chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: after about and hour and a half of reveiving pnuemovax 23, patinet called pharmacy to report swelling in in right arm from injection site to past elbow; otherwise reported no anaphylactic reactions, no increased HR and BLood pressure elevated prior to coming in since she was here to pick up blood pressure medicine; I had coubnseld of swelling at arm injection site to be normal and advised to keep an eye on swelling (spreading), any trouble breathing or increased hr/BP should then call 911, but meanwhile to apply cold compress, take Benadryl and Tylenol(she is diabetic) and keep eye on swelling for next 30 minuites, to please call us if needed for further guidance; called her back and she said selling is gong down, did not end up taking Benadryl nor Tylenol
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; patient was administered an improperly stored dose of VARIVAX intramuscularly; patient was administered an improperly stored dose of VARIVAX intramuscularly; This spontaneous report was received from a physician and refers to a 28-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 31-MAR-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S031494, expiration date 07-OCT-2021, intramuscularly (dose and dose# were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 15 Fahrenheit (F) degrees to 46 F degrees for 21 hours. There were no previous excursions reported. The digital data logger was not involved to capture the temperature excursion. No additional adverse effects were reported.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; the patient received an improperly stored dose of VARIVAX on 5/4/2020; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On 04-MAY-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, frequency and route of administration were not reported) lot # S022755 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 22-JUL-2022, but upon internal validation established as 22-JUL-2021. The vaccine was reconstituted with sterile diluent, it was not reported if sterile diluent was stored with the vaccine. No adverse symptoms were reported.  The vaccine was stored in -14 degrees Celsius (C) -10 C (-12.9 C) for 1 hour and 8 minutes. There was no previous temperature excursion. The storage was recorded by Digital Data Logger.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age.  No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On or about 19-MAY-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (lot number, dosage, vaccination site and route of administration were not provided), as recommended for routine adult health maintenance for the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a very painful rash on the left chest spreading to the back. The patient was diagnosed with shingles. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the Company's product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), The patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality was related.   The event of shingles was considered to be disabling.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient was administered a dose of improperly stored VARIVAX; The patient experienced no symptoms; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug allergies/reactions and concomitant medications were not provided.  On 24-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not provided), lot# S028920, expiration date 16-SEP-2021, administered subcutaneously, as prophylaxis. Varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).  The improperly stored of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature of -8.1 degree Celsius (C) for 1 hours and 30 minutes; without a previous temperature excursion and was called because of a digital data logger. The patient experienced no symptoms. No further information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: diarrhea; fever; leg pain; arm swollen; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included neuropathy peripheral.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced diarrhea, fever, leg pain and swelling arm. On an unknown date, the outcome of the diarrhea, fever, leg pain and swelling arm were recovered/resolved.   It was unknown if the reporter considered the diarrhea, fever, leg pain and swelling arm to be related to Shingrix.  Additional details were reported as follows: The age at the vaccination was not reported. The patient received vaccine and experienced fever, diarrhea, leg pain and swollen arm. The reporter did not consent to follow up. This case has been linked with US2020AMR074112, reported by same reporter.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: There was a temperature excursion on 4/21/2020. I unfortunately did not discover this excursion until I came back this week from leave.  The dose was given from an open, multi dose vial. This dose and opened vial was deemed unusable by manufacturer and health department. Patient is to be re-vaccinated per manufacturer and health department recommendation.  The patient's physician will be reaching out to the patients parents to explain what happened and to have them come back for their Polio vaccine. At this time the parents have not reported any adverse reactions from the vaccine that was given.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: There was a temperature excursion on 4/21/2020. This dose came from an open multi dose vial of Polio. Per manufacturer and health department, the open multi vial was compromised by the excursion and deemed unusable. Per recommendation from the health department and and manufacturer, the child should he re vaccinated. The patient's physician or Dr. will be reaching out to the parents today or next week to inform them of what happened. They will scheduled to come back to receive their polio vaccine. At this time the parents have not reported any adverse reactions to the vaccine that was given.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pyrexia
