chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: DTAPIPV, FLU4, HEPA, PNC13
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was outside of the approved age range to receive the Quadracel vaccine. She did not have any adverse outcomes/signs/symptoms.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Injection was more painful than in previous years administered in posterior shoulder. After injection the arm was sore with increasing loss of ROM, strength and increasing pain. Pain, and decreased functional mobility continued to increase with time instead of resolve.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Tendon disorder, Tendon injury
Clinical narrative: Injection was more painful than in previous years administered in posterior shoulder. After injection the arm was sore with increasing loss of ROM, strength and increasing pain. Pain, and decreased functional mobility continued to increase with time instead of resolve.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: Erythema that hasn't resolved after approximately 3 days.  Patient took antihistamine without improvement. Patient also had 101 fever and some arm pain.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Pain in extremity, Skin reaction
Clinical narrative: patient arm was sore and then got red- went to his primary provider and was diagnosed with cellulitis and given antibiotics- pt is doing fine now per patient on 10/24/2020
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: CUSTOMER NOTICED ITCHY PALMS AND SOLES OF FEET A DAY AFTER RECIEVING VACCINE, CLAIMS IT IS SUBSIDING
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness, swelling from under deltoid to above elbow.  Referred patient to clinic
Age: 1.58
Sex: F
Vaccine: PNC13
Symptoms: Gait inability, Hypotonia, Posture abnormal, Somnolence, Vomiting
Clinical narrative: Sleepy Unable to hold self up, very limp Unable to walk (previously able) Only sit for majority of the day Puking bright yellow
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Eye swelling, Pruritus, Rash macular, Urticaria
Clinical narrative: Received phone call from school nurse and child had been in school and had swollen eyes, itching all over, blotches on hands and arms. Reaction started on 10/14/2020.Case was sent to Urgent Care for evaluation on 10/15/2020. On 10/21/2020 spoke with mother and was informed case received high dose steroid at Urgent Care  and hives were subsiding .
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Facial paralysis
Clinical narrative: Pt went to UC, diagnosis of Bell's Palsy
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test, Chills, Ear pruritus, Lip swelling, Nasal pruritus
Clinical narrative: Patient had shingles vaccination administered. The symptoms started around 30 hrs later with chills around 7pm.Also exp itching around nose,ears and lips are swollen. Seen by allergy doctor on 10/14/20 for itching but believes the shingles vaccination is causing the events.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Soreness., Redness, Swelling , Aching and Hotness
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; improperly stored vaccine of PROQUAD was administered; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 19-OCT-2020, the patient was vaccinated with improperly stored dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 ml (frequency reported as "once", lot # reported as T01691 with expiration date reported as 11-NOV-2021, anatomical location was not provided) for prophylaxis.  The temperature excursion was 30.1 Fahrenheit (F) for 40 hours and 40 minutes. There were no previous excursions reported. The digital data logger was not involved. No adverse effects were reported.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Inappropriate schedule of product administration, Injection site pain, Muscle swelling
Clinical narrative: Incomplete course of vaccination; Pain at site of injection; Redness at site of injection / Redness extended all the way to the elbow; Swelling of the bicep; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 27th November 2019, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, erythema and muscle swelling. On an unknown date, the patient experienced incomplete course of vaccination. On 29th November 2019, the outcome of the injection site pain, erythema and muscle swelling were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain, erythema and muscle swelling to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of shingrix after more than recommended time frame which led to incomplete course of vaccination. The patient received the 1st dose on 26th november 2019 and experienced erythema, injection site pain and muscle swelling which was recovered in 2-3 days. The reporter consented to follow up. No further information was available.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient had the flu once, and it was the year the patient took the shot; Initial information received on 15-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves patient of unknown demography (a sixth-grade teacher) who had the flu once, and it was the year the patient took the shot (influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu once, and it was the year the patient took the shot (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE. And it was reported that teacher's immune systems build up quickly.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the event influenza.  There will be no information on the batch number for tis case.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Cold sweat, Fall, Joint injury, Magnetic resonance imaging normal
