chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 66-year-old female patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. On 15th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), pain, rash, skin red, skin warm, skin induration and skin tenderness. On an unknown date, the outcome of the cellulitis, rash, skin red, skin warm, skin induration and skin tenderness were not recovered/not resolved and the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the cellulitis, pain, rash, skin red, skin warm, skin induration and skin tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient started feeling a little bit achy for a few days after the SHINGRIX injection. The injection site looked good but about 4 centimeters below the injection site, the patient had a red cellulitis type of thing that was 6 by 9 cm.  The patient was told by her pharmacist that it looked like a rash, but she said that it was more like a cellulitis that was red, hot, firm and tender. At the time of reporting, the patient was still having these symptoms, but they looked worse. The patient did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Pain, Pain of skin
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 66-year-old female patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. On 15th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), pain, rash, skin red, skin warm, skin induration and skin tenderness. On an unknown date, the outcome of the cellulitis, rash, skin red, skin warm, skin induration and skin tenderness were not recovered/not resolved and the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the cellulitis, pain, rash, skin red, skin warm, skin induration and skin tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient started feeling a little bit achy for a few days after the SHINGRIX injection. The injection site looked good but about 4 centimeters below the injection site, the patient had a red cellulitis type of thing that was 6 by 9 cm.  The patient was told by her pharmacist that it looked like a rash, but she said that it was more like a cellulitis that was red, hot, firm and tender. At the time of reporting, the patient was still having these symptoms, but they looked worse. The patient did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin induration, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 66-year-old female patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. On 15th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), pain, rash, skin red, skin warm, skin induration and skin tenderness. On an unknown date, the outcome of the cellulitis, rash, skin red, skin warm, skin induration and skin tenderness were not recovered/not resolved and the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the cellulitis, pain, rash, skin red, skin warm, skin induration and skin tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient started feeling a little bit achy for a few days after the SHINGRIX injection. The injection site looked good but about 4 centimeters below the injection site, the patient had a red cellulitis type of thing that was 6 by 9 cm.  The patient was told by her pharmacist that it looked like a rash, but she said that it was more like a cellulitis that was red, hot, firm and tender. At the time of reporting, the patient was still having these symptoms, but they looked worse. The patient did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Red, warm to touch, about 2x3 inch area of arm where the shot was given within 2 days of administration. Prescribed cephalexin. Diagnosis cellulitis.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Bedridden, Pain
Clinical narrative: Body/Joint ack. Bed ridden for 4 days. Similar reaction on second shoot. Jan 2019.
Age: 24.0
Sex: M
Vaccine: FLU4, HEP
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt w/ flattened erythematous rash to bilat posterior arms, L>R. No pain/ pruritus or open lesions. Pt's partner noticed it, pt did not see him until partner noted this.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Impaired work ability, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Starting day after vaccination, left arm became swollen, red, and very sore. Swelling in arm grew to two times regular size and went from top of shoulder down to elbow. A lot of soreness, especially in shoulder area more so than at injection site; unable to lift arm enough to lift trays at work. Lasted about 10 days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Starting day after vaccination, left arm became swollen, red, and very sore. Swelling in arm grew to two times regular size and went from top of shoulder down to elbow. A lot of soreness, especially in shoulder area more so than at injection site; unable to lift arm enough to lift trays at work. Lasted about 10 days.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Erythema, Hypersomnia, Influenza like illness
Clinical narrative: SHINGRIX was injected into left arm. Arm swelled, turned red and is still red. And somewhat swollen.    That evening I had chills and fever. Continued with fever the next day and flu like symptoms, aching, lack of appetite, slept a lot. Began feeling better afternoon of 2/25/2019.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: SHINGRIX was injected into left arm. Arm swelled, turned red and is still red. And somewhat swollen.    That evening I had chills and fever. Continued with fever the next day and flu like symptoms, aching, lack of appetite, slept a lot. Began feeling better afternoon of 2/25/2019.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Hyperaesthesia, Pain, Skin warm
Clinical narrative: Patient's arm is red, warm to touch. It is about 4 inches below the injection site. It is about 5-7 inches in diameter. It is sore and sensitive to touch.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Medication error. Mother made aware of error MMRV and Varicella administered simultaneously.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever of 104, body aches, nausea, headache, and cough.