Clinical narrative: Redness is getting worse; Feel feverish; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced erythema and feeling hot. On an unknown date, the outcome of the erythema was not recovered/not resolved and the outcome of the feeling hot was unknown.   It was unknown if the reporter considered the erythema and feeling hot to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient himself or herself. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient made an inquiry about how long do the side effects last after vaccination with Shingrix. The patient reported that redness was getting worse and he or she also felt feverish.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Decreased appetite, Malaise, Nausea
Clinical narrative: shivers; body aches; nausea; loss of appetite; "sick feeling and in bed all day"; "sick feeling and in bed all day"; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, shivers, general body pain, nausea, appetite lost, feeling unwell and bedridden. On an unknown date, the outcome of the pain in arm, shivers, general body pain, nausea, appetite lost, feeling unwell and bedridden were recovered/resolved.   It was unknown if the reporter considered the pain in arm, shivers, general body pain, nausea, appetite lost, feeling unwell and bedridden to be related to Shingrix.  Additional details were received as follows: The reporter reported, that his wife's aunt, had dose 2 of Shingrix and developed a sore arm, nausea, loss of appetite, stayed in bed sick for a day, shivers, and body aches. He states she told him this lasted for twenty-four hours and resolved. The reporter consented to follow up. The reporter had no additional details for this AE. This case was linked with case US2020049313, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: shivers; body aches; nausea; loss of appetite; "sick feeling and in bed all day"; "sick feeling and in bed all day"; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, shivers, general body pain, nausea, appetite lost, feeling unwell and bedridden. On an unknown date, the outcome of the pain in arm, shivers, general body pain, nausea, appetite lost, feeling unwell and bedridden were recovered/resolved.   It was unknown if the reporter considered the pain in arm, shivers, general body pain, nausea, appetite lost, feeling unwell and bedridden to be related to Shingrix.  Additional details were received as follows: The reporter reported, that his wife's aunt, had dose 2 of Shingrix and developed a sore arm, nausea, loss of appetite, stayed in bed sick for a day, shivers, and body aches. He states she told him this lasted for twenty-four hours and resolved. The reporter consented to follow up. The reporter had no additional details for this AE. This case was linked with case US2020049313, reported by the same reporter.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: swelling, pain, erythema at injection site and nearby lymph nodes developed within a few hours of injection; persisted for 40 hrs and now gradually improving
Age: 29.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Paraesthesia, Tuberculin test
Clinical narrative: Pt states an hour after getting vaccine her Left arm started to get numb and tingle. Also stated that her neck and both arms became stuff as well as her fingers.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Aching arm, unable to stretch shoulder and upper arm without pain. Pressure or weight put on shoulder also causes pain. Pain is ongoing and intermittent in severity.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother sent photo of left upper arm which showed a 6 inch by 3 inch area of redness and swelling..  Advised to give an antihistamine and apply ice to  area and monitor.  Follow up phone call on 5/8/20, mother reports area had greatly improved.  Informed that second dose will be given in future but with not other vaccine in same extremity.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Dyskinesia, Syncope
Clinical narrative: Syncope with jerking for a few seconds.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Decreased appetite, Feeling abnormal, Headache
Clinical narrative: Pt stated that later in the afternoon, on the day of the immunization, she got really sleepy. then had body aches, upset stomach with some vomiting, had an awful headache, decreased appetite.   today pt called and felt she is on the upswing.  Still having a headache but not as near as bad, feels weak, stomach still a little upset, but sx are improving. she will continue to update if needed.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Somnolence, Vomiting
Clinical narrative: Pt stated that later in the afternoon, on the day of the immunization, she got really sleepy. then had body aches, upset stomach with some vomiting, had an awful headache, decreased appetite.   today pt called and felt she is on the upswing.  Still having a headache but not as near as bad, feels weak, stomach still a little upset, but sx are improving. she will continue to update if needed.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Severe body aches over entire body, chills, fever (known high of 102.1), headache, fatigue, light headed, very sore in arm near and around injection site, slight upset stomach.  These symptoms began within approximately 7 hours of injection.  It is now 24 hours later and I am still having them.   This is the 2nd injection in a series of 2.   The first injection was given in November 2019 (about 5-1/2 months ago).  I had all of the exact same symptoms then also.  But I think  it was dismissed because the side effects are seemingly rare?
