chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Diarrhoea, Headache, Musculoskeletal pain, Neuralgia
Clinical narrative: Had the first shot August 2019 without ill effects, this was the follow-up vaccination. I started diarrhea the following evening through the night and most of the day. Next day diarrhea got a little less violent, but Headache and pain in lower back, buttock into the upper legs started. This was not like normal back pain but more like nerves hurting all over the lower body. Had to take Tylenol 500 mg every 4 hours and tried Gabapentin 300mg  at night from Saturday to Sunday and Sunday to Monday. Diarrhea got bad again on Saturday. I finally got better yesterday morning (3/10/2020) and did not require pain medication any longer.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Had the first shot August 2019 without ill effects, this was the follow-up vaccination. I started diarrhea the following evening through the night and most of the day. Next day diarrhea got a little less violent, but Headache and pain in lower back, buttock into the upper legs started. This was not like normal back pain but more like nerves hurting all over the lower body. Had to take Tylenol 500 mg every 4 hours and tried Gabapentin 300mg  at night from Saturday to Sunday and Sunday to Monday. Diarrhea got bad again on Saturday. I finally got better yesterday morning (3/10/2020) and did not require pain medication any longer.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Patient reported fever of 100.3F upon waking up the next day. Took Tylenol OTC for fever. She also reported fatigue, chills, all over body ache the day after the vaccination; Symptoms resolved after 23 hours; These symptoms did not occur after her first vaccine of the series.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Rash vesicular
Clinical narrative: Blistering rash upper right shoulder (no itching, burning, pain); fatigue
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Right back arm that is warm to touch, 4-5 inches in diameter with redness.  inner area of redness has a hard area that is about 2 inches in diameter.  Encourage to alternate cool and warm compresses to area. ENC patient to mark area with sharpie to monitor redness/swelling. F/U with PCP as needed.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Decreased appetite, Hypersomnia, Impaired work ability, Limb discomfort
Clinical narrative: Client called  3/4/20 to report symptoms after receiving Tdap vaccine.  Client states her arm was sore and "felt like dead weight" all day.  She says it did not get red or swollen.  She states she had chills and slept for several hours over the next 2 days, and that she had called into work sick.  Says she took her temperature, but never ran a fever. She reports loss of appetite during this time.  States she did not take medication or do any type of intervention for the symptoms.  Client states she has never had any type of reaction to any vaccine in the past.  States she has not notified her PCP.  States her arm is better today and getting better each hour.  Advised client to notify PCP of events.  Advised her to get further management recommendations from her PCP if arm does not get better or gets worse.  Advised her to keep health department apprised of any additional interventions or if condition does not get better or worsens.  Alert placed in client''s chart. Client called back on 3/11/20 advising her arm continued to be painful until 3/10/20, but is not painful today (3/11/20).  Client did not advise of any additional comfort measures or medical treatments received since vaccination.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Client called  3/4/20 to report symptoms after receiving Tdap vaccine.  Client states her arm was sore and "felt like dead weight" all day.  She says it did not get red or swollen.  She states she had chills and slept for several hours over the next 2 days, and that she had called into work sick.  Says she took her temperature, but never ran a fever. She reports loss of appetite during this time.  States she did not take medication or do any type of intervention for the symptoms.  Client states she has never had any type of reaction to any vaccine in the past.  States she has not notified her PCP.  States her arm is better today and getting better each hour.  Advised client to notify PCP of events.  Advised her to get further management recommendations from her PCP if arm does not get better or gets worse.  Advised her to keep health department apprised of any additional interventions or if condition does not get better or worsens.  Alert placed in client''s chart. Client called back on 3/11/20 advising her arm continued to be painful until 3/10/20, but is not painful today (3/11/20).  Client did not advise of any additional comfort measures or medical treatments received since vaccination.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of Hep A was given too soon.  Dose given on 03/04/2020 and should not have been given until 05/12/2020.  Error found on 03/11/2020. Medical director informed and client's guardian was informed. Client will get second dose after 05/12/2020 per client's guardian.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Customer said that her arm went numb several minutes after she had the vaccine.  She said that it lasted for 2 to 3 days.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Faint 1 or 2 minutes after vaccine was administered
