chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Rhinorrhoea, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I received the Moderna Bivalent booster on 9/15/2022. On 12/11/2022, I developed a scratchy throat, a slight cough, and post-nasal drip during the afternoon. On 12/12/2022, I still felt like I was developing a mild cold, so I just stayed at home and did not go out. I took ROBITUSSIN DM cough medicine and SUDAFED, which provided a little bit of relief. When I woke up on 12/13/2022, I had a very runny nose. It was then that I decided to take a home antigen test, which yielded a positive result. I then called my doctor, who prescribed me PAXLOVID. On 12/15/2022, I felt really good and like I had recovered, and I wanted to go out and go shopping, but I took another test that yielded another positive result, so the shopping trip was nixed. At the time of this writing, I feel like the symptoms I thought I had beaten are back. I currently have a scratchy throat, a slight cough, and post-nasal drip. During my illness, though, I have never experienced a fever.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Upper-airway cough syndrome
Clinical narrative: I received the Moderna Bivalent booster on 9/15/2022. On 12/11/2022, I developed a scratchy throat, a slight cough, and post-nasal drip during the afternoon. On 12/12/2022, I still felt like I was developing a mild cold, so I just stayed at home and did not go out. I took ROBITUSSIN DM cough medicine and SUDAFED, which provided a little bit of relief. When I woke up on 12/13/2022, I had a very runny nose. It was then that I decided to take a home antigen test, which yielded a positive result. I then called my doctor, who prescribed me PAXLOVID. On 12/15/2022, I felt really good and like I had recovered, and I wanted to go out and go shopping, but I took another test that yielded another positive result, so the shopping trip was nixed. At the time of this writing, I feel like the symptoms I thought I had beaten are back. I currently have a scratchy throat, a slight cough, and post-nasal drip. During my illness, though, I have never experienced a fever.
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Patient was given wrong vaccine, patient received pediatric hep a vaccine when he needed adult hep. Clinic pharmacist was informed, and she stated patient is able to receive the full dose 1 ml of the adult hep a vaccine at his next visit, Patient and provider are both understanding about this information.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Gait disturbance, Joint swelling, Mobility decreased, Pain
Clinical narrative: Started having painful AC joint swelling and tenderness and aggravated by lifting arm and sideways extension and weight baring; Went to doctor and had an X-ray, no concrete findings; still sore and can't lift well, started Physical Therapy but it hasn't helped, Therapist believes that it may be a Tendon issue and if it doesn't clear up soon they'll have to give me an MRI if it doesn't get better by the new year; Also started having problems with Peroneal Tendon, making it hard to walk; went to urgent care and I was told it is a Tendon tear, am wearing a boot and going to start Physical Therapy.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tendon disorder, Tendon rupture, X-ray
Clinical narrative: Started having painful AC joint swelling and tenderness and aggravated by lifting arm and sideways extension and weight baring; Went to doctor and had an X-ray, no concrete findings; still sore and can't lift well, started Physical Therapy but it hasn't helped, Therapist believes that it may be a Tendon issue and if it doesn't clear up soon they'll have to give me an MRI if it doesn't get better by the new year; Also started having problems with Peroneal Tendon, making it hard to walk; went to urgent care and I was told it is a Tendon tear, am wearing a boot and going to start Physical Therapy.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: no known adverse events
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Herpes zoster, Rash
Clinical narrative: Had bumps, contacted doctor, doctor stated I had shingles and gave me antiviral.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: no known adverse event
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous, Rash pruritic
Clinical narrative: Patient called today and said that she had her moderna bivalent booster and that last night she started to get redness, swelling and a rash on the injection site and it is increasing in size and very itchy.  She said she  did not have any previous reactions to previous covid vaccinations.   I recommended taking  Benadryl and putting an ice pack on it.  I recommended if it gets worse or doesn't get better with treatment to contact her primary care physician or be seen.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Immediate post-injection reaction, Palpitations, Throat irritation
Clinical narrative: Pt had immediate feeling of racing heart, tickly throat, and lightheadedness. Felt fine after several minutes with no treatment. Did not lose consciousness at all.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 6.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Wrong patient received product
Clinical narrative: Immunizations were given to the incorrect patient.