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Severe body aches over entire body, chills, fever (known high of 102.1), headache, fatigue, light headed, very sore in arm near and around injection site, slight upset stomach.  These symptoms began within approximately 7 hours of injection.  It is now 24 hours later and I am still having them.   This is the 2nd injection in a series of 2.   The first injection was given in November 2019 (about 5-1/2 months ago).  I had all of the exact same symptoms then also.  But I think  it was dismissed because the side effects are seemingly rare?
Age: 31.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: Pt called pharmacy next day complaining of tingling, numbness, slight redness, and itching in left hand (same side as injection).  Took Claritin for itching. Contacted patient next day to see if improvement, Pt reported slight improvement and stated that PCP is aware and monitoring  symptoms.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Myalgia, Nausea, Tremor
Clinical narrative: Severe headache, muscle pain, nausea, shakes, sweating
Age: 25.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Dehydration, Erythema, Full blood count abnormal, Haematocrit abnormal, Haemoglobin abnormal
Clinical narrative: Around 10:30 PM started to get a sharp burning pain above left collar bone and halfway up side of neck, which turned into 10/10 pain over the course of an hour. Area had slight swelling and redness above left collar bone and at the left side, base of the kneck. Went to the ER, and was given motrin and ativan and sent home. Woke unable to move kneck or raise left arm without extreme pain. Area/skin extremely sensitive to the touch, such that even a gentle touching caused extreme pain. A red line started to appear from the front/top of the shoulder down the left arm (~3 inches long). Started treatment with Cephalexin, Doxycycline, ibuprofen, and methocarbomal (4/24/2020). Redness spread and swelled over the next 3 days, becoming raised and more sensitive across the bicep underneath both injection sites (roughly 2x5 in in length) . Movement was difficult because it caused severe pain. Around 4 days after initial ER visit, swelling and redness started to subside. By 5/4/2020 pain was gone and redness was mostly faded, stopped taking antibiotics, ibuprofen, methocarbamol. By 5/8/2020 no more symptoms, swelling, or pain. Slight redness on left arm underneath injection site.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Hyperaesthesia, Metabolic function test normal, Pain, Red blood cell sedimentation rate normal, Swelling
Clinical narrative: Around 10:30 PM started to get a sharp burning pain above left collar bone and halfway up side of neck, which turned into 10/10 pain over the course of an hour. Area had slight swelling and redness above left collar bone and at the left side, base of the kneck. Went to the ER, and was given motrin and ativan and sent home. Woke unable to move kneck or raise left arm without extreme pain. Area/skin extremely sensitive to the touch, such that even a gentle touching caused extreme pain. A red line started to appear from the front/top of the shoulder down the left arm (~3 inches long). Started treatment with Cephalexin, Doxycycline, ibuprofen, and methocarbomal (4/24/2020). Redness spread and swelled over the next 3 days, becoming raised and more sensitive across the bicep underneath both injection sites (roughly 2x5 in in length) . Movement was difficult because it caused severe pain. Around 4 days after initial ER visit, swelling and redness started to subside. By 5/4/2020 pain was gone and redness was mostly faded, stopped taking antibiotics, ibuprofen, methocarbamol. By 5/8/2020 no more symptoms, swelling, or pain. Slight redness on left arm underneath injection site.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Chest X-ray normal, Neck pain, Pain, Spinal X-ray normal
Clinical narrative: Around 10:30 PM started to get a sharp burning pain above left collar bone and halfway up side of neck, which turned into 10/10 pain over the course of an hour. Area had slight swelling and redness above left collar bone and at the left side, base of the kneck. Went to the ER, and was given motrin and ativan and sent home. Woke unable to move kneck or raise left arm without extreme pain. Area/skin extremely sensitive to the touch, such that even a gentle touching caused extreme pain. A red line started to appear from the front/top of the shoulder down the left arm (~3 inches long). Started treatment with Cephalexin, Doxycycline, ibuprofen, and methocarbomal (4/24/2020). Redness spread and swelled over the next 3 days, becoming raised and more sensitive across the bicep underneath both injection sites (roughly 2x5 in in length) . Movement was difficult because it caused severe pain. Around 4 days after initial ER visit, swelling and redness started to subside. By 5/4/2020 pain was gone and redness was mostly faded, stopped taking antibiotics, ibuprofen, methocarbamol. By 5/8/2020 no more symptoms, swelling, or pain. Slight redness on left arm underneath injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Patient had first dose of the vaccine on 09/03/2019. She said that her upper arm was sore after the vaccine and never returned to normal.  She had the 2nd dose on 10/02/2019 and said that her upper arm/shoulder area was sore again.  Over the last 7 months she said that she has had soreness and some pain.  She said that it hurts to lift her arm abover her head, for example taking off a shirt, or putting her arm behind her back, for example unhooking her bra.  She said that it won't hurt when she is doing nothing, but will always hurt on those situations.  She asked her doctor about it around December and the doctor said to keep an eye on it and let them know if there wasn't any improvement.  She has not been back due to the COVID 19 outbreak, but does intend to see the doctor again.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Injection site reaction, Injection site warmth, Pain
