chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: The patient was administered an improperly stored dose of ROTATEQ; No adverse event; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug allergies/reactions and concomitant medications were not provided.   On 11-MAR-2020, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, dose and frequency were not provided), lot #1660112, expiration date 18-OCT-2020, taken orally for prophylaxis.   The reporter stated that on that date, the vaccine dose administered was improperly stored (product storage error). The vaccine presented a temperature excursion with temperature above 47°F and 52.1°F for 15 minutes. Another previous temperature excursion was above 47°F and 55°F for 21 minutes.
Age: 0.17
Sex: U
Vaccine: HPV9
Symptoms: Product use issue
Clinical narrative: 2 month old patient received one dose of Gardasil 9; This spontaneous report was received from a physician concerning a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 31-MAR-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45t 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular for prophylaxis (strengh, anatomical location, lor number and expiration date were unknown) (product use issue).  At the reporting time, the patient's outcome was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness, Pain, Pneumonia
Clinical narrative: hearing loss; pneumonia; Chronic body pain; This spontaneous report as received from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 26-FEB-2013, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (strength, route, dosage schedule, lot number and expiration date were not reported).    On an unknown date, the patient experienced hearing loss, chronic body pain and pneumonia. As a direct and proximate result, the patient's symptoms have resulted in physical limitations not present prior to using Merck's product. Plaintiff also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition.   As a result, the patient sustained severe, serious, progressive, permanent, and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of deafness, pain and pneumonia was not recovered.   The reporter considered deafness, pain and pneumonia to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, deafness and pneumonia were considered medically significant events.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects were reported.; two patients received improperly stored PROQUAD; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 13-MAR-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S022109 with expiration date of 12-JAN-2021, for prophylaxis (route of administration and frequency were not reported). The sterile diluent (STERILE DILUENT MRK) used to reconstitute measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored.    No adverse effects were reported.    It was stated that the vaccines underwent a temperature excursion of 47°C (degrees Celsius) to 8°C (-7C) for 41 minutes on 20-DEC-2019. Previous temperature excursion was done. The call was because of a "data logger".  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2004USA000405: US-009507513-2003USA008859:
Age: 1.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Herpes zoster, Staphylococcal infection
Clinical narrative: the patient was diagnosed with herpes zoster and staph infection of the left leg; the patient was diagnosed with herpes zoster and staph infection of the left leg; Information has been received from a physician referring to a 3 years 2 months old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  In approximately 2018 (reported as about two years ago), the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose detail, lot# and expiration date were unknown) subcutaneously for prophylaxis (reported as vaccination). Sterile diluent (manufacturer unknown)  (strength, dose detail, lot#, expiration date and indication were unknown)  was also suspect therapy.  On 09-FEB-2020, the patient came into the office, the patient was diagnosed with herpes zoster and staph infection of the left leg. The patient was given acyclovir and cephalexin as treatment. On 26-FEB-2020, the patient came back to the office for a follow up visit, it was reported that the patient's lesions were much better. Therapy with  sterile diluent (manufacturer unknown) was unknown. The outcome of herpes zoster and staph infection of the left leg was reported as recovering. The causality assessment was not provided.  Upon internal review, staph infection of the left leg was determined to be medically significant.
