chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Moaning, Respiratory tract congestion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of respiratory tract congestion in a 77-year-old male patient who received SHINGRIX. Concurrent medical conditions included blood pressure high, cardiac arrhythmia and allergy (had drainage from allergies). Concomitant products included NORVASC and PRADAXA. On 10th April 2018, the patient received the 1st dose of SHINGRIX. On 10th April 2018, several hours after receiving SHINGRIX, the patient experienced respiratory tract congestion and cough. In April 2018, the patient experienced coughing blood, moaning, feeling cold, labored respiration and fatigue. On 11th April 2018, the outcome of the moaning and labored respiration were recovered/resolved. On an unknown date, the outcome of the respiratory tract congestion, coughing blood, feeling cold and cough were unknown and the outcome of the fatigue was not recovered/not resolved. The reporter considered the respiratory tract congestion, coughing blood, feeling cold, cough and fatigue to be possibly related to SHINGRIX. It was unknown if the reporter considered the moaning and labored respiration to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. Prior to the vaccination, the patient had some drainage from allergies. At 16:00, the patient received SHINGRIX on an unknown arm. During the night, the patient started coughing and several times had to get up and spit up the congestion. The next day, in the morning, when the patient spit up the congestion, there were blood traces in it. The caller also noted that, instead of the patient's usual snoring, he was moaning in his sleep. Around at 6 AM (14 hours after vaccination), he felt very cold, but when the caller checked patient's temperature at 7 AM, he did not have fever. The patient felt very fatigued and did not want to get up in the morning, which was very unusual for him. He was asleep at the time of the call, so the reporter did not know how the symptoms were progressed, but she did note that, the patient had stopped heavier breathing and moaning he had earlier in the morning.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a female patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm, fever and pain in arm. On an unknown date, the outcome of the swelling arm was unknown and the outcome of the fever and pain in arm were recovered/resolved. It was unknown if the reporter considered the swelling arm, fever and pain in arm to be related to SHINGRIX. Additional details were provide as follows: The age at administration was not reported. The patient had the SHINGRIX shingles vaccine on Saturday before the time of reporting, since that time the patient arm had swollen up. The patient experienced low grade fever and was achy for about 2.5 days. The patient was thinking that was a normal reaction but the patient arm was looked pretty bad. The patient was worried about having to get the second shot of SHINGRIX and wanted to know that the range of a normal response. The patient had attached picture of her arm. The patient said the patient's arm had actually got worse at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site bruising, Injection site mass, Injection site nodule, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site burning, injection site lump, numbness, tingling and injection site bruising. On an unknown date, the outcome of the injection site burning, injection site lump and injection site bruising were recovered/resoled and the outcome of the numbness and tingling were not recovered/not resolved. The reporter considered the injection site  burning, injection site lump, numbness, tingling and injection site bruising to be possibly related to SHINGRIX. Additional details were provided as follows: The patient picked up the prescription for the vaccine at her pharmacy and took it over to her doctor's office where it was administered. The person administering the vaccine told her it was being given intramuscularly into her left upper arm muscle. While the vaccine was being administered, the patient felt a feeling of burning in her left upper arm which resolved soon after the vaccine was administered. The patient was not sure what was administered. The patient commented aloud about the burning feeling during the vaccine administration and was told that she was the first patient who had complained of that symptom ever before. The patient arm then hurt at the site of injection for about three or four days. Within about one week after she received the vaccination, from her shoulder to her elbow she started feeling numbness and tingling which comes and goes and had not changed or not yet resolved. The patient described that the numbness and tingling felt like the feeling of her arm's falling asleep. The patient wondered if the vaccine was perhaps administered incorrectly or if possibly a nerve was hit while the vaccine was being administered. The patient did not know if she wants to have the second dose in the series. The vaccine was administered a couple of months ago. The day after the vaccine was administered a small bruise started around the injection site of her left upper arm muscle, and it grew in size within the next couple of days to the size of a 50 cent piece. The bruise lasted about one and one half weeks. The next day after the vaccine was administered she had a lump described also as a knot at the injection site which within one week resolved. The patient had denied permission to contact their physician. The patient declined to provide concomitant medications, reporting that she never had the reported symptoms while using her regular medicines prior to the vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site burning, injection site lump, numbness, tingling and injection site bruising. On an unknown date, the outcome of the injection site burning, injection site lump and injection site bruising were recovered/resoled and the outcome of the numbness and tingling were not recovered/not resolved. The reporter considered the injection site  burning, injection site lump, numbness, tingling and injection site bruising to be possibly related to SHINGRIX. Additional details were provided as follows: The patient picked up the prescription for the vaccine at her pharmacy and took it over to her doctor's office where it was administered. The person administering the vaccine told her it was being given intramuscularly into her left upper arm muscle. While the vaccine was being administered, the patient felt a feeling of burning in her left upper arm which resolved soon after the vaccine was administered. The patient was not sure what was administered. The patient commented aloud about the burning feeling during the vaccine administration and was told that she was the first patient who had complained of that symptom ever before. The patient arm then hurt at the site of injection for about three or four days. Within about one week after she received the vaccination, from her shoulder to her elbow she started feeling numbness and tingling which comes and goes and had not changed or not yet resolved. The patient described that the numbness and tingling felt like the feeling of her arm's falling asleep. The patient wondered if the vaccine was perhaps administered incorrectly or if possibly a nerve was hit while the vaccine was being administered. The patient did not know if she wants to have the second dose in the series. The vaccine was administered a couple of months ago. The day after the vaccine was administered a small bruise started around the injection site of her left upper arm muscle, and it grew in size within the next couple of days to the size of a 50 cent piece. The bruise lasted about one and one half weeks. The next day after the vaccine was administered she had a lump described also as a knot at the injection site which within one week resolved. The patient had denied permission to contact their physician. The patient declined to provide concomitant medications, reporting that she never had the reported symptoms while using her regular medicines prior to the vaccine administration.
Sex: F
Vaccine: HEPA
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a adult female patient who received HAVRIX 1440 adult. In November 2017, the patient received the 1st dose of HAVRIX 1440 adult (intramuscular) .5 ml. On an unknown date, less than a year after receiving HAVRIX 1440 adult, the patient experienced pain in arm and injected limb mobility decreased. HAVRIX 1440 adult was discontinued. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. The reporter considered the pain in arm and injected limb mobility decreased to be related to HAVRIX 1440 adult. Additional details were provided as follows: The age at vaccination was not reported. There was a Hepatitis A break out at the facility, so the patient was required to get the vaccine. The reporter was also a healthcare provider but her title was unknown. The reporter herself was the patient. The reporter (patient) did not know the exact date of vaccination but knows it was in November of 2017. It was given in her upper deltoid but unknown if it was on the right or left. She experienced pain at the injection site for 3 weeks. She was unable to raise her arm and was still experiencing soreness. She has elected not to receive the 2nd dose.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient called and stated that he had redness 5 inches long and 1 inch wide with the injection site at the center of the redness. The site was sore to touch. He received vaccine on 4/21/18 and redness was seen for first time on 4/22/18. He has no other reaction going on.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient presents to pharmacy to pick up rx for steroidal agent and antihistamine. She tells me about a breakout of hives that she experienced a few days ago and how she presented to her physician for assistance. Vaccine was given 2+ weeks prior to breakout; however, patient is not sure where the reaction has come from.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Hypersensitivity, Injection site cellulitis, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: First noticed Redness and egg shape bump on left thigh on 04/20/18 at 7:00 am while getting dressed for school sent him to school. After school around 1 pm on 4/20/18 the redness had spread now the left thigh felt hot to the touch and the redness was spreading more than I had originally noticed he was also running a low grade fever 99.9 at this point I notified Pediatrician of what was happening to my son after getting both vaccines on the same leg in such close vicinity to each other. It was late Friday evening I treated my son with some Zyrtec to help with the Itching he was experiencing I also gave him Children's Motrin to lower the fever. Next morning I scheduled a visit at my Urgent care were he was diagnosed with Cellulitis of the Left lower leg and Allergic reaction.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Pyrexia
Clinical narrative: First noticed Redness and egg shape bump on left thigh on 04/20/18 at 7:00 am while getting dressed for school sent him to school. After school around 1 pm on 4/20/18 the redness had spread now the left thigh felt hot to the touch and the redness was spreading more than I had originally noticed he was also running a low grade fever 99.9 at this point I notified Pediatrician of what was happening to my son after getting both vaccines on the same leg in such close vicinity to each other. It was late Friday evening I treated my son with some Zyrtec to help with the Itching he was experiencing I also gave him Children's Motrin to lower the fever. Next morning I scheduled a visit at my Urgent care were he was diagnosed with Cellulitis of the Left lower leg and Allergic reaction.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Shingles lower back larger than baseball size stated to blister 30 days later.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site swelling
Clinical narrative: Patient reports receiving SHINGRIX around 11am. That afternoon the injection site was red. As time went on, it became swollen and now her wrist is hurting. She has a dr appointment this afternoon.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site pain, Product preparation error, Vaccination error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of the patients who received SHINGRIX. On 10th April 2018, the patient received SHINGRIX. On 10th April 2018, unknown after receiving SHINGRIX, the patient experienced wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and vaccination error. In April 2018, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and vaccination error were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was a client service manager with a pharmacy and covers 16 stores. The age at vaccination was not reported. SHINGRIX was inadvertently reconstituted with ZOSTAVAX diluent and administered to the patient, which led to wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and vaccination error. The reporter that reported the incident was a regional manager and did not have any information on the patient or vaccine and administration. An update (not further specified) after call escalation was received. The healthcare professional reported that he was heard from other pharmacists that the patients have complained about pain, more so than with TDaP (did not specify BOOSTRIX), at the injection site day after vaccination. This case has been linked with case US2018GSK068224, reported by same reporter.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pruritus generalised
Clinical narrative: 12 month old presents today 4/23/18 with itching all over. No swelling of mouth or lips. EM? vs Allergic reaction. No involvement of breathing or mucous membranes. Hives all over with some coalescing legs and ankles. Started on Saturday 4/21 after vaccines given on 4/20. Possible reaction to vaccine.  Started on diphenhydramine every 6 hours and to return to office in 2 days or call prn.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Patient claimed no pain at the time of injection. She stated the injection was the most comfortable shot she has ever had. About a month later developed shoulder pain.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Nodule, Peripheral swelling, Skin warm
Clinical narrative: The nurse at Dr's office called and stated the patient had a reaction to the vaccine that was administered in the left arm. She states patient came to see Dr on 4/10/18, arm was red, swelling and had a knot in it. He came back today 4/18/18 and it has remained red and swollen, hot to touch. Dr prescribed antibiotics for 10 days and steroids for 5 days.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Several large, patchy, red, slightly raised areas to upper rt. arm that are warm to touch. Patient had put vapor rub and lotion with ginger to upper rt arm when "rash" appeared.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen, red hot.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Patient called on 04/07/2018 mentioning that the day after she recieved the vaccine when she came back from work the area that she got the SHINGRIX vaccine was hot, red and had a hard lump. On Wednesday 04/04/2018 went to her doctor and according to the doctor she was infected with the vaccine and prescribed her cephalexine 500 mg four times a day for seven days. Pt had had no complain, but wanted to just let us know abouT the situation. Also said. according to the physician the vaccine was injected too low.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Eczema, Pain, Rash pruritic
Clinical narrative: Patient states approximately 1 and 1/2 weeks after receiving the vaccine he developed a painful, itchy rash on the right side of his body on his elbow, knee, and ankle. Patient stated looked like eczema type rash.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test normal, Neck pain, Odynophagia
Clinical narrative: Student had 2nd dose of Hep B left upper arm at 11:45am at clinic on 04/19/2018. Student states while driving home from school on 04/19/2018 about 4pm began to experience pain in her neck and pain while swallowing. Was seen in ER of hospital treated with and released.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria, Urticaria, Urticaria papular
Clinical narrative: 8-10 days after VARIVAX local urticaria's occurred near and overlying the site of injection. May be coincidental as she appeared to have popular urticaria's as well - generalized.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pruritus, Swelling
Clinical narrative: Swollen on injection side, itchiness and pain on arm, take TYLENOL or ibuprofen, use ice packs but not directly 2-3 times a day for 5-10 minutes. Patient's symptoms went away within the next 2-3 days.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Crying, Head discomfort, Irritability, Platelet count normal, Pyrexia
Clinical narrative: This spontaneous report as received from a pediatrician via company representative refers to a 12 months old female patient. Information regarding patient's pertinent medical history, concomitant medications, drug reactions or allergies were reported as unknown. Information regarding patient's concomitant medication and past therapies were not reported. On 07-MAR-2018 the patient was vaccinated with first dose of M-M-R II, subcutaneous in the right vastus lateralis, lot # N019126, Expiry date: 22-JUN-2019 also reported as unknown for routine vaccination (dose was not reported).Other suspect therapies included VARIVAX (therapy start date: 07-MAR-2018, first dose, subcutaneous in the left vastus lateralis, lot #N017397, expiry date: 07-JUN-2019 for prophylaxis whose dose was not reported). On 19-MAR-2018, 13 days after onset of therapy the patient "broke out in a bright red rash on cheeks (Rash erythematous). On 21-MAR-2018, the patient developed a fever of 100.8 degree F (pyrexia), cranky (Irritability), cried for 14 hours, holding head (head discomfort), cheeks erythematous, diffuse red raised bumps to trunks and extremities (rash papular) for which the patient was brought to an outpatient clinic, emergency room and then to pediatrician's office on the same day. On an unspecified date, the patient had underwent strep test which showed negative. On an unspecified date, the patient had underwent platelet count evaluation which was found to be normal. Patient received an unspecified treatment for the adverse events rash erythematous and crying. No treatment was given for the adverse events pyrexia, irritability, cheeks erythematous, head discomfort and rash papular. The outcome of pyrexia, irritability, cheeks erythematous, head discomfort and rash popular was reported as recovered/resolved. The outcome of rash erythematous and crying was reported as recovering. The pediatrician thinks "rash is a from a reaction of the of M-M-R II vaccine. The pediatrician did not provide the causal relationship of events pyrexia, irritability, cheeks erythematous, head discomfort and crying with M-M-R II vaccine. The pediatrician did not provide the causal relationship of events rash erythematous, crying, pyrexia, irritability, cheeks erythematous, head discomfort and rash popular with VARIVAX. It was reported that "temperature excursion occurred as a result of reading from a digital data logger." There was no product quality complaint (PQC) involved.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash papular, Streptococcus test negative
Clinical narrative: This spontaneous report as received from a pediatrician via company representative refers to a 12 months old female patient. Information regarding patient's pertinent medical history, concomitant medications, drug reactions or allergies were reported as unknown. Information regarding patient's concomitant medication and past therapies were not reported. On 07-MAR-2018 the patient was vaccinated with first dose of M-M-R II, subcutaneous in the right vastus lateralis, lot # N019126, Expiry date: 22-JUN-2019 also reported as unknown for routine vaccination (dose was not reported).Other suspect therapies included VARIVAX (therapy start date: 07-MAR-2018, first dose, subcutaneous in the left vastus lateralis, lot #N017397, expiry date: 07-JUN-2019 for prophylaxis whose dose was not reported). On 19-MAR-2018, 13 days after onset of therapy the patient "broke out in a bright red rash on cheeks (Rash erythematous). On 21-MAR-2018, the patient developed a fever of 100.8 degree F (pyrexia), cranky (Irritability), cried for 14 hours, holding head (head discomfort), cheeks erythematous, diffuse red raised bumps to trunks and extremities (rash papular) for which the patient was brought to an outpatient clinic, emergency room and then to pediatrician's office on the same day. On an unspecified date, the patient had underwent strep test which showed negative. On an unspecified date, the patient had underwent platelet count evaluation which was found to be normal. Patient received an unspecified treatment for the adverse events rash erythematous and crying. No treatment was given for the adverse events pyrexia, irritability, cheeks erythematous, head discomfort and rash papular. The outcome of pyrexia, irritability, cheeks erythematous, head discomfort and rash popular was reported as recovered/resolved. The outcome of rash erythematous and crying was reported as recovering. The pediatrician thinks "rash is a from a reaction of the of M-M-R II vaccine. The pediatrician did not provide the causal relationship of events pyrexia, irritability, cheeks erythematous, head discomfort and crying with M-M-R II vaccine. The pediatrician did not provide the causal relationship of events rash erythematous, crying, pyrexia, irritability, cheeks erythematous, head discomfort and rash popular with VARIVAX. It was reported that "temperature excursion occurred as a result of reading from a digital data logger." There was no product quality complaint (PQC) involved.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included Diluent MRK inj. On 22-MAR-2018, the patient was vaccinated with expired dose of ZOSTAVAX (dose, units and frequency not reported) (lot # M041085 and expiration date: 03-JAN-2018) subcutaneously. No adverse effect reported. No product quality complaint was involved.
Sex: F
Vaccine: HPV9
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On an unknown date, the patient was vaccinated with GARDASIL 9, 0.5 ml, intramuscularly for cervical cancer prevention (lot number and expiration date were not provided). It was unknown if it was the patient's first, second or third dose of the vaccine. On an unknown date in 2017 (reported as 6 to 12 months ago), the patient experienced tingling down her left leg. It was reported that the event was probably not a result of an overdose. Treatment and event outcome of the event were unknown. The relatedness between the event and GARDASIL 9 was not provided.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Pain, Urticaria
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 72 year old female patient. Pertinent medical history, concurrent condition and concomitant medications were reported as none. On 06-MAR-2018, the patient was vaccinated with a second dose of PNEUMOVAX 23 via intramuscular route in the right arm for Pneumococcal vaccination. On 06-MAR-2018, 3 hours after receiving the vaccine, patient had an onset of allergic reactions. Patient developed a large quarter sized hive, that broke out in rash under right armpit. Patient reports that there was an area about 4 to 5 inches above waistline around rib cage and liver, very painful, but nothing visible. Pain increased, spread from original location, and persisted. On an unspecified date, the rash stopped after taking BENADRYL 50mg, orally one time (unspecified lot number and expiration date). On an unspecified date, patient called an unspecified pharmacist and physician and asked what to do about the pain. The outcome of pain was reported as not recovered/not resolved. The outcome of urticaria was reported as recovered/resolved. Causality assessment was not provided. No product quality complaint was present.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. On 09-APR-2018 the patient was vaccinated with expired dose of ZOSTAVAX vial 19400 PFU (dose and frequency were not reported) (lot # M041182, expiry date: 04-JAN-2018) subcutaneously for prophylaxis. The vaccine was reconstituted with a Merck sterile diluent. No adverse effects were reported. No product quality complaint was involved. This is a non-valid report due to lack of patient identifiers. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. Follow up information has been received from the pharmacist on 19-APR-2018. This report concerned a 64 year old female patient. The patient was presented for her ZOSTAVAX vaccination to the outpatient clinic. After an order from the patient's provider was put in, the registered nurse came to the pharmacy to obtain the vaccine. The nurse was given the vaccine and diluent from the freezer. The nurse then went back to the clinic to reconstitute the vaccine with diluent. On 09-APR-2018, the patient was vaccinated with expired dose of ZOSTAVAX subcutaneously, in the left arm. After vaccine administration, the nurse noticed the expiration date was 04-JAN-2018. The provider, pharmacy and patient were notified immediately. The patient was informed of the need for revaccination. No adverse reactions were observed. The error was caused by inappropriate inventory management and not by documenting vaccine information prior to administration.
Sex: U
Vaccine: MMR
Symptoms: Gait inability
Clinical narrative: This non-valid spontaneous report was received from a registered nurse and refers to an unspecified number of patients that were shown in a documentary. No information regarding the patients' medical histories, concurrent conditions or concomitant medications was provided. On unknown dates, the patient were vaccinated with doses of M-M-R II injection (dose, route of administration, lot number and expiration date were not reported). On unknown dates, the patients could not walk. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported.
Age: 5.0
Sex: M
Vaccine: VARCEL, DTAPIPVHIB, HEP
Symptoms: Induration, Injection site cellulitis, Injection site swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding a 5 year old male patient. The patient's medical history included low grade fever. Patient's historical drugs included PENTACEL. Patient's concomitant medication included acetaminophen. Patient did not have any pertinent medical history. On 09-APR-2018, the patient was vaccinated with VARIVAX, (strength, dose, frequency, lot number and expiry date not reported), intramuscularly in the upper right deltoid (incorrect route of administration), for prophylaxis. On the same day around 15:30 (shortly after receiving the vaccination), the patient experienced pain and stiffness in the arm. On the same day, he received acetaminophen as a treatment for the event. On 10-APR-2018, morning, patient's arm was extremely swollen (further described as "hard, hot, twice the size as normal"). The patient was treated with ice packs and with unknown amount of acetaminophen as per doctor's instructions. On 12-APR-2018, the patient injection site was "cellulitis looking" (further described as "now it has divets around the upper right arm and it's still swollen"). The patient sought medical attention but was not hospitalized for the events. Lab diagnostics/studies were not performed. Outcome of the events was reported as not recovered. A causality assessment was not provided. A product quality complaint (PQC) was not filed. Upon internal review, the event of cellulitis was considered as medically significant. This is one of two reports from the same reporter.
Age: 5.0
Sex: M
Vaccine: VARCEL, DTAPIPVHIB, HEP
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding a 5 year old male patient. The patient's medical history included low grade fever. Patient's historical drugs included PENTACEL. Patient's concomitant medication included acetaminophen. Patient did not have any pertinent medical history. On 09-APR-2018, the patient was vaccinated with VARIVAX, (strength, dose, frequency, lot number and expiry date not reported), intramuscularly in the upper right deltoid (incorrect route of administration), for prophylaxis. On the same day around 15:30 (shortly after receiving the vaccination), the patient experienced pain and stiffness in the arm. On the same day, he received acetaminophen as a treatment for the event. On 10-APR-2018, morning, patient's arm was extremely swollen (further described as "hard, hot, twice the size as normal"). The patient was treated with ice packs and with unknown amount of acetaminophen as per doctor's instructions. On 12-APR-2018, the patient injection site was "cellulitis looking" (further described as "now it has divets around the upper right arm and it's still swollen"). The patient sought medical attention but was not hospitalized for the events. Lab diagnostics/studies were not performed. Outcome of the events was reported as not recovered. A causality assessment was not provided. A product quality complaint (PQC) was not filed. Upon internal review, the event of cellulitis was considered as medically significant. This is one of two reports from the same reporter.
Age: 5.0
Sex: M
Vaccine: VARCEL, DTAPIPVHIB, HEP
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding a 5 year old male patient. The patient's medical history included low grade fever. Patient's historical drugs included PENTACEL. Patient's concomitant medication included acetaminophen. Patient did not have any pertinent medical history. On 09-APR-2018, the patient was vaccinated with VARIVAX, (strength, dose, frequency, lot number and expiry date not reported), intramuscularly in the upper right deltoid (incorrect route of administration), for prophylaxis. On the same day around 15:30 (shortly after receiving the vaccination), the patient experienced pain and stiffness in the arm. On the same day, he received acetaminophen as a treatment for the event. On 10-APR-2018, morning, patient's arm was extremely swollen (further described as "hard, hot, twice the size as normal"). The patient was treated with ice packs and with unknown amount of acetaminophen as per doctor's instructions. On 12-APR-2018, the patient injection site was "cellulitis looking" (further described as "now it has divets around the upper right arm and it's still swollen"). The patient sought medical attention but was not hospitalized for the events. Lab diagnostics/studies were not performed. Outcome of the events was reported as not recovered. A causality assessment was not provided. A product quality complaint (PQC) was not filed. Upon internal review, the event of cellulitis was considered as medically significant. This is one of two reports from the same reporter.
Sex: M
Vaccine: VARCEL, DTAPIPVHIB, HEP
Symptoms: Induration, Injection site cellulitis, Injection site swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding a 5 year old male patient. Patient's concurrent conditions, concomitant medications, historical conditions and historical drug allergies/reactions were not reported. On an unknown date, the patient was vaccinated with unspecified hepatitis B vaccine (manufacturer, strength, dose, frequency, route, lot number and expiry date not reported) and PENTACEL (strength, dose, frequency, route, lot number and expiry date not reported) for prophylaxis. On an unknown date, the patient experienced low grade fever (pyrexia). Outcome of pyrexia was not reported. The relationship between vaccines and pyrexia was not reported. This is one of two reports from the same reporter.
Sex: M
Vaccine: VARCEL, DTAPIPVHIB, HEP
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding a 5 year old male patient. Patient's concurrent conditions, concomitant medications, historical conditions and historical drug allergies/reactions were not reported. On an unknown date, the patient was vaccinated with unspecified hepatitis B vaccine (manufacturer, strength, dose, frequency, route, lot number and expiry date not reported) and PENTACEL (strength, dose, frequency, route, lot number and expiry date not reported) for prophylaxis. On an unknown date, the patient experienced low grade fever (pyrexia). Outcome of pyrexia was not reported. The relationship between vaccines and pyrexia was not reported. This is one of two reports from the same reporter.
Sex: M
Vaccine: VARCEL, DTAPIPVHIB, HEP
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding a 5 year old male patient. Patient's concurrent conditions, concomitant medications, historical conditions and historical drug allergies/reactions were not reported. On an unknown date, the patient was vaccinated with unspecified hepatitis B vaccine (manufacturer, strength, dose, frequency, route, lot number and expiry date not reported) and PENTACEL (strength, dose, frequency, route, lot number and expiry date not reported) for prophylaxis. On an unknown date, the patient experienced low grade fever (pyrexia). Outcome of pyrexia was not reported. The relationship between vaccines and pyrexia was not reported. This is one of two reports from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On or about 01-SEP-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-FEB-2016 the patient was treated at a medical center for a vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation. During 2016, the patient, age and gender unspecified, was inoculated with ZOSTAVAX at a medical office (by an unspecified health care professional) as recommended for routine adult health maintenance for prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. Later in 2016 the patient was treated (by an unspecified health care professional) at a medical office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 16 year old female patient. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medication were not reported. On 19-MAR-2018 the patient was vaccinated with GARDASIL 9 (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. Estimated last menstrual period was 15-MAR-2018 (also reported as 4 weeks) and estimated delivery date was 20-DEC-2018. Estimated conception date was 29-MAR-2018. On 12-APR-2018, the patient's mother informed to the reporter that the patient was pregnant. Pregnancy was confirmed by a home pregnancy test, on an unknown date. No product quality complaint was involved.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified 15 year old patient. On 13-APR-2018 the patient was vaccinated with first dose of GARDASIL 9 from lot N014464 expiry date 19-DEC-2017 for prophylaxis. On 09-FEB-2018, the patient received the second dose of GARDASIL 9 from lot N019104 expiry date 3-FEB-2020 and on 13-APR-2018, the patient received third dose of GARDASIL 9 from lot reported as "N02969"  expiry date 17-MAY-2020 (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint was involved. This is one of the two reports linked via same reporter link. Sender's Comments: US-009507513-1804USA007821.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 17-APR-2018, the patient was vaccinated with an expired dose of VAQTA strength: 50/1.0 U/ml, lot number N005605, expiration date 17-APR-2018 (dose and route were not reported) for prophylaxis. No symptoms were reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified 17 year old patient. On 13-APR-2018 the patient was vaccinated with first dose of GARDASIL 9 from lot N014464 expiry date 19-DEC-2017 for prophylaxis.  On 09-FEB-2018, the patient received the second dose of GARDASIL 9 from lot N019104 expiry date 3-FEB-2020 and on 13-APR-2018, the patient received third dose of GARDASIL 9 from lot reported as "N02969"  expiry date 17-MAY-2020 (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint was involved. This is one of the two reports linked via same reporter link. Sender's Comments: US-009507513-1804USA007716.
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site pain, Nausea
Clinical narrative: This spontaneous report was received from a male patient of unknown age regarding himself. The patient's pertinent medical history, concurrent conditions, concomitant medications and laboratory data were not reported. On 16-APR-2018 (reported as yesterday), the patient was vaccinated with PNEUMOVAX 23 (dosing details, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies were not reported. On 16-APR-2018, the patient reported that after he received the vaccine, he felt tired in a weird way, drained at "2:24pm" and experienced pain at the injection site. On 17-APR-2018 (reported as today), the patient reported that he was feeling better, but he was nauseated from eating and on the same day, the patient was vaccinated (reported as booster) with PNEUMOVAX 23 (dosing details, lot # and expiration date were not reported) for prophylaxis. The experience of feeling tired in a weird way, drained and pain at the injection site had resolved. The experience of feeling nauseated while eating was ongoing. The causality of the events were not reported. This is one of the 2 reports with the same reporter. Sender's Comments: US-009507513-1804USA008015.
Sex: F
Vaccine: MMR
Symptoms: Exposure via eye contact, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a female patient (the patient's mother) of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-APR-2018, the patient inadvertently got (reconstituted with sterile diluent) M-M-R II (lot# and expiry date were not reported) in her eye. No adverse effects were reported.
Age: 21.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a 21 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 04-OCT-2017, the patient was vaccinated with the first dose of GARDASIL 9, intramuscular route of administration, for prophylaxis, (strength, dose, frequency, lot number and expiration date were not provided). On 24-JAN-2018, the patient was vaccinated with the second dose of GARDASIL 9, intramuscular route of administration, for prophylaxis, (strength, dose, frequency, lot number and expiration date were not provided) and on 13-APR-2018, the patient was vaccinated with the third dose of GARDASIL 9, intramuscular route of administration, for prophylaxis, (strength, dose, frequency, lot number and expiration date were not provided). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding patient's medical history, concurrent conditions, drug reactions or allergies, concomitant medications and past therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N022856, expiry date: 23-AUG-2019) for prophylaxis whose dose and route of administration were not reported. It was reported that the vaccine administered was reconstituted with properly stored Merck sterile diluent) whose lot number and expiry date were reported as unknown. No adverse effects were reported. VARIVAX administered was subjected to a temperature excursion of 6 degree F to 14 degree F for a duration of 432 hours which was noted from a data logger. It was reported that VARIVAX administered was subjected to a previous temperature excursion of 6 degree F to 14 degree F for a time frame of 24 hours. There was no product quality complaint (PQC) involved.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 19-APR-2018, the patient was vaccinated with M-M-R II (intramuscular route instead of subcutaneous, lot # N013295, expiration date 28-APR-2019), for prophylaxis (strength, dose and frequency were not reported). The vaccine was reconstituted with a Merck sterile diluent (lot # N002579, expiration date 10-JUL-2019). No adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9, administered by intramuscular route (strength, dose, anatomical location, lot # and expiration date were not provided), for prophylaxis. It was reported that the patient went to the pharmacist's facility to receive the second dose of GARDASIL 9, and an unspecified time period between doses that was longer than recommended in the prescribing information had elapsed since the initial dose. No adverse effects have been reported.