Clinical narrative: I started having a throbbing/sloshing headache that night and went to bed. sometime i must have had a fever sometime through out the night because it broke and i was soaking in sweat. I had body aches and slept until 2pm that afternoon(Thursday, May 7th) still with a severe headache. i took my temp then and it was 101.6. I proceeded to take advil and went back to sleep for another 2 hours. my fever started to go down throughout the evening until it was down to my "normal" 97.5. My arm hurt but it wasn't unbearable but there is a red blotch around the site and it is warm to the touch. As of now, 6:30pm on Friday, May 8th, my headache has returned and i feel cold and shivering. I just took advil to help as my temp is starting to rise but as of now it is at 99.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash macular
Clinical narrative: I started having a throbbing/sloshing headache that night and went to bed. sometime i must have had a fever sometime through out the night because it broke and i was soaking in sweat. I had body aches and slept until 2pm that afternoon(Thursday, May 7th) still with a severe headache. i took my temp then and it was 101.6. I proceeded to take advil and went back to sleep for another 2 hours. my fever started to go down throughout the evening until it was down to my "normal" 97.5. My arm hurt but it wasn't unbearable but there is a red blotch around the site and it is warm to the touch. As of now, 6:30pm on Friday, May 8th, my headache has returned and i feel cold and shivering. I just took advil to help as my temp is starting to rise but as of now it is at 99.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Epistaxis
Clinical narrative: Mother stated that patient had profuse bouts of epistaxis over the last 24 hours. 5 in total.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives on face and trunk
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: has a spots all over his torso similar to chicken pox. Showed up within 4 hours after receiving the vaccines.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, IPV, MMRV, RV1, TDAP
Symptoms: Computerised tomogram normal, Electroencephalogram abnormal, Epilepsy, Magnetic resonance imaging normal, Seizure
Clinical narrative: 2 days after receiving her month shots she started having small seizures. Her seizures got longer In length and more frequent. 5 days later she was having 14 seizures. She was rushed to the ER where they diagnosed her with epileptic seizures. She was put on keppra which didn?t help. 2 months later was switched to trileptol.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Pain in extremity
Clinical narrative: Arm pain, fatigue, headache, joint pain
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Body temperature increased, Erythema, Muscular weakness, Peripheral swelling, Restlessness
Clinical narrative: Temperature ~100', restless, legs feel like jelly fatigue, crawled into bed with Dad, swelling, redness left arm.
Age: 56.0
Sex: F
Vaccine: YF
Symptoms: Arthralgia, Choking, Groin pain, Pain in extremity
Clinical narrative: (1) Enduring daily or intermittent limber joint pain originating @ (L) hip/groin area started after receiving STAMARIL vaccine (2) Occasional/weekly choking on saliva started ~ 1 month after receiving STAMARIL during speaking or breathing
Age: 6.0
Sex: M
Vaccine: PNC13
Symptoms: Bone pain, Constipation, Emotional disorder, Gait disturbance, Pain
Clinical narrative: Beginning that evening 4/28/20 child complains of increased pain in bone of right leg injection given.  Pain level rated by child an 8.  4/29/20 child complains of increases pain in leg, can't walk on leg without leg giving out the to pain.  Pain rated 10.  Doctor office contacted for advise and concern. Informed common reaction, given imstructions on how to help pain go away.  Child complains skin itches along inner thigh, itch and stinging pain.  Constipated.  Child has history of having 1 -2 BM daily, constipated now. 5/3/20 child has three tiny moles.  5/4/20 child complains of rash along waist, stinging pain, itches, sore opened, bright red.  Also child develops a breakout of tiny bumps skin colored.  Called doctor office, lft msg with answer service.  5/5/20 Follow up with doctor office, appt made same day, saw doctor over rash and skin reaction outbreak.  No mention from provider that the rash may be his immune system trying to deal with the vaccine ingredients and aluminum.  Over the last 10 days, child has had increases emotional breakdowns.  Continue to keep up with provider to assure child well taken care of and helped through.  Will continue documenting.