Age: 64.0
Sex: M
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: 1. Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency. 2. Patient received flu vaccine that is approved for 65 yr and older. pt was 64yrs at the time of administration
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Feeling abnormal, Impaired work ability
Clinical narrative: I had sore throat, tickle cough, fatigue, and low-grade fever. I took a rapid test at work, and I tested positive for COVID-19. I contacted my doctor, and she prescribed me PAXLOVID. After the second of taking PAXLOVID I started feeling better. I tested negative 11/14/2022 and went back to work. I started feeling bad again on 11/18/2022. I tested positive again 11/19/2022 at home. I had the same symptoms but the coughing was worse.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I had sore throat, tickle cough, fatigue, and low-grade fever. I took a rapid test at work, and I tested positive for COVID-19. I contacted my doctor, and she prescribed me PAXLOVID. After the second of taking PAXLOVID I started feeling better. I tested negative 11/14/2022 and went back to work. I started feeling bad again on 11/18/2022. I tested positive again 11/19/2022 at home. I had the same symptoms but the coughing was worse.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: no known adverse event
Age: 66.0
Sex: F
Vaccine: FLUN4
Symptoms: Pain, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: Patient given Flumist and above 49 years of age. Does not report any current illnesses. Patient is 66 years old. Experience minor body aches, took Tylenol for this and it's feel better. No other additional symptoms reported by patient.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Heart rate increased, Heart rate irregular
Clinical narrative: The onset of atrial fibrillation, something I had never experienced before.  Rapid and unsteady heartbeat.  About a month later, following the flu vaccine, I experienced it again.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I got Covid from family gathering, was exposed 11/10 and 11/11, I departed on the 12th to return home, PCR Covid test results were positive on the 11/14.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chemotherapy, Oesophageal carcinoma, Peritoneal neoplasm, Scan abnormal
Clinical narrative: Patient had a scan and should stage 4 peritoneal cancer after going through esophageal cancer and being on neoadjunct chemo.  Scan in July '21 showed no evidence of mets
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Headache, Lethargy
Clinical narrative: I felt itchy, headache, cough, difficulty breathing, fever, and lethargic. I tested positive for COVID-19 at home. I talked to my doctor, and she prescribed albuterol, but I did not pick up the prescription because I already had one. I did use it a few times. I am still having difficulty breathing and cough.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I felt itchy, headache, cough, difficulty breathing, fever, and lethargic. I tested positive for COVID-19 at home. I talked to my doctor, and she prescribed albuterol, but I did not pick up the prescription because I already had one. I did use it a few times. I am still having difficulty breathing and cough.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling hot, Gaze palsy, Insomnia
Clinical narrative: Insomnia, overheating with sub normal temp 98.1 at 2am. Followed by headache that lasted 12 hours
Age: 5.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: patient was given the bivalent instead of the monovalent pfizer . it was his second dose .
Age: 8.0
Sex: F
Vaccine: FLUA4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient mother was asked if patient had received any vaccines within the last two weeks and they declined.  Flu questionnaire was filled out by patient mother and no indication was given that patient had any vaccines within two weeks.  Patient received two doses of Flu within two days apart. We noticed right after vaccine was given when patient mother gave us the immunization record.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Electric shock sensation, Laboratory test normal, Muscular weakness, Neuropathy peripheral
Clinical narrative: Peripheral neoropathy. Pins and needles, weakness in legs, shocking jolts. It started very subtle within a month of vaccine than continued to spread and mess up my legs. Now my legs are burning and aching.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Peripheral neoropathy. Pins and needles, weakness in legs, shocking jolts. It started very subtle within a month of vaccine than continued to spread and mess up my legs. Now my legs are burning and aching.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Chills, Cough, Fatigue, Headache
Clinical narrative: Dec 2, 2022: nausea, chills, sore throat, headache  Dec 13, 2022: runny nose, chills, body aches, fatigue, cough
