chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Asthenia, Dyskinesia, Feeling abnormal, Flat affect, Gaze palsy
Clinical narrative: @ ~4:50 PM after receiving all the vaccinations client was standing at front desk, became very pale, rested head on the counter, weak "feeling like in a dream". Had client sit down in chair, 4:50 Nurse at side Pulse checked 68, gaze fixed, eyes glassy, began having spastic like movement in the upper and lower extremities lasting <30 seconds, eyes open, skin very pale. Placed client into head down position places cool cloth to back of neck. Both nurses at side, client sat up still very pale with glassy eyes no more spastic movement. Placed O2 on at 4L via nasal cannula. Continued O2, client verbally responding however very glassy eyed, flat affect, slow deliberate speech and very pale. VS P 66, SaO2 on 4L 99%, BP 132/72. Decreased O2 to 2L and continued to monitor. Nurse reviewed VIS statements, we discussed adverse reaction form and that we would be placing one, instructed on side effect to monitor for and to take to Emergency department should symptoms persist, reoccur or worsen. @1715 client was much improved able to ambulate on own. Continued to have glassy eyes and flat affect, escorted to car where parent took them home. 4/16/2019 Called parent and she states client has returned to normal and hasn't had anymore symptoms as displayed yesterday.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Glassy eyes, Pallor, Slow speech
Clinical narrative: @ ~4:50 PM after receiving all the vaccinations client was standing at front desk, became very pale, rested head on the counter, weak "feeling like in a dream". Had client sit down in chair, 4:50 Nurse at side Pulse checked 68, gaze fixed, eyes glassy, began having spastic like movement in the upper and lower extremities lasting <30 seconds, eyes open, skin very pale. Placed client into head down position places cool cloth to back of neck. Both nurses at side, client sat up still very pale with glassy eyes no more spastic movement. Placed O2 on at 4L via nasal cannula. Continued O2, client verbally responding however very glassy eyed, flat affect, slow deliberate speech and very pale. VS P 66, SaO2 on 4L 99%, BP 132/72. Decreased O2 to 2L and continued to monitor. Nurse reviewed VIS statements, we discussed adverse reaction form and that we would be placing one, instructed on side effect to monitor for and to take to Emergency department should symptoms persist, reoccur or worsen. @1715 client was much improved able to ambulate on own. Continued to have glassy eyes and flat affect, escorted to car where parent took them home. 4/16/2019 Called parent and she states client has returned to normal and hasn't had anymore symptoms as displayed yesterday.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Grip strength decreased, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: My Arm started throbbing at first (about 3 hours) after the injection,  then became (severe) stabbing, burning pain.  My arm swelled up twice the size about 5 hours after the injection.  It was Hot and Painful to touch.   I started chilling for several hours.  I could Not stand to have my arm touch the bed covers.  I couldn't lay on my right side.    I couldn't sleep the 1st night because of the pain.    The swelling, hot to the touch and pain lasted for 3 days.  The chills lasted for about 24 hours.   For 3 days I couldn't lift my arm past my chest without cramps starting.     My right hand is still weak in the grip 6 days later.  There is still slight swelling and  tenderness at the injection site 6 days later.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Muscle spasms, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: My Arm started throbbing at first (about 3 hours) after the injection,  then became (severe) stabbing, burning pain.  My arm swelled up twice the size about 5 hours after the injection.  It was Hot and Painful to touch.   I started chilling for several hours.  I could Not stand to have my arm touch the bed covers.  I couldn't lay on my right side.    I couldn't sleep the 1st night because of the pain.    The swelling, hot to the touch and pain lasted for 3 days.  The chills lasted for about 24 hours.   For 3 days I couldn't lift my arm past my chest without cramps starting.     My right hand is still weak in the grip 6 days later.  There is still slight swelling and  tenderness at the injection site 6 days later.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: My Arm started throbbing at first (about 3 hours) after the injection,  then became (severe) stabbing, burning pain.  My arm swelled up twice the size about 5 hours after the injection.  It was Hot and Painful to touch.   I started chilling for several hours.  I could Not stand to have my arm touch the bed covers.  I couldn't lay on my right side.    I couldn't sleep the 1st night because of the pain.    The swelling, hot to the touch and pain lasted for 3 days.  The chills lasted for about 24 hours.   For 3 days I couldn't lift my arm past my chest without cramps starting.     