Age: 0.33
Sex: M
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: Information has been received from a nurse referring to a 4 month old male patient. The patient had no relevant medical history or concomitant medications. On 18-FEB-2019, the patient was unintentionally administered a GARDASIL 9 (0.5 ml, intramuscularly into unknown which leg, lot # R020948, expiration date 04-MAY-2020) for prophylaxis. The nurse reported that the GARDASIL 9 was in a PREVNAR box and was administered to the patient by accident instead of PREVNAR (wrong product administered). At the time of the report, the patient had no untoward reaction as a result of the unintentional administration of GARDASIL 9, which was not a vaccine inidicated for his age group. As of 18-FEB-2019, it was unknown if the patient would receive additional GARDASIL 9 doses in the future, and the outcome of the unintentional administration of GARDASIL 9 was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from unspecified reporter (clinical research coordinator) regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medication were unknown. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ (strength, dose, frequency, route not reported) lot # R016790 and expiry date 20-APR-2020 for prophylaxis (product storage error). The vaccine underwent temperature excursion of 2 degree Celsius (1.6 C) for 22 hours and 10 minutes and total time of temperature excursion of vaccine was 9 degree Celsius (10.6 C) for 2 days 14 hours 57 minutes. Previously no temperature excursion was reported. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refering to a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 16-NOV-2018, 23-JAN-2019 and 20-FEB-2019, the patient was vaccinated with doses of GARDASIL 9 1 dosage form, intramuscular for prophylaxis (strength, frequency, lot number and expiration date were not reported). No adverse effects were reported.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Inappropriate schedule of product administration, Injection site pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 76-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included VALTREX tablet for shingles. The patient's past medical history included shingles (in 2016 on her breasts associated with swelling and welts), swelling and welts. On 6th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the patient started VALTREX at an unknown dose and frequency. On 14th February 2019, the dose was changed to an unknown dose and frequency. On 6th February 2019, not applicable after receiving SHINGRIX and unknown after starting VALTREX, the patient experienced inappropriate schedule of drug administration. In February 2019, the patient experienced extensive swelling of vaccinated limb, erythema, pruritus, muscle pain, injection site pain and stress. On an unknown date, the patient experienced inappropriate dose of drug administered. VALTREX was continued with no change. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema, pruritus, muscle pain, injection site pain, stress, inappropriate schedule of drug administration and inappropriate dose of drug administered were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema, pruritus, muscle pain, injection site pain and stress to be related to SHINGRIX. It was unknown if the reporter considered the stress to be related to VALTREX. Additional details were received as follows: The patient was on VALTREX as maintenance dose prescribed to her by her eye doctor. The patient was supposed to take the VALTREX every day but she has only been taking it three times a week prior to receiving SHINGRIX vaccine, which led to inappropriate schedule of drug administration and inappropriate dose of drug administered. The stopped taking VALTREX before she received the SHINGRIX. The patient received SHINGRIX in the left arm. The patient experienced itching, redness and swelling below the injection site which went all the way down to her elbow. The patient also experienced muscle pain and pain at injection site. These side effects were progressively getting worse, except the redness which was not as bad as before. On 14th February 2019, the patient started taking VALTREX 1g three times a day that she had on hand from before. On 15th February 2019, the patient met with an accident as someone hit her from the back, and this has caused increase in stress. At the time of reporting, the patient had an appointment scheduled with her dermatologist. The reporter did not consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Stress
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 76-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included VALTREX tablet for shingles. The patient's past medical history included shingles (in 2016 on her breasts associated with swelling and welts), swelling and welts. On 6th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the patient started VALTREX at an unknown dose and frequency. On 14th February 2019, the dose was changed to an unknown dose and frequency. On 6th February 2019, not applicable after receiving SHINGRIX and unknown after starting VALTREX, the patient experienced inappropriate schedule of drug administration. In February 2019, the patient experienced extensive swelling of vaccinated limb, erythema, pruritus, muscle pain, injection site pain and stress. On an unknown date, the patient experienced inappropriate dose of drug administered. VALTREX was continued with no change. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema, pruritus, muscle pain, injection site pain, stress, inappropriate schedule of drug administration and inappropriate dose of drug administered were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema, pruritus, muscle pain, injection site pain and stress to be related to SHINGRIX. It was unknown if the reporter considered the stress to be related to VALTREX. Additional details were received as follows: The patient was on VALTREX as maintenance dose prescribed to her by her eye doctor. The patient was supposed to take the VALTREX every day but she has only been taking it three times a week prior to receiving SHINGRIX vaccine, which led to inappropriate schedule of drug administration and inappropriate dose of drug administered. The stopped taking VALTREX before she received the SHINGRIX. The patient received SHINGRIX in the left arm. The patient experienced itching, redness and swelling below the injection site which went all the way down to her elbow. The patient also experienced muscle pain and pain at injection site. These side effects were progressively getting worse, except the redness which was not as bad as before. On 14th February 2019, the patient started taking VALTREX 1g three times a day that she had on hand from before. On 15th February 2019, the patient met with an accident as someone hit her from the back, and this has caused increase in stress. At the time of reporting, the patient had an appointment scheduled with her dermatologist. The reporter did not consent to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Thirst
Clinical narrative: This is a spontaneous report from a contactable nurse. An adult female patient received PREVNAR 13, (lot number: X13847, expiration date: 01Jul2020), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously took a dose of PREVNAR 13 on Jan2016 for immunization. It was reported that the patient just had a pneumococcal PREVNAR 13 injection on Tuesday (unspecified date), and they found out or realized that they just had the injection also in Jan2016 so they wanted to check, the wife or the patient herself, she noticed that she was very thirsty, well extremely thirsty and she did not know that if that was the side effect and she also wanted to know if there might be any long term effects of just having the injection two times. The outcome of the events was unknown.
Sex: M
Vaccine: MENB
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 14Feb2019, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician received via a sales representative. The physician reported similar event for 2 patients. This is the 1st of 2 reports. An 18-year-old male patient received TRUMENBA, lot number and expiration date was not provided, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced flu like symptoms, fever 102 x 2 days, large area red and sore at site for both doses. The outcome of the events was unknown. Information on the lot number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2019080961 Same reporter/product, similar event, different patient.
Sex: F
Vaccine: MENB
Symptoms: Influenza like illness
Clinical narrative: The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 14Feb2019 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician received via a sales representative. The physician reported similar event for 2 patients. This is the 2nd of 2 reports. A 17-year-old female patient received TRUMENBA, lot number and expiration date was not provided, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced flu like symptoms on an unspecified date. The outcome of the event was unknown. Information on the lot number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2019080948 Same reporter/product, similar event, different patient.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Exposure during pregnancy, Gestational diabetes, Ultrasound antenatal screen normal
Clinical narrative: This is a serious observational study case, initially received from other health professional on 15-Feb-2019, concerning a 31-year-old, adult female pregnant subject of body weight: 222 lbs, height: 62  inches and body mass index (BMI): 40.6, a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy. The subject had 1 previous pregnancy with preterm-term live birth. There was no history of maternal or paternal congenital malformation. The subject had not used tobacco, alcohol or elicit drugs during pregnancy. The subject's current conditions included late prenatal care, acid reflux, depression, anxiety and Rh-negative. The subject's concomitant medications included RHoGAM (anti-D immunoglobulin) for RH negative and Prilosec (omeprazole) for acid reflux. The subject's last menstrual period (LMP) date was 15-Apr-2018. On 20-Sep-2018, at gestational age of 22 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252226, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication. On 23-Sep-2018, maternal Serum Alpha-Fetoprotein Screening (MSAFP) was performed and no major congenital malformation noted. On 02-Oct-2018, ultrasound was performed, and no major congenital malformation noted. On 08-Jan-2019, 3 months and 19 days after vaccination, the subject experienced gestational diabetes mellitus and anaemia. The subject received treatment drug metformin (500 mg, oral, 2 tablets qd, from 24-Jan-2019) and Humulin (insulin human, insulin human injection, isophane, 100 units, qd, subcutaneous, from 31-Jan-2019) for gestational diabetes mellitus. The subject had not yet recovered from the events. The subject's estimated delivery date (EDD) was reported as 25-Feb-2019.; Reporter's Comments: A 31-year-old female pregnant subject with late prenatal care experienced gestational diabetes mellitus and anaemia, 3 months and 19 days after receipt of study vaccine. Considering the implausible temporal relationship between vaccination and reported events and no evidence for a biological mechanism that could cause the events, the events were assessed as not related to the study product. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event drug exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The reporter assessed the case as serious (medically significant).