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Nausea, Oropharyngeal pain, Pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Dec 2, 2022: nausea, chills, sore throat, headache  Dec 13, 2022: runny nose, chills, body aches, fatigue, cough
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13, UNK
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: redness, swelling, and fever
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Dyspnoea, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Wheezing
Clinical narrative: Cough, shortness of breath, wheezing
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Cough
Clinical narrative: Pt stated she thought her throat closing up because she could not see her uvula in the mirror.  Pt was coughing (she already had a lingering cough), but no complaints about struggling to breath.  She stated she was coughing before she got her shot, and she has hx of asthma.  She has no hx of anaphylaxis to medications/food/vaccine, and gets her flu shot yearly with no reaction.      Pt had no other symptoms, other than her visually not seeing her uvula.  Pharmacist gave pt small dose of benadryl and had pt sit down for another 30 minutes.  After thirty minutes, pt said she could see her uvula and went home.  Rph recommended someone drive her home as she took benadryl, but pt refused and left.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Influenza virus test, Productive cough, SARS-CoV-2 test, Streptococcus test
Clinical narrative: Upper Respiratory Infection (coughing and phlegm)
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Upper respiratory tract infection
Clinical narrative: Upper Respiratory Infection (coughing and phlegm)
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was accidentally given a duplicate dose of Moderna bivalent vaccine on 12/15/22. Patient received the initial bivalent booster on 9/28/22. Patient presented to the pharmacy without their vaccine record. Upon returning that evening with their record, it was discovered that the patient had already received the Moderna bivalent booster. The patient was counselled and reported feeling no adverse effects.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Patient is still having pain on the administration site 2 months after the injection.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was accidentally given a duplicate dose of Moderna bivalent vaccine on 12/15/22. Patient received the initial bivalent booster on 9/28/22. Patient presented to the pharmacy without their vaccine record. Upon returning that evening with their record, it was discovered that the patient had already received the Moderna bivalent booster. The patient was counselled and reported feeling no adverse effects.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product preparation issue
Clinical narrative: Patient was injected with 0.3mL of undiluted 5-11year-old bivalent vaccine instead of adult dose. Patient was contacted and informed. Endorses feeling well and will return to be seen if concerns emerge. Message was left for Pfizer requesting guidance.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was injected with 0.3mL of undiluted 5-11year-old bivalent vaccine instead of adult dose. Patient was contacted and informed. Endorses feeling well and will return to be seen if concerns emerge. Message was left for Pfizer requesting guidance.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Bile duct cancer stage IV, Hepatic enzyme increased
Clinical narrative: Patient developed elevated liver enzymes then diagnosed with cholangeal cancer stage 4
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Malaise
Clinical narrative: Today about 1:00 she got a meningitis booster (required for her to go to college). At about 4:00 she started feeling bad and laid down in the floor. She got up went to lay down.  At 6:20 she came out to say she feels sick like she?s going to throw up and pass out and her skin is achy to the touch. (She also started her period today.) She is pale. Has a headache. Her jaw hurts. Her body looks as if she?s shivering).
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pain in jaw, Pain of skin, Pallor
Clinical narrative: Today about 1:00 she got a meningitis booster (required for her to go to college). At about 4:00 she started feeling bad and laid down in the floor. She got up went to lay down.  At 6:20 she came out to say she feels sick like she?s going to throw up and pass out and her skin is achy to the touch. (She also started her period today.) She is pale. Has a headache. Her jaw hurts. Her body looks as if she?s shivering).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersomnia, Immunisation reaction, Muscle atrophy, Muscle spasms
