chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blood pressure increased, Dermatitis allergic, Insomnia, Pain
Clinical narrative: Hypersensitive Dermatitis; blood pressure was elevated; Fever of 101 degrees; Pain; Gastric Upset; could not sleep.; rash reappeared on her thighs, arms and her chin; the back of her thighs became Itchy / on her arms / was itching so badly, she could not sleep; This case was reported by a consumer via call center representative and described the occurrence of allergic dermatitis in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unkown date refer case id US2020188896). Concomitant products included camphor, levomenthol, phenol (Sarna).   On 1st July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 7th July 2020, 6 days after receiving Shingrix, the patient experienced rash and pruritus. On an unknown date, the patient experienced allergic dermatitis, increased blood pressure, fever, pain, upset stomach and difficulty sleeping. The patient was treated with PREDNISONE, HYDROCORTISONE (CORTISONE TOPICAL CREAM) and magnesium sulfate (Epsom Salt). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the allergic dermatitis, increased blood pressure, rash, pruritus, fever, pain, upset stomach and difficulty sleeping were unknown.   It was unknown if the reporter considered the allergic dermatitis, increased blood pressure, rash, pruritus, fever, pain, upset stomach and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix (intramuscular) and experienced fever, Gastric Upset, Pain,itchy without rash,Hypersensitive Dermatitis,blood pressure was elevated. The patient tried cortisone cream ,prednisone and sarna for relieving pain and used epsom salt bathtime she reduced prednisone to subdue the Itching.  The dermatologist suggested her starting on a cyclosporine. The patient experienced a fever of 101 degrees, Gastric Upset, and Pain for first couple of days. The patient also experienced after 6 days of vaccination, the back of her thighs became Itchy without rash or redness. The reporter stated that after first week of taking prednisone, the rash on her arms and thighs disappeared, but her thighs still itched intermittently. The rash reappeared on her thighs, arms and her chin on 17th sepetember 2020. The reporter consented to follow up. No further information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020188896:Same patient- 2nd dose
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Rash, Vaccine positive rechallenge
Clinical narrative: Hypersensitive Dermatitis; blood pressure was elevated; Fever of 101 degrees; Pain; Gastric Upset; could not sleep.; rash reappeared on her thighs, arms and her chin; the back of her thighs became Itchy / on her arms / was itching so badly, she could not sleep; This case was reported by a consumer via call center representative and described the occurrence of allergic dermatitis in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unkown date refer case id US2020188896). Concomitant products included camphor, levomenthol, phenol (Sarna).   On 1st July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 7th July 2020, 6 days after receiving Shingrix, the patient experienced rash and pruritus. On an unknown date, the patient experienced allergic dermatitis, increased blood pressure, fever, pain, upset stomach and difficulty sleeping. The patient was treated with PREDNISONE, HYDROCORTISONE (CORTISONE TOPICAL CREAM) and magnesium sulfate (Epsom Salt). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the allergic dermatitis, increased blood pressure, rash, pruritus, fever, pain, upset stomach and difficulty sleeping were unknown.   It was unknown if the reporter considered the allergic dermatitis, increased blood pressure, rash, pruritus, fever, pain, upset stomach and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix (intramuscular) and experienced fever, Gastric Upset, Pain,itchy without rash,Hypersensitive Dermatitis,blood pressure was elevated. The patient tried cortisone cream ,prednisone and sarna for relieving pain and used epsom salt bathtime she reduced prednisone to subdue the Itching.  The dermatologist suggested her starting on a cyclosporine. The patient experienced a fever of 101 degrees, Gastric Upset, and Pain for first couple of days. The patient also experienced after 6 days of vaccination, the back of her thighs became Itchy without rash or redness. The reporter stated that after first week of taking prednisone, the rash on her arms and thighs disappeared, but her thighs still itched intermittently. The rash reappeared on her thighs, arms and her chin on 17th sepetember 2020. The reporter consented to follow up. No further information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020188896:Same patient- 2nd dose
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abscess limb, Flank pain
Clinical narrative: large abscess pocket on vaccine arm.; Left posterior flank with soreness; This case was reported by a physician via sales rep and described the occurrence of abscess limb in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced abscess limb and flank pain. On an unknown date, the outcome of the abscess limb and flank pain were unknown.   It was unknown if the reporter considered the abscess limb and flank pain to be related to Shingrix.  Additional details were provided as follows: The patient had an adverse reaction to first dose Shingrix within the last 30 days from  the time of reporting. The left posterior flank of patient was with soreness and large abscess pocket on vaccine arm..
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever after Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient experienced fever after Shingrix.
