chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: localized cellulitis after vaccination; Initial information was received on 01-Dec-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA378451(CLUSTER), 2023SA378449(CLUSTER) and 2023SA378916(CLUSTER).  This case involves a 2 years old female patient who experienced localized cellulitis after vaccination after receiving influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Nov-2023, the patient received a  dose of 0.5 ml of suspect influenza quadrival A-B vaccine  (Suspension for injection) (lot UT8219KA, Expiry date:30-Jun-2024, strength was unknown) via intramuscular route in the left thigh for prophylactic vaccination(Immunization).  On an unknown date the patient developed localized cellulitis after vaccination (cellulitis) (unknown latency) following the administration of influenza quadrival A-B vaccine.  Action taken was not applicable.  The patient received antibiotics for treatment.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event localized cellulitis after vaccination.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Punctured IPOL was exposed to temperature excursion at 9.44 C for 1 hour and 30 minutes and vaccine adminsitered to a patient (with no reported adverse event); Initial information received on 01-Dec-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient and it was reported that punctured IPV (VERO) [IPOL] was exposed to temperature excursion at 9.44 C for 1 hour and 30 minutes and vaccine was adminsitered to a patient (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) and measles vaccine, mumps vaccine, rubella vaccine (MMR) both for Prophylactic vaccination.  On 14-Nov-2023, the patient received a dose of 0.5 ml of suspect IPV (VERO) (Suspension for injection) (lot: V1B901M; expiry date: 02-Jun-2024; strength: standard; frequency: once) which was exposed to temperature excursion at 9.44 C for 1 hour and 30 minutes (poor quality product administered) (latency: same day) via intramuscular route in deltoid NOS (Not Otherwise Specified) for Immunization. No adverse event experienced by the patient.  It was reported, "Temperature excursion occurred on 22-Sep-2023. Reason: They had no idea but they suspect that the surrounding environment became too hot and it affected the temperature of their storage. Max/low temperature reached: 9.44 C Duration: 1 hour and 30 minutes Human error? No"   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 the Directive and Regulatory Authority 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.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired PENTACEL was administered with no reported adverse event; Initial information received on 05-Dec-2023 regarding an unsolicited valid  non-serious case received via physician.  This case involves a 2-month-old male patient who and expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 20V (CRM197) (PREVNAR 20) and rotavirus vaccine for Prophylactic vaccination.  On 05-Dec-2023, the patient received a dose 1 of 0.5 ml dose of suspect diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ791AB, expiry date: 10-Oct-2023) via intramuscular route in thigh unknown if left or right for immunization and expired pentacel was administered with no reported adverse event (expired product administered) (latency: same day).   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 the 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.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Swelling
Clinical narrative: PATIENT RECEIVED SHOT ON 11/02/23. PATIENT CAME IN TO PHARMACY ON 11/08/23 STATING HER SHOT WAS GIVEN IN THE WRONG AREA, THAT IT WAS SUPPOSED TO BE GIVEN IN THE "ELBOW AREA." SHE TOLD ME THAT HER ARM WAS SORE/PAINFUL AND HAD LIMITED RANGE OF MOTION. PATIENT POINTED TO AREA WHERE SHOT WAS GIVEN, WHICH WAS ABOUT AN INCH TO 2 INCHES BELOW SHOULDER JOINT. THE AREA THAT SHE POINTED OUT WAS NOT RED, INFLAMED, OR SWOLLEN. HOWEVER, HER CLAVICLE/SHOULDER AREA WAS SWOLLEN WITH NO REDNESS. WHILE EXAMINING HER ARM, THERE WAS NOT A NOTABLE INJECTION SITE (NO REDNESS, SWELLING, POINT OF INJECTION). SHE HAD A PRESCRIPTION FOR DICLOFENAC GEL 1% SENT IN ON 11/07/23 AND PICKED UP PRESCRIPTION 11/08/23. NO COMMUNICATION HAS BEEN RELAYED TO PHARMACY STAFF ABOUT OUTCOME OF EVENT.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Patient's arm swelled upon injection of the Fluzone Quad vaccine. Pt was given cold compress and Oral Benadryl.
