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Product COVID 19 Treatment; Product 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 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Aug2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years 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: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "Product COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) positive, notes: antigen test was still positive; (23Sep2023) Negative, notes: First negative antigen tests were on 23Sep & 24Sep; (24Sep2023) Negative, notes: First negative antigen tests were on 23Sep & 24Sep. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Covid symptoms mostly resolved following Paxlovid treatment, but antigen test was still positive. Covid symptoms returned on 12Sep. First negative antigen tests were on 23Sep & 24Sep.  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.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: she developed blood clots in her lungs, legs and all over her body; 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 female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she is allergic to a lot of things" (unspecified if ongoing), notes: she is allergic to a lot of things. The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (states last year, she had a flu vaccine that was 'mixed' together with a Pfizer covid vaccine and developed blood clots as well), administration date: 2022, reaction(s): "blood clots". The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "she developed blood clots in her lungs, legs and all over her body". Additional information: Reporter States she wants to know the ingredients as after she took the pfizer covid vaccine, she developed blood clots in her lungs, legs and all over her body. States she almost died. States she has respiratory problems (unclear of timing) and needs to take the 'lung vaccine." States she is allergic to a lot of things. She is not sure that she wants to take the Pfizer RSV vaccine as states pfizer has ingredients in their vaccine (covid) that is not good for her." Upon further clarification, caller states she had 2 Pfizer covid shots and one pfizer booster for covid and after every shot, she developed blood clots.  Also states last year, she had a flu vaccine that was 'mixed' together with a pfizer covid vaccine and developed blood clots as well. Attempted to clarify further however caller unable to clarify. states she is 75 years of age.     The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312116 same patient, same event, different dose of vaccine;US-PFIZER INC-202300312117 same patient, same event, different dose of vaccine;
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Sep2023, outcome "recovered" (Sep2023), described as "Pain at the injection site". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: No other vaccine received in four weeks. No Covid prior vaccination. Not tested Covid post vaccination.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, FLUA4
Symptoms: Pruritus
Clinical narrative: my arm is extremely itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine inact sag 4v (FLUAD QUAD), on 26Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 26Sep2023, outcome "unknown", described as "my arm is extremely itchy".  Additional information: The patient stated that well I got my flu shot along with my the latest COVID vaccine booster (Clarified as Comirnaty) about 2 hours ago and my arm is extremely itchy. Is that common as a side effect?. The patient stated that right and I wondered is there, does a massaging the area where I had the shot help dissipate the injected fluid or is that not advisable?. Patient stated Is it going to help dissipate the injected fluid?. Patient stated that flu shot (Fluad Quad 2023-24 syringe) was for the 65 an older patients.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling hot, Headache, Illness, Pain
Clinical narrative: headache; body ache; Stomach ache; felt like fever, was hot; little soreness in upper arm; ill; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset Sep2023, outcome "unknown", described as "Stomach ache"; PAIN (non-serious) with onset Sep2023, outcome "unknown", described as "body ache"; FEELING HOT (non-serious) with onset Sep2023, outcome "unknown", described as "felt like fever, was hot"; HEADACHE (non-serious) with onset Sep2023, outcome "unknown"; ILLNESS (non-serious) with onset Sep2023, outcome "unknown", described as "ill"; PAIN IN EXTREMITY (non-serious) with onset Sep2023, outcome "unknown", described as "little soreness in upper arm". Additional information: The patient's wife (reporter) stated that this time, there was not only soreness but, overnight, got very ill, had headache, body aches, stomach aches, thinks she had fever. Was too sick to get up and check temperature. Eventually, it subsided, just surprised her a lot. Reporter and husband were in 2 different places, both had same reaction. Both had vaccines at same place.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312069 same reporter/vaccine/event, different patient;US-PFIZER INC-202300312076 different patient/vaccine, different dose and event;US-PFIZER INC-202300024576 different patient/vaccine, different dose and event;
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: headache; body ache; Stomach ache; felt like fever, was hot; little soreness in upper arm; ill; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset Sep2023, outcome "unknown", described as "Stomach ache"; PAIN (non-serious) with onset Sep2023, outcome "unknown", described as "body ache"; FEELING HOT (non-serious) with onset Sep2023, outcome "unknown", described as "felt like fever, was hot"; HEADACHE (non-serious) with onset Sep2023, outcome "unknown"; ILLNESS (non-serious) with onset Sep2023, outcome "unknown", described as "ill"; PAIN IN EXTREMITY (non-serious) with onset Sep2023, outcome "unknown", described as "little soreness in upper arm". Additional information: The patient's wife (reporter) stated that this time, there was not only soreness but, overnight, got very ill, had headache, body aches, stomach aches, thinks she had fever. Was too sick to get up and check temperature. Eventually, it subsided, just surprised her a lot. Reporter and husband were in 2 different places, both had same reaction. Both had vaccines at same place.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312069 same reporter/vaccine/event, different patient;US-PFIZER INC-202300312076 different patient/vaccine, different dose and event;US-PFIZER INC-202300024576 different patient/vaccine, different dose and event;