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Swelling face
Clinical narrative: anaphylactic reaction; swollen face; This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a 63-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Fluarix (received Fluarix in 2018 and did not develop adverse events).   In November 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than a year after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and facial swelling. On an unknown date, the outcome of the anaphylactic reaction and facial swelling were recovered/resolved.   It was unknown if the reporter considered the anaphylactic reaction and facial swelling to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported, however it could be 62 or 63 years. The patient developed an anaphylactic reaction with swollen face. The vaccines batch number or expiration date was not recorded. The reporter consented to follow-up.
Sex: M
Vaccine: RAB, RAB
Symptoms: Animal bite, No adverse event, Poor quality product administered
Clinical narrative: stability of the Imovax vaccine once it was reconstituted. Her husband stated that the product was mixed 45 minutes prior to administration, no AE; Initial information received on 24-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves male patient of unknown age who was vaccinated with first and third doses of RABIES (HDC) VACCINE [IMOVAX RABIES] (injection, lot number and expiration date were not reported) and the second dose of RABIES VACCINE INACT (CHICK EMBRYO) [RABAVERT] (lot number and expiration date were not reported) after being bitten by a bat, via unknown route in unknown administration site for post-exposure immunization. And the patient reported that the imovax vaccine was reconstituted and was mixed 45 minutes prior to administration (PT:poor quality product administered).  Medical history included Animal bite.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was an actual medication error case due to deteriorated drug administered.  No adverse event reported at the time of reporting.  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 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.  There will be no information on the batch number for this case.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Dysphonia, Dyspnoea, Erythema
Clinical narrative: -extreme fatigue started 4 hours after the dose, 2 1/2 weeks later better but not resolved -irregular welts: 10 of varying sizes on anterior trunk, antecubital fossa and lateral leg just above the knee. Raised, red, hot to touch, improved in a week, have not faded in 2/12 weeks. - October 13 in afternoon:  --palpitations: lasted 2 1/2 weeks, better not gone, quite intense, occurred at rest, without dizziness -- tightness of breathing, no wheezing, occurred at rest, better in 2 weeks, then only occurring with minimal exertion (walking across a room) --muscle aches, headaches, chills, low grade fever (99.5 was highest) off an on for 2 weeks, but not completely resolved at 2 1/2 weeks -- weakness: lack of energy, was able to pick up usually daily items and climb stairs to the 3rd floor, but that drained my energy, increased shortness of breath and palpitations. - hoarse voice started at 2 weeks and has not resolved.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Myalgia, Palpitations, Pyrexia
Clinical narrative: -extreme fatigue started 4 hours after the dose, 2 1/2 weeks later better but not resolved -irregular welts: 10 of varying sizes on anterior trunk, antecubital fossa and lateral leg just above the knee. Raised, red, hot to touch, improved in a week, have not faded in 2/12 weeks. - October 13 in afternoon:  --palpitations: lasted 2 1/2 weeks, better not gone, quite intense, occurred at rest, without dizziness -- tightness of breathing, no wheezing, occurred at rest, better in 2 weeks, then only occurring with minimal exertion (walking across a room) --muscle aches, headaches, chills, low grade fever (99.5 was highest) off an on for 2 weeks, but not completely resolved at 2 1/2 weeks -- weakness: lack of energy, was able to pick up usually daily items and climb stairs to the 3rd floor, but that drained my energy, increased shortness of breath and palpitations. - hoarse voice started at 2 weeks and has not resolved.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Rash papular, SARS-CoV-2 test negative, Skin warm, Urticaria
Clinical narrative: -extreme fatigue started 4 hours after the dose, 2 1/2 weeks later better but not resolved -irregular welts: 10 of varying sizes on anterior trunk, antecubital fossa and lateral leg just above the knee. Raised, red, hot to touch, improved in a week, have not faded in 2/12 weeks. - October 13 in afternoon:  --palpitations: lasted 2 1/2 weeks, better not gone, quite intense, occurred at rest, without dizziness -- tightness of breathing, no wheezing, occurred at rest, better in 2 weeks, then only occurring with minimal exertion (walking across a room) --muscle aches, headaches, chills, low grade fever (99.5 was highest) off an on for 2 weeks, but not completely resolved at 2 1/2 weeks -- weakness: lack of energy, was able to pick up usually daily items and climb stairs to the 3rd floor, but that drained my energy, increased shortness of breath and palpitations. - hoarse voice started at 2 weeks and has not resolved.