Sex: F
Vaccine: TYP
Symptoms: Nausea, Product storage error
Clinical narrative: FELT A LITTLE BIT NAUSEOUS; TOOK VIVOTIF WHICH STORED AT 30 DEGREES FARHEINITE; This spontaneous case report was received from a nurse (PVX2019-420) on 13-Feb-2019. The report describes a female consumer who felt a little bit nauseous following the intake of Vivotif for an unknown indication. The consumer also "took Vivotif which stored at 30 degrees Fahrenheit".  The consumer had a history of tendonitis and motion sickness.  The consumer was not taking any concomitant medications.  It was reported that the consumer completed the doses of Vivotif, which were stored at 30 degree Fahrenheit. She also felt a little bit nauseous after her last dose.   The action taken with Vivotif with respect to the events felt a little bit nauseous and "took Vivotif which stored at 30 degrees Fahrenheit" was not applicable.  The clinical outcome of the event felt a little bit nauseous was resolved while with respect to the event "took Vivotif which stored at 30 degrees Fahrenheit" was unknown.  Company's comment:  In this case, the consumer developed "little bit nauseous" following administration of Vivotif. The event was reported with reasonable time relationship to intake of the vaccine. Hence, the causality of the event "little bit nauseous" with Vivotif was assessed as possible. The causality of the event "took Vivotif which stored at 30 degrees Fahrenheit" was considered as not applicable.; Sender's Comments: Company's comment:  In this case, the consumer developed "little bit nauseous" following administration of Vivotif. The event was reported with reasonable time relationship to intake of the vaccine. Hence, the causality of the event "little bit nauseous" with Vivotif was assessed as possible. The causality of the event "took Vivotif which stored at 30 degrees Fahrenheit" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Oral administration complication, Vomiting
Clinical narrative: VOMITED THE THIRD DOSE OF VIVOTIF; DID NOT TAKE THE FOURTH DOSE; This spontaneous case report was received from a nurse (PVX2019-414) on 13-Feb-2019 and an additional information was received on 18-Feb-2019. The report describes a 32-year-old adult female consumer who vomited the third dose of Vivotif. The consumer "did not take fourth dose". The consumer was receiving Vivotif for an unknown indication.  The consumer was a healthy adult with no medical history.  The consumer had some vaccines before she took Vivotif but she did not take any vaccines or medications at the same time as Vivotif.  It was reported that the consumer took the first two doses of Vivotif properly but she could not keep down the third dose and vomited it. The reporter confirmed that the consumer did not take the fourth dose.  The action taken with Vivotif with respect to the event vomited the third dose of Vivotif was drug discontinued while with respect to the event "did not take fourth dose" was not applicable.  The clinical outcome of the events vomited the third dose of Vivotif and "did not take fourth dose" was unknown.  Company's Comment: In this case, a 32-year-old adult female consumer vomited the third dose of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also vomiting is labeled as per CCDS. Hence, the causality of the event with Vivotif was assessed as possible. The causality of the event "did not take fourth dose" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, a 32-year-old adult female consumer vomited the third dose of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also vomiting is labeled as per CCDS. Hence, the causality of the event with Vivotif was assessed as possible. The causality of the event "did not take fourth dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal pain upper, Feeling abnormal, Flatulence, Nausea
Clinical narrative: AWFUL; GASSY; BURNING IN HER STOMACH; ACHING IN HER STOMACH; DID NOT THROW UP BUT SHE FELT LIKE SHE WAS GOING TO; BURNING IN HER STOMACH; ACHING IN HER STOMACH; This spontaneous case report was received from a consumer (PVX2019-655) on 14-Mar-2019. It described a 59-year-old female consumer who experienced the events burning in her stomach, aching in her stomach, awful, gassy, and did not throw up, but she felt like she was going to following the intake of oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   It was reported that the consumer completed the Vivotif course on 14-Mar-2019. She was experiencing burning and aching in her stomach when she took Vivotif but she also experienced a bit on days when she did not take it as well. She stated that it helped when she did not eat food such as the second dose of Vivotif she took, she did not eat most of the day until 04:30 PM and that seemed to help. However, she was feeling uncomfortable (in regards to the burning and aching). The adverse events were worst for her after taking the first dose of Vivotif. She stated that she did not throw up, but she felt like she was going to and she felt awful. She also stated that the adverse event got better at night. She also felt very gassy. She stated that she did not take any treatment for the adverse events.  The action taken with Vivotif with respect to the events burning in her stomach, aching in her stomach, awful, gassy, and did not throw up, but she felt like she was going to was dosage maintained.  The clinical outcome of the events "burning in her stomach, aching in her stomach, awful, gassy, and did not throw up, but she felt like she was going to" was resolving.  Company's Comment: In this case, it was reported that a 59-year-old female consumer experienced the following events "burning in her stomach, aching in her stomach, awful, gassy, and did not throw up, but she felt like she was going to" following the intake of Vivotif. The events were reported with reasonable time relationship to intake of the vaccine. Hence, the causality of the events with Vivotif is assessed as possible to vivotif. However, lack of information on concomitant medication and past medical history precludes further assessment of case.; Sender's Comments: Company's Comment: In this case, it was reported that a 59-year-old female consumer experienced the following events "burning in her stomach, aching in her stomach, awful, gassy, and did not throw up, but she felt like she was going to" following the intake of Vivotif. The events were reported with reasonable time relationship to intake of the vaccine. Hence, the causality of the events with Vivotif is assessed as possible to vivotif. However, lack of information on concomitant medication and past medical history precludes further assessment of case.
