chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient who got one of the three doses of Gardasil 9; This spontaneous report was received from a pharmacist concerning a female patient of unknown age. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) via intramuscular for prophylaxis (strength, and anatomical location were not reported; lot number and expiration date were unknown by the reporter). However, that was the only dose received by the patient (reported as got one of the three doses). Therefore, on 17-AUG-2020, the patient experienced inappropriate schedule of product administration. The outcome of inappropriate schedule of product administration was unknown.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Decreased appetite, Diarrhoea, Erythema, Injection site erythema, Injection site induration
Clinical narrative: Reaction at vaccination site, red; Reaction at vaccination site...red, sore; Reaction at vaccination site...red, sore, hard; Lethargy; Loss of appetite; Loose bowel movement; Red in area distal to injection; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   In August 2020, the patient received Bexsero. In August 2020, less than a week after receiving Bexsero, the patient experienced injection site erythema, injection site pain, injection site induration, lethargy, appetite lost, loose bowel and erythema. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site induration, lethargy, appetite lost, loose bowel and erythema were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site induration, lethargy, appetite lost, loose bowel and erythema to be related to Bexsero.  Additional information was provided as follows: The patient was almost 19 years old. The patient received Bexsero one week prior to the date of reporting and had reaction at vaccination site which included red, sore, hard. Then lethargy, loss of appetite and loose bowel movement. After 3 days, The adverse events started to improve and at the time of reporting, now the patient had redness in area distal to injection. The follow up was not possible.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Lethargy
Clinical narrative: Reaction at vaccination site, red; Reaction at vaccination site...red, sore; Reaction at vaccination site...red, sore, hard; Lethargy; Loss of appetite; Loose bowel movement; Red in area distal to injection; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   In August 2020, the patient received Bexsero. In August 2020, less than a week after receiving Bexsero, the patient experienced injection site erythema, injection site pain, injection site induration, lethargy, appetite lost, loose bowel and erythema. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site induration, lethargy, appetite lost, loose bowel and erythema were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site induration, lethargy, appetite lost, loose bowel and erythema to be related to Bexsero.  Additional information was provided as follows: The patient was almost 19 years old. The patient received Bexsero one week prior to the date of reporting and had reaction at vaccination site which included red, sore, hard. Then lethargy, loss of appetite and loose bowel movement. After 3 days, The adverse events started to improve and at the time of reporting, now the patient had redness in area distal to injection. The follow up was not possible.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: experiencing itchiness; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received Shingrix. In August 2020, less than 2 weeks after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix two weeks prior to the report, and at the time of report the patient experienced itchiness. The patient wanted to ask if this was side effect of Shingrix. The follow up is not possible.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feeling crappy; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingrix.  Additional details were reported as follows: The patient had his first injection and did not have any side effects except  feeling crappy. The reporter did not consent to follow up. This case is linked to case US2020164435, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020164435:same reporter
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Nephropathy
Clinical narrative: nephropathy; shingles rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose either January or March 2020).   On 19th June 2020, the patient received the 2nd dose of Shingrix. On 5th July 2020, 16 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced nephropathy. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the nephropathy was not recovered/not resolved.   It was unknown if the reporter considered the shingles and nephropathy to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and diagnosed with shingles. The shingles rash has resolved but the nephropathy has not. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Post herpetic neuralgia, Pruritus, Pustule
Clinical narrative: nephropathy; shingles rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose either January or March 2020).   On 19th June 2020, the patient received the 2nd dose of Shingrix. On 5th July 2020, 16 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced nephropathy. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the nephropathy was not recovered/not resolved.   It was unknown if the reporter considered the shingles and nephropathy to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and diagnosed with shingles. The shingles rash has resolved but the nephropathy has not. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: nephropathy; shingles rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose either January or March 2020).   On 19th June 2020, the patient received the 2nd dose of Shingrix. On 5th July 2020, 16 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced nephropathy. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the nephropathy was not recovered/not resolved.   It was unknown if the reporter considered the shingles and nephropathy to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and diagnosed with shingles. The shingles rash has resolved but the nephropathy has not. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: sore arm (on injection site arm); has not yet received the second shot; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received in 2008).   In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The received 1st dose of Shingrix in July 2018 and she thought that she might had a sore arm (on injection site arm) but she was not 100 persent sure. She indicates that she always has a sore arm after injections.  She indicated that she did not experience (systemic) side effects. Till the time of reporting the patient did not received 2nd dose which led to  No further information was collected due to reporter reluctance and the fact that the first shot was in 2018.  The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159659:Same reporter