Age: 82.0
Sex: M
Vaccine: FLUR4, PPV
Symptoms: Fatigue, Lethargy, Pyrexia
Clinical narrative: pt reported a fever of 99.0F and lethargy/ being tired mor than usualy the next morning after the shot
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Computerised tomogram abdomen, Headache, Injection site pain, Injection site swelling
Clinical narrative: Significant left arm pain, swelling; high fever; myalgias; headache; significant GI symptoms including nausea, vomiting, abdominal pain and cramping
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Muscle spasms, Myalgia, Nausea, Pain in extremity
Clinical narrative: Significant left arm pain, swelling; high fever; myalgias; headache; significant GI symptoms including nausea, vomiting, abdominal pain and cramping
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Ultrasound abdomen, Vomiting
Clinical narrative: Significant left arm pain, swelling; high fever; myalgias; headache; significant GI symptoms including nausea, vomiting, abdominal pain and cramping
Age: 4.0
Sex: U
Vaccine: MMRV, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Large area of erythema and slight swelling on right thigh. Slightly pruritic, not tender or painful, slightly warm to the touch. Sore and Fussy day after vaccines but normal active self since.  Treatment, cold compress, ibuprofen for pain and Benadryl if needed for itching.
Age: 4.0
Sex: U
Vaccine: MMRV, PNC13
Symptoms: Pain, Pruritus
Clinical narrative: Large area of erythema and slight swelling on right thigh. Slightly pruritic, not tender or painful, slightly warm to the touch. Sore and Fussy day after vaccines but normal active self since.  Treatment, cold compress, ibuprofen for pain and Benadryl if needed for itching.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypersensitivity, Inflammation, Pruritus, Rash, Rash erythematous
Clinical narrative: PATIENT REPORTED HAVING MINOR ALLERGIC REACTION (RED RASH) ON LEFT ARM TO FLUCELVAX IMMUNIZATION 2 DAYS AFTER SHOT.  PATIENT TOOK BENADRYL AND THE RASH RESOLVED, THEN TWO DAYS LATER SHE STARTED HAVING RASH ON RIGHT LEG AND PROGRESSED TO BOTH LEGS THE DAY AFTER AND INCREASED IN SEVERITY. ADVERSE EFFECT ON LEGS WAS REPORTED TO BE SEVERLY INFLAMED AND HOT TO THE TOUCH. PATIENT ALSO COMPLAINED OF SEVERE ITCHING.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Skin warm
Clinical narrative: PATIENT REPORTED HAVING MINOR ALLERGIC REACTION (RED RASH) ON LEFT ARM TO FLUCELVAX IMMUNIZATION 2 DAYS AFTER SHOT.  PATIENT TOOK BENADRYL AND THE RASH RESOLVED, THEN TWO DAYS LATER SHE STARTED HAVING RASH ON RIGHT LEG AND PROGRESSED TO BOTH LEGS THE DAY AFTER AND INCREASED IN SEVERITY. ADVERSE EFFECT ON LEGS WAS REPORTED TO BE SEVERLY INFLAMED AND HOT TO THE TOUCH. PATIENT ALSO COMPLAINED OF SEVERE ITCHING.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Monday 0730 am had flu shot at work (mandatory). Itching , redness, hives within 3 hours, swelling  and warmth at injection site, large area of erythema to my left upper arm by the end of my 12 hour shift .  Full body rash by midnight. Took Benadryl to be able to sleep. Worked 12 hour shift the next day after taking loratadine, but still itching, rash, erythema, body aches,  and large hives. The next day I was off, went to healthcare professional, they said to continue what I was doing, and call them on Friday (2 days later) if it wasn't any better. Friday they sent me to see the physicians, who gave me steroids, I still had the rash, itching, and hives (was RTW that day, I had been off work since Wednesday). I called off work  Saturday, worked Sunday, still had rash and itching. Monday rash and itching were gone, I was taking my 4th day of steroid treatment.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Monday 0730 am had flu shot at work (mandatory). Itching , redness, hives within 3 hours, swelling  and warmth at injection site, large area of erythema to my left upper arm by the end of my 12 hour shift .  Full body rash by midnight. Took Benadryl to be able to sleep. Worked 12 hour shift the next day after taking loratadine, but still itching, rash, erythema, body aches,  and large hives. The next day I was off, went to healthcare professional, they said to continue what I was doing, and call them on Friday (2 days later) if it wasn't any better. Friday they sent me to see the physicians, who gave me steroids, I still had the rash, itching, and hives (was RTW that day, I had been off work since Wednesday). I called off work  Saturday, worked Sunday, still had rash and itching. Monday rash and itching were gone, I was taking my 4th day of steroid treatment.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: THERE WAS AN ORANGE-SIZED SWELLING ON THE RIGHT DELTOID THAT WAS ERYTHAMATOUS AND FIRM THAT LASTED APPROXIMATELY 10 DAYS. THE PATIENT NEVER EXPERIENCED PAIN, BUT IT REMAINED SORE UNTIL IT RESOLVED ON ITS OWN.