Sex: M
Vaccine: TYP
Symptoms: Arthralgia, Musculoskeletal pain, Pyrexia, Tremor
Clinical narrative: SHAKING OF HANDS AND UPPER TORSO; ACHING IN SHOULDER AND ELBOW JOINTS; FEVER; This spontaneous case report was received from a consumer (PVX2019-676) on 19-Mar-2019. It described a male consumer who experienced fever, shaking of hands and upper torso, and aching in shoulder and elbow joints following the intake of oral Vivotif (one dose every other day) for typhoid prophylaxis.  The consumer's medical history included pneumonia, seizures, and ulcer.  The consumer's concomitant medications included lamotrigine tablet (200 mg) for seizures and omeprazole capsule (20 mg) for ulcer.  It was reported that the consumer took the first and the second dose of Vivotif on 16-Mar-2019 and 18-Mar-2019, respectively. He reported that after taking the second dose, he experienced fever slightly above 100 degrees Fahrenheit and he also had very severe shakes in his hands and upper torso, and some aching in his shoulder and elbow joints. He reported that all the events were resolved within an hour.  He took ibuprofen (two tablets of 200 mg each) for treatment. He stated that a few hours before, he had taken lamotrigine (200 mg) and omeprazole (20 mg). He had been taken them for years but never had any adverse reactions.  The action taken with Vivotif with respect to the events fever, shaking of hands and upper torso, and aching in shoulder and elbow joints was unknown.  The clinical outcome of the events fever, shaking of hands and upper torso, and aching in shoulder and elbow joints was resolved.  Company's Comment: In this case, it was reported that a male consumer experienced fever, shaking of hands and upper torso, and aching in shoulder and elbow joints following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, the reported events are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a male consumer experienced fever, shaking of hands and upper torso, and aching in shoulder and elbow joints following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, the reported events are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: UNABLE TO TOLERATE VIVOTIF; STOMACH DISCOMFORT; NAUSEA; This spontaneous case (PVX2019-830) was received from a nurse on 08-Apr-2019. It describes a 26-year-old female consumer who was unable to tolerate Vivotif and experienced stomach discomfort and nausea after the intake of oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   Case report: The consumer took the first dose of Vivotif and unable to tolerate it. She experienced stomach discomfort and nausea.   She did not take any treatment for the adverse events.  Action taken with Vivotif for the events unable to tolerate Vivotif, stomach discomfort, and nausea was vaccine discontinued.  The clinical outcome of the events unable to tolerate Vivotif, stomach discomfort, and nausea was resolved.  Company's Comment: In this case, it was reported that the consumer was unable to tolerate Vivotif, and had stomach discomfort, and nausea after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, stomach discomfort, and nausea are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer was  unable to tolerate Vivotif, and had stomach discomfort, and nausea after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, stomach discomfort, and nausea are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; This spontaneous case (PVX2019-1452) was received from a physician on 05-Jun-2019. It describes a 9-year-old female consumer who had fever and headache, after the administration of Vivotif for an unknown indication.  Case report: The consumer took the second dose on 03-Jun-2019. On 04-Jun-2019, he had headache and fever (101.4 degree Fahrenheit)  The consumer had no medical history.  The consumer had not taken any concomitant or treatment medication.  Action taken with Vivotif was unknown.  The consumer had not recovered from the event fever while the clinical outcome of the event headache was unknown.  Company's Comment: In this case, it was reported that a 9-year-old female consumer who had fever and headache after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, fever and headache are labelled as per agency. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a 9-year-old female consumer who had fever and headache after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, fever and headache are labelled as per agency. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Feeling abnormal, Product storage error, Pyrexia
Clinical narrative: LITTLE BIT OF DIARRHEA; TOOK THE FIRST PILL THAT WAS LEFT OUT AT ROOM TEMPERATURE FOR 36 HOUR; LITTLE BIT FEVERISH; This case (PVX2019-2166) was received from a consumer on 26-Aug-2019. It described a male consumer who felt "little bit feverish" (PT: Pyrexia) and had "little bit of diarrhea" (PT: Diarrhoea), after the administration of Vivotif for an unknown indication. He also "took the first pill that was left out at room temperature for 36 hour" (PT: Product storage error).  Case report: The consumer left Vivotif doses at room temperature for 36 hour and took the first dose on 25-Aug-2019. Afterwards, he felt a little bit feverish on the same day. On 26-Aug-2019, he had a little bit of diarrhea in the morning. He stated it was not too bad. Also, he stated he felt off.  Action taken with Vivotif with respect to the events "little bit feverish" and "little bit of diarrhea" was unknown, while with respect to the event "took the first pill that was left out at room temperature for 36 hour" was not applicable.  The consumer had recovered from the events "little bit feverish" and "little bit of diarrhea" on 25-Aug-2019 & 26-Aug-2019, respectively. The clinical outcome of the event "took the first pill that was left out at room temperature for 36 hour" was unknown.  Company's Comment: In this case, it was reported that the consumer felt "little bit feverish" and had "little bit of diarrhea" after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, fever and diarrhoea is labelled as per agency. The causality of the event "took the first pill that was left out at room temperature for 36 hour" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer  felt "little bit feverish" and also had "little bit of diarrhea" after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events.Hence, the causality of the events with Vivotif is assessed as possible. Also, fever and diarrhoea is labelled as per agency. The causality of the event "took the first pill that was left out at room temperature for 36 hour" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS; This spontaneous case report (PVX2019-2659) was received from a consumer on 24-Oct-2019. Additional information was received on 28-Oct-2019. It described a 71-year-old elderly female consumer who experienced flu-like symptoms (PT: Influenza like illness), while being on Vivotif (lot number: 3003277) for traveling.   Case report: The consumer took her first dose of Vivotif on 18-Oct-2019. On 23-Oct-2019, she started experiencing flu-like symptoms included feeling sick and coming down with the cold or flu. She was coughing all day and she had a runny nose. She took her last dose of Vivotif on 24-Oct-2019. The consumer stated that the symptoms were not getting better or worse. She started gargling with warm salt water as a treatment which was not helping a lot and was planning to take Sudafed.  The consumer's past medication included flu shot on 17-Sep-2019.  Action taken with Vivotif with respect to reported event was dosage maintained.  The consumer had not recovered from the reported event.  Company's Comment: In this case, it was reported that the consumer had flu-like symptoms following administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, flu-like symptoms are labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had flu-like symptoms following administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, flu-like symptoms is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: injection site pain; flu-like symptoms; fev; chills; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, fev and chills. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, fev and chills were recovered/resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, fev and chills to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced flu-like symptoms that lasted for 3 days and  injection site pain, fev and chills.  For tolerance after 2nd dose refer case US2020AMR034882.  This case is linked to the case US2020034256 and US2020AMR034880 wife's case.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Inappropriate schedule of product administration, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: injection site pain; flu-like symptoms; fev; chills; received her 2nd dose of Shingrix 9 day earlier than the 2 month mark; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix.   On 22nd February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, fev, chills and drug dose administration interval too short. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, fev and chills were recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, fev and chills to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced flu-like symptoms, but they were more intense and that lasted for 24 hours. The patient his 2nd dose of Shingrix 9 day earlier than the 2 month mark which led to drug dose administration interval too short. Reporter did not consent to follow-up.  For tolerance after 2nd dose refer case US2020AMR034881. This case is linked to the case US2020034256 and US2020AMR034880 wife's case.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Myalgia
Clinical narrative: chills; muscle aches; headache; stomach upset; This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced chills, myalgia, headache and upset stomach. On an unknown date, the outcome of the chills, myalgia, headache and upset stomach were unknown.   It was unknown if the reporter considered the chills, myalgia, headache and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient experienced headache , muscle aches, chills , stomach upset. The patient enquired how long symptoms would last.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: a herpes rash on nose; This case was reported by a physician via sales rep and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient recived shingrix and after 4 days presented to physician's office with a herpes zoster rash on nose.  There was no PCR confirmation. Patient was not immunocompromised or receiving any immunocompromising treatments. Doctor shared that he would be referring the patient to the eye doctor since the herpes zoster rash is on her nose.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2020, the patient received Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had shot on Tuesday. The patient was experiencing side effects after receiving a Shingrix. The patient enquired how long would the side effects last.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Joint swelling