Age: 23.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Miscommunication between patient and pharmacy intern, patient requested Covid vaccine, received flu vaccine, but had already received the flu vaccine on previous date (10/18/2023)
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acupuncture, Blood test, Chills, Computerised tomogram, Contusion
Clinical narrative: next day--cold, shivering, couldn't lift my legs or arms.  later--foot swelled, then the other foot swelled. then knees, hands, fingers, wrists. couldn't walk, couldn't bend down, couldn't wear my rings, couldn't hold the steering wheel to drive. painful, very painful!! muscles hurt. couldn't bend fingers, or if they were bent, I couldn't straighten them. couldn't wear shoes. tingly leg.  bruises for no reason.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Feeling cold, Gait inability, Haematology test, Impaired driving ability
Clinical narrative: next day--cold, shivering, couldn't lift my legs or arms.  later--foot swelled, then the other foot swelled. then knees, hands, fingers, wrists. couldn't walk, couldn't bend down, couldn't wear my rings, couldn't hold the steering wheel to drive. painful, very painful!! muscles hurt. couldn't bend fingers, or if they were bent, I couldn't straighten them. couldn't wear shoes. tingly leg.  bruises for no reason.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Mobility decreased, Myalgia, Pain, Paraesthesia
Clinical narrative: next day--cold, shivering, couldn't lift my legs or arms.  later--foot swelled, then the other foot swelled. then knees, hands, fingers, wrists. couldn't walk, couldn't bend down, couldn't wear my rings, couldn't hold the steering wheel to drive. painful, very painful!! muscles hurt. couldn't bend fingers, or if they were bent, I couldn't straighten them. couldn't wear shoes. tingly leg.  bruises for no reason.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: next day--cold, shivering, couldn't lift my legs or arms.  later--foot swelled, then the other foot swelled. then knees, hands, fingers, wrists. couldn't walk, couldn't bend down, couldn't wear my rings, couldn't hold the steering wheel to drive. painful, very painful!! muscles hurt. couldn't bend fingers, or if they were bent, I couldn't straighten them. couldn't wear shoes. tingly leg.  bruises for no reason.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Dizziness, Hypoaesthesia, Nausea
Clinical narrative: Patient reported dizziness, nausea, numbness of face, shivering, elevated blood pressure. Patient was transported to the ED.
Age: 53.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Erythema, Urticaria
Clinical narrative: Red welts on both arms; not itchy; lasted about 5 days
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Malaise, Photopsia
Clinical narrative: Had an episode of vasovagal syncope shortly after getting out of bed.  Told mom she didn't feel well, became sweaty, dizzy, saw stars, then passed out and regained consciousness after about 1 minute without any sequelae.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Had an episode of vasovagal syncope shortly after getting out of bed.  Told mom she didn't feel well, became sweaty, dizzy, saw stars, then passed out and regained consciousness after about 1 minute without any sequelae.
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site rash
Clinical narrative: Patient began experiencing a spreading rash at the injection site beginning today, 12/12/23.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Hypoaesthesia, Vertigo
Clinical narrative: The night of the 12th I got up from the couch to turn off the TV and suddenly felt light footed. Like I was walking on air. Then I realized I needed to sit back down on the couch or I might fall.  I sat on the edge of the couch.  Felt dizzy.  My left arm was numb and felt paralyzed.  My head was spinning.  After about 20 to 35 seconds it dissipated.  I sat on the couch for a while.  Debated calling emergency services.  I decided not to.  Went to bed and felt normal the next morning. I called facility the next day to make an urgent care appointment.
Age: 62.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Patient began experiencing pain and redness at the injection site within a day of receiving the vaccines.  She also reports a small red bubble, with large bruising, beginning on day 2.  The bruising/discoloration of skin continues to today, 12/12/23, when the patient received her second Shingrix vaccine, and reported the adverse events to me.
Age: 90.0
Sex: M
Vaccine: RSV
Symptoms: Muscle spasms, Myocardial infarction, Pain in extremity
Clinical narrative: Patient reports a little over 1hr post-vaccine being administered in left arm, that his feet bilaterally, and left leg, became cold mildly painful (cramping), as well as left arm became cramped but less so.   Patient reports seeking medical attention and that he was told he experienced "...a mild heart attack that resolved on its own."
