chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given regular pfizer vaccine as a booster dose instead of the Bivalent
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: an expired vaccine was administered
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Several weeks after vaccin,e, noticed Tinnitus increased
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling, Malaise, Nausea
Clinical narrative: Patient stated they started feeling very sick and nausceous the day after the vaccine. They also got several  red swollen streak that spread from the site of injection to their armpit.  They went to the emergency room and eventually got steroids and antibiotics which made the patient feel better except for some lingering soreness.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Patient stated they started feeling very sick and nausceous the day after the vaccine. They also got several  red swollen streak that spread from the site of injection to their armpit.  They went to the emergency room and eventually got steroids and antibiotics which made the patient feel better except for some lingering soreness.
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia, Wrong product administered
Clinical narrative: Pt was given a booster with Moderna instead of Pfizer, no adverse events. Pt is only experiencing common side effects: pain at injection site and a slight fever on the day of the booster was given.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given the regular Pfizer 12+ vaccine  instead of the Bivalent Pfizer 12+ booster dose
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: mild fever, body ache, fatigue, headache
Age: 37.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: I received the 1st monkeypox dose as an intradermal injection. When I woke up the day after my vaccine - about 22 hours later, I had a raised, firm, red, itchy lump on the inside of my forearm about halfway between my wrist and elbow. It is about an inch diameter and circular, centered around the vaccine injection site. Pain 1/10, 2/10 when I press on it.
Age: 37.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site swelling
Clinical narrative: I received the 1st monkeypox dose as an intradermal injection. When I woke up the day after my vaccine - about 22 hours later, I had a raised, firm, red, itchy lump on the inside of my forearm about halfway between my wrist and elbow. It is about an inch diameter and circular, centered around the vaccine injection site. Pain 1/10, 2/10 when I press on it.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site irritation, Injection site pain, Injection site scab, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Patient reported a bump forming at injection site approximately 3 to 4 days after vaccination. Also reported pain at site of injection, stated pain was greater in comparison to previous vaccinations. Spoke to pharmacist at another pharmacy for counsel on 9/26/22, observed and thought this could have been due to the vaccination administered too low in shoulder muscle.  Scabbing and irritation has also developed around site.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Intracardiac thrombus, Ventricular septal defect
Clinical narrative: On 11-17-21, suffered stroke caused by a blood clot that went thru a hole in the heart
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient recieved a regular pfizer 12+ vaccine as a booster dose instead of the Bivalent Pfizer Booster
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis
Clinical narrative: Pink Eye! Diagnosed by Eye Dr
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site bruising, Injection site nodule
Clinical narrative: Nodule under the skin at site of injection. Later turned into a large bruise (about the size of an orange) at the injection site.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient recieved a regular pfizer 12+ vaccine as a booster dose instead of the Bivalent Pfizer Booster
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product use issue
Clinical narrative: Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time
Age: 0.17
Sex: M
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: No adverse events/outcome/treatments at this time
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Lost hearing in one ear. Tinnitus in one ear
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nausea, Pain in extremity, Pruritus, Vertigo
Clinical narrative: Continuing vertigo/nausea and itchy inner ear, pain in hips and legs
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Gait disturbance, Influenza like illness, Pain
