chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: make me sick when I take them; Initial information received on 03-Nov-2021 regarding an unsolicited valid non-serious case from consumer/ non-health care professional via social media.  This case involves a patient (unknown age and gender) who was sick (illness), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious event "make me sick when i take them" (illness) (unknown latency) following the administration of vaccine.  It was reported "My shot make me sick when I take them so therefore I don't take the flu shot."  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Got very sick; Initial information received on 04-Nov-2021regarding an unsolicited valid social media non-serious case received from a consumer or non-healthcare professional via social media via Digital Media.  This case involves adult patient (unknown demographic) who had got very sick (Illness) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious got very sick (Illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  It was reported "Got one once. got very sick. never again."  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: when administering vaccine "little to none" was actually injected with no adverse event; not attached properly to the prefilled syringe with no adverse event; Initial information was received on 01-Nov-2021 regarding an unsolicited valid non-serious case received from a pharmacist and non-healthcare professional via the Regulatory Authority (Regulatory Authority Number - 00836403).   This case involves a 61-years old male patient who was administered with suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] had little to none was actually injected due to needle not attached properly to the prefilled syringe with no adverse event (Incorrect dose administered) (needle issue).   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On 31-Oct-2021, the patient received 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number UJ687AA and expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate dose of vaccine administered and needle issue (latency was on same day).  At the time of report, no adverse event reported.  Events outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The vaccine was administered incorrectly and they received the adult version instead of the children's with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the consumer or non-healthcare professional via the Regulatory Authority (Reference number: 00845187) and transmitted to Sanofi on 05-Nov-2021.  This case involves a 11-year-old female patient receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] incorrectly and they received the adult version instead of the children (product administered to patient of inappropriate age).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient past medical treatment, vaccination, concomitant medication and family history were not provided.  On 04-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [Frequency: once, Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test, Strength: standard, lot number and expiry date not reported] via unknown route in the left arm for prophylactic vaccination.  It was an actual medication error case due to Inappropriate age at vaccine administration (latency: same day).  It was reported "Caller stated that his son and daughter ages 11 and 6 received FLUBLOK yesterday. Caller stated that the vaccine was administered incorrectly and they received the adult version instead of the children."   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Bell's palsy, Facial paralysis, Facial paresis
Clinical narrative: bell's palsy; facial weakness; drooping; Initial information regarding an unsolicited valid serious case was received from a nurse via consumer/non-healthcare professional via  Medical Information (Reference number- 00847325) and transmitted to sanofi on 08-Nov-2021 .  This case involves a 50 year old female patient who experienced bells palsy, facial weakness (facial paresis) and drooping (facial paralysis) after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE for Prophylactic vaccination.  On 18-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE  produced by Sanofi Pasteur (lot number: U6737AA and expiry date: 09-Jul-2022) via intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious bells palsy with symptoms facial weakness (facial paresis) and drooping (facial paralysis) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.   These events were assessed as medically significant.  A Nurse stated they had a patient have an adverse reaction to the ADACEL vaccine. Nurse was looking to report the adverse event (AE) as well as for more information into the Bells Palsy side effect of ADACEL. She was seen in the emergency department (ED) on 05-Nov-2021 for left sided facial weakness and drooping. She was diagnosed with bells palsy and it was attributed to ADACEL. She was followed up on 08-Nov-2021. Caller stated that she called the office to get more information to see how it is being linked. She was also told the patient recently received the flu shot but she did not see it documented. She will contact. She asked whether there was a correlation between Adacel and Bells Palsy and a correlation between flu vaccine and bells palsy.