chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient came to pharmacy with daughter, said she got the vaccine on 04-01-24, redness and itching and pain started to show within a few days, went to urgent care on 04-08-24 and got antibiotic for a cellulitis diagnosis.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Systemic: Flu like symptoms-Medium, Additional Details: Information provided by Patient's caregiver (Parent)
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Other Vaccines:  VaccineTypeBrand: FLUCELVAX; Manufacturer: SERUIRUS; LotNumber: 388522; Route: IM; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Other Vaccines:  VaccineTypeBrand: FLUCELVAX; Manufacturer: SERUIRUS; LotNumber: 388522; Route: IM; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Additional Details: Patient went to urgent care upon advise from pharmacist.  Physician did not think it was an infected site, but prescribed a course of cephalexin "just in case"., Other Vaccines:  VaccineTypeBrand: spikevax; Manufacturer: moderna; LotNumber: 8080748; Route: im; BodySite: left arm; Dose: ; VaxDate: 09/16/2024
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Anaphylactic reaction, Anaphylaxis treatment
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Additional Details: Patient called today and informed me within 15 minutes of leaving after her flu vaccine she had an anaphylactic reaction. She said she went to the ER and was given epinephrine, and recieved prescriptions for epinephrine and steroids to take today. Patient not upset, but understandably shaken up. She indicated she has alwasys gotten her flu shot and never had an issue with it.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Injection site pain, Lethargy, Pruritus
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Weakness-Mild, Other Vaccines:  VaccineTypeBrand: Fluzone High Dose; Manufacturer: Sanofi Pasteur; LotNumber: u8499ca; Route: IM; BodySite: Right Arm; Dose: ; VaxDate: UNKNOWN
Age: 20.0
Sex: M
Vaccine: FLUC4
Symptoms: Chills, Dizziness, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted after leaving the pharmacy for a second and regained consciousness right away. Had mom with him and both denied 911. Measured bp was low. Patient states did not eat at all for the entire day and the immunizations were given at 4:30 pm. Perhaps pt had hypoglycemia with chills and sweat. Patient sat for 15 min observation and re-measured bp which was normal around 118/78 and pulse of 70. Patient comfortable going home with mom. States he had fainted before after shots in middle sch
Age: 20.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted after leaving the pharmacy for a second and regained consciousness right away. Had mom with him and both denied 911. Measured bp was low. Patient states did not eat at all for the entire day and the immunizations were given at 4:30 pm. Perhaps pt had hypoglycemia with chills and sweat. Patient sat for 15 min observation and re-measured bp which was normal around 118/78 and pulse of 70. Patient comfortable going home with mom. States he had fainted before after shots in middle sch
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Paraesthesia, Tenderness
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Right side very tender from neck area down to arm and tingling sensation in fingers.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: patient developed a welt after Moderna covid vaccine. She said it went from her elbow to her shoulder, about 5-6". She took Xyzal and Benadryl and it started getting better. It was getting better and then resolved so she did not go to her doctor.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: I took one dose of the twinrix combined Hep A and B vaccine in 2015. Do I still have any immunity or do do I need the full 3 dose course; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix in 2015).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: I took one dose of the twinrix combined Hep A and B vaccine in 2015. Do I still have any immunity or do do I need the full 3 dose course). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-SEP-2024 The patient self-reported this case of himself/herself. The patient took one dose of the twinrix combined Hepatitis A and B vaccine in 2015.  The patient asked do he/she still had any immunity or do he/she need the full 3 dose course. The patient was provided package insert. The patient reported that it just said you need 3 doses.  The patient reported it doesn't say anything about the scenario if you had one shot previously. Till the time of reporting the patient did not received second do of Twinrix which led to incomplete course of vaccination.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Vomiting
Clinical narrative: Reported Emergency Room visit morning after receiving vaccine due to vomitting, dizziness, shortness of breath
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Contusion, Erythema, Induration, Peripheral swelling
Clinical narrative: arm swelling, firmness, redness, bruising that started day after vaccination
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Joint swelling, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Employee had systemic hives, itching, swelling of wrists, hands & ankles.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Confusional state, Decreased appetite, Dry mouth