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Delirium, Erythema, Injection site pain, Pyrexia
Clinical narrative: Soreness at site of injection 5:30 p.m. High fever - delirious 8:30 p.m. Confusion - later. Next day developed severe rash around head/hairline. Treated w/CORTIZONE 10 creme. Red skin remains.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Soreness at site of injection 5:30 p.m. High fever - delirious 8:30 p.m. Confusion - later. Next day developed severe rash around head/hairline. Treated w/CORTIZONE 10 creme. Red skin remains.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Activated partial thromboplastin time normal, Apparent life threatening event, Arthropathy, CSF cell count normal, CSF protein normal
Clinical narrative: Fussy, restless, no sleep after vaccines. After 28 hours of vaccine administration, weird involuntary movements of extremities, starting right upper limb, moving to Rt leg - Lt leg - Lt upper limb; dystonic movements described. Tics on face also with eye involvement. At 36 hrs, acute life threatening event while in mom's arm, arching, slowed breathing, tongue rolling back. Needed mom's intervention to open airway. Lasted 20 seconds. Baby dazed. Taken to ER. Similar episode at 40 hrs. Hospitalized to date. Continued twitches, dystonic movement in Hosp. Somewhat better. Had Sats initially. Neck stiffness, buckling knees episodic. Reflexes intact. No fever. No LOC even though dazed off and on. No obvious seizures. No resp symptoms. Feeding mostly well. IV BENADRYL helps.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF red blood cell count positive, CSF test, Dystonia, Electroencephalogram normal, Feeling abnormal
Clinical narrative: Fussy, restless, no sleep after vaccines. After 28 hours of vaccine administration, weird involuntary movements of extremities, starting right upper limb, moving to Rt leg - Lt leg - Lt upper limb; dystonic movements described. Tics on face also with eye involvement. At 36 hrs, acute life threatening event while in mom's arm, arching, slowed breathing, tongue rolling back. Needed mom's intervention to open airway. Lasted 20 seconds. Baby dazed. Taken to ER. Similar episode at 40 hrs. Hospitalized to date. Continued twitches, dystonic movement in Hosp. Somewhat better. Had Sats initially. Neck stiffness, buckling knees episodic. Reflexes intact. No fever. No LOC even though dazed off and on. No obvious seizures. No resp symptoms. Feeding mostly well. IV BENADRYL helps.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Full blood count normal, Infantile back arching, Insomnia, Irritability, Metabolic function test normal
Clinical narrative: Fussy, restless, no sleep after vaccines. After 28 hours of vaccine administration, weird involuntary movements of extremities, starting right upper limb, moving to Rt leg - Lt leg - Lt upper limb; dystonic movements described. Tics on face also with eye involvement. At 36 hrs, acute life threatening event while in mom's arm, arching, slowed breathing, tongue rolling back. Needed mom's intervention to open airway. Lasted 20 seconds. Baby dazed. Taken to ER. Similar episode at 40 hrs. Hospitalized to date. Continued twitches, dystonic movement in Hosp. Somewhat better. Had Sats initially. Neck stiffness, buckling knees episodic. Reflexes intact. No fever. No LOC even though dazed off and on. No obvious seizures. No resp symptoms. Feeding mostly well. IV BENADRYL helps.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Muscle twitching, Muscular weakness, Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: Fussy, restless, no sleep after vaccines. After 28 hours of vaccine administration, weird involuntary movements of extremities, starting right upper limb, moving to Rt leg - Lt leg - Lt upper limb; dystonic movements described. Tics on face also with eye involvement. At 36 hrs, acute life threatening event while in mom's arm, arching, slowed breathing, tongue rolling back. Needed mom's intervention to open airway. Lasted 20 seconds. Baby dazed. Taken to ER. Similar episode at 40 hrs. Hospitalized to date. Continued twitches, dystonic movement in Hosp. Somewhat better. Had Sats initially. Neck stiffness, buckling knees episodic. Reflexes intact. No fever. No LOC even though dazed off and on. No obvious seizures. No resp symptoms. Feeding mostly well. IV BENADRYL helps.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Obstructive airways disorder, Opisthotonus, Prothrombin time normal, Respiratory disorder, Respiratory rate decreased
Clinical narrative: Fussy, restless, no sleep after vaccines. After 28 hours of vaccine administration, weird involuntary movements of extremities, starting right upper limb, moving to Rt leg - Lt leg - Lt upper limb; dystonic movements described. Tics on face also with eye involvement. At 36 hrs, acute life threatening event while in mom's arm, arching, slowed breathing, tongue rolling back. Needed mom's intervention to open airway. Lasted 20 seconds. Baby dazed. Taken to ER. Similar episode at 40 hrs. Hospitalized to date. Continued twitches, dystonic movement in Hosp. Somewhat better. Had Sats initially. Neck stiffness, buckling knees episodic. Reflexes intact. No fever. No LOC even though dazed off and on. No obvious seizures. No resp symptoms. Feeding mostly well. IV BENADRYL helps.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Restlessness, Tic, Tongue movement disturbance, Unresponsive to stimuli, Upper airway obstruction