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pain in extremity
Clinical narrative: Interchange of vaccine products; Little soreness in upper arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Feb2023 as dose 4 (booster), single (Lot number: GJ3274) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure abnormal" (unspecified if ongoing), notes: Takes blood pressure medicine, takes a statin, has been taking now for a year, or 9 months. The patient took concomitant medications. Vaccination history included: janssen covid-19 vaccine (DOSE 1, SINGLE, Anatomical location: Left arm), administration date: 12May2021, for COVID-19 immunisation; janssen covid-19 vaccine (DOSE 2, SINGLE, Anatomical location: Left arm), administration date: 22Dec2021, for COVID-19 immunisation; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot number: FP7138, Anatomical location: Left arm), administration date: 24Aug2022, for COVID-19 immunisation, reaction(s): "Interchange of vaccine products", "On 10Dec2022 she had an ischemic stroke that she described as mild and deep in the brain". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "recovered" (2023), described as "Little soreness in upper arm"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "recovered". Additional information: This report was not related to a study or programme. Previously had one of the boosters, did not have much as much reaction, had a little soreness, nothing to speak of. Just had a little soreness in upper arm, which was fine. Had that before, did not think much of it. All COVID vaccines given in left arm. Is right-handed, would have likely had in left arm. Nothing changed before she took this, was all same stuff she had always been taking and supplements, stuff like that. Never had COVID, thank God. There was no Family Medical History Relevant to Adverse Events (AEs).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312069 same patient/vaccine, different dose and event;US-PFIZER INC-202300312075 different patient/vaccine, different dose and event;US-PFIZER INC-202300024576 same patient/vaccine, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: She developed blood clots in her lungs, legs and all over her body; She developed blood clots in her lungs; 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 female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she is allergic to a lot of things" (unspecified if ongoing), notes: She is allergic to a lot of things. The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "She developed blood clots in her lungs, legs and all over her body"; PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "She developed blood clots in her lungs".  Clinical course: Reporter States she wants to know the ingredients as after she took the pfizer covid vaccine, she developed blood clots in her lungs, legs and all over her body. States she almost died. States she has respiratory problems (unclear of timing) and needs to take the 'lung vaccine."  States she is allergic to a lot of things. She is not sure that she wants to take the Pfizer RSV vaccine as states pfizer has ingredients in their vaccine (covid) that 'is not good for her."   Upon further clarification, caller states she had 2 Pfizer covid shots and one pfizer booster for covid and after every shot, she developed blood clots. Also states last year, she had a flu vaccine that was 'mixed' together with a pfizer covid vaccine and developed blood clots as well. Attempted to clarify further however caller unable to clarify. states she is 75 years of age.    The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311939 same reporter, patient,event, different dose;US-PFIZER INC-202300312117 same reporter, patient,event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: she developed blood clots in her lungs, legs and all over her body; she developed blood clots in her lungs; 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 female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "She is allergic to a lot of things" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: Unknown), for COVID-19 immunization, reaction(s): "Clot blood"; Bnt162b2 (DOSE 2, SINGLE, Lot number: Unknown), for COVID-19 immunization, reaction(s): "She got clot in lungs", "Clot blood". The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "she developed blood clots in her lungs, legs and all over her body"; PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "she developed blood clots in her lungs".  Clinical course: Reporter States she wants to know the ingredients as after she took the pfizer covid vaccine, she developed blood clots in her lungs, legs and all over her body. States she almost died. States she has respiratory problems (unclear of timing) and needs to take the 'lung vaccine."  States she is allergic to a lot of things. She is not sure that she wants to take the Pfizer RSV vaccine as states pfizer has ingredients in their vaccine (covid) that 'is not good for her."   Upon further clarification, caller states she had 2 Pfizer covid shots and one pfizer booster for covid and after every shot, she developed blood clots. Also states last year, she had a flu vaccine that was 'mixed' together with a pfizer covid vaccine and developed blood clots as well. Attempted to clarify further however caller unable to clarify. states she is 75 years of age.    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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311939 same reporter, patient, event, different dose;US-PFIZER INC-202300312116 same reporter, patient, event, different dose;