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Mobility decreased, Myalgia, Pain
Clinical narrative: SHOOTING PAIN , FEELING MUSCLE PRICK PAIN , HARD TO LIFT ARM
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Urticaria
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: employee received flu vaccine at 11am, 10-15min later she began to experience extreme itchiness in her right arm (arm of injection), warmth, and redness that spread up the right side of her neck, ear, chest, and down her right shoulder blade/back. experience hives on her back and chest. no breathing difficulty. she took 50mg of PO benadryl, a Pepcid, and an antihistamine to help with the itching. spoke with her at 3:30pm and she still has some itching, but it has lessened since taking the medications  and the amount of hives has decreased as well.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: shivering, low grade fever, muscle aches arms back, legs, headache, low energy began in early morning after vaccine. Slept extra during the day and took Tylenol and Ibuprofen
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Chills
Clinical narrative: Patient received pneumovax and fluad yesterday.  She said she had a fever of 99 and chills like she has never experienced before in her life. She said her blood pressure went up to 183 over something (she didn't know). Today her blood pressure and temp are now normal.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Limb discomfort, Peripheral swelling, Pruritus
Clinical narrative: Client received Flucelvax Lot 283849 exp. 06-30-2021 on 9-29-2020 per protocol. I received a call from client at 8:30 am on 09-30-2020 stating that her arm was swollen and "heavy" She reported to me that her arm itched on the way home after taking the vaccine and she didn't think much of it because she had always taken flu vaccine without problems. She reported that once home her arm began to turn red and swell below the injection site and her inner arm. She reported taking Tylenol and using cold compresses but that it isn't getting any better. Client arrived at the health department for evaluation of her arm. Erythema and slight swelling noted 2 inches below injection sight extending to inner arm down to elbow. No redness or swelling noted on back of arm. Client reports some slight itching but reports she does not like to take Benadryl because of how it makes her feel.  Client was encouraged to follow up with her PCP for further evaluation and possible treatment of redness and swelling. Client reported she would call as soon as she leaves health department.  Received a call from client 10-01-2020 at 8:00 a.m. stating that she went to clinic on 9-30-2020 and doctor feels like symptoms were likely related to the flu vaccine. Reports the doctor is still trying to decide if she should take future doses of flu. Reports she was prescribed steroid injection, antibiotic and took Benadryl last night along with some anti itch cream and has improvement this morning in both swelling and redness.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion
Clinical narrative: Patient developed large, dark bruise hours after receiving the vaccination.
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient received vaccination in the left arm and in the evening noticed the side affect , that he had difficulty moving arm above the chest line. We advised the patient to contact his doctor to make him aware of this side effect and his symptoms.
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Dizziness, Pain
Clinical narrative: Patient experienced body aches that started the morning after receiving the Shingrix vaccine. Patient states they later experienced light headedness and then experienced painful aches into the night (9/15/2020). Patient states these symptoms lasted approximately 3 days.
Age: 61.0
Sex: F
Vaccine: FLUA3
Symptoms: Blood test, Computerised tomogram, Head discomfort, Injection site pain, Muscle strain
Clinical narrative: Left arm began hurting. Within 2 days it moved up to my shoulder. Within a week I began to realize it was hard to hold my head up. I still have trouble holding my head up. My head feels like it is very heavy. This is putting more strain on my shoulders.
Age: 61.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: Left arm began hurting. Within 2 days it moved up to my shoulder. Within a week I began to realize it was hard to hold my head up. I still have trouble holding my head up. My head feels like it is very heavy. This is putting more strain on my shoulders.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site swelling, Pain, Peripheral swelling
Clinical narrative: Headache, chills, general body aches, and fever of 100.9 F. The patient stated there was swelling of the left arm around the injection site that seems to be spreading down to the left hand. The patient stated that the skin of her left arm/hand feels warm to the touch. The patient reported the adverse events to the pharmacy the morning of 10-1-20. At the time when I spoke with the patient (at about 2:15 pm on 10-1-20) she did not mention any treatment yet. I told her that based on what she was describing that she should seek medical attention. She indicated that she would be seeking medical attention, so treatment and outcomes are pending.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Headache, chills, general body aches, and fever of 100.9 F. The patient stated there was swelling of the left arm around the injection site that seems to be spreading down to the left hand. The patient stated that the skin of her left arm/hand feels warm to the touch. The patient reported the adverse events to the pharmacy the morning of 10-1-20. At the time when I spoke with the patient (at about 2:15 pm on 10-1-20) she did not mention any treatment yet. I told her that based on what she was describing that she should seek medical attention. She indicated that she would be seeking medical attention, so treatment and outcomes are pending.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Urticaria
Clinical narrative: Redness, swelling, rash to injection site on 9/28/2020.   Benadryl given to patient.     On 9/29/2020  redness, swelling  to injection site,  hives to body.    Patient was seen in urgent care and instructed to continue Benadryl for the next few days.  No hives present today.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Swelling
Clinical narrative: Redness around injection site. swelling.