Clinical narrative: Getting it (vaccine administration)hurt; my arm was so bad I couldn't lift it / Whole forearm is still frozen / could not move her arm at all because it hurt so bad; Hand and fingers got stiff / forearm is still; Hand and fingers got swollen / pad under thumb is swollen; Hand and fingers got painful / pad under thumb is very painful / Severe arm pain; Huge lump in front of elbow where the flesh creases / Lump in her forearm joint; joints in her elbow and fingers also were swollen; joints in her elbow and fingers also were very painful; This case was reported by a consumer and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2020, the patient received Shingrix. On 28th February 2020, immediately after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased, limbs stiffness, peripheral swelling, pain in extremity, upper extremity mass, joint swelling of hand and pain in joint involving hand. The patient was treated with ibuprofen (Advil) and naproxen. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, peripheral swelling, pain in extremity, upper extremity mass, joint swelling of hand and pain in joint involving hand were unknown and the outcome of the limbs stiffness was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, limbs stiffness, peripheral swelling, pain in extremity, upper extremity mass, joint swelling of hand and pain in joint involving hand to be related to Shingrix.  Additional details were provided as follows: The patient reported that even getting the vaccine hurts. The patient was in agony, her arm was so bad that she could not lift it then her hand and fingers got stiff swollen and painful. She had severe arm pain. The joints in her elbow and fingers also were swollen and very painful. The pad under thumb was swallow and very painful, huge lump in front of elbow were the flesh creases. she had a lump in her forearm joint. The patient's whole forearm was still frozen at the time of reporting. She also had been doing heat therapy with her physical therapist. She had notified her HCP and had a visit with them also. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb mass, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Getting it (vaccine administration)hurt; my arm was so bad I couldn't lift it / Whole forearm is still frozen / could not move her arm at all because it hurt so bad; Hand and fingers got stiff / forearm is still; Hand and fingers got swollen / pad under thumb is swollen; Hand and fingers got painful / pad under thumb is very painful / Severe arm pain; Huge lump in front of elbow where the flesh creases / Lump in her forearm joint; joints in her elbow and fingers also were swollen; joints in her elbow and fingers also were very painful; This case was reported by a consumer and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2020, the patient received Shingrix. On 28th February 2020, immediately after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased, limbs stiffness, peripheral swelling, pain in extremity, upper extremity mass, joint swelling of hand and pain in joint involving hand. The patient was treated with ibuprofen (Advil) and naproxen. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, peripheral swelling, pain in extremity, upper extremity mass, joint swelling of hand and pain in joint involving hand were unknown and the outcome of the limbs stiffness was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, limbs stiffness, peripheral swelling, pain in extremity, upper extremity mass, joint swelling of hand and pain in joint involving hand to be related to Shingrix.  Additional details were provided as follows: The patient reported that even getting the vaccine hurts. The patient was in agony, her arm was so bad that she could not lift it then her hand and fingers got stiff swollen and painful. She had severe arm pain. The joints in her elbow and fingers also were swollen and very painful. The pad under thumb was swallow and very painful, huge lump in front of elbow were the flesh creases. she had a lump in her forearm joint. The patient's whole forearm was still frozen at the time of reporting. She also had been doing heat therapy with her physical therapist. She had notified her HCP and had a visit with them also. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: had a severe breakout of cold sores on my face; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores.   On 31st January 2020, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that the patient just had a severe breakout of cold sores on face. The patient also specified that the patient never had cold sores this bad before. The patient wanted to know whether there any possible correlation between vaccine and event. No other information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Urinary tract infection
Clinical narrative: Currently taking Macrobid for a UTI; This case was reported by a consumer and described the occurrence of urinary tract infection in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced urinary tract infection. The patient was treated with macrobid (nos) (Macrobid). On an unknown date, the outcome of the urinary tract infection was not recovered/not resolved.   It was unknown if the reporter considered the urinary tract infection to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient was currently taking Macrobid for a urinary tract infection. The patient's last dose of Macrobid was 2nd April 2020. The patient second Shingrix vaccine was due by April 24th to be in the 6 months second dose guidelines. The drug information  received from the pharmacy on the Macrobid said do not have any immunizations/vaccinations while using the medication. The reporter wanted to know when is it safe to take the Shingrix vaccine. Also, what was the last date the patient could receive the second dose of Shingrix and not risk the effectiveness of the vaccine.