Clinical narrative: knee pain; patient fell 4 times in 20 minutes; The patient was clammy; The patient was ashen; The patient injured both of his knees during the falls. one of his knees had cuts all over it due to the shattered glass; Initial information received on 19-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 58 years old male patient who fell 4 times in 20 minutes (fall), was clammy (cold sweat), ashen (pallor), had injured both of his knees during the falls. one of his knees had cuts all over it due to the shattered glass (joint injury) and knee pain (arthralgia), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included TAMSULOSIN HYDROCHLORIDE (FLOMAX) and no other vaccines were given to patient.  On 16-Oct-2020 a 08:50, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiration date not reported) via intramuscular route in the left arm for prophylactic vaccination.  On 17-Oct-2020, the patient who fell 4 times in 20 minutes (fall), clammy (cold sweat), ashen (pallor), had injured both of his knees during the falls/ one of his knees had cuts all over it due to the shattered glass (joint injury), 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date, the patient developed a non-serious knee pain (arthralgia) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  All these events were non serious. Health Care Professional was concerned that he may have a blood clot.  Relevant laboratory test results included:  On 17-Oct-2020: Blood pressure measurement - 50/44 [BP in the ambulance was 50/44]. On an unknown date: Magnetic resonance imaging - Negative; Scan: Negative  The patient was treated in the ER (emergency room) for 6 hours and then discharged.     At the time of reporting, the outcome was unknown for all the events.  There will be no information on the batch number for this case.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Pallor, Skin laceration, Whole body scan
Clinical narrative: knee pain; patient fell 4 times in 20 minutes; The patient was clammy; The patient was ashen; The patient injured both of his knees during the falls. one of his knees had cuts all over it due to the shattered glass; Initial information received on 19-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 58 years old male patient who fell 4 times in 20 minutes (fall), was clammy (cold sweat), ashen (pallor), had injured both of his knees during the falls. one of his knees had cuts all over it due to the shattered glass (joint injury) and knee pain (arthralgia), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included TAMSULOSIN HYDROCHLORIDE (FLOMAX) and no other vaccines were given to patient.  On 16-Oct-2020 a 08:50, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiration date not reported) via intramuscular route in the left arm for prophylactic vaccination.  On 17-Oct-2020, the patient who fell 4 times in 20 minutes (fall), clammy (cold sweat), ashen (pallor), had injured both of his knees during the falls/ one of his knees had cuts all over it due to the shattered glass (joint injury), 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date, the patient developed a non-serious knee pain (arthralgia) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  All these events were non serious. Health Care Professional was concerned that he may have a blood clot.  Relevant laboratory test results included:  On 17-Oct-2020: Blood pressure measurement - 50/44 [BP in the ambulance was 50/44]. On an unknown date: Magnetic resonance imaging - Negative; Scan: Negative  The patient was treated in the ER (emergency room) for 6 hours and then discharged.     At the time of reporting, the outcome was unknown for all the events.  There will be no information on the batch number for this case.
Age: 69.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria rash, itching of the skin
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Product administered at inappropriate site
Clinical narrative: Left shoulder bursitis due to injection administered high on shoulder
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Swelling
Clinical narrative: small red spot about size of quarter on Thursday PM,  Friday Morning - raised red ring larger than 50 cent piece.  Went back to pharmacy and they advised to take bendryl and if got larger contact physician. Drew circle around ring to monitor.   Took bendryl and tylenol before bed.   Saturday morning more red and outside of circle.  Went to clinic where I was given a shot of decadron 10 mg and shot of Clindamycin HCL 300mg.   Was given 10 mg of Predizone to take 3 times a day for 5 days.  Also given 150 mg of Clindamycin HCL 3 tablets a day for 5 days.    Doctor drew circle again to watch for more reaction.  Sunday afternoon it was beyond circle and again headache.   Took medicines as directed.   Monday Morning site is not as red and is starting to look better.  I have photos of each day if needed.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: for a few days after receiving immunization, site was very sore. no redness or swelling reported. pain faded but was still present. upon waking at 5am on 10/23/2020, injection site felt hot to the touch to to patient, but not to someone else (boyfriend) who tried to note a difference. Patient did a telehealth visit with an urgent care, who, upon looking at the site and hearing description of events, prescribed a z-pak. at the time of this form being completed, patient has taken 3 out of 5 days of this zpak and has 2 days remaining.  on day 1, seemed like site was getting better (no longer hot, pain decreased) but on evening of 24th, pain returned in a new and more painful way.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Agitation, Crying, Screaming, Sleep disorder
Clinical narrative: After waking up from a nap approximately one hour after vaccines patient had uncontrollable crying/agitation.  This lasted for three hours.  She was seen back in office and was very agitated.  I was able to give bottle and she napped with multiple episodes of waking up screaming.  When she woke up she was back to normal and has been her normal self since.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Shoulder injury related to vaccine administration, X-ray
Clinical narrative: Pt started showing signs of SIRVA 2 days after vaccine was administered. Vaccine was administered into the Right Deltoid. Pt is currently having ongoing treatment with Ortho and PT
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Shoulder injury related to vaccine administration, X-ray
Clinical narrative: Pt started having sign of SIRVA after vaccine was administered. Vaccine was administered in Left deltoid. Pt is having ongoing treatmetn with Ortho.