Clinical narrative: She got her vaccine it hurt when she got the needle in, but was fine the rest of Monday and Monday night.  She was fine until Thursday which stated with cold and chills Thursday afternoon around 2:30 PM.  Her hands were cold, and then she started to run a fever.  She took some Tylenol and then started to get tremendous heat feeling in her body.  Her temperature starting rising and went up to 100.4 to 101.2.  She red the AE and said that she could get a fever within the week of the vaccine.  She was concerned about this and she called the pharmacy and felt it was a reaction to the vaccine.  She then called the pharmacy  yesterday, and still running temp and was told that she had never such a thing regarding the heating feeling and was told it was something else.  She told her that she was having a severe reaction to the vaccine and that she was going to call the immunization place today and she was going to call her back today.  All her doctors told her to get it.  Her temperature was 99.9 last night and is taking more than 3000 mg of Tylenol a day.  She has an APT with  her doctor's NP today.  With the chills she would cover up with a lot of blankets and then she would get hot without sweating and would use a fan to cool her off.  She then started to sweat slightly and felt that it may be the beginning of something breaking up.  She would wake up every morning with dry mouth, temp of 100.4, 100.9, today still bone dry mouth and temp of 99.9.  She has had no appetite since getting the vaccine, and has lost 7-8 #.  Last night she was OK, and felt OK, had taken Tylenol but then the fever increased and by 9:00 she had 102 fever, and at 9:20-9:30 she had 102.6 temp, and then she took the Tylenol.  She then got very nauseous and started to heave, but had nothing to throw up and gagging as shehad not had anything to eat.  She then got something up and felt better.  The pain in her joints and body have increased and has been screaming at night and could not move due to the pain and the Tylenol was not helping with the pain.  Then there was a bit of confusion that she had.  She would be doing something and wonder what she was doing, and would put things in the bed, and could not figure out what she was doing and had to sit down.   When she got the vaccine she sat in the chair, was startled by her touching her and not telling her she was going to give her the shot, and she just came up and gave her the shot and yelped and jumped and did not tell her she was going to inject her, puckered her skin and gave her the shot.  She has had pneumonia 4 times and had lung problems, and was encouraged to get the RSV vaccine.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Feeling cold, Feeling hot, Hyperhidrosis, Injection site pain, Mobility decreased
Clinical narrative: She got her vaccine it hurt when she got the needle in, but was fine the rest of Monday and Monday night.  She was fine until Thursday which stated with cold and chills Thursday afternoon around 2:30 PM.  Her hands were cold, and then she started to run a fever.  She took some Tylenol and then started to get tremendous heat feeling in her body.  Her temperature starting rising and went up to 100.4 to 101.2.  She red the AE and said that she could get a fever within the week of the vaccine.  She was concerned about this and she called the pharmacy and felt it was a reaction to the vaccine.  She then called the pharmacy  yesterday, and still running temp and was told that she had never such a thing regarding the heating feeling and was told it was something else.  She told her that she was having a severe reaction to the vaccine and that she was going to call the immunization place today and she was going to call her back today.  All her doctors told her to get it.  Her temperature was 99.9 last night and is taking more than 3000 mg of Tylenol a day.  She has an APT with  her doctor's NP today.  With the chills she would cover up with a lot of blankets and then she would get hot without sweating and would use a fan to cool her off.  She then started to sweat slightly and felt that it may be the beginning of something breaking up.  She would wake up every morning with dry mouth, temp of 100.4, 100.9, today still bone dry mouth and temp of 99.9.  She has had no appetite since getting the vaccine, and has lost 7-8 #.  Last night she was OK, and felt OK, had taken Tylenol but then the fever increased and by 9:00 she had 102 fever, and at 9:20-9:30 she had 102.6 temp, and then she took the Tylenol.  She then got very nauseous and started to heave, but had nothing to throw up and gagging as shehad not had anything to eat.  She then got something up and felt better.  The pain in her joints and body have increased and has been screaming at night and could not move due to the pain and the Tylenol was not helping with the pain.  Then there was a bit of confusion that she had.  She would be doing something and wonder what she was doing, and would put things in the bed, and could not figure out what she was doing and had to sit down.   When she got the vaccine she sat in the chair, was startled by her touching her and not telling her she was going to give her the shot, and she just came up and gave her the shot and yelped and jumped and did not tell her she was going to inject her, puckered her skin and gave her the shot.  She has had pneumonia 4 times and had lung problems, and was encouraged to get the RSV vaccine.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pain, Peripheral coldness, Pyrexia, Retching