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome of the events was unknown.; Sender's Comments: This case involves a 50 year old female patient who experienced bell's palsy, facial paresis and facial paralysis after receiving ADACEL. The time to onset is compatible. Concomitant medications included INFLUENZA VACCINE for Prophylactic vaccination. Additional information regarding patient's medical history, condition at the time of vaccination and lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 11.0
Sex: U
Vaccine: FLUC3
Symptoms: Rash
Clinical narrative: Rash on stomach then moved to cheek and seems to be spreading to other side of face; This spontaneous case from the United States was received on 14-Oct-2021 from other health professional (nurse) via agency (reference number: SEQW21-03946) and concerned a 11-year-old patient of unspecified gender.  The patient's concurrent conditions were not reported. The patient's historical condition included cold the week prior vaccination.  The patient's concomitant medications were not reported.  On 11-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (Influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration, indication and anatomical: not reported). The batch number was not reported.  On the same day, Monday evening, the patient started experiencing rash on stomach then moved to cheek and seemed to be spreading to other side of face. The rash was not itchy.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 11-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, after receiving vaccine, the patient developed rash. Temporal relationship is plausible. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: A 11-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, after receiving vaccine, the patient developed rash. Temporal relationship is plausible. Causal role of the suspect vaccine is assessed as possibly related.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Discomfort, Dyspnoea, Facial discomfort, Hypersensitivity
Clinical narrative: Trouble breathing; Throat swelled; Lips and tongue felt numb and swollen; Lips and tongue felt numb and swollen; Lips and tongue felt numb and swollen; Had a lot of pressure in my nose/face like when I have migraine; Allergic reaction; This spontaneous case was received on 01-Nov-2021 from other non-health professional via Seqirus' Customer services and concerned a 57-year-old female patient.  The patient's medical history and concomitant medications were not reported. The patient never had a reaction to any vaccine before.  On an unspecified date in 12-Oct-2021, the patient was vaccinated with Afluria Quadrivalent (influenza Vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm; indication: not reported). The batch number reported was P100365587.  On an unspecified date in 2021, an unknown amount of time after receiving Afluria Quadrivalent, the patient had an allergic reaction to the flu vaccine. Her throat swelled, lips and tongue felt numb and swollen, she had trouble breathing, and had a lot of pressure in her nose/face like when she had migraine. The patient went to the emergency room (ER) and was treated with Benadryl (diphenhydramine hydrochloride). Patient will go to the allergist.   The outcome of the events was not reported.  The reporter considered events to be related to Afluria Quadrivalent.  All events were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 57-year-old patient was vaccinated with Afluria Quadrivalent. An unknown amount of time after receiving Afluria Quadrivalent, the patient had an allergic reaction to the flu vaccine. Her throat swelled, lips and tongue felt numb and swollen, she had trouble breathing, and had a lot of pressure in her nose/face like when she had migraine. The patient went to the emergency room (ER) and was treated with Benadryl (diphenhydramine hydrochloride). Due to unclear time relationship, causal role of the suspect vaccine is unassessable. As per Brighton collaboration criteria, presented information may suggest hypersensitivity reaction and correspond to level 2 diagnostic certainty for anaphylaxis.; Reporter's Comments: Had an allergic reaction to the flu vaccine.; Sender's Comments: A 57-year-old patient was vaccinated with Afluria Quadrivalent. An unknown amount of time after receiving Afluria Quadrivalent, the patient had an allergic reaction to the flu vaccine. Her throat swelled, lips and tongue felt numb and swollen, she had trouble breathing, and had a lot of pressure in her nose/face like when she had migraine. The patient went to the emergency room (ER) and was treated with Benadryl (diphenhydramine hydrochloride). Due to unclear time relationship, causal role of the suspect vaccine is unassessable. As per Brighton collaboration criteria, presented information may suggest hypersensitivity reaction and correspond to level 2 diagnostic certainty for anaphylaxis.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Lip swelling, Migraine, Nasal discomfort, Pharyngeal swelling
