chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Rash, Seizure, Vomiting projectile
Clinical narrative: On 11/10/2017 his stools became watery and full of mucus. On 11/13/2017 Patient started waking up startled out of his sleep. He would curl up and stop breathing for a few seconds. He would do this on and off for a few minutes and he would be crying uncontrollably in between. This would happen in the middle of the night, up to 3 times a night as well as naps throughout the day. I thought something was just scaring him like having a bad dream but I had a really bad feeling about it. He stopped breastfeeding around this same time so I was feeding him pumped milk I had stored. He was projectile vomiting on 12/05 Doctors said it might be his reflux. I took him to the ER for the vomiting on 12/21/17. Doctors didn't say much. They told me to feed him smaller portions more often. He then developed a rash on his belly looked like eczema. On 12/26/17 I took Patient to the ER after I saw a video of infantile spasms on YouTube. He was then hospitalized for 20 days for having seizures.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient has inflammation around injection site. It feels hot, swollen, and burns in the area. She also complains of diarrhea.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Patient reported fever & chills. He said the 3 days later he also had muscle aches but thinks that could be due to shivering from fever/chills.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: 40 year old administered a pediatric dose of RECOMBIVAX HB; No adverse event; This spontaneous report was received from a nurse referring to a 40 year old female patient. The patient's medical history, concurrent condition and concomitant therapy details were not provided. On an unknown date, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) therapy type: Thimerosal Free, (lot # R006746 expiration date: 09-NOV-2020) (dosing details, route and anatomical location were not reported) for prophylaxis(incorrect dose administered). No adverse event was reported. No product quality complaint was reported.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included tennis elbow. On 22nd January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved. It was unknown if the reporter considered the injection site muscle pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on right arm. The patient had intense pain at the injection site for a while but that had resolved and she noted she couldn't sleep on her arm for 2 to 3 nights. The patient now had a nagging muscle pain still at the injection site. The patient also noted she was supposed to get a cortisone shot in the same arm for tennis elbow in a few weeks. The patient noted she had made her physician aware. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache aggravated in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included headache. Concurrent medical conditions included migraine. Concomitant products included AIMOVIG and Calcium Channel Blocker. On 2nd April 2019, the patient received the 1st dose of SHINGRIX. On 3rd April 2019, 1 days after receiving SHINGRIX, the patient experienced headache aggravated. On an unknown date, the outcome of the headache aggravated was not recovered/not resolved. It was unknown if the reporter considered the headache aggravated to be related to SHINGRIX. Additional case details were provided as follows: This case was reported by the patient's boyfriend. The patient had a history of headaches which being in a warmer climate, the headaches had gone away. The patient received the dose of SHINGRIX vaccine and next day, the patient had minor headache and a couple days after the first headache, the patient had another one. Last night of day before reporting, the patient had the worst headache she has had in years. The reporter stated that the patient was also decreasing some of her migraine medications. So, the reporter was not sure the headaches are related to the SHINGRIX vaccine. The reporter did not want to provide any additional details regarding the patient as well as address details. The reporter did not give the consent for follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Incomplete course of vaccination, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 22nd August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site warmth and incomplete course of vaccination. On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovered/resolved and the outcome of the injection site warmth and incomplete course of vaccination were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: The reporter was the patient. The patient received SHINGRIX on left arm. The day after receiving the 1st dose, the patient developed swelling in the left arm and the left arm was warm to the touch. The swelling was from the shoulder to the elbow and lasted for approximately 10 days. The pharmacist wrote on the paper that the patient could get the 2nd dose of SHINGRIX between 22nd October 2018 and 22nd April 2019. The patient realized, the day of reporting that it had been almost 8 months since she got the first dose and not 6 months the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: PNC13
Symptoms: Malaise, Pyrexia, Rash macular, Swelling face
Clinical narrative: Malaise; Pyrexia; Rash Macular; Swelling Face; This is a spontaneous report from a contactable other health professional based on the information received by Pfizer from Sanofi-Aventis (reference number: 1-1700051315). A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced malaise, pyrexia, rash macular, and swelling face on an unspecified date. The outcome of the events was unknown.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: patient presented with a large red area on the arm where the shot was administered.  patient used ice and said it seems to be a little better the next day
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Myalgia, Pyrexia
Clinical narrative: Patient reported that she started to feel sick the day after she got the shot. Symptoms included fever/chills/muscle aches and lasted 12-24 hours. This did not happen after she got the 1st dose, only the 2nd.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Nausea, mild headache, muscle soreness, soreness at injection site, very tired.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Skin warm, Swelling
Clinical narrative: local erythema and swelling, warmth, discomfort involving the upper arm
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient came into pharmacy on 4/17/19 complaining of sore, red, hot, and swollen arm. She said it started the day before and the swelling has gone down some she said since 4/16/19. Was advised to see doctor today.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Malaise
Clinical narrative: Approximately 10 hours after receiving vaccine I felt chills and had a low grade fever. By the next morning I had a headache and felt nauseous. Had to take off from work. Felt tired and had no appetite. Fever was gone, but general malaise persisted until evening time.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Approximately 10 hours after receiving vaccine I felt chills and had a low grade fever. By the next morning I had a headache and felt nauseous. Had to take off from work. Felt tired and had no appetite. Fever was gone, but general malaise persisted until evening time.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received regarding a case in litigation from a lawyer, an elderly female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2014, at approximately age 70, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2011, at approximately age 75, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at a hospital for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Sex: U
Vaccine: HPV9, MMR, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non-valid report was received from a nurse concerning a patients of an unknown age and gender. Information regarding the patients' concurrent conditions, medical history, drug reactions and allergies and concomitant medication was not reported. On an unknown date, the patients were vaccinated with improperly stored M-M-R II, lot # R027063, expiration date 20-SEP-2020, GARDASIL 9, lot # R020200, 1586749, expiration dates 05-MAY-2021, 13-FEB-2021 respectively, PNEUMOVAX 23 lot # R033079, batch # R027063, expiration dates 06-JUN-2020, 06-JUN-2020 respectively, and ROTATEQ, orally, lot # R013861, expiration date 04-DEC-2019, (strength, dosage schedule and route of administration were not reported) all for prophylaxis. The vaccines were stored at a temperature of 10.5 C (Celsius degrees) for the time frame of 2 hours. The vaccines previously temperature excursion was at 23.37 C for 3 hours and 40 minutes. The call was because of data logger. No adverse effects reported (no adverse event).
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash erythematous, Rash papular, Scab
Clinical narrative: Erythematous papule on trunk and extremities; rash with red bumps; itchiness; scab; This case was reported by a consumer via other manufacturer and described the occurrence of red rash in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 29th March 2019, the patient received Boostrix. On an unknown date, less than a month after receiving Boostrix, the patient experienced red rash, papular rash, pruritus and scab. The patient was treated with ambiguous medication nos (Campho Phenique (Nos)). On an unknown date, the outcome of the red rash, papular rash, pruritus and scab were not recovered/not resolved.   It was unknown if the reporter considered the red rash, papular rash, pruritus and scab to be related to Boostrix.  Additional details were provided as follows: The patient's age was not reported. The patient received Boostrix during the normal course of business. In the afternoon, when the patient was at home, she started to present rash with red bumps and itchiness on her legs. Then patient's mother noticed it was up to her thighs when she was in dancing class.  They applied Campho Phenique which helped a little.  Three days later the same rash also appeared on her arms and trunk.  Since then it was still there and not going away.  The reporter stated, nobody else at their home had anything similar events.  Upon examination, it was confirmed as erythematous papules on trunk and extremities, some with scab on top. No additional information was provided.  Permission was given to follow up with the reporter.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain in extremity, Tendonitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received SHINGRIX for prophylaxis. On 21st March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st March 2019, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 22nd March 2019, the patient experienced leg pain and Achilles tendonitis. On an unknown date, the outcome of the injection site pain, leg pain and Achilles tendonitis were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, leg pain and Achilles tendonitis to be related to SHINGRIX. Additional details were provided as follows: The patient reported that injection of SHINGRIX was very painful. The next day she woke up with bad leg pain and felt like she ran a marathon. About 2 weeks after getting SHINGRIX she developed Achilles tendonitis. Her arm and legs still ache. The pain in her arm comes and goes, but if she touches the area she can feel where she got the vaccine. The patient has not had to take ibuprofen for her legs for several days, but they still ache. The patient Achilles tendon has not improved. The patient was a runner, and was running prior to getting the vaccine. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antinuclear antibody positive, Arthralgia, Injection site pain, Pain in extremity, Red blood cell sedimentation rate abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received SHINGRIX for prophylaxis. On 21st March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st March 2019, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 22nd March 2019, the patient experienced leg pain and Achilles tendonitis. On an unknown date, the outcome of the injection site pain, leg pain and Achilles tendonitis were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, leg pain and Achilles tendonitis to be related to SHINGRIX. Additional details were provided as follows: The patient reported that injection of SHINGRIX was very painful. The next day she woke up with bad leg pain and felt like she ran a marathon. About 2 weeks after getting SHINGRIX she developed Achilles tendonitis. Her arm and legs still ache. The pain in her arm comes and goes, but if she touches the area she can feel where she got the vaccine. The patient has not had to take ibuprofen for her legs for several days, but they still ache. The patient Achilles tendon has not improved. The patient was a runner, and was running prior to getting the vaccine. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tendonitis, Vaccination complication
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received SHINGRIX for prophylaxis. On 21st March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st March 2019, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 22nd March 2019, the patient experienced leg pain and Achilles tendonitis. On an unknown date, the outcome of the injection site pain, leg pain and Achilles tendonitis were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, leg pain and Achilles tendonitis to be related to SHINGRIX. Additional details were provided as follows: The patient reported that injection of SHINGRIX was very painful. The next day she woke up with bad leg pain and felt like she ran a marathon. About 2 weeks after getting SHINGRIX she developed Achilles tendonitis. Her arm and legs still ache. The pain in her arm comes and goes, but if she touches the area she can feel where she got the vaccine. The patient has not had to take ibuprofen for her legs for several days, but they still ache. The patient Achilles tendon has not improved. The patient was a runner, and was running prior to getting the vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection, Ear infection, Sinusitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ear infection in a 88-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included post herpetic neuralgia and chronic obstructive pulmonary disease. On 11th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced ear infection, sinus infection and bacterial infection. On an unknown date, the outcome of the ear infection, sinus infection and bacterial infection were unknown. It was unknown if the reporter considered the ear infection, sinus infection and bacterial infection to be related to SHINGRIX.  Additional details were provided as follows: The patient got her first SHINGRIX vaccination in November but could not get her 2nd dose scheduled on January 11 because she got an ear and sinus infection. She got the 2nd shot on 8th March 2019. Emergency room visit required.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Product administered at inappropriate site
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 59-year-old female patient who received SHINGRIX (batch number 2YN4S, expiry date 9th July 2021) for prophylaxis. On 10th April 2019, the patient received the 1st dose of SHINGRIX. On 10th April 2019, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. In April 2019, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injected limb mobility decreased and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient received SHINGRIX vaccination yesterday that was administered very close to the shoulder bone, which led to vaccine administered at inappropriate site. The reporter described it as the bursa area. She reported that the patient told her the same day of reporting that she was unable to move her arm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site induration, Injection site pain, Injection site swelling, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included heart racing (not regularly and the racing heart would usually occur when she was stressed). On 15th January 2019, the patient received the 1st dose of SHINGRIX. On 15th January 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, feeling unwell and injection site induration. In January 2019, the patient experienced papular rash and itchy rash. On 17th January 2019, the patient experienced heart racing. On 18th January 2019, the patient experienced dizziness. On 17th January 2019, the outcome of the injection site pain, injection site swelling, feeling unwell and injection site induration were recovered/resolved. On 18th January 2019, the outcome of the heart racing was recovered/resolved. On an unknown date, the outcome of the dizziness was recovered/resolved and the outcome of the papular rash was unknown and the outcome of the itchy rash was recovering/resolving. It was unknown if the reporter considered the injection site pain, injection site swelling, feeling unwell, heart racing, dizziness, papular rash, injection site induration and itchy rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX left arm. The patient felt pain, swelling on her left arm at the injection site and the area was hurting and hard to touch. The patient felt sick and these symptoms started in the evening and continued the following day. The patient laid around for a while and then when she got back up and started to move around again after a few days, she experienced two episodes where her heart was racing. The patient experienced heart racing before but not regularly and the racing heart would usually occur when she was stressed. On 17th January 2019, 2 days after vaccination the patient experienced racing heart and continued the following day and then resolved. Three days after vaccination, the patient was also pretty dizzy for a couple of days on 18th January 2019 or 19th January 2019 but seemed ok after that. The patient reported a bump at the top of her chest close to her neck and another bump on her right arm with little tiny bumps that itch. The bumps were drying up but they started about a week after she received the SHINGRIX vaccination. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Rash papular, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included heart racing (not regularly and the racing heart would usually occur when she was stressed). On 15th January 2019, the patient received the 1st dose of SHINGRIX. On 15th January 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, feeling unwell and injection site induration. In January 2019, the patient experienced papular rash and itchy rash. On 17th January 2019, the patient experienced heart racing. On 18th January 2019, the patient experienced dizziness. On 17th January 2019, the outcome of the injection site pain, injection site swelling, feeling unwell and injection site induration were recovered/resolved. On 18th January 2019, the outcome of the heart racing was recovered/resolved. On an unknown date, the outcome of the dizziness was recovered/resolved and the outcome of the papular rash was unknown and the outcome of the itchy rash was recovering/resolving. It was unknown if the reporter considered the injection site pain, injection site swelling, feeling unwell, heart racing, dizziness, papular rash, injection site induration and itchy rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX left arm. The patient felt pain, swelling on her left arm at the injection site and the area was hurting and hard to touch. The patient felt sick and these symptoms started in the evening and continued the following day. The patient laid around for a while and then when she got back up and started to move around again after a few days, she experienced two episodes where her heart was racing. The patient experienced heart racing before but not regularly and the racing heart would usually occur when she was stressed. On 17th January 2019, 2 days after vaccination the patient experienced racing heart and continued the following day and then resolved. Three days after vaccination, the patient was also pretty dizzy for a couple of days on 18th January 2019 or 19th January 2019 but seemed ok after that. The patient reported a bump at the top of her chest close to her neck and another bump on her right arm with little tiny bumps that itch. The bumps were drying up but they started about a week after she received the SHINGRIX vaccination. The reporter consented to follow up.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 54-year-old male patient who received SHINGRIX (batch number 32ZG4, expiry date 9th July 2021) for prophylaxis. On 4th April 2019, the patient received the 1st dose of SHINGRIX. In April 2019, less than a month after receiving SHINGRIX, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown. It was unknown if the reporter considered the vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that patient received SHINGRIX immunization, at the time of reporting he had diffuse vesicular rash on trunk and back.
Sex: F
Vaccine: PNC13
Symptoms: Bronchitis, Cough, Inflammation, Pneumonia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Consumer via Pfizer sales representative. A 68-year-old female patient received first dose of PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got shot and 3 days later, she woke up without any prior ax and felt like she had a full blown case of bronchitis (continuously coughing) without any other symptoms. Just a horrendous cough. Then 2 days later she went to a minute close mic and the Physician Assistant said she had a 101 fever and diagnosed her with pneumonia in both lungs. She got a Z pack and gave her albuterol and some OTC cough medicine, she continued to call and 3 days later went back to the doctor for a follow up (but she was still coughing). The MD said her lungs were clear and that she didn't have pneumonia or bronchitis, and then he said that she had a inflammatory response to the vaccine. The outcome of the coughing was not recovered, while the rest events was unknown.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician received via a sales representative. A 20-year-old female patient started to receive TRUMENBA, via an unspecified route of administration from 20Sep2016 to 20Sep2016 at a single dose for meningitis B vaccine. The patient's medical history and concomitant medications were not reported. The patient experienced pain and swelling and redness in her left arm for about one week after the patient's first dose of meningococcal group b rlp2086 on 20Sep2016. The outcome of the events was recovered.
Sex: F
Vaccine: MENB
Symptoms: Diplegia
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A female patient of an unspecified age received TRUMENBA, via an unspecified route of administration in Mar2019 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced paralysis of both legs lasting 24 hours after vaccine on Mar2019. The outcome of the event was recovered. The information on the batch number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Pain in the arm when given in the same arm as the flu shot; This is a spontaneous report from a contactable pharmacist. An elderly male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were not reported), via an unspecified route of administration in arm on an unspecified date at a single dose for immunization. The patient's medical history was not reported. Concomitant medications included flu shot. On an unspecified date, the patient experienced pain in the arm when given in the same arm as the flu shot. So recommended to pharmacists to give future flu/pneumonia vaccines in two separate arms. The outcome of the event was unknown.
Age: 20.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness
Clinical narrative: Patient observed for 15 minutes after immunizations, no complaints and returned to class. Patient returned to health center 30 minutes later complaining of slight dizziness, denies dyspnea, no diaphoresis, hives or rash noted, alert and oriented x 3, ambulation stable, BP 122/70 Pulse 70. Patient observed for one hour, vital signs checked every 15 minutes, BP 120/66 P 70, BP 116/70 P 66, BP 118/70 Pulse 66. Patient remained stable no other complaints. RN, health center nurse, present during entire observation. Patient provided list of urgent care centers and emergency department addresses and phone numbers if symptoms became worse. Patient's resident assistant contacted and walked patient to dorm room, will remain with patient for a few hours and another resident assistant will check on patient later in evening. Patient voiced understanding of all education provided to include going to urgent care/emergency department if symptoms become worse. Patient called morning of 4/17/19 and stated "I'm good."
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Diarrhoea, Dizziness, Dysstasia, Head discomfort
Clinical narrative: I almost fainted after the injection. I felt nauseous, and very dizzy. I felt my blood pressure drop. I broke out into a sweat. I couldn't stand up. My heart is beating  rapidly, and I am still nauseous, and light headed. I have severe pain in my arm, and a feeling of pressure in my head. Also, I had watery stool.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Hyperhidrosis, Nausea, Pain in extremity, Presyncope
Clinical narrative: I almost fainted after the injection. I felt nauseous, and very dizzy. I felt my blood pressure drop. I broke out into a sweat. I couldn't stand up. My heart is beating  rapidly, and I am still nauseous, and light headed. I have severe pain in my arm, and a feeling of pressure in my head. Also, I had watery stool.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Injection site rash, Nausea, Pyrexia
Clinical narrative: severe nausea, headache, backache, fever, large rash around injection site.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient received an intramuscular dose of MMR II instead of subcutaneously; No adverse effect reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, albumin status of rHA (recombinant human albumin) (M-M-R II) for prophylaxis, lot # N027781, expiration date 08-AUG-2019 (formulation, strength, frequency were not provided). The patient received an intramuscular dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) instead of subcutaneously. There was no adverse effect reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effects reported; the patient received first dose of VAQTA (lot number and expiration date unknown by reporter) on 1/7/2019. Medical Assistant reported the same patient received a second dose of VAQTA (R034339, expiration 11/23/2019) on 4/10/2019).; This spontaneous report was received from a medical assistant regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.  On 07-JAN-2019, the patient received the first dose of Hepatitis A Vaccine, Inactivated (VAQTA) administered for prophylaxis (route, dose, location of administration, lot # and expiration date were not reported). On 10-APR-2019, the patient received the second dose of Hepatitis A Vaccine, Inactivated (VAQTA) administered for prophylaxis (route, dose and location of administration not reported) (lot # R034339, expiration date: 23-NOV-2019). No adverse events were reported.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 10-NOV-2015, at age 62, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2012, at approximately age 60, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 28-OCT-2010, at age 61, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a nurse practitioner (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received regarding a case in litigation from a lawyer, an elderly female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In January 2017, at age 72, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 22-DEC-2011, at age 66, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported; The patient was vaccinated with expired M-M-R II; This spontaneous report as received from a other health professional referred to a patient of unknown age.    On 16-APR-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # N010495 for prophylaxis.       On 16-APR-2019, 1 day after onset of therapy the patient experienced expired product administered.  The outcome of expired product administered and no adverse event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient received SHINGRIX by subcutaneous route instead of intramuscular route, which led to intramuscular formulation administered by other route. About 1 year ago, the patient experienced injection site pain after a dose of SHINGRIX which lasted for 5 to 6 days. The reporter agree to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pain, Injection site reaction, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site nodule in a female patient who received SHINGRIX for prophylaxis. Concomitant products included TYLENOL. On 5th April 2019, the patient received SHINGRIX. On 5th April 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. In April 2019, the patient experienced injection site nodule. On an unknown date, the outcome of the injection site nodule and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the injection site nodule and injection site pain to be related to SHINGRIX. Additional case details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX in unknown arm. On Friday, the patient received the vaccine into the back of her arm and reported that her injection site was still painful without much relief from TYLENOL and reported that less than a week after receiving SHINGRIX had a 2 by 3 nodular welp. The patient asked how long did SHINGRIX side effects last. The patient abandoned call before reporter was able to obtain consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site reaction, Muscular weakness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper extremities in a 58-year-old female patient who received SHINGRIX (batch number 4LH35, expiry date 11th September 2021) for prophylaxis. Concomitant products included SHINGRIX. On 5th April 2019, the patient received the 2nd dose of SHINGRIX. In April 2019, less than a week after receiving SHINGRIX, the patient experienced numbness of upper extremities, weakness of upper extremities and injection site reaction. On an unknown date, the outcome of the numbness of upper extremities, weakness of upper extremities and injection site reaction were unknown. It was unknown if the reporter considered the numbness of upper extremities, weakness of upper extremities and injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The patient did not had reaction with the 1st dose of SHINGRIX vaccine. The patient received SHINGRIX in the left deltoid. At the time of reporting, the patient was experiencing numbness of upper extremities, muscle weakness upper limb and these was described as injection site reaction sized about 2 inches by 4 inches.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Gait disturbance, Myalgia, Neuralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of myalgia in a 78-year-old female patient who received SHINGRIX (batch number P57AA, expiry date 5th July 2021) for prophylaxis. Concurrent medical conditions included neurological disorder nos (the patient did indicate having a nerve condition disorder). On 12th March 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced myalgia, nerve pain, feelings of weakness and walking difficulty. On an unknown date, the outcome of the myalgia, nerve pain, feelings of weakness and walking difficulty were not recovered/not resolved. It was unknown if the reporter considered the myalgia, nerve pain, feelings of weakness and walking difficulty to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experience myalgia and nerve pain. The patient visited her physician and was informed that the symptoms would subside, however the symptoms have persisted for nearly a month. The patient did report a small amount of improvement with her symptoms but also reports she still feels weak and was having difficulty walking. The pharmacist reported that the patient did indicate having a nerve condition disorder. The exact condition was not known by the reporter. The patient did not report having taken any medications to alleviate her symptoms since receiving the vaccine. The onset of the symptoms after the vaccine was administered was unknown by the reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 71-year-old female patient who received SHINGRIX (batch number 4X733, expiry date 8th March 2021) for prophylaxis. On 28th March 2019, the SHINGRIX in left arm and a few days after, she started developing a rash on left ear and neck. After treatment from her provider she received acyclovir. No definite diagnosis of Shingles was reported. No additional details were provided.