chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR, UNK, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects.; received one dose of MMR II (R036582  12/17/2020) and one dose of VARIVAX  reconstituted with expired DILUENT; Information has been received from a office manager referring to a unknown gender patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On 15-JUL-2019, the patient received one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (therapy type: Albumin status rHA (recombinant Human albumin)) (lot # :R036582, expiration date:17-DEC-2020, dose, frequency and route were not reported) and one dose of varicella virus vaccine live (oka/merck)(VARIVAX) ( lot #: N021582, expiration date:09-AUG-2019, dose and frequency, route were not reported) reconstituted with expired  sterile diluent(lot #: N026990, expiration date:26-SEP-2018, dose, frequency and route were not reported) (expired product administered). Products had been stored properly with no temperature excursions. No adverse effects.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA011428: US-009507513-1907USA011374:
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Urticaria
Clinical narrative: hives on arm/neck/up into her hair/shoulders/legs/itchy hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 35 days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   The reporter considered the hives to be unrelated to Shingrix.  Additional details were provided as follows: The case was reported by the daughter of the patient. The batch number was not reported. The patient received the vaccine at the end of February or early March.  Five to six weeks later in April, she developed hives on her arms, neck, up into her hair, on her shoulders and legs. A biopsy was done which confirmed it was hives.   Emergency room visit required. The reporter did not know the specific dates or which arm the vaccines were administered.  For tolerances of 2nd dose, refer case US2019AMR124345, reported by same reporter.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site pain, Pain in extremity
Clinical narrative: Pain in arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number CF9K4, expiry date 11th September 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injected site pain (received 1st dose on 4th March 2019 and experienced Injected site pain).   On 16th May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the 2nd dose administered to patient reactivated the soreness at the injection site in the left arm from the first dose. The reporter was unable to provide any additional information. This case has been linked with cases US2019AMR126798, US2019125918, reported by the same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; spots on my arm lower than the injection site; This case was reported by a consumer and described the occurrence of shingles in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd July 2019, the patient received the 1st dose of Shingrix. On 6th July 2019, 4 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional information received were as follows: In the evening, the patient received Shingrix shot. The patient experienced few spots on arm lower than the injection site and those spots have now developed into shingles. The patient would like to know was how common is this for the Shingrix shot to bring shingles. The patient did not understood that to be possible, but she had proof that it was.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: arm hurts; red spot; arm is warm; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The age group was captured as adult as per vaccine indication. The patient received Shingrix and patient's arm still hurts a bit. There was also a red spot (approximately 4 inches round) next to the shot mark.  The arm was also warm to the touch.  The patient asked if this was normal?
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain; This case was reported by a pharmacist via sales rep and described the occurrence of pain in an unspecified number of adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The sales representative reported that the pharmacist said that the patients were experiencing pain from vaccination.  The sales representative mentioned pharmacist would not like to receive acknowledgement letter. This case linked with US2019AMR127498, reported by same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Extensive swelling of vaccinated limb
Clinical narrative: Grapefruit size Injection site swelling; extreme discomfort; This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number FG2D4, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and discomfort. On an unknown date, the outcome of the extensive swelling of vaccinated limb and discomfort were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and discomfort to be related to Shingrix.  Additional details were provided as follows: The patient experienced grapefruit size swelling in left arm and extreme discomfort 3 days following vaccination.  The patient received vaccine at nursing home and came to clinic due to reaction. The reporter agreed to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Herpes ophthalmic, Pain in extremity, Peripheral swelling
Clinical narrative: herpes lesion in cornea; arm swelled; red arm; painful arm; This case was reported by a consumer via call center representative and described the occurrence of corneal herpes in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received Shingrix. On an unknown date, 28 days after receiving Shingrix, the patient experienced corneal herpes (serious criteria GSK medically significant), pain in arm, swelling arm and erythema of extremities. On an unknown date, the outcome of the corneal herpes, swelling arm and erythema of extremities were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the corneal herpes, pain in arm, swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix, 4 weeks ago from the time of reporting. After that the patient experienced painful reaction for 8 days. The patient's arm swelled and became very red and painful. The patient had a herpes lesion in cornea.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Headache, Nausea, Pain in extremity
Clinical narrative: itching/ itching in her head; whelps that were streaks of small bumps on legs, butt, chest and arms; arm redness; warmth; arm soreness; headache; nausea; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On 8th July 2019, less than a week after receiving Shingrix, the patient experienced pruritus and welts. In July 2019, the patient experienced erythema of extremities, feeling of warmth, pain in arm, headache and nausea. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the erythema of extremities, feeling of warmth and pain in arm were recovering/resolving and the outcome of the headache, nausea and welts were recovered/resolved and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, feeling of warmth, pain in arm, headache, nausea, pruritus and welts to be related to Shingrix.  Additional details were provided as follows: The patient had redness, warmth and soreness about 2 to 3 inches below the site of injection. The patient had a slight headache and nausea. On 8th July 2019, the patient awoke with itching and whelps that were streaks of small bumps on her legs, butt, chest and arms. The patient experienced itching in her head. The patient took a bath and that helped the whelps resolved. The patient called the health department, that is where her daughter, an register nurse. The patient was referred to her physician. The patient consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: itching/ itching in her head; whelps that were streaks of small bumps on legs, butt, chest and arms; arm redness; warmth; arm soreness; headache; nausea; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On 8th July 2019, less than a week after receiving Shingrix, the patient experienced pruritus and welts. In July 2019, the patient experienced erythema of extremities, feeling of warmth, pain in arm, headache and nausea. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the erythema of extremities, feeling of warmth and pain in arm were recovering/resolving and the outcome of the headache, nausea and welts were recovered/resolved and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, feeling of warmth, pain in arm, headache, nausea, pruritus and welts to be related to Shingrix.  Additional details were provided as follows: The patient had redness, warmth and soreness about 2 to 3 inches below the site of injection. The patient had a slight headache and nausea. On 8th July 2019, the patient awoke with itching and whelps that were streaks of small bumps on her legs, butt, chest and arms. The patient experienced itching in her head. The patient took a bath and that helped the whelps resolved. The patient called the health department, that is where her daughter, an register nurse. The patient was referred to her physician. The patient consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nausea, Peripheral swelling
Clinical narrative: left arm red; left arm swollen; nauseous; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unk date, the patient did not recalled the vaccination date).   On 6th July 2019, the patient received the 2nd dose of Shingrix. On 7th July 2019, 1 days after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and nausea. On an unknown date, the outcome of the erythema of extremities, swelling arm and nausea were recovering/resolving.   It was unknown if the reporter considered the erythema of extremities, swelling arm and nausea to be related to Shingrix.  Additional details were reported as follows: The patient stated that, the  experience with her 2nd dose of Shingrix was very different from the 1st. The patient stated that her left arm was red and swollen. The patient felt nauseous. The patient did not know if vaccine was administered intramuscular but said did not hurt at the time of injection. The reporter did not consent  to follow up.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Anxiety, Urticaria
Clinical narrative: hives all over the body including the soles of the feet; This case was reported by a consumer via call center representative and described the occurrence of hives in a 19-year-old female patient who received HAV (Havrix adult) for prophylaxis.   Concomitant products included escitalopram (Lexapro), sertraline hydrochloride (Zoloft), benadryl (nos) (Benadryl) and cetirizine hydrochloride (Zyrtec).   In August 2018, the patient received the 1st dose of Havrix adult (intramuscular). In December 2018, less than a year after receiving Havrix adult, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Havrix adult.  Additional details were provided as follows: This case was reported by the patient's mother. The reporter stated that, the patient developed hives but at the time had also had dose of Zoloft increased for treating anxiety. The reporter stated that, the patient had hives since then was seeing allergist to try and determine root cause. The reporter did not consent to follow up. The reporter declined follow up with the patient's healthcare professional.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: left arm sore / localized pain in upper arm; Unable to lift over 2 pounds; really hurts; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 22nd May 2019, the patient received Boostrix. On an unknown date, less than a year after receiving Boostrix, the patient experienced pain in arm, weight bearing difficulty and pain localized. On an unknown date, the outcome of the pain in arm, weight bearing difficulty and pain localized were unknown.   It was unknown if the reporter considered the pain in arm, weight bearing difficulty and pain localized to be related to Boostrix.  Additional information received were as follows: The age at vaccination was not reported. The patient received Boostrix on left arm. The patient called in to get information on Boostrix reaction. The patient experienced left arm sore, localized pain upper arm area, hardly lift anything over 2 pounds, and was really hurting.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pain, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Possible allergic reaction; red rash; Red, raised mark; Itchy; patient reported it was sore; Pain; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L794, expiry date 21st September 2021) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st July 2019, less than a day after receiving Shingrix, the patient experienced allergic reaction, red rash, raised rash, itchy rash, painful rash and pain. On an unknown date, the outcome of the allergic reaction, red rash, raised rash, itchy rash, painful rash and pain were unknown.   It was unknown if the reporter considered the allergic reaction, red rash, raised rash, itchy rash, painful rash and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient developed a red, raised mark which was slightly itchy, and about 1.5 to 2 inches in diameter. The reporter was concerned for a possible allergic reaction and also stated that patient experienced pain. The reporter stated that at the timing of reporting it was unknown whether any of the symptoms have resolved. The reporter was okay with follow up from safety.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Blood test normal, Computerised tomogram normal, Fatigue
Clinical narrative: Weight loss; lower back neuromuscular pain; Muscle Aches; Joint Aches; Nerve Aches; Extreme Fatigue; Loss of Strength; Sore Arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th April 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 18th April 2019, the patient experienced muscle pain, joint pain, nerve pain, fatigue and strength loss of. On an unknown date, the patient experienced weight loss and neuromuscular pain. The patient was treated with paracetamol (Tylenol). Shingrix was discontinued. On an unknown date, the outcome of the pain in arm, muscle pain, joint pain, nerve pain, fatigue and strength loss of were recovering/resolving and the outcome of the weight loss and neuromuscular pain were unknown.   It was unknown if the reporter considered the pain in arm, muscle pain, joint pain, nerve pain, fatigue, strength loss of, weight loss and neuromuscular pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient experienced sore arm, aching muscles, joints, and nerves in the body. The patient also experienced extreme fatigue and loss of strength resulting in lack of desire to get out of bed except to use bathroom and to eat but still experienced weight loss. On 14th June 2019, the patient went to emergency room due to lower back neuromuscular pain. The reporter consented to follow up. The reporter stated that the patient will not receive the 2nd dose. This case has been linked with cases US2019123862, US2019123865, reported by the same reporter.      Lab Comments: blood work and CT scan showed no significant findings
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neuralgia, Neuromuscular pain, Pain in extremity, Weight decreased
Clinical narrative: Weight loss; lower back neuromuscular pain; Muscle Aches; Joint Aches; Nerve Aches; Extreme Fatigue; Loss of Strength; Sore Arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th April 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 18th April 2019, the patient experienced muscle pain, joint pain, nerve pain, fatigue and strength loss of. On an unknown date, the patient experienced weight loss and neuromuscular pain. The patient was treated with paracetamol (Tylenol). Shingrix was discontinued. On an unknown date, the outcome of the pain in arm, muscle pain, joint pain, nerve pain, fatigue and strength loss of were recovering/resolving and the outcome of the weight loss and neuromuscular pain were unknown.   It was unknown if the reporter considered the pain in arm, muscle pain, joint pain, nerve pain, fatigue, strength loss of, weight loss and neuromuscular pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient experienced sore arm, aching muscles, joints, and nerves in the body. The patient also experienced extreme fatigue and loss of strength resulting in lack of desire to get out of bed except to use bathroom and to eat but still experienced weight loss. On 14th June 2019, the patient went to emergency room due to lower back neuromuscular pain. The reporter consented to follow up. The reporter stated that the patient will not receive the 2nd dose. This case has been linked with cases US2019123862, US2019123865, reported by the same reporter.      Lab Comments: blood work and CT scan showed no significant findings
Sex: U
Vaccine: VARZOS
Symptoms: Impaired work ability
Clinical narrative: Inability to Work; This case was reported by a consumer via call center representative and described the occurrence of inability to work in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inability to work. On an unknown date, the outcome of the inability to work was recovered/resolved.   It was unknown if the reporter considered the inability to work to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not applicable for this report. The caller reported that the patient experienced side effects that stopped them from going to work for several days. There were multiple persons with unspecified demographic information.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The reporter reported that, electrocardiographist wife experienced rash.
Sex: M
Vaccine: VARZOS
Symptoms: Rash macular, Rash vesicular
Clinical narrative: rash; shingles/ it looks like shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of spot-like rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, less than a week after receiving Shingrix, the patient experienced spot-like rash and vesicular rash. On an unknown date, the outcome of the spot-like rash and vesicular rash were unknown.   It was unknown if the reporter considered the spot-like rash and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient received first dose of Shingrix and experienced rash in spots about the size of a 50-cent piece on his stomach, back and sides. It was reported that it looks like shingles outbreak but the patient had not been to see physician till the time of reporting. The reporter declined to provide any further details or information, including demographics. The reporter did not consent to follow-up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: Malaise; fever; chills; upset stomach; swollen lymph nodes; rash on scalp; This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number BB24A, expiry date 26th September 2021) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th June 2019, 2 days after receiving Shingrix, the patient experienced malaise, fever, chills, upset stomach, enlargement of lymph nodes and rash. On an unknown date, the outcome of the malaise, fever, chills, upset stomach, enlargement of lymph nodes and rash were unknown.   It was unknown if the reporter considered the malaise, fever, chills, upset stomach, enlargement of lymph nodes and rash to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left deltoid. The paient experienced malaise, fever, chills, upset stomach, three swollen lymph nodes, and rash on top of scalp.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Malaise; fever; chills; upset stomach; swollen lymph nodes; rash on scalp; This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number BB24A, expiry date 26th September 2021) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th June 2019, 2 days after receiving Shingrix, the patient experienced malaise, fever, chills, upset stomach, enlargement of lymph nodes and rash. On an unknown date, the outcome of the malaise, fever, chills, upset stomach, enlargement of lymph nodes and rash were unknown.   It was unknown if the reporter considered the malaise, fever, chills, upset stomach, enlargement of lymph nodes and rash to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left deltoid. The paient experienced malaise, fever, chills, upset stomach, three swollen lymph nodes, and rash on top of scalp.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: pain right arm; swelling at injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain in arm, injection site swelling and injection site erythema. On an unknown date, the outcome of the pain in arm, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the pain in arm, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The patient received the 1st dose of shingrix in the right arm, approximately 3 to 4 weeks before the time of reporting.  The patient experienced pain in the right arm immediately after injection.  Three days after receiving the vaccine, the patient developed swelling and redness at the injection site.  These symptoms were resolved after 5 to 6 days. The patient did not consent to follow-up. The patient did not provide any additional details.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced sore arms after receiving the Shingrix vaccine. The reporter was unable to obtain additional information. The reporter did not consent to follow up. This case has been linked with US2019125912, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Rash vesicular, Scab, Secretion discharge
Clinical narrative: Vesicular Rash with Oozing and Crusting; Vesicular Rash with Oozing and Crusting; Fever; Myalgia; This case was reported by a physician via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) (batch number E3Z7E, expiry date 18th May 2021) for prophylaxis.   On 2nd May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, myalgia, vesicular rash and discharge. On an unknown date, the outcome of the fever, myalgia, vesicular rash and discharge were recovered/resolved.   It was unknown if the reporter considered the fever, myalgia, vesicular rash and discharge to be related to Shingrix.  Additional details were provided as follows: The reporting patient was physician herself. The patient received Shingrix in the left arm. After vaccination with a dose of Shingrix, the patient had fever of 102 degree F that lasted for 2 days and myalgia that lasted for 4 days. The patient also experienced vesicular rash on nose and across the lower back that had serum like oozing and crusted over which healed within a week. The patient consented to follow up. No futher details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Erythema, Feeling cold, Malaise
Clinical narrative: diarrhea; upset stomach; arm redness; being sick; nausea; muscle aches; feel cold; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Shingrix. On 11th July 2019, 3 days after receiving Shingrix, the patient experienced diarrhea and upset stomach. In July 2019, the patient experienced nausea, muscle pain, feeling cold, erythema of extremities and sickness. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the nausea, muscle pain, feeling cold, erythema of extremities and sickness were unknown and the outcome of the diarrhea and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the nausea, muscle pain, feeling cold, diarrhea, upset stomach, erythema of extremities and sickness to be related to Shingrix.  Additional details were provided as follows: The patient was sick since the the day of vaccination. Three days after vaccination, the patient expereinced diarrhea and upset stomach. The patient also mentioned redness in her arm. She was taking Tylenol for her symptoms. The reporter decline to provide additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: diarrhea; upset stomach; arm redness; being sick; nausea; muscle aches; feel cold; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Shingrix. On 11th July 2019, 3 days after receiving Shingrix, the patient experienced diarrhea and upset stomach. In July 2019, the patient experienced nausea, muscle pain, feeling cold, erythema of extremities and sickness. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the nausea, muscle pain, feeling cold, erythema of extremities and sickness were unknown and the outcome of the diarrhea and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the nausea, muscle pain, feeling cold, diarrhea, upset stomach, erythema of extremities and sickness to be related to Shingrix.  Additional details were provided as follows: The patient was sick since the the day of vaccination. Three days after vaccination, the patient expereinced diarrhea and upset stomach. The patient also mentioned redness in her arm. She was taking Tylenol for her symptoms. The reporter decline to provide additional information.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Abnormal behaviour, Tic
Clinical narrative: more tics and behavioral changes.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Eye swelling, Swelling face
Clinical narrative: facial and eye swelling
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Bad headache, fever, body aches, chills
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: Similar to first dose: Significant aches in joints and pain in arm with injection making sleep difficult. Ongoing.  Last time, soreness lasted about 3 days but was tolerable.  Different side effects from first dose: Painful headache with significant nausea. I never threw up but had dry heaves for 3-4 hours. These symptoms appear to have subsided.
Age: 0.33
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects; dose of VAQTA accidentaly administered to 4 month old patient; This spontaneous report was received from a nurse and refers to a 4-month-old patient of an unknown gender. There was no information about the patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On 17-JUN-2019, the patient was accidentally vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (unit not reported), intramuscular injection, one dose, lot # R034548, expiration date 29-DEC-2019 (site and route of administration were not provided) for prophylaxis. (product administered to patient of inappropriate age). No adverse effects were reported.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; administered improperly stored PROQUAD; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 04-JUN-2019, the patient was administered with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number S002503 with expiration date in 23-JUL-2020 (strength, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (C) to 8 C (-3 C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA008643: US-009507513-1906USA010325: US-009507513-1906USA010323: US-009507513-1906USA008695: US-009507513-1907USA011955: US-009507513-1907USA011954:
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; administered improperly stored PROQUAD; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 18-JUN-2019, the patient was administered with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number S002503 with expiration date in 23-JUL-2020 (strength, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (C) to 8 C (-3 C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA008643: US-009507513-1906USA010325: US-009507513-1906USA010323: US-009507513-1906USA008695: US-009507513-1907USA011955: US-009507513-1906USA008903:
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: pain in arm; muscle pain; This case was reported by a consumer and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and muscle pain. On an unknown date, the outcome of the pain in arm and muscle pain were unknown.   It was unknown if the reporter considered the pain in arm and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st shot of Shingrix in arm. The patient experienced pain in arm and muscle pain. The patient asked to have to take ibuprofen for the shot muscle pain. The Agency recommends if localized reaction occurs, such as soreness, redness, itching, or swelling at the injection site, apply a cold compress to the injection site. Consider giving an analgesic (pain reliever) or antipruritic (anti-itch) medication. It was important to note that these were general recommendations from Agency and had not been evaluated with Shingrix. The pharmacist checked for interaction between Shingrix and ibuprofen and no known drug interactions between Shingrix and ibuprofen. The pharmacist suggested to follow-up with doctor.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Appears Shingles rash; Appears Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash zosteriform in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix. On 4th July 2019, 3 days after receiving Shingrix, the patient experienced rash zosteriform and shingles. On an unknown date, the outcome of the rash zosteriform and shingles were unknown.   It was unknown if the reporter considered the rash zosteriform and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient received a dose of Shingrix on an unknown arm. The patient appeared as Shingles rash. The reporter wanted to know, how to proceed with the 2nd dose of the Shingrix vaccine. The reporter was unable to provide patient and vaccine details. This case has been linked with case US2019123785, reported by the same reporter.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Feeling hot, Heart rate increased, Pyrexia, Tremor
Clinical narrative: hard to breath/  trouble breathing; shaking; feeling feverish; increased heart rate; This case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included carcinoma excision (Basal cell carcinoma removal from right arm on 8th July 2019 (prior to receiving the vaccine)). Concomitant products included pneumococcal vaccine (Pneumonia Vaccine).   On 8th July 2019 13:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th July 2019 23:00, 10 hrs after receiving Shingrix, the patient experienced difficulty breathing, tremor, feeling hot and heart rate increased. On an unknown date, the outcome of the difficulty breathing, tremor, feeling hot and heart rate increased were recovered/resolved.   It was unknown if the reporter considered the difficulty breathing, tremor, feeling hot and heart rate increased to be related to Shingrix.  Additional details were provided as follows: The caller was a patient.  The patient received Shingrix and before the date of reporting he had trouble breathing, felt feverish, heart rate increased to 125 and it was hard to breath.  The patient stated that these symptoms lasted for approximately 1-2 hours. The patient also received the pneumonia vaccine at the same time and in the same arm.  The reporter consented to follow up.      Lab Comments: lab test performed on unknown date
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Sore arm/Achy /Pain in arm; Warm/Feeling of warmth; arm was red from the injection site/red arm; Itched; Rash; painful rash / Raised rash; Unable to sleep; Scabs; Red bumps; Itchy bumps; Burned; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2019, 1 day after receiving Shingrix, the patient experienced injection site pain, injection site warmth, injection site erythema, injection site itching, injection site rash, papular rash, sleeplessness, scab, red rash, itchy rash and burning sensation skin. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site erythema, injection site itching, injection site rash, papular rash, sleeplessness, scab, red rash, itchy rash and burning sensation skin were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema, injection site itching, injection site rash, papular rash, sleeplessness, scab, red rash, itchy rash and burning sensation skin to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received dose of Shingrix in the left arm at around 5:30pm. Less than an hour, the patient experienced sore arm. The patient stated that, her arm was red from the injection site down to her elbow and approximately four inches in width, the redness changed to a rash which she described as raised, red bumps that itch. The patient could not sleep for a week because it was so painful. The patient stated that, the area involved has reduced in size and is appearing to resolve. There was discrepancy between the outcome reported in the structured field and the outcome reported in the source document (recovered or recovered with sequel) for all events.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Insomnia, Pain in extremity, Rash erythematous, Rash pruritic
Clinical narrative: Sore arm/Achy /Pain in arm; Warm/Feeling of warmth; arm was red from the injection site/red arm; Itched; Rash; painful rash / Raised rash; Unable to sleep; Scabs; Red bumps; Itchy bumps; Burned; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2019, 1 day after receiving Shingrix, the patient experienced injection site pain, injection site warmth, injection site erythema, injection site itching, injection site rash, papular rash, sleeplessness, scab, red rash, itchy rash and burning sensation skin. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site erythema, injection site itching, injection site rash, papular rash, sleeplessness, scab, red rash, itchy rash and burning sensation skin were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema, injection site itching, injection site rash, papular rash, sleeplessness, scab, red rash, itchy rash and burning sensation skin to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received dose of Shingrix in the left arm at around 5:30pm. Less than an hour, the patient experienced sore arm. The patient stated that, her arm was red from the injection site down to her elbow and approximately four inches in width, the redness changed to a rash which she described as raised, red bumps that itch. The patient could not sleep for a week because it was so painful. The patient stated that, the area involved has reduced in size and is appearing to resolve. There was discrepancy between the outcome reported in the structured field and the outcome reported in the source document (recovered or recovered with sequel) for all events.