Clinical narrative: Trouble breathing; Throat swelled; Lips and tongue felt numb and swollen; Lips and tongue felt numb and swollen; Lips and tongue felt numb and swollen; Had a lot of pressure in my nose/face like when I have migraine; Allergic reaction; This spontaneous case was received on 01-Nov-2021 from other non-health professional via Seqirus' Customer services and concerned a 57-year-old female patient.  The patient's medical history and concomitant medications were not reported. The patient never had a reaction to any vaccine before.  On an unspecified date in 12-Oct-2021, the patient was vaccinated with Afluria Quadrivalent (influenza Vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm; indication: not reported). The batch number reported was P100365587.  On an unspecified date in 2021, an unknown amount of time after receiving Afluria Quadrivalent, the patient had an allergic reaction to the flu vaccine. Her throat swelled, lips and tongue felt numb and swollen, she had trouble breathing, and had a lot of pressure in her nose/face like when she had migraine. The patient went to the emergency room (ER) and was treated with Benadryl (diphenhydramine hydrochloride). Patient will go to the allergist.   The outcome of the events was not reported.  The reporter considered events to be related to Afluria Quadrivalent.  All events were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 57-year-old patient was vaccinated with Afluria Quadrivalent. An unknown amount of time after receiving Afluria Quadrivalent, the patient had an allergic reaction to the flu vaccine. Her throat swelled, lips and tongue felt numb and swollen, she had trouble breathing, and had a lot of pressure in her nose/face like when she had migraine. The patient went to the emergency room (ER) and was treated with Benadryl (diphenhydramine hydrochloride). Due to unclear time relationship, causal role of the suspect vaccine is unassessable. As per Brighton collaboration criteria, presented information may suggest hypersensitivity reaction and correspond to level 2 diagnostic certainty for anaphylaxis.; Reporter's Comments: Had an allergic reaction to the flu vaccine.; Sender's Comments: A 57-year-old patient was vaccinated with Afluria Quadrivalent. An unknown amount of time after receiving Afluria Quadrivalent, the patient had an allergic reaction to the flu vaccine. Her throat swelled, lips and tongue felt numb and swollen, she had trouble breathing, and had a lot of pressure in her nose/face like when she had migraine. The patient went to the emergency room (ER) and was treated with Benadryl (diphenhydramine hydrochloride). Due to unclear time relationship, causal role of the suspect vaccine is unassessable. As per Brighton collaboration criteria, presented information may suggest hypersensitivity reaction and correspond to level 2 diagnostic certainty for anaphylaxis.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Swollen tongue
Clinical narrative: Trouble breathing; Throat swelled; Lips and tongue felt numb and swollen; Lips and tongue felt numb and swollen; Lips and tongue felt numb and swollen; Had a lot of pressure in my nose/face like when I have migraine; Allergic reaction; This spontaneous case was received on 01-Nov-2021 from other non-health professional via Seqirus' Customer services and concerned a 57-year-old female patient.  The patient's medical history and concomitant medications were not reported. The patient never had a reaction to any vaccine before.  On an unspecified date in 12-Oct-2021, the patient was vaccinated with Afluria Quadrivalent (influenza Vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm; indication: not reported). The batch number reported was P100365587.  On an unspecified date in 2021, an unknown amount of time after receiving Afluria Quadrivalent, the patient had an allergic reaction to the flu vaccine. Her throat swelled, lips and tongue felt numb and swollen, she had trouble breathing, and had a lot of pressure in her nose/face like when she had migraine. The patient went to the emergency room (ER) and was treated with Benadryl (diphenhydramine hydrochloride). Patient will go to the allergist.   The outcome of the events was not reported.  The reporter considered events to be related to Afluria Quadrivalent.  