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received Trumemba vaccine instead of Menactra, No AE; Initial information received on 10-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to 2020SA209115 (same reporter).  This case involves a 16-years-old male patient who received MENINGOCOCCAL VACCINE B RFHBPA/FHBPB [TRUMENBA] (not produced by Sanofi Pasteur) (batch number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination on 03-Aug-2020 instead of second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's medical history, past medical treatment, vaccinations, family history and concomitant medication were not provided.  It was an actual medication error case due to wrong vaccine administered.  The patient has not had any adverse reactions to this and is not currently behind in his Menactra doses.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient came in on morning of 8/19 complaining of severe pain from right shoulder down arm. She explained she was vaccinated on 8/17 and started experiencing symptoms 8/18. Patient did not experience difficulty lifting arm, numbness, or tingling sensation when asked. She explained her symptoms as a severe, dull, ache throughout her arm. She took Advil on 8/18 to help with discomfort. I recommended her use cool compress to alleviate the area and continue using NSAIDs for pain relief, and if symptoms do not begin to resolve in a few days to contact PCP.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: I am describing side effects experienced by me.   I had nausea, sore arm, headaches.  None of these effects are normal for me.  I have also had shingles twice (small outbreaks caught early) and had chicken pox as a child.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea
Clinical narrative: extreme diarrhea and nausea for about 3 hours
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Fever (100.7), vomiting, nausea, diarrhea, near Syncope, dizziness, redness and swelling size of baseball to left arm (injection area), hot to touch, and tenderness.  Missed two days of work from symptoms.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Loss of personal independence in daily activities, Nausea, Presyncope, Pyrexia
Clinical narrative: Fever (100.7), vomiting, nausea, diarrhea, near Syncope, dizziness, redness and swelling size of baseball to left arm (injection area), hot to touch, and tenderness.  Missed two days of work from symptoms.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Fever (100.7), vomiting, nausea, diarrhea, near Syncope, dizziness, redness and swelling size of baseball to left arm (injection area), hot to touch, and tenderness.  Missed two days of work from symptoms.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain, Rash
Clinical narrative: Patient started experiencing severe pain, patient went to ER and was later diagnosed with Shingles after vaccine was administered. Patient had nerve pain and active rash. Patient was treated by PCP.  Shingles is still not fully cleared.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient was administered expired Vaqta; This spontaneous report as received from a registered nurse refers to an 8 years old male patient. Information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was not reported.  On 09-AUG-2020 (on Saturday), the patient was vaccinated with an expired dose of pediatric hepatitis a vaccine, inactivated (VAQTA) (dose, route of administration and lot# were not reported, expiration date 24-JUL-2020), for prphylaxis.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was recovered/resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The reporter was the patient's friend. The age at vaccination was not reported. After receiving Influenza vaccine, the patient experienced Guillain barre syndrome. The reporter stated that, it took over a year for the patient to recover. The reporter stated it was life changing. This case is 1 of 3 linked cases, reported by the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR164914:same reporter US-GLAXOSMITHKLINE-US2020AMR164910:same reporter
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: arm ache; arm swelling; swelling that extended all over the elbow.; adverse event extended to elbow/ arm ache and arm swelling that extended all over the elbow.; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number L7S74, expiry date 26th March 2022) for prophylaxis.   On 2nd June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm, swelling arm, swelling of elbows and pain in elbow. On an unknown date, the outcome of the pain in arm, swelling arm, swelling of elbows and pain in elbow were unknown.   It was unknown if the reporter considered the pain in arm, swelling arm, swelling of elbows and pain in elbow to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced arm ache and arm swelling that extended all over the elbow. The reporter consented to follow up.  No further details were provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Malaise, Pain
Clinical narrative: was so sick; body aches; she may get a 3rd Shingrix shot; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix and the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced malaise, general body pain and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the malaise, general body pain and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the malaise and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient was so sick.  The patient had body aches. The reporter stated that, the pharmacy failed to record her 1st dose and the patient's job was requiring proof of 2 doses so might get a 3rd Shingrix dose (circumstance or information capable of leading to medication error).