Clinical narrative: Fussy, restless, no sleep after vaccines. After 28 hours of vaccine administration, weird involuntary movements of extremities, starting right upper limb, moving to Rt leg - Lt leg - Lt upper limb; dystonic movements described. Tics on face also with eye involvement. At 36 hrs, acute life threatening event while in mom's arm, arching, slowed breathing, tongue rolling back. Needed mom's intervention to open airway. Lasted 20 seconds. Baby dazed. Taken to ER. Similar episode at 40 hrs. Hospitalized to date. Continued twitches, dystonic movement in Hosp. Somewhat better. Had Sats initially. Neck stiffness, buckling knees episodic. Reflexes intact. No fever. No LOC even though dazed off and on. No obvious seizures. No resp symptoms. Feeding mostly well. IV BENADRYL helps.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Electroencephalogram normal, Febrile convulsion
Clinical narrative: 3/4/18 Pt went to E.D. for complex febrile seizure. EEG done no abnormalities.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Apnoea, Electroencephalogram normal, Febrile convulsion, Generalised tonic-clonic seizure, Influenza
Clinical narrative: 3/4/18 Pt went to E.D. for complex febrile seizure. EEG done no abnormalities.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Nuclear magnetic resonance imaging normal, Pneumonia, Seizure, Staring
Clinical narrative: 3/4/18 Pt went to E.D. for complex febrile seizure. EEG done no abnormalities.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Pt c/o chills, nausea and low grade fever x 2 days after receiving vaccine. Also c/o redness and swelling of the injection site. Redness and swelling have improved by time of reporting, but still mild.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Hypersensitivity, Pruritus generalised, Rash generalised
Clinical narrative: The day after the vaccines were administered the child developed generalize rash in face, chest, back and arms and itchiness. Mother took child to ER where he received IV medication for allergies. The day after treatment all rash was gone and the child completely recuperated.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Diarrhoea, Pain, Screaming
Clinical narrative: She awoke from being sound asleep to screaming the loudest, screeching, cry that I have ever heard before. She had never made this type of cry before and hasn't since. She screamed in pain for 45 minutes-1 hour inconsolably. Nothing I did consoled her, not feeding, rocking, shhing, bouncing, diaper change, absolutely nothing. Prior to this incidence, she was never inconsolable like this, had never screamed like this, had never cried longer than a few minutes. She's generally a very happy, easy baby who doesn't fuss. I called the nurse line while she screamed in pain and I had to scream over her cries to the nurse who instructed me to giver her Tylenol every 4 hours, which I did. She screamed/cried, red-faced and pained looking, on and off for the continuation of the night. She had to be held to sleep and if we moved even the slightest bit she awoke screaming in pain. We had to be careful not to touch her legs while holding her. The leg that she had two shots on had redness and swelling at the injection site as well. I think this was her right leg. She also had terrible diarrhea.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left arm above the elbow area is red, swollen, painful.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Hypersensitivity, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Patient was given Men B vaccine and went home and later her arm was little sore and red. Some itching. Patient went to bed and woke in am with hives all over body. Patient went to Urgent Care for hives told allergic reaction to either Men B or new drug she started same day as Men B (ZOLOFT). Patient's hives cleared and she came in for follow up with Dr. to discuss reaction. Dr. felt it was from the Men B and had patient continue with ZOLOFT.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Death
Clinical narrative: The decedent's condition didn't get better. 2 days after the vaccine, he was dead.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, HPV9, IPV, MMR, TDAP
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Per guardian child had pain to site, later developed redness and swelling to site that lasted 2 weeks. Child continues to complain of pain with movement of left arm. Child was brought in today by guardian. Upon inspection of site no redness or swelling to site was noted. Child complained of having discomfort with movement of left arm and pain at night. No other problems at this time.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Syncope