Age: 79.0
Sex: F
Vaccine: FLUA3
Symptoms: Balance disorder, Chills, Dizziness
Clinical narrative: Patient states last night she was experiencing dizziness and chills.  This caused her to have trouble with balance as she is blind.  She stated that she felt fine today though.
Age: 70.0
Sex: M
Vaccine: FLUA4
Symptoms: Chills, Dizziness
Clinical narrative: PATIENT STATED THAT HE HAD SEVERE CHILLS/DIZZINESS AND ALMOST FELL DUE TO THIS LAST NIGHT.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Nasal congestion, Rash, Rash pruritic
Clinical narrative: itchy rash around the neck that spread over her torso - started evening of receiving vaccine , temporary nasal congestion initially with the onset of the rash.
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site infection
Clinical narrative: Patient had infection at the injection site. Progressively got worse so they ended up going to the emergency room. MD started antibiotic  and will check progress over the next 3 days and decide on further course at that point.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Enema administration, Haematochezia, Intussusception, Lethargy, Occult blood positive
Clinical narrative: Patient developed Intussusception on 8/21/20. She started having vomiting, lethargy and bloody stools on that day and parents took her to ER where the diagnosis was made.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: SARS-CoV-2 test negative, Ultrasound abdomen abnormal, Urine analysis normal, Vomiting
Clinical narrative: Patient developed Intussusception on 8/21/20. She started having vomiting, lethargy and bloody stools on that day and parents took her to ER where the diagnosis was made.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: started getting itchy and skin eruptions all over the hands and feet, still occuring 7 days afterwards
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was brought to clinic by staff at facility she resides in for influenza vaccination.  She was administered the vaccine, it was determined a short time later that she had already had same vaccine 9-4-20 at another facility.  Contact was made with the vaccine manufacturer, who had no specific recommendations or guidance as no studies have been conducted on extra dose by this company.  Contact was made with CDC who offered that  extra dose in same season of Flulaval has not been found to be harmful.  Event was reported to contact person at facility where patient resides, who reports that she will contact resident's guardian and physician.
Age: 67.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient came in on 10/1/2020 saying he has a large, itchy rash on front and back of torso. No other common symptoms of allergic reaction were present (e.g. no shortness of breath or swelling of throat). He took a benadryl and bought some hydrocortisone cream and was instructed to let us know if anything more happens and to call 911 if severe symptoms occur. This patient did get his flu shot a few days before on 9/26 and was told he can get the three shots mentioned above after a few weeks. He came back early and another pharmacist gave the 3 shots on the 29th. Getting so many vaccines in a short amount of time could have contributed to the reaction.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema
Clinical narrative: pt recieved both vaccine on left arm where she got her lymph node removal. She reported to have redness spread like a size of a dollar bill located insert side of left arm. Pt had consulted doctor to monitor if redness continue spreading by drawing lines. Pt have no other syptoms other than redness.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Pain, Rotator cuff syndrome, X-ray
Clinical narrative: Pain, stiffness, and decrease in range of motion following injection. Evaluated by Nurse Practitioner on 9/9/2020. Recommended Orthopedist visit for 9/14/2020. Determined that there was injury to the rotator cuff. Treatment should consist of physical therapy.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: Injection administered too high on arm.  Pt experienced pain and limited mobility begining the day after recieving the flu shot. She visited her primary care who diagnosed her with brutitis and prescribed physical therapy.  Pt called today to report to the pharmacy.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: hand and feet swelling started 1 day after vaccination
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Localized swelling at site. Progressed to SOB and throat tightness.