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Rash
Clinical narrative: Shingles rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rash (noted a rash prior to getting Shingrix).   On 14th August 2020, the patient received the 1st dose of Shingrix. On 15th August 2020, 1 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The GSK rep notes the patient was his wife and noted the patient noticed a rash prior to getting Shingrix.  The patient went to her primary care provider, but the provider did not look at the rash and administered dose one of Shingrix.  The patient went to Urgent Care and the rash was diagnosed as shingles. Since the rash began it had increased in size, no exact size provided.
Age: 12.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Blood test normal, Computerised tomogram normal, Hypoaesthesia, Loss of consciousness, Muscle tightness
Clinical narrative: Less than 10 minutes after receiving the vaccine, he had a seizure in the car on the way home. He said his vision went fuzzy, he lost feeling in his arms and legs and then passed out. I pulled over immediately and got out of the car to assist him in the back seat. When I got to the back seat, he had a seizure (right arm tensed and he urinating himself). He stopped breathing for 10-20 seconds and came to before I initiated CPR. I am a healthcare provider myself.
Age: 12.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Respiratory arrest, Resuscitation, Seizure, Urinary incontinence, Vision blurred
Clinical narrative: Less than 10 minutes after receiving the vaccine, he had a seizure in the car on the way home. He said his vision went fuzzy, he lost feeling in his arms and legs and then passed out. I pulled over immediately and got out of the car to assist him in the back seat. When I got to the back seat, he had a seizure (right arm tensed and he urinating himself). He stopped breathing for 10-20 seconds and came to before I initiated CPR. I am a healthcare provider myself.
Age: 12.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Agitation, Apnoea, Computerised tomogram, Fear, Seizure
Clinical narrative: Less than 10 minutes after receiving the vaccine, he had a seizure in the car on the way home. He said his vision went fuzzy, he lost feeling in his arms and legs and then passed out. I pulled over immediately and got out of the car to assist him in the back seat. When I got to the back seat, he had a seizure (right arm tensed and he urinating himself). He stopped breathing for 10-20 seconds and came to before I initiated CPR. I am a healthcare provider myself.