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral infarction, Dizziness, Magnetic resonance imaging head abnormal, Photopsia, Vertigo
Clinical narrative: Walking back to my office from bathroom my left eye was suddenly darkened as if by a veil.  The veil lifted and a shimmering green, diagonal slash appeared in the middle of my left eye.  Over the next four hours it gradually dissipated. Next day I made an emergency appointment with a Retina specialist thinking it might be a detached retina.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Walking back to my office from bathroom my left eye was suddenly darkened as if by a veil.  The veil lifted and a shimmering green, diagonal slash appeared in the middle of my left eye.  Over the next four hours it gradually dissipated. Next day I made an emergency appointment with a Retina specialist thinking it might be a detached retina.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient said she had redness, injection site was swollen and it hurt excessively. A large area of the arm is still red after almost a week
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLUC4, VARZOS
Symptoms: Dizziness
Clinical narrative: On 11.29.2023, a patient came over in the morning around 10.30 am and took the three vaccinations (shingrix, flucelvax and spikevax) and she was fine when she was leaving the pharmacy. But in the evening after her dinner around 7.30 pm she started felling dizzy and went to the emergency room. She called the pharmacy today to find out if there is any issue with vaccinations or the combination
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Metastases to spine, Metastatic uterine cancer
Clinical narrative: Pt had hx uterine cancer. Found to have a T7 met in August 21
Age: 68.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Patient returned to the pharmacy after 4 weeks to complain of shoulder soreness.  She said that it was very painful for about a week and then it went away.  Recently, the pain have came back to the site of her injection.  I recommended her to see her PCP for follow up
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia, Injected limb mobility decreased, Magnetic resonance imaging, Pain
Clinical narrative: Received shot in upper right arm shoulder area. While at work during my over night shift.  After waking up from my sleep from working over night I had severe pain, more than any other flu shot I have ever received.  About the second day after the shot I was unable to sleep on my right side,  pain in shoulder radiating down to my elbow, and even numbness in my fingers periodically as well as limited range in motion  and unable to lift anything heavy. The symptoms have been persistent with no relief to this day
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Sleep disorder, Weight bearing difficulty, X-ray
Clinical narrative: Received shot in upper right arm shoulder area. While at work during my over night shift.  After waking up from my sleep from working over night I had severe pain, more than any other flu shot I have ever received.  About the second day after the shot I was unable to sleep on my right side,  pain in shoulder radiating down to my elbow, and even numbness in my fingers periodically as well as limited range in motion  and unable to lift anything heavy. The symptoms have been persistent with no relief to this day
Age: 60.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: The vaccine was given with a 5/8 inch needle rather than a 1 inch needle. By the time the patient left, there were no adverse events related to the short needle.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Mobility decreased, Muscle spasms
Clinical narrative: PATIENT HAD CHRONIC CRAMPING, SEVERAL PARTS OF HER BODY, SEVERE CRAMPING IN THE ARM(UNABLE TO MOVE) LEAD HER TO GO TO ER
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Dizziness, Flushing, Vomiting
Clinical narrative: vomiting, flushing, dizziness 5 minutes after vaccines
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Itching, warm sensation throughout body, tight itchy throat, redness, swelling, nausea, diarrhea. Treated with IV benadryl, IM benadryl, IV zofran, Zyrtec, epi pen, all within 10-60 mins of reaction.  Approximately 2 weeks after the vaccine I had return of redness, swelling and pain at injection site treated with antibiotics and Prednisone
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea, Pruritus, Swelling, Throat irritation
Clinical narrative: Itching, warm sensation throughout body, tight itchy throat, redness, swelling, nausea, diarrhea. Treated with IV benadryl, IM benadryl, IV zofran, Zyrtec, epi pen, all within 10-60 mins of reaction.  Approximately 2 weeks after the vaccine I had return of redness, swelling and pain at injection site treated with antibiotics and Prednisone
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Itching, warm sensation throughout body, tight itchy throat, redness, swelling, nausea, diarrhea. Treated with IV benadryl, IM benadryl, IV zofran, Zyrtec, epi pen, all within 10-60 mins of reaction.  Approximately 2 weeks after the vaccine I had return of redness, swelling and pain at injection site treated with antibiotics and Prednisone
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Muscle spasms
Clinical narrative: Back spasms
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscle swelling, Obstructive sleep apnoea syndrome, Pharyngeal swelling, Sinus congestion
Clinical narrative: Obstructive sleep apnoea (2+ years to date), acute swelling of tissues, notably lymph nodes, intramuscular, sinus, throat. Sinus infection resultant.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Obstructive sleep apnoea (2+ years to date), acute swelling of tissues, notably lymph nodes, intramuscular, sinus, throat. Sinus infection resultant.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Muscular weakness, Pain, Pain in extremity, Sleep disorder
Clinical narrative: 13 days post injection and my shoulder is still hurting and not right following receiving the  flu shot vaccination on 11/29/23. Immediately the evening of the flu shot I had more arm pain than I ever had with all the vaccines I have received over the years. My right arm hurt so much that I could not sleep that night and my arm was so weak I could not even pull the blanket up on myself. I had pain in my shoulder and mild weakness in my right arm that continues with tomorrow marking two weeks post vaccine. I feel the injection must have gone in on a weird angle and hit something too close to my shoulder to cause this unpleasant issue for me. I will see an orthopedic tomorrow morning since I am hoping this will improve. I have shooting pain in my shoulder depending on how I move my arm and actually have been having difficulty sleeping. Frustrated that this happened following a routine flu shot.
Age: 82.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: ARM BETWEEN ELBOW AND SHOULDER SWOLLEN AND RED.  EXTREME ITCHING GPT 8 DAYS. FINALLY LAID ON ICE PACK WITH MY ARM OVERNIGHT.  ITCHING GONE IN MORNING
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Above influenza vaccine was administered on 12:00 PM on 10/27/23. Around midnight that night, the patient began having a rash/hives and presented to the ER. Patient complained of very itchy skin especially on upper extremities. Patient received IV diphenhydramine in the ER at 2:57 AM on 10/28/23. Patient was noted to be feeling better at 4:59 AM. Patient was discharged home from ER at 5:30 AM on 10/28/23 will plan to continue diphenhydramine as needed at home. Other Relevant HX: Other:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Reported Symptoms:  10028411:MYALGIA; Narrative: Patient reported to walk-in nurse clinic complaining of right elbow pain that began earlier that morning (10/17/23) requiring him to use his left hand to lift the right. Patient had COVID vaccine in left arm but right elbow and forearm was
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Reported Symptoms: 10037087:PRURITUS; 10046735:URTICARIA; Narrative: Other Relevant HX: Other: URTICARIA; PRURITUS
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Headache, Insomnia
Clinical narrative: Reported Symptoms: 10000056:ABDOMINAL CRAMP; 10013573:DIZZINESS; 10019211:HEADACHE; 10022437:INSOMNIA; Narrative: Symptoms subsided after patient went to bed but symptoms had started to occur 6 hours after the vaccination.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia
Clinical narrative: Reported Symptoms:  10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Other Relevant HX: Other:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin depigmentation, Skin hypopigmentation, Vitiligo
Clinical narrative: Reported Symptoms: 10037844:RASH; 10047642:VITILIGO; Narrative: The patient received four Pfizer COVID 19 Vaccines (Mar/Apr/Oct 2021 and Apr 2022). The patient experienced rash on bilateral thighs with hypopigmented/depigmented patches without overlying scale, which was diagnosed as vitiligo after receiving the 4th vaccination on 4 April 2022. The patient was treated with topical tacrolimus ointment and is followed by dermatology. Other Relevant HX: Other: vertiligo
Age: 88.0
Sex: M
Vaccine: FLUX
Symptoms: Myalgia, Pyrexia
Clinical narrative: Reported Symptoms: 10016558:FEVER; 10028322:MUSCLE PAIN; Narrative: Other Relevant HX: Other: MUSCLE PAIN
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Reported Symptoms: 10016558:FEVER; Narrative: Other
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Headache
Clinical narrative: Clammy, Light headed, dizzy, headaches
Age: 71.0
Sex: F
Vaccine: COVID19, FLUX, RSV
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Pain, Pain in extremity, Sleep disorder
Clinical narrative: I reported my concerns to both my Allergy/Immunity Doctor and Primary Care Physician who both thought it would go away soon, so they were not too concerned. I found information regarding self reporting adverse reactions on the information sheet sent home with me by the pharmacist who gave me the COVID injection in my right arm and the RSV and Flu shots in my left arm, all on the same day. For about 20 years I got frequent allergy shots, and never had any reactions or long term adverse effects. My right upper arm started hurting the day I received the injections, as I expected. There is still a "thickened" area at the site of the injection. I continue to experience intermittent sharp pains in my upper arm. They most often occur when I am extending my arm out or upward; worsened upon also lifting something; using the lever on my recliner; twisting my arm. Each incident of pain is then followed by an ache that lasts for some time. For instance, if I reach from my easy chair to the side table to pick up my coffee cup, my arm hurts immediately and the ache lingers on for quite some time. Now I avoid having to drive long distances with my arm stretched out that long. Luckily, for now my husband can still drive. Unfortunately, I have pain when I'm crocheting, which is interfering with my Christmas gifting plans and one of my favorite hobbies. All the activities involved with preparing for bed, especially changing clothes, brushing and flossing my teeth; coupled with the fact that I can no longer sleep on my preferred right side because my arm hurts, result in sleep deprivation. I kept thinking these resultant pains would slowly go away. However, it has been four weeks and they have not improved. I am very worried about how long these adverse effects will interfere with my daily comfort, crafting, and general enjoyment of life. Thank you for your time and attention to this matter.