My right hand is still weak in the grip 6 days later.  There is still slight swelling and  tenderness at the injection site 6 days later.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Developed a swelling and induration at right arm injection site. Size 5"x3". Possible cellulitis.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Shivers in the middle of the night, aches, slight temperature, threw up, headache most of the time (I never get headaches- haven't had a headache since I was a teenager). I slept until 3 o'clock in the afternoon.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event. I was unaware at the time of giving the immunization that our refrigerator had at some point reached freezing over night.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Pain, Peripheral swelling, Pyrexia
Clinical narrative: PATIENT RETURNED TO THE PHARMACY STATING THAT HER ARM SWELLED FROM SHOULDER TO ELBOW ALL AROUND THE ARM FOR 10 DAYS. SHE ALSO HAD A PATCH OF SHINGLES RASH ON HER LOWER LEFT ABDOMEN ABOUT 3 INCHES BY 3 INCHES FOR 5 DAYS. THE PATIENT ALSO HAD A BODY ACHES, FEVER AND ARM PAIN AT INJECTION SITE FOR 48 HOURS.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: PATIENT RETURNED TO THE PHARMACY STATING THAT HER ARM SWELLED FROM SHOULDER TO ELBOW ALL AROUND THE ARM FOR 10 DAYS. SHE ALSO HAD A PATCH OF SHINGLES RASH ON HER LOWER LEFT ABDOMEN ABOUT 3 INCHES BY 3 INCHES FOR 5 DAYS. THE PATIENT ALSO HAD A BODY ACHES, FEVER AND ARM PAIN AT INJECTION SITE FOR 48 HOURS.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Fever beginning four hours after administration. Fever of over 103 for the next 52 hours. Severe upper arm pain, unable to lift arm past 90 degrees. Rash appearing on entire upper left arm on 4/15/19. Symptoms improved the afternoon of 4/15/19 after doctor prescribed steroids to stop reaction.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Muscular weakness, Nausea
Clinical narrative: She woke up saying her legs were weak, had headache and nausea. By 7:00am she ate a good breakfast but complained of a mild headache.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Headache, Injection site swelling, Insomnia
Clinical narrative: Approximately 5 1/2 hours after receiving my second dose of the shingles vaccine I began to experience aching and soreness in the injection arm. Approximately 8 PM I began to experience chills. I took two doses of MOTRIN prior to midnight, and around 2 AM I took two EXCEDRIN. I was on able to sleep most of the night and was very uncomfortable. I had to take the following day off of work and could do no more than just lying in bed and wait for it to subside. I'm on day two and I still have aching and some chills. I have also developed a slight headache. The injection site was swollen in the evening but seems to be subsiding a little bit. I did not apply ice.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Approximately 5 1/2 hours after receiving my second dose of the shingles vaccine I began to experience aching and soreness in the injection arm. Approximately 8 PM I began to experience chills. I took two doses of MOTRIN prior to midnight, and around 2 AM I took two EXCEDRIN. I was on able to sleep most of the night and was very uncomfortable. I had to take the following day off of work and could do no more than just lying in bed and wait for it to subside. I'm on day two and I still have aching and some chills. I have also developed a slight headache. The injection site was swollen in the evening but seems to be subsiding a little bit. I did not apply ice.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Pyrexia, Wrong patient received product
Clinical narrative: Pt came to visit with 3 year old sibling. 4 month old was given FLULAVAL vaccine by new medical assistant by error instead of 3 yo sibling. Followed with mother today pt has subjective fever, mom gave tylenol. Otherwise doing fine.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 02-JUN-2014, the patient was inoculated with ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX vaccine, the patient suffered an outbreak of shingles including nerve damage. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient experienced serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses, the loss of accumulation and other economic and non-economic damages. Outbreak of shingles and nerve damage were considered disabling. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation from a lawyer, a 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) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 07-SEP-2012, at age 67, the patient was administered the zoster vaccine live (ZOSTAVAX) by a physician (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: F