Age: 6.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity, Pruritus, Rash, Skin ulcer
Clinical narrative: Beginning that evening 4/28/20 child complains of increased pain in bone of right leg injection given.  Pain level rated by child an 8.  4/29/20 child complains of increases pain in leg, can't walk on leg without leg giving out the to pain.  Pain rated 10.  Doctor office contacted for advise and concern. Informed common reaction, given imstructions on how to help pain go away.  Child complains skin itches along inner thigh, itch and stinging pain.  Constipated.  Child has history of having 1 -2 BM daily, constipated now. 5/3/20 child has three tiny moles.  5/4/20 child complains of rash along waist, stinging pain, itches, sore opened, bright red.  Also child develops a breakout of tiny bumps skin colored.  Called doctor office, lft msg with answer service.  5/5/20 Follow up with doctor office, appt made same day, saw doctor over rash and skin reaction outbreak.  No mention from provider that the rash may be his immune system trying to deal with the vaccine ingredients and aluminum.  Over the last 10 days, child has had increases emotional breakdowns.  Continue to keep up with provider to assure child well taken care of and helped through.  Will continue documenting.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site reaction, Loss of personal independence in daily activities, Nausea, Pyrexia
Clinical narrative: Fever 101.5 for 36 hours, then diminishing to 99.5  Cherry red blotch/ at injection site by second day, 4? long and narrow Felt strong flu like symptoms for 2 days Nausea first night, which resolved by morning. Overall, strongest reaction I have ever had to a vaccine, and I have experienced many, including For yellow fever and other tropical diseases. Took Tylenol For two which eased symptoms, but only minor relief. Spent much of first day after vaccine in bed, cancelling a 10 mile hike and golf that day.  I am a fit and Very active person.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: Fever 101.5 for 36 hours, then diminishing to 99.5  Cherry red blotch/ at injection site by second day, 4? long and narrow Felt strong flu like symptoms for 2 days Nausea first night, which resolved by morning. Overall, strongest reaction I have ever had to a vaccine, and I have experienced many, including For yellow fever and other tropical diseases. Took Tylenol For two which eased symptoms, but only minor relief. Spent much of first day after vaccine in bed, cancelling a 10 mile hike and golf that day.  I am a fit and Very active person.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pallor, Pyrexia, Rash, Rash erythematous, Skin warm
Clinical narrative: Fever 102 degrees 8 days after injection. Following fever was a red rash on shoulders that blanches when touched and hot to touch. A day later no longer a fever and now a red pimple like rash all over body including face and groin areas.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Disorientation, Generalised tonic-clonic seizure, Unresponsive to stimuli
Clinical narrative: The minor came into the store with her guardian to get a flu shot. The pre screening questions were done with my help, i asked if patient had any seizures in the past, guardian said she had one previously, but only one. Patient was seated while wating for the vaccinatio. I administered it, using proper technique. Directly after, i asked how the patient was feeling, she said she wanted to sit for a while. I went back into the pharmacy to gather her paperwork for checkout, and patient began to convulse. Guardian shouted at patient to get patient's attention, but she was unresponsive during the seizure. I immediately ran to her aid. Patient slipped through the chair and caught her neck where the chair handle was. I was able to free her from the chair without hurting her and place her on the ground to her side. I also cleared the area and stayed by her side until she woke up, approiximately 10 seconds at this point. I would describe the seizure as a 20-30 second tonic-clonic episode in full. 911 was called by a bystander. Patient woke after, disoriented and confused. She didnt realize fully what happened. She stayed on the floor seated until EMS arrived and stated she felt fine when they showed up. She was still taken away on a stretcher.