chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpez zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 25-JAN-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions by a pharmacist. On an unspecified date, the patient experienced herpes zoster and  was treated by a physician. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Shingles; Nerve pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 10th July 2019, 20 days after receiving Shingrix, the patient experienced shingles and nerve pain. On an unknown date, the outcome of the shingles and nerve pain were unknown.   It was unknown if the reporter considered the shingles and nerve pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The reporter did not have the lot number or expiration date but she would follow up with the pharmacy to obtain the information. The patient developed shingles with a very violent eruption of nerve pain. The reporter did not consent to follow-up and declined to give her treating physician's information. The GlaxoSmithKline (GSK) contact number and case number for follow up lot number and expiration date information was provided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Internal fixation of fracture, Pain in extremity, Pyrexia, Radius fracture
Clinical narrative: Broken ulna and radius bones on the arm; Broken ulna and radius bones on the arm; tripped and fell down on rigth arm; Fever; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of ulna fracture in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced ulna fracture, radius fracture, fall, fever and pain in arm. On an unknown date, the outcome of the ulna fracture, radius fracture and fall were unknown and the outcome of the fever and pain in arm were recovered/resolved.   It was unknown if the reporter considered the ulna fracture, radius fracture, fall, fever and pain in arm to be related to Shingrix.  Additional details were received as follows: About 17 to 18 days before the reporting date, the patient received Shingrix.  The patient experienced sore arm that lasted for 2 days.  About a week later, the patient tripped and fell down on her right arm. She broke her ulna and radius bones on the arm.  The patient had a surgery with plates and screws.  The patient also had a fever of 102 degree C before going into the surgery which lasted for 24 hours post surgery. The patient consented to follow up and provided her physician's details. The patient did not have a zip code for her doctor. The patient stated that her doctor briefly mentioned to her that anyone that received Shingrix vaccine came in with a fever. No further details were provided.      Lab Comments: on an unknown date, the lab test was performed.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Ulna fracture
Clinical narrative: Broken ulna and radius bones on the arm; Broken ulna and radius bones on the arm; tripped and fell down on rigth arm; Fever; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of ulna fracture in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced ulna fracture, radius fracture, fall, fever and pain in arm. On an unknown date, the outcome of the ulna fracture, radius fracture and fall were unknown and the outcome of the fever and pain in arm were recovered/resolved.   It was unknown if the reporter considered the ulna fracture, radius fracture, fall, fever and pain in arm to be related to Shingrix.  Additional details were received as follows: About 17 to 18 days before the reporting date, the patient received Shingrix.  The patient experienced sore arm that lasted for 2 days.  About a week later, the patient tripped and fell down on her right arm. She broke her ulna and radius bones on the arm.  The patient had a surgery with plates and screws.  The patient also had a fever of 102 degree C before going into the surgery which lasted for 24 hours post surgery. The patient consented to follow up and provided her physician's details. The patient did not have a zip code for her doctor. The patient stated that her doctor briefly mentioned to her that anyone that received Shingrix vaccine came in with a fever. No further details were provided.      Lab Comments: on an unknown date, the lab test was performed.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site joint inflammation, Product administered at inappropriate site
Clinical narrative: Inflammation of Shoulder Joint; Inadvertently administered vaccine in shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of injection site joint inflammation in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site joint inflammation (serious criteria hospitalization) and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site joint inflammation and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site joint inflammation to be related to Shingrix.  Additional details were received as follows: The patient's age at vaccination was not reported. The patient was inadvertently administered Shingrix in the shoulder, which led to vaccine administered at inappropriate site. The patient was taken to the emergency room and was currently in the hospital due to inflammation to shoulder joint.  The reporter stated that, the patient was initially admitted with septic shoulder, but it was not septic and was a working diagnosis on admissions. It was then confirmed as inflammation of shoulder joint.  The reporter was unable to provide if this was 1st or 2nd dose of Shingrix, date of administration, batch number and expiration date of vaccine.  The reporter was asking about any information with this type of reaction with Shingrix vaccine and any available recommendations for the health care professional. The reporter consented to follow up.
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Ear infection, Hypersensitivity, Nasopharyngitis
Clinical narrative: Ear infection; Treated for allergies; She had a cold; This is a spontaneous report from a contactable consumer (Medical Assistant) and a contactable consumer.   A 6-month-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot # T78675, Expiry date: 31Mar2020, NDC # 00005-1971-02) intramuscular at 0.5ml on 27Aug2018 for immunisation, prescribed by a Pediatrics. There were no other medical conditions, or concomitant medications, or relevant investigations to provide. On unknown date he patient experienced allergies, she had a cold and ear infection and was prescribed ZITHROMYCIN on that same day. The reporter did not provide a seriousness criteria or outcome.   Follow-up (29Aug2018): New information reported from the same contactable consumer, an Office Manager (Medical Assistant) includes: reporter occupation; patient age/gender and details; suspect details; no medical conditions, concomitant medications or relevant investigations.  Follow-up (29May2019): Follow-up attempts completed. No further information expected  Follow-up (16Jul2019): additional information received from a contactable consumer includes no patients were given the vaccine during temperature outage.  Follow-up attempts completed. No further information expected
Sex: U
Vaccine: MENB
Symptoms: Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Developed a fever between 102-104F; sore arms; injection site that was hot to the touch; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. This nurse reported similar events for three adolescent patients between the ages of 16-18. This is the 1st of three reports.   A patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the arm on an unspecified date at a single dose for immunization. The patient's medical history was not reported. Concomitant vaccine included meningococcal vaccine (MCV-4) on unspecified date for immunization. On an unspecified date, after use of the product, the patient developed a fever between 102-104F along with sore arms and an injection site that was hot to the touch. Injections were given in separate arms. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019306418 same drug/event, different patient;US-PFIZER INC-2019306417 same drug/event, different patient
Sex: U
Vaccine: MENB
Symptoms: Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Developed a fever between 102-104F; Sore arms; Injection site that was hot to the touch; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. This nurse reported similar events for three patients. This is the second of three reports.  An adolescent patient (reported between 16-18 year-old) of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the arm on an unspecified date at a single dose for immunization. The patient's medical history was not reported. Concomitant vaccine included meningococcal vaccine (MCV-4) for immunization. On an unspecified date, the patient developed a fever between 102-104F along with sore arms and an injection site that was hot to the touch. The outcome of the events was unknown.  Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019306418 same reporter, suspect drug and event; different patient;US-PFIZER INC-2019306395 same reporter, suspect drug and event; different patient
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: Swelling on the arm for 2 weeks post vaccination; This is a spontaneous report from a contactable physician received via a sales representative. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria 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 swelling on the arm for 2 weeks post vaccination on an unspecified date. The patient recovered from the event on an unspecified date.  Information on the batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: His arm has been sore since; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose in arm for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced his arm had been sore since receiving the vaccine on an unspecified date. The outcome of the event was unknown.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: sore arm/ pain that went down his arm; This is a spontaneous report from a contactable consumer.  A 71-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number X93809), at his 71 years old via an unspecified route of administration on 28Jun2019 at single dose for immunisation/prevention. There was no medical history or concomitant medications. The patient experienced sore arm three weeks after it was administered, the patient had to put ice packs as having pain that went down his arm.
Sex: M
Vaccine: PPV
Symptoms: Allergy to vaccine, Drug hypersensitivity, Rash
Clinical narrative: Drug Allergies: Niacin, Pneumococcal vaccine-rash; Drug Allergies: Niacin, Pneumococcal vaccine-rash; This is a spontaneous report from a contactable nurse.  A 78-year-old male patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date at single dose for immunisation and nicotinic acid (NIACIN), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication.  The patient medical history and concomitant medications were not reported.  It was reported on an unspecified date that the patient had drug allergies: niacin, pneumococcal vaccine-rash. The action taken in response to the event for nicotinic acid was unknown. The outcome of the events was unknown.   Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein)  in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of (pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  Information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: Drug ineffective (pneumonia); Pneumonia; This is a spontaneous report based on information received by Pfizer from Merck & Co., Inc., (manufacturer report number 01276238).   A contactable female consumer of an unspecified age reported that she was vaccinated with pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, manufacturer by Pfizer) on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. Subsequently on an unspecified date, the patient developed pneumonia. Clinical outcome of the adverse event was unknown at time of this report. No further information provided.  No follow-up attempts are possible, information about lot number cannot be obtained.
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Dizziness
Clinical narrative: 16 y/0 female received Trumenba in one arm and Menactra and Hep A in other arm and next day reported to her mom feeling dizzy; This is a spontaneous report from a contactable nurse via Pfizer sales representative.   A 16-year-old female patient received on an unspecified date for immunization,meningococcal group b rlp2086 (TRUMENBA) at single dose in one arm and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) and hepatitis a vaccine (unknown manufacturer)  in other arm. The patient medical history and concomitant medications were not reported.  On an unspecified date, the day after vaccinations, patient reported to her mom feeling dizzy. Patient was seen by pediatrician and vitals checked and patient monitored and sent home.The outcome of the event was unknown.  Information on the batch number has been requested
Age: 28.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Culture throat, Oropharyngeal pain, Pain, Pharyngeal enanthema, Pyrexia
Clinical narrative: Rash-1 week after vaccination fever, body aches, sore throat and white spots in throat- 10 days after vaccination
Age: 28.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Rash, Streptococcus test negative
Clinical narrative: Rash-1 week after vaccination fever, body aches, sore throat and white spots in throat- 10 days after vaccination
Age: 49.0
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Inflammation, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: By the end of the day I received the Pneumococcal Polysaccharide Vaccine (PPSV23), which was 7/10/19, my right shoulder area began to hurt. By the next morning, the pain was so bad that I could hardly move my right arm. By the evening of 7/11/19, the pain associated with any movement of my arm was at the level of 8 out of 10.  Called the doctor on Friday morning. They recommended I go to their Urgent Care if it didn't improve, which I did on Sunday, 7/14/19. At that point, I had some movement pain, but was still in pain (5 out of 10). They attributed the pain to receiving the injection in the wrong place on my right arm (i.e. missed the muscle) and it had caused severe inflammation. They prescribed a strong anti-inflammatory which helped with the pain and has helped me regain 90% of my arm mobility back. I still feel like I don't have full range of motion with the use of my right arm, especially when reaching across my chest or behind my back.
Age: 49.0
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Product administered at inappropriate site
Clinical narrative: By the end of the day I received the Pneumococcal Polysaccharide Vaccine (PPSV23), which was 7/10/19, my right shoulder area began to hurt. By the next morning, the pain was so bad that I could hardly move my right arm. By the evening of 7/11/19, the pain associated with any movement of my arm was at the level of 8 out of 10.  Called the doctor on Friday morning. They recommended I go to their Urgent Care if it didn't improve, which I did on Sunday, 7/14/19. At that point, I had some movement pain, but was still in pain (5 out of 10). They attributed the pain to receiving the injection in the wrong place on my right arm (i.e. missed the muscle) and it had caused severe inflammation. They prescribed a strong anti-inflammatory which helped with the pain and has helped me regain 90% of my arm mobility back. I still feel like I don't have full range of motion with the use of my right arm, especially when reaching across my chest or behind my back.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Pain, Swelling
Clinical narrative: Patient experienced hot swollen and sore after shot on 8/07/2019. she is going to see MD
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Fall, Feeling abnormal, Vomiting
Clinical narrative: MOTHER CALLED TO NOTIFY THE PROVIDER THAT THE PATIENT WAS SEEN IN OFFICE YESTERDAY 8/8/19 AND RECEIVED THE MEN B VACCINE. YESTERDAY NIGHT THE PATIENT BEGAN TO FEEL LIGHT HEADED AND FELL TO THE GROUND MOTHER SAID HE WAS "OUT OF IT FOR 5 SECONDS" THEN IMMEDIATELY VOMITED.  MOTHER DECIDED TO JUST KEEP AN EYE ON HIM THE REST OF THE NIGHT AND HE SEEMED WELL. TODAY HE IS WELL-APPEARING AND DENIES ANY N/V, HEADACHE, PAIN, NO LOCAL REACTION SURROUND THE INJECTION SITE. PT IS EATING AND DRINKING WELL.
Age: 15.0
Sex: M
Vaccine: HEPA, IPV, MNQ, TDAP, VARCEL
Symptoms: Blood glucose decreased, Cold sweat, Dizziness, Nervousness, Pallor
Clinical narrative: Patient and his adult brother were in lobby waiting to be called up to window for payment when patient began to feel "as if he was going to faint". Adult brother called out for help,  upon arrival noticed patient was being held in a standing position by his brother and was supporting his head, patient's eyes were closed, lips were pale, palms of hands were cold and clammy. Instruction given to brother to sit patient back in chair and while giving instructions to brother patient opened his eyes, was able to focus on his brother then on me and asked what happened. From time of call for help to patient opening his eyes and speaking was no more than 15-20 seconds. Per patient and his brother he had been very nervous from vaccines, also mentioned that he had not eaten since early in the morning. Patient was taken into lab area and vitals done: 1410 - BP 137/69, Pulse 53, Resp 16, blood glucose 83mg/dL 1415 - BP 124/84, Pulse 88, Resp 16, lips noted to be pink in color 1422 - BP 118/79, Pulse 84, palms no longer cold or clammy Patient and his brother left clinic stating he felt fine, they refused that EMS be called. Brother and patient given instructions to go to nearest emergency room if he begins to feel unwell again and to take copy of immunization record so they will know what was administered  Call made to brother on 8/9/19, states he took patient to eat when they left clinic and has been doing well since, has not felt any symptoms as he did after vaccines. States they are planning to take patient to neurologist to assure nothing is wrong with him.
Age: 15.0
Sex: M
Vaccine: HEPA, IPV, MNQ, TDAP, VARCEL
Symptoms: Peripheral coldness
Clinical narrative: Patient and his adult brother were in lobby waiting to be called up to window for payment when patient began to feel "as if he was going to faint". Adult brother called out for help,  upon arrival noticed patient was being held in a standing position by his brother and was supporting his head, patient's eyes were closed, lips were pale, palms of hands were cold and clammy. Instruction given to brother to sit patient back in chair and while giving instructions to brother patient opened his eyes, was able to focus on his brother then on me and asked what happened. From time of call for help to patient opening his eyes and speaking was no more than 15-20 seconds. Per patient and his brother he had been very nervous from vaccines, also mentioned that he had not eaten since early in the morning. Patient was taken into lab area and vitals done: 1410 - BP 137/69, Pulse 53, Resp 16, blood glucose 83mg/dL 1415 - BP 124/84, Pulse 88, Resp 16, lips noted to be pink in color 1422 - BP 118/79, Pulse 84, palms no longer cold or clammy Patient and his brother left clinic stating he felt fine, they refused that EMS be called. Brother and patient given instructions to go to nearest emergency room if he begins to feel unwell again and to take copy of immunization record so they will know what was administered  Call made to brother on 8/9/19, states he took patient to eat when they left clinic and has been doing well since, has not felt any symptoms as he did after vaccines. States they are planning to take patient to neurologist to assure nothing is wrong with him.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Dysgeusia, Feeling cold
Clinical narrative: SEVERE HEAT (FELT LIKE BODY WAS ON FIRE), THEN BODY WAS COLD (CHILL SYMPTOMS), LASTED ALL DAY LONG SINCE 8/2 UNTIL PRESENT STILL EXPERIENCING THESE SYMPTOMS STOMACH HUNGRY BUT DOESN'T WANT TO EAT BECAUSE EVERYTHING TASTES  NASTY (COPPER TASTE) AND UPSETS STOMACH WHEN SHE DOES EAT DIARRHEA
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Hunger
Clinical narrative: SEVERE HEAT (FELT LIKE BODY WAS ON FIRE), THEN BODY WAS COLD (CHILL SYMPTOMS), LASTED ALL DAY LONG SINCE 8/2 UNTIL PRESENT STILL EXPERIENCING THESE SYMPTOMS STOMACH HUNGRY BUT DOESN'T WANT TO EAT BECAUSE EVERYTHING TASTES  NASTY (COPPER TASTE) AND UPSETS STOMACH WHEN SHE DOES EAT DIARRHEA
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Dysgeusia, Feeling cold, Feeling hot
Clinical narrative: SEVERE HEAT (FELT LIKE BODY WAS ON FIRE), THEN BODY WAS COLD (CHILL SYMPTOMS), LASTED ALL DAY LONG SINCE 8/2 UNTIL PRESENT STILL EXPERIENCING THESE SYMPTOMS STOMACH HUNGRY BUT DOESN'T WANT TO EAT BECAUSE EVERYTHING TASTES  NASTY (COPPER TASTE) AND UPSETS STOMACH WHEN SHE DOES EAT DIARRHEA
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Stomatitis
Clinical narrative: SEVERE HEAT (FELT LIKE BODY WAS ON FIRE), THEN BODY WAS COLD (CHILL SYMPTOMS), LASTED ALL DAY LONG SINCE 8/2 UNTIL PRESENT STILL EXPERIENCING THESE SYMPTOMS STOMACH HUNGRY BUT DOESN'T WANT TO EAT BECAUSE EVERYTHING TASTES  NASTY (COPPER TASTE) AND UPSETS STOMACH WHEN SHE DOES EAT DIARRHEA
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye swelling, Heart rate increased, Heart rate irregular, Pain in extremity, Pharyngeal swelling
Clinical narrative: For first 3 days left arm hurt but no other effects were felt. After 8 days of getting the Shingrix vaccine  swelling began in the eyes and rash appeared.  Next morning eyes and throat were swollen and rash appeared under arms and groin area. Felt irregular and fast heart beat. Swelling and rash came and went within hours upon taking Claritin/Benadryl. After 48 hours swelling and rash disappeared.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: For first 3 days left arm hurt but no other effects were felt. After 8 days of getting the Shingrix vaccine  swelling began in the eyes and rash appeared.  Next morning eyes and throat were swollen and rash appeared under arms and groin area. Felt irregular and fast heart beat. Swelling and rash came and went within hours upon taking Claritin/Benadryl. After 48 hours swelling and rash disappeared.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: The patient's upper arm became red, swollen, and warm to the touch. The patient's husband received from the same box and suffered no adverse event.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain ,redness, and swelling at site of injection. Headache, muscle aches, fever, chills
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: pain ,redness, and swelling at site of injection. Headache, muscle aches, fever, chills
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: 2nd of 2 shots of shingles vaccine, recombinant zoster, RZV on the afternoon of August 5, 2019.   On the morning of August 6, 2019, chills,  fever and headaches started.  These continued through August 8th.  Site of injection, left arm, swelled and got very red and very hot and itchy.  Redness spread and covered upper arm.  Went to the doctor on August 8th in the afternoon.  Doctor examined and outlined the redness with a marker.  Still had a temperature.  He diagnosed Cellulitis and prescribed Keflex for 10 days.  He advised that if anything changed such as more fever or redness continued to grow even slightly, I was to go to the emergency room immediately.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 2nd of 2 shots of shingles vaccine, recombinant zoster, RZV on the afternoon of August 5, 2019.   On the morning of August 6, 2019, chills,  fever and headaches started.  These continued through August 8th.  Site of injection, left arm, swelled and got very red and very hot and itchy.  Redness spread and covered upper arm.  Went to the doctor on August 8th in the afternoon.  Doctor examined and outlined the redness with a marker.  Still had a temperature.  He diagnosed Cellulitis and prescribed Keflex for 10 days.  He advised that if anything changed such as more fever or redness continued to grow even slightly, I was to go to the emergency room immediately.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Pain in extremity, Pyrexia, Sensitive skin
Clinical narrative: arm soreness, fever, headache, sensitive skin, aching joints
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Flushing, Pruritus, Scratch, Urticaria
Clinical narrative: Child had itchy,  hives around his neck, under his arms, and on his chest and his face was flushed. Child kept complaining of how much he was itching and was violently scratching his neck and under his arms. He would also cough periodically. He denies shortness of breath; no labored breathing noted. 0.5 ml of Bendryl was administered IM and  they stayed in the clinic for 30 minutes. Patient no longer complained of itching, his hives weren't as pronounced, and his face was no longer flushed.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash generalised, Skin exfoliation
Clinical narrative: After receiving dose 2/2 of the Shingrix  vaccine, patient noticed a rash that started the next day. She reports that the rash was from head to toe and was not itchy or burning. She said it resembled a heat rash. She also had a fever (patient did not actually take her temperature but could tell). This lasted for 3 days. The rash then peeled. During the rash phase, she applied cetaphil to her skin. After receiving the first dose of Shingrix, patient said she got a mild rash on the areas around her joints, thighs, chest, and had a mild fever for 24 hours. Because of this, the pharmacist recommended the patient to take Aleve and Benadryl as prophylaxis for the second shot.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient states that she started having fever, pain in her left arm and redness and swelling in left arm that night after receiving the shot.  She said her fever was 99-100 degrees and lasted about 4 days.  The redness and swelling in her arm lasted 5-6 days.  Those symptoms have since resolved.  She is still having arm pain 9 days later.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt came to clinic this morning c/o pain redness and swelling at injection site. It was warm to the touch. Reports she felt "flu-like symptoms" and had had a small  episode of nausea, vomiting and diarrhea last night.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Vomiting
Clinical narrative: Pt came to clinic this morning c/o pain redness and swelling at injection site. It was warm to the touch. Reports she felt "flu-like symptoms" and had had a small  episode of nausea, vomiting and diarrhea last night.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: pt reported sore arm with redness spreading down arm, pain getting worse not better
Age: 23.0
Sex: F
Vaccine: HEPA, HPV9, TDAP
Symptoms: Chest pain, Dizziness, Hyperhidrosis, Hypoacusis, Nausea
Clinical narrative: Patient requested for 3(HPV, Hep A, Tdap) vaccines. She was told to relax her arm and breathe through the shots, to not hold her breathe. She did as told, and relaxed and breathed. After the vaccines were completed being administered, she stated she felt fine and they didn?t even hurt. I had sat down and was completing paperwork for her, and talking to her about her next steps to do. She stated she couldn?t hear me very well and felt dizzy. At 1055 she felt dizzy, hearing was hard for her, and she felt nauseous. I called for assistance. I handed the patient the trash can in case she were to throw up. At 1057 I obtained her blood pressure of 113/47 and heart rate of 62. She was alert and oriented x4. At 1100 she stated her hearing was a little better, still felt dizzy, and still felt nauseous. She was given a cool rag for her head, she said she felt sweaty. She was given water, juice and crackers. She said she felt like her heart started racing. At 1103 she stated she felt a sharp chest pain, I then called 911. At 1104 I obtained her BP of 93/46 and heart rate of 74. At 1106 she stated her chest pain wasn?t as bad, hearing is better, and didn?t feel as dizzy and nausea is better as well. She stated she doesn?t have insurance and doesn?t want to go to the emergency room. At 1110 she stated she felt normal again and wasn?t having chest pain. BP of 102/55 and heart rate of 61 obtained at 1109. EMT arrived at 1111, patient refused to go to the hospital or go with EMT?s, she signed a waiver for refusal with the EMT?s. She remained sitting this whole time during the situation, and had not stood up at all. She was encouraged not to drive herself home and to have someone come to pick her up. She called her mom and her mom stated she would come get her. She remained sitting in my office during this time. Her mother came to follow her home to make sure she was okay. She stated she felt fine, and normal, and stood herself up with me at her side in case of anything were to happen.  She stood without any help and didn?t feel dizzy. I watched her leave the front door with her mother, gait normal. She never fell or lost consciousness during this time.
Age: 23.0
Sex: F
Vaccine: HEPA, HPV9, TDAP
Symptoms: Palpitations
Clinical narrative: Patient requested for 3(HPV, Hep A, Tdap) vaccines. She was told to relax her arm and breathe through the shots, to not hold her breathe. She did as told, and relaxed and breathed. After the vaccines were completed being administered, she stated she felt fine and they didn?t even hurt. I had sat down and was completing paperwork for her, and talking to her about her next steps to do. She stated she couldn?t hear me very well and felt dizzy. At 1055 she felt dizzy, hearing was hard for her, and she felt nauseous. I called for assistance. I handed the patient the trash can in case she were to throw up. At 1057 I obtained her blood pressure of 113/47 and heart rate of 62. She was alert and oriented x4. At 1100 she stated her hearing was a little better, still felt dizzy, and still felt nauseous. She was given a cool rag for her head, she said she felt sweaty. She was given water, juice and crackers. She said she felt like her heart started racing. At 1103 she stated she felt a sharp chest pain, I then called 911. At 1104 I obtained her BP of 93/46 and heart rate of 74. At 1106 she stated her chest pain wasn?t as bad, hearing is better, and didn?t feel as dizzy and nausea is better as well. She stated she doesn?t have insurance and doesn?t want to go to the emergency room. At 1110 she stated she felt normal again and wasn?t having chest pain. BP of 102/55 and heart rate of 61 obtained at 1109. EMT arrived at 1111, patient refused to go to the hospital or go with EMT?s, she signed a waiver for refusal with the EMT?s. She remained sitting this whole time during the situation, and had not stood up at all. She was encouraged not to drive herself home and to have someone come to pick her up. She called her mom and her mom stated she would come get her. She remained sitting in my office during this time. Her mother came to follow her home to make sure she was okay. She stated she felt fine, and normal, and stood herself up with me at her side in case of anything were to happen.  She stood without any help and didn?t feel dizzy. I watched her leave the front door with her mother, gait normal. She never fell or lost consciousness during this time.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received PPSV23 vaccine 8/6/19 @1431 as a hospital inpatient.  Sometime between 8/7/19 PM and 8/8/19 AM, nursing staff noted some redness and swelling (minor) at the injection site.  The physician was contacted.  He instructed staff to circle the area and monitor for changes in size.  The redness and swelling decreased over the following 24 hours and disappeared without intervention.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Impaired work ability, Injection site pain, Injection site swelling
Clinical narrative: Late in the day of vaccination developed swelling, pain and tenderness of the injection site, along with malaise, generalized muscle pain, dizziness and tenderness and headache.  Day 2 - Worse and moderately severe the next day, both arm and generalized symptoms.   Unable to work, mostly in bed.  Treated with Naproxen and Acetaminophen with mild to moderate benefit.  Day 3 - Getting better. Up around the house. Still taking Naproxen/Acetaminophen.  Day 4 - Nearly back to normal.  Back to work.  Day 5 - Resolved.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Tenderness
Clinical narrative: Late in the day of vaccination developed swelling, pain and tenderness of the injection site, along with malaise, generalized muscle pain, dizziness and tenderness and headache.  Day 2 - Worse and moderately severe the next day, both arm and generalized symptoms.   Unable to work, mostly in bed.  Treated with Naproxen and Acetaminophen with mild to moderate benefit.  Day 3 - Getting better. Up around the house. Still taking Naproxen/Acetaminophen.  Day 4 - Nearly back to normal.  Back to work.  Day 5 - Resolved.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial pain, Skin ulcer
Clinical narrative: Whole face hurt, had a sore on the right side of his outer nose
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain
Clinical narrative: This patient had possible adverse reaction to the Smallpox vaccine. Pt reported to the ER complaining of chest pain. Patient was admitted to the hospital for 3 days. He  was discharged with the diagnosis of unspecified chest pain. Patient has fully recovered.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient reports that since yesterday, she has had redness of the injection site and pain.  States that she did not have this reaction with the first dose.  Denies chest pain, shortness of breath, and worsening/spreading of the redness.  Has not done anything for it.  Advised her to mark the borders of the redness with a pen and to monitor if the redness spreads.  Also advised her to apply a cold compress to the area and to take ibuprofen/tylenol for the pain.  Advised her to follow-up with urgent care/ER if symptoms worsen or do not improve in the next few days.
Age: 26.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal distension, Abdominal pain upper, Blood pressure decreased, Cold sweat, Diarrhoea
Clinical narrative: On Thursday I was given my first Gardasil shot in my left arm. I remember my nurse putting a band aid on my arm and instantly my vision was becoming bright and I felt nauseous.  My nurse told me to stay seated. At this point I passed out, I woke up what felt like instantly to a bunch of people saying my name, I was told I was unconscious for 7+ minutes. There were 5 or 6 nurses holding me up in my chair,  2 doctors, and EMT in the room. I was told I had a seizure and I had an oxygen mask on. I had urinated on myself while I was unconscious. I was soaked in sweat, freezing cold & trembling. My blood pressure had dropped significantly.  2 EMT carried me to the stretcher because I could barely feel my legs.  When I arrived to the ER I felt almost normal, I could talk again and I had quit trembling. It is day two and my body is instantly rejecting any food I eat- I have thrown up 2 times the day of the occurrence and have diarrhea . I am extremely bloated and have severe stomach aches that give me the cold sweats. I have a follow up appointment with my primary doctor on Monday.
Age: 26.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Feeling cold, Hyperhidrosis, Loss of consciousness, Nausea, Seizure
Clinical narrative: On Thursday I was given my first Gardasil shot in my left arm. I remember my nurse putting a band aid on my arm and instantly my vision was becoming bright and I felt nauseous.  My nurse told me to stay seated. At this point I passed out, I woke up what felt like instantly to a bunch of people saying my name, I was told I was unconscious for 7+ minutes. There were 5 or 6 nurses holding me up in my chair,  2 doctors, and EMT in the room. I was told I had a seizure and I had an oxygen mask on. I had urinated on myself while I was unconscious. I was soaked in sweat, freezing cold & trembling. My blood pressure had dropped significantly.  2 EMT carried me to the stretcher because I could barely feel my legs.  When I arrived to the ER I felt almost normal, I could talk again and I had quit trembling. It is day two and my body is instantly rejecting any food I eat- I have thrown up 2 times the day of the occurrence and have diarrhea . I am extremely bloated and have severe stomach aches that give me the cold sweats. I have a follow up appointment with my primary doctor on Monday.
Age: 26.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Sensory loss, Tremor, Urinary incontinence, Visual impairment, Vomiting
Clinical narrative: On Thursday I was given my first Gardasil shot in my left arm. I remember my nurse putting a band aid on my arm and instantly my vision was becoming bright and I felt nauseous.  My nurse told me to stay seated. At this point I passed out, I woke up what felt like instantly to a bunch of people saying my name, I was told I was unconscious for 7+ minutes. There were 5 or 6 nurses holding me up in my chair,  2 doctors, and EMT in the room. I was told I had a seizure and I had an oxygen mask on. I had urinated on myself while I was unconscious. I was soaked in sweat, freezing cold & trembling. My blood pressure had dropped significantly.  2 EMT carried me to the stretcher because I could barely feel my legs.  When I arrived to the ER I felt almost normal, I could talk again and I had quit trembling. It is day two and my body is instantly rejecting any food I eat- I have thrown up 2 times the day of the occurrence and have diarrhea . I am extremely bloated and have severe stomach aches that give me the cold sweats. I have a follow up appointment with my primary doctor on Monday.
Age: 26.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Hyperhidrosis, Incontinence, Loss of consciousness, Seizure like phenomena
Clinical narrative: On Thursday I was given my first Gardasil shot in my left arm. I remember my nurse putting a band aid on my arm and instantly my vision was becoming bright and I felt nauseous.  My nurse told me to stay seated. At this point I passed out, I woke up what felt like instantly to a bunch of people saying my name, I was told I was unconscious for 7+ minutes. There were 5 or 6 nurses holding me up in my chair,  2 doctors, and EMT in the room. I was told I had a seizure and I had an oxygen mask on. I had urinated on myself while I was unconscious. I was soaked in sweat, freezing cold & trembling. My blood pressure had dropped significantly.  2 EMT carried me to the stretcher because I could barely feel my legs.  When I arrived to the ER I felt almost normal, I could talk again and I had quit trembling. It is day two and my body is instantly rejecting any food I eat- I have thrown up 2 times the day of the occurrence and have diarrhea . I am extremely bloated and have severe stomach aches that give me the cold sweats. I have a follow up appointment with my primary doctor on Monday.
Age: 26.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: On Thursday I was given my first Gardasil shot in my left arm. I remember my nurse putting a band aid on my arm and instantly my vision was becoming bright and I felt nauseous.  My nurse told me to stay seated. At this point I passed out, I woke up what felt like instantly to a bunch of people saying my name, I was told I was unconscious for 7+ minutes. There were 5 or 6 nurses holding me up in my chair,  2 doctors, and EMT in the room. I was told I had a seizure and I had an oxygen mask on. I had urinated on myself while I was unconscious. I was soaked in sweat, freezing cold & trembling. My blood pressure had dropped significantly.  2 EMT carried me to the stretcher because I could barely feel my legs.  When I arrived to the ER I felt almost normal, I could talk again and I had quit trembling. It is day two and my body is instantly rejecting any food I eat- I have thrown up 2 times the day of the occurrence and have diarrhea . I am extremely bloated and have severe stomach aches that give me the cold sweats. I have a follow up appointment with my primary doctor on Monday.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Insomnia, Mobility decreased
Clinical narrative: Beginning Tuesday afternoon she because having severe pain in her arm, she couldn't raise her arm above her shoulder. She had a horrible headache, was very nauseous, could not even lie on her back to sleep. She had chills and flu like symptoms in addition.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: Beginning Tuesday afternoon she because having severe pain in her arm, she couldn't raise her arm above her shoulder. She had a horrible headache, was very nauseous, could not even lie on her back to sleep. She had chills and flu like symptoms in addition.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Musculoskeletal stiffness, Nausea, Pain, Pain in extremity
Clinical narrative: Sore arm that night.   Body ache, stifness, nausea by 8 AM.   Feels like a very bad flu.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Muscular weakness
Clinical narrative: pt reported numbness in chin and lips and weakness in right arm
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness, Nausea, Vision blurred, Vomiting
Clinical narrative: Customer was walking out of store with father when he stated to Dad that he was felling lightheaded, dizzy, and had blurred vision. Customer passed out. Father caught son and helped him to the ground.  Father came back to get pharmacist. Upon arriving to the customer, patient was alert but was very lightheaded and nausea.  No anaphylactic reaction observed.  Helped customer sit up but was nauseated.  Customer vomited twice.  Gave customer water, orange juice and cookies to help with nausea.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported; one patient received one dose of PROQUAD via the intramuscular route in the left thigh.; This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. The patient's historical conditions, previous drug reactions, allergies, concurrent condition and concomitant medications were not provided.      On 29-JUL-2019, the patient received one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S003861 and expiration date 08-AUG-2020) ) and recombinant human albumin (rHA) by intramuscular routed (incorrect route of product administration ) in the left thigh; as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date were not provided). No adverse effects reported.  Lot number and expiration date were reported in the source document. But, when entering the lot number in MARRS the system automatically auto-populated the correct expiration date, which sometimes  may differs from the expiration date reported by the source.
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; a patient was administered an expired dose of MMR II; This spontaneous report was received from a nurse, via company representative, referring to a 13 month old patient.  No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies.  Concomitant therapies included sterile diluent.      On 05-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (dose, dose nu,number, route and site of administration were not reported).     The vaccine administered was lot # N020927 and had expired on 01-AUG-2019.     It was reported that the patient received all other vaccines that were routine for a 12 month old child.  No adverse event.