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Side effects; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported).   Since an unspecified date, after having been administered the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), the patient was experiencing unspecified common side effects (adverse event) listed in the prescribing information of the suspect vaccine.  At the time of reporting, the events were ongoing and the reporter did not assess the causal relationship between vaccination with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and the events.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: unspecified number of MMR II doses by route of intramuscular to unspecified "infants"; No adverse effects; This spontaneous report was received from a pharmacist and refers to unspecified infants. No information was given regarding the patient's concomitant medications, medical history or concurrent conditions.  On unknowns dates,  the infants were vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), intramuscularly for prophylaxis (dose, lot number and expiration date were not reported). However, no adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; 2 patients received unspecified doses of ROTATEQ that were improperly stored; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On 12-APR-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R016791, expiration date: 16-APR-2020, administered orally (dose was not provided) as prophylaxis. The vaccine underwent a temperature of 48.2 Fahrenheit (F) degrees during a time frame of 1 hour as recorded by a data logger. No previous temperature excursion was reported, as well as no adverse effects.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA006649:
Sex: F
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site pain
Clinical narrative: the injection caused an immediate burning sensation upon injection; some mild bleeding at the injection site; This spontaneous report was received from a registered pharmacist referring to a 38 year old female patient with no pertinent medical history or drug reactions/allergies.  No other information was provided regarding the patient's concurrent conditions.  There was no concomitant medication.    On 12-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R027997 expiring on 01-OCT-2020, subcutaneously, for vaccination (immunisation) (strength, dose and site of administration were not provided).         On the same day of vaccination, the injection caused an immediate burning sensation upon injection (injection site pain ) and some mild bleeding at the injection site (injection site haemorrhage).  The patient seek medical attention through the pharmacist, who would call patient's physician.  The patient did not received any treatment and not any laboratory test was performed.  The events were not considered as cancer, disabling, life threatening or overdose.  There was no PQC present.   The patient's symptoms resolved within a few minutes, on the same date.   The reporter did not assess the causal relationship between therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the events.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; 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) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 01-DEC-2015, at age 60, the patient was administered the zoster vaccine live (ZOSTAVAX) 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: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (experienced repeated outbreaks of Shingles). Previously administered products included Shingles vaccine (Shingles vaccine 7 years ago). On 25th February 2019, the patient received the 1st dose of SHINGRIX. In March 2019, 7 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced injection site erythema. The patient was treated with acyclovir, Valacyclovir and ZOVIRAX Cream. On an unknown date, the outcome of the shingles and injection site erythema were recovered/resolved. It was unknown if the reporter considered the shingles and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient states that before receiving his 1st dose of SHINGRIX he was experiencing repeated outbreaks of Shingles. Patient took acyclovir, valacyclovir and ZOVIRAX cream. The patient stated that he did not have any Shingles outbreak for approximately 10 days so he decided to go ahead and get the 1st dose of ZOVIRAX in the left arm. The patient experienced redness at the injection site following the dose and that this redness resolved within a couple of days. The patient stated that approximately 7 to 10 days after receiving the ZOVIRAX vaccine, he had another Shingles outbreak. The patient stated that he had a Shingles outbreak on the top of both feet and this outbreak took approximately 1 week to resolve. The patient stated that since getting the vaccine, the Shingles outbreaks were more numerous and more frequent. Emergency room visit required. The patient stated that the ZOVIRAX ointment and Valacyclovir were not as effective anymore. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chronic graft versus host disease, Dry mouth, Fatigue, Muscle spasms