Age: 66.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal discomfort, Myalgia, Pyrexia
Clinical narrative: Full body muscle aches, upset stomach, fever (100.5),( normal temp is 97.6)
Age: 87.0
Sex: M
Vaccine: UNK
Symptoms: Gait inability, Peripheral swelling, Pyrexia
Clinical narrative: Did shingles vaccine. Fever, feet swollen, Couldn't walk.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site bruising
Clinical narrative: Patient had significant bruising at injection site (approximately 3 inches in diameter). The bruising started shortly after the shot and is still there 3 weeks later. She is also on Warfarin.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain in extremity
Clinical narrative: PATIENT WAS ADMINISTERED FLU VACCINE IN LEFT ARM.  COMPLAINTS OF PAIN THAT IS RADIATING ABOVE ARM AND INTO NECK.  SHE HAS GOOD RANGE OF MOTION, BUT THE PAIN IS CONSTANT. DENIES ANY NUMBNESS OR TINGLING.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: At injection site: raised, red and itchy area about the size of a silver dollar
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: pt got light headed and felt faint
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swelling, warmness, pain, and itching (with no rash or hives)
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Pain, Peripheral swelling, Skin warm
Clinical narrative: Left arm swelling after vaccines on 9/29/20, no pain, slightly sore, warm to touch
Age: 55.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: HE HAD VASOVAGAL SYNCOPE FOR LESS THAN A MINUTE (MORE OR LESS), REGAINED CONSCIOUSNESS AND WAS FINE AFTER.  HE WAS ALSO SWEATING A LOT. WE WERE ABOUT TO CALL 911 BUT WIFE REFUSED AND SAID THIS SOMETIMES HAPPEN TO HIM WHEN GETTING AN INJECTION OR GIVING BLOOD. WIFE WAS FANNING HIM AND SHE ASKED FOR ICE PACK WHICH WAS PROVIDED RIGHT AWAY.  PATIENT WAS FINE AFTER ABOUT 15 MINS AND LEFT PHARMACY.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Injected limb mobility decreased, Pain in extremity
Clinical narrative: left arm blisters and pain lost shoulder use  as of now blisters are drying up  arm still not useable 10-1-2020
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fall, Muscular weakness, Pyrexia
Clinical narrative: Patient had chills and low grade fever. Patient fell down after his legs gave way after getting out of bed.
Age: 62.0
Sex: F
Vaccine: FLU4, HEP, VARZOS
Symptoms: Abdominal pain, Back pain, Cough, Diarrhoea, Dry throat
Clinical narrative: Patient states that symptoms of dry cough and throat started at 0330 this morning. She states she has generalized itchy hives and injection site pain on left arm, her back and abdomen. Pt states she also has a headache and had two  episodes of diarrhea this morning. Over the counter Benadryl recommended for hives and itching, encouraged symptomatic relief with cold application as needed and over the counter analgesics for pain.
Age: 62.0
Sex: F
Vaccine: FLU4, HEP, VARZOS
Symptoms: Headache, Injection site pain, Pruritus, Urticaria
Clinical narrative: Patient states that symptoms of dry cough and throat started at 0330 this morning. She states she has generalized itchy hives and injection site pain on left arm, her back and abdomen. Pt states she also has a headache and had two  episodes of diarrhea this morning. Over the counter Benadryl recommended for hives and itching, encouraged symptomatic relief with cold application as needed and over the counter analgesics for pain.
Age: 81.0
Sex: M
Vaccine: FLUA4
Symptoms: Back pain, Skin discolouration
Clinical narrative: arm turned purple from shoulder to elbow and still has not fully gone away, intense lower back pain that is still affecting patient
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site pain, Injection site pustule, Lymphadenopathy
Clinical narrative: Pustule formed at the site of injection , two days later swollen lymph node was palpable in the left axillary region  . Pain and discomfort under left arm and left shoulder . Treated with over the counter medication Ibuprofen , resolved on its own after a few days .
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: pt came in with redness, swelling, warm to touch injection site and extreme soreness.. recommended cold compress and nsaid along with benadryl and to come back tomorrow
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Pallor
Clinical narrative: Pt felt lightheaded and got pale, she sat down in a chair and I took her vitals which were normal BP/94/62 HR 68 and oxygen sat 98, her dad bought her a pop and after taking some time putting cold packs on neck and forehead and taking sips of her pop she felt better
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: PT STATES SHE RECEIVED FLUAD MONDAY 9-28-20. SYMPTOMS APPEARD THE FOLLOWING DAY AND CONTINUED TO TODAY 10-01-20. SYMPTOMS INCLUDED PAIN AT INJECTION SITE, PAIN TO THE TOUCH, REDNESS(APPX 2INCHES IN DIAMETER), ITCHING, SKIN HARDNESS IN AREA, MILD BRUISING ABOVE INJECTION SITE.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives, to torso, face, legs, arms, feet, head/scalp
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pallor
Clinical narrative: worsening generalized blanching confluent erythema of the trunk and upper extremities
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Fatigue, Feeling hot, Pain in extremity
Clinical narrative: 48 hours after the injection, patient reported feeling warm and having temperature of 99.8 orally.  Pt was extremely fatigued and  bedrest.  Patient treated self with ibuprofen.  No nausea, vomiting or diarrhea.  Arm was sore with no redness.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Presents with redness warmth and tenderness to the touch including pain and swelling in the left upper extremity at injection site,
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Ageusia
Clinical narrative: acute onset of loss of taste occurring within days of receiving Prevnar that lasted for several weeks then slowly resolved over weeks to months.