Clinical narrative: Pain in chest at top half of my breast plate, in front of it.   I'm very fit and always walk up the 8 flights to my apartment but, a few times starting within a few days of my vaccine, it hurt so much I had to stop. Then on Thurs 9/22, it hurt after going down the stairs and just a part of my block, to the point where I had to stop.  No other symptoms.  Breathing was fine, no chills, fever, nothing.  Just a suprisingly big pain in that area that lasted probably no more than a minute or two after I stopped.  It seems to have subsided since then.  I had no other reaction to the shot, despite a wee bit of flu-like stuff after the others.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysgeusia, Parosmia
Clinical narrative: Pervasive smell and taste of soap or something sweet. It overpowers all taste and smell.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Pain in jaw, Paraesthesia, Trigeminal neuralgia
Clinical narrative: Developed severe jaw pain bilaterally, Seemed to be trigeminal neuralgia. 8/10 pain. Lasted at least 90 minutes. Took Ibuprofen 400mg and Tylenol 650 just prior to the pain beginning due to myalgias with previous immunizations of Covid. Stayed on nonsteroidals for 60 hours with no recurrence Day 5 around 5pm developed facial paresthesia, dizziness and fatigue with slow onset. Normal daily activity and patterns. Took 400mg Ibuprofen with resolution of symptoms
Age: 52.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Both vaccines appeared to have been given subcutaneously as they were not near the patient's deltoid. Vaccines were re-administered. Patient appeared satisified with resolution.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Anxiety, Arthralgia, Back pain, Chills, Extra dose administered
Clinical narrative: I was victim of a medical error by a pharmacist, in a drug store. Instead of giving me a Flu shot and the COVID Moderna Bivalent, she later confessed she gave me 2 COVID vaccines. I was so scared, I asked her what was going to happen to me, and she said she didn't know, the she said  I was going to be ok. I was so anxious to talk to a Pharmacist, but after 25min. I already had gotten a hold of my doctors nurse and she researched, finding no precedent, so she said the drug store had to report to the CDC, do a report of Vaccine Administration Error. The drug store employees handled all very poorly, nobody helped me and the person who gave the vaccine hided. I had the most horrible 36 HRS. Headache that would not go away, chilis, joint pain, backache, and vomit. I am still pretty shook up, as I suffer Fromm Ulcerative Colitis and take Entyvio with a nurse.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Fear, Headache, Vomiting
Clinical narrative: I was victim of a medical error by a pharmacist, in a drug store. Instead of giving me a Flu shot and the COVID Moderna Bivalent, she later confessed she gave me 2 COVID vaccines. I was so scared, I asked her what was going to happen to me, and she said she didn't know, the she said  I was going to be ok. I was so anxious to talk to a Pharmacist, but after 25min. I already had gotten a hold of my doctors nurse and she researched, finding no precedent, so she said the drug store had to report to the CDC, do a report of Vaccine Administration Error. The drug store employees handled all very poorly, nobody helped me and the person who gave the vaccine hided. I had the most horrible 36 HRS. Headache that would not go away, chilis, joint pain, backache, and vomit. I am still pretty shook up, as I suffer Fromm Ulcerative Colitis and take Entyvio with a nurse.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: I was victim of a medical error by a pharmacist, in a drug store. Instead of giving me a Flu shot and the COVID Moderna Bivalent, she later confessed she gave me 2 COVID vaccines. I was so scared, I asked her what was going to happen to me, and she said she didn't know, the she said  I was going to be ok. I was so anxious to talk to a Pharmacist, but after 25min. I already had gotten a hold of my doctors nurse and she researched, finding no precedent, so she said the drug store had to report to the CDC, do a report of Vaccine Administration Error. The drug store employees handled all very poorly, nobody helped me and the person who gave the vaccine hided. I had the most horrible 36 HRS. Headache that would not go away, chilis, joint pain, backache, and vomit. I am still pretty shook up, as I suffer Fromm Ulcerative Colitis and take Entyvio with a nurse.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Accidental overdose, Arthralgia, Chills, Feeling abnormal, Headache
Clinical narrative: I was victim of a medical error by a pharmacist, in a drug store. Instead of giving me a Flu shot and the COVID Moderna Bivalent, she later confessed she gave me 2 COVID vaccines. I was so scared, I asked her what was going to happen to me, and she said she didn't know, the she said  I was going to be ok. I was so anxious to talk to a Pharmacist, but after 25min. I already had gotten a hold of my doctors nurse and she researched, finding no precedent, so she said the drug store had to report to the CDC, do a report of Vaccine Administration Error. The drug store employees handled all very poorly, nobody helped me and the person who gave the vaccine hided. I had the most horrible 36 HRS. Headache that would not go away, chilis, joint pain, backache, and vomit. I am still pretty shook up, as I suffer Fromm Ulcerative Colitis and take Entyvio with a nurse.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Illness, Pyrexia, Vomiting
