chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Myalgia, Pain
Clinical narrative: The patient reported that she experienced significant pain, weakness, somess, chills, and muscle ache in her left arm; The patient reported that she experienced significant pain, weakness, somess, chills, and muscle ache in her left arm; The patient reported that she experienced significant pain, weakness, somess, chills, and muscle ache in her left arm; The patient reported that she experienced significant pain, weakness, somess, chills, and muscle ache in her left arm; This spontaneous report was received from a 66-year-old female patient referring to herself. The patient's pertinent concurrent conditions included an unspecified hernia, rheumatoid arthritis, and osteoporosis, her concomitant medications included hydroxychloroquine sulfate (PLAQUENIL) pantoprazole and TYMLOS. The patient had a history of drug hypersensitivity while on prior therapy with montelukast sodium (SINGULAIR) (case # 0806USA00025), also the patient had a previous drug reaction or allergy to diazepam (VALIUM), celecoxib (CELEBREX), codeine and tramadol.  On 14-APR-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) on shot in the left arm for prevention of pneumococcal infection (prophylaxis). On the same date, the patient experienced significant pain, weakness, soreness, chills, and muscle ache in her left arm after receiving the vaccine (pain, myalgia, chills and asthenia). The patient did not seek any medical attention, no treatment was given to the patient however an unspecified blood work was performed on an unknown date but no results were provided.  At the time of this report, the outcome of pain, myalgia, chills and asthenia was reported as not recovered.  The causality assessment between suspect therapy and the aforementioned events were not reported.; Sender's Comments:  US-009507513-0806USA00025:
Sex: F
Vaccine: MMR, UNK
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous report as received from a nurse practitioner refers to a 25-year-old female patient. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. The patient's concurrent condition included asthma. On 14-MAR-2020, the patient underwent insertion with etonogestrel implant (NEXPLANON) 68 milligram 1 every three years (1 dosage form , lot#, expiry date were not reported) subdermally for contraception. The patient was administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot#, expiry date, dose, route of administration and anatomical locations were not reported) for prophylaxis. On 16-MAR-2020 (reported as 5 weeks ago), the patient started experiencing dizziness. On 20-APR-2020, the patient was called for a post-partum check-up and the patient reported she experienced unspecified dizziness 5 to 7 times a day since the implant was inserted. She was instructed to drink more water just in case the dizziness was caused by dehydration. Nurse Practitioner reported they were not seeing patients in the office right now due to the coronavirus and felt if she could see her in person and she could do on a diagnostic level. No additional information. Therapy with etonogestrel implant (NEXPLANON) was continued. The outcome of dizziness was reported as not recovered/not resolved.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired dose of M-M-R II; This spontaneous report as received from a Nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 21-APR-2020, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # R011221, expiry date: 17-APR-2020) therapy type recombinant human albumin (rHA) for prophylaxis. Concomitant therapies included sterile diluent. No additional adverse event. The outcome of expired product administered and no adverse event was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: pain; swelling; redness; Weldts below the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema and injection site wheal. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and injection site wheal were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and injection site wheal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced pain, swelling, redness and welts below the injection site. The reporter consented for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Musculoskeletal pain, Pruritus
Clinical narrative: began to itch; the worse headache as n hour later; 2 days later I'm still tired / Still tired after 3 days; shoulder hurts a lot; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 hrs after receiving Shingrix, the patient experienced pruritus, headache, tiredness and shoulder pain. On an unknown date, the outcome of the pruritus and headache were unknown and the outcome of the tiredness and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the pruritus, headache, tiredness and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. Two hours after vaccination, the patient began to itch and the worse headache as an hour later.  The patient did not have trouble in breathing. Less than a day after vaccination, the patient experienced tiredness. At the time of reporting, the patient tired after 3 days of vaccination.  Less than a week after vaccination the patient experienced shoulder pain. The patient reported shoulder hurts a lot. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were recovered/resolved.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, after receiving first dose the side effects started that night, with fever, chills etc. The patient did not know how long the first shots effects lasted as he slept through the whole weekend. For the tolerability of 2nd dose, refer case US2020AMR046622 reported for same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Nasopharyngitis
Clinical narrative: fighting a cold; feeling fatigued; This case was reported by a consumer via other manufacturer and described the occurrence of cold in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced cold and fatigue. On an unknown date, the outcome of the cold and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the cold and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated she was fighting a cold and reported feeling fatigued after her last Shingrix injection. Otherwise doing well.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: itching; chicken pox type lesions; This case was reported by a consumer via call center representative and described the occurrence of itching in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th February 2020, the patient received Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced itching and varicella-like rash. On an unknown date, the outcome of the itching and varicella-like rash were recovered/resolved.   It was unknown if the reporter considered the itching and varicella-like rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated even though they never had chicken pox as a child and I told the doctor. They started having terrible itching and chicken pox type lesions after vaccination. Events lasted for about three days and subsided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles rash; Rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 5 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient stated that it was strange that had never had shingles before but 5 days after vaccination experienced shingles and rash. The patient had shingles on right thigh. The patient asked can you get a shingles rash when you get the vaccine.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Pyrexia
Clinical narrative: Fever; Chills / Lots of chills; Abdominal pain; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma. Concomitant products included salbutamol sulphate (Albuterol).   In March 2020, the patient received Shingrix. In March 2020, 7 days after receiving Shingrix and an unknown time after starting Albuterol, the patient experienced fever, chills and abdominal pain. On an unknown date, the outcome of the fever, chills and abdominal pain were unknown.   It was unknown if the reporter considered the fever, chills and abdominal pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient's wife. The patient was on inhaled steroids due to asthma. The patient received vaccine 7 days prior to the date of reporting. The reporter enquired if Shingrix reaction of fever and chills could develop a week post vaccination. She also enquired if these reactions should be considered as Shingrix reaction or medical care need to be sought.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Social problem
Clinical narrative: I had reaction (102 fever); Coronavirus concerns; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever and social problem. On an unknown date, the outcome of the fever and social problem were unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. After receiving 1st dose of Shingrix, the patient had a strong reaction. The patient had 102 fever. The reporter wanted to know could he/she wait longer than 6 months for the second dose due to Coronavirus concerns. It's already been just over 6 months since first dose. The reporter wanted to know should wait until June and it still be effective or would need to start over with the process, which led to social problem. The physician still wanted to have 2nd dose but wait for flu season to slow so there wouldn't be confusion over whether had flu or reaction to shingrix.      Lab Comments: On an unknown date, lab test was performed.
Age: 58.0
Sex: U
Vaccine: TDAP, VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: body aches; shivering; fever of 99.5F; This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 4th March 2020, the patient received the 2nd dose of Shingrix and Boostrix. In March 2020, less than a week after receiving Shingrix and Boostrix, the patient experienced general body pain, shivering and fever. On an unknown date, the outcome of the general body pain, shivering and fever were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, shivering and fever to be related to Shingrix and Boostrix.  Additional details were provided as follows: The patient had experienced body aches, shivering, and a fever temperature of 99.5F. The events were ongoing at the time of this report. The patient mentioned her concern about the symptoms and concerned with the Corona virus. The patient did not have the lot/exp of either vaccine.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Rash
Clinical narrative: raised bumps/rash; redness at injection site; injection site pain; headache; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th January 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site pain and headache. On 16th January 2020, the patient experienced raised rash. On an unknown date, the outcome of the injection site erythema, injection site pain and headache were recovered/resolved and the outcome of the raised rash was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, headache and raised rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. Within 12 hours after vaccination, the patient experienced pain at injection site of left arm, headache, and redness at injection site. Two days after vaccination, the patient began to develop a rash, described as raised bumps, on her chest. Outcome for adverse events injection site redness, injection site pain and headache was reported as recovered in database while discrepantly mentioned as recovered resolved with sequeale in the source document. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: first dose of Shingrix and experienced shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown 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 case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient experienced shingles after vaccination. The reporter asked if patient could receive the 2nd dose. The reporter consented to follow up.
Age: 62.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Peripheral swelling, Rash, Skin warm
Clinical narrative: her arm got swollen; Warm to touch; developed rash; received the first dose of Shingrix on 11Feb2019 /  has not received the second dose yet; This case was reported by a nurse via call center representative and described the occurrence of swelling arm in a adult female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 24th November 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced swelling arm, skin warm, rash and incomplete course of vaccination. On an unknown date, the outcome of the swelling arm, skin warm, rash and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the swelling arm, skin warm and rash to be related to Shingrix.  Additional details were provided as follows: The patient's arm got swollen, warm to touch and developed rash after received the 1st dose of Shingrix.  The patient had not received the second dose yet, this led to incomplete course of vaccination.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Pulmonary pain
Clinical narrative: left sided lung pain; "spent the day in bed"; This case was reported by a consumer via call center representative and described the occurrence of pulmonary pain in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 17th March 2020, 1 days after receiving Shingrix, the patient experienced pulmonary pain and bedridden. On an unknown date, the outcome of the pulmonary pain was unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the pulmonary pain and bedridden to be related to Shingrix.  Additional details were received as follows: The reporter mother received dose 2 of Shingrix. He states that on 17 th March 2020, she started to have left sided lung pain, on 18th March 2020 right sided lung pain, and on 19th March 2020, lung pain on both sides. She describes the pain as, spasm that goes from the back down to the lungs. The reporter did not consented to follow up.  The reporter has no vaccine information for this case, does not consent to follow up. This case was linked with case US2020049311, reported by the same reporter.
Age: 70.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms; Fever; Chills; Feeling achy; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills and general body pain. On an unknown date, the outcome of the influenza-like symptoms, fever, chills and general body pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills and general body pain to be related to Shingrix.  Additional details were received as follows: The patient received 1st Shingrix dose 6 months ago and had flu like symptoms consisting of fever, chills, and feeling achy.  Pharmacist provided limited information.  Pharmacist had another call coming in and states she may call back to provide more information if patient consents.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Product administered at inappropriate site
Clinical narrative: Shingrix was administered in a patient's tricep; pain; erythema; This case was reported by a physician via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain, erythema and vaccine administered at inappropriate site. On an unknown date, the outcome of the pain and erythema were recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the pain and erythema to be related to Shingrix.  Additional case details were reported 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 a dose of Shingrix in his or her tricep, which led to vaccine administered at inappropriate site. The patient experienced pain and erythema for two days.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash vesicular, Urticaria
Clinical narrative: rash with blisters on his shoulders and upper back; urticaria; fever; sore arm; This case was reported by a consumer via call center representative and described the occurrence of blistery rash in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix (intramuscular). In March 2020, 5 days after receiving Shingrix, the patient experienced blistery rash, fever and pain in arm. On an unknown date, the outcome of the blistery rash was unknown and the outcome of the fever and pain in arm were recovered/resolved.   It was unknown if the reporter considered the blistery rash, fever and pain in arm to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The dose of Shingrix about 2.5 weeks ago.   The patient reported that he experienced sore arm and fever that resolved within about one day.  The reporter reported, that about 5 days after dose, he experienced rash with blisters on his shoulders and upper back. The reporter consented to follow up.   Follow up information received from physician on 16th April 2020: The patient's demographic details were updated. Concurrent medical conditions included seafood allergy. In March 2020, the patient experienced urticaria. The patient was treated with antihistamine and hydrocortisone. On an unknown date, the outcome of the blistery rash was recovered/resolved. The reporter considered the blistery rash and fever to be possibly related to Shingrix. The reporter considered the pain in arm to be probably related to Shingrix. The reporter considered the urticaria to be unlikely related to Shingrix.
Sex: U
Vaccine: FLUX
Symptoms: Skin reaction
Clinical narrative: Skin reaction to an injectable therapy but not to routine vaccines; This case was reported by a physician via call center representative and described the occurrence of skin reaction 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 at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced skin reaction. On an unknown date, the outcome of the skin reaction was unknown.   It was unknown if the reporter considered the skin reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received influenza vaccine and experienced skin reaction. The reporter wanted to know about the ingredient list in influenza vaccine as his patient had skin reaction to an injectable therapy but not to routine vaccines so he was trying to figure out which ingredient might cause it. The reporter did not consent to follow up. No other information was reported.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient received an expired Adacel/ NO AE; Initial information received on 20-Apr-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of an unknown demographics who was administered with an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination on 17-Apr-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  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.
Sex: U
Vaccine: RV5
Symptoms: Syringe issue
Clinical narrative: I noticed that the ROTATEQ was leaking out of the neck of the tube instead of coming out of the top of the tube; I noticed that the ROTATEQ was leaking out of the neck of the tube instead of coming out of the top of the tube; I noticed that the ROTATEQ was leaking out of the neck of the tube instead of coming out of the top of the tube; I noticed that the ROTATEQ was leaking out of the neck of the tube instead of coming out of the top of the tube; This spontaneous report was received from a nurse and physician via company representative referring to a patient of unknown age and gender. Information about patient's concurrent condition, concomitant medication, medical history and drug allergy/reaction was not reported.  On 16-APR-2020, the nurse was administrating rotavirus vaccine, live, oral, pentavalent(ROTATEQ) to a patient and noticed that rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # 1660947, expiry date: 16-FEB-2021) was leaking out of the neck of the tube instead of coming out of the top of the tube (product quality issue, product leakage, accidental exposure to product and circumstance or information capable of leading to medication error), immediately stopped and administered a new rotavirus vaccine, live, oral, pentavalent(ROTATEQ) without difficulty on same visit for prophylaxis (strength, dose, dose number, route, lot/batch #, expiry date was not reported). It was also reported that the nurse had difficulty breaking the seal of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) every time while administering from past a year and half, so used the needle to break the seal.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: Right knee pain and right shoulder pain - patient refused further work up or treatment. Symptoms persist as of 4/23/2020.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Cor pulmonale chronic
Clinical narrative: chronic cardio-resp disease; between shortages and my health- on prednisone twice, never got 2nd shot; This case was reported by a consumer via call center representative and described the occurrence of chronic pulmonary heart disease in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Approximately 4.5 years after receiving Shingrix). Previously administered products included Shingles vaccine (received shot 6 years ago) and Prednisone (received twice).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced chronic pulmonary heart disease (serious criteria GSK medically significant) and product supply issue. On an unknown date, the outcome of the chronic pulmonary heart disease and product supply issue were unknown.   It was unknown if the reporter considered the chronic pulmonary heart disease to be related to Shingrix. It was unknown if the reporter considered the product supply issue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had 1st dose of Shingrix approximately 14 months ago from the time of reporting. Then between shortages and health- On Prednisolone twice, the patient never got 2nd shot. Finally the patient was diagnosed with chronic cardio-respiratory disease.  The patient asked, It was likely that, the patient had any protection from 1st dose alone? Would he/she need to start over or could just get 2nd shot? The patient asked 3 physician who said didn't know.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: received dose two of Shingrix one month after dose one; experienced a fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On 15th April 2020, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced fever. On an unknown date, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the fever and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.   Additional case details were reported as follows: The age at vaccination was not reported. The age group was selected as ana adult as per vaccination indication. The patient experienced fever after vaccination. The patient received dose two of Shingrix one month after dose one, which led to shortening of vaccination schedule. The reporter did not consent to follow up.      Lab Comments: on an unknown date body temperature recorede
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Patient developed skin lesions that are suspicious for varicella the previous day.  Over 1 day, there has been a change in appearance, consistent with the natural history of varicella
Sex: F
Vaccine: RV5
Symptoms: Device leakage, No adverse event
Clinical narrative: did not have any adverse effects; she got some of the ROTATEQ on her hands; 2 of the ROTATEQ tubes from a pack of 25 were leaking and the spikes were broken off; she got some of the ROTATEQ on her hands; she got some of the ROTATEQ on her hands; This spontaneous report was received from a 30-year-old female medical assistant, who refers to herself. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 06-APR-2020, after opening the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1660970, expiration date 17-JAN-2021) foil pouch, the medical assistant got some of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) on her hands. She stated that 2 of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) tubes (lot # 1660970, expiration date 17-JAN-2021) from a pack of 25 were leaking and the spikes were broken off. It was also reported that 5 doses of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) from the same pack of 25, were administered on multiple unspecified dates prior to finding the 2 broken tubes, there were no issues with those 5 tubes. She did not seek medical attention, as the event occurred at the office and the physician was notified immediately. No adverse effects were reported. Lab diagnostic studies were not performed.  This is one of several reports received from the same reporter.
Sex: M
Vaccine: TYP
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Nausea, Pain
Clinical narrative: SWEAT; BODY ACHE; CHILLS; DIARRHEA; VOMITING; NAUSEA; A spontaneous case report was received from a healthcare professional on 07-Jun-2019 for two consumers.  Based on the information obtained from the reporter, two individual case safety reports PVX201906-000466 (first consumer) and PVX201906-000467 (second consumer) were created and cross-linked in the database.  This case describes a 57-year-old female consumer (weight: 207 lbs/ 93 kg) who had diarrhea, vomiting, nausea, body aches, chills, and sweat, after taking Vivotif for unknown indication.  Case report: The consumer took the first dose of Vivotif on 27-May-2019 and the third dose on 31-May-2019. On an unknown date, she had diarrhea, vomiting, nausea, body aches, chills, and sweat. She took no treatment medication for the events.  The consumer's medical history included urge incontinence, asthma, borderline elevated cholesterol, and seasonal allergies.  Concomitant medication included oxybutynin (5 mg: once in a day), multivitamin (once in a day), and cetirizine (10 mg; once in a day).  Action taken with Vivotif was dosage discontinued.  The consumer had recovered from the events on 04-Jun-2019.  Company's Comment: In this case, it was reported that female consumer had diarrhea, vomiting, nausea, body aches, chills, and sweat after intake 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. ; Sender's Comments: Company's Comment: In this case, it was reported that female consumer had diarrhea, vomiting, nausea, body aches, chills, and sweat after intake 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.  US-PaxVax Berna GmbH-PVX201906-000467:
Sex: M
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: SWEAT; BODY ACHE; CHILLS; DIARRHEA; VOMITING; NAUSEA; A spontaneous case report was received from a healthcare professional on 07-Jun-2019 for two consumers.  Based on the information obtained from the reporter, two individual case safety reports PVX201906-000466 (first consumer) and PVX201906-000467 (second consumer) were created and cross-linked in the database.  This case describes a 57-year-old female consumer (weight: 207 lbs/ 93 kg) who had diarrhea, vomiting, nausea, body aches, chills, and sweat, after taking Vivotif for unknown indication.  Case report: The consumer took the first dose of Vivotif on 27-May-2019 and the third dose on 31-May-2019. On an unknown date, she had diarrhea, vomiting, nausea, body aches, chills, and sweat. She took no treatment medication for the events.  The consumer's medical history included urge incontinence, asthma, borderline elevated cholesterol, and seasonal allergies.  Concomitant medication included oxybutynin (5 mg: once in a day), multivitamin (once in a day), and cetirizine (10 mg; once in a day).  Action taken with Vivotif was dosage discontinued.  The consumer had recovered from the events on 04-Jun-2019.  Company's Comment: In this case, it was reported that female consumer had diarrhea, vomiting, nausea, body aches, chills, and sweat after intake 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. ; Sender's Comments: Company's Comment: In this case, it was reported that female consumer had diarrhea, vomiting, nausea, body aches, chills, and sweat after intake 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.  US-PaxVax Berna GmbH-PVX201906-000467:
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; A spontaneous case report was received from a physician on 10-Feb-2019 for four consumers.  Based on the information obtained from the physician, four individual case safety reports PVX201902-000103 (PVX2019-369; physician), PVX201902-000104 (PVX2019-371, male consumer), PVX201902-000105 (PVX2019-372, female 1) and PVX201902-000106 (PVX2019-373, female 2) were created and cross-linked in the database.  This case report describes a 63-year-old adult male consumer who "took unrefrigerated doses". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took all the unrefrigerated doses of Vivotif. The doses were taken on 30-Jan-2019, 01-Feb-2019, 03-Feb-2019, and 05-Feb-2019 respectively.  The action taken with Vivotif with respect to event "took unrefrigerated doses" was not applicable.  The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201902-000104: US-PaxVax Berna GmbH-PVX201902-000105: US-PaxVax Berna GmbH-PVX201902-000106:
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK AN UNREFRIGERATED DOSE; A spontaneous case report was received from a physician on 11-Feb-2019 for four consumers.  Based on the information obtained from the physician, four individual case safety reports PVX201902-000103 (PVX2019-369; physician), PVX201902-000104 (PVX2019-371, male consumer), PVX201902-000105 (PVX2019-372, female 1) and PVX201902-000106 (PVX2019-373, female 2) were created and cross-linked in the database.  The case report describes a 17-year-old adolescent male consumer who "took an unrefrigerated dose". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took the first dose of Vivotif that was not refrigerated.  The action taken with Vivotif with respect to the event "took an unrefrigerated dose" was not applicable.  The clinical outcome of the event "took an unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201902-000103:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK AN UNREFRIGERATED DOSE; A spontaneous case report was received from a physician on 11-Feb-2019 for four consumers.  Based on the information obtained from the physician, four individual case safety reports PVX201902-000103 (PVX2019-369; physician), PVX201902-000104 (PVX2019-371, male consumer), PVX201902-000105 (PVX2019-372, female 1) and PVX201902-000106 (PVX2019-373, female 2) were created and cross-linked in the database.  The report describes a 22-year-old adult female consumer who "took an unrefrigerated dose". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took the first dose of Vivotif that was not refrigerated.  The action taken with Vivotif with respect to the event "took an unrefrigerated dose" was not applicable.  The clinical outcome of the event "took an unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201902-000103:
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: TOOK ONLY ONE DOSE; A spontaneous case report was received from a physician on 11-Feb-2019 for four consumers.  Based on the information obtained from the physician, four individual case safety reports PVX201902-000103 (PVX2019-369; physician), PVX201902-000104 (PVX2019-371, male consumer), PVX201902-000105 (PVX2019-372, female 1) and PVX201902-000106 (PVX2019-373, female 2) were created and cross-linked in the database.  The report describes a 25-year-old adult female consumer who "took only one dose". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took the first dose of Vivotif on 02-Feb-2019. She did not take the other doses since then.  The action taken with Vivotif with respect to the event "took only one dose" was not applicable.  The clinical outcome of the event "took only one dose" was unknown.  Company's Comment: The causality of the event "took only one dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only one dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201902-000103:
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK LAST DOSE ON DAY 9; TOOK AN UNREFRIGERATED DOSE; This spontaneous case report was received from a nurse (PVX2019-383) on 11-Feb-2019. The report describes a male consumer who "took an unrefrigerated dose" and "took last dose on day 9". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer put Vivotif in his luggage while traveling  and his luggage got lost for two days. He took his last dose on day 9 (08-Feb-2019). His first three doses had been taken appropriately. He was unsure of the temperature that Vivotif was exposed to while the luggage was lost.  The action taken with Vivotif with respect to the events "took an unrefrigerated dose" and "took last dose on day 9" was not applicable.  The clinical outcome of the events "took an unrefrigerated dose" and "took last dose on day 9" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" and "took last dose on day 9" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" and "took last dose on day 9" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: MISSED TO TAKE THE THIRD DOSE OF VIVOTIF; This spontaneous case report was received from a pharmacist (PVX2019-385) on 12-Feb-2018. The report describes a male consumer who "missed to take the third dose of Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer took doses of Vivotif on Wednesday (06-Feb-2019) and Friday (08-Feb-2019). He missed to take her third dose of Vivotif and did not take any further dose.  The action taken with Vivotif with respect to the event "missed to take the third dose of Vivotif" was not applicable.  The clinical outcome of the event "missed to take the third dose of Vivotif" was unknown.  Company's Comment: The causality of the event "missed to take the third dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take the third dose of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK FIRST THREE DOSES WITH FOOD; This spontaneous case report was received from a consumer (PVX2019-390) on 12-Feb-2019. The report describes a 20-year-old female consumer who "took first three doses with food". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer ate food 10 minutes after taking the first three doses. The doses were taken on 06-Feb-2019, 08-Feb-2019, and 10-Feb-2019 respectively. She took the fourth dose properly.   The action taken with Vivotif with respect to the event "took first three doses with food" was not applicable.  The clinical outcome of the event "took first three doses with food" was unknown.  Company's Comment: The causality of the event "took first three doses with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first three doses with food" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: DID NOT COMPLETE DOSES ONE WEEK PRIOR TO TRAVEL; This spontaneous case report was received from a consumer (PVX2019-392) on 12-Feb-2018. The report describes a 23-year-old female consumer who "did not complete her doses one week prior to travel". The consumer was receiving Vivotif (lot number: 3003239 and expiry date: Oct 2019) for an unknown indication.  It was reported that the consumer started Vivotif yesterday and she will be going out of the country tomorrow. She would be arriving in foreign country in about two days.  The action taken with Vivotif with respect to the event "did not complete her doses one week prior to travel" was not applicable.  The clinical outcome of the event "did not complete her doses one week prior to travel" was unknown.  Company's Comment: The causality of the event "did not complete her doses one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete her doses one week prior to travel" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK DOSES 1, 2, AND 3 AND THEN HOPPED ON A PLANE WITHOUT TAKING 4; This spontaneous case report was received from a nurse (PVX2019-445) on 18-Feb-2019. The report describes a male consumer who "took doses 1, 2, and 3 and then hopped on a plane without taking 4". The consumer was receiving oral Vivotif for typhoid prophylaxis.   It was reported that the consumer took the three doses of Vivotif on 18-Jan-2019, 20-Jan-2019, and 22-Jan-2019 respectively before travelling for three weeks. Then, he took his last dose today on 18-Feb-2019, after returning home.  The action taken with Vivotif with respect to the event "took doses 1, 2, and 3 and then hopped on a plane without taking 4" was not applicable.  The clinical outcome of the event "took doses 1, 2, and 3 and then hopped on a plane without taking 4" was unknown.  Company's Comment: The causality of the event "took doses 1, 2, and 3 and then hopped on a plane without taking 4" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took doses 1, 2, and 3 and then hopped on a plane without taking 4" was considered as not applicable.