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chronic graft versus host disease in a 70-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included herpes zoster ophthalmic. Concurrent medical conditions included sight disability (shingles destroyed sight in one eye). On 22nd February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced chronic graft versus host disease (serious criteria GSK medically significant), fatigue, dry mouth and muscle cramp. On an unknown date, the outcome of the chronic graft versus host disease, fatigue, dry mouth and muscle cramp were recovered/resolved. The reporter considered the chronic graft versus host disease, fatigue, dry mouth and muscle cramp to be related to SHINGRIX. Additional details were reported as follows: The case reported by the patient who was a retired physician. The patient mentioned that the reason that he retired prematurely was because he got shingles in his left retina in his eye and  it destroyed his sight. About a week after the vaccination, the patient got reforming of three symptoms of chronic graft versus host disease (GVHD). The specific symptoms that, the patient had as intense fatigue, dryness and muscle cramping. The symptoms were lasted for about 3 weeks. The reporter did not consent to follow-up. This case has been linked with the case US2019064000, reported by same reporter.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Induration, Injection site rash, Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable physician. A 66-year-old female patient received PREVNAR 13 lot number and expiration date unknown intramuscular on 01Apr2019 at a single dose for routine pneumonia vaccine. Medical history included low vitamin D level vitamin D 12 level (as reported). It was reported that the patient discovered to have low vitamin D level, vitamin D 12 level for which she was supposed to go on supplements but have not started it. The patient has no concomitant medications. On 02Apr2019, the physician reported a moderately serious reaction to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). The physician reported that it caused a very large rash it's almost like 3 inch/ 5 inch long rash and reported that it started 2 days later (as reported) and has become larger after a week. The physician described the rash as itchy and hard. The physician has applied betamethasone cream (treatment) because of the rash and the itching. The patient has not recovered from the events. The physician really believed that rash experienced by consumer is because of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and stated that "Absolutely because, it start in that location and started like within a day, there is no question." The following information on the batch number has been requested.; Sender's Comments:  Considering a plausible drug-event temporal association and the consistency of the event with the known safety profile of the suspect product, a reasonable possibility that itchy rash is related to PREVNAR 13 administration cannot be excluded.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: an expired Menactra to a patient; Initial information received on 11-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 18 years old female patient who was vaccinated with a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Batch number: U5848AAand expiry date: 11-Mar-2019, dose, dose in series, route and site of administration were not reported) on 10-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The child received Pentacel vaccine instead Prevnar 13/ no adverse event; Initial information received on 11-Apr-2019 regarding an unsolicited valid non-serious case received from a Nurse. (case was Forwarded by Pfizer).   This case involves a eight months old male patient (70 cm and 8.16 kg) who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (formulation Suspension for injection) (lot: C5517AA, expiry date: 15-Sep-2019) via intramuscular route in the left thigh instead of PREVNAR 13 (formulation: unknown) on 09 Jan 2019.  The patient's had no past medical history and had no family history and did not receive any concomitant therapy.   It was an actual medication error due to wrong vaccine administered.  It was unable to clarify if Pentacel was included in the temperature excursion with Prevnar 13.  The patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 13 month old received a dose of Quadracel vaccine/ no symptoms; Initial information received on 11-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse manager.   This case involves a 13 months old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patients past medical history and family history were not provided.  Concomitant medications included PROQUAD and HEPATITIS A VACCINE, on unknown date.  On 09-Apr-2019, the patient received a 0.5ml dose 4th in series of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5325BA, expiry date 14-Nov-2019 via intramuscular route in the right thigh.  It was an actual medication error due to inappropriate age at vaccine administration.  It was reported that 13 month old received a dose of Quadracel vaccine.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
Age: 29.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: patient states given four vaccines (Tdap HepA pneumonia and menigitis) all in same arm right deltoid at Pharmacy on 4/5/19