Age: 46.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Pain, Pain in extremity, Skin warm, Urticaria
Clinical narrative: Patient was seen in clinic this morning for Tdap and Pneumovax vaccination. She called just now and stated that her upper arm has a large welt on it the size of a softball. It is painful even when she doesn't move her arm and extremely painful when she moves it. States she is barely able to lift her arm without throbbing pain. Slightly warm feeling to her. No redness, no feverish feeling although she has not taken her temperature. States she has had adverse reaction in the past but never this severe.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Pruritus
Clinical narrative: Client and foster father returned to office approximately a half hour after immunization administration reporting that the client was scratching her chest. CLient's upper chest appeared red from scratches and witnessed client trying to scratch her chest. Immunization sites examined with RN and skin around injection sites where varicella and MMR were given appear bright red. Client appeared to be in no acute distress, no crying noted, and no dyspnea noted. Instructed client's foster father to have child examined by a healthcare provider as soon as possible. Client's foster father verbalized understanding and took client to nearby urgent care where she received treatment.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Pain, Swelling
Clinical narrative: Patient had immediate excruciating pain.  Tried ice and ibuprofen.  After 3 hours went to ER where they had to give her narcotics to help alleviate the pain.  Minimal swelling and redness.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site urticaria, Pyrexia
Clinical narrative: included 104 degree fever the next day; hives around the injection site; headache for 2-3 days
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Headache, Hyperaesthesia
Clinical narrative: Headache and light headedness Weakness Skin sensitivity Took 800mg Ibuprofen, went to bed, and in one hour felt fine.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Condition aggravated, Magnetic resonance imaging, Parotitis, Salivary gland calculus
Clinical narrative: Calcification of the parotid glands and develops chronic parotitis.
Age: 32.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Nausea, lightheadedness, and fatigue noticed the morning after vaccinations.  Needed to stay in bed all day due to lightheadedness.  Nausea improved with zofran.  Symptoms gradually improving.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: SAME EVENING AS SHOT (GIVEN IN MORNING HOURS)-REDNESS AND SWELLING OF ARM. PT ALSO REPORTS FEVER AND CHILLS, REPORTED TO PHARMACY ON 3/11 AT APPROX. 5:30 PM . AT THIS TIME PATIENT REPORTS SWELLING AND REDNESS HAS EXTENDED DOWN ARM JUST PAST ELBOW. PT ADVISED TO SEE PHYSICIAN. PT CONTACTED MD VIA PHONE AND WILL BE SEEN IN THE MORNING
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site induration, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient's daughter called clinic to report adverse reaction. Call transferred to nursing supervisor: LVN. Per nurse daughter stated patient complained of having : fever, chills, body aches, swollen area of injection site and it being tender and hard. Nurse supervisors: LVN and RN advised patient to go to the hospital to be examined as soon as possible.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient's daughter called clinic to report adverse reaction. Call transferred to nursing supervisor: LVN. Per nurse daughter stated patient complained of having : fever, chills, body aches, swollen area of injection site and it being tender and hard. Nurse supervisors: LVN and RN advised patient to go to the hospital to be examined as soon as possible.
Age: 61.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Asthenia, Impaired driving ability, Injection site bruising, Injection site inflammation, Injection site pain
Clinical narrative: Onset of symptoms was 30 hours post-injection including pain and swelling at the injection site and within a few hours the pain expanded throughout the deltoid muscle.  In the days that followed, the pain extended from left shoulder through the deltoid and outside of forearm into the left most fingers of left hand.  Two weeks following loss of sensation occurred in left most finger of left hand and half of the adjacent finger and entire left arm weakness was remarkable.  Two months after injection, bruising and swelling was remarkable at the injection site.  At three months, bruising diminished.  At four months, swelling diminished.  Ongoing symptoms include loss of sensation and strength in left most fingers of left hand. and strength is entire left arm has shown no improvement as of the date of this report.
Age: 61.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Injection site swelling, Loss of personal independence in daily activities, Muscular weakness, Pain in extremity, Sensory loss
Clinical narrative: Onset of symptoms was 30 hours post-injection including pain and swelling at the injection site and within a few hours the pain expanded throughout the deltoid muscle.  In the days that followed, the pain extended from left shoulder through the deltoid and outside of forearm into the left most fingers of left hand.  Two weeks following loss of sensation occurred in left most finger of left hand and half of the adjacent finger and entire left arm weakness was remarkable.  Two months after injection, bruising and swelling was remarkable at the injection site.  At three months, bruising diminished.  At four months, swelling diminished.  Ongoing symptoms include loss of sensation and strength in left most fingers of left hand. and strength is entire left arm has shown no improvement as of the date of this report.
Age: 61.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Sleep disorder
Clinical narrative: Onset of symptoms was 30 hours post-injection including pain and swelling at the injection site and within a few hours the pain expanded throughout the deltoid muscle.  In the days that followed, the pain extended from left shoulder through the deltoid and outside of forearm into the left most fingers of left hand.  Two weeks following loss of sensation occurred in left most finger of left hand and half of the adjacent finger and entire left arm weakness was remarkable.  Two months after injection, bruising and swelling was remarkable at the injection site.  At three months, bruising diminished.  At four months, swelling diminished.  Ongoing symptoms include loss of sensation and strength in left most fingers of left hand. and strength is entire left arm has shown no improvement as of the date of this report.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Crying, Injected limb mobility decreased, Injection site joint pain, Injection site pain
Clinical narrative: The shot was given in my left arm below my shoulder on 11/15/19. The shot was a little painful. I went home and within a few hours my arm and shoulder area was extremely sore and painful. At one point, I was crying because of the sharp pain and almost had frozen shoulder because I was not able to move it for a bit. This sharp pain last for two weeks, receding slightly. I called the same doctor after these two weeks of pain, and they did nothing. They asked me to give it more time. I called a month later, and they prescribed me Gabapention, which did not help. The sharp pain got a little better, but then it started to turn into deep shoulder pains in my shoulder joint. Four months later on 2/20/2020, I went back to the doctor because the pain was not getting any better. Then, they referred me to the orthopedic doctor.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion measurement, Pain in extremity, Shoulder injury related to vaccine administration, X-ray
Clinical narrative: The shot was given in my left arm below my shoulder on 11/15/19. The shot was a little painful. I went home and within a few hours my arm and shoulder area was extremely sore and painful. At one point, I was crying because of the sharp pain and almost had frozen shoulder because I was not able to move it for a bit. This sharp pain last for two weeks, receding slightly. I called the same doctor after these two weeks of pain, and they did nothing. They asked me to give it more time. I called a month later, and they prescribed me Gabapention, which did not help. The sharp pain got a little better, but then it started to turn into deep shoulder pains in my shoulder joint. Four months later on 2/20/2020, I went back to the doctor because the pain was not getting any better. Then, they referred me to the orthopedic doctor.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Two ladies (a grandmother and her granddaughter) came to the drop-off window and stated they wanted a flu shot.  The technician gave both of them paperwork to fill out.  The first person to turn in her paperwork was the granddaughter.  I prepared her IMZ and was going to go and administer it, but the grandmother turned her paperwork in as well.  I thought I would go out at the same time and give them each an IMZ while I was out there.  I prepared one Fluzone Quad and one Fluzone HD.  When I went to give the granddaughter her IMZ, I used the handheld to verify her name and DOB and correctly verified the NDC on the syringe that I was going to use for her.  Instead of putting it on the table, I put her IMZ in the tote where the Fluzone HD for the grandmother was.  When I picked up the syringe and administered it, I noticed that I had injected the Fluzone HD instead of the Fluzone Quad.  Otherwise no adverse event.  Incorrect vaccine administered.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Clavicle fracture, Cognitive disorder, Dysarthria, Fall