All events were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 57-year-old patient was vaccinated with Afluria Quadrivalent. An unknown amount of time after receiving Afluria Quadrivalent, the patient had an allergic reaction to the flu vaccine. Her throat swelled, lips and tongue felt numb and swollen, she had trouble breathing, and had a lot of pressure in her nose/face like when she had migraine. The patient went to the emergency room (ER) and was treated with Benadryl (diphenhydramine hydrochloride). Due to unclear time relationship, causal role of the suspect vaccine is unassessable. As per Brighton collaboration criteria, presented information may suggest hypersensitivity reaction and correspond to level 2 diagnostic certainty for anaphylaxis.; Reporter's Comments: Had an allergic reaction to the flu vaccine.; Sender's Comments: A 57-year-old patient was vaccinated with Afluria Quadrivalent. An unknown amount of time after receiving Afluria Quadrivalent, the patient had an allergic reaction to the flu vaccine. Her throat swelled, lips and tongue felt numb and swollen, she had trouble breathing, and had a lot of pressure in her nose/face like when she had migraine. The patient went to the emergency room (ER) and was treated with Benadryl (diphenhydramine hydrochloride). Due to unclear time relationship, causal role of the suspect vaccine is unassessable. As per Brighton collaboration criteria, presented information may suggest hypersensitivity reaction and correspond to level 2 diagnostic certainty for anaphylaxis.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reactions have been noted by patient or family. This information is current as of November 14, 2021, 11PM Central.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Headache, Herpes zoster
Clinical narrative: Herpes Zoster in Face and one Eye (Shingles) with extreme pain on head over about 6 month. Almost got blinded in one Eye. Treated with special pills and steroid Eye drops over several month.....until today. Eye sight back to about 95%. but still under treatment by Eye Doctor.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reactions have been noted by patient or family. This information is current as of November 14, 2021, 11PM Central.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Extra dose administered, Peripheral swelling
Clinical narrative: Pain and swelling in my right armpit area. Applying ice. Still experiencing symptoms 48 hours out from my booster dose.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Facial paralysis, Lacrimation increased, Lagophthalmos
Clinical narrative: Facial Paralysis
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Limb discomfort, Paraesthesia, Paralysis, Sleep disorder
Clinical narrative: Symptoms - woke up from sleep with tingling hands and feet, felt paralyzed (heavy hands and feet), breathing affected - felt paralyzed, but still able to breathe Treatment - considered whether to go to hospital emergency department, but symptoms resolved by morning
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Impaired work ability, Inflammation, Pain, Periarthritis
Clinical narrative: On 9/28 /21  after the vaccine , i experience inflammation on my left arm and finally got a frozen shoulder that radiate to my left hand. I'm allergic to cortizone vaccine for the inflammation. I lost my job because they couldn't accommodated me. I'm doing acupuncture and physical therapy
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect route of product administration, Pruritus, Rash, Skin warm
Clinical narrative: Approx 48 hours after receiving Moderna booster vaccination, the area around the injection site developed a HUGE (3") rash, very itchy, and raised from the surrounding skin, as thought the vaccine didn't go in the muscle and was sitting just under the skin.  Rash is also extremely warm to the touch.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Approx 48 hours after receiving Moderna booster vaccination, the area around the injection site developed a HUGE (3") rash, very itchy, and raised from the surrounding skin, as thought the vaccine didn't go in the muscle and was sitting just under the skin.  Rash is also extremely warm to the touch.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac function test, Dyspnoea, Pain in extremity, Paraesthesia, Pulmonary function test
Clinical narrative: Shortness of breath, buzzing/ringing in the right ear, and continuous and painful tingling along the outside of the entire right arm and fingers.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Shortness of breath, buzzing/ringing in the right ear, and continuous and painful tingling along the outside of the entire right arm and fingers.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding, Menstruation delayed
Clinical narrative: Sudden onset of extreme mensural cramps after never having them. Breakthrough bleeding multiple times throughout the last several months. Missed periods. Periods every two weeks. None of this has ever been a problem.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site pain
Clinical narrative: Fever, chills, fatigue, loss of appetite, swollen lymph node in left armpit, sore arm at injection site. Fatigue lasting 3 days, headaches lasting 4 days, extremely thirsty, nauseous
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pyrexia, Thirst
Clinical narrative: Fever, chills, fatigue, loss of appetite, swollen lymph node in left armpit, sore arm at injection site. Fatigue lasting 3 days, headaches lasting 4 days, extremely thirsty, nauseous