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenopathy, Malaise, Vaccination complication
Clinical narrative: No adverse reaction. Patient was seen on 11 April by PCM told that he was having normal vaccine reaction, malaise, swollen lymph nodes. Went to ER 15 April with same complaint and was again told normal vaccine reaction. Was seen for ER follow up by third provider (myself) 16 April and again told this is a normal vaccine reaction. Report required by our local Joint Commission Coordinator/Risk Manager
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Client states that she initially had swelling, redness, and soreness at the site; swelling decreased after days or weeks- she is unsure; soreness continued; when client presses on "site", it hurts; does not hurt when client moves arm; client sleeps on her left side and states that her arm is sore while sleeping on it.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Headache, Hyperacusis, Peripheral swelling
Clinical narrative: Patient stated his arm was swollen and warm and painful to the touch. He had fever of 102F for 2 weeks along with headaches that were sensitive to noise and light. He stated he also suffered severe hip and lower back pain for about 5 days after receiving the vaccine. Patient stated he did not seek medical treatment and used OTC pain relievers to treat. This was his second dose and he did not have any issues with the first dose.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Photophobia, Pyrexia, Skin warm, Tenderness
Clinical narrative: Patient stated his arm was swollen and warm and painful to the touch. He had fever of 102F for 2 weeks along with headaches that were sensitive to noise and light. He stated he also suffered severe hip and lower back pain for about 5 days after receiving the vaccine. Patient stated he did not seek medical treatment and used OTC pain relievers to treat. This was his second dose and he did not have any issues with the first dose.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Hypersensitivity, Injection site erythema, Injection site scar, Injection site swelling
Clinical narrative: I received the shot quite high on my upper rt arm. By bedtime, I had swelling and redness on the area. The next day I noticed red bumps like measles on the inner and top side of my lft. arm behind my lft. bicep, across my chest above my breasts and across my upper back from shoulder blade and up. The bumps started to get water on the heads and the itching was unbearable. I tried using cortisone but to no avail and my husband felt we should go to urgent care to see Dr. My husband and I talked about anything different or new I had eaten or put on my skin and came up with nothing. The Dr. asked about the injection checked all the areas and came to the conclusion I was having an allergic reaction to the flu shot I had received. I was also vomiting. Was running a slight to high fever, fatigued and falling asleep constantly.  I was given a prescription for triamcinolone acetonide ointment USP. 0.1% with directions to use up to 3/4 x's daily. It took almost two months for it to heal. I have a few scars left on my inner and outer left arm. It was one of the worse reactions I have had. I have had flu shots given to me yearly due to my health and never had a reaction to it. I believe she never checked my date of birth and gave me wrong shot.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Pyrexia, Rash morbilliform, Rash vesicular, Somnolence
Clinical narrative: I received the shot quite high on my upper rt arm. By bedtime, I had swelling and redness on the area. The next day I noticed red bumps like measles on the inner and top side of my lft. arm behind my lft. bicep, across my chest above my breasts and across my upper back from shoulder blade and up. The bumps started to get water on the heads and the itching was unbearable. I tried using cortisone but to no avail and my husband felt we should go to urgent care to see Dr. My husband and I talked about anything different or new I had eaten or put on my skin and came up with nothing. The Dr. asked about the injection checked all the areas and came to the conclusion I was having an allergic reaction to the flu shot I had received. I was also vomiting. Was running a slight to high fever, fatigued and falling asleep constantly.  I was given a prescription for triamcinolone acetonide ointment USP. 0.1% with directions to use up to 3/4 x's daily. It took almost two months for it to heal. I have a few scars left on my inner and outer left arm. It was one of the worse reactions I have had. I have had flu shots given to me yearly due to my health and never had a reaction to it. I believe she never checked my date of birth and gave me wrong shot.