Clinical narrative: Patient was injected IM with SHINGRIX 50mcg in his left arm at approximately 12:03pm. While walking away from the pharmacy with a shopping cart, he slowly fell to the ground, fainted. He did not hit his head, or lose consciousness. 911 was called and took care of the patient.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Body temperature increased, Feeling cold, Injection site erythema, Injection site warmth
Clinical narrative: Patient stated feeling cold on the day after vaccination. Had a temperature of 102 degrees. Patient passed out later in the afternoon on Friday and woke up on the floor. Patient had increased blood pressure at doctor's appointment today (146/?), normally 118/?. Injection site is extremely red and covers most of upper arm, hot to the touch.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: Patient stated feeling cold on the day after vaccination. Had a temperature of 102 degrees. Patient passed out later in the afternoon on Friday and woke up on the floor. Patient had increased blood pressure at doctor's appointment today (146/?), normally 118/?. Injection site is extremely red and covers most of upper arm, hot to the touch.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that the VARIVAX subcutaneously, lot # R002507, expiration date 25-JAN-2022, indicated for prophylaxis (strength and dose were not provided), underwent multiple excursions since August 2018 and, on 16-OCT-2018 the vaccine VARIVAX was administered to one patient. The administered dose of the vaccine experienced a temperature excursion since August 2018 to 31-JAN-2019, the reported excursions were: 6 °Fahrenheit (F) to 14 °F (8.7F) for 15 minutes. 6 °F to 14 °F (8.7F) for 45 minutes. 15 °F to 46 °F (17.6F) for 2 hours. 15 °F to 146°F (19F) for 1 hour and 45 minutes. 6 °F to 14 °F (8.8F) for 15 minutes. 15 °F to 46 °F (20.5F) for 2 hours. 6 °F to 14 °F (12.8F) for 2 hour and 45 minutes. 6 °F to 14 °F (5.95F) for 15 minutes. 6 °F to 14 °F (8.8F). There was a digital data logger involved, and there was previous temperature excursion. No adverse effect was reported.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pyrexia
Clinical narrative: This spontaneous report was received from a physician concerning a 12 year old female patient. The patient's medical history, historical drug, concurrent condition and concomitant therapy details were not reported. On an unknown date, the patient was vaccinated with GARDASIL lot # H021861 expiration date: 09-OCT-2015 (dose, frequency, route and anatomical location were not provided) for prophylaxis. On an unknown date, post vaccination the patient had fever up to 103 Fahrenheit and dizziness. The patient was given with TYLENOL for fever. After 3 days, the patient was afebrile and considered to be recovered. No product quality complaint was reported. Causality assessment was not provided by the reporter.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 13-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours on 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323  US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009326: Original Case : 1902USA009323.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 11-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 month old child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 07-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours on 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868 US-009507513-1902USA009324:Original Case : 1902USA009323 US-009507513-1902USA009325:Original Case : 1902USA009323 US-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Pain, Sunburn
Clinical narrative: Tiredness, chills, shivering, achy, skin feels sunburned.
Age: 1.75
Sex: M
Vaccine: FLU4, MMR
Symptoms: Blood potassium increased, Decreased eye contact, Hair metal test abnormal, Language disorder, Loss of personal independence in daily activities
Clinical narrative: Patient began losing language, lost daily living skills, and stopped making eye contact with others.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Redness, itchy and tenderness at site of injection. Injection given on Sunday 2/2/2019 patient noticed small reaction but didn't think much of it. On Tuesday 02/05/2019, patient had surgery and nurse noted red area on arm.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Surgery
Clinical narrative: Redness, itchy and tenderness at site of injection. Injection given on Sunday 2/2/2019 patient noticed small reaction but didn't think much of it. On Tuesday 02/05/2019, patient had surgery and nurse noted red area on arm.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Myalgia, Pharyngeal swelling, Pyrexia
Clinical narrative: Fever. Muscle aches. Some, though minimal, swelling of tongue and throat. Severe Chills. Fever. Some difficulty breathing at first.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Swollen tongue
Clinical narrative: Fever. Muscle aches. Some, though minimal, swelling of tongue and throat. Severe Chills. Fever. Some difficulty breathing at first.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: Was received Pneumo23, was supposed to get PREVNAR 13 - will return one year from now for PREVNAR 13.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Eye injury, Fall, Lip injury
Clinical narrative: Patient received the flu shot then got in line to pick up a Rx. 5-10 minutes after the shot and while being helped at the counter he fell forward and hit his eye and lip on the counter. He then laid down and waited for paramedics to arrive. He left with them after they checked him out. I am not certain his status at this point.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Eating disorder, Tremor, Vomiting
Clinical narrative: A couple of days after the vaccine she developed chills, vomiting, tremors and had difficulty eating for 3 weeks. She called her physician and then went in to see her. The physician suggested not to receive the flu vaccine in the future.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Blood magnesium, Borrelia test, C-reactive protein, Dental examination
Clinical narrative: Headache, joint pain, myalgia, tingling, neck pain, jaw/tooth pain, concentration issue/problems neck/back stiffness, flu like symptoms, general unwell feeling.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Differential white blood cell count, Disturbance in attention, Ear, nose and throat examination, Full blood count, Headache
Clinical narrative: Headache, joint pain, myalgia, tingling, neck pain, jaw/tooth pain, concentration issue/problems neck/back stiffness, flu like symptoms, general unwell feeling.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Influenza like illness, Laboratory test, Malaise, Metabolic function test, Musculoskeletal discomfort
Clinical narrative: Headache, joint pain, myalgia, tingling, neck pain, jaw/tooth pain, concentration issue/problems neck/back stiffness, flu like symptoms, general unwell feeling.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Myalgia, Neck pain, Nuclear magnetic resonance imaging, Ophthalmological examination
Clinical narrative: Headache, joint pain, myalgia, tingling, neck pain, jaw/tooth pain, concentration issue/problems neck/back stiffness, flu like symptoms, general unwell feeling.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in jaw, Paraesthesia, Red blood cell sedimentation rate, Scan with contrast, Toothache
Clinical narrative: Headache, joint pain, myalgia, tingling, neck pain, jaw/tooth pain, concentration issue/problems neck/back stiffness, flu like symptoms, general unwell feeling.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Urine analysis, X-ray dental
Clinical narrative: Headache, joint pain, myalgia, tingling, neck pain, jaw/tooth pain, concentration issue/problems neck/back stiffness, flu like symptoms, general unwell feeling.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Fatigue, Headache, Injection site bruising, Injection site erythema
Clinical narrative: Swollen red hot injection site continued to swell heat and redness spread for 11 days to 3 inches wide by 4 inches long, still have bruising and tenderness with small hard bump about size of quarter at injection site 14 days after injecton ,severe headache 7 days, Pain in left arm, armpit, down ribs and up neck 9 days, Swollen lymph nodes in left armpit, neck and under chin 10 days, sleepiness & Fatigue 13 days, Increased urination 12 days.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Lymphadenopathy, Musculoskeletal chest pain
Clinical narrative: Swollen red hot injection site continued to swell heat and redness spread for 11 days to 3 inches wide by 4 inches long, still have bruising and tenderness with small hard bump about size of quarter at injection site 14 days after injecton ,severe headache 7 days, Pain in left arm, armpit, down ribs and up neck 9 days, Swollen lymph nodes in left armpit, neck and under chin 10 days, sleepiness & Fatigue 13 days, Increased urination 12 days.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain in extremity, Pollakiuria, Somnolence
Clinical narrative: Swollen red hot injection site continued to swell heat and redness spread for 11 days to 3 inches wide by 4 inches long, still have bruising and tenderness with small hard bump about size of quarter at injection site 14 days after injecton ,severe headache 7 days, Pain in left arm, armpit, down ribs and up neck 9 days, Swollen lymph nodes in left armpit, neck and under chin 10 days, sleepiness & Fatigue 13 days, Increased urination 12 days.
Sex: U
Vaccine: HIBV, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager concerning unspecified patients of unknown age and gender. Information on the patient's concomitant medications, pertinent medical history and drug reactions or allergies was unknown. On an unknown date (reported as "between the months of "May to July""), the patients were vaccinated with improperly stored GARDASIL 9 lot # N017697, expiry date: 21-JAN-2020 and LIQUID PEDVAXHIB lot# N024572, expiry date: 02-MAY-2020 for prophylaxis (dosing details not reported for both). No adverse effects were reported. Time frame of temperature excursion were from 32 degree Fahrenheit to 35 degree Fahrenheit for 192 hours and 47 degree Fahrenheit to 77 degree Fahrenheit for 122 hours 30 minutes. Previous temperature excursion was 47 degree Fahrenheit to 77 degree Fahrenheit for 7 hours. Data logger was involved. No product quality complaint (PQC) was involved.