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Extra dose administered, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: My husband has been in increasingly bad pain and limited functionality of left Arm  since 3 hours after he received the Moderna 3rd shot  booster at the pharmacy yesterday at 3pm MST.   Unable to use left arm, yelling in pain, unable to get comfortable or sleep.   This is not a complainer kind of guy.   He hurts badly.    Used cold packs last night and advil.    Today worse, used Icy Hot patch.   Chicken soup.  It is now 10:52 pm ,  a full day later and he is in difficulty.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site nodule, Injection site pain, Injection site rash
Clinical narrative: Slight bleeding immediately from/at injection (hit a vein, apparently). Immediate bruising and small, hard knot bump at injection site. Mild soreness. All on Friday 11/12. Felt extra sleepy that night too. Didn?t realize at first but think due to vacc reaction. Like a numbing sleepy but okay.  On Saturday 11/13, still bruising but bump less hard. still tender.  Sunday 11/14, large red rash right underneath bruised injection site. Same reaction and timing I had from first initial Moderna Dose #1 back in January.  Slight itchy at rash area and still tender but tolerable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Slight bleeding immediately from/at injection (hit a vein, apparently). Immediate bruising and small, hard knot bump at injection site. Mild soreness. All on Friday 11/12. Felt extra sleepy that night too. Didn?t realize at first but think due to vacc reaction. Like a numbing sleepy but okay.  On Saturday 11/13, still bruising but bump less hard. still tender.  Sunday 11/14, large red rash right underneath bruised injection site. Same reaction and timing I had from first initial Moderna Dose #1 back in January.  Slight itchy at rash area and still tender but tolerable.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Vomiting, nausea, and low grade fever
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cystitis interstitial, Discomfort, Dysuria, Electric shock sensation
Clinical narrative: Two hours after injection experienced buzzing, vibrating, electrical pressure in bladder and urinary tract. Within four hours had severe UTI symptoms. Painful, burning and frequent urination with no relief.  Pressure and cramping.  Treated with D-Mannose over the counter which gave some relief for one day. Symptoms returned. Doctor tested my urine for infection. No signs of infection. Clean urine. Symptoms have remained every day and night. Prognosis is possible IC (Interstitial Cystitis)
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pollakiuria, Urinary tract infection, Urine analysis normal
Clinical narrative: Two hours after injection experienced buzzing, vibrating, electrical pressure in bladder and urinary tract. Within four hours had severe UTI symptoms. Painful, burning and frequent urination with no relief.  Pressure and cramping.  Treated with D-Mannose over the counter which gave some relief for one day. Symptoms returned. Doctor tested my urine for infection. No signs of infection. Clean urine. Symptoms have remained every day and night. Prognosis is possible IC (Interstitial Cystitis)
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pruritus, Injection site rash, Pain
Clinical narrative: Rash/itching around the injection site that has persisted for two weeks so far.  Mild Body/shoulder aches which have persisted for two weeks so far.  Occasional feelings of fatigue (perhaps once every day) which have peristed for two weeks so far.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hypoaesthesia, Neuralgia
Clinical narrative: Patient's relative reported patient had stroke 2 days after COVID-19 shot. Patient's relative then reported patient had long-lasting nerve pain and numbness in extremities that are currently experienced on a daily basis.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Pruritus, Rash, Swelling
Clinical narrative: Day 1 - injection site pain high Day 2 - injection site pain moderate Day 3 - arm pain, itching, swelling, and rash ("Covid Arm) high Day 4 - continued Day 5 - itching, swelling, and rash ("Covid Arm) moderate Day 6 - itching, swelling, and rash ("Covid Arm) moderate Day 7 - itching, swelling, and rash ("Covid Arm) mild Day 8 - itching, swelling, and rash ("Covid Arm) mild
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Day 1 - injection site pain high Day 2 - injection site pain moderate Day 3 - arm pain, itching, swelling, and rash ("Covid Arm) high Day 4 - continued Day 5 - itching, swelling, and rash ("Covid Arm) moderate Day 6 - itching, swelling, and rash ("Covid Arm) moderate Day 7 - itching, swelling, and rash ("Covid Arm) mild Day 8 - itching, swelling, and rash ("Covid Arm) mild
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: arthralgia, myalgia
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Fever, chills, nausea, body aches, headache, sore and swollen armpit, sore swollen warm to the touch injection site, fatigue
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pain, Peripheral swelling
Clinical narrative: Fever, chills, nausea, body aches, headache, sore and swollen armpit, sore swollen warm to the touch injection site, fatigue
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, chills, nausea, body aches, headache, sore and swollen armpit, sore swollen warm to the touch injection site, fatigue
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Extra dose administered, Fatigue, Influenza like illness
Clinical narrative: Flu-like symptoms until 24 hours post-vaccination. General joint pain (6 of 10) with severe joint pain in left SI joint, left shoulder, B/L hip joints. Extreme fatigue, but could not sleep due to pain. Loss of appetite.  Most symptoms resolved with 24 hours after booster shot. Sporadic tinnitus B/L still persists on 11/14.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: Flu-like symptoms until 24 hours post-vaccination. General joint pain (6 of 10) with severe joint pain in left SI joint, left shoulder, B/L hip joints. Extreme fatigue, but could not sleep due to pain. Loss of appetite.  Most symptoms resolved with 24 hours after booster shot. Sporadic tinnitus B/L still persists on 11/14.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Asthma, Cardiac failure congestive, Cardiomegaly, Disorientation
Clinical narrative: Fever disoriented sweating heavier abnormal menses tooth infection loss of smell respiratory illness acute onset of asthma difficulty breathing and new diagnosis of congestive heart failure fluid in lungs enlarged heart
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heavy menstrual bleeding, Hyperhidrosis, Menstrual disorder, Pulmonary oedema
Clinical narrative: Fever disoriented sweating heavier abnormal menses tooth infection loss of smell respiratory illness acute onset of asthma difficulty breathing and new diagnosis of congestive heart failure fluid in lungs enlarged heart
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory disorder, Tooth infection
Clinical narrative: Fever disoriented sweating heavier abnormal menses tooth infection loss of smell respiratory illness acute onset of asthma difficulty breathing and new diagnosis of congestive heart failure fluid in lungs enlarged heart
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Herpes zoster, Hypoaesthesia, Nipple pain
Clinical narrative: I started feeling back pain,   right lung area specially,  my right side ribs area was itching and felt numb but I ignored the symptoms thinking it was just normal side effects, On Thursday I noticed a rush on my right Brest (located on the lower left side above the bra underwire) it was itching and burning at the same time. I thought I got a rash but didn't think on nothing major so I applied corn starch to lower the itchiness. Friday the rash was getting bigger and the numbness on the side was itching more. I called my insurance on Saturday and they advise to go to a minute clinic near me. Unfortunately they didn't have any availability for me and i had to make an appointment for the following day at a different location  (Sunday November 14) the pain was increasing, not only the burning/itching sensation due to the rash but my nipple started to hurt, It feels like a needle is perforing my skin.  I was diagnosed with shingles
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash pruritic
Clinical narrative: I started feeling back pain,   right lung area specially,  my right side ribs area was itching and felt numb but I ignored the symptoms thinking it was just normal side effects, On Thursday I noticed a rush on my right Brest (located on the lower left side above the bra underwire) it was itching and burning at the same time. I thought I got a rash but didn't think on nothing major so I applied corn starch to lower the itchiness. Friday the rash was getting bigger and the numbness on the side was itching more. I called my insurance on Saturday and they advise to go to a minute clinic near me. Unfortunately they didn't have any availability for me and i had to make an appointment for the following day at a different location  (Sunday November 14) the pain was increasing, not only the burning/itching sensation due to the rash but my nipple started to hurt, It feels like a needle is perforing my skin.  I was diagnosed with shingles
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: I have not had my period
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath. Went away after 48 hours.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Chest pain, Cough, Decreased activity, Dyspnoea
Clinical narrative: Shortness of breath and chest pain development 1 hour after shot.  Continued for 5 days afterwards.  Appeared to resolve then roughly two weeks after injection chest pain and shortness of breath returned along with cough.  Cough resolved. Shortness of breath and chest pain still prevalent one month after shot. Unable to engage in previous level of physical activity.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Haematocrit increased, Heart rate increased, X-ray
Clinical narrative: Shortness of breath and chest pain development 1 hour after shot.  Continued for 5 days afterwards.  Appeared to resolve then roughly two weeks after injection chest pain and shortness of breath returned along with cough.  Cough resolved. Shortness of breath and chest pain still prevalent one month after shot. Unable to engage in previous level of physical activity.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Syncope, Throat tightness
Clinical narrative: 5 minutes after the vaccine, I experienced shortness of breath and tightening of the throat and then fainted in the clinic. When I woke up I was told that I had a possible seizure.  I was injected with an epipen and made a full recovery before the paramedics arrived. My vital signs were checked and I was not allowed to return home for an hour. I was not given the last two injections of the Gardasil vaccine.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Irritability
Clinical narrative: Red ring around vaccination site, itchy and irritable. Did not appear until 3 days post injection
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Acute myocardial infarction, Anticoagulant therapy, Antiplatelet therapy, Chest pain
Clinical narrative: Patient is a 50 y.o. male with a history of end-stage renal disease on hemodialysis.  His normal dialysis days are Mondays, Wednesdays and Fridays at the clinic where he is followed by Dr.  He was transferred from the hospital in the late evening on 11/13/2021 with a non-ST elevated myocardial infarction.  He apparently had coronary stenting done on 11/11/2021.  He did have coronary artery bypass x 2 grafting done 8/18/2021 by Dr.  He was transferred to this facility for further recommendations from a cardiology standpoint.  He is on a heparin infusion.  Apparently has been compliant with his antiplatelet drugs.  Did have a Covid booster vaccine 2 weeks ago.  On exam he denies any chest pain or overt shortness of breath.  Does complain of abdominal pain and some diarrhea which appears to be a chronic issue for him.  Flagyl and Cipro has been started by the primary care physician.  From our standpoint we will plan dialysis tomorrow per his schedule.  We will await further recommendations per cardiology.  Other pertinent medical history includes coronary artery disease, type 2 diabetes, hypertension, hypothyroidism, congestive heart failure, pleural effusion requiring chest tube placement and anemia secondary to chronic kidney disease. MD note per renal MD
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary arterial stent insertion, Diarrhoea, Electrocardiogram abnormal, Painful respiration, Palpitations
Clinical narrative: Patient is a 50 y.o. male with a history of end-stage renal disease on hemodialysis.  His normal dialysis days are Mondays, Wednesdays and Fridays at the clinic where he is followed by Dr.  He was transferred from the hospital in the late evening on 11/13/2021 with a non-ST elevated myocardial infarction.  He apparently had coronary stenting done on 11/11/2021.  He did have coronary artery bypass x 2 grafting done 8/18/2021 by Dr.  He was transferred to this facility for further recommendations from a cardiology standpoint.  He is on a heparin infusion.  Apparently has been compliant with his antiplatelet drugs.  Did have a Covid booster vaccine 2 weeks ago.  On exam he denies any chest pain or overt shortness of breath.  Does complain of abdominal pain and some diarrhea which appears to be a chronic issue for him.  Flagyl and Cipro has been started by the primary care physician.  From our standpoint we will plan dialysis tomorrow per his schedule.  We will await further recommendations per cardiology.  Other pertinent medical history includes coronary artery disease, type 2 diabetes, hypertension, hypothyroidism, congestive heart failure, pleural effusion requiring chest tube placement and anemia secondary to chronic kidney disease. MD note per renal MD
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Percutaneous coronary intervention, Troponin increased
Clinical narrative: Patient is a 50 y.o. male with a history of end-stage renal disease on hemodialysis.  His normal dialysis days are Mondays, Wednesdays and Fridays at the clinic where he is followed by Dr.  He was transferred from the hospital in the late evening on 11/13/2021 with a non-ST elevated myocardial infarction.  He apparently had coronary stenting done on 11/11/2021.  He did have coronary artery bypass x 2 grafting done 8/18/2021 by Dr.  He was transferred to this facility for further recommendations from a cardiology standpoint.  He is on a heparin infusion.  Apparently has been compliant with his antiplatelet drugs.  Did have a Covid booster vaccine 2 weeks ago.  On exam he denies any chest pain or overt shortness of breath.  Does complain of abdominal pain and some diarrhea which appears to be a chronic issue for him.  Flagyl and Cipro has been started by the primary care physician.  From our standpoint we will plan dialysis tomorrow per his schedule.  We will await further recommendations per cardiology.  Other pertinent medical history includes coronary artery disease, type 2 diabetes, hypertension, hypothyroidism, congestive heart failure, pleural effusion requiring chest tube placement and anemia secondary to chronic kidney disease. MD note per renal MD
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives (urticaria multiforme) covering head, face, neck, front and back of torso, arms, hands, and legs
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: Burnt Taste/Smell. Everything smells and tastes the same. Going on 2 months now.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Hypersomnia, Malaise
Clinical narrative: Headache, malaise and nausea followed by vomiting. Patient felt better until the next afternoon about the same time when nausea and vomiting returned. Patient was fatigued and fell asleep at 6:30 pm and slept through the night. Following day, patient felt nauseous off and on until evening when strong nausea and fatigue set in. Patient had no appetite and ate very little for two days.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Headache, malaise and nausea followed by vomiting. Patient felt better until the next afternoon about the same time when nausea and vomiting returned. Patient was fatigued and fell asleep at 6:30 pm and slept through the night. Following day, patient felt nauseous off and on until evening when strong nausea and fatigue set in. Patient had no appetite and ate very little for two days.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Stiff neck, sore neck, sore back, sore arm. Stiff neck and sore neck is still lasting up to 8 months even until booster shot. Had trigger point injection and massages. Taking flexeril and Motrin for pain. Some days really bad and cannot get out of bed.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Eye contusion, Fall, Lip injury, Tongue biting
Clinical narrative: Acted out a vivid nightmare and dove face-first off the bed onto the floor. Fell on a large flashlight by the bed and bit through my tongue, split my lip, and had a huge black eye that covered the right side of my face for two weeks..
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cough, Dizziness, Lymphadenopathy, Oropharyngeal discomfort
Clinical narrative: immediate onset -severe pain and burning to arm and spread from injection site to fingers  ~ 20 mins later vertigo, dizziness, coughing/throat discomfort, benadryl received  ~ 4-5 hours discharge from ED ~1 week after inflamed lymph nodes/sever pain to side of body for injection   ~5 - 6 weeks to fully resolve
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vertigo
Clinical narrative: immediate onset -severe pain and burning to arm and spread from injection site to fingers  ~ 20 mins later vertigo, dizziness, coughing/throat discomfort, benadryl received  ~ 4-5 hours discharge from ED ~1 week after inflamed lymph nodes/sever pain to side of body for injection   ~5 - 6 weeks to fully resolve
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Myalgia, Neck pain
Clinical narrative: I felt extreme soreness in my neck and back. My neck stiffen up even worse. The neck pain started on my left neck. 1 week later, I experience muscle soreness in my right quads. The pain in my neck is so extreme that it started giving me pounding headache. I took flexeril and Motrin to help pain. Also took some Tylenol for pain. Still have symptoms. Chills started the next day and lasted for 2 days.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details; a RECOMBIV AX HB vaccine which expired 10/31/2021 was administered today 11/09/2021; Information has been received from a clinical manager referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.  On 09-NOV-2021, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot# S022584, expiration date: 31-OCT-2021; dose, strength, frequency and route were not provided) for prophylaxis (Expired product administered). No additional adverse event provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot / several yeas later i am down again/suspected vaccination failure; several yeas later i am down again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles twice after the shot, refer case US2021AMR148561).   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. Several years after vaccination, at the time of reporting the patient was down again with shingles. The patient asked for explanation. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR148561:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got 1st, 8 months later didn't get 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 8 months before the time of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient got the first shot, did not know about 2nd shot, it was 8 months later till the time of reporting not received the 2nd shot of Shingrix which led to incomplete course of vaccination.  The reporter asked what to do now, how long was Shingrix effective and do he/she need to be re-vaccinated. Permission denied for follow up.