Clinical narrative: I was a completely healthy person, I never had any medication reactions, I eat correctly, since I received a single dose of the Janssen COVID-19 vaccine Vaccinate. I am not the same as before,  different reactions have appeared in my body,  I have different symptoms,  such as loss of muscle mass, loss of weight, since I got that single dose  I sleep a lot, I have cramps in my calves, I  show glycoidal phlegm in the form of jelly,  and a vision appeared in my vision that I can see very thin fibers in the form of a spider web and black dots in my vision,  apart from a lot of nervousness and a constant itching in the lower parts of my legs and in my testicles.  When they applied that dose to me, a ball grew in my testicles that grew and they stripped it off.  It appeared as a small ball and it grew until it reached 2.5 cm when I consulted the doctor, which was they did some cancer despite me and they told me no it was malignant,  if this vaccine accelerated something in my body I want to see how I can get some compensation for the inconvenience this vaccine has caused me, the vaccine was received locally where they gave me a record card from the CDC  I am 60 years old and I will be turning 61 soon.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Nervousness, Productive cough, Pruritus, Testicular mass, Testis cancer
Clinical narrative: I was a completely healthy person, I never had any medication reactions, I eat correctly, since I received a single dose of the Janssen COVID-19 vaccine Vaccinate. I am not the same as before,  different reactions have appeared in my body,  I have different symptoms,  such as loss of muscle mass, loss of weight, since I got that single dose  I sleep a lot, I have cramps in my calves, I  show glycoidal phlegm in the form of jelly,  and a vision appeared in my vision that I can see very thin fibers in the form of a spider web and black dots in my vision,  apart from a lot of nervousness and a constant itching in the lower parts of my legs and in my testicles.  When they applied that dose to me, a ball grew in my testicles that grew and they stripped it off.  It appeared as a small ball and it grew until it reached 2.5 cm when I consulted the doctor, which was they did some cancer despite me and they told me no it was malignant,  if this vaccine accelerated something in my body I want to see how I can get some compensation for the inconvenience this vaccine has caused me, the vaccine was received locally where they gave me a record card from the CDC  I am 60 years old and I will be turning 61 soon.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment, Weight decreased
Clinical narrative: I was a completely healthy person, I never had any medication reactions, I eat correctly, since I received a single dose of the Janssen COVID-19 vaccine Vaccinate. I am not the same as before,  different reactions have appeared in my body,  I have different symptoms,  such as loss of muscle mass, loss of weight, since I got that single dose  I sleep a lot, I have cramps in my calves, I  show glycoidal phlegm in the form of jelly,  and a vision appeared in my vision that I can see very thin fibers in the form of a spider web and black dots in my vision,  apart from a lot of nervousness and a constant itching in the lower parts of my legs and in my testicles.  When they applied that dose to me, a ball grew in my testicles that grew and they stripped it off.  It appeared as a small ball and it grew until it reached 2.5 cm when I consulted the doctor, which was they did some cancer despite me and they told me no it was malignant,  if this vaccine accelerated something in my body I want to see how I can get some compensation for the inconvenience this vaccine has caused me, the vaccine was received locally where they gave me a record card from the CDC  I am 60 years old and I will be turning 61 soon.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Peripheral swelling, Pruritus, Rash
Clinical narrative: 11/11/22 - Patient presents for diffuse rash to bilateral arms s/p 2nd dose of novavax vaccine yesterday. She states she had the same reaction after the first vaccine and the meds from UC worked well for her. She after the shot yesterday she felt swollen in her arms, had ear itching, itching on her feet as well. She took a left over cetirizine last night which helped and rash is improved today. She denies any SOB, cough, itching mouth, swelling in face or lips, or wheezing.  11/14/22 - Patient presents for acute worsening of rash and now with chest tightness. She states she did now do well on the 40mg of prednisone and when she tapered to 1 yesterday, all her sx came back with associated chest tightness. No wheezing, SOB, itching to mouth, cough, swelling, etc.
Age: 17.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 21.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: syncope -- Pt fainted after receiving both vaccines approximately 5 minutes after administration. Pt recovered and regained consciousness in 10-15 seconds. 911 dispatch was called. EMT team worked up patient and took vitals. Everything resulted within normal limits.  Pt reportedly hadn't eaten anything since the night prior and  EMT team lead assessed it was the most probable reason for syncope. Lead EMT felt comfortable letting the patient go home with a designated driver, with no further reported incident.