Clinical narrative: She got her vaccine it hurt when she got the needle in, but was fine the rest of Monday and Monday night.  She was fine until Thursday which stated with cold and chills Thursday afternoon around 2:30 PM.  Her hands were cold, and then she started to run a fever.  She took some Tylenol and then started to get tremendous heat feeling in her body.  Her temperature starting rising and went up to 100.4 to 101.2.  She red the AE and said that she could get a fever within the week of the vaccine.  She was concerned about this and she called the pharmacy and felt it was a reaction to the vaccine.  She then called the pharmacy  yesterday, and still running temp and was told that she had never such a thing regarding the heating feeling and was told it was something else.  She told her that she was having a severe reaction to the vaccine and that she was going to call the immunization place today and she was going to call her back today.  All her doctors told her to get it.  Her temperature was 99.9 last night and is taking more than 3000 mg of Tylenol a day.  She has an APT with  her doctor's NP today.  With the chills she would cover up with a lot of blankets and then she would get hot without sweating and would use a fan to cool her off.  She then started to sweat slightly and felt that it may be the beginning of something breaking up.  She would wake up every morning with dry mouth, temp of 100.4, 100.9, today still bone dry mouth and temp of 99.9.  She has had no appetite since getting the vaccine, and has lost 7-8 #.  Last night she was OK, and felt OK, had taken Tylenol but then the fever increased and by 9:00 she had 102 fever, and at 9:20-9:30 she had 102.6 temp, and then she took the Tylenol.  She then got very nauseous and started to heave, but had nothing to throw up and gagging as shehad not had anything to eat.  She then got something up and felt better.  The pain in her joints and body have increased and has been screaming at night and could not move due to the pain and the Tylenol was not helping with the pain.  Then there was a bit of confusion that she had.  She would be doing something and wonder what she was doing, and would put things in the bed, and could not figure out what she was doing and had to sit down.   When she got the vaccine she sat in the chair, was startled by her touching her and not telling her she was going to give her the shot, and she just came up and gave her the shot and yelped and jumped and did not tell her she was going to inject her, puckered her skin and gave her the shot.  She has had pneumonia 4 times and had lung problems, and was encouraged to get the RSV vaccine.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Screaming, Weight decreased
Clinical narrative: She got her vaccine it hurt when she got the needle in, but was fine the rest of Monday and Monday night.  She was fine until Thursday which stated with cold and chills Thursday afternoon around 2:30 PM.  Her hands were cold, and then she started to run a fever.  She took some Tylenol and then started to get tremendous heat feeling in her body.  Her temperature starting rising and went up to 100.4 to 101.2.  She red the AE and said that she could get a fever within the week of the vaccine.  She was concerned about this and she called the pharmacy and felt it was a reaction to the vaccine.  She then called the pharmacy  yesterday, and still running temp and was told that she had never such a thing regarding the heating feeling and was told it was something else.  She told her that she was having a severe reaction to the vaccine and that she was going to call the immunization place today and she was going to call her back today.  All her doctors told her to get it.  Her temperature was 99.9 last night and is taking more than 3000 mg of Tylenol a day.  She has an APT with  her doctor's NP today.  With the chills she would cover up with a lot of blankets and then she would get hot without sweating and would use a fan to cool her off.  She then started to sweat slightly and felt that it may be the beginning of something breaking up.  She would wake up every morning with dry mouth, temp of 100.4, 100.9, today still bone dry mouth and temp of 99.9.  She has had no appetite since getting the vaccine, and has lost 7-8 #.  Last night she was OK, and felt OK, had taken Tylenol but then the fever increased and by 9:00 she had 102 fever, and at 9:20-9:30 she had 102.6 temp, and then she took the Tylenol.  She then got very nauseous and started to heave, but had nothing to throw up and gagging as shehad not had anything to eat.  She then got something up and felt better.  The pain in her joints and body have increased and has been screaming at night and could not move due to the pain and the Tylenol was not helping with the pain.  Then there was a bit of confusion that she had.  She would be doing something and wonder what she was doing, and would put things in the bed, and could not figure out what she was doing and had to sit down.   When she got the vaccine she sat in the chair, was startled by her touching her and not telling her she was going to give her the shot, and she just came up and gave her the shot and yelped and jumped and did not tell her she was going to inject her, puckered her skin and gave her the shot.  She has had pneumonia 4 times and had lung problems, and was encouraged to get the RSV vaccine.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site macule, Injection site pain
Clinical narrative: Fever, medial left knee swelling, macular erythema on distal medial left thigh approximately half the length of his thigh, lateral thigh induration, lateral thigh tenderness. Limping.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Joint swelling, Pyrexia
Clinical narrative: Fever, medial left knee swelling, macular erythema on distal medial left thigh approximately half the length of his thigh, lateral thigh induration, lateral thigh tenderness. Limping.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient given a Moderna 6m-11y Covid vaccine instead of what she should have received - a Pfizer 12+ covid vaccine
Age: 81.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Loss of personal independence in daily activities, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Patient experienced loss of control of her left arm and severe pain. She called the pharmacy around 4 hours after vaccine administration and was told her to put an ice pack on the injection site and proceed to urgent care/ED if the pain was not improved. It was the weekend and her primary office was closed. She went to the ED and they did some imaging of her arm....there was nothing to note on the xray, further testing was recommended. She was given medications to control pain. MD mentioned that a nerve could have been hit or a bursa punctured...no way to know for sure. Nothing odd happened during administration, no immediate pain, all vaccines were given correctly by pharmacy intern working that day. Pain was improved on 09/23, but still had to have help dressing and showering
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Nausea, Vomiting
Clinical narrative: 09/18/2024 - 09:30 AM family came into clinic (three siblings were going to get their shot) and their papers were processed.  Family screened for any previous adverse history with vaccines. Mother of clients denied any. Around 10:00 AM Patient was the second to be vaccinated. Varivax  (lot # Y005919) was administered subcutaneous in right arm and tolerated well. Patient after being vaccinated did not express any signs of nausea. However, as family was leaving clinic (around 10:15). after delivering education regarding post-vaccination, patient stated to mother that he was feeling nauseous and wanting to vomit. RN retrieved a disposable vomit bag and gave to patient. Patient vomits. Mother of client fans child. RN gave water to child. Child denied any signs of dizziness, fainting, nor blurry vision. Mother of child stated it was nerves that caused him to feel nauseated. Mother of child expressed at this time; the last time child had felt this way was after getting his blood drawn in the past. RN educated client to seek medical attention if symptoms persist with the help of an interpreter. Client observed for 15 minutes. Client denied any pain, dizziness, feeling nausea or wanting to vomit more. Client and client mom stated they were ok to leave. Client left clinic around 10:30 AM with a steady gait, skin WNL, and no signs of further distress. Called client 09/19/2024 for a follow up, mom of client verbalized client was feeling better and reiterated it was the nerves.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Facial paralysis, Scan with contrast
Clinical narrative: Facial Droop eye on left side, possible stroke. 6 hours after given shot. Was told to go the ER.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Two days after vaccine, noticed very slight blurred vision. On day three, the blurred vision continued. After reading peer reviewed article and learning blurred vision is a side effect, I notified my eye doctor and will be seen tomorrow (day four after vaccine). I do not have a history of blurred vison. From what i read, patients have been treated with steroid eye drops, so that may be an option my doctor recommends. I do have a history of psoriatic arthritis and uveitis is known risk of that, but I see my eye doctor annually and have never had any type of eye inflammation in the past.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Patient received duplicate flu shot on 9/18/24. Had already received this vaccination on 8/16/24 for the flucelvax lot #946588 intramuscular into left arm. Patient requested the flu shot both times, but said that the second time she forgot she had already gotten it.
Age: 24.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: MMRV PROQUAD WAS GIVEN IN PLACE OF MMR.  MMRV WAS GIVEN  2 WEEKS AFTER  VARICELLA VAC. WAS GIVEN. PATIENT WAS NOTIFIED OF MISTAKE. GIVEN INFORMATION CONCERNING TOO SOON AND WRONG VACCINE GIVEN.  PT DENIED ANY PROBLEMS  OR REACTIONS WITH VACCINE. WILL FOLLOW UP WITH PATIENT AGAIN  IN 1 WEEK .
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Abdominal pain upper, Erythema, Migraine, Peripheral swelling, Pyrexia
Clinical narrative: Patient had a migraine, fever,  and stomach ache.  Patient's arm was red hot and swollen for 5 days.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Skin warm
Clinical narrative: Patient had a migraine, fever,  and stomach ache.  Patient's arm was red hot and swollen for 5 days.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Chest pain, Chills
Clinical narrative: Severe chest pain with chills.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema
Clinical narrative: Redness and burning. Patient believes it might be interacting with metal plate in arm. mentioned that that is most likely not the case
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Injection site erythema, Pain, Pyrexia
Clinical narrative: Day after immunizations patient experienced: redness at injection site (3x8" in size), fever, chills, body aches. Symptoms fully resolved within 48 hours.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient was administered pediatric dose of Hepatitis B. Hepatitis B vaccine is only .5 ml, so patient also had to receive Hepatitis B vaccine for adult containing the 1 ml. Patient was aware of incorrect vaccine that was administered and the follow up plan that was needed. Patient tolerated everything well , and did not have any problems. No further actions taken.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Patient had hard time breathing for 2 days.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Herpes labialis outbreak requiring treatment with Valtrex
Age: 86.0
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: LEFT ARM WAS SWOLLEN, RED, AND WARM TO THE TOUCH WHERE VACCINE WAS GIVEN. GOT VACCINE ON 9/17/24 AND SYMPTOMS STARTED ON 9/22/24.
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Vaccine positive rechallenge
Clinical narrative: pain at injection site following Shingrix vaccination/both doses were very painful; couldn't lift their arm until around a half hour after applying the cream; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injected limb mobility decreased (received 1st dose on an unknown date and experienced injection site pain, For tolerance to 1st dose, refer case US2024AMR113276).   On an unknown date, the patient received the 2nd dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site following Shingrix vaccination/both doses were very painful) and injected limb mobility decreased (Verbatim: couldn't lift their arm until around a half hour after applying the cream). Rechallenge with Shingrix was positive. The outcome of the injection site pain and injected limb mobility decreased were resolved.   It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to Shingrix.     It was unknown if the company considered the injection site pain and injected limb mobility decreased to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR113276   Additional Information: GSK Receipt Date: 10-SEP-2024 This case was reported by a patient via interactive digital media. The patient stated that, a pointer for anyone thinking about the Shingrix vaccine; CBD cream works amazingly well for the painful arm at the injection site.  Both doses for patient were extremely painful, and he/she could not lift her arm until about half hour after he/she applied the cream. For tolerance of 1st dose reference case US2024AMR113276.; Sender's Comments:  US-GSK-US2024AMR113276:Same reporter
Age: 77.0
Sex: F
Vaccine: SMALL
Symptoms: Imaging procedure, Pain in extremity, X-ray normal
Clinical narrative: Three days after receiving flu shot, patient had arm pain.  After a week, she went to the hospital.  They took imaging and everything looked fine.  They said a nerve was probably hit during the shot.  Patient's arm still hurts after a month.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medication administered after expiration date on 05/10/2024.  No known adverse reactions.
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Pt set up appointment for RSV vaccine, and received it today around 11:15am. I checked the Immunization site before giving the immunization, and  I did not notice that the patient had already received a dose of Arexvy on 11/13/23.  Patient did not experience and side effects from the first dose last year, and I don't anticipate any unusual effects from the duplicate vaccine just given.
Age: 46.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Agitation, Chills, Discomfort
Clinical narrative: Within 30 min agitation, general discomfort, shivering
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered after expiration date of 05/10/2024. No known adverse symptoms.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Paraesthesia
Clinical narrative: tingling, nausea, headache
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram abnormal, Malaise, Palpitations
Clinical narrative: At approximately 1 AM on 9/18/2024 (about 14 hours after vaccination) patient awoke feeling unwell.  He experienced heart palpitations, and proceeded to check his blood pressure.  He said his blood pressure machine was giving error messages and unusual readings.  He contacted his physician in the morning, who requested that he be seen at a nearby facility to be evaluated.  They did an EKG which showed A-fib.  The patient then re-contacted his physician, who recommended that he come be seen at his normal clinic.  So later that same day, the patient was seen by Dr., and they did a 12-lead EKG to confirm the A-fib.  Patient had a few medication changes:  Discontinued low-dose aspirin & Amlodipine, and they started Diltiazem CD 180mg 1 capsule daily, and Eliquis 5mg, 1 tablet twice daily.  He has been schedule for an ablative cardioversion on 10/1/2024.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: 12 yr old patient received dose for 5-11yr olds.  No adverse reactions noted. Vaccine given outside of recommended age range.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Blood urea nitrogen/creatinine ratio, Fluid intake restriction, Metabolic function test normal, Oedema peripheral, Urine output decreased
Clinical narrative: Approximately 24 hours after vaccine began having lower extremity edema- this increased and worsened over several days and was accompanied by decreased urine out put and weight gain. I was seen by my medical provider office twice.  At the second visit I was directed to fluid intake restrict, begin strict intake/output measurements, and prescribed Lasix (furosemide).
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Weight increased
Clinical narrative: Approximately 24 hours after vaccine began having lower extremity edema- this increased and worsened over several days and was accompanied by decreased urine out put and weight gain. I was seen by my medical provider office twice.  At the second visit I was directed to fluid intake restrict, begin strict intake/output measurements, and prescribed Lasix (furosemide).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: PER SPOUSE, THE NEXT DAY THE PATIENT ENDED UP IN THE ER AND SUFFERED A HEART ATTACK. WAS TOLD BY THE HOSPITAL TO THE PATIENT THAT THEY BELIEVE THE HEART ATTACK WAS DUE TO THE COVID SHOT. THE PATIENT IS STILL IN THE HOSPITAL RECOVERING.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Lymphadenopathy, Swelling
Clinical narrative: Swollen lymph node in neck up to clavical down arm to fingers. Shoulder hurting, swollen and pain.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection sight expanding from elbow to shoulder. Redness. Soreness. Has been this way for ~60 hours as of this report.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Incisional drainage, Injection site infection, Injection site nodule
Clinical narrative: Patient stated he had a knot to form at the injection site the next day after. It became infected and MD had to lanced the site and gave the patient antibiotics.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Facial hives/rash, itchy skin
Age: 4.0
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC20
Symptoms: Ear pruritus, Erythema, Eye pruritus, Ocular hyperaemia, Pruritus
Clinical narrative: Child face, eyes. ears, red, itchy hives. Was given 10mL of Benadryl, time elapsed maybe 15 minutes from being vaccinated.
Age: 4.0
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC20
Symptoms: Urticaria
Clinical narrative: Child face, eyes. ears, red, itchy hives. Was given 10mL of Benadryl, time elapsed maybe 15 minutes from being vaccinated.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired - pt was not harmed
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Condition aggravated, Cough, Erythema
Clinical narrative: Raised red welt on the arm. Itchiness at the welt, also on the arms, chest, and back. Body aches, headache. Increased asthma, coughing, and breathing problems. New need for multiple nebulizer treatments with albuterol (asthma was managed without treatments prior to the vaccination). Tightness in chest and difficulty with exertion.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mobility decreased, Pain, Pruritus, Respiratory disorder
Clinical narrative: Raised red welt on the arm. Itchiness at the welt, also on the arms, chest, and back. Body aches, headache. Increased asthma, coughing, and breathing problems. New need for multiple nebulizer treatments with albuterol (asthma was managed without treatments prior to the vaccination). Tightness in chest and difficulty with exertion.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Raised red welt on the arm. Itchiness at the welt, also on the arms, chest, and back. Body aches, headache. Increased asthma, coughing, and breathing problems. New need for multiple nebulizer treatments with albuterol (asthma was managed without treatments prior to the vaccination). Tightness in chest and difficulty with exertion.
Age: 62.0
Sex: F
Vaccine: SMALL
Symptoms: Contusion, Hypoaesthesia, Pain
Clinical narrative: Whole arm bruising, stinging, numbness
Age: 87.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Gait disturbance, Speech disorder
Clinical narrative: Patient had Flu and Covid vaccine at 11am, around 3 or 4pm patient had trouble with speech and around 6pm he had trouble walking. Family then took him to the emergency room.
Age: 73.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Fatigue, Peripheral swelling
Clinical narrative: patient came into the pharmacy 9/22/2024 and stated that his hand was swollen started the following day after getting vaccinated on 9/18/2024. pt said he felt tired and no other injury to the hand. patient stated that he has an appt with his pcp on 9/25/2024 and with specialist friday 9/27/2024.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: No immediate reaction on 09/20/24. Patient said next morning woke up on 09/21/24 with redness, swelling, itching around injection site. Later in day, the redness spread down the arm to bicep area where it continues until 09/23/24. The redness has reduced slightly.