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: I received the shot quite high on my upper rt arm. By bedtime, I had swelling and redness on the area. The next day I noticed red bumps like measles on the inner and top side of my lft. arm behind my lft. bicep, across my chest above my breasts and across my upper back from shoulder blade and up. The bumps started to get water on the heads and the itching was unbearable. I tried using cortisone but to no avail and my husband felt we should go to urgent care to see Dr. My husband and I talked about anything different or new I had eaten or put on my skin and came up with nothing. The Dr. asked about the injection checked all the areas and came to the conclusion I was having an allergic reaction to the flu shot I had received. I was also vomiting. Was running a slight to high fever, fatigued and falling asleep constantly.  I was given a prescription for triamcinolone acetonide ointment USP. 0.1% with directions to use up to 3/4 x's daily. It took almost two months for it to heal. I have a few scars left on my inner and outer left arm. It was one of the worse reactions I have had. I have had flu shots given to me yearly due to my health and never had a reaction to it. I believe she never checked my date of birth and gave me wrong shot.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site reaction, Pruritus, Rash erythematous
Clinical narrative: Typical side effects experienced prior to adverse event. On 3/31/19 the arm given the injection became very itchy 3:00 PM. At 7:00 PM I showered & saw a red rash starting at the bruised injection site going down my arm at an angle. Applied homeopathic gel for itching again at bedtime. In morning the rash was longer so saw Dr. for betamethasone dipropionate cream .05%. used twice daily for 10 days.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Chiropractic, Discomfort, Injection site pain, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: (Received PREVNAR in past w/o reaction). Experienced normal soreness (L)UA evening of injection. Over next few days pain gradually increased in (L)UA to elbow - shoulder, shoulder blade and (L) side neck. Muscle pain, stiffness. Muscle contraction. Wearing sling to keep in neutral position pain 4 in AM and 7 by end of day. Using heat/ice. Seeing a neurologist and chiro per pt and receiving laser tx class 3 - heat to muscle/relax. Slowly improving still a problem, swollen. He is seen today because of left shoulder pain radiating to the tricipital area and left deltoid tenderness radiating to the left scapular area shortly after receiving the PNEUMOVAX immunization on March 21st; patient had no reaction to PREVNAR immunization. He was unable to enjoy his athletic activities. He underwent chiropractic treatments with some improvement in his discomfort; he never experienced tricipital edema, heat or erythema. Patient denies any trauma or fall; he remembers he had strained his left shoulder around a week prior to PNEUMOVAX immunization and has decreased his athletic activities to allow healing.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Muscle contractions involuntary, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: (Received PREVNAR in past w/o reaction). Experienced normal soreness (L)UA evening of injection. Over next few days pain gradually increased in (L)UA to elbow - shoulder, shoulder blade and (L) side neck. Muscle pain, stiffness. Muscle contraction. Wearing sling to keep in neutral position pain 4 in AM and 7 by end of day. Using heat/ice. Seeing a neurologist and chiro per pt and receiving laser tx class 3 - heat to muscle/relax. Slowly improving still a problem, swollen. He is seen today because of left shoulder pain radiating to the tricipital area and left deltoid tenderness radiating to the left scapular area shortly after receiving the PNEUMOVAX immunization on March 21st; patient had no reaction to PREVNAR immunization. He was unable to enjoy his athletic activities. He underwent chiropractic treatments with some improvement in his discomfort; he never experienced tricipital edema, heat or erythema. Patient denies any trauma or fall; he remembers he had strained his left shoulder around a week prior to PNEUMOVAX immunization and has decreased his athletic activities to allow healing.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: (Received PREVNAR in past w/o reaction). Experienced normal soreness (L)UA evening of injection. Over next few days pain gradually increased in (L)UA to elbow - shoulder, shoulder blade and (L) side neck. Muscle pain, stiffness. Muscle contraction. Wearing sling to keep in neutral position pain 4 in AM and 7 by end of day. Using heat/ice. Seeing a neurologist and chiro per pt and receiving laser tx class 3 - heat to muscle/relax. Slowly improving still a problem, swollen. He is seen today because of left shoulder pain radiating to the tricipital area and left deltoid tenderness radiating to the left scapular area shortly after receiving the PNEUMOVAX immunization on March 21st; patient had no reaction to PREVNAR immunization. He was unable to enjoy his athletic activities. He underwent chiropractic treatments with some improvement in his discomfort; he never experienced tricipital edema, heat or erythema. Patient denies any trauma or fall; he remembers he had strained his left shoulder around a week prior to PNEUMOVAX immunization and has decreased his athletic activities to allow healing.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: Fever arm red swelling headache muscle pain still residual HA lasted week.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Dizziness, Dysgraphia, Extrasystoles, Impaired driving ability