Clinical narrative: I was victim of a medical error by a pharmacist, in a drug store. Instead of giving me a Flu shot and the COVID Moderna Bivalent, she later confessed she gave me 2 COVID vaccines. I was so scared, I asked her what was going to happen to me, and she said she didn't know, the she said  I was going to be ok. I was so anxious to talk to a Pharmacist, but after 25min. I already had gotten a hold of my doctors nurse and she researched, finding no precedent, so she said the drug store had to report to the CDC, do a report of Vaccine Administration Error. The drug store employees handled all very poorly, nobody helped me and the person who gave the vaccine hided. I had the most horrible 36 HRS. Headache that would not go away, chilis, joint pain, backache, and vomit. I am still pretty shook up, as I suffer Fromm Ulcerative Colitis and take Entyvio with a nurse.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Headache, Paraesthesia
Clinical narrative: Headache ,  lightheadedness, dizziness, tingling from upper arms  all the way down to the fingers on the first 2 days then tingling is localized only to the fingers on the 4th day
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Fatigue, Impaired work ability, Nausea, Night sweats
Clinical narrative: Starting six hours after receiving vaccine, I felt nausea and extreme fatigue. My concern is that the fatigue lasted full 72 hours. (9/24, 9/25, and 9/26) I had to come home from work  early on 9/26 to take 2.5 hour nap and went to bed early. I slept 9 hours and experienced severe night sweating. Today, 9/27 is first day I have energy back.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: PATIENT DESCRIBES RED/WELTY SKIN ON THE LEGS AND COMPLAINS OF ITCH
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Disorientation, Electrocardiogram abnormal
Clinical narrative: Rapid and irregular heart beat, chest pain, headache, jaw ache, muscle ache, sweats, chills, fatigue, disorientation, cough.  Went to urgent care.  Conservative treatment and rest was prescribed.  Symptoms reduced about a week later but some remained for 1-2 months.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Heart rate irregular, Hyperhidrosis
Clinical narrative: Rapid and irregular heart beat, chest pain, headache, jaw ache, muscle ache, sweats, chills, fatigue, disorientation, cough.  Went to urgent care.  Conservative treatment and rest was prescribed.  Symptoms reduced about a week later but some remained for 1-2 months.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: Rapid and irregular heart beat, chest pain, headache, jaw ache, muscle ache, sweats, chills, fatigue, disorientation, cough.  Went to urgent care.  Conservative treatment and rest was prescribed.  Symptoms reduced about a week later but some remained for 1-2 months.
Age: 0.83
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product use issue
Clinical narrative: Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient took vaccination on 23rd Sept 2022 (4:30 pm ) and from next day around 12:00 pm he started developing hives ,rashes with itchiness. Hives,rashes would come and go after 1-2 hours and randomly re-appear on other parts of body(arms,hips,thighs,face,neck). We haven't given him any medication yet except Tylenol which we gave him after vaccination around 9:00 pm.  We are still seeing symptoms as of 09/27/2022 9:55 pm CT.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Arthropathy, Fall
Clinical narrative: over past week major increase in falls and legs giving out on him
Age: 1.83
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: given a 0.5 ml dose of original moderna instead of bivalent moderna
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Chest pain, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient said she was not able to lift her left arm. The area at the injection was tender and she experienced a burning sensation that spread from the injection site to her chest. After 5 days she has been able to lift her arm a little more but she still does not have full range of motion.
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Glossodynia, Pain in extremity, Taste disorder
Clinical narrative: About one week after the injection, I developed pain in my tongue. It feels as though I am always something extremely spicy. The gums underneath my toe hurts feel like sandpaper and my taste buds are inflamed. Everything seems much more spicy and unbearable. Also, mint has been bothering me a lot since the booster. My tongue seems more sensitive and painful.
