chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Diarrhoea, Nausea, Vomiting
Clinical narrative: Sore Arm; felt cold; Chills; Fever; Felt very tired; Scared; Stomach was gurgling and rumbling; Diarrhea; Vomiting; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number AP257, expiry date 31st August 2020) for prophylaxis.   The patient's past medical history included ovarian cancer (For about 15.5 years).   On 5th August 2019 15:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, feeling cold, chills, fever and tiredness. In August 2019, the patient experienced borborygmus, diarrhea, vomiting and fear. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm and tiredness were not recovered/not resolved and the outcome of the feeling cold, chills, fever and fear were unknown and the outcome of the borborygmus, diarrhea and vomiting were recovered/resolved.   It was unknown if the reporter considered the pain in arm, feeling cold, chills, fever, tiredness, borborygmus, diarrhea, vomiting and fear to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm. The patient had sore arm, felt cold with chills, fever, felt very tired and took Tylenol to help.  On the previous night of reporting date, at 11PM, the patient's stomach was gurgling and rumbling. She put on a diaper or pull up without knowing what to expect. Shortly after doing so she had diarrhea. Then she woke up again at 1:15 AM and reported vomiting that lasted for approximately 3 hours. The patient reported that the she had diarrhea and vomiting in the middle of the night, and she was frightened. The patient asked the representative to contact the pharmacist and physician, and to list the side effects as containing not only an upset stomach, which was not very severe, but to include that side effects could include diarrhea and vomiting. It was reported that the more than upset stomach, the vomiting was very very scary in the middle of the night. The patient also reported that, she had a PET (positron emission tomography) scan appt (appointment) on 7th August 2019 as well as a dermatology appointment but canceled both due to these symptoms. The patient was scared, especially due to being a cancer survivor. These events reminded her of being sick during past chemo treatments. The patient requested that, this acknowledgement also be sent to pharmacy that administered vaccine. The patient consented to follow up and provided her physician's details. The patient provided feedback that, upset stomach should be mentioned on VIS or Shingrix FAQs (frequently asked questions) gastrointestinal symptoms and should be spelled out.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Fear, Feeling cold
Clinical narrative: Sore Arm; felt cold; Chills; Fever; Felt very tired; Scared; Stomach was gurgling and rumbling; Diarrhea; Vomiting; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number AP257, expiry date 31st August 2020) for prophylaxis.   The patient's past medical history included ovarian cancer (For about 15.5 years).   On 5th August 2019 15:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, feeling cold, chills, fever and tiredness. In August 2019, the patient experienced borborygmus, diarrhea, vomiting and fear. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm and tiredness were not recovered/not resolved and the outcome of the feeling cold, chills, fever and fear were unknown and the outcome of the borborygmus, diarrhea and vomiting were recovered/resolved.   It was unknown if the reporter considered the pain in arm, feeling cold, chills, fever, tiredness, borborygmus, diarrhea, vomiting and fear to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm. The patient had sore arm, felt cold with chills, fever, felt very tired and took Tylenol to help.  On the previous night of reporting date, at 11PM, the patient's stomach was gurgling and rumbling. She put on a diaper or pull up without knowing what to expect. Shortly after doing so she had diarrhea. Then she woke up again at 1:15 AM and reported vomiting that lasted for approximately 3 hours. The patient reported that the she had diarrhea and vomiting in the middle of the night, and she was frightened. The patient asked the representative to contact the pharmacist and physician, and to list the side effects as containing not only an upset stomach, which was not very severe, but to include that side effects could include diarrhea and vomiting. It was reported that the more than upset stomach, the vomiting was very very scary in the middle of the night. The patient also reported that, she had a PET (positron emission tomography) scan appt (appointment) on 7th August 2019 as well as a dermatology appointment but canceled both due to these symptoms. The patient was scared, especially due to being a cancer survivor. These events reminded her of being sick during past chemo treatments. The patient requested that, this acknowledgement also be sent to pharmacy that administered vaccine. The patient consented to follow up and provided her physician's details. The patient provided feedback that, upset stomach should be mentioned on VIS or Shingrix FAQs (frequently asked questions) gastrointestinal symptoms and should be spelled out.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gastrointestinal sounds abnormal, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Sore Arm; felt cold; Chills; Fever; Felt very tired; Scared; Stomach was gurgling and rumbling; Diarrhea; Vomiting; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number AP257, expiry date 31st August 2020) for prophylaxis.   The patient's past medical history included ovarian cancer (For about 15.5 years).   On 5th August 2019 15:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, feeling cold, chills, fever and tiredness. In August 2019, the patient experienced borborygmus, diarrhea, vomiting and fear. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm and tiredness were not recovered/not resolved and the outcome of the feeling cold, chills, fever and fear were unknown and the outcome of the borborygmus, diarrhea and vomiting were recovered/resolved.   It was unknown if the reporter considered the pain in arm, feeling cold, chills, fever, tiredness, borborygmus, diarrhea, vomiting and fear to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm. The patient had sore arm, felt cold with chills, fever, felt very tired and took Tylenol to help.  On the previous night of reporting date, at 11PM, the patient's stomach was gurgling and rumbling. She put on a diaper or pull up without knowing what to expect. Shortly after doing so she had diarrhea. Then she woke up again at 1:15 AM and reported vomiting that lasted for approximately 3 hours. The patient reported that the she had diarrhea and vomiting in the middle of the night, and she was frightened. The patient asked the representative to contact the pharmacist and physician, and to list the side effects as containing not only an upset stomach, which was not very severe, but to include that side effects could include diarrhea and vomiting. It was reported that the more than upset stomach, the vomiting was very very scary in the middle of the night. The patient also reported that, she had a PET (positron emission tomography) scan appt (appointment) on 7th August 2019 as well as a dermatology appointment but canceled both due to these symptoms. The patient was scared, especially due to being a cancer survivor. These events reminded her of being sick during past chemo treatments. The patient requested that, this acknowledgement also be sent to pharmacy that administered vaccine. The patient consented to follow up and provided her physician's details. The patient provided feedback that, upset stomach should be mentioned on VIS or Shingrix FAQs (frequently asked questions) gastrointestinal symptoms and should be spelled out.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness
Clinical narrative: discomfort in the right arm; fatigue; nausea; wrong site at vaccine; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15th May 2019, in left arm, refer case, refer case US2019144918).   On 26th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site discomfort, fatigue, nausea and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site discomfort, fatigue, nausea and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site discomfort, fatigue and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. The patient stated that, Shingrix vaccine injected into the fatty tissue and not inthe muscle, which led to vaccine administered at inappropriate site. The patient experienced some discomfort in the right arm and also developed nausea and fatigue. No additional information was provided. The patient consented to follow up. For the tollerence of 1st dose refer case US2019144918, reported by same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site discomfort, Nausea, Product administered at inappropriate site
Clinical narrative: discomfort in the right arm; fatigue; nausea; wrong site at vaccine; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15th May 2019, in left arm, refer case, refer case US2019144918).   On 26th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site discomfort, fatigue, nausea and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site discomfort, fatigue, nausea and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site discomfort, fatigue and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. The patient stated that, Shingrix vaccine injected into the fatty tissue and not inthe muscle, which led to vaccine administered at inappropriate site. The patient experienced some discomfort in the right arm and also developed nausea and fatigue. No additional information was provided. The patient consented to follow up. For the tollerence of 1st dose refer case US2019144918, reported by same reporter.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Haematoma, Injection site rash, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Patient developed "blotchy" rash and swelling at site of injection, which resolved after few days. Patient also developed palpable "lump/lump" size of golf ball at site of injection under skin - bump was not visible. Pt. also developed "restless arm" sensation in Left arm the day after receiving vaccine; this sensation occurred for about 3 weeks.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Restlessness
Clinical narrative: Patient developed "blotchy" rash and swelling at site of injection, which resolved after few days. Patient also developed palpable "lump/lump" size of golf ball at site of injection under skin - bump was not visible. Pt. also developed "restless arm" sensation in Left arm the day after receiving vaccine; this sensation occurred for about 3 weeks.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site mass, Injection site reaction, Injection site swelling, Rash macular, Restlessness
Clinical narrative: Patient developed "blotchy" rash and swelling at site of injection, which resolved after few days. Patient also developed palpable "lump/lump" size of golf ball at site of injection under skin - bump was not visible. Pt. also developed "restless arm" sensation in Left arm the day after receiving vaccine; this sensation occurred for about 3 weeks.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Insomnia, Musculoskeletal pain
Clinical narrative: Very painfil shoulder, tiredness, loss of appetite, difficulty sleeping, headache
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered a dose of VAQTA on 7/5/2019,  that had been improperly stored; Information has been received from a vaccine coordinator (also reported as administrator), referring to a patient of unknown age or gender. Information of concurrent condition, medical history and concomitant therapy was not provided.   On 05-JUL-2019, the patient inadvertently administered a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) (strength and route were unknown) (the involved vaccine included: lot # was reported as R023606 and expiration date 06-MAY-2021; lot # S002460 and expiration date 15-MAY-2020; lot # R034340 and expiration date 23-NOV-2019) for prophylaxis (product storage error). No adverse effect reported.  It was reported that the vaccine underwent a temperature excursion of 49.3 Fahrenheit degrees for 4 hours 30 minutes. There was no previous excursion. The call was because of a data logger.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 74 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 70 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effect reported.; patient was inadvertently administered a dose of PROQUAD, instead of MMR II and VARIVAX; patient was inadvertently administered a dose of PROQUAD, instead of MMR II and VARIVAX; This spontaneous report was received from a nurse regarding a 14-year-old patient of unknown gender. There was no information reported about the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On 30-JUL-2019, the patient was inadvertently administered a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (Lot number reported as: S003176 and expiration date reported as: 30-JUL-2020) (dose and route were not provided) for prophylaxis, instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX). No adverse effect reported.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effect; been vaccinated with a complete series of Hepatitis B vaccine, accidentally received doses of RECOMBIVAX; This spontaneous report was received from a nurse referred to a patient of unknown demographics. Information on pertinent medical history, drug reactions or allergy and concomitant medications were not provided. On 18-OCT-2006, the patient had already been vaccinated with a complete series Hepatitis B Vaccine, on 31-JUL-2019, accidentally received Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose details and route unknown), (lot # R03617 (this lot is not valid for Hepatitis B Vaccine (Recombinant), expiry date: 08-OCT-2021) for prophylaxis (accidental overdose). The two doses of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) were the patient's fourth and fifth lifetime doses of Hepatitis B Vaccine. No adverse effects reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Herpes zoster; Post-Herpetic Neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 87 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced herpes zoster and post-Herpetic neuralgia. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster and post-Herpetic neuralgia. The outcome of the events herpes zoster and post-Herpetic neuralgia was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 71 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 12-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; two patients were administered an expired dose of properly stored PNEUMOV AX 23 (lot R012713 and expiration 03-AUG-2019); This spontaneous report has been received from a nurse referring to a 75-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not provided.         On 06-AUG-2019, the patient was vaccinated with an expired dose of properly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (lot # R012713, expiration date was reported as 03-AUG-2019; dose and route were not reported) in the left deltoid for prophylaxis. No adverse effects reported. Post expiry memo vaccines and biologics administered did support the administration of expired vaccine. No additional information provided. The outcome of the event was unknown.     The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.   This is one of 2 reports received from the same reporter.
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; two patients were administered an expired dose of properly stored PNEUMOV AX 23 (lot R012713 and expiration 03-AUG-2019); This spontaneous report has been received from a nurse referring to a 71 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not provided.         On 06-AUG-2019, the patient was vaccinated with an expired dose of properly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (lot # R012713, expiration date was reported as 03-AUG-2019; dose and route were not reported) in the left deltoid for prophylaxis. No adverse effects reported. Post expiry memo vaccines and biologics administered did support the administration of expired vaccine. No additional information provided. The outcome of the event was unknown.     The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.   This is one of 2 reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: No adverse effect reported; the patient received "less than a full recommended dose ofGARDASIL 9 because of needle leakage".; The medical assistant reports that is was not a manufacturer syringe, it was a plastic syringe used to withdraw vaccine from vial; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. Information about pertinent medical history, concomitant medication and drug reactions or allergies was not reported.  On 07-AUG-2019, the patient received less than a full recommended dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot # N023828, expiration date: 25-JUN-2020, indication: prophylaxis; dose and route were not reported) because of needle leakage. The medical assistant reported that was not a manufacturer syringe, it was a plastic syringe used to withdraw vaccine from vial (Wrong technique in product usage process). No adverse effect reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; The patient was "inadvertently administered an adult dose of VAQTA instead of a pediatric dose today"; This spontaneous report was received from a physician assistant concerning a 16-year-old patient of unknown gender.    The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 08-AUG-2019, the patient was inadvertently vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S007265; Expiration date: 07-JUL-2020) instead of pediatric dose (indication and dose were not provided).    No adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; the patient was inadvertently administered one dose of expired PNEUMOVAX 23; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.       On 07-AUG-2019, the patient was inadvertently administered one dose of expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # R012713, expiration date: 03-AUG-2019), for prophylaxis (strength, frequency and route were not reported) (expired vaccine used). No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Injection site nodule
Clinical narrative: has a non-tender dime sized hard nodule; This spontaneous report was received from a pharmacist, regarding a 55 year old female patient. The patient's concurrent conditions, concomitant medications and medical history were not reported. It was reported that the patient had not known allergies.   On 22-MAY-2019, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscularly, (dose and anatomical location were not reported) (lot # R017624, expiration date 17-MAY-2021) administered for prophylaxis.   On that day, the patient experienced a non-tender dime sized hard nodule at the injection site (injection site nodule) and at the moment of this report the patient still had it. It was unknown if the patient received treatment for this event.   The causality assessment between injection site nodule and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Urticarial lesions; pruritic reticular nonpalpable, nonblanching lesions over his thighs and ankles; This case was reported by a other health professional via call center representative and described the occurrence of urticaria in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.   On 5th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th July 2019, 1 days after receiving Shingrix, the patient experienced urticaria and itchy rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the urticaria and itchy rash were recovering/resolving.   It was unknown if the reporter considered the urticaria and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right deltoid. The reporter was the office manager and provided the initial information. On 6th July 2019, in the morning, the patient experienced urticarial lesions over the upper extremities, neck and arms and at the same time pruritic reticular nonpalpable, nonblanching lesions over his thighs and ankles. The patient went to emergency room and was seen by the physician on the date of reporting. The physician provided little more information
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Injection site pain, Malaise, Pyrexia
Clinical narrative: significant soreness in and around injection site, headaches, stomach cramps, mild fever, malaise
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Gait disturbance, Impaired driving ability
Clinical narrative: Around 4pm, patient started feeling dizzy.   Last night got up and felt dizzy; patient sat on the floor since could hardly walk.   Patient got up this morning and felt dizzy still.   Patient tried to rest, keep hydrated but did not take any medicine.   Patient has same amount of dizziness today.    Planning to contact doctor doctor but doesn't feel well enough to drive.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Insomnia, Musculoskeletal pain
Clinical narrative: severe shoulder pain -no redness or swelling, but enough pain to prevent sleep.  Iced that day, administered tylenol and more ice following morning.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site haemorrhage, Pain in extremity, Peripheral swelling
Clinical narrative: When patient received a shot, blood gushed out.  Later patient reported some swelling, bruising and pain in the arm.  It got better over the next few days.  She was advised to apply heat and take Tylenol if needed and it helped.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This was the first dose of Quadracel for the patient, but 4th doses of DTaP and IPV- patient previously received in Pentacel. On 7/11/19 injection site erythematous, swollen 3 inches in diameter, significant warmth, no drainage or fluctuance, no fever. Pt had history of cellulitis and staph so started on  Clindamycin. On 7/12/19 redness extended from day prior, swelling and pain decreased, no drainage or fever present. Pt completed antibiotic.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is the first dose of Quadracel for the patient, but 4th doses of DTaP and IPV. Patient's parent called doctor's office on 7/13/19 to report redness and swelling on right thigh at injection site of Quadracel. Site described as tennis ball in circumference, hot to touch, and painful. No fever. Advised to continue to monitor - parent did not follow up to report any worsening of condition.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Decreased appetite, Fatigue, Injection site erythema, Injection site inflammation
Clinical narrative: This is the first dose of Quadracel for the patient, but 4th doses of DTaP and IPV. On 7/11/19 pt received vaccinations - on 7/12/19 patient's mom called our office to report vaccination site of Quadracel on right thigh noted as red, inflamed and warm to touch. Pt fever 102.2, increased fatigue and decreased appetite. Swelling felt like fluid under the skin, not firm. Patient taken to urgent care, diagnosed with cellulitis and prescribed Cephalexin for 7 days. Pt seen again on 7/15/19 at urgent care for spreading of redness on skin near injection site; advised to continue antibiotics and monitor.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth, Pyrexia, Swelling
Clinical narrative: This is the first dose of Quadracel for the patient, but 4th doses of DTaP and IPV. On 7/11/19 pt received vaccinations - on 7/12/19 patient's mom called our office to report vaccination site of Quadracel on right thigh noted as red, inflamed and warm to touch. Pt fever 102.2, increased fatigue and decreased appetite. Swelling felt like fluid under the skin, not firm. Patient taken to urgent care, diagnosed with cellulitis and prescribed Cephalexin for 7 days. Pt seen again on 7/15/19 at urgent care for spreading of redness on skin near injection site; advised to continue antibiotics and monitor.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This was the first dose of Quadracel for the patient, but 4th doses of DTaP and IPV. On 6/26/19, patient's mother reported the vaccination site reported red, swollen, non-tender, warm to touch, 4-5 in in circumference. The redness spread through following day of 6/27/19 and then started to resolve over the rest of the week. Patient given Benedryl.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Dysaesthesia
Clinical narrative: Dysesthesia with mild aching from lower back to ankles
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Nervousness
Clinical narrative: felt weak; Felt shaky; This case was reported by a physician via sales rep and described the occurrence of feelings of weakness in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, couple of hours after receiving Bexsero, the patient experienced feelings of weakness and shaky feelings. On an unknown date, the outcome of the feelings of weakness and shaky feelings were recovered/resolved.   It was unknown if the reporter considered the feelings of weakness and shaky feelings to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient's parent indicated that the patient felt weak and shaky. The reporter thought the symptoms were too soon after the vaccination to be related to the vaccine and ultimately the symptoms resolved with no additional issue.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Malaise, Vomiting
Clinical narrative: headache; vomited; not feeling well; This case was reported by a other health professional via interactive digital media and described the occurrence of headache in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2019, the patient received the 2nd dose of Shingrix. On 7th August 2019, less than a day after receiving Shingrix, the patient experienced headache, vomiting and feeling unwell. On an unknown date, the outcome of the headache, vomiting and feeling unwell were unknown.   It was unknown if the reporter considered the headache, vomiting and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient was reporter's husband. The reporter stated that, in the morning of vaccination day, the patient experienced headache, vomiting and feeling unwell.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: flu-like symptoms; fever; chills; body aches; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 7M2KB, expiry date 30th March 2020) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years 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 provided as follows: The age at vaccination was not reported. The patient experienced flu like symptoms, fever, chills, body aches. The reporter did not give consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Rash, Rash pruritic, Skin warm
Clinical narrative: Itchy rash; Warm ears; Feeling tired; painful rash; This case was reported by a other health professional via call center representative and described the occurrence of itchy rash in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 377MK, expiry date 25th September 2021) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix. On 27th July 2019, 3 days after receiving Shingrix, the patient experienced itchy rash, skin warm, tiredness and painful rash. On an unknown date, the outcome of the itchy rash and painful rash were not recovered/not resolved and the outcome of the skin warm and tiredness were unknown.   It was unknown if the reporter considered the itchy rash, skin warm, tiredness and painful rash to be related to Shingrix.  Additional details were provided as follows: The pharmacy intern reported the patient experienced approximately 3 days after receiving 1st dose of Shingrix, a rash, warm ears, and feeling tired. The health care professional described rash as itchy and painful. rash was not resolved. The outcome of warm ears and feeling tired was unknown. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: tired; sore at the injection site; flu like symptoms; weak; headache; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 7D9C3, expiry date unknown) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix .5 ml. On 7th August 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, weakness, headache and injection site pain. On 8th August 2019, the patient experienced tiredness. The patient was treated with acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the influenza-like symptoms, weakness and headache were recovered/resolved and the outcome of the tiredness and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, weakness, headache, tiredness and injection site pain to be related to Shingrix.  Additional details were provided as follows: In the night of the day of vaccination, the patient experienced influenza-like symptoms, feeling weak, and having a bad headache. In the morning of the day of reporting, the patient took Aspirin and so far just felt tired. The patient did not consent to follow up
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site pain, Peripheral swelling, Pyrexia
Clinical narrative: swelling left arm; it still hurts in the spot where she received the vaccine; low grade fever; shivering; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 15th May 2019, less than a day after receiving Shingrix, the patient experienced low grade fever and shivering. On an unknown date, the patient experienced swelling arm and injection site pain. On an unknown date, the outcome of the low grade fever, shivering, swelling arm and injection site pain were recovered/resolved.   It was unknown if the reporter considered the low grade fever, shivering, swelling arm and injection site pain to be related to Shingrix. Additional details were providded as follows: The patient received dose of Shingrix in the left arm. In the evening of day of vaccination, the patient experienced low grade fever and shivering, and lasted for approximately 3 days before resolving. The patient stated that, when she lift her left arm, it still hurts in the spot where, received the vaccine. For the tolerance of 2nd dose, refer case US2019AMR145250
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Product complaint, Skin warm
Clinical narrative: Product Complaint; Red; Raised; Hot to touch; Painful; This case was reported by a pharmacist via call center representative and described the occurrence of skin warm in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number K9L3M, expiry date 29th October 2021) for prophylaxis.   On 2nd August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd August 2019, less than a day after receiving Shingrix, the patient experienced skin warm and pain in arm. On 6th August 2019, the patient experienced injection site erythema and injection site swelling. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the skin warm, pain in arm, injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown.   It was unknown if the reporter considered the skin warm, pain in arm, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. On the same day of vaccination, the patient's arm felt hot to touch and painful starting.  On 6th August 2019, the injection site became red and raised. It was not in a complete circle. All of which were not resolved. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Product complaint, Pyrexia
Clinical narrative: Pharmaceutical product complaint; Swelling in foot; Low grade fever; Swelling in arm; arm being painful/Aching; This case was reported by a pharmacist via call center representative and described the occurrence of swelling of feet in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number K9L3M, expiry date 29th October 2021) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st August 2019, 1 days after receiving Shingrix, the patient experienced swelling of feet, low grade fever, swelling arm and pain in arm. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the swelling of feet, low grade fever, swelling arm and pain in arm were recovering/resolving and the outcome of the pharmaceutical product complaint was unknown.   It was unknown if the reporter considered the swelling of feet, low grade fever, swelling arm and pain in arm to be related to Shingrix.  Additional details were provided as follows: The pharmacist on the line reporting that the patient received Shingrix and had swelling in her foot on the same side of the body as the site of injection, low grade fever, and the arm being painful, swollen, and aching.  The events were improving when she spoke to her two days ago, but unknown if they had resolved.  The reporter consented to follow up. The reporter stated that three patients reported side effects after receiving this batch number. Product quality complaint (PQC) was filed for this reason.
Age: 56.0
Sex: M
Vaccine: HEPA
Symptoms: Burning sensation, Urticaria
Clinical narrative: Healthcare worker developed hives around his neck after receiving the Hep A vaccine appx 5 hours earlier.  He was never Short of breath.  Took Benadryl at work, and took another dose at home.  He states that the hives were burning.  by the time he came back to work the next morning, all hives were gone.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: Very sore arm with moderate pain and a patch of redness, measuring four inches long by about three inches wide (no swelling) about two inches lower than the injection site.  Experienced extreme tiredness and lethargy after the injection (lasting about two days), overall muscle pain, headache, shivering, fever, mild lightheadedness, and nausea.  These side effects were so pronounced that they prevented me from doing regular activities until two days after.  After two days, the symptoms were still there, especially the soreness on the arm where the injection was given, but I'm at least up-and-about two days later and am back to a regular routine--albeit, more slowly than normal.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy, Loss of personal independence in daily activities, Myalgia, Nausea
Clinical narrative: Very sore arm with moderate pain and a patch of redness, measuring four inches long by about three inches wide (no swelling) about two inches lower than the injection site.  Experienced extreme tiredness and lethargy after the injection (lasting about two days), overall muscle pain, headache, shivering, fever, mild lightheadedness, and nausea.  These side effects were so pronounced that they prevented me from doing regular activities until two days after.  After two days, the symptoms were still there, especially the soreness on the arm where the injection was given, but I'm at least up-and-about two days later and am back to a regular routine--albeit, more slowly than normal.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Very sore arm with moderate pain and a patch of redness, measuring four inches long by about three inches wide (no swelling) about two inches lower than the injection site.  Experienced extreme tiredness and lethargy after the injection (lasting about two days), overall muscle pain, headache, shivering, fever, mild lightheadedness, and nausea.  These side effects were so pronounced that they prevented me from doing regular activities until two days after.  After two days, the symptoms were still there, especially the soreness on the arm where the injection was given, but I'm at least up-and-about two days later and am back to a regular routine--albeit, more slowly than normal.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injected limb mobility decreased, Insomnia, Pain
Clinical narrative: Left arm became immobile on the evening after the 8/14 vaccination. Very painful if I tried to move it with my right arm. Was unable to sleep that night due to discomfort. This morning, 8/16 I finally can raise my left arm, but still with some pain.
Age: 23.0
Sex: M
Vaccine: UNK
Symptoms: Chest pain, Hypotension, Intensive care, Troponin increased
Clinical narrative: Pt present self to ER with central chest pain with hx of vaccination on 5 AUG 2019 of Smallpox. Onset of symptoms was. Approximately 3 hrs in ER he became hypotensive. Labs remarkable for Troponin to 0.50.  He was eventually admitted to ICU at Medical Center for concern of myopericarditis.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Lip swelling
Clinical narrative: At around 9:30 am, as per mother, the child developed severe swelling to both lips that continued to worsen. The child was brought back to the clinic and vital signs were assessed: Blood pressure was 110/74, pulse 65. At 10 am, 0.5 ml of epinephrine and 1 ml of Benadryl were administered. At the time of assessment, the child was not showing any of symptoms of difficulty breathing or lethargy. EMS was called for further assessment and the child was transported via ambulance to Medical Center. Child was discharged a couple of hours later from the hospital and has remained stable.
Age: 16.0
Sex: F
Vaccine: MMR
Symptoms: Anxiety, Asthenia, Insomnia, Loss of personal independence in daily activities, Lymph node pain
Clinical narrative: Withing 5 days had a severe episode of insomnia, which she had never experienced in her life. 10 later protruding neck glands, & very painful lymph nodes.  Trouble with simple tasks, could not recall basic piano notes/chords. 26 days later debilitating  insomnia returned and this time lasted nightly for almost 5 weeks. Sleeping very little and saying she "forgot" how to sleep. Didn't matter how tired she was, she would not fall asleep. She was baffled and could not figure out what/why this was happening. She refused to take naps for fear of being even more awake at night.  Sleeping finally improved after much research and giving her anti inflammatories such as Turmeric. However, she continues to have a "racing heart" beat, excessive worry, nervousness which she never had before.