Clinical narrative: The morning after I woke up horribly dizzy. Made my way to the bathroom and fainted. Got up to call to my husband and fainted again in the bedroom. The dizziness subsided, but have felt woozy on and off since then. Have only felt comfortable driving 2 of the 7 days. Monday morning (4/1) and today (4/4) my heart felt like it was skipping a beat. Monday it didn't last long. Today while I was lying down, it continued for about 2 hrs.  This afternoon, my wrist has become so painful, I can hardly write or move my hand. I thought I was out of the woods when I actually felt normal yesterday once I got up and moving. They say shingles are worse than any of the vaccine's side effects but if mine do not clear up soon, I will not be getting the second shot. (Yesterday I would have said I would get it but this wrist pain is horrific). P.S. My husband had his shot a few weeks ago w/out incident. P.S.S. Would have submitted this online, but since I did not have some of the information, didn't want to fill it all out then not be able to submit it because needed fields were left blank.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Syncope
Clinical narrative: The morning after I woke up horribly dizzy. Made my way to the bathroom and fainted. Got up to call to my husband and fainted again in the bedroom. The dizziness subsided, but have felt woozy on and off since then. Have only felt comfortable driving 2 of the 7 days. Monday morning (4/1) and today (4/4) my heart felt like it was skipping a beat. Monday it didn't last long. Today while I was lying down, it continued for about 2 hrs.  This afternoon, my wrist has become so painful, I can hardly write or move my hand. I thought I was out of the woods when I actually felt normal yesterday once I got up and moving. They say shingles are worse than any of the vaccine's side effects but if mine do not clear up soon, I will not be getting the second shot. (Yesterday I would have said I would get it but this wrist pain is horrific). P.S. My husband had his shot a few weeks ago w/out incident. P.S.S. Would have submitted this online, but since I did not have some of the information, didn't want to fill it all out then not be able to submit it because needed fields were left blank.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Cardiac stress test, Dizziness, Echocardiogram, Electrocardiogram ambulatory abnormal
Clinical narrative: The morning after I woke up horribly dizzy. Made my way to the bathroom and fainted. Got up to call to my husband and fainted again in the bedroom. The dizziness subsided, but have felt woozy on and off since then. Have only felt comfortable driving 2 of the 7 days. Monday morning (4/1) and today (4/4) my heart felt like it was skipping a beat. Monday it didn't last long. Today while I was lying down, it continued for about 2 hrs.  This afternoon, my wrist has become so painful, I can hardly write or move my hand. I thought I was out of the woods when I actually felt normal yesterday once I got up and moving. They say shingles are worse than any of the vaccine's side effects but if mine do not clear up soon, I will not be getting the second shot. (Yesterday I would have said I would get it but this wrist pain is horrific). P.S. My husband had his shot a few weeks ago w/out incident. P.S.S. Would have submitted this online, but since I did not have some of the information, didn't want to fill it all out then not be able to submit it because needed fields were left blank.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Electrocardiogram normal, Extrasystoles, Fatigue, Malaise, Palpitations
Clinical narrative: The morning after I woke up horribly dizzy. Made my way to the bathroom and fainted. Got up to call to my husband and fainted again in the bedroom. The dizziness subsided, but have felt woozy on and off since then. Have only felt comfortable driving 2 of the 7 days. Monday morning (4/1) and today (4/4) my heart felt like it was skipping a beat. Monday it didn't last long. Today while I was lying down, it continued for about 2 hrs.  This afternoon, my wrist has become so painful, I can hardly write or move my hand. I thought I was out of the woods when I actually felt normal yesterday once I got up and moving. They say shingles are worse than any of the vaccine's side effects but if mine do not clear up soon, I will not be getting the second shot. (Yesterday I would have said I would get it but this wrist pain is horrific). P.S. My husband had his shot a few weeks ago w/out incident. P.S.S. Would have submitted this online, but since I did not have some of the information, didn't want to fill it all out then not be able to submit it because needed fields were left blank.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Syncope, Urticaria, X-ray normal
Clinical narrative: The morning after I woke up horribly dizzy. Made my way to the bathroom and fainted. Got up to call to my husband and fainted again in the bedroom. The dizziness subsided, but have felt woozy on and off since then. Have only felt comfortable driving 2 of the 7 days. Monday morning (4/1) and today (4/4) my heart felt like it was skipping a beat. Monday it didn't last long. Today while I was lying down, it continued for about 2 hrs.  This afternoon, my wrist has become so painful, I can hardly write or move my hand. I thought I was out of the woods when I actually felt normal yesterday once I got up and moving. They say shingles are worse than any of the vaccine's side effects but if mine do not clear up soon, I will not be getting the second shot. (Yesterday I would have said I would get it but this wrist pain is horrific). P.S. My husband had his shot a few weeks ago w/out incident. P.S.S. Would have submitted this online, but since I did not have some of the information, didn't want to fill it all out then not be able to submit it because needed fields were left blank.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Brain oedema, Chest X-ray abnormal, Cyanosis, Nuclear magnetic resonance imaging brain abnormal, Pneumothorax
Clinical narrative: 4:47am  March 27th Wednesday morning, patient has a temperature of 102.4. I, and pt's mom, woke her up, gave a cool wash down, 2.5ml Tylenol (as stated by the doctor if she ever has a temperature after shots) and a cooler than room temperature bottle. She went back to sleep. I stayed up (2 hours later) just to watch her. Around 6:40am-6:50am I took her again (you're supposed to check their temperature every two hours when temperatures is high) and it was 100.2. I finally went to sleep feeling assured that her temperature was going down. My mom called me around 8am and I hopped up and looked over and my baby was blue in the face and not breathing.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Respiratory arrest
Clinical narrative: 4:47am  March 27th Wednesday morning, patient has a temperature of 102.4. I, and pt's mom, woke her up, gave a cool wash down, 2.5ml Tylenol (as stated by the doctor if she ever has a temperature after shots) and a cooler than room temperature bottle. She went back to sleep. I stayed up (2 hours later) just to watch her. Around 6:40am-6:50am I took her again (you're supposed to check their temperature every two hours when temperatures is high) and it was 100.2. I finally went to sleep feeling assured that her temperature was going down. My mom called me around 8am and I hopped up and looked over and my baby was blue in the face and not breathing.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Chills, Hypoaesthesia, Pyrexia
Clinical narrative: Patient called to report that she had numbness of the right arm and a funny sensation in her chest as well as fever and chills. The adverse event has resolved at 3 days after vaccination.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Chills, Condition aggravated, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Patient called to report that she had numbness of the right arm and a funny sensation in her chest as well as fever and chills. The adverse event has resolved at 3 days after vaccination.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal disorder, Pyrexia, Rheumatoid arthritis, Seizure like phenomena, Tremor
Clinical narrative: Patient called to report that she had numbness of the right arm and a funny sensation in her chest as well as fever and chills. The adverse event has resolved at 3 days after vaccination.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Injected limb mobility decreased, Injection site pain, Neck pain, Pain
Clinical narrative: severe pain at injection site, immobility in upper arm, radiating pain to neck and back
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: PT SHOULD HAVE BEEN GIVEN A MENACTRA INSTEAD OF MEN B. HEALTH DEPT WAS NOTIFIED AND WE ARE WAITING TO HEAR FROM THEM WHAT WE NEED TO TELL PATIENT IN REGARDS TO REPEATING WITH CORRECT VACCINE AND IF THE MEN B WILL COUNT.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Pyrexia
Clinical narrative: Chills and severe shivering, for about an hour starting at 9:30 pm.  Fever overnight and into the next day, 101 degrees at 6:00 am, 100 degrees at 11 am.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, and 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 ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 01-JUL-2008, at age 61, the patient was administered the ZOSTAVAX by a physician (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 ZOSTAVAX use: Guillain-Barre syndrome. The patient claimed damages as a result of: injury to themselves,  and economic losses. The outcome of Guillain-Barre syndrome is unknown. Upon internal review, Guillain-Barre syndrome was determined to be medically significant. Additional information has been requested.