chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via The Agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310354, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310464 and 2020SA277871 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via an unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage (latency: same day).  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  At the time of report, 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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via The Agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter)  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, 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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, 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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via The Agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, 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.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Malaise
Clinical narrative: did not feel well; Initial information was received on 14-Nov-2020 regarding an unsolicited valid non-serious social media  case from the consumer.  This case involves an unknown demographic patient who did not feel well (malaise), after receiving INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  The patient had received flu shots in the past and had no adverse events post vaccination.  The patient's past medical treatment, family history and concomitant medication were not reported.   On an unknown date (same day), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer and a dose of suspect PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient did not feel well (malaise), (unknown latency) following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: every time got the flu after flushot; They are not effective, got the flu after flushot; Initial information was received on 19-Nov-2020 regarding an unsolicited valid serious social media case from a consumer via social media.  This case involves patient (unknown demography) who every time got the flu (influenza) after receiving the INFLUENZA VACCINE which was not effective (vaccination failure).  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, expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. It was reported that the patient did not get the flu if did not get the vaccine.  This was also a case of vaccination failure (as per the reporter the vaccine was not effective).  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown for the events.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly documented social media case concerns a patient (unknown demography) who presented with influenza after and despite vaccination with INFLUENZA VACCINE from unknown manufacturer. The time to onset is unknown. Further information regarding medical history, medical condition during vaccination, immune status, details of vaccination schedule completion were not reported. Based upon the reported information, the role of the suspect vaccine and a case of vaccination failure cannot be assessed.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: HIB component of Pentacel was mixed with normal saline instead of the diluent it came with the box with no AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a unknown demographics patient who received HIB component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] mixed with normal saline (lot: not reported, expiry date: not reported), via unknown route, on an unknown date for prophylactic vaccination (product preparation error).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to Wrong diluent used. It was reported that HIB component of Pentacel was mixed with normal saline instead of the diluent it came with the box and received by patient.  At the time of reporting, the 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.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: diluted with sterile water instead of the provided diluent with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via phone at call center via Medical Information (Reference number- 00319980) and transmitted to Sanofi on 16-Oct-2020.   This case involved a 4 months old female patient who received HIB (PRP/T) VACCINE [ACT-HIB] (lot number-UJ355AA, expiry date: 24-Jul-2021) via unknown route in the left thigh for prophylactic vaccination on 16-Oct-2020, which was diluted with sterile water instead of the provided diluent with no adverse event (Product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  It was an actual medication error due to Wrong solution used in drug reconstitution (latency- same day).   At the time of reporting, the 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.
Age: 88.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Dizziness, Memory impairment, Nausea
Clinical narrative: unable to remember body site of vax, unable to remember which flu vax was received.  10:00am started having dizziness, after sitting down, had nausea. Husband called the ambulance. Was carried out on the stretcher (do not remember any events). Doctors informed of a possible UTI. A few weeks ago, physician stated that I may not need to get the shot anymore. Next day after hospital, I was fine.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Pruritus, Rash