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Eczema, Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: 4/14/2020 - MMR, Varicella, Hep A vaccines given 4/15/2020 - red rash at injection site, low fever 99.8, diarrhea, tylenol and motrin given to reduce fever 4/16/2020-4/19/2020 - continuing fever between 99.9-100.8, diarrhea, tylenol and motrin given to reduce fever 4/19/2020 - red rash covering torso, arms, legs, diarrhea 4/20/2020-4/21/2020 - red rash covering body develops into full body hives and fever of 102. diarrhea, Benadryl given to reduce rash and hives 4/22/2020 - hives gone, but still a lingering minor body rash, eczema spots, fever 103.3 4/23/2020 - low grad fever 99, lingering minor body rash, eczema spots  4/24/2020 - diarrhea, fever gone, lingering minor body rash, eczema spots 4/25/2020-current - continuous lingering minor body rash, eczema spots
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: 4/14/2020 - MMR, Varicella, Hep A vaccines given 4/15/2020 - red rash at injection site, low fever 99.8, diarrhea, tylenol and motrin given to reduce fever 4/16/2020-4/19/2020 - continuing fever between 99.9-100.8, diarrhea, tylenol and motrin given to reduce fever 4/19/2020 - red rash covering torso, arms, legs, diarrhea 4/20/2020-4/21/2020 - red rash covering body develops into full body hives and fever of 102. diarrhea, Benadryl given to reduce rash and hives 4/22/2020 - hives gone, but still a lingering minor body rash, eczema spots, fever 103.3 4/23/2020 - low grad fever 99, lingering minor body rash, eczema spots  4/24/2020 - diarrhea, fever gone, lingering minor body rash, eczema spots 4/25/2020-current - continuous lingering minor body rash, eczema spots
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Back pain, Chills, Injection site erythema, Injection site pain
Clinical narrative: Very sore arm/neck/shoulders developed around 8:15PM.   Chills/aches all night into next day.  Minimal redness at site.  Further soreness of left arm and into armpit next day.   Achy upper back/neck all  next day.  Chilled.   I had no symptoms prior to 8:15PM other than mild soreness at site of injection.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Very sore arm/neck/shoulders developed around 8:15PM.   Chills/aches all night into next day.  Minimal redness at site.  Further soreness of left arm and into armpit next day.   Achy upper back/neck all  next day.  Chilled.   I had no symptoms prior to 8:15PM other than mild soreness at site of injection.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Pain at site, fever, chills, fatigue
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pyrexia
Clinical narrative: fever 100.3
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Anosmia, Taste disorder
Clinical narrative: Woke up with unpleasant taste in mouth/mucus.  Became aware that I could not smell coffee, etc.  This continued through day; the onset was sudden and while I have managed to get used to having no taste or smell ability to this day, it was rapid--from one day to the next--and as I say it continues to this day.  Notified primary care Dr. at time.  She stated she had never heard of this kind of condition but I contacted her again when I heard Corona 19 symptom.  She reminded me it was well before the Corona outbreak.  I have family living in country, and have traveled for last three years in country and country.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Woke up Saturday morning with swollen, red, hard lump at injection site. As the day went on, I started to feel more tired and run down. Got a headache at the base of my of my neck. Felt so tired, went to bed at 9:30 pm and woke up at 10:20 and got up for about 20 minutes and went back to bed until 2 pm. - very unusual for me. Still achy and tired for the rest of the day. When I checked the injection site on Sunday night, it was bigger around, warm and still red. That's when we looked up more about the side effects and found this form. Hopefully will be better tomorrow!
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: Woke up Saturday morning with swollen, red, hard lump at injection site. As the day went on, I started to feel more tired and run down. Got a headache at the base of my of my neck. Felt so tired, went to bed at 9:30 pm and woke up at 10:20 and got up for about 20 minutes and went back to bed until 2 pm. - very unusual for me. Still achy and tired for the rest of the day. When I checked the injection site on Sunday night, it was bigger around, warm and still red. That's when we looked up more about the side effects and found this form. Hopefully will be better tomorrow!