Sex: U
Vaccine: TDAP
Symptoms: Arthralgia, Dyspnoea, Fatigue, Injection site erythema, Injection site pruritus
Clinical narrative: arthralgia, myalgias, fatigue, dyspnea, arm (local site) swelling, itching, redness, nausea, fever
Sex: U
Vaccine: TDAP
Symptoms: Injection site swelling, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: arthralgia, myalgias, fatigue, dyspnea, arm (local site) swelling, itching, redness, nausea, fever
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular, Varicella
Clinical narrative: Varicella rash on trunk/abdomen/torso; Pt has been diagnosed with chicken pox 3/2022 at the age 3.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis, Injection site pain, Magnetic resonance imaging
Clinical narrative: Bursitis type symptoms afterward; Pain at site; This spontaneous case was retrieved on 06-Sep-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 0901716-1), reported by other healthcare professional and concerned a 44-year-old, female patient.  The patient's medical history and concomitant medications were not reported.   On 30-Oct-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v;  route of administration: intramuscular; anatomical location: left arm; dose and indication: not reported). The batch number reported was 276584  (reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent instead of reported suspect product Fluad Quadrivalent).  On the same date, after receiving Flucelvax Quadrivalent  the patient experienced pain at site (reported as "sight") and bursitis type symptoms afterward.  On 08-Dec-2020, the patient had a magnetic resonance imaging (MRI), but the results were not provided.   On an unspecified date in 2020, the patient visited physician's office, however, further details were not reported.   At the time of initial reporting, the patient had not recovered from the events of ' vaccination site pain' and 'bursitis'.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 44-year-old female patient experienced vaccination site pain and developed bursitis on the same date after being vaccinated with the suspect Flucelvax Quadrivalent vaccine. Information regarding the underlying medical history and concomitant medications, as well as related diagnostic findings was not provided. Due to biological and chronological plausibility, causality is assessed as possibly related.; Sender's Comments: A 44-year-old female patient experienced vaccination site pain and developed bursitis on the same date after being vaccinated with the suspect Flucelvax Quadrivalent vaccine. Information regarding the underlying medical history and concomitant medications, as well as related diagnostic findings was not provided. Due to biological and chronological plausibility, causality is assessed as possibly related.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Disturbance in attention, Fatigue, Malaise
Clinical narrative: Could not walk up stairs, stayed in bed over half of the day; Inability to concentrate; General malaise; Rendom pain across back and shoulders; Extreme muscle weakness; Fatigue; Rendom pain across back and shoulders; This spontaneous case was retrieved on 06-Sep-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 0901813-1), reported by other non-healthcare professional (consumer) and concerned a 46-year-old, male patient.  The patient's concurrent condition included chronic fatigue. The patient's concomitant medications were not reported. The patient's historical vaccine included anthrax vaccine (batch number: FAV164) received on 21-May-2009 with no reported adverse events.  On 30-Nov-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; route of administration: intramuscular, anatomical location: left arm, dose and indication: not reported). The batch number reported was P100247696 (reported batch number was identified by Seqirus to be linked to suspect product Afluria Quadrivalent instead of reported suspect product Fluad Quadrivalent).   On 01-Dec-2020, at 04:00 a.m., the morning after receiving Afluria Quadrivalent, the patient woke up with random pain across back and shoulders. Throughout the day, he felt extreme muscle weakness and fatigue.   On 02-Dec-2020, the second day after receiving Afluria Quadrivalent, the symptoms were even worse. The patient could not walk up on stairs and stayed in bed over half of the day. Fatigue was accompanied with inability to concentrate and general malaise.  On an unspecified date in Dec-2020, the patient visited emergency room, however further information was not provided. She was diagnosed with chronic fatigue so they did not perform any tests.   At the time of initial reporting, the patient had not recovered from all events.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 46-year-old male patient experienced shoulder pain, back pain, muscular weakness, decreased mobility, malaise, fatigue and concentration loss within 2 days after vaccination with Afluria Quadrivalent. Causality for concentration loss is assessed as not related since concomitant conditions provide a plausible etiology. Based on plausible temporal relationship, causality for the rest of the events is assessed as possibly related.; Sender's Comments: A 46-year-old male patient experienced shoulder pain, back pain, muscular weakness, decreased mobility, malaise, fatigue and concentration loss within 2 days after vaccination with Afluria Quadrivalent. Causality for concentration loss is assessed as not related since concomitant conditions provide a plausible etiology. Based on plausible temporal relationship, causality for the rest of the events is assessed as possibly related.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Muscular weakness
Clinical narrative: Could not walk up stairs, stayed in bed over half of the day; Inability to concentrate; General malaise; Rendom pain across back and shoulders; Extreme muscle weakness; Fatigue; Rendom pain across back and shoulders; This spontaneous case was retrieved on 06-Sep-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 0901813-1), reported by other non-healthcare professional (consumer) and concerned a 46-year-old, male patient.  The patient's concurrent condition included chronic fatigue. The patient's concomitant medications were not reported. The patient's historical vaccine included anthrax vaccine (batch number: FAV164) received on 21-May-2009 with no reported adverse events.  On 30-Nov-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; route of administration: intramuscular, anatomical location: left arm, dose and indication: not reported). The batch number reported was P100247696 (reported batch number was identified by Seqirus to be linked to suspect product Afluria Quadrivalent instead of reported suspect product Fluad Quadrivalent).   On 01-Dec-2020, at 04:00 a.m., the morning after receiving Afluria Quadrivalent, the patient woke up with random pain across back and shoulders. Throughout the day, he felt extreme muscle weakness and fatigue.   On 02-Dec-2020, the second day after receiving Afluria Quadrivalent, the symptoms were even worse. The patient could not walk up on stairs and stayed in bed over half of the day. Fatigue was accompanied with inability to concentrate and general malaise.  On an unspecified date in Dec-2020, the patient visited emergency room, however further information was not provided. She was diagnosed with chronic fatigue so they did not perform any tests.   At the time of initial reporting, the patient had not recovered from all events.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 46-year-old male patient experienced shoulder pain, back pain, muscular weakness, decreased mobility, malaise, fatigue and concentration loss within 2 days after vaccination with Afluria Quadrivalent. Causality for concentration loss is assessed as not related since concomitant conditions provide a plausible etiology. Based on plausible temporal relationship, causality for the rest of the events is assessed as possibly related.; Sender's Comments: A 46-year-old male patient experienced shoulder pain, back pain, muscular weakness, decreased mobility, malaise, fatigue and concentration loss within 2 days after vaccination with Afluria Quadrivalent. Causality for concentration loss is assessed as not related since concomitant conditions provide a plausible etiology. Based on plausible temporal relationship, causality for the rest of the events is assessed as possibly related.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Positive for COVID and hospitalized while being vaccinated
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive for COVID and hospitalized while being vaccinated
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Positive for COVID and hospitalized while while being vaccinated
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive for COVID and hospitalized while while being vaccinated
Age: 95.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Positive for COVID and hospitalized while being vaccinated
Age: 95.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive for COVID and hospitalized while being vaccinated
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Positive for COVID and hospitalized while being vaccinated
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive for COVID and hospitalized while being vaccinated
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: the first two and 3 boosters / dose 5 (booster); the first two and 3 boosters / dose 5 (booster); made her tired and she had a sore arm; made her tired and she had a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 07Jul2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "cholesterol/ High cholesterol" (unspecified if ongoing), notes: diagnosed most of her life. Her liver produces too much but it is pretty even; "a lot of allergic reactions" (unspecified if ongoing), notes: had a lot of allergic reactions to a lot of stuff.; "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high diagnosed most of her life; "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL HCTZ taken for hypertension; PRAVASTATIN taken for blood cholesterol increased. Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML SINGLE), administration date: 08Feb2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "have Covid"; BNT162b2 (DOSE 2, SINGLE), administration date: 03Mar2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "have Covid"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 01Sep2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "have Covid"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 01Feb2022, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "have Covid". The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "the first two and 3 boosters / dose 5 (booster)"; FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "made her tired and she had a sore arm".  Additional information: The patient had COVID-19 vaccines, all Pfizer, the first two and 3 boosters, reported that she was up to date. She had taken all Pfizer shots and boosters. She didn't know the effects' it does. The regular Pfizer shot made her tired and she had a sore arm. Stated she doesn't  know about the other variant's in the shots. It is too soon to tell.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (23Sep2022): This is a spontaneous follow-up report received from the same contactable consumer (patient). Updated information included : Patient's height and weight added. Relevant medical History added, Agency added. New events "made her tired and she had a sore arm" added.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Immunisation, Off label use, Pain in extremity
Clinical narrative: the first two and 3 boosters / dose 5 (booster); the first two and 3 boosters / dose 5 (booster); made her tired and she had a sore arm; made her tired and she had a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 07Jul2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "cholesterol/ High cholesterol" (unspecified if ongoing), notes: diagnosed most of her life. Her liver produces too much but it is pretty even; "a lot of allergic reactions" (unspecified if ongoing), notes: had a lot of allergic reactions to a lot of stuff.; "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high diagnosed most of her life; "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL HCTZ taken for hypertension; PRAVASTATIN taken for blood cholesterol increased. Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML SINGLE), administration date: 08Feb2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "have Covid"; BNT162b2 (DOSE 2, SINGLE), administration date: 03Mar2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "have Covid"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 01Sep2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "have Covid"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 01Feb2022, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "have Covid". The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "the first two and 3 boosters / dose 5 (booster)"; FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "made her tired and she had a sore arm".  Additional information: The patient had COVID-19 vaccines, all Pfizer, the first two and 3 boosters, reported that she was up to date. She had taken all Pfizer shots and boosters. She didn't know the effects' it does. The regular Pfizer shot made her tired and she had a sore arm. Stated she doesn't  know about the other variant's in the shots. It is too soon to tell.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (23Sep2022): This is a spontaneous follow-up report received from the same contactable consumer (patient). Updated information included : Patient's height and weight added. Relevant medical History added, Agency added. New events "made her tired and she had a sore arm" added.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 0.17
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE reported; Customer reported that MMR II and VARIVAX were administered to a 2 month old baby in error today (09/13/2022). Patient was not due for these vaccines until she was 12 months; This spontaneous report has been received from a nurse concerning a 2-month-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 13-SEP-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 milliliter (ml) (lot # U006486, has been verified to be a valid lot number for measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live [rHA] [M-M-R II], expiration date reported and upon internal validation established as 26-FEB-2023) (anatomical location and route of administration were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U032852, has been verified to be a valid lot number for varicella virus vaccine live [oka/merck] [VARIVAX], expiration date reported and upon internal validation established as 20-OCT-2023) (anatomical location and route of administration were not reported). Both vaccines were given as prophylaxis. The patient was not due for these vaccines until she was 12 months old (Product administered to patient of inappropriate age).  No adverse event was reported.
Age: 0.17
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; Customer reported that MMR II and VARIVAX were administered to a 2 month old baby in error today (09/13/2022). Patient was not due for these vaccines until she was 12 months; This spontaneous report has been received from a nurse concerning a 2-month-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 13-SEP-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 milliliter (ml) (lot # U006486, has been verified to be a valid lot number for measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live [rHA] [M-M-R II], expiration date reported and upon internal validation established as 26-FEB-2023) (anatomical location and route of administration were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U032852, has been verified to be a valid lot number for varicella virus vaccine live [oka/merck] [VARIVAX], expiration date reported and upon internal validation established as 20-OCT-2023) (anatomical location and route of administration were not reported). Both vaccines were given as prophylaxis. The patient was not due for these vaccines until she was 12 months old (Product administered to patient of inappropriate age).  No adverse event was reported.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Notified that patient received the MONOVALENT version of the Pfizer COVID-19 booster vaccine rather than the intended BIVALENT version of the Pfizer COVID-19 booster vaccine on 09/13/2022.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered at inappropriate site, Swelling, Tendonitis
Clinical narrative: experiencing nerve damage in the upper left arm; lingering pain; nerve twitches all over; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Aug2022 at 12:15 as dose 3 (booster), single (Lot number: FP7138) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: ERE729, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 14Apr2021, when the patient was 53-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 24Mar2021, when the patient was 53-year-old, for Covid-19 Immunization. The following information was reported: NERVE INJURY (non-serious) with onset 02Aug2022 at 07:00, outcome "not recovered", described as "experiencing nerve damage in the upper left arm"; PAIN (non-serious) with onset 02Aug2022 at 07:00, outcome "not recovered", described as "lingering pain"; MUSCLE TWITCHING (non-serious) with onset 02Aug2022 at 07:00, outcome "not recovered", described as "nerve twitches all over". The events "experiencing nerve damage in the upper left arm", "lingering pain" and "nerve twitches all over" required physician office visit. Therapeutic measures were not taken as a result of nerve injury, pain, muscle twitching.  Addition information: Other vaccine in four weeks was none. It was reported that: I was experiencing nerve damage in the upper left arm. I had lingering pain, and nerve twitches all over. Covid prior vaccination was none. Covid tested post vaccination was none. Known allergy was none.  Follow-Up (27Sep2022): Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching, Nerve injury, Pain
Clinical narrative: experiencing nerve damage in the upper left arm; lingering pain; nerve twitches all over; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Aug2022 at 12:15 as dose 3 (booster), single (Lot number: FP7138) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: ERE729, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 14Apr2021, when the patient was 53-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 24Mar2021, when the patient was 53-year-old, for Covid-19 Immunization. The following information was reported: NERVE INJURY (non-serious) with onset 02Aug2022 at 07:00, outcome "not recovered", described as "experiencing nerve damage in the upper left arm"; PAIN (non-serious) with onset 02Aug2022 at 07:00, outcome "not recovered", described as "lingering pain"; MUSCLE TWITCHING (non-serious) with onset 02Aug2022 at 07:00, outcome "not recovered", described as "nerve twitches all over". The events "experiencing nerve damage in the upper left arm", "lingering pain" and "nerve twitches all over" required physician office visit. Therapeutic measures were not taken as a result of nerve injury, pain, muscle twitching.  Addition information: Other vaccine in four weeks was none. It was reported that: I was experiencing nerve damage in the upper left arm. I had lingering pain, and nerve twitches all over. Covid prior vaccination was none. Covid tested post vaccination was none. Known allergy was none.  Follow-Up (27Sep2022): Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Burning sensation, Chills, Cough, Feeling abnormal, Feeling hot
Clinical narrative: Pt left and felt symptoms of fatigue, swelling, hotness.
Age: 72.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Hypoaesthesia, Lacrimation increased, Musculoskeletal stiffness, Pain in extremity, Rhinorrhoea
Clinical narrative: Pt left and felt symptoms of fatigue, swelling, hotness.
Age: 72.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Skin warm, Sleep disorder, Sneezing
Clinical narrative: Pt left and felt symptoms of fatigue, swelling, hotness.
Age: 72.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Fatigue, Feeling hot, Swelling
Clinical narrative: Pt left and felt symptoms of fatigue, swelling, hotness.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Dyspnoea exertional, Embolism, Erythema, Peripheral swelling
Clinical narrative: Positive COVID Test (Nasal Swab) post vaccination; Positive COVID Test (Nasal Swab) post vaccination; This is a spontaneous report received from contactable reporter (Nurse). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EK9231), in left arm and on 08Feb2021 as dose 2, single (Lot number: EL9263) at the age of 60 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "mild HTN" (unspecified if ongoing); "mild asthma" (unspecified if ongoing). Concomitant medications included: AMLODIPINE; VITAMIN D [VITAMIN D NOS]; COQ10 [UBIDECARENONE]; GABAPENTIN. Past drug history included: Cymbalta, reaction: "drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive COVID Test (Nasal Swab) post vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The facility where the most recent COVID-19 vaccine administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination including multivitamin. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on possible temporal association the causal association of suspect drug -BNT162b2cannot be excluded for reported events-DRUG INEFFECTIVE and COVID-19,Linked Report(s) : US-PFIZER INC-202201178945 same patient/product, different dose/event;
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Presyncope, Scan
Clinical narrative: Positive COVID Test (Nasal Swab) post vaccination; Positive COVID Test (Nasal Swab) post vaccination; This is a spontaneous report received from contactable reporter (Nurse). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EK9231), in left arm and on 08Feb2021 as dose 2, single (Lot number: EL9263) at the age of 60 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "mild HTN" (unspecified if ongoing); "mild asthma" (unspecified if ongoing). Concomitant medications included: AMLODIPINE; VITAMIN D [VITAMIN D NOS]; COQ10 [UBIDECARENONE]; GABAPENTIN. Past drug history included: Cymbalta, reaction: "drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive COVID Test (Nasal Swab) post vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The facility where the most recent COVID-19 vaccine administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination including multivitamin. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on possible temporal association the causal association of suspect drug -BNT162b2cannot be excluded for reported events-DRUG INEFFECTIVE and COVID-19,Linked Report(s) : US-PFIZER INC-202201178945 same patient/product, different dose/event;
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID Test (Nasal Swab) post vaccination; Positive COVID Test (Nasal Swab) post vaccination; This is a spontaneous report received from contactable reporter (Nurse). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EK9231), in left arm and on 08Feb2021 as dose 2, single (Lot number: EL9263) at the age of 60 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "mild HTN" (unspecified if ongoing); "mild asthma" (unspecified if ongoing). Concomitant medications included: AMLODIPINE; VITAMIN D [VITAMIN D NOS]; COQ10 [UBIDECARENONE]; GABAPENTIN. Past drug history included: Cymbalta, reaction: "drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive COVID Test (Nasal Swab) post vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The facility where the most recent COVID-19 vaccine administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination including multivitamin. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on possible temporal association the causal association of suspect drug -BNT162b2cannot be excluded for reported events-DRUG INEFFECTIVE and COVID-19,Linked Report(s) : US-PFIZER INC-202201178945 same patient/product, different dose/event;