Age: 78.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Lip swelling
Clinical narrative: Swollen upper lip; This spontaneous case was reported by a patient and describes the occurrence of LIP SWELLING (Swollen upper lip) in a 78-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU39218) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. In November 2023, the patient experienced LIP SWELLING (Swollen upper lip). At the time of the report, LIP SWELLING (Swollen upper lip) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Injection site cellulitis, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: I received the Prevnar 20 in the middle of my left upper arm. I experienced redness,  swelling, pain, limited range of motion to my left arm, and the area was hot.  I experienced intermittent pain to my left upper arm within the first 24 hours. 2 days after the injection, I experienced the rest of the symptoms.  I was prescribed Keflex. I have one more day of Keflex out of a 7 day course of treatment. The cellulitis has pretty much resolved.
Age: 51.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Cellulitis, Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: I received the Prevnar 20 in the middle of my left upper arm. I experienced redness,  swelling, pain, limited range of motion to my left arm, and the area was hot.  I experienced intermittent pain to my left upper arm within the first 24 hours. 2 days after the injection, I experienced the rest of the symptoms.  I was prescribed Keflex. I have one more day of Keflex out of a 7 day course of treatment. The cellulitis has pretty much resolved.
Age: 51.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Skin warm
Clinical narrative: I received the Prevnar 20 in the middle of my left upper arm. I experienced redness,  swelling, pain, limited range of motion to my left arm, and the area was hot.  I experienced intermittent pain to my left upper arm within the first 24 hours. 2 days after the injection, I experienced the rest of the symptoms.  I was prescribed Keflex. I have one more day of Keflex out of a 7 day course of treatment. The cellulitis has pretty much resolved.
Age: 3.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC.; HCP called to report inadvertent administration of GARDASIL 9 to a 3-year-old patient. The vaccine was administered on 28NOV2023 and no additional symptoms were reported. No additional AE/PQC.; This spontaneous report was received from a medical assistant referring to a 3-year-old male. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 28-NOV-2023, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (Inappropriate age at vaccine administration), 0.5 milliliter, once, administered intramuscularly for prophylaxis (strength, lot #, and expiry date were not provided).  The patient experienced no additional adverse event.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: No additional AEs; received a total of 5 vaccinations of GARDASIL 9.  Dates of administration were 8/5/2016, 10/10/2016, 2/10/2017, 7/24/2023; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-AUG-2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On 10-OCT-2016, the second dose was administered, then on 10-FEB-2017 the third dose and on 24-JUL-2023 a fourth dose (extra dose administered) (strength, route, dosage schedule, lot number and expiration date were not reported for any of the doses).  On 28-NOV-2023, the patient was vaccinated with the fifth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #W029724, expiration date: 08-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).  No additional adverse event.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; HCP called to stated patient age 20 plus received RECOMBIVAX HB pediatrics PFS as their booster.; This spontaneous report was received from a nurse and refers to an adult (age reported as 20 plus (units not provided)) patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-NOV-2023, the patient was vaccinated with pediatric dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 5 mcg/0.5 mL intramuscular injection syringe carton of 10 (lot #W025817 is a valid lot number, expiration date was reported and upon internal validation was stablished as 21-MAY-2025) administered 1 dose (route of administration and anatomical location were not provided) for prophylaxis as a booster (adult use of a child product). The patient needed to get booster for school purposes. No additional adverse event was reported (no adverse event).
Age: 0.75
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs were reported; 9 month old patient received GARDASIL 9 today 12/8/2023.; This spontaneous report was received from a pharmacist and refers to a 9-month-old patient of unknown gender.  The patient's medical history concurrent conditions and concomitant therapies were not reported.   On 08-DEC-2023 (reported as today), the 9-month-old patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose (strength, lot #, expiry date, route of administration, and indication were not provided)(Product administered to patient of inappropriate age). No additional adverse events (AEs) were reported (No adverse event). No further information was provided.
Age: 93.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; red spot on her hip with the case of shingles; Blister; red spot on her hip with the case of shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 4 or 5 times in the last year, about every other month.). Previously administered products included Varicella Zoster vaccine (2 to 3 years ago received 1st dose.) and Varicella Zoster vaccine (2 to 3 years ago received 2nd dose.). Concurrent medical conditions included breast cancer (since 2015).   On an unknown date, the patient received the 2nd dose of Shingrix. In JUN-2023, the patient received the 1st dose of Shingrix (left arm). On 09-NOV