Age: 34.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 25.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 27.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 8.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 23.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 52.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 68.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event
Clinical narrative: No adverse effects or outcomes Immunization given per physician order
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia
Clinical narrative: Caught Covid/ the husband got a mild case but the wife had a fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caught Covid/ the husband got a mild case but the wife had a fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caught Covid/ the husband got a mild case but the wife had a fever). At the time of the report, COVID-19 (Caught Covid/ the husband got a mild case but the wife had a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Did not get 4th dose but had 3rd dose on Oct2021.  No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Received these vaccines post excursion; Temperature excursion; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received these vaccines post excursion) had not resolved and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Received these vaccines post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion).    No concomitant medications were reported. The nurse reported that, there was temperature excursion on 01-Nov-2022 in the refrigerator. At the time of excursion, the vials were in refrigerated storage. It was individual vials and vial size was unknown. The patient received the vaccine post excursion and remaining vials were discarded.  The maximum or minimum temperatures reached at time of excursion was minimum 34.8 F (Fahrenheit) and maximum at 42.49 F for 14 Minutes duration. The vials were moved from freezer to refrigerator in less than 30 days. On visual inspection vials were in normal state. No treatment medications were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid). At the time of the report, COVID-19 (Covid) outcome was unknown. Not Provided          No Concomitant medication was reported. No treatment information was provided.   Reporter did not allow further contact
Age: 1.17
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Rash, Viral rash
Clinical narrative: Patient experienced  trunk rash 10 minutes after vaccination. Mother stated the child was given cow's milk in the post vaccination area. Patient was placed in the EMS staging area for observation.  No difficultly breathing, no cyanosis, and no difficulty swallowing. While in observation the rash began to spread to legs and periobrital swelling was noted. EMS called, patient transferred to Hospital.
Age: 1.17
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Periorbital swelling, Rash
Clinical narrative: Patient experienced  trunk rash 10 minutes after vaccination. Mother stated the child was given cow's milk in the post vaccination area. Patient was placed in the EMS staging area for observation.  No difficultly breathing, no cyanosis, and no difficulty swallowing. While in observation the rash began to spread to legs and periobrital swelling was noted. EMS called, patient transferred to Hospital.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, HPV9, TDAP
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: The patient received Gardasil 9, dap Boostrix and Covid Vaccine Bivalent Booster on the same date.; The patient received an expired Covid Vaccine; Information has been received from Pfizer (MFR # 202201356357) on 08-DEC-2022. This spontaneous report was received from a nurse and refers to a 12-year-old male patient. The patient's concurrent conditions, drug reactions or allergies and pertinent medical history were not reported.    On 01-DEC-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly, 0.5 milliliter, lot # reported as W00030191, expiration date 10-AUG-2024  for prophylaxis.  On the same date, the patient also received first dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid(BOOSTRIX), intramuscularly, in the left deltoid, 0.5 milliliter, lot # 34FR4, expiration date 23-SEP-2024; a first dose of covid-19 vaccine nrvv, lot # GK1657, expiration date 31-JUL-2023  and a dose of covid-19 vaccine(manufacturer unknown), expiration date 30-NOV-2022 (expired product administered) (dose quantity, lot # and route were not reported) for prophylaxis (inappropriate schedule of product administration). There was not concomitant therapy.  On 01-DEC-2022, complete blood count (CBC), a lipid laboratory, rapid plasma reagin (RPR) and human immunodeficiency virus (HIV) test were performed. Results not provided.     Lot number W00030191 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 16 year old had completed a full series of the GARDASIL 9 and then was given a 4th or additional dose; No additional AE details; This spontaneous report has been received from a pharmacist and refers to a 16-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot number, expiration date, and route of administration were not provided). The patient completed the full series of the vaccine and then was given a 4th dose. No additional adverse event reported (extra dose administered).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE.; An expired dose of PNEUMOVAX 23 was administered to a patient.; This spontaneous report was received from a pharmacist regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-DEC-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) use as directed to prevent pneumococcal infection, product quantity 1, lot #U003306, expiration date: 15-OCT-2022, (strength, anatomical location, and route of administration were not provided) administered as prophylaxis (Expired product administered). No adverse events were reported.