Age: 68.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Chills, Erythema, Hyperhidrosis, Injection site erythema, Injection site swelling
Clinical narrative: Patient came in Sunday around noon after she received her shot on Friday evening. Her arm was red and swollen from just under the vaccination site to her elbow. She stated that about 2 hours after receiving the Pneumovax shot, her right arm began to swell and turn red around the injection site and that she did have some fever/sweating/chills and the redness and swelling has since moved down her arm. She stated she had been taking  Advil about every 8 hours and had taken 1  Claritin.  She said it did seem slightly better on Sunday  than it was on Saturday. She is going to continue taking Advil and will take Benadryl too. Patient also received her flu shot in the left arm, no issues with the left arm.
Age: 68.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Patient came in Sunday around noon after she received her shot on Friday evening. Her arm was red and swollen from just under the vaccination site to her elbow. She stated that about 2 hours after receiving the Pneumovax shot, her right arm began to swell and turn red around the injection site and that she did have some fever/sweating/chills and the redness and swelling has since moved down her arm. She stated she had been taking  Advil about every 8 hours and had taken 1  Claritin.  She said it did seem slightly better on Sunday  than it was on Saturday. She is going to continue taking Advil and will take Benadryl too. Patient also received her flu shot in the left arm, no issues with the left arm.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Mobility decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: Pt called and left a message with the clinic messaging service. She reports red painful right arm. ?Unable to move arm much? and ?shooting sharp pain? down to her hand and up to her neck
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Feeling cold, Pain
Clinical narrative: I had the senior flu shot on Thursday and that night I had cold chills, fever and body aches. This lasted until Saturday.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Dermatitis atopic, Rash
Clinical narrative: Patient developed a rash from the vaccine. He went to an urgent care clinic who stated that it was atopic dermatitis. The rash is still present to this date despite over the counter treatment recommended by urgent care provider.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Disorientation, Dizziness, Fatigue, Headache
Clinical narrative: 10/12/20 arm a little sore and late afternoon one shooting pain down arm then gone.  I was very sick from midnight on. I woke up with a very bad headache and my jaw was extremely painful like everything had swelled. I was very dizzy and disoriented and had to hold onto cabinets getting to the bathroom to remove my MAD sleep appliance & put on my jaw aligner. Had chills all night, fever and headache.  I took Advil- one of the meds advised for side effects on the list given me and it reduced fever.  Later temp went to 99 and I took advil again. No sleep at all. Temp went down, but in the morning 8am-10am I still had chills, headache and temp started to go up to 100.7.  I took more Advil, temp went to normal.  By afternoon I was okay, but tired. Everything cleared up by late afternoon around 5:00pm.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Illness, Pain, Pain in extremity, Pain in jaw, Pyrexia
Clinical narrative: 10/12/20 arm a little sore and late afternoon one shooting pain down arm then gone.  I was very sick from midnight on. I woke up with a very bad headache and my jaw was extremely painful like everything had swelled. I was very dizzy and disoriented and had to hold onto cabinets getting to the bathroom to remove my MAD sleep appliance & put on my jaw aligner. Had chills all night, fever and headache.  I took Advil- one of the meds advised for side effects on the list given me and it reduced fever.  Later temp went to 99 and I took advil again. No sleep at all. Temp went down, but in the morning 8am-10am I still had chills, headache and temp started to go up to 100.7.  I took more Advil, temp went to normal.  By afternoon I was okay, but tired. Everything cleared up by late afternoon around 5:00pm.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder, Swelling
Clinical narrative: 10/12/20 arm a little sore and late afternoon one shooting pain down arm then gone.  I was very sick from midnight on. I woke up with a very bad headache and my jaw was extremely painful like everything had swelled. I was very dizzy and disoriented and had to hold onto cabinets getting to the bathroom to remove my MAD sleep appliance & put on my jaw aligner. Had chills all night, fever and headache.  I took Advil- one of the meds advised for side effects on the list given me and it reduced fever.  Later temp went to 99 and I took advil again. No sleep at all. Temp went down, but in the morning 8am-10am I still had chills, headache and temp started to go up to 100.7.  I took more Advil, temp went to normal.  By afternoon I was okay, but tired. Everything cleared up by late afternoon around 5:00pm.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Abnormal sleep-related event, Altered state of consciousness, Balance disorder, Cold sweat, Dizziness
Clinical narrative: That afternoon I was off balance.  I was working and busy and did not stop to assess.  Upon sitting down for dinner 7:30 pm, discovered dizziness was increasing.  Sat down to read and body felt like it wanted to pass out.  Fell into a strange sleep 8:00pm(passed out) and then awoke at 10:30PM.  Full vertigo at this point, felt very queasy and faint.  Began to feel like I was going to pass out.  Became very warm and clammy all over.  Sat in bathroom on floor hugging toilet for about 30 minutes.  Husband thought I needed to go to the ER.  I was in a strange consciousness at this point.  Husband reported very pale color and he stayed with me.  Fell back asleep again, like passing out.  Awoke at 2:00am and felt better, but next day still felt a little strange.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Feeling hot, Nausea, Pallor, Vertigo
Clinical narrative: That afternoon I was off balance.  I was working and busy and did not stop to assess.  Upon sitting down for dinner 7:30 pm, discovered dizziness was increasing.  Sat down to read and body felt like it wanted to pass out.  Fell into a strange sleep 8:00pm(passed out) and then awoke at 10:30PM.  Full vertigo at this point, felt very queasy and faint.  Began to feel like I was going to pass out.  Became very warm and clammy all over.  Sat in bathroom on floor hugging toilet for about 30 minutes.  Husband thought I needed to go to the ER.  I was in a strange consciousness at this point.  Husband reported very pale color and he stayed with me.  Fell back asleep again, like passing out.  Awoke at 2:00am and felt better, but next day still felt a little strange.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: hives on vaccinated arm and puritis
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: About 6 hours after injection, the upper outer arm turned red from shoulder down to just above elbow and was warm to the touch.  2 days after injection, the reaction began subsiding.  3 days after the injection, the soreness in the arm is subsiding and the arm is only red on the outside of the arm just above the elbow.  The patient declined to go see a doctor about the reaction.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site discomfort, Pain, Wrong technique in product usage process
Clinical narrative: This was a drive through shot clinic held at the parking lot on October 8th. The shot was administered through an open car window at an angle more vertical than horizontal and was given at the very tip of my shoulder. The injection felt unusual immediately. I waited for 10 minutes after the shot and did not mention any pain but I was experiencing a mild discomfort which I didn't think too abnormal. As the day progressed I lost mobility in my arm and within two days could barely move my arm at all. It did start to feel better after several days but I have not regained the ability to move my arm or shoulder to remove clothing, brush teeth, hair, etc.  The pain is significant  when I try to do so.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site reaction, Loss of personal independence in daily activities, Musculoskeletal disorder, Product administered at inappropriate site, Sensory disturbance
Clinical narrative: This was a drive through shot clinic held at the parking lot on October 8th. The shot was administered through an open car window at an angle more vertical than horizontal and was given at the very tip of my shoulder. The injection felt unusual immediately. I waited for 10 minutes after the shot and did not mention any pain but I was experiencing a mild discomfort which I didn't think too abnormal. As the day progressed I lost mobility in my arm and within two days could barely move my arm at all. It did start to feel better after several days but I have not regained the ability to move my arm or shoulder to remove clothing, brush teeth, hair, etc.  The pain is significant  when I try to do so.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: PATIENT FELT FAINT/DIZZY UPON STANDING AFTER IMMUNIZATION. PATIENT PRESENTED TO PICK UP WINDOW STATING THEY WERE LIGHTHEADED. RPH ASSISTED THEM IN LOWERING TO THE GROUND. PATIENT WAS COHERENT AND RESPONDED TO THEIR NAME. PATIENT WAS ASSITED TO RPH TO A SITTING POSITION. PATIENT STATED THEY HAD NOT EATEN BREAKFAST AND WAS PROVIDED AND DRANK ORANGE JUICE WHILE SEATED IN THE WAITING AREA.  PT WAS OBSERVED FOR 15 MINUTES WHILE SEATED. PATIENT STATED NO ADDITONAL DIZZINESS/LIGHTHEADEDNESS/ONGOING PROBLEMS OR CONCERNS AND LEFT WITHOUT FUTHER ASSITANCE.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: hives on vaccinated arm and stomach, pruritic (itching).
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Injection site vesicles, Pain
Clinical narrative: Patient discovered 2 blisters and drainage at the site of flu shot injection when bandage was removed. Wound is currently 0.9 x 0.5 inches. Antibiotic ointment and a bandage applied.  Patient instructed to keep aerea clean with gentle soap and water and keep it open to air.  Advised to ise ice pack in case of itching. Patient encouraged to take OTC Tylenol or Aleve for pain as needed.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Headache-2 days Decreased appetite-2 days Body aches- 2 days Fatigue- 2 days  Redness, swelling and pain at injection site- 3 days Symptoms started on day 2. Filing this report on day 3.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain
Clinical narrative: Headache-2 days Decreased appetite-2 days Body aches- 2 days Fatigue- 2 days  Redness, swelling and pain at injection site- 3 days Symptoms started on day 2. Filing this report on day 3.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Joint noise, Mobility decreased, Muscular weakness
Clinical narrative: While I was given the shot a pain went down into my shoulder unlike any shot that I had before. My shoulder hurt to move and could not life. The entire 5-6 days following my shot I could not move my arm without my shoulder hurting,  popping and grinding painfully. Arm is still weak.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: While I was given the shot a pain went down into my shoulder unlike any shot that I had before. My shoulder hurt to move and could not life. The entire 5-6 days following my shot I could not move my arm without my shoulder hurting,  popping and grinding painfully. Arm is still weak.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Ear congestion, Electrocardiogram, Head discomfort, Increased upper airway secretion
Clinical narrative: local reaction to the site, slight redness. Next day had a large bout of dizziness, neck fullness and ear fullness with head pressure
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Laboratory test, Local reaction
Clinical narrative: local reaction to the site, slight redness. Next day had a large bout of dizziness, neck fullness and ear fullness with head pressure
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Pt states she experienced severe pain and stiffness in her arm and up her neck on the left side. It was so bad she saw her MD who said her lymph nodes were swollen. It has nearly resolved now, pain far less
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Mobility decreased, Pyrexia, Retching, SARS-CoV-2 test negative
Clinical narrative: Dry heaves, fever 100.3, low grade temp following day (10/4/20), malaise, unable to lift Left arm x 3 days.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Blood culture, Chest X-ray, Decreased appetite, Diarrhoea, Fluid intake reduced
Clinical narrative: Patient had the following symptoms: fever (up to 102.4), screaming inconsolably, arching back with screaming, vomiting, not eating/drinking, restless, lethargic, and has diarrhea.  Patient was sent to ER for further evaluation on 10/23/2020, and then was sent to hospital for IV fluids and additional testing.  Patient stayed in hospital for 1 day and was discharged.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Full blood count, Lethargy, Metabolic function test, Opisthotonus, Pyrexia
Clinical narrative: Patient had the following symptoms: fever (up to 102.4), screaming inconsolably, arching back with screaming, vomiting, not eating/drinking, restless, lethargic, and has diarrhea.  Patient was sent to ER for further evaluation on 10/23/2020, and then was sent to hospital for IV fluids and additional testing.  Patient stayed in hospital for 1 day and was discharged.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Restlessness, Screaming, Vomiting
Clinical narrative: Patient had the following symptoms: fever (up to 102.4), screaming inconsolably, arching back with screaming, vomiting, not eating/drinking, restless, lethargic, and has diarrhea.  Patient was sent to ER for further evaluation on 10/23/2020, and then was sent to hospital for IV fluids and additional testing.  Patient stayed in hospital for 1 day and was discharged.
Age: 73.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Chills, Decreased appetite, Dizziness, Heart rate increased, Hypersomnia
Clinical narrative: A day after the vaccines, I had chills, nauseous, rapid heartbeat (pounding hard), dizzy, and slept all day.  On the 2nd day after, still had rapid heartbeat, light headed, and loss of appetite for several days. Most of these symptoms lasted up to 5 days, and it's been a week and I still don't feel back to normal.
Age: 73.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Nausea, Palpitations
Clinical narrative: A day after the vaccines, I had chills, nauseous, rapid heartbeat (pounding hard), dizzy, and slept all day.  On the 2nd day after, still had rapid heartbeat, light headed, and loss of appetite for several days. Most of these symptoms lasted up to 5 days, and it's been a week and I still don't feel back to normal.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Metabolic function test normal, Pain in extremity, White blood cell count increased
Clinical narrative: Soreness in left arm began the evening of the PCV 23 shot.  Severe pain . It seemed to get a bit better with benadryl and prednisone, but even after slight improvement on day 1, has continued to be painful in the high deltoid where the shot was given.
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 25-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-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 meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 28-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-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 meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: There were no additional AE's; the vaccine was expired when administered; This spontaneous report was received from a pharmacist, referring to an approximately 50-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 21-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, 0.5 milliliter (injection site, route of administration, lot number and expiration date were not provided) for prophylaxis. There were no additional adverse events reported. The reporter was seeking to determine if the vaccine is effective if administered after the expiration date. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; 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 meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2020, the patient received Shingrix. On 15th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Age group was selected as adult as per product indication. Consumer states that they received a dose of Shingrix yesterday from the day of reporting and that they had soreness at the injection site. Did not consent to follow-up. The case had been linked with US2020206901 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020206901:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Severe headaches; This case was reported by a other health professional via sales rep and described the occurrence of headache in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   On an unknown date, the patient received Fluarix Tetra. On an unknown date, unknown after receiving Fluarix Tetra, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Fluarix Tetra.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Fluarix Tetra vaccine and had severe headaches after receiving the vaccine. No further information was available. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2020, the patient received Shingrix. On 15th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving.   It was unknown if the reporter considered the injection site pain 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 was captured as an adult as per vaccine indication. The patient had received a dose of Shingrix day before reporting date and had soreness at the injection site.  The patient declined to provide any additional information other than that the soreness was already better. The reporter did not consent to follow-up. This case has been linked to US2020AMR208235, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR208235:same reporter
Age: 70.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Asthenia, Body temperature decreased, Chills, Dizziness, Injection site pain
Clinical narrative: lack of energy; Temperature dropped to 97.1; chills; dizzy; joint stiffness; muscle stiffness; soreness; peripheral neuropathy; pain at injection site; tingling sensation; This case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 73T27, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included shingles (had shingles 15 years before day of reporting, on the upper left thigh) and neuropathy (experienced neuropathy in this area about 3 to 4 times since having shingles).   On 28th September 2020, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season. On 28th September 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), injection site pain and tingling sensation. On 29th September 2020, the patient experienced loss of energy, body temperature decreased, chills, dizziness, stiff joint, muscle stiffness and pain. On an unknown date, the outcome of the peripheral neuropathy and tingling sensation were not recovered/not resolved and the outcome of the injection site pain, loss of energy, body temperature decreased, chills, dizziness, stiff joint, muscle stiffness and pain were recovered/resolved.   It was unknown if the reporter considered the peripheral neuropathy, injection site pain, tingling sensation, loss of energy, body temperature decreased, chills, dizziness, stiff joint, muscle stiffness and pain to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional case details were reported as follows: The patient reported case for himself. The patient received first dose of Shingrix vaccine in the left arm and the high dose flu shot at the same time in the right arm. The patient reported peripheral neuropathy in upper left thigh and a tingling sensation that was fairly pronounced at night when goes to sleep and that began after receiving the vaccine and was still ongoing but not as severe. The patient reported pain around the injection site that began on 28th September 2020 after receiving the Shingrix vaccine and was resolved. The patient reported on 29th September 2020, had soreness, muscle and joint stiffness in the left wrist and hand and these lasted until the weekend after the vaccine was given and was resolved. The patient reported on 29th September 2020, had felt dizzy, had chills, temperature dropped to 97.1, and a lack of energy that lasted until the weekend after the vaccine was given and was resolved. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Joint stiffness, Musculoskeletal stiffness, Neuropathy peripheral, Pain, Paraesthesia
Clinical narrative: lack of energy; Temperature dropped to 97.1; chills; dizzy; joint stiffness; muscle stiffness; soreness; peripheral neuropathy; pain at injection site; tingling sensation; This case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 73T27, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included shingles (had shingles 15 years before day of reporting, on the upper left thigh) and neuropathy (experienced neuropathy in this area about 3 to 4 times since having shingles).   On 28th September 2020, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season. On 28th September 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), injection site pain and tingling sensation. On 29th September 2020, the patient experienced loss of energy, body temperature decreased, chills, dizziness, stiff joint, muscle stiffness and pain. On an unknown date, the outcome of the peripheral neuropathy and tingling sensation were not recovered/not resolved and the outcome of the injection site pain, loss of energy, body temperature decreased, chills, dizziness, stiff joint, muscle stiffness and pain were recovered/resolved.   It was unknown if the reporter considered the peripheral neuropathy, injection site pain, tingling sensation, loss of energy, body temperature decreased, chills, dizziness, stiff joint, muscle stiffness and pain to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional case details were reported as follows: The patient reported case for himself. The patient received first dose of Shingrix vaccine in the left arm and the high dose flu shot at the same time in the right arm. The patient reported peripheral neuropathy in upper left thigh and a tingling sensation that was fairly pronounced at night when goes to sleep and that began after receiving the vaccine and was still ongoing but not as severe. The patient reported pain around the injection site that began on 28th September 2020 after receiving the Shingrix vaccine and was resolved. The patient reported on 29th September 2020, had soreness, muscle and joint stiffness in the left wrist and hand and these lasted until the weekend after the vaccine was given and was resolved. The patient reported on 29th September 2020, had felt dizzy, had chills, temperature dropped to 97.1, and a lack of energy that lasted until the weekend after the vaccine was given and was resolved. The reporter consented to follow up.
Sex: U
Vaccine: PNC13
Symptoms: Product storage error
Clinical narrative: Incorrect product Storage (no patient involved); This case is considered invalid as no patient received the incorrectly stored vaccine, no adverse event.  This is a spontaneous report from a contactable nurse via Pfizer sales Representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported new shipping containers do not maintain as cold a temperature as the old packaging. The new shipment was ok. Event did not take place after use of the product.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow-up (20Oct2020): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included:  Query: Could you please help to confirm if the there's a patient involved or had been administered with the vaccine in this report? Query: Kindly see below query and reply all with response.  Response: Thank you for your attention, there was not a patient involved with this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: PNC13
Symptoms: Bursal fluid accumulation, Injected limb mobility decreased, Injection site reaction, Pain in extremity, Rash
Clinical narrative: I have severe pain in my arm and my neck broke out, loosed out; I have severe pain in my arm and my neck broke out, loosed out; I have no or any movement in my arm; I have limited mobility in my arm; They found a fluid sac where the injection was put in that; I have a fluid around where the injection was in my arm; This is a spontaneous report from a contactable consumer reported a 66-year-old male received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on Sep2020 either 17 or 24th at a single dose on his arm for immunization. The patient's medical history was not reported. The patient took 'Fragmin' and he was not sure what he took his wife does all that for him. The reporter stated that he had the shot a month ago and ever since then for the first two weeks, he had severe pain in his arm and his neck broke out, loosed out, now that healed up, his doctor put him on couple of medications (Unspecified Medication) but now he had no or any movement in his arm and now the doctor was going to send him to an orthopedic. He had an ultrasound of the arm and shoulder done and they found a fluid sac where the injection was put in that, now do ever hear anything like that. The patient did not know if they had any solutions to how he can solve this because his doctor put him on antibiotics (unspecified medication) but that did not work. The sac (Intent: fluid sac) on the injection was immobilizing the patient. The patient added he can move his neck and limited mobility in his arm. The consumer stated that he had been taking Gabapentin 300 mg capsules and just started Amoxicillin-Clav 125 mg and the doctor had him on some pain pills but he didn't really take pain pills (Unspecified Medications). The outcome of the events severe pain in his arm and his neck broke out, loosed out was recovered and the outcome of the other events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.