Clinical narrative: Within 5 hours from the time that the vaccine was administered, patient was taken to the ER and was hospitalized as a result of the slurred speech, marked loss of cognitive abilities including any memory of the hours after this shot and fall with a broken clavicle. December 17, 2019, at 3:34 pm, patient received her first dose and required ER and hospital observation on December 18, 2019, due to seizure with marked loss of cognitive abilities including any memory of the hours after this shot but patient and family were told that this was not due to the Shingix vaccination.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging
Clinical narrative: Within 5 hours from the time that the vaccine was administered, patient was taken to the ER and was hospitalized as a result of the slurred speech, marked loss of cognitive abilities including any memory of the hours after this shot and fall with a broken clavicle. December 17, 2019, at 3:34 pm, patient received her first dose and required ER and hospital observation on December 18, 2019, due to seizure with marked loss of cognitive abilities including any memory of the hours after this shot but patient and family were told that this was not due to the Shingix vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Stress
Clinical narrative: Patient received 2nd Shingrix dose today.  Within 1 minute of administration, patient became dizzy and sat on the chair and eventually sat on the floor and laid on the floor of the immunization room.  She was conscious the whole time and had a conversation with me.  She refused 911.  She felt dizzy.  So I stayed in the room to keep her company and to make sure she was doing ok.  As were were talking, she stated that she didn't eat much during lunch and that was at 11AM and had a lot of stress today.  We are not entirely sure what caused it, it could have been the vaccine or the stress and not eating since 11AM.  She came outside of the IMZ room to try to check her blood pressure but was dizzy again so she came back to IMZ room to rest.  Then she ate some food and had juice and felt better.  By then her husband arrived.  She checked her blood pressure before leaving at the machine and it was ok.  She will follow up with PCP.  She hasn't gone yet but stated she will see PCP.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Erythema, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Adverse Reaction included fever lasting at least 2 days, swollen arm, redness, itchy. Patient has an appointment with primary to get it checked out
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal disorder, Pyrexia, Swelling, Vomiting
Clinical narrative: AT 5 PM AFTER SHOT COULDN'T BEND ARM.  99 DEGREE FEVER.  THREW UP SEVERAL TIMES.  SWELLING ALL OVER BODY.  COULDN'T USE ARM FOR 4 DAYS BECAUSE IT WAS COMPLETELY LOCKED UP.  GOT STEROID SHOT AND ZPAK AS A  RESULT.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Golf Ball sized swelling that is red and warm to touch.  Started about 24 hours post immunization.  Slightly painful to touch but does not limit movement / motion of the extremity.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Painful red swelling at injection site 3? in diameter, flu like symptoms next day with achy joints, swollen glands, tiredness during the with low-grade fever of 99.5 F by 5:00 pm
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lymphadenopathy, Pyrexia
Clinical narrative: Painful red swelling at injection site 3? in diameter, flu like symptoms next day with achy joints, swollen glands, tiredness during the with low-grade fever of 99.5 F by 5:00 pm
Age: 16.0
Sex: M
Vaccine: IPV, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling @ injection site left shoulder on 3/7/20. Sore & red dropped into elbow area. Now redness & swelling gone 5 days after MCV4O #2 vaccine. Swelling minimal around elbow. No pain
Age: 0.17
Sex: M
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: The vaccine given was the wrong vaccine. Patient was to receive PCV13 and was given HPV.; The vaccine given was the wrong vaccine. Patient was to receive PCV13 and was given HPV.; Indicate at which point in ttie process the medication error occurred: preparation for administration; This report was identified on request by the Company from the FDA under the Freedom of Information Act (VAERS ID 812969) on 08-JAN-2020.  This spontaneous report was received from a health care professional and refers to a 2 month old male patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 06-MAY-2019 at 15:00, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1, intramuscularly in the right leg, for prophylaxis, lot # 1586752 expiration date not reported, but upon internal validation established as 16-FEB-2021.  It was reported that the patient was given the wrong vaccine; the patient was to receive pneumococcal 13v conj vaccine (CRM197), but was given hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Follow-up information was received from a health care professional (unspecified) on 04-MAR-2020.  Concomitant vaccines administered to the patient included hepatitis b vaccine (recombinant) (RECOMBIVAX HB) and diphtheria toxoid (+) hib conj vaccine (tet toxoid) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (mrc-5) (+) tetanus toxoid (PENTACEL).  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered was purchased with public funds and other vaccine administration details were updated. Anatomical location in which the vaccine was administered was the right thigh.  The reporter indicated that the point in the process the medication error occurred (wrong vaccine administered) was during the preparation of the administration, however, it was also reported that the vaccine was used according to the instruction leaflet. At the moment of the wrong administration, the patient's parent were called to inform them and a report was raised. The operator of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was a health care professional. No drug treatment was prescribed for the event, no product quality complaint was involved, and the vaccine was not available for return.  The reporter considered wrong vaccine administered to be attributable to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) due to a vaccine-vaccine/device malfunction (unspecified). On the other hand, wrong vaccine administered was determined to be a medically significant event by the reporter. In addition, patient's demographic details were updated.
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Confusional state, Dizziness, Fall, Feeling abnormal, Head injury
Clinical narrative: had a syncopal episode/ He slumped; he was unconscious for less than a minute; Hit his head on the floor; Fell over; he was dazed; he was confused; unable to say anything; had a vomiting episode; significant neck pain; his head hurt; was medicated with Zofran for the nausea; This case was reported by a physician via call center representative and described the occurrence of syncope in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA171A, expiry date 31st July 2020) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number A29KM, expiry date 3rd December 2021) for prophylaxis.   On 26th February 2020, the patient received Menveo (intramuscular) and Boostrix (intramuscular). On 26th February 2020, less than a day after receiving Menveo and Boostrix, the patient experienced syncope (serious criteria GSK medically significant), unconscious (serious criteria GSK medically significant), head injury, fall, feeling dazed, confusion, aphasia, vomiting, neck pain, headache and nausea. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the syncope, head injury, fall, feeling dazed, confusion, aphasia, vomiting, neck pain and nausea were resolved with sequelae and the outcome of the unconscious and headache were recovered/resolved.   It was unknown if the reporter considered the syncope, unconscious, head injury, fall, feeling dazed, confusion, aphasia, vomiting, neck pain, headache and nausea to be related to Menveo and Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Boostrix and Menveo at the same time and had a syncopal episode , slumped over and fell over and hit his head on the floor. The reporter thinks that he was unconscious for less than a minute, but when he came to, he was dazed and confused, and unable to say anything. The reporter states that it took several minutes for him to return to baseline and was sent to the emergency room and had a vomiting episode.  The patient also complained of significant neck pain and also that his head hurt.  The patient was medicated with Zofran for the nausea and was released and was back to total baseline the next day. The follow up consent was granted. This case has been linked with case US2020041052, reported by same reporter.
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Headache, Neck pain, Pallor, Unresponsive to stimuli, Vomiting
Clinical narrative: had a syncopal episode/ He slumped; he was unconscious for less than a minute; Hit his head on the floor; Fell over; he was dazed; he was confused; unable to say anything; had a vomiting episode; significant neck pain; his head hurt; was medicated with Zofran for the nausea; This case was reported by a physician via call center representative and described the occurrence of syncope in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA171A, expiry date 31st July 2020) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number A29KM, expiry date 3rd December 2021) for prophylaxis.   On 26th February 2020, the patient received Menveo (intramuscular) and Boostrix (intramuscular). On 26th February 2020, less than a day after receiving Menveo and Boostrix, the patient experienced syncope (serious criteria GSK medically significant), unconscious (serious criteria GSK medically significant), head injury, fall, feeling dazed, confusion, aphasia, vomiting, neck pain, headache and nausea. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the syncope, head injury, fall, feeling dazed, confusion, aphasia, vomiting, neck pain and nausea were resolved with sequelae and the outcome of the unconscious and headache were recovered/resolved.   It was unknown if the reporter considered the syncope, unconscious, head injury, fall, feeling dazed, confusion, aphasia, vomiting, neck pain, headache and nausea to be related to Menveo and Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Boostrix and Menveo at the same time and had a syncopal episode , slumped over and fell over and hit his head on the floor. The reporter thinks that he was unconscious for less than a minute, but when he came to, he was dazed and confused, and unable to say anything. The reporter states that it took several minutes for him to return to baseline and was sent to the emergency room and had a vomiting episode.  The patient also complained of significant neck pain and also that his head hurt.  The patient was medicated with Zofran for the nausea and was released and was back to total baseline the next day. The follow up consent was granted. This case has been linked with case US2020041052, reported by same reporter.
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Aphasia, Confusional state, Fall, Feeling abnormal, Head injury
Clinical narrative: had a syncopal episode/ He slumped; he was unconscious for less than a minute; Hit his head on the floor; Fell over; he was dazed; he was confused; unable to say anything; had a vomiting episode; significant neck pain; his head hurt; was medicated with Zofran for the nausea; This case was reported by a physician via call center representative and described the occurrence of syncope in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA171A, expiry date 31st July 2020) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number A29KM, expiry date 3rd December 2021) for prophylaxis.   On 26th February 2020, the patient received Menveo (intramuscular) and Boostrix (intramuscular). On 26th February 2020, less than a day after receiving Menveo and Boostrix, the patient experienced syncope (serious criteria GSK medically significant), unconscious (serious criteria GSK medically significant), head injury, fall, feeling dazed, confusion, aphasia, vomiting, neck pain, headache and nausea. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the syncope, head injury, fall, feeling dazed, confusion, aphasia, vomiting, neck pain and nausea were resolved with sequelae and the outcome of the unconscious and headache were recovered/resolved.   It was unknown if the reporter considered the syncope, unconscious, head injury, fall, feeling dazed, confusion, aphasia, vomiting, neck pain, headache and nausea to be related to Menveo and Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Boostrix and Menveo at the same time and had a syncopal episode , slumped over and fell over and hit his head on the floor. The reporter thinks that he was unconscious for less than a minute, but when he came to, he was dazed and confused, and unable to say anything. The reporter states that it took several minutes for him to return to baseline and was sent to the emergency room and had a vomiting episode.  The patient also complained of significant neck pain and also that his head hurt.  The patient was medicated with Zofran for the nausea and was released and was back to total baseline the next day. The follow up consent was granted. This case has been linked with case US2020041052, reported by same reporter.
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Headache, Loss of consciousness, Nausea, Neck pain, Posture abnormal
Clinical narrative: had a syncopal episode/ He slumped; he was unconscious for less than a minute; Hit his head on the floor; Fell over; he was dazed; he was confused; unable to say anything; had a vomiting episode; significant neck pain; his head hurt; was medicated with Zofran for the nausea; This case was reported by a physician via call center representative and described the occurrence of syncope in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA171A, expiry date 31st July 2020) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number A29KM, expiry date 3rd December 2021) for prophylaxis.   On 26th February 2020, the patient received Menveo (intramuscular) and Boostrix (intramuscular). On 26th February 2020, less than a day after receiving Menveo and Boostrix, the patient experienced syncope (serious criteria GSK medically significant), unconscious (serious criteria GSK medically significant), head injury, fall, feeling dazed, confusion, aphasia, vomiting, neck pain, headache and nausea. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the syncope, head injury, fall, feeling dazed, confusion, aphasia, vomiting, neck pain and nausea were resolved with sequelae and the outcome of the unconscious and headache were recovered/resolved.   It was unknown if the reporter considered the syncope, unconscious, head injury, fall, feeling dazed, confusion, aphasia, vomiting, neck pain, headache and nausea to be related to Menveo and Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Boostrix and Menveo at the same time and had a syncopal episode , slumped over and fell over and hit his head on the floor. The reporter thinks that he was unconscious for less than a minute, but when he came to, he was dazed and confused, and unable to say anything. The reporter states that it took several minutes for him to return to baseline and was sent to the emergency room and had a vomiting episode.  The patient also complained of significant neck pain and also that his head hurt.  The patient was medicated with Zofran for the nausea and was released and was back to total baseline the next day. The follow up consent was granted. This case has been linked with case US2020041052, reported by same reporter.
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Syncope, Vomiting
Clinical narrative: had a syncopal episode/ He slumped; he was unconscious for less than a minute; Hit his head on the floor; Fell over; he was dazed; he was confused; unable to say anything; had a vomiting episode; significant neck pain; his head hurt; was medicated with Zofran for the nausea; This case was reported by a physician via call center representative and described the occurrence of syncope in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA171A, expiry date 31st July 2020) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number A29KM, expiry date 3rd December 2021) for prophylaxis.   On 26th February 2020, the patient received Menveo (intramuscular) and Boostrix (intramuscular). On 26th February 2020, less than a day after receiving Menveo and Boostrix, the patient experienced syncope (serious criteria GSK medically significant), unconscious (serious criteria GSK medically significant), head injury, fall, feeling dazed, confusion, aphasia, vomiting, neck pain, headache and nausea. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the syncope, head injury, fall, feeling dazed, confusion, aphasia, vomiting, neck pain and nausea were resolved with sequelae and the outcome of the unconscious and headache were recovered/resolved.   It was unknown if the reporter considered the syncope, unconscious, head injury, fall, feeling dazed, confusion, aphasia, vomiting, neck pain, headache and nausea to be related to Menveo and Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Boostrix and Menveo at the same time and had a syncopal episode , slumped over and fell over and hit his head on the floor. The reporter thinks that he was unconscious for less than a minute, but when he came to, he was dazed and confused, and unable to say anything. The reporter states that it took several minutes for him to return to baseline and was sent to the emergency room and had a vomiting episode.  The patient also complained of significant neck pain and also that his head hurt.  The patient was medicated with Zofran for the nausea and was released and was back to total baseline the next day. The follow up consent was granted. This case has been linked with case US2020041052, reported by same reporter.
Age: 39.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Discomfort, Injection site pain, Pain, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Patient reports pain following influenza shot that was administered in right deltoid on Dec 7, 2019.  She reports pain with movement, limited range of motion, muscle soreness.  Treated with Medrol dose pack and now physical therapy. There are concerns of a rotator cuff injury from injection site.  No history of trauma or soreness prior to injection.
Age: 39.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Myalgia, Pain
Clinical narrative: Patient reports pain following influenza shot that was administered in right deltoid on Dec 7, 2019.  She reports pain with movement, limited range of motion, muscle soreness.  Treated with Medrol dose pack and now physical therapy. There are concerns of a rotator cuff injury from injection site.  No history of trauma or soreness prior to injection.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Insomnia, Pain in extremity, Pyrexia
Clinical narrative: Fever >102F, limb pain, sleeplessness
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Patient right arm is swollen, red, warm, and tender for 24 hours.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Hypoaesthesia, Injected limb mobility decreased, Insomnia, Pain
Clinical narrative: Pain in left arm about 20-30 minutes after injection. Excruciating pain during the evening that night. I am currently a week out from receiving that vaccine and still have excruciating pain when moving my arm and a decrease range in motion with the left arm. The pain has caused lack of sleep. I woke up around 2:00 AM on 3/12 and my left arm was numb. I mentioned these issues to my doctor, who suggested giving it more time and if it?s not improved in a week, then she recommended a referral to a sports medicine specialist. I am currently 32 weeks pregnant with an estimated due date of 5/4/2020.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm about 20-30 minutes after injection. Excruciating pain during the evening that night. I am currently a week out from receiving that vaccine and still have excruciating pain when moving my arm and a decrease range in motion with the left arm. The pain has caused lack of sleep. I woke up around 2:00 AM on 3/12 and my left arm was numb. I mentioned these issues to my doctor, who suggested giving it more time and if it?s not improved in a week, then she recommended a referral to a sports medicine specialist. I am currently 32 weeks pregnant with an estimated due date of 5/4/2020.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Muscle fatigue, Pain
Clinical narrative: Shivering, muscle fatigue and  low level pain
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse effects; She reported that an administered dose of PNEUMOVAX underwent a temperature excursion on 02/13/2020 prior to being administered to 1 patient on 02/17/2020; Information has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions, and concomitant medications were not reported.  On 13-FEB-2020, a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection for prophylaxis (lot number: S006778 and expiration date: 28-NOV-2020) (route of administration, strength and anatomical location were not reported) underwent a temperature excursion and subsequently, on 17-FEB-2020. the improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered to 1 patient (incorrect product storage).   The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored at a temperature range of 1.9 degrees Celsius (°C) for the time frame of 3 hours and 51 minutes. There was no previous temperature excursion and the call was because of a data logger.   No known adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; This initial spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 04-MAR-2020. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On or about 19-JAN-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided), by a healthcare provider at the clinic, for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to vaccination, on an unspecified date, the patient was treated by a healthcare provider at the hospital for zoster related hearing loss. As a direct an proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient had a would continue suffer ongoing injuries, including but limited to mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the reporting time, the outcome of hearing loss was considered as not recovered. The reporters considered hearing loss to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review the event of hearing loss was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided.   In 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) .  On an unspecified date (reported as "subsequent to inoculation"), the pt was treated at a medical office by a healthcare for shingles and was hospitalized on an unknown date. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the pt suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for this injuries; significant medical and related expenses as a result of this injuries, including but no limited to medical losses and costs included care for hospitalizations, physical care, monitoring, treatment, medications and supplies; diminished of quality and capacity for the enjoyment of life, increase risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continued to suffer such losses, and damages in the future.   At the reporting time, the pt had not recovered from the event and the causality assessment was considered as related.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received on 04-MAR-2020 from a lawyer regarding a case in litigation. This case refers to a male patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On or about 08-AUG-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) by a pharmacist for the long-term prevention of shingles and zoster-related conditions. Subsequent to inoculation, pt was treated by a healthcare provider at the medical office of a doctor for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications and supplies: diminished capacity for the enjoyment of life; diminished capacity of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses and damages in the future. At the reporting time, the patient was not recovered from shingles and it was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long term prevention of shingles and zoster-related condition (the dosage regimen information was not reported). Subsequently, the patient was treated by a healthcare professional for Bell's palsy. As a direct and proximate result of vaccination with zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to mental and physical pain and suffering, medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including nut not limited to medical losses and cost include care for hospitalization, physician care, monitoring, treatment, medications, and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions, and other losses and damages, and would continue to suffer such losses and damages in the future.  At the time of the report, the patient's outcome was unknown.  Upon internal review, Bell's palsy was considered to be medically significant.
Sex: U
Vaccine: HPV9, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; improperly stored GARDASIL 9 was administered to a unspecified patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.    On 21-FEB-2020 the patient was vaccinated with improperly stored of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R020948, expiration date was reported as 04-APR-2021, but upon internal validation established as 04-MAY-2021; dose, frequency and route were not reported) for prophylaxis (product storage error). The administered dose of the vaccine experienced a temperature of 33.4 Fahrenheit (F). Time frame was 933 hours. No previous temperature excursion. The digital data logger was involved. No additional adverse effects were reported. 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: R020948; expirationdate: 04-MAY-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability