chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects were reported.  This is one of eleven reports from the same reporter.; Sender's Comments:  US-009507513-1904USA013268: US-009507513-1904USA013276: US-009507513-1904USA013272: US-009507513-1904USA013270: US-009507513-1904USA013275: US-009507513-1904USA013265: US-009507513-1904USA013269: US-009507513-1904USA000187: US-009507513-1904USA013210: US-009507513-1904USA013278:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient who got the zostavax vaccine years ago, and has already gotten the first shot of shingrix; This spontaneous report was received from a male patient of unknown age regarding himself. The patient's concurrent conditions, medical history, historical drugs, drug allergies, concomitant medications were not reported. On an unknown date(reported as years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and expiry date were not reported), subcutaneously for prophylaxis. On an unknown date, it was reported that the patient had already gotten the first shot of zoster vaccine recombinant, adjuvanted (SHINGRIX). It was unknown why the patient received zoster vaccine recombinant, adjuvanted (SHINGRIX). The product quality complaint was not involved in the case. The outcome of the event was unknown. Causality assessment was not provided.
Age: 15.0
Sex: F
Vaccine: HPV2, HPV4
Symptoms: Anogenital warts
Clinical narrative: genital warts; the nurse was not sure which vaccine the patient had received; the nurse was not sure which vaccine the patient had received; This spontaneous report as received from a nurse via company representative and refers to a 22-year-old female patient. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not provided.  Approximately in 2012 (the patient's vaccination age was reported as 15 years), the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection or hpv rl1 16 18 vlp vaccine (baculovirus) (CERVARIX) (for both lot #, expiration date and anatomical location were not provided), both for prophylaxis (the nurse was not sure which vaccine the patient had received). On an unknown date in 2012, she received second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot #, expiration date and anatomical location were not provided) for prophylaxis. On an unknown date in April 2019 (reported as last week), the patient experienced  genital warts.  The outcome of reported event was not recovered.  The causality assessment was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; The patient was inadvertently administered a dose of VAQTA that was expired; This solicited report was received from a medical assistant referring to a patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 03-MAY-2019 the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) (lot # R002487, expiry date 21-APR-2019, strength 25/0.5 (units not provided)) for prophylaxis.    It was reported that the dose was expired (expired vaccine used). No adverse event was reported. The outcome of expired vaccine used was unknown.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effect; The patient received a dose of M-M-R ii via the intramuscular route in error; This spontaneous report was received from a pharmacist regarding a patient of unknown gender and age. Information on pertinent medical history and concomitant medication was not reported. On 03-MAY-2019, the patient received a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) via intramuscular route in error for prophylaxis (dose, frequency and lot number was not reported) (Incorrect route of product administration). No adverse effect was reported. No product quality complaint was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Tenderness
Clinical narrative: redness/ red strip; tenderness/ tender to touch; This case was reported by a nurse via sales rep and described the occurrence of red rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date, 6 months prior).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced red rash and tenderness. On an unknown date, the outcome of the red rash and tenderness were recovered/resolved.   It was unknown if the reporter considered the red rash and tenderness to be related to Shingrix.  Additional details were provided as follows: The patient was healthy. The age at vaccination was not reported. The patient experienced a 6 inch red strip and tender to touch for 3-5 days after 2nd dose of Shingrix. All the events were resolved. The reporter did not agree to follow up from GSK.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash generalised, Serology test, Stomatitis
Clinical narrative: elevated titer; generalized rash; sores in mouth; body aches; low grade temperature; This case was reported by a physician via call center representative and described the occurrence of viral titer increased in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced viral titer increased, generalized rash, sores mouth, general body pain and slight temperature. On an unknown date, the outcome of the viral titer increased, generalized rash, sores mouth, general body pain and slight temperature were unknown.   It was unknown if the reporter considered the viral titer increased, generalized rash, sores mouth, general body pain and slight temperature to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Batch number was not reported. The patient received both doses of Shingrix vaccine on time. The patient presented high titers. The patient expereinced rash, sores in mouth, low grade fever and body pain.      Lab Comments: On an unknown date serolgy test was performed.
Sex: F
Vaccine: VARZOS
Symptoms: Viral titre increased
Clinical narrative: elevated titer; generalized rash; sores in mouth; body aches; low grade temperature; This case was reported by a physician via call center representative and described the occurrence of viral titer increased in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced viral titer increased, generalized rash, sores mouth, general body pain and slight temperature. On an unknown date, the outcome of the viral titer increased, generalized rash, sores mouth, general body pain and slight temperature were unknown.   It was unknown if the reporter considered the viral titer increased, generalized rash, sores mouth, general body pain and slight temperature to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Batch number was not reported. The patient received both doses of Shingrix vaccine on time. The patient presented high titers. The patient expereinced rash, sores in mouth, low grade fever and body pain.      Lab Comments: On an unknown date serolgy test was performed.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, 7 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 reported as follows: The age at vaccination was not reported. One week after vaccination, the patient experienced broke out with Shingles.  The patient visited the urgent care and was treated by her physician for Shingles. No further details were provided.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Local reaction
Clinical narrative: 15CM X 15CM localized reaction. area was war., red, and edematous but only central area measuring 5cm x 5cm. First Dtap/Poilo combination but 5th Dtap in the series.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site pain, Lethargy, Nausea
Clinical narrative: Pain at injection site, chills, feel feverish, nausea, lethargic, joint pain
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain at injection site, chills, feel feverish, nausea, lethargic, joint pain
Age: 9.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain
Clinical narrative: Patient presented with puncture wound requiring tetanus vaccine. We did not have Td vaccine available at this office, so patient was given at Dtap vaccine instead. Patient had some soreness at injection site, no other reports of adverse reactions or problems. No further treatment was given.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Pain at injection sight with severe swelling redness heat.  Dizziness.  Fatigue.  Excessive sleeping.  Headache.  GI distress.  Muscle aches.   Chills.  SHINGLES!!!!  Near injection site.  Responded to Valtrex.  Some residual post herpatic neuralgia.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypersomnia, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Pain at injection sight with severe swelling redness heat.  Dizziness.  Fatigue.  Excessive sleeping.  Headache.  GI distress.  Muscle aches.   Chills.  SHINGLES!!!!  Near injection site.  Responded to Valtrex.  Some residual post herpatic neuralgia.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Post herpetic neuralgia
Clinical narrative: Pain at injection sight with severe swelling redness heat.  Dizziness.  Fatigue.  Excessive sleeping.  Headache.  GI distress.  Muscle aches.   Chills.  SHINGLES!!!!  Near injection site.  Responded to Valtrex.  Some residual post herpatic neuralgia.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: child patient received MMR II intramuscularly; No adverse effects; This spontaneous report was received from a pharmacist and refers to a child patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intramuscularly (instead of subcutaneously) for prophylaxis. Concomitant medication included sterile diluent. No adverse effects were reported
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site warmth, Malaise
Clinical narrative: 04/30/19--patient reports "not feeling well: in the afternoon around 16:00. 17:30 reports symptoms of shaking and chills. 22:00 reports feeling fevered, did not take temperature. 5/1/19 patient woke up around 7:00am and had a headache and neck pain that were resolved with over-the-counter ibuprofen. She informed her primary care provider of her symptoms and was offered an appointment that day, 5/1/19 however denied need for appointment. Later in the day the patient reports redness and warmth at the site, left deltoid. She did not have any shortness of breath or feelings of throat closing at any time. 5/6/19 reports to office and all symptoms have resolved.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pyrexia, Tremor
Clinical narrative: 04/30/19--patient reports "not feeling well: in the afternoon around 16:00. 17:30 reports symptoms of shaking and chills. 22:00 reports feeling fevered, did not take temperature. 5/1/19 patient woke up around 7:00am and had a headache and neck pain that were resolved with over-the-counter ibuprofen. She informed her primary care provider of her symptoms and was offered an appointment that day, 5/1/19 however denied need for appointment. Later in the day the patient reports redness and warmth at the site, left deltoid. She did not have any shortness of breath or feelings of throat closing at any time. 5/6/19 reports to office and all symptoms have resolved.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, International normalised ratio decreased, Malaise
Clinical narrative: Patient has a plastic aortic valve and has a home INR monitor to help her monitor her INR.  The morning of the vaccination her INR was 3.6.  She got the vaccine and later started to feel exhausted, malaise, and "like she was dying." When her blood is not anticoagulated enough it cannot pass through her valve as easily and she feels miserable she said.  She checked her INR the following morning and it was 2.6.  She talked to her cardiologist and they suggested she take an additional 2.5mg of warfarin that morning.  She started to feel better relatively quickly.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV
Symptoms: Seizure, Unresponsive to stimuli
Clinical narrative: Patient presented today for a 30 month check up. Patient's mom reports that a few hours after receiving vaccines at 11/07/2018 appt, she had a seizure. Mother states she did not take patient's temperature. She says she laid her in her bed and she started convulsing and was not responsive for about 3 minutes. She seemed fine after the seizure per mom. They did not seek any medical care or notify us of event at that time.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Pyrexia, Seizure like phenomena
Clinical narrative: Patient had fever and two seizure like events within 4 hours of the shots. Went to local emergency room, and was cleared without testing.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Full blood count normal, Injection site nodule, Pyrexia
Clinical narrative: Large knot at site of DTaP-IPV.  Started fever in afternoon.  Fever to 104 at 6am this morning.
Sex: M
Vaccine: HPV9
Symptoms: Hypersensitivity
Clinical narrative: Patient developed an unspecified hypersensitivity reaction; Information has been received from a physician via a company representative concerning to an adolescent male patient. No medical history, concurrent conditions nor concomitant medications were performed. On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route, lot number and expiration date not reported) for prophylaxis (reported as "adolescent patient"). On an unknown date, the patient experienced an unspecified hypersensitivity reaction (hypersensitivity). The patient sought medical attention. The outcome of hypersensitivity was unknown.       The relationship between hypersensitivity reaction and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Age: 66.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient does not recall any adverse effects at the time from any of the vaccines given; Patient received three doses of pneumococcal vaccines (PREVNAR 13 & PNEUMOVAX 23) in a one month period; Patient received three doses of pneumococcal vaccines (PREVNAR 13 & PNEUMOVAX 23) in a one month period; This spontaneous report was received from a pharmacist refers to a 66 year old male patient. The patient's current condition included type 2 diabetes mellitus. The patient's historical conditions, drug reactions/allergies and concomitant medications were not reported. The patient received three doses of different pneumococcal vaccines. On 15-SEP-2014, the patient received the first dose with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) as prophylaxis. On 17-SEP-2014, the patient was vaccinated with second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) as prophylaxis (dosing details, route, lot # and expiration date not reported). On 15-OCT-2014, the patient received the third dose with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) at an unspecified clinic. Patient received three doses of pneumococcal vaccines (pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23)) in a one month period (inappropriate schedule of product administration, interchange of vaccine products). The patient did not recall any adverse effects at the time from any of the vaccines given.  Product quality complaint not involved.
Sex: M
Vaccine: HPV9
Symptoms: Migraine
Clinical narrative: Developed a migraine headache shortly afterwards; Information has been received from a pharmacist via a company representative concerning to a male patient (age not reported). No medical history, concurrent condition nor concomitant medications were reported. On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, lot number and expiration date not reported), intramuscular for prophylaxis. On an unknown date, the patient developed a migraine headache shortly afterwards. The patient was offered an aspirin to treat the migraine , but he declined treatment. The patient sought medical attention (called physician). The outcome of migraine was unknown.  The causal relationship between migraine and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Injection site swelling; Injection site pain; Injection site redness; swollen area was feverish to the touch; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 2nd dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site pain, injection site redness, feeling of warmth and fever. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site redness, feeling of warmth and fever were unknown.   It was unknown if the reporter considered the injection site swelling, injection site pain, injection site redness, feeling of warmth and fever to be related to Shingrix.  Additional details were provided as follows: The patient experienced fever and the area of the injection was swollen, sore, and red. The swollen area was feverish to the touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Pain
Clinical narrative: Red, hot rash occurred around the injection site (about 2 inches in diameter) and lasted for two days. Parents gave ibuprofen as needed to help ease pain.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: felt tired and minor chills for 3 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Injection site pain, Insomnia, Myalgia
Clinical narrative: Extreme soreness at injection sight, cold shivering, muscle aches, insomnia
Age: 4.0
Sex: F
Vaccine: DTAPIPV, UNK, UNK, UNK
Symptoms: Injection site bruising, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, hot to touch tightness at injection site was noticed on january 30th the day after injections in her left thigh. The swelling got worse and spread covering her thigh. After weeks of it like this, it faded to a bruise that lasted until april.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, UNK, UNK, UNK
Symptoms: Skin tightness
Clinical narrative: Swelling, redness, hot to touch tightness at injection site was noticed on january 30th the day after injections in her left thigh. The swelling got worse and spread covering her thigh. After weeks of it like this, it faded to a bruise that lasted until april.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: large area of redness and swelling around injection site.  patient reports sore and warm to touch
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling abnormal, Full blood count, Infection, Metabolic function test, Peripheral swelling
Clinical narrative: Patient had varicella vaccine on 4/19/19 on her right arm. On 4/20/19 she had fever of 101 and continued to feel bad through the next day. Right arm began to swell on 4/21/19. Patient says it was tender and warm to touch. Was seen at clinic on 4/22/19. Treated with Keflex for secondary skin infection. Patient was advised to do cool compresses and avoid strenuous activity.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Skin warm, Tenderness
Clinical narrative: Patient had varicella vaccine on 4/19/19 on her right arm. On 4/20/19 she had fever of 101 and continued to feel bad through the next day. Right arm began to swell on 4/21/19. Patient says it was tender and warm to touch. Was seen at clinic on 4/22/19. Treated with Keflex for secondary skin infection. Patient was advised to do cool compresses and avoid strenuous activity.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Swelling. hives after 3-4 days of receiving vaccine. But she did not have any fever or pain. Just swelling, a hive at left arm, and itchiness.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; the administration of one separate dose of an improperly stored vaccine, VARIVAX, to one separate patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions and allergies were not reported.   On 22-APR-2019, the patient was vaccinated with one separate dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot number: R026548, expiration date: 17-SEP-2020) administered subcutaneously (dose was not provided) that was diluted in properly stored sterile diluent. The vaccine was still experiencing a temperature excursion at the reporting time. On 16-APR-2019, there was a previous temperature excursion in 11.28 degrees Fahrenheit for 15 minutes and 9.1 degrees Fahrenheit for 45 minutes. Digital data lodger was involved.   No adverse event was reported.
Age: 71.0
Sex: F
Vaccine: MMR, UNK
Symptoms: Incorrect route of product administration, Injection site pain
Clinical narrative: The patient complained of pain at the injection site; MMR II was administered via the intramuscular route; This spontaneous report as received from a pharmacist refers to a 71-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, lot number and expiration date were not provided), diluted in sterile diluent (DILUENT MRK INJ) (dose, lot number and expiration date were not provided), intramuscularly, for prophylaxis. On an unknown date, the patient complained of pain at the injection site. The outcome of injection site pain was unknown.  The relatedness between the event of injection site pain and suspect therapies was not provided.
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, Expired product administered, Metabolic function test
Clinical narrative: expired product administered; This spontaneous report was received from nurse concerning a 4-year-old male patient of unknown race.  The patient's medical history included infection. The patient's concomitant medications included albuterol and ranitidine hydrochloride (ZANTAC). The patient's concurrent conditions included asthma, upper respiratory tract infection, pneumonia and streptococcal infection. The patient had no drug reactions or allergies. The patient's historical drugs included 4 doses of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) and unspecified antibiotics for infections.  The patient was under physician's care (clinician unspecified) for history of asthma, recurring upper respiratory infections, pneumonia, streptococcus infection ("strep"). The clinician decided to evaluate the patient's immune function and drew titers in recent past and titers came back low. Treatment for this was to vaccinate with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The patient underwent a comprehensive metabolic panel (results not reported).  On 01-MAY-2019 (also reported as 19-APR-2019) the patient was vaccinated intramuscularly with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # N025384, expiration date 19-APR-2019, for "low titers for pneumococcal" (prophylaxis) (strength was not reported).
Age: 23.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; patient received the first dose of gardasil 9 on 08/02/2019 and the second dose of the series on 05/03/2019; This spontaneous report was received from a medical assistant regarding to a 23 year old patient of unspecified gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On 08-FEB-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 via intramuscular (strength, dose, lot#  and expiry were not reported) for prophylaxis. The medical assistant described that, on 05-MAR-2019, the patient vaccinated 2nd dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) via intramuscular (strength, dose, lot#  and expiry were not reported) for prophylaxis, outside of the recommended time in the prescribed information (inappropriate schedule of product administration), and no adverse reactions reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: injection site reaction; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction 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 injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's husband. The age at vaccination was not reported. The patient experienced injection site reaction for 2 to 3 days after receiving a dose of Shingrix vaccine.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number MX2LT, expiry date 29th May 2021) and (batch number 42D4K, expiry date 29th May 2021) for prophylaxis.   On 19th February 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 19th February 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. It was reported that the patient experienced pain at the injection site when he received Shingrix and at the time of reporting the patient still had pain at the injection site.
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Rash, Scar
Clinical narrative: rash/persistent rash; scars; This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax and Shingrix (on an unknown date the patient received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, immediately after receiving Shingrix, the patient experienced rash and scar. The patient was treated with neosporin (nos) (Neosporin). On an unknown date, the outcome of the rash and scar were not recovered/not resolved.   It was unknown if the reporter considered the rash and scar to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. Not long after getting Zostavax, the patient was advised to get the new shingles vaccine, Shingrix.  The patient received both doses of Shingrix, with the 2nd dose administered about 1 year ago.  Shortly after the 2nd dose of Shingrix he developed a rash on his right buttock and it had persisted since then. He had tried putting creams on it, neosporin and just keeping it dry, but the rash never goes away and it had started leaving scars. The emergency room visit required.
Sex: F
Vaccine: PPV
Symptoms: Drug hypersensitivity, Swelling
Clinical narrative: Drug Allergies: Iodine, Pneumonia Vaccine; swelling; This is a spontaneous report from a Pfizer sponsored program. A contactable physician reported that a 77-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) via an unspecified route of administration on an unspecified date at single dose for pneumonia vaccine and iodine via an unspecified route of administration on an unspecified date at an unspecified dose and frequency for an unspecified indication. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced drug allergies  and swelling. The action taken in response to the events for iodine was unknown. The outcome of the events was unknown.  The information on the batch number has been requested.  Pfizer is a Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence. This may be a duplicate report if another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness, swelling at injection site; redness, swelling at injection site; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative.   An elderly (age: 65 plus) female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced redness, swelling at injection site on an unspecified date with outcome of unknown.  The information on the lot number has been requested.
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Injection site swelling; Injection site redness; Looks like induration as well; This is a spontaneous report from a contactable nurse. A 12-month-old male patient received the forth dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at 0.5 ml, single in the right thigh for standard vaccination schedule, received varicella zoster vaccine (VARICELLA VACCINE), via an unspecified route of administration on an unspecified date at unknown dose for standard vaccination schedule. There were no medical history and concomitant medications. The patient previously received three doses of pneumococcal 13-val conj vac (dipht crm197 protein) for immunization on unspecified dates. On 29Apr2019, the patient experienced injection site swelling, injection site redness, and looked like induration as well. Therapeutic measures were taken with Thlenol as a result of the events. The outcome of the events was not recovered.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash erythematous, Rash macular, Skin warm
Clinical narrative: Student complaining of blotchy red rash, noted on hands to just above her elbow.  Student states rash is hot.  Mom did not pick up.  Vital signs remain stable, rash has not spread on any other areas.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Pain
Clinical narrative: temp of 103.1 with associated body aches
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: Fever, headache, nausea, body aches, general malaise
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received her doses for twinrin backwards. She received her 2nd dose 5 months after her first dose and 4 weeks after her 2nd dose.
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site pruritus, Injection site rash, Injection site swelling, Pain
Clinical narrative: Left arm pain; Body aches; Headaches; Fever; At the site of injection she had a rash, swelling and itching.; At the site of injection she had a rash, swelling and itching.; At the site of injection she had a rash, swelling and itching.; This is a spontaneous report from a contactable physician via a Pfizer sales representative.  A 67-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on 16Apr2019 at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced left arm pain, body aches, headaches, fever and at the site of injection she had a rash, swelling and itching. At the time of the report, the outcome of the events was unknown.  The information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Left arm pain; Body aches; Headaches; Fever; At the site of injection she had a rash, swelling and itching.; At the site of injection she had a rash, swelling and itching.; At the site of injection she had a rash, swelling and itching.; This is a spontaneous report from a contactable physician via a Pfizer sales representative.  A 67-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on 16Apr2019 at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced left arm pain, body aches, headaches, fever and at the site of injection she had a rash, swelling and itching. At the time of the report, the outcome of the events was unknown.  The information on the batch number has been requested.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Erythema, Erythema multiforme, Peripheral swelling, Skin warm
Clinical narrative: Patient received vaccination on 4/4/2019. Called provider on 4/11/19 to report his arm became red, warm, the size of half a melon, swelled from shoulder to elbow. Denies fever but positive for chills. Patient states reaction took place on 4/4/19 after getting home from appointment. Denies these symptoms at present. ErythemaMultiform & swelling
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Patient received vaccination on 4/4/2019. Called provider on 4/11/19 to report his arm became red, warm, the size of half a melon, swelled from shoulder to elbow. Denies fever but positive for chills. Patient states reaction took place on 4/4/19 after getting home from appointment. Denies these symptoms at present. ErythemaMultiform & swelling
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site paraesthesia, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site redness swelling, tingling, Warmth, Itching, Growing every day now at 6 inches wide after 6 days.
Age: 24.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Rash generalised, Rash macular
Clinical narrative: Patient Red splotches all over body.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Child was given 2 Tdap vaccines on same date.  1st  in Right deltoid and 2nd in Left deltoid. Per father on 5/6/19- child was fine, and had no untoward reactions.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Pain in extremity
Clinical narrative: Sore and  a lot pain in arm; feverish around shot sight.  Keflex for 7 days therapy and tramadol ordered on 5/7/2019.  Pt is still experiencing pain
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose normal, Blood pressure decreased, Dizziness, Feeling hot
Clinical narrative: Patient was anxious to receive vaccine. vaccine was administered. Patient started feeling light headed. We asked her to sit down. Patient said she was light headed and dizzy and hot in temperature. Patient stated she has not eaten anything since the morning.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects were reported; patient received GARDASIL 9 on the following dates: an unspecified date in November 2017, 9/15/2018, and 10/29/2018; This spontaneous report was received from a pharmacist and refers to a 15-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On unspecified date in November 2017, 15-SEP-2018 and 29-OCT-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly for prophylaxis (strength, dose, site, lot # and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; a patient was inadvertently administered an expired dose of MMR II; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported.       On 06-MAY-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human album (RHA), lot # N013868 with expiration date 04-MAY-2019, for prophylaxis (route of administration and anatomical location were not reported). Concomitant therapies included sterile diluent(MERCK STERILE DILUENT), which was not expired. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: Injection site pain; Headache; general body pain; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2008, the patient received the 1st dose of Shingrix. In November 2018, 1 day after receiving Shingrix, the patient experienced headache and general body pain. On an unknown date, the patient experienced injection site pain. In November 2018, the outcome of the headache and general body pain were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 62 or 63 years. In mid-November 2018, the patient received Shingrix on left arm. 24 hours after receiving Shingrix, the patient experienced headache and general body aches which lasted for 1 week. The patient also experienced sore arm where injection was administered for about 3 to 4 days. The reporter did think the effects were related to product and was prepared based on product information (PI) safety information. The reporter did not consent to follow up.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: soreness; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of pain in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th April 2019, the patient received the 1st dose of Shingrix. On 20th April 2019, less than a day after receiving Shingrix, the patient experienced pain and influenza-like symptoms. On 21st April 2019, the outcome of the pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the pain and influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The patient asked did the 2nd shot have the same side effect as the first shingix. The patient had shot on Saturday very sore and felt flu like symptom that evening of vaccination and was ok for the next day. The patient just wants to know about the 2nd shot was it the same as the first and was just The patient was curious, would received in 6 months. The patient did not gave permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms for one day following dose of vaccine. The reporter did not agree to follow up with GlaxoSmithKline.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Hyperhidrosis, Hypotension, Pallor, Presyncope, Tachycardia
Clinical narrative: -Patient developing palor, sweating, tachycardia, blurry vision, Low BP, almost fainting 1-2 m after shots given -VS was checked q 5-10 minutes and self improved after changing position, given fluids. Last checked BP 105/70 HR 72/min SpO2 99% after 30 minutes  Rechecked on the next day, pt totally normal, no concerns.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Vision blurred
Clinical narrative: -Patient developing palor, sweating, tachycardia, blurry vision, Low BP, almost fainting 1-2 m after shots given -VS was checked q 5-10 minutes and self improved after changing position, given fluids. Last checked BP 105/70 HR 72/min SpO2 99% after 30 minutes  Rechecked on the next day, pt totally normal, no concerns.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Herpes simplex, Prenatal screening test, Ultrasound antenatal screen, Ultrasound antenatal screen normal
Clinical narrative: This is a serious observational study case initially received on 26-Apr-2019, concerning a 21-year-old adult female, pregnant subject of body weight 170.5 lbs, height 62.8 inches and body mass index (BMI) 30.4, enrolled in study. The subject's obstetrical history noted that the subject had 3 previous pregnancies with 2 full term live births and one pregnancy with spontaneous abortion. No birth defects were reported. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period (LMP) date was 13-Feb-2018 (as reported). The type of pregnancy was singleton. The pregnancy status of the subject was collected, and no pregnancy complications were noted. The subject's concomitant medications included prenatal vitamins for general health. On 14-Jan-2019, the subject was administered Flu Vaccine Egg Split QIV CSL [batch number: YF41608 (reported as YF1608), dose, route of administration, anatomical location, batch number and expiry date: not reported) for an unknown indication. On 23-Jan-2019, the subject had undergone first trimester screen and maternal screen with nuchal translucency and no major congenital malformations were noted. On 27-Feb-2019, the subject had undergone ultrasound antenatal screen and no major congenital malformations were noted. On an unspecified date in 2019, the subject experienced herpes simplex virus infection. The subject was treated with Valacyclovir [start date: 01-Apr-2019, dose: 1 g, frequency: twice a day (bid), route of administration: oral and stop date: 02-Apr-2019) for herpes simplex virus infection. The outcome of the event herpes simplex virus infection was not recovered (reported as ongoing). The subject's corrected estimated date of delivery (CEDD) was 29-Jul-2019 (as reported). Reporter's Comments: A 21-year-old pregnant subject experienced herpes simplex virus infection, unspecified period of time after receipt of Flu Vaccine Egg Split QIV. Despite the lack of onset latency, the causality of the event herpes simplex virus infection assessed as not related considering the infectious aetiology of the event. The event vaccine exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company assessed the event 'herpes simplex virus infection' as serious (medically significant).