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Middle insomnia, Myalgia
Clinical narrative: Patient states that he had pain at injection site that has not subsided since receiving the vaccine.  He states that it did not get better or worse since the vaccine was received 1/16/2020.  Visual inspection of the left deltoid area shows no signs of inflammation or redness.  Referred patient to Primary care physician for evaluation.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient states that he had pain at injection site that has not subsided since receiving the vaccine.  He states that it did not get better or worse since the vaccine was received 1/16/2020.  Visual inspection of the left deltoid area shows no signs of inflammation or redness.  Referred patient to Primary care physician for evaluation.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: In approximately 24 hrs. I had lesions on my back and then my right torso soon followed with many angry rashes as well. The itching soon turned to terrible pain and burning sensation. Within a few days I knew I needed to see my internist who confirmed it was shingles. I was put on valcyclovir + opiods for the severe pain. Fearful of opiods, I only took them for 3 days + was unable to have bowel movements for a full week after taking laxatives + stool softeners. I was unable to sleep or eat from the severe pain + went to a pain specialist 3 times who prescribed LYRICA - which gave me some relief at last. Over the course of the next 8-9 wks, I developed an eye infection and an inflamed liver (which caused me more pain). I also went to eye doctor who prescribed med. + eye treatment I waited until there was a non-live virus vaccine because my doctors said the previous kind could cause adverse reactions. I was never advised by the pharmacy, nor GSK, that I would suffer so much. If filling out this form save one person it will be worth it.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Malaise, Rash, Rash pruritic
Clinical narrative: In approximately 24 hrs. I had lesions on my back and then my right torso soon followed with many angry rashes as well. The itching soon turned to terrible pain and burning sensation. Within a few days I knew I needed to see my internist who confirmed it was shingles. I was put on valcyclovir + opiods for the severe pain. Fearful of opiods, I only took them for 3 days + was unable to have bowel movements for a full week after taking laxatives + stool softeners. I was unable to sleep or eat from the severe pain + went to a pain specialist 3 times who prescribed LYRICA - which gave me some relief at last. Over the course of the next 8-9 wks, I developed an eye infection and an inflamed liver (which caused me more pain). I also went to eye doctor who prescribed med. + eye treatment I waited until there was a non-live virus vaccine because my doctors said the previous kind could cause adverse reactions. I was never advised by the pharmacy, nor GSK, that I would suffer so much. If filling out this form save one person it will be worth it.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Burning sensation, Eye infection, Feeding disorder
Clinical narrative: In approximately 24 hrs. I had lesions on my back and then my right torso soon followed with many angry rashes as well. The itching soon turned to terrible pain and burning sensation. Within a few days I knew I needed to see my internist who confirmed it was shingles. I was put on valcyclovir + opiods for the severe pain. Fearful of opiods, I only took them for 3 days + was unable to have bowel movements for a full week after taking laxatives + stool softeners. I was unable to sleep or eat from the severe pain + went to a pain specialist 3 times who prescribed LYRICA - which gave me some relief at last. Over the course of the next 8-9 wks, I developed an eye infection and an inflamed liver (which caused me more pain). I also went to eye doctor who prescribed med. + eye treatment I waited until there was a non-live virus vaccine because my doctors said the previous kind could cause adverse reactions. I was never advised by the pharmacy, nor GSK, that I would suffer so much. If filling out this form save one person it will be worth it.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Hepatitis, Herpes zoster, Insomnia, Pain, Pruritus
Clinical narrative: In approximately 24 hrs. I had lesions on my back and then my right torso soon followed with many angry rashes as well. The itching soon turned to terrible pain and burning sensation. Within a few days I knew I needed to see my internist who confirmed it was shingles. I was put on valcyclovir + opiods for the severe pain. Fearful of opiods, I only took them for 3 days + was unable to have bowel movements for a full week after taking laxatives + stool softeners. I was unable to sleep or eat from the severe pain + went to a pain specialist 3 times who prescribed LYRICA - which gave me some relief at last. Over the course of the next 8-9 wks, I developed an eye infection and an inflamed liver (which caused me more pain). I also went to eye doctor who prescribed med. + eye treatment I waited until there was a non-live virus vaccine because my doctors said the previous kind could cause adverse reactions. I was never advised by the pharmacy, nor GSK, that I would suffer so much. If filling out this form save one person it will be worth it.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Rash, Skin lesion
Clinical narrative: In approximately 24 hrs. I had lesions on my back and then my right torso soon followed with many angry rashes as well. The itching soon turned to terrible pain and burning sensation. Within a few days I knew I needed to see my internist who confirmed it was shingles. I was put on valcyclovir + opiods for the severe pain. Fearful of opiods, I only took them for 3 days + was unable to have bowel movements for a full week after taking laxatives + stool softeners. I was unable to sleep or eat from the severe pain + went to a pain specialist 3 times who prescribed LYRICA - which gave me some relief at last. Over the course of the next 8-9 wks, I developed an eye infection and an inflamed liver (which caused me more pain). I also went to eye doctor who prescribed med. + eye treatment I waited until there was a non-live virus vaccine because my doctors said the previous kind could cause adverse reactions. I was never advised by the pharmacy, nor GSK, that I would suffer so much. If filling out this form save one person it will be worth it.
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; approximately 125 unspecified patients were vaccinated with improperly stored ROTATEQ and approximately 50 unspecified patients were vaccinated with improperly stored VAQTA on multiple unspecified dates; This spontaneous report was received from a medical assistant, concerning 175 patients of unknown age and gender. Information about the patients' medical history, concurrent conditions and concomitant medications was not provided.  It was reported that on multiple unspecified dates between 09-SEP-2019 and 25-OCT-2019, approximately 125 unidentified patients were vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (strength, dose number, route of administration and anatomical location of vaccination were not provided; lot numbers S010702, S010045, 1660932, R035369 and R035371 has been verified to be valid; expiration dates 16-JAN-2021, 24-NOV-2020, 25-OCT-2020, 10-OCT-2020 and 07-OCT-2020, respectively); and approximately 50 unidentified patients were vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (strength, dose number, route of administration and anatomical location of vaccination were not provided; lot number S010727 and expiration date 26-JUL-2020; lot number S005725 has been verified to be valid; expiration date 10-JUL-2020) (product storage error).  The temperature of the vaccines administered was reported as above 9 degree Celsius (C) (10 C) and cumulative; there were multiple excursions, during a time frame of 4 hours and 16 minutes. There were no previous temperature excursions. The call was placed because of a Digital Data logger report.  No adverse effects were reported.  This is a non-valid case due to lack of patient identifiers.  Lot # S010727 has been verified to be a valid lot # for hepatitis A vaccine, inactivated.  As of 06-MAY-2020, all telephone attempts trying to obtain additional information has been unsuccessful.  As of 07-MAY-2020, the medical assistant reported that due to office moving to a new location, the administration dates and patient's identifiers would not be provided.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; The patient received a dose of ROTATEQ on 22-APR-2020 that had been improperly stored.; This spontaneous report was received from a medical assistan refering to a female patient of unknown age. Information regarding the patient's concurrent conditions, concomitant medications, drug allergies or reaction was not provided.      On 22-APR-2020 the patient was inadvertently vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, for prophylaxis, lot number 1660947, expiration date: 16-APR-2021. (Dose, vaccination scheme frequency were not reported). The vaccine was at a temperature of 47.7 fahrenheit (F) for 12 minutes and also experienced a previous excursion of  58.3 F for 14 hours. It was reported that a Data logger was involved. No additional adverse event reported. (Product storage error).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity vasculitis, Joint swelling, Joint warmth, Skin ulcer
Clinical narrative: leukocytoclastic vasculitis; Information has been received regarding a case in litigation from a lawyer referring to a currently 66 year old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided.  On 06-SEP-2012 the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(lot#, expiration date, concentration, dose and route were unknown) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On unknown dates, patients suffered the following injuries and was diagnosed on the following as a result of the zoster vaccine live(ZOSTAVAX) vaccine: sores on legs spreading to arms and trunk, joint swelling and warmth involving wrists, elbows, knees, hips, etc; the patient was diagnosed with leukocytoclastic vasculitis. The outcome of leukocytoclastic vasculitis was unknown. The reporter considered leukocytoclastic vasculitis to be related to zoster vaccine live(ZOSTAVAX).  Upon internal review, leukocytoclastic vasculitis was determined to be medically significant.
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; the patient was administered an improperly stored dose of Pneumovax23; This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 19-DEC-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (route and dosage schedule were not reported) lot # S004548 exp date: 12-AUG-2020 for profilaxis. No adverse event was unknown.     The temperature excursion was of 47.3 degrees Fahrenheit, for 20 minutes. No previous temperature excursion reported. A data logger was used.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; 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-009507513-2005USA000302: