chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUR4
Symptoms: Arthralgia, Cough, Headache, Insomnia, Malaise
Clinical narrative: sleep lose due to the pain; sleep lose due to the pain; pressure behind his eyes; fever of 102.8; trouble moving his head due to pain; pain in all his joints; Malaise; coughing; Initial information was received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a other healthcare professional.  This case involves a 61 year old male patient who had pressure behind his eyes (Ocular discomfort), sleep lose due to the pain (Insomnia and Pain), fever of 102.8 (Pyrexia), trouble moving his head due to pain (Headache), pain in all his joints (Arthralgia), malaise and coughing (Cough), while he received vaccine quadrivalent recombinant influenza vaccine (Flublok QIV).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On 05-Nov-2020, the patient received quadrivalent recombinant influenza vaccine at a dose of 0.5 ml once via an unknown route in the left deltoid (lot QFAA2026, expiry dates were unknown) as prophylactic vaccination.  On 06-Nov-2020, 1 day, after taking the suspect, the patient had pressure behind his eyes (Ocular discomfort), fever of 102.8 (Pyrexia), trouble moving his head due to pain (Headache), pain in all his joints (Arthralgia), malaise and coughing (Cough).  On an unknown date (latency unknown) after taking the suspect, sleep lose due to the pain (Insomnia and Pain) was reported for the patient. On the same date, coronavirus (COVID-19) test reported negative.  Action taken was reported as unknown and therapy status with the suspect was not reported. Corrective treatment was not reported. Outcome was reported as unknown for all the events.  No further information was reported.
Sex: M
Vaccine: FLUR4
Symptoms: Ocular discomfort, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: sleep lose due to the pain; sleep lose due to the pain; pressure behind his eyes; fever of 102.8; trouble moving his head due to pain; pain in all his joints; Malaise; coughing; Initial information was received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a other healthcare professional.  This case involves a 61 year old male patient who had pressure behind his eyes (Ocular discomfort), sleep lose due to the pain (Insomnia and Pain), fever of 102.8 (Pyrexia), trouble moving his head due to pain (Headache), pain in all his joints (Arthralgia), malaise and coughing (Cough), while he received vaccine quadrivalent recombinant influenza vaccine (Flublok QIV).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On 05-Nov-2020, the patient received quadrivalent recombinant influenza vaccine at a dose of 0.5 ml once via an unknown route in the left deltoid (lot QFAA2026, expiry dates were unknown) as prophylactic vaccination.  On 06-Nov-2020, 1 day, after taking the suspect, the patient had pressure behind his eyes (Ocular discomfort), fever of 102.8 (Pyrexia), trouble moving his head due to pain (Headache), pain in all his joints (Arthralgia), malaise and coughing (Cough).  On an unknown date (latency unknown) after taking the suspect, sleep lose due to the pain (Insomnia and Pain) was reported for the patient. On the same date, coronavirus (COVID-19) test reported negative.  Action taken was reported as unknown and therapy status with the suspect was not reported. Corrective treatment was not reported. Outcome was reported as unknown for all the events.  No further information was reported.
Sex: M
Vaccine: FLU4
Symptoms: Contraindication to vaccination, Injection site urticaria, Urticaria
Clinical narrative: Welt at the injection site; Contraindication to vaccination; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via regulatory authority (Reference number- 00356473) and transmitted to Sanofi on 12-Nov-2020 via call-center.  This case involves an eleventh-month-old male patient who experienced Welt at the injection site (Injection site urticaria) and Contraindication to vaccination, while she received quadrivalent influenza vaccine (fluzone Quadrivalent).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication not reported.   On 11-Nov-2020, the patient received a dose of suspect quadrivalent influenza vaccine (fluzone Quadrivalent) (Injectable suspension, lot UT7007JA, expiry date 30-Jun-2020) via an unknown route in an unknown administration site for prophylactic vaccination.  On 12-Nov-2020, the patient experienced welt at the injection site (Injection site urticaria) and Contraindication to vaccination, 1day following the administration of quadrivalent influenza vaccine (fluzone Quadrivalent).  The details of laboratory data were not reported. It was not reported if the patient received a corrective treatment.   Outcome of the both events was unknown.
Sex: F
Vaccine: FLU4
Symptoms: Gout, Herpes zoster, Infectious mononucleosis, Laboratory test abnormal, Pain in extremity
Clinical narrative: Gout; Severe pain in feet; Initial information regarding an unsolicited valid non-serious case was received on 23-Nov-2020 from a consumer via The agency (Reference number- 00368889) and transmitted to Sanofi on 23-Nov-2020.  This case involves a 69-year-old female patient who experienced gout and severe pain in feet (pain in extremity), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history included Shingles (herpes zoster) and Bell's Palsy (facial paralysis) with on her right side (of face) but then facial paralysis came back on her left side a few weeks ago. She was put on Valtrex; 1500mg daily for 10 days, but as the medication began to wear off, her symptoms returned, but on the right side of her face. Her lab work came back positive for both mononucleosis and shingles antigens. She also stated that her blood work also shows evidence of Lupus, but she did not have any symptoms of that, so her doctors said they did not want to give her asymptomatic presentation a diagnosis of Lupus Past medical treatment included Valtrex. Past vaccination, concomitant medication and family history were not provided. She also reported that she had history of thyroid (hypothyroidism), hyper parathyroid (blood parathyroid hormone increased) and hashimoto's disease (autoimmune thyroiditis) and she was also immunocompromised.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious gout and severe pain in feet (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome were unknown for both the events.  There will be no information available on batch number for this case.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Myalgia
Clinical narrative: pt has complained of muscle pain and decreased range of motion
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pyrexia
Clinical narrative: Chills, fever, upset stomach, headache. Chills and fever were overnight for a few hours. Upset stomach and headache lasted about 12 hours
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Immediate post-injection reaction, Loss of consciousness, Malaise, Pyrexia
Clinical narrative: Could not be awakened / taken to the hospital; Diarrhea; Vomiting; felt blah; Felt feverish; This case was reported by a consumer via call center representative and described the occurrence of unconscious in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th July 2020, immediately after receiving Shingrix, the patient experienced fever and malaise. In July 2020, the patient experienced diarrhea and vomiting. On 29th July 2020, the patient experienced unconscious (serious criteria hospitalization and GSK medically significant). In August 2020, the outcome of the unconscious, fever, diarrhea and vomiting were recovered/resolved. On an unknown date, the outcome of the malaise was unknown.   The reporter considered the unconscious, fever, diarrhea, vomiting and malaise to be related to Shingrix.  Additional details were provided as follows: The patient stated immediately after having the 1st shot of Shingrix, the patient felt feverish and blah.  It worsened over the next few days and she started to have diarrhea and vomiting.  On 29th July 2020, she could not be awakened so she was taken to the hospital where she was admitted for two days.  Her doctors determined she had a bad adverse reaction to the Shingrix shot. All symptoms were resolved around mid of August 2020. The reporter consented to follow up. Emergency room visit required.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication, Vomiting
Clinical narrative: Could not be awakened / taken to the hospital; Diarrhea; Vomiting; felt blah; Felt feverish; This case was reported by a consumer via call center representative and described the occurrence of unconscious in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th July 2020, immediately after receiving Shingrix, the patient experienced fever and malaise. In July 2020, the patient experienced diarrhea and vomiting. On 29th July 2020, the patient experienced unconscious (serious criteria hospitalization and GSK medically significant). In August 2020, the outcome of the unconscious, fever, diarrhea and vomiting were recovered/resolved. On an unknown date, the outcome of the malaise was unknown.   The reporter considered the unconscious, fever, diarrhea, vomiting and malaise to be related to Shingrix.  Additional details were provided as follows: The patient stated immediately after having the 1st shot of Shingrix, the patient felt feverish and blah.  It worsened over the next few days and she started to have diarrhea and vomiting.  On 29th July 2020, she could not be awakened so she was taken to the hospital where she was admitted for two days.  Her doctors determined she had a bad adverse reaction to the Shingrix shot. All symptoms were resolved around mid of August 2020. The reporter consented to follow up. Emergency room visit required.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: so sick didn't known I was in this world, almost killed; Initial information was received on 28-Oct-2020 and follow-up information received on 01-Dec-2020 regarding an unsolicited valid serious case from a consumer via social media.  This case involves a patient (unknown demography) who was sick and ended up in hospital (illness), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, 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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was so sick that didn't know was in this world and ended up in hospital (illness) (unknown latency) (serious) following the administration of INFLUENZA VACCINE.   The patient thought there was something in it that almost killed to the patient. It was also reported that the vaccine put the patient in hospital every time after taking it.  Details of laboratory data were not reported.  Corrective treatment was unknown.  At the time of report, the event outcome was unknown.  Information on the batch number was requested.; Sender's Comments: This was a poorly documented social media case received from social media involves a patient (unknown demography) who had illness and  hospitalized after receiving INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. Additional information regarding patient's relevant medical history, health condition at time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Paralysis
Clinical narrative: paralyzed from head to foot; Initial information was received on 29-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media.  This case involves a male patient (age unspecified) who was paralyzed from head to foot (paralysis), when he received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medications 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, expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was paralyzed from head to foot (paralysis), (unknown latency, serious event) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Reporter stated that it ruined patient's and his family life.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  Information on lot number was requested for this case.; Sender's Comments: This case concerns a patient (age and gender unspecified) who had paralysis after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding 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.
Sex: U
Vaccine: FLUX
Symptoms: Bronchitis, Respiratory disorder, Sinusitis, Upper respiratory tract infection
Clinical narrative: patient stayed sick for over a year with upper respiratory infection; sinus infections; bronchitis; other respiratory illnesses; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (of unknown demography) who stayed sick for over a year with upper respiratory infection (upper respiratory tract infection), sinus infections (sinusitis), bronchitis and other respiratory illnesses (respiratory disorder), after receiving INFLUENZA VACCINE.  Medical history, 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 not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient stayed sick for over a year with upper respiratory infection (upper respiratory tract infection), sinus infections (sinusitis), bronchitis and other respiratory illnesses (respiratory disorder) (non serious events, unknown latency) following the administration of INFLUENZA VACCINE.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reports, the outcome was not reported for the reported events.  There will be no information on the batch number for this case
Age: 73.0
Sex: U
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received Fluzone Quadrivalent vaccine instead of Fluzone high dose with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Medical Information (MI) (Reference number- 00341763) and transmitted to Sanofi on 02-Nov-2020.  This case involves a 73 years old gender unknown patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination on an unknown date instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered).   Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error due to wrong vaccine administered (latency: same day).   Reporter states that the caller was asking information on any side effects from a patient receiving Fluzone High Dose after having the Fluzone Quadrivalent vaccine.  At the time of this reporting, patient had no adverse event.   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 on the lot number for this case.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: 25 weeks pregnant patient was administered Fluzone Quadrivalent, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via The Agency (Reference number- 00370249) and transmitted to Sanofi on 24-Nov-2020.  This case involves a 30 year old female patient who was received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] while she was 25 weeks pregnant (exposure during pregnancy).   Data regarding this pregnancy were received prospectively.   The date of last menstrual period was not reported.  The estimated due date was not reported.  Previous pregnancy (if any) not reported.  Medical history, medical treatment, vaccination and family history were not provided.  No other concomitant vaccines were used.    On 24-Nov-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7108MA and expiry date: 30-Jun-2021) (prefilled syringe) once via an unknown route in the right deltoid for prophylactic vaccination.  It was the case of vaccine exposure during pregnancy (latency same day).   At the time of report, no adverse event reported following vaccination.  Pregnancy outcome was unknown at the time of report  Reporter was informed that they will be receiving a follow-up questionnaire and all pregnancy cases were added to the registry as per FDA (Food and Drug Administration) requirement. It was reported as product, device was used and no potential product technical complaint involved in this case.
Age: 1.0
Sex: F
Vaccine: DF, FLU4, HEPA, MMR, VARCEL
Symptoms: Erythema, Pruritus, Rash maculo-papular
Clinical narrative: maculopapular, red, itchy patches on back and abdomen.   Benadryl, unscented lotions, cool baths- return in 1 week if no improvements
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, body aches, fever 101 next morning
Age: 55.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever, body aches, shivering
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: Large round (3 inch diameter) swollen and hot red area at injection site.  Headache.
Age: 43.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: I am writing because this is the second time it happens, and my doctor treats like nonchallant.  It happened when I got the first shot of VARIVAX (June 26, 2020), I broke into bump symptoms that look like chicken pox, they were raised fluid bumps a few, no more than 10 spread around my chest, neck and head. They did not itch or burn, only lasted for 5 days and were gone.  I let the time passed and got the 2nd dosage, though it was not within 60 days, the nurse said it was ok. So, I got the 2nd dosage for the VARIVAX - nothing happened in the office, I went home and  continued with normal activities. It was not until almost 2 weeks later that I started to itch, at first I didn't pay much attention but as the days went by it started to itch more. First started in my stomach, then it spread to my side trunks, then to my armpits. It is raised looked like hives - hot the touch. It started to itch, and more started coming out. It is now... on both arms, sides, butt, armpits. See pictures attached, they itch, very itchy.  I called my doctor, but he didn't do much... he just said I had a reaction to the vaccine and that it will go away. Then, he said he would call a dermatologist but so far have not heard anything. I have been taking Benadryl but that doesn't help so I stop taking it, then I put calamine lotion but that only helps for 5 minutes then it itches again.  I have pictures that I took that I would like to share.
Age: 57.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Chills, Pain, Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: One week after the immunizations patient reports that 1 day after receiving shots he developed a fever of 103F associated with chills and generalized aches and developed a rash around his neck and upper chest.  He did not seek medical attention.  He took Naproxen and Tylenol and fever and aches resolved within 3 days.  Rash however persisted at 1 week later.  Was taking loratadine at that time.
Age: 28.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm pain. Pain worse with shoulder movement.  Advised heat, ibuprofen 400-600 mg tid x 5 days, avoid lifting.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site erythema, Rash, Skin warm, Swelling
Clinical narrative: Swelling worsened. Patient has erythema in the right shoulder. Patient experience headaches, rash and arm is warm at the touch. Also noticeable readiness on the shoulder site when vaccine was given
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MENB, RV5
Symptoms: Irritability, Poor feeding infant, Pyrexia, Wrong product administered
Clinical narrative: Trumenba(Men B) was given in error instead of Prevnar 13.  Day after vaccine, parent reported the baby was very fussy, would not feed and started a fever.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Computerised tomogram normal, Electromyogram normal, Hypoaesthesia, Magnetic resonance imaging normal
Clinical narrative: Severe l shoulder and arm pain, Advil for pain--some relief from pain. Follow up with Dr end of April -- possible pinched nerve per PCP prescribed muscle relaxer-- 5 day prescription, after 5 day June 12 ER visit severe pain in neck down to hand shaking and numbness. ER prescribed Sling for arm, cold packs and new prescription for muscle relaxer same as prescribed by PCP. PCP gave MRI order June 19. Follow up with neurologist  in July, neurologist order for Physical Therapy. August 27 EMG test -- result no muscle or nerve damage. Patient has had some relief with Physical Therapy -- PT finished in September.  Hand pain at times and arm tires easily when stressed.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Neck pain, Pain in extremity, Tremor, X-ray normal
Clinical narrative: Severe l shoulder and arm pain, Advil for pain--some relief from pain. Follow up with Dr end of April -- possible pinched nerve per PCP prescribed muscle relaxer-- 5 day prescription, after 5 day June 12 ER visit severe pain in neck down to hand shaking and numbness. ER prescribed Sling for arm, cold packs and new prescription for muscle relaxer same as prescribed by PCP. PCP gave MRI order June 19. Follow up with neurologist  in July, neurologist order for Physical Therapy. August 27 EMG test -- result no muscle or nerve damage. Patient has had some relief with Physical Therapy -- PT finished in September.  Hand pain at times and arm tires easily when stressed.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Heart rate increased, Injection site pain, Injection site swelling
Clinical narrative: Other than the normal swollen and sore area around the shot, I had very bad chills (even with multiple blankets on) and my heart felt like it was going to beat out of my chest.  I took my pulse and it was in the 160s for several hours, but it is back around 100 now.  I also had a very bad headache and still have a slightly swollen and sore gland in my armpit
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Other than the normal swollen and sore area around the shot, I had very bad chills (even with multiple blankets on) and my heart felt like it was going to beat out of my chest.  I took my pulse and it was in the 160s for several hours, but it is back around 100 now.  I also had a very bad headache and still have a slightly swollen and sore gland in my armpit
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Chronic headaches for 5 days (still counting)
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Incorrect route of product administration, Surgery
Clinical narrative: Patient states that the vaccine was administered into the shoulder joint instead of the muscle. Patient has experienced shoulder pain and has undergone physical therapy and surgery after the administeration of the vaccine.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse event reported; HBP calling to report a temperature excursion on PROQUAD, MMR II and VARIVAX; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 10-SEP-2020, the patient was vaccinated with improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 1 dosage form, lot number S027465, expiration date 02-MAR-2021 (route of administration not provided) for prophylaxis. No other adverse event was reported.  This is 1 of 2 cases reported by the same reporter; Sender's Comments:  US-009507513-2012USA001539:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: Nurse calling from HCP office to report that a dose of ROTATEQ was given on 12/1/2020 and had expired on 11/26/2020.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 01-DEC-2020, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered by oral route, as prophylaxis (formulation, strength and vaccination scheme were not provided; lot number S005876, which has been verified to be valid, expiration date reported as 26-NOV-2020, but upon internal review was established as 25-NOV-2020). The vaccine administered did no experience previous temperature excursion.
Age: 75.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no adverse event; vaccinated with pneumonia 13 on 2015 and pneumonia 23 on 2016; This spontaneous report was received from a 76-year-old female patient, concerning to herself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unspecified date in 2015, the patient was vaccinated with pneumococcal 13v conj vaccine (CRM197) (reported as pneumonia 13) and On an unknown date in 2016, the patient was vaccinated with pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (reported as pneumonia 23) for prophylaxis (inappropriate schedule of product administration), for bot vaccines (strengths, doses, anatomical locations, routes of administration, lots numbers, and expirations date were not reported). No adverse event reported.  This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-1903USA006184:
Sex: U
Vaccine: FLUX
Symptoms: Cough, Illness, Influenza, Malaise
Clinical narrative: sick; flu; cough; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves patient (unknown demographic) who had sick (illness), flu (influenza) and cough, while patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication 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 were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness), flu (influenza) and cough (unknown latency) after the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting the outcome of events were unknown for all events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: When injecting vaccine it just squirted everywhere very quickly. Patient did not get a full dose (1/2 lost) but declined another today, no AE; Fluid leaked at juncture of needle to syringe, no AE; Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves patient (unknown demography) who did not get a full dose (1/2 lost) while was getting injected with the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (underdose, lot number UT7058JA and expiration date and other dosing details not reported , prophylactic vaccination) as it just got squirted everywhere very quickly o an unknown date. But patient declined another vaccine. Also, the fluid leaked at juncture of needle to syringe (needle issue).  The patient's medical history and concomitant medications were not reported.   It was an actual medication error case due to vaccine underdose (same day latency). It was also a case of needle leak.   No adverse event reported at the time of reporting.   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: 57.0
Sex: F
Vaccine: UNK
Symptoms: Herpes zoster, Musculoskeletal chest pain, Rash
Clinical narrative: I had pain on the left side under my ribs and then I developed a painful rash.  I saw my doctor and he said it was the shingles.  So apparently I got the shingles from the shingles vaccine.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in arm pit area, I don't exact influenza strain vaccine given.
Age: 0.42
Sex: M
Vaccine: PNC13
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: Patient was not acting like himself.He did not react to stimuli. He did not respond with his eyes. He was staring. There was no movement. When he took him on the shoulder he was limp and staring. It was like this for about 15 minutes then it started to react slowly. Days later he began to act slowly. As the week passed, he began to be more active until he returned to normal. He gave him something similar but milder two months later.
Age: 76.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Fatigue, Injection site induration, Injection site warmth
Clinical narrative: Patient mentioned she was feeling very tired following the vaccinations. She also noted that a local reaction started on the same day she received the two vaccines. She reported that it started forming a knot, feeling warm to the touch and increasing in size.  She came to the clinic today to get evaluated due to her symptoms. She states she has only taken Tramadol for pain with slight improvement. She mentioned she also  iced the area which makes it feel better. She states her arm looks better today than it did the past few days. Denies systemic symptoms.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Shooting pain in the injected arm (left arm)  starting 3 days post injection.  Current symptoms include decreased range of motion and pain.  Pain has increased over the last 7 days.
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Patient received his fluzone vaccine, appeared normal, talking, active. He walked from his chair in vaccination area to the register. I began to ring him up and he passed out. His mother was with him and was able to assist. He appeared to have no trauma from falling , woke up quickly. We had him stay on the floor. His mother said he had a seizure.  911 was called, they arrived and took him to the hospital
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Inflammation, Mobility decreased, Pain, Rotator cuff syndrome, Sleep disorder
Clinical narrative: Next day could hardly move his arm. Ongoing aching when moves his arm. Difficulty sleeping due to pain. Still having pain 21 days later but improving
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Constipation, Crying, Lethargy
Clinical narrative: cry weak, lethargic, constipated
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Impaired work ability, Injection site pain, Malaise
Clinical narrative: I went for a hike yesterday about 2pm after the injection.  The injection site began to ache a little so I began rubbing it during the hike and after about 6-8 hours after the injection I begin feeling very fatigued and nauseated.  My head began to hurt and I have really bad body aches and the injection site really is achy and stung a little when injected.  I have chills and is shivering at the moment the thermometer states I have a high fever but fails to give the actual temp.  I had shingles while in College back in the late 70's early 80s.  I still have my taste and smell but I don't feel well today which caused me to have to call into work.  I have not seeked any medical attention at this time but if it doesnt get any better by 12Noon I will contact my PCP for further instructions.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: I went for a hike yesterday about 2pm after the injection.  The injection site began to ache a little so I began rubbing it during the hike and after about 6-8 hours after the injection I begin feeling very fatigued and nauseated.  My head began to hurt and I have really bad body aches and the injection site really is achy and stung a little when injected.  I have chills and is shivering at the moment the thermometer states I have a high fever but fails to give the actual temp.  I had shingles while in College back in the late 70's early 80s.  I still have my taste and smell but I don't feel well today which caused me to have to call into work.  I have not seeked any medical attention at this time but if it doesnt get any better by 12Noon I will contact my PCP for further instructions.
Age: 66.0
Sex: F
Vaccine: FLUA4, FLUA4, VARZOS, VARZOS
Symptoms: Asthenia, Body temperature increased, Chills, Gastric disorder, Headache
Clinical narrative: At about 9pm, patient started to lie down but couldn't because of stomach issues. Temp increased to 102. Periods of intense vomiting all night and all day. Patient body aches, fever, chills, headache. Symptoms lasted till 10/1/2020 in the afternoon, temp started to stabilize. Started to feel better but very weak.  Advised by PCP to drink plenty of fluids, tylenol as-need and rest.
Age: 66.0
Sex: F
Vaccine: FLUA4, FLUA4, VARZOS, VARZOS
Symptoms: Migraine, Pain, Pyrexia, Vomiting
Clinical narrative: At about 9pm, patient started to lie down but couldn't because of stomach issues. Temp increased to 102. Periods of intense vomiting all night and all day. Patient body aches, fever, chills, headache. Symptoms lasted till 10/1/2020 in the afternoon, temp started to stabilize. Started to feel better but very weak.  Advised by PCP to drink plenty of fluids, tylenol as-need and rest.
Age: 48.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Arthralgia, Fatigue, Joint stiffness, Pyrexia
Clinical narrative: Abnormally sore arm after shot. Went back to work section and through the rest of afternoon arm became more sore, began feeling feverish though did not take temp, went home, went to bed. Woke up at 2330, shaking, feverish, joints not moving well and painful. Continued all of Saturday. Sunday all symptoms improved except continues to experience extreme fatigue. Monday all symptoms continue to improve but still very fatigued.
Age: 48.0
Sex: M
Vaccine: TYP
Symptoms: Tremor
Clinical narrative: Abnormally sore arm after shot. Went back to work section and through the rest of afternoon arm became more sore, began feeling feverish though did not take temp, went home, went to bed. Woke up at 2330, shaking, feverish, joints not moving well and painful. Continued all of Saturday. Sunday all symptoms improved except continues to experience extreme fatigue. Monday all symptoms continue to improve but still very fatigued.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Dizziness postural, Loss of consciousness
Clinical narrative: Began feeling lightheaded on drive home, about 10-15 minutes after the injection. Breathing rate increased - I wouldn't describe it as shortness of breath, more like an anxiety reaction. Lightheadedness increased when I got out of the vehicle to swap seats with my wife so she could drive. I lost consciousness as I was reaching the passenger side door, regained almost immediately after hitting the ground. Paramedics arrived, took vital signs. Blood pressure was reading 127/89, blood sugar 68. Not sure what my resting heart rate was. Nothing was found to be alarming enough at the time to require transport or hospitalization, so I went home and rested. One additional dizzy spell occurred upon standing about four hours after the event, but cleared up after sitting down, and no further events occurred after that.
Age: 70.0
Sex: F
Vaccine: DTAP, FLUX, HEPA
Symptoms: Crying, Depression, Gait disturbance, Hypoaesthesia, Injection site pain
Clinical narrative: Patient started feeling her finger tips numb about 3 days after taking her vaccination. Consulted with her PCP that did not do anything at the time. In the beginning of September the symptoms got worse. Her fingers she can not move then or do anything. Then her arms started getting numb, and painful. It is from her fingers up to her neck. Her fingers are mostly numb. After some weeks she started having problems walking. Her daughter had to buy her a wheelchair. She can't move her head very well and she can't take care of her primary daily activities by herself as taking a shower, going to the bathroom, she can't dress herself without help, wash dishes doing nothing. She also got depressed, crying a lot and a family family member told her to talk to her PCP who referred her to a specialist and she does not remember her name. She said the specialist prescribed her some pills that are helping her with depression. Patient said the pain at the injection site is so severe she can't wear long sleeves. A Sleeve touching the site is very painful to her. She also says her fingers are swollen and she said she does not feel them anymore. She states she does not have any mobility in both arms. She was prescribed physical therapy but she does not believe it is helping.
Age: 70.0
Sex: F
Vaccine: DTAP, FLUX, HEPA
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient started feeling her finger tips numb about 3 days after taking her vaccination. Consulted with her PCP that did not do anything at the time. In the beginning of September the symptoms got worse. Her fingers she can not move then or do anything. Then her arms started getting numb, and painful. It is from her fingers up to her neck. Her fingers are mostly numb. After some weeks she started having problems walking. Her daughter had to buy her a wheelchair. She can't move her head very well and she can't take care of her primary daily activities by herself as taking a shower, going to the bathroom, she can't dress herself without help, wash dishes doing nothing. She also got depressed, crying a lot and a family family member told her to talk to her PCP who referred her to a specialist and she does not remember her name. She said the specialist prescribed her some pills that are helping her with depression. Patient said the pain at the injection site is so severe she can't wear long sleeves. A Sleeve touching the site is very painful to her. She also says her fingers are swollen and she said she does not feel them anymore. She states she does not have any mobility in both arms. She was prescribed physical therapy but she does not believe it is helping.
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Abdominal discomfort, Anxiety, Blood test abnormal, Decreased appetite, Depression
Clinical narrative: 2 days after the vaccine I began to experience extreme decreased appetite, on and off numbness/weakness in my extremities, restless leg, heart palpitations, shortness of breath, extreme anxiety, depression, and OCD, weightloss, upset stomach/loose stools,  dizziness/ as if I was rocking on a boat that was and still is present but manageable with Physical Therapy and other treatment.  None of these symptoms did I ever struggle with until the vaccine event. At the time of the vaccine I was a healthy 19 year old, full time college student and part time nanny. I was very active in my school's community and was very active. I went from working out 5-6 times a week to getting breathless going up a few stairs and extreme weakness. I lost about 10ish pounds, but keep in mind I am 5'3 and prior to the vaccine was around 123-125 pounds.   While many of my symptoms have gotten better, it was not without running all around to the cardiologist, ENT, SEVERAL visits to my pediatricians office of which the doctors did not listen to me. I did not get the help I needed to start feeling better until I started seeing Dr. and Dr.
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Endoscopy abnormal, Gastrointestinal bacterial overgrowth
Clinical narrative: 2 days after the vaccine I began to experience extreme decreased appetite, on and off numbness/weakness in my extremities, restless leg, heart palpitations, shortness of breath, extreme anxiety, depression, and OCD, weightloss, upset stomach/loose stools,  dizziness/ as if I was rocking on a boat that was and still is present but manageable with Physical Therapy and other treatment.  None of these symptoms did I ever struggle with until the vaccine event. At the time of the vaccine I was a healthy 19 year old, full time college student and part time nanny. I was very active in my school's community and was very active. I went from working out 5-6 times a week to getting breathless going up a few stairs and extreme weakness. I lost about 10ish pounds, but keep in mind I am 5'3 and prior to the vaccine was around 123-125 pounds.   While many of my symptoms have gotten better, it was not without running all around to the cardiologist, ENT, SEVERAL visits to my pediatricians office of which the doctors did not listen to me. I did not get the help I needed to start feeling better until I started seeing Dr. and Dr.
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Hair metal test abnormal, Hypoaesthesia, Muscular weakness, Obsessive-compulsive disorder, Palpitations
Clinical narrative: 2 days after the vaccine I began to experience extreme decreased appetite, on and off numbness/weakness in my extremities, restless leg, heart palpitations, shortness of breath, extreme anxiety, depression, and OCD, weightloss, upset stomach/loose stools,  dizziness/ as if I was rocking on a boat that was and still is present but manageable with Physical Therapy and other treatment.  None of these symptoms did I ever struggle with until the vaccine event. At the time of the vaccine I was a healthy 19 year old, full time college student and part time nanny. I was very active in my school's community and was very active. I went from working out 5-6 times a week to getting breathless going up a few stairs and extreme weakness. I lost about 10ish pounds, but keep in mind I am 5'3 and prior to the vaccine was around 123-125 pounds.   While many of my symptoms have gotten better, it was not without running all around to the cardiologist, ENT, SEVERAL visits to my pediatricians office of which the doctors did not listen to me. I did not get the help I needed to start feeling better until I started seeing Dr. and Dr.
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Restless legs syndrome, Urine analysis abnormal, Weight decreased
Clinical narrative: 2 days after the vaccine I began to experience extreme decreased appetite, on and off numbness/weakness in my extremities, restless leg, heart palpitations, shortness of breath, extreme anxiety, depression, and OCD, weightloss, upset stomach/loose stools,  dizziness/ as if I was rocking on a boat that was and still is present but manageable with Physical Therapy and other treatment.  None of these symptoms did I ever struggle with until the vaccine event. At the time of the vaccine I was a healthy 19 year old, full time college student and part time nanny. I was very active in my school's community and was very active. I went from working out 5-6 times a week to getting breathless going up a few stairs and extreme weakness. I lost about 10ish pounds, but keep in mind I am 5'3 and prior to the vaccine was around 123-125 pounds.   While many of my symptoms have gotten better, it was not without running all around to the cardiologist, ENT, SEVERAL visits to my pediatricians office of which the doctors did not listen to me. I did not get the help I needed to start feeling better until I started seeing Dr. and Dr.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and tenderness on vaccine spot, reported by the patient five days after noticing, Has applied ice and hot creams, was advised to see a physician for possible skin infection.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Caller stated that after shot he had muscle swelling  at the injection site. Day two red warm streaks leading down the arm towards the bicep area. Fever, chills, nausea and fatigue.
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Caller stated that after shot he had muscle swelling  at the injection site. Day two red warm streaks leading down the arm towards the bicep area. Fever, chills, nausea and fatigue.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Patient reports that within 24 hours of receiving injection she developed rash extending over her neck torso and contralateral arm from which she received the injection. She also felt fatigued and generalized body aches. Symptoms resolved within 72 hours. This was her second injection.