Age: 49.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age
Clinical narrative: who received the shingrix vaccine 11/14/19 & 1/29/20 / diagnosis in mid February with Shingles; was only 49 at time of vaccine; was only 49 at time of vaccine; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 49-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2019, the patient received the 1st dose of Shingrix. On 29th January 2020, the patient received the 2nd dose of Shingrix. On 14th November 2019, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 29th January 2020, the patient experienced inappropriate age at vaccine administration. In February 2020, the patient experienced shingles. On an unknown date, the outcome of the shingles, inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provide as follows: A 49 years old patient received two dose of Shingrix, which led to inappropriate age at vaccine administration. In mid of February 2020, the patient was diagnosed with shingles. The insurance did not cover the vaccines due to her age, was only 49 at time of vaccine.  The patient was requesting to be reimbursed for her vaccines.  The reporter wanted to know, did have any recommendations for this patient.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Ear pain, Fatigue, Headache, Herpes zoster
Clinical narrative: shingles; soreness near her right ear; soreness right side of her head,  neck and under her jaw; head soreness; jaw soreness; rash; tiredness; chills; muscle ache; pain in arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox when she was young). Previously administered products included Shingrix with an associated reaction of chills (for tolerance to the 1st dose refer case US2020052377).   On 17th March 2020, the patient received the 2nd dose of Shingrix. On 13th March 2020, the patient received PREVNAR. In March 2020, less than a week after receiving Shingrix, the patient experienced tiredness, chills, muscle pain and pain in arm. On 19th March 2020, the patient experienced shingles, ear pain, neck pain, headache, jaw pain and rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the shingles, ear pain, neck pain, headache, jaw pain and rash were unknown and the outcome of the tiredness, chills, muscle pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the shingles, tiredness, chills, muscle pain, pain in arm, ear pain, neck pain, headache, jaw pain and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Prevnar vaccine in her left arm. The patient received Shingrix vaccine on right arm and stated she did have some muscle aches, chills and tiredness with a sore right arm for about three days. 2 days after receiving vaccination, the patient started to have some soreness near her right ear and right side of her head,  neck and under her jaw. She stated it looked like a rash and day of reporting she was seen by her doctor and was diagnosed with shingles. Consent to follow up was granted.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain, Pain in extremity, Pain in jaw, Rash
Clinical narrative: shingles; soreness near her right ear; soreness right side of her head,  neck and under her jaw; head soreness; jaw soreness; rash; tiredness; chills; muscle ache; pain in arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox when she was young). Previously administered products included Shingrix with an associated reaction of chills (for tolerance to the 1st dose refer case US2020052377).   On 17th March 2020, the patient received the 2nd dose of Shingrix. On 13th March 2020, the patient received PREVNAR. In March 2020, less than a week after receiving Shingrix, the patient experienced tiredness, chills, muscle pain and pain in arm. On 19th March 2020, the patient experienced shingles, ear pain, neck pain, headache, jaw pain and rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the shingles, ear pain, neck pain, headache, jaw pain and rash were unknown and the outcome of the tiredness, chills, muscle pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the shingles, tiredness, chills, muscle pain, pain in arm, ear pain, neck pain, headache, jaw pain and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Prevnar vaccine in her left arm. The patient received Shingrix vaccine on right arm and stated she did have some muscle aches, chills and tiredness with a sore right arm for about three days. 2 days after receiving vaccination, the patient started to have some soreness near her right ear and right side of her head,  neck and under her jaw. She stated it looked like a rash and day of reporting she was seen by her doctor and was diagnosed with shingles. Consent to follow up was granted.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Extensive swelling of vaccinated limb, Pain