Clinical narrative: Patient said that she was itchy after receiving the vaccine and weeks later had a rash and her back was hurting.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Fever, chills, headache , nausea, body aches, Fatigue A vein was punctured while injecting shot.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, headache , nausea, body aches, Fatigue A vein was punctured while injecting shot.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Guillain-Barre syndrome, Impaired work ability, Intensive care, Paralysis
Clinical narrative: The patient had guillain barre syndrome after her swine flu vaccine 40-50 years ago. She was paralysed and stayed in the hospital for 77 days. 10 days in intensive care. 20 days in intermediate unite and the rest in regulair floor. . it took her 7- 8 months to be able to go back to work.  THE REASON FOR REPORTING: She has been avoiding all virus vaccine. Now, with the availability of the covid vaccine and her high risk (because of her age), we are wondering, can she take the covid vaccine? if Which one? Thanks
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain
Clinical narrative: L shoulder discomfort and and pain w ROM
Age: 42.0
Sex: F
Vaccine: HEP, HEPA, PPV
Symptoms: Headache, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: 42yr old patient with PMH of kidney transplant (1994, 1999), chronic insomnia, thrombocytopenia, and other comorbidities presented to clinic for follow up of abdominal pain on 11/23.  During visit, patient requested to receive vaccines as recommended by GI.  MD entered orders for Hepatitis A vaccine adult IM, Heplisav-B, Hepatitis B Vaccine (Recombinant), Adjuvant, and Pneumococcal polysaccharide vaccine 23-valent greater than or equal to 2yo SQ/IM (PNEUMOVAX-23).  CMA prepared vaccines and administered the following:  Hepatitis A vaccine (LOT # X9A9B, GSK) IM to patient?s LD, Hepatitis B vaccine (LOT # 934599, Dynavax) IM to patient?s LD, and Pneumococcal P23V vaccine (LOT # T021485, Merck) IM to patient?s LD.  Later patient endorsed headache and left arm pain within 2hrs of vaccination and gradual immobility of left should due to swelling and pain.  Patient endorsed icing, applying heat, and acetaminophen with no improvement.  Patient reevaluated in office on 11/24 with no indication of anaphylaxis, but positive for erythematous rash along left deltoid area with swelling and tenderness as well as poor range of motion of left shoulder.  Of note, follow up not on 11/24 states hepatitis A and B vaccines administered to RD, not LD as documented in Immunizations.  Patient given should slinger for support and advised to monitor.  Patient discharged home in stable condition.   Of note patient administered HPV vaccine on 11/18/20 in LD.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Hot flush, Malaise, Neck pain, Pain
Clinical narrative: body aches, neck pain, malaise first couple of days following shot hot flash, purple face, bright red rash upper body on the forth day after shot one day temperature of 99.5 forth day fifth day filling out this form, better but not sure if this is over?
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin discolouration
Clinical narrative: body aches, neck pain, malaise first couple of days following shot hot flash, purple face, bright red rash upper body on the forth day after shot one day temperature of 99.5 forth day fifth day filling out this form, better but not sure if this is over?
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Per email from the employee who received the vaccine... "The day I got my vaccine, 9/25/20, I started developing severe itchiness, and redness from my chest throughout my neck up to my face within the first 30 minutes after the shot which broke out into hives hives. I took Benadryl to see if that work and it didn?t help much. I continued to itch and have hives on my neck for the rest of that day but continued to take Benadryl to try to calm down the reaction and itchiness a bit.  I did not see a medical provider for my symptoms because it happened while I was working that day. I notified my nurse manager and she was the one who bought me Benadryl and tried to help so I could continue working.  I did not report my reaction to the VAERS either."
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Anxiety, Feeling abnormal, Hormone level abnormal, Injected limb mobility decreased, Injection site pain
Clinical narrative: I felt a pop, push in my arm on initial shot that really really hurted.  two weeks after Left arm still had lump in it, pain to life and move, could not depend on the arm to help pull up my pants or carry anything.  Called  (10/14/20) dr and was given Prednisone 50 mg, I think, twice a day for 5 days.started 10/17/20 to 10/21/20.  Ended up in ER on 10/24/20 after calling dr because of anxiety, hormones raging, body felt like it was racing.  ER results, reaction to Prednisone.  Still had pain in Left Arm.  Went for a massage  on November 6th and had her try to smooth out lump in arm and massage soreness.  Seen pain management for back on 11/11 and he would not put trigger shots in arm to relieve muscle pain. said to take my gabepentin  100 mg capsules.  Seen Primary for follow up on 10/30/20, 11/6/20 and 11/11/20 and she said it may take time for the muscle to heal.  I have a regular scheduled appt on 1/18/21,  Seen Chiropractor on 11/18 and he gave me some exercises to help me and said no lifting or unsupported use of that left arm.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Limb mass, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: I felt a pop, push in my arm on initial shot that really really hurted.  two weeks after Left arm still had lump in it, pain to life and move, could not depend on the arm to help pull up my pants or carry anything.  Called  (10/14/20) dr and was given Prednisone 50 mg, I think, twice a day for 5 days.started 10/17/20 to 10/21/20.  Ended up in ER on 10/24/20 after calling dr because of anxiety, hormones raging, body felt like it was racing.  ER results, reaction to Prednisone.  Still had pain in Left Arm.  Went for a massage  on November 6th and had her try to smooth out lump in arm and massage soreness.  Seen pain management for back on 11/11 and he would not put trigger shots in arm to relieve muscle pain. said to take my gabepentin  100 mg capsules.  Seen Primary for follow up on 10/30/20, 11/6/20 and 11/11/20 and she said it may take time for the muscle to heal.  I have a regular scheduled appt on 1/18/21,  Seen Chiropractor on 11/18 and he gave me some exercises to help me and said no lifting or unsupported use of that left arm.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient reported soreness at the injection site (deltoid) beginning the day after receiving the vaccine
Age: 25.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Nausea, Pyrexia, Tenderness
Clinical narrative: Fever 101.1, nausea, tenderness in arm.  No redness at site of injection.  No vomiting.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient reported soreness at the injection site (Deltoid) beginning the day after receiving the vaccine
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration, X-ray
Clinical narrative: SIRVA- severe shoulder pain. The most telltale symptom of SIRVA is severe pain in the shoulder that begins within 48 hours of injection...  Decreased ROM.  If you hae a shoulder injury from a vaccine, you will likely lose mobility in your injured arm...  arm pain.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Fatigue, Hallucination, Headache, Injection site pain, Injection site swelling
Clinical narrative: Patient at about 7pm became extremely tired. Slept 2 hours. Couldn't sleep rest of the night. Headache; felt like head was 'going to explode' till 4am. Hallucinations; unkown duration. Still has headached presently at 1300 11/25/2020. Sore at the injections site, swollen.   Pt did notify PCP.   Had back surgery 1 month prior; October, out-patient.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Sleep disorder, Spinal operation
Clinical narrative: Patient at about 7pm became extremely tired. Slept 2 hours. Couldn't sleep rest of the night. Headache; felt like head was 'going to explode' till 4am. Hallucinations; unkown duration. Still has headached presently at 1300 11/25/2020. Sore at the injections site, swollen.   Pt did notify PCP.   Had back surgery 1 month prior; October, out-patient.
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Neuralgia, Pain
Clinical narrative: Patient called to let us know a few weeks later that since the shot she has had nerve pain shooting down her arm randomly.  She said that she will be cooking dinner and lift a pot and suddenly drop it due to the pain.  She went to the doctor's office and they prescribed her gabapentin 100mg tid.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Arthritis, Polymyalgia rheumatica
Clinical narrative: Sudden severe joint inflammation response 4-5 days after receiving high dose influenza vaccine. Diagnosis of polymyalgia rheumatica.  Pain control thru steroid Presidone. Now on reducing doses and pain free one year later.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Mobility decreased, Muscular weakness, Myalgia, Periarthritis
Clinical narrative: Muscular soreness in the shoulder, loss of movement without pain, muscle weakness & loss of strength, frozen shoulder
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: X-ray normal
Clinical narrative: Muscular soreness in the shoulder, loss of movement without pain, muscle weakness & loss of strength, frozen shoulder
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: temperature excursion; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.  On 26-OCT-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # S040483, expiration date 19-JUN-2021 (dose and strength were unknown, route of administration was not reported) for prophylaxis. The vaccine had reported temperature excursion (product storage error). It was not reported, if the temperature excursion was detected by digital data logger.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2011USA001282: US-009507513-2011USA001517:
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion; Temperature= -13.9C to -14.7C; This spontaneous report as received from a nurse refers to a 5-year-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 02-NOV-2020, the patient was vaccinated with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number: S035110, expiration date: 03-MAY-2021; route of administration was not provided) 0.5 ml (product storage error temperature too high). The vaccine was stored in temperatures between -13.9 and -14.7 degrees Celsius (-14 to -10 degrees Celsius (-13.9 degrees Celsius) for 0 hours 30 minutes and 0 seconds; -14 to -10 degrees Celsius (-14.2 degrees Celsius) for 0 hours 15 minutes and 0 seconds; -14 to -10 degrees Celsius (-14.7 degrees Celsius) for 0 hours 20 minutes and 0 seconds; -14 to -10 degrees Celsius (-14.6 degrees Celsius) for 0 hours 5 minutes and 0 seconds). There was no previous temperature excursion. Digital data lodger was involved.; Sender's Comments:  US-009507513-2011USA001488: US-009507513-2011USA001736: US-009507513-2011USA001846: US-009507513-2011USA001953: US-009507513-2011USA001966: US-009507513-2011USA001975: US-009507513-2011USA002208: US-009507513-2011USA002225: US-009507513-2011USA002242: US-009507513-2011USA002568: US-009507513-2011USA002572: US-009507513-2011USA002578: US-009507513-2011USA002620: US-009507513-2011USA002622: US-009507513-2011USA002642:
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion; This spontaneous report as received from a nurse refers to a 15-month-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 02-NOV-2020, the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T000344, expiration date: 05-JAN-2022; route of administration was not provided) 0.5 ml. The vaccine was stored in temperatures between -13.9 and -14.7 degrees Celsius (-14 to -10 degrees Celsius (-13.9 degrees Celsius) for 0 hours 30 minutes and 0 seconds; -14 to -10 degrees Celsius (-14.2 degrees Celsius) for 0 hours 15 minutes and 0 seconds; -14 to -10 degrees Celsius (-14.7 degrees Celsius) for 0 hours 20 minutes and 0 seconds; -14 to -10 degrees Celsius (-14.6 degrees Celsius) for 0 hours 5 minutes and 0 seconds). There was no previous temperature excursion. Digital data lodger was involved.; Sender's Comments:  US-009507513-2011USA001488: US-009507513-2011USA001736: US-009507513-2011USA001846: US-009507513-2011USA001953: US-009507513-2011USA001966: US-009507513-2011USA001975: US-009507513-2011USA002208: US-009507513-2011USA002225: US-009507513-2011USA002242: US-009507513-2011USA002568: US-009507513-2011USA002572: US-009507513-2011USA002578: US-009507513-2011USA002615: US-009507513-2011USA002620: US-009507513-2011USA002622:
Sex: M
Vaccine: PPV
Symptoms: Back pain, Blood pressure decreased, Computerised tomogram pelvis abnormal, Dyspnoea, Fatigue
Clinical narrative: Severe pneumonia/ Was very tired/ Feeling out of breath/ consumer's oxygen dropped/ is on a ventilator/ physician saw ground glass in bottom portion of lungs; consumer may have kidney stones; back pain; arm pain; blood pressure levels dropped; This spontaneous information has been received from the patient's daughter, concerning a 77-years-old male patient. The patient's pertinent medical history included diabetes, high blood pressure and an unspecified thyroid issue. The patient had no previous drug reactions or allergies. The patient's concomitant medications included famotidine, amlodipine, glimepiride, valsartan, torsemide, levothyroxine sodium, dulaglutide (TRULICITY), vitamins (unspecified), metformin, hydralazine hydrochloride, omega-3 marine triglycerides and ezetimibe (ZETIA).  On 25-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) route of administration reported as injection in arm, lot number S033516 with expiration date 29-JUN-2021, indication reported as elderly with diabetes (strength, dose and frequency were not reported).  On an unknown date in early October 2020, the patient began to feel out of breath and was very tired. The patient also reported that he experienced back pain and arm pain. On an unknown date in October 2020, the patient went to the physician's office for a computerized tomography (CT) scan of his pelvic area, and the physician thought the patient may have kidney stones (nephrolithiasis). The physician was also able to see that the consumer's bottom portion of lungs on the CT scan was ground glass (also reported as multiple pneumonias, completely white up to collar bone). Physician wanted the patient to have a CT scan of lungs and heart but he was admitted to the hospital prior to having the scan done. The patient experienced severe pneumonia and his oxygen and blood pressure levels dropped. The patient did not received treatment for the aforementioned adverse events. At the time of this report, the patient was still in the intensive care unit (ICU) at the hospital and had not recovered from pneumonia. The outcome of the aforementioned adverse events was unknown.  The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the aforementioned adverse events was not provided.  Upon internal review, pneumonia and nephrolithiasis were determined to be medically significant events. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S033516; expirationdate: 29-JUN-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: M
Vaccine: PPV
Symptoms: Intensive care, Lung opacity, Oxygen saturation decreased, Pain in extremity, Pneumonia
Clinical narrative: Severe pneumonia/ Was very tired/ Feeling out of breath/ consumer's oxygen dropped/ is on a ventilator/ physician saw ground glass in bottom portion of lungs; consumer may have kidney stones; back pain; arm pain; blood pressure levels dropped; This spontaneous information has been received from the patient's daughter, concerning a 77-years-old male patient. The patient's pertinent medical history included diabetes, high blood pressure and an unspecified thyroid issue. The patient had no previous drug reactions or allergies. The patient's concomitant medications included famotidine, amlodipine, glimepiride, valsartan, torsemide, levothyroxine sodium, dulaglutide (TRULICITY), vitamins (unspecified), metformin, hydralazine hydrochloride, omega-3 marine triglycerides and ezetimibe (ZETIA).  On 25-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) route of administration reported as injection in arm, lot number S033516 with expiration date 29-JUN-2021, indication reported as elderly with diabetes (strength, dose and frequency were not reported).  On an unknown date in early October 2020, the patient began to feel out of breath and was very tired. The patient also reported that he experienced back pain and arm pain. On an unknown date in October 2020, the patient went to the physician's office for a computerized tomography (CT) scan of his pelvic area, and the physician thought the patient may have kidney stones (nephrolithiasis). The physician was also able to see that the consumer's bottom portion of lungs on the CT scan was ground glass (also reported as multiple pneumonias, completely white up to collar bone). Physician wanted the patient to have a CT scan of lungs and heart but he was admitted to the hospital prior to having the scan done. The patient experienced severe pneumonia and his oxygen and blood pressure levels dropped. The patient did not received treatment for the aforementioned adverse events. At the time of this report, the patient was still in the intensive care unit (ICU) at the hospital and had not recovered from pneumonia. The outcome of the aforementioned adverse events was unknown.  The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the aforementioned adverse events was not provided.  Upon internal review, pneumonia and nephrolithiasis were determined to be medically significant events. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S033516; expirationdate: 29-JUN-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: HPV9, UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 12 month old female patient was inadvertently administered GARDASIL 9 instead ofVAQTA; 12 month old female patient was inadvertently administered GARDASIL 9 instead ofVAQTA; the patient has not had any residual side effects from receiving the GARDASIL 9; This spontaneous report was received from a registered nurse concerning a 12-month-old female patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 12-NOV-2020, the patient was inadvertently administered vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), prefilled syringe,  lot # S031287 expiration date not reported, but upon internal validation established as 08-APR-2022(dose, and route of administration, were not reported instead of hepatitis a vaccine, inactivated(VAQTA) (dose, route of administration, lot number and expiration date were not reported). prophylaxis. The nurse stated that she was not sure how this error occurred. The nurse mentioned currently, the patient had not had any residual side effects from receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in error. No additional adverse events. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: S031287; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Headache, Nausea
Clinical narrative: Feeling awful; Headache; Nausea; Very tired; Cold arm; Painful arm; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2020, the patient received the 1st dose of Shingrix. On 15th November 2020, 1 days after receiving Shingrix, the patient experienced feels awful, headache, nausea, tiredness, cold extremities and pain in arm. On an unknown date, the outcome of the feels awful, headache, nausea, tiredness, cold extremities and pain in arm were unknown.   It was unknown if the reporter considered the feels awful, headache, nausea, tiredness, cold extremities and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and woke up feeling awful. The patient had headache nausea, very tired, cold and painful arm.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Feeling awful; Headache; Nausea; Very tired; Cold arm; Painful arm; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2020, the patient received the 1st dose of Shingrix. On 15th November 2020, 1 days after receiving Shingrix, the patient experienced feels awful, headache, nausea, tiredness, cold extremities and pain in arm. On an unknown date, the outcome of the feels awful, headache, nausea, tiredness, cold extremities and pain in arm were unknown.   It was unknown if the reporter considered the feels awful, headache, nausea, tiredness, cold extremities and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and woke up feeling awful. The patient had headache nausea, very tired, cold and painful arm.
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased, Nausea, Pyrexia
Clinical narrative: fever of 101; NAUSEA; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and nausea. On an unknown date, the outcome of the fever and nausea were unknown.   It was unknown if the reporter considered the fever and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and experienced a fever and nausea.  The reporter asked was that a normal side effect or reaction to the second injection of Shingrix.
Sex: U
Vaccine: MEN
Symptoms: Death, Meningitis bacterial, Vaccination failure
Clinical narrative: four children including my son went in with this illness/DID NOT PROTECT HIM FROM BACTERIAL MENINGITIS; four children including my son went in with this illness/Suspected vaccination failure; This case was reported by a consumer via interactive digital media and described the occurrence of bacterial meningitis in a child patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced bacterial meningitis (serious criteria death and GSK medically significant) and vaccination failure (serious criteria GSK medically significant). On an unknown date, the outcome of the bacterial meningitis was fatal and the outcome of the vaccination failure was unknown. The reported cause of death was bacterial meningitis.   The reporter considered the bacterial meningitis and vaccination failure to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. The patient was given meningitis B vaccine and it did not protect from bacterial meningitis. The reporter reported children went in with this illness. The patient did not survive. This case was considered as suspected vaccination failure, since the details regarding dose number, time to onset and laboratory confirmation were not provided. This case is linked to the case US2020AMR232425, US2020AMR232426 and US2020AMR232267.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR232267:same reporter US-GLAXOSMITHKLINE-US2020AMR232425:same reporter US-GLAXOSMITHKLINE-US2020AMR232426:same reporter; Reported Cause(s) of Death: Bacterial meningitis
Sex: U
Vaccine: MEN
Symptoms: Death, Meningitis bacterial, Vaccination failure
Clinical narrative: four children including my son went in with this illness; Suspected vaccination failure; This case was reported by a consumer via interactive digital media and described the occurrence of bacterial meningitis in a child patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced bacterial meningitis (serious criteria death and GSK medically significant) and vaccination failure (serious criteria GSK medically significant). On an unknown date, the outcome of the bacterial meningitis was fatal and the outcome of the vaccination failure was unknown. The reported cause of death was bacterial meningitis.   The reporter considered the bacterial meningitis and vaccination failure to be related to Meningococcal B vaccine.  Additional details were provided as follows: Age at vaccination was not reported. It was reported that vaccine meningitis B, did not protect from bacterial meningitis. The patient went in with this illness and did not survive. This case was considered as vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR232424:same reporter US-GLAXOSMITHKLINE-US2020AMR232426:same reporter US-GLAXOSMITHKLINE-US2020AMR232267:same reporter; Reported Cause(s) of Death: Meningitis bacterial
Sex: U
Vaccine: MEN
Symptoms: Death, Meningitis bacterial, Vaccination failure
Clinical narrative: four children including my son went in with this illness; four children including my son went in with this illness/Suspected vaccination failure; This case was reported by a consumer via interactive digital media and described the occurrence of bacterial meningitis in a child patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced bacterial meningitis (serious criteria death and GSK medically significant) and vaccination failure (serious criteria GSK medically significant). On an unknown date, the outcome of the bacterial meningitis was fatal and the outcome of the vaccination failure was unknown. The reported cause of death was bacterial meningitis.   The reporter considered the bacterial meningitis and vaccination failure to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. The patient was given meningitis B vaccine and it did not protect from bacterial meningitis. The reporter reported children went in with this illness. The patient did not survive. This case was considered as suspected vaccination failure, since the details regarding dose number, time to onset and laboratory confirmation were not provided. This case is linked to the case US2020AMR232425, US2020AMR232424 and US2020AMR232267.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR232425:same reporter US-GLAXOSMITHKLINE-US2020AMR232424:same reporter US-GLAXOSMITHKLINE-US2020AMR232267:same reporter; Reported Cause(s) of Death: Meningitis bacterial