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE; MA reported that one Patients ( name or initials not provided when asked) received  GARDASIL 9 ( lot number 1780878 exp: 12/02/2023) exposed to 55 F for 15 min. Temperature excursion happened on  Sept 7,2022 and patient received it on 12/06/2022.; This spontaneous report was received from  a Medical Assistant regarding a 13-year-old patient of an unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 07-SEP-2022, an improperly stored vaccine of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) underwent a temperature excursion of 55 degrees Fahrenheit (F) for 15 minutes.  On 06-DEC-2022, the patient was vaccinated with the improper stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #1780878, expiration date: 02-DEC-2023, (strength, dosage regimen, anatomical location, and route of administration were not provided) administered as prophylaxis (Product storage error). No adverse events were reported.  This is one of two case received from the same reported. ; Sender's Comments:  US-009507513-2212USA005886:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; MA reported that one Patients ( name or initials not provided when asked) received  ROTATEQ ( lot number U038854 exp: 04/20/2023) exposed to 55 F for 15 min. Temperature excursion happened on  Sept 7,2022 and patient received it on 11/18/2022.; This spontaneous report was received from a Medical Assistant regarding a 6-month-old patient of an unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 07-SEP-2022, an improperly stored vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent a temperature excursion of 55 degrees Fahrenheit (F) for 15 minutes.  On 18-NOV-2022, the patient was vaccinated with the improper stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U038854, expiration date: 20-APR-2023, taken orally as prophylaxis (strength was not provided) (Product storage error). No adverse events were reported.  This is one of two case received from the same reported.; Sender's Comments:  US-009507513-2212USA005869:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. Past drug history included: Bactrin, reaction(s): "Known allergies: Bactrin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 10:00 as dose 4 (booster), single (Lot number: gh9694), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Nov2022) Positive; (05Dec2022) Negative; (06Dec2022) Negative; (08Dec2022) Positive. Therapeutic measures were taken as a result of covid-19.  Additional information: Patient didn't received other medication in 2 weeks. Tested positive Covid on 29Nov, started paxlovid on 29Nov completed on 03Dec, tested neg on Mon/ Tues 05Dec, 06Dec. On 08Dec morning woke up with symptoms sore throat/ cough/ running nose, tested positive COVID since 08Dec - rebound covid. On 12dec2022 product quality group providing investigation results were reported.  Investigational details: This is a daily notification generated from the system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the One and Done business process. Refer to the below table for details.Conclusion of Previously Completed Investigation: The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9694. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Metabolic syndrome" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "depression-stable" (unspecified if ongoing), notes: depression-stable; "Insomnia" (unspecified if ongoing); "Overweight" (unspecified if ongoing); "bmi almost 30" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "PCOS" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; SPIRONOLACTONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Conclusion of Previously Completed Investigation: The complaint for PFIZERBIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9693. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Agency concluded that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hashimoto's syndrome" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; FLUOXETINE; WELLBUTRIN; GABAPENTIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the event and the suspect drug BNT162B2 cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient did not have any known allergies. Concomitant medications and other medications in 2 weeks included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; REPATHA; SYMBICORT; ZETIA; BYSTOLIC; BABY ASPIRIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 30Nov2022 to 04Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: General physical health deterioration, Lymphoedema, Peripheral swelling, Weight, Weight increased
Clinical narrative: I gained like 60 pounds of water weight; since I got the Booster my leg swelled up; my feet were swollen because I had lymph edema; my health just deteriorated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: WEIGHT INCREASED (medically significant) with onset 2022, outcome "unknown", described as "I gained like 60 pounds of water weight"; LYMPHOEDEMA (non-serious) with onset 2022, outcome "unknown", described as "my feet were swollen because I had lymph edema"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious) with onset 2022, outcome "unknown", described as "my health just deteriorated"; PERIPHERAL SWELLING (non-serious) with onset 2022, outcome "unknown", described as "since I got the Booster my leg swelled up". The patient underwent the following laboratory tests and procedures: Weight: (2022) 65 lbs, notes: gained like 65 pounds.  Clinical course: Patient was vaccinated with Pfizer COVID-19 Vaccines, the first two prior about 18 months ago patient think in Mar or it was before like something, and everything was fine and then patient got the Booster (Pfizer COVID-19 booster Vaccine) in Jan2022 and since patient got the Booster patient leg swelled up like that day and then last year since patient got, patient gained like 60 pounds of water weight. It was something patient like to know it could be hurt patient or something, patient asked. Again, stated got the booster and patient legs swelled up the next day patient gained like 65 pounds of water whatever fats, patient legs were all swollen, patient feet were swollen because patient had lymph edema or something like that patient don't know much but it screwed up after the vaccine, the booster patient health just deteriorated in last year end. This report was not related to a study or programme.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.