Age: 79.0
Sex: F
Vaccine: FLUA4
Symptoms: Neck pain, Oropharyngeal pain, Pain in extremity
Clinical narrative: pt experienced sore arm and neck as well as sore throat for aboput 48 hours after shot
Age: 84.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Asthenia, Dizziness, Feeling abnormal, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt called the next morning complaining of "a lot of pain at the site of injection, not being able to move her arm and feeling like she was having a stroke". She also stated that she felt "dizzy, ill and weak".
Age: 84.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Malaise
Clinical narrative: Pt called the next morning complaining of "a lot of pain at the site of injection, not being able to move her arm and feeling like she was having a stroke". She also stated that she felt "dizzy, ill and weak".
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm became red, slightly swollen and sore.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Left-handedness, Pain
Clinical narrative: Patient reports that she has had persistent pain in R arm at site of injection (Pt is left hand dominant). Denies redness or swelling. Movement (ie flexion, extension, abduction) and lifting exacerbate pain. Some relief with voltaren gel and tylenol.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Vaccination site pain
Clinical narrative: 3 days after administration, patient experience numbness down Left arm, pain/soreness starts on area of vaccine, travels down outside of left arm to the wrist, no radiation upward.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Condition aggravated, Hidradenitis, Subcutaneous abscess
Clinical narrative: patient was wondering if flu shot was responsible for a flare in hidradenitis suppurativa creating abscesses which started within a week. patient went to doctor on 9/24 and referred to surgeon. no other treatment or medication was given by primary.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain, Injection site rash
Clinical narrative: injection site pain and rash on left shoulder front and back
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Body temperature increased, Injection site erythema, Injection site warmth, Irritability, Pallor
Clinical narrative: Temperature of 99.4 from 7:30am-12pm, redness and warmth around injection area, pale skin, and  irritable.
Age: 34.0
Sex: M
Vaccine: FLUR4
Symptoms: Blood pressure decreased, Computerised tomogram normal, Electrocardiogram normal, Fall, Head injury
Clinical narrative: On 09/25/2020 at around 745pm, patient felt queasy after given two vaccines (Flublok and Boostrix) and fainted on the bench and hit his left side of the head. This was the first time the patient had received the flu vaccine.  Prior to administering the vaccine, patient was informed of the adverse effects of the vaccine. While discussing the adverse effects of the vaccine, patient did claim that he always gets queasy when getting a vaccine and or blood drawn.  After providing the vaccine, he started sweating and a couple minutes later fell over while seated on the bench and his left side of the head.  After being awoken, the patient was conscious and was able to  verbally speak.   At that time, he sat on the floor and was able to remove his mask.  Apparently, he had vomited and needed the mask removed.  While doing so, he also grabbed his phone and was able to text his friend. He was able to reach out to a friend who arrived several minutes later. Paramedics arrived and evaluated the patient to be okay.  Patient didn't want to go the emergency room.  As soon as his friend arrived, he was a lot better and complained of a headache.  His friend asked if there was a nearby urgent care.  I recommended nearby facility since they are opened 7 days a week.  On Wednesday  09/30/20 patient followed up with pharmacy.  Patient was seen by Urgent Care and CT scan and EKG were normal.  There was also no bleeding.  According to urgent care, his blood pressure had dropped causing him to faint.
Age: 34.0
Sex: M
Vaccine: FLUR4
Symptoms: Headache, Hyperhidrosis, Loss of consciousness, Nausea, Syncope
Clinical narrative: On 09/25/2020 at around 745pm, patient felt queasy after given two vaccines (Flublok and Boostrix) and fainted on the bench and hit his left side of the head. This was the first time the patient had received the flu vaccine.  Prior to administering the vaccine, patient was informed of the adverse effects of the vaccine. While discussing the adverse effects of the vaccine, patient did claim that he always gets queasy when getting a vaccine and or blood drawn.  After providing the vaccine, he started sweating and a couple minutes later fell over while seated on the bench and his left side of the head.  After being awoken, the patient was conscious and was able to  verbally speak.   At that time, he sat on the floor and was able to remove his mask.  Apparently, he had vomited and needed the mask removed.  While doing so, he also grabbed his phone and was able to text his friend. He was able to reach out to a friend who arrived several minutes later. Paramedics arrived and evaluated the patient to be okay.  Patient didn't want to go the emergency room.  As soon as his friend arrived, he was a lot better and complained of a headache.  His friend asked if there was a nearby urgent care.  I recommended nearby facility since they are opened 7 days a week.  On Wednesday  09/30/20 patient followed up with pharmacy.  Patient was seen by Urgent Care and CT scan and EKG were normal.  There was also no bleeding.  According to urgent care, his blood pressure had dropped causing him to faint.
Age: 34.0
Sex: M
Vaccine: FLUR4
Symptoms: Vomiting
Clinical narrative: On 09/25/2020 at around 745pm, patient felt queasy after given two vaccines (Flublok and Boostrix) and fainted on the bench and hit his left side of the head. This was the first time the patient had received the flu vaccine.  Prior to administering the vaccine, patient was informed of the adverse effects of the vaccine. While discussing the adverse effects of the vaccine, patient did claim that he always gets queasy when getting a vaccine and or blood drawn.  After providing the vaccine, he started sweating and a couple minutes later fell over while seated on the bench and his left side of the head.  After being awoken, the patient was conscious and was able to  verbally speak.   At that time, he sat on the floor and was able to remove his mask.  Apparently, he had vomited and needed the mask removed.  While doing so, he also grabbed his phone and was able to text his friend. He was able to reach out to a friend who arrived several minutes later. Paramedics arrived and evaluated the patient to be okay.  Patient didn't want to go the emergency room.  As soon as his friend arrived, he was a lot better and complained of a headache.  His friend asked if there was a nearby urgent care.  I recommended nearby facility since they are opened 7 days a week.  On Wednesday  09/30/20 patient followed up with pharmacy.  Patient was seen by Urgent Care and CT scan and EKG were normal.  There was also no bleeding.  According to urgent care, his blood pressure had dropped causing him to faint.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Gait inability, Tremor
Clinical narrative: Patient had tremors and was unable to walk for 15 minutes. This resolved and he felt normal afterward. When he called in on the next day (10/01/2020) he had no further symptoms.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: red blotches (hives) all over patient stated appeared day after receiving vaccinations and patient feels continue to appear. Itchy in some spots. No reported difficulty breathing, swelling of face/tongue/throat, heart palpitations, sweating. no other vaccine history on file
Age: 79.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Back pain, Discomfort, Headache, Lethargy, Nausea
Clinical narrative: Patient received flu shot and approximately 10 minutes later was standing at her car while I administered her husband's flu shot she started to feel like her body was "pulsing". She went to the driver's seat and sat down in obvious discomfort. The pulsing turned into a painful pulse through her entire body and then localized to her lower back. She felt slightly nauseated and within 5-10 minutes began to have a headache. After contacting Sanofi to see if this had been reported per the patient's request, I went back out to the car and patient claimed she felt better as she sucked on a lolipop, but felt like going home to sleep. She felt ok to drive and I said I would call her the next day. After 24 hours, patient returned pharmacist's call to say she was still having a slight headache and was lethargic all day, but was feeling overall better.
Age: 79.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Somnolence
Clinical narrative: Patient received flu shot and approximately 10 minutes later was standing at her car while I administered her husband's flu shot she started to feel like her body was "pulsing". She went to the driver's seat and sat down in obvious discomfort. The pulsing turned into a painful pulse through her entire body and then localized to her lower back. She felt slightly nauseated and within 5-10 minutes began to have a headache. After contacting Sanofi to see if this had been reported per the patient's request, I went back out to the car and patient claimed she felt better as she sucked on a lolipop, but felt like going home to sleep. She felt ok to drive and I said I would call her the next day. After 24 hours, patient returned pharmacist's call to say she was still having a slight headache and was lethargic all day, but was feeling overall better.
Age: 79.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain
Clinical narrative: Patient received flu shot and approximately 10 minutes later was standing at her car while I administered her husband's flu shot she started to feel like her body was "pulsing". She went to the driver's seat and sat down in obvious discomfort. The pulsing turned into a painful pulse through her entire body and then localized to her lower back. She felt slightly nauseated and within 5-10 minutes began to have a headache. After contacting Sanofi to see if this had been reported per the patient's request, I went back out to the car and patient claimed she felt better as she sucked on a lolipop, but felt like going home to sleep. She felt ok to drive and I said I would call her the next day. After 24 hours, patient returned pharmacist's call to say she was still having a slight headache and was lethargic all day, but was feeling overall better.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: pt had a reaction in left arm after receiving her first dose of Shingrix.  Pt stated she had redness, similar to a sunburn, from injection sight that ran all the way down to her elbow.  Her arm also hurt for several days.  Pt did not have any hives or allergic reaction symptoms.  The redness lasted for several days to almost a week
Age: 22.0
Sex: F
Vaccine: JEV1
Symptoms: Rash
Clinical narrative: Approximately 3 days after receiving vaccination, I broke out in a bad rash all over my torso. I was seen at a medical facility where I was prescribed Prednisone and hydroxyzine. After finishing the medicine days later, my rash had spread to my legs, lower back, chest, neck and face. I went to health clinic and mentioned that I had received the vaccination. They decided to treat me with the same exact prescriptions that didn?t help me before. My rash is continuing to spread.