Age: 23.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swollen, red, warm and painful to touch.  Symptoms resolved in 72 hours.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face, Tooth disorder, X-ray dental normal
Clinical narrative: Client reports that 6 days after vaccine on 8/19/20 , he was cooking and tasting his food  during the process. As they sat down to eat , the right side of his face and jaw area swelled up like "elephant man". He thought it was a tooth problem and had the dentist do an x-ray which was negative . The swelling decreased last night by 70 percent but still has residual today. Instructed client to call his physician.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenopia, Decreased appetite, Malaise, Muscle fatigue
Clinical narrative: Achy in joints, tired eyes and muscles, low grade fever 100 degrees tympanic, general malaise. loss of appetite
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Achy in joints, tired eyes and muscles, low grade fever 100 degrees tympanic, general malaise. loss of appetite
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Nurse reported administration ofROTATEQ after temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 23-JUL-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, orally, lot # 1676324 has been verified to be a valid lot number, expiration date 21-APR-2020 (frequency was not provided) for prophylaxis.   The the vaccine was stored in 8 Celsius degrees (C) (8.83 C) for 20 hours. There were no previous excursions reported. The storage was recorded by digital data logger. No adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects; an expired dose of properly stored VARIVAX which was inadvertently administered to a patient; This spontaneous report was received from a nurse, referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 27-JUL-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R009410, expiration date 29-MAR-2020 for prophylaxis (exact dose, route of administration were not provided). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT). There was no adverse effect reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; on 7/27/2020 a patient was administered an improperly stored dose of PROQUAD; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.    On 27-JUL-2020, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live  (PROQUAD) injection, lot # T001187, expiration date: 11-JUL-2021, albumin status has been verified as recombinant human albumin (rHA), subcutaneously for prophylaxis (strength, dose, frequency were not reported); which was reconstituted with properly stored sterile diluent, lot # S038697, expiration date: 10-AUG-2022. Administered dose of vaccine experienced the temperature excursion of 28.4 degrees Fahrenheit (F) for 6 hours and 38 minutes. Data logger was involved. There was no previous excursion reported. No adverse symptoms were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PEDVAX HIB was improperly stored and administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-JUL-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S031500, expiration date 21-APR-2022 (exact dose, frequency and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine was stored in 50 degrees Fahrenheit (F) for 1 hour and 46 minutes.  The improper storage was recoded by digital data logger. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA012014: US-009507513-2007USA012054: US-009507513-2007USA012060: US-009507513-2007USA012061: US-009507513-2007USA012124: US-009507513-2008USA000307: US-009507513-2008USA000314: US-009507513-2008USA000367: US-009507513-2008USA000370: US-009507513-2008USA000372:
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; The patient was vaccinated with improperly stored vaccines.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 09-MAR-2020, the patient was vaccinated with an improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live  recombinant Human albumin (rHA) (PROQUAD) 0.5 milliliter, subcutaneous in the left thigh, with lot# S030093, expiration date on 24-MAR-2021, and with diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid(KINRIX) (strength, frequency, and expiration date were unknown) 0.5 milliliter, intramuscular in the left thigh, with lot# PP9L5 for prophylaxis.   Administered doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced the temperature excursion between -14 and -10 degrees Celsius (-11.2C) for 3 hour and 42 minutes. There was a digital data logger invloved, but there was no previous temperature excursion. No adverse effects reported.  The temperarure excursion was no reported for the other vaccine.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA008876: US-009507513-2008USA008889: US-009507513-2008USA008890: US-009507513-2008USA008885: US-009507513-2008USA008883: US-009507513-2008USA008933: US-009507513-2008USA008875: US-009507513-2008USA008877: US-009507513-2003USA002275: US-009507513-2008USA008878: US-009507513-2008USA008879: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008882: US-009507513-2008USA008884: US-009507513-2008USA008886: US-009507513-2008USA008888: US-009507513-2008USA008887: US-009507513-2008USA008891: US-009507513-2008USA008892: US-009507513-2008USA008893: US-009507513-2008USA008894: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904: US-009507513-2008USA008905: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008879:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On 12th August 2020, couple of hours after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patient had her first shot in February or March. She developed a sore arm several hours later but it resolved in a day or so. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020160502.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020160502:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at the site of the injection; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The nurse practitioners said she had approximately five patients that had received the Shingrix vaccine over the last three months and complained of pain at the site of injection. The reporter consented to follow up.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Swelling
Clinical narrative: Large red spot; Swelling; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a 13-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 13th August 2020, the patient received Bexsero. In August 2020, less than a week after receiving Bexsero, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were not recovered/not resolved.   It was unknown if the reporter considered the erythema and swelling to be related to Bexsero.  Additional details were provided as follows: The case was reported by the parent of the patient. The age at vaccination was not reported. The patient received Bexsero booster 2 days ago and had a large red spot and swelling. The reporter wanted to know should he/she should be alarmed.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Malaise, Pain in extremity, Pyrexia
Clinical narrative: patient has not received the second dose; Sickness the day after the shot; The patient also reports a low grade fever; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. In 2019, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm. In November 2019, the patient experienced sickness and low grade fever. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the pain in arm, sickness and low grade fever were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm, sickness and low grade fever to be related to Shingrix.  Additional details were received as follows: The patient received his first dose of Shingrix in November last year.  Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The patient also reported a low grade fever, sickness the day after the shot, and arm  soreness with the first dose. The reporter consented o follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain at the injection site that woke him up; Some soreness in his arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2020 04:00, the patient received the 1st dose of Shingrix. On 11th August 2020, 4 days after receiving Shingrix, the patient experienced injection site pain. In August 2020, the patient experienced pain in arm. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain was unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix around 4:00 pm and experienced some soreness in his arm that resolved but last night the day of reporting he had a pain at the injection site that woke him up.  The patient took an Advil which helped.  At the time of reporting the pain resolved. This case linked with US2020159616, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159616:same reporter
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Nausea, Sensitive skin, Vomiting
Clinical narrative: Flu-like symptoms; Skin Sensitivity; Emesis; Nausea; Headache; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 4RF5J, expiry date 25th April 2022) and (batch number 57EE5, expiry date 25th April 2022) for prophylaxis.   On 31st July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th August 2020, 9 days after receiving Shingrix, the patient experienced influenza-like symptoms, sensitive skin, vomiting, nausea and headache. On an unknown date, the outcome of the influenza-like symptoms, sensitive skin, vomiting, nausea and headache were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, sensitive skin, vomiting, nausea and headache to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on left arm and experienced flu-like symptoms: headache, nausea, vomiting and skin sensitivity approximately 10 days after. The reporter did state the patient was starting to feel better but not fully recovered. The reporter consented for follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Lymphoma
Clinical narrative: Lymphoma; This case was reported by a consumer via call center representative and described the occurrence of lymphoma in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced lymphoma (serious criteria GSK medically significant). On an unknown date, the outcome of the lymphoma was unknown.   It was unknown if the reporter considered the lymphoma to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient was diagnosed with lymphoma after receiving vaccine. The reporter consented to follow up. All information was not available.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Bartonella test negative, C-reactive protein normal, Differential white blood cell count normal, Full blood count normal, Inflammation
Clinical narrative: Five days after receiving the Shingrix vaccine in my left upper arm, I noticed an inflamed lymph node in my left clavicle area.  Node remained inflamed, and on 6/3 I noticed a rash on that arm.  At the end of the day on 6/4 I noticed that my left arm was swollen significantly (enough to notice by just looking at it).  Rash persisted until late July, swollen arm and swollen lymph node persist to this day (8/20) although severity is reduced.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Peripheral swelling, Rash, Red blood cell sedimentation rate normal, Ultrasound scan normal
Clinical narrative: Five days after receiving the Shingrix vaccine in my left upper arm, I noticed an inflamed lymph node in my left clavicle area.  Node remained inflamed, and on 6/3 I noticed a rash on that arm.  At the end of the day on 6/4 I noticed that my left arm was swollen significantly (enough to notice by just looking at it).  Rash persisted until late July, swollen arm and swollen lymph node persist to this day (8/20) although severity is reduced.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site rash, Malaise, Tinnitus
Clinical narrative: Patient says she had rash at injection site, general feelings of malaise for approx. 2 days, headache, and tinnitus (uncertain if tinnitus is related to receiving shingrix).
Age: 55.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Tinnitus
Clinical narrative: Patient experienced redness and pain at the site, as well as headache that lasted about a week. She also reports tinnitus in her right ear. After 2 weeks, there is still a raised bump at the injection site and tinnitus.
Age: 55.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Chills, Influenza like illness, Injection site pain, Migraine, Pyrexia
Clinical narrative: Patient experienced redness and pain at the site, as well as headache that lasted about a week. She also reports tinnitus in her right ear. After 2 weeks, there is still a raised bump at the injection site and tinnitus.
Age: 55.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Tinnitus
Clinical narrative: Patient experienced redness and pain at the site, as well as headache that lasted about a week. She also reports tinnitus in her right ear. After 2 weeks, there is still a raised bump at the injection site and tinnitus.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Patient allegedy had a "shingles" reaction in her abdomen and eye.
Age: 79.0
Sex: F
Vaccine: FLUR4
Symptoms: Asthenia, Balance disorder, Seizure
Clinical narrative: Patient felt like she was having a seizure.  She was laying down at the time.  Was extremely weak and called out to me that she was having a seizure.  I immediately responded to her and asked if I should call EMS.  She said no.  I checked her blood pressure and it was normal.  Within about 5 minutes she was coherent and able to talk to me.  She got up and went to the bathroom about 5 minutes later.  She felt kind of unsteady the rest of the day but didn't show any signs of seizure.  She appears to be okay today
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Feeling abnormal, Injection site pain, Mobility decreased, Pyrexia, Vertigo
Clinical narrative: a few hours after the vaccine I felt weird. The next morning I had severe vertigo, Could not get out of bed. By 7PM I was able to carefully move around. The small print says it is a possible reaction. I have had many flu shots before, with no problems..2 pharmacists said that , that is not a usual reaction. I am scared to get the shot again.  I would be scared to get the covid shot when and if available. I know 7PM because that is when called me back, and offered my primary Drs. phone number - they closed at 7. Treatment - do not move , watch recorded movies with head stationary on the bed. No food or drink since I could not get out of bed. (FYI) I had the shingles second shot - just a VERY sore arm at injection site (many days) and low grade fever (for one day)  I WOULD LIKE THE REACTION TO BE LISTED AS A POSSIBLE ADVERSE EVENT
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; the patient was inadvertently administered a dose of ROTATEQ that was expired; This spontaneous report was received from a registered nurse and refers to a 10-week-old male patient. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 22-JUL-2020, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R033252, expiration date 29-JUN-2020, (exact dose, injection site and route of administration were not reported) for prophylaxis. No additional adverse event was reported.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: pneumococcal vaccine, Date of vaccination 30-JUL-2015 and 02-MAY-2019; This spontaneous report was received from a 68-year-old female patient, concerning to herlself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.     On 30-JUL-2015, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as "Pneumococcal") for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). On the same date, she was vaccinated with zoster live vaccine (ZOSTAVAX) and experienced herpes zoster and other events (captured in MARRS 1910USA006737). It was reported that another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as "Pneumococcal") was administered on 02-MAY-2019 (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-1910USA006737:
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS 10/2015; This case was reported by a physician via other manufacturer and described the occurrence of guillain barre syndrome in a 69-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   The patient's past medical history included stevens johnson syndrome (Biaxin-stevens-johnson syndrome and mouth sores), sores mouth (Biaxin-stevens-johnson syndrome and mouth sores), central nervous system disorder (Compazine), vomiting (Phenergan), rash, difficulty breathing, pruritus (Vicodine) and feeling abnormal (Talwin). Concurrent medical conditions included fibromyalgia, drug allergy, iodine contrast media allergy (rash and breathing), latex allergy and penicillin allergy (itching and rash). Concomitant products included celecoxib.   On an unknown date, the patient received Fluarix Tetra. In October 2015, unknown after receiving Fluarix Tetra, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Fluarix Tetra.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced guillain barre syndrome. The reporter consented to follow up. The case has been linked with the case US2020AMR163487, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR163487:Same patient
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Pruritus, Pyrexia
Clinical narrative: huge cellulitis on arm; itchy all over for 1 week; Fever for 3 days; This case was reported by a other health professional via sales rep and described the occurrence of cellulitis in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), pruritus and fever. On an unknown date, the outcome of the cellulitis was unknown and the outcome of the pruritus and fever were recovered/resolved.   The reporter considered the cellulitis, pruritus and fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fever for 3 days post Shingrix vaccine, huge cellulitis on arm requiring treatment with antibiotics. The patient itchy all over for more than 1 week post immunization. The reporter consented for follow up.