Age: 20.0
Sex: F
Vaccine: HEP, HPV9, MMR
Symptoms: Blood glucose normal, Heart rate decreased, Hypotension, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: patient received the first 2 IM doses of Gardasil and Engerix-B. Immediately after receiving the 3rd vaccine, MMR II, the patient passed out in the chair. She regained consciousness 5-10 seconds later. She had low blood pressure and heart rate 5 minutes after but by 15 minutes after it was back to normal and patient felt better.EMS was sent just in case and patient left on her own.
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT HAD VACCINATIONS 9/21/24 AND STARTED ITCHING AT THE INJECTION SITE OF THE MODERNA SPIKEVAX VACCINE THAT DAY WITH THE ITCHING INCREASING AND SWELLING OF 2" IN RADIUS AROUND THE INJECTION SITE.  AS OF 9/23/24 ITCHING HAS GONE SYSTEMIC AND SITE IS SORE.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Vaccine administered past expiration date of 05/10/2024
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Erythema and swelling around vaccine site. Swelling from slightly below hip to a little above the knee. No circumfirential. Increased in size the first 4 days, significantly improved on day 5. No fevers or other rash. Previously with severe swelling with vaccines. Saw allergy specialist prior to vaccination who also discussed reactio with family.
Age: 44.0
Sex: F
Vaccine: SMALL
Symptoms: Asthenia, Fatigue, Oropharyngeal pain, Papule, Rash
Clinical narrative: Pharmacy record shows the site was my left arm, but it was given in my right arm. On Saturday morning, 9/21, after my shower, I noticed raised red bumps all over my left hip. Throughout the day, bumps spread down my left leg, up my back and onto my stomach. It looks to me like Chickenpox. The next day, more bumps appeared on my right side as well. I had a mild sore throat that morning, and felt fatigued. By midday on Sunday, the papules were drying out and scabbing over. My sore throat stopped (no meds taken), and my energy returned.
Age: 44.0
Sex: F
Vaccine: SMALL
Symptoms: Rash erythematous, Rash papular, Rash vesicular, Scab
Clinical narrative: Pharmacy record shows the site was my left arm, but it was given in my right arm. On Saturday morning, 9/21, after my shower, I noticed raised red bumps all over my left hip. Throughout the day, bumps spread down my left leg, up my back and onto my stomach. It looks to me like Chickenpox. The next day, more bumps appeared on my right side as well. I had a mild sore throat that morning, and felt fatigued. By midday on Sunday, the papules were drying out and scabbing over. My sore throat stopped (no meds taken), and my energy returned.
Age: 9.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Wrong product administered
Clinical narrative: Two siblings were together in the exam room. I confirmed the order for both clients, the mom accidentally responded to the wrong client name, and the child was not correct in identifying their name either. The wrong sibling received the opposite vaccines. Provider, mom, child aware of error, no adverse reactions
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient made appointment online for several vaccines. We went over vaccines before administration, confirmed with patient what he was getting, and administered the vaccines. After administration, it was brought up by patient's wife that she thinks he already got the RSV vaccine. Upon investigation it was confirmed that  he already received a dose of arexvy in 2023. Patient is not experiencing any side effects. He received a 2nd dose of arexvy when not needed per IMZ guidelines.
Age: 72.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site discolouration
Clinical narrative: Patient said she had black and blue spots near injection site 3 to 4 days after vaccination. Its going away now after week and a half.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia, Malaise, Myalgia, Pain in extremity
Clinical narrative: the day of the vaccine, I didn't feel any pain in left arm at all where vaccine was given. But later that night I felt sick with a headache and deep pain within thigh muscle, and it has travel to my left leg calves. I took Aleve back and muscle pain tablets but didn't help. 5 days later, I took oxycodone 10mg which has helped with the pain but I'm feeling numb under my left foot.
Age: 34.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient did NOT have any adverse reactions to 2 vaccines provided on 09/23/2024. However, patient was supposed to receive Flucel vaccine and received Fluad for the flu vaccine.
Age: 7.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fatigue, Injection site pain, Pyrexia, Vaccination error
Clinical narrative: Provider administered an inadvertent dose of Flucelvax trivalent, preservative-free vaccine to the patient. Provider also administered a scheduled, registered dose of Moderna pediatric COVID-19 vaccine to the patient. Inadvertent dose was administered violations of multiple company policies and procedures. Disciplinary action has resulted in termination of clinicians responsible for the incident. Reporter, CEO spoke with patient's guardian about the incident and answered guardian's questions. State immunization records have been updated to accurately reflect the inadvertently administered dose, and reflect that the patient received a previous dose of Flucelvax trivalent, preservative-free vaccine on 9/3/24. Provider on record for prior influenza immunization is Pharmacy. Guardian reports that patient is experiencing side effects consistent with known adverse reactions of administered vaccines including injection site pain, fatigue and low-grade fever. Guardian will monitor patient, and provider recommends that any negative changes to the patient's condition be reported to patient's pediatrician.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given the 12+ vaccine and the patient is 11 years old
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Caregiver presented to office with complaint of redness, swelling, and warmth at site of injection. Appears to be displaying symptoms of 'Covid Arm'. Noted approx. 4 x 6 inch area of redness and mild swelling to left upper arm.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Anxiety, Dyspnoea, Flushing
Clinical narrative: Shortly after receiving vaccine, patients husband came up to counter and said patient was having a reaction to her vaccines. He stated she may be having a panic attack but was not sure. She was flushed, anxious, and said she was having trouble breathing.  Her pulse was 99. I attempted to take her BP, but the blood pressure cuff was not functioning.  Her husband and I were talking with her and she said she didn't think she could breathe. I injected her with an epinephrine 0.3mg autoinjector in her left quadriceps muscle at approximately 11:55am The pharmacy called 911. and the squad arrived in about 6 minutes and took her from the store.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash on left arm and left chest
Age: 72.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, SWELLING, WARMTH AND PAIN COMING FROM ARM OF INJECTION SITE.  SUGGESTED PATIENT APPLY A COMPRESS AND FOLLOW UP WITH PHYSICIAN DUE TO THE WARM FEELING IN THE ARM
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient was in for a 1 yr well appt. Vaccines ordered Hep A, Flu, MMR and Varicella. Patient given Hep A, MMR, MMRV and Flu in error.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Head pain  (internal).  Prescribed Prednisone.   Still taking the medicine
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Swelling face
Clinical narrative: pt stated they received jaw swelling on left side in lymph node
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: We  forgot to mix the Liquid Conjugate component  with the Men A Lyophilized conjugate  compound powder together.  Was only given the liquid
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The injection site is red, raised, painful and hot to the touch and has grown in size over the past few days.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Severe swelling, blisters, and pain at the injection site
Age: 1.67
Sex: F
Vaccine: DTPPVHBHPB, HIBV, MMR, PNC20, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was accidentally given a Hib vaccine with a Vaxelis vaccine, which already contains Hib. So patient had a double dose of Hib vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles symptoms on 9/11.  Diagnosed with Shingles on 9/13
Age: 80.0
Sex: F
Vaccine: COVID19, FLU3, TDAP
Symptoms: Asthenia, Death
Clinical narrative: the patient felt weak and died - no further details communicated
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Impaired driving ability, Injection site swelling
Clinical narrative: PT STATED THAT A FEW HOURS AFTER SHE RECEIVED HER MODERNA DOSE, HER ARM NEAR THE INJECTION SITE SWELLED UP TO THE SIZE OF AN EGG.  SHE CALLED 7 DAYS LATER ON 9/18/24 AND SPOKE WITH ME TO INFORM ME OF THE REACTION.  IN ADDITION, SHE STATED THAT SHE BECAME VERY DIZZY WITHIN A FEW HOURS AFTER GETTING THE INJECTION TO THE POINT THAT SHE WAS SCARED TO DRIVE, SO SHE STAYED HOME UP UNTIL THE 18TH WHEN SHE CALLED.  SHE DID SAY THE DIZZINESS HAD GOTTEN A BIT BETTER OVER THE COURSE OF THE WEEK SINCE SHE HAD GOTTEN THE SHOT.  SHE ALSO STATED THAT SHE HAD RECEIVED PFIZER FOR ALL PREVIOUS DOSES AND THIS WAS THE FIRST TIME SHE RECEIVED MODERNA.  SHE INQUIRED WHAT SHE COULD TAKE FOR THE DIZZINESS.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Chills, Condition aggravated, Diabetes mellitus, Palpitations
Clinical narrative: FEVER, CHILLS, HEART PALPITATIONS, INCREASED BLOOD SUGAR.  SYMPTOMS LASTED FOR TWENTY-FOUR HOURS
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER, CHILLS, HEART PALPITATIONS, INCREASED BLOOD SUGAR.  SYMPTOMS LASTED FOR TWENTY-FOUR HOURS