Clinical narrative: Swelling / goes into the axilla and has a "formation"; Redness / erythema around the entire left upper arm where he got the injection; Pain; This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA197A, expiry date 31st October 2020) for prophylaxis.   On 26th February 2020, the patient received the 1st dose of Menveo (intramuscular). In February 2020, less than a week after receiving Menveo, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and pain. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the extensive swelling of vaccinated limb was not recovered/not resolved and the outcome of the erythema of extremities and pain were recovering/resolving.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities and pain to be related to Menveo.  Additional details were reported as follows: The patient was administered his 1st dose of the Menveo vaccine 2 days prior to the reporting. The patient stated that the patient developed swelling and redness below where the vaccine was administered. The reporter stated that the patient was given Benadryl but on day of reporting, the swelling was much bigger and there was erythema around the entire left upper arm where he got the injection. The reporter stated that the area does not felt hard or like cellulitis and that the swelling got into the axilla and had a formation. The patient stated that the patient reported pain. The reporter consented to follow up.
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: strong pain in the arm; was born on 21-Dec-1970, so he is 49 years old / received the first dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 49-year-old male patient who received Herpes zoster (Shingrix) (batch number 5CE54, expiry date 25th February 2022) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. In February 2020, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received first dose of Shingrix a week ago, was suffering strong pain in the arm. The healthcare professional want to know how long it was going to last. The healthcare professional reported the patient was 49 years old, which led to inappropriate age at vaccine administration. The Shingrix was recommended for patients 50 years and older. The reporter consented to follow up. As per sales data sheet reported batch number was changed from 8-5CE54 to 5CE54.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pruritus, Rash vesicular
Clinical narrative: Shingles; blister like rash presented this morning on her husband's forehead; All areas are also itchy; chest has also started to look red; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th February 2020, the patient received the 1st dose of Shingrix. On 11th March 2020, 14 days after receiving Shingrix, the patient experienced shingles, blistery rash, pruritus and erythema. On an unknown date, the outcome of the shingles and erythema were unknown and the outcome of the blistery rash and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blistery rash, pruritus and erythema to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. In the morning of the day of reporting the patient experinced a shingles blister like rash on his forehead and right cheek. The chest has also started to look red although there are no blisters there, All areas were also itchy. Consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Shingles after 1st dose; Neuralgia pain; This case was reported by a physician via call center representative and described the occurrence of shingles in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix. On 3rd February 2020, 116 days after receiving Shingrix, the patient experienced shingles and neuralgia. On an unknown date, the outcome of the shingles and neuralgia were unknown.   It was unknown if the reporter considered the shingles and neuralgia to be related to Shingrix.  Additional information was received as follows: The patient received Shingrix and experienced shingles and also had neuralgia pain. The reporter consented for follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Coronavirus infection, Malaise
Clinical narrative: had all the symptoms of the coronavirus; sick; This case was reported by a consumer via call center representative and described the occurrence of coronavirus infection in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In February 2020, less than 6 months after receiving Shingrix, the patient experienced coronavirus infection and sickness. On an unknown date, the outcome of the coronavirus infection was unknown and the outcome of the sickness was recovered/resolved.   The reporter considered the coronavirus infection and sickness to be unrelated to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. At the end of 2019, the patient received Shingrix. In the first week of February 2020, the patient had all the symptoms of the coronavirus and was sick for two weeks. The reporter specified that the symptoms had nothing to do with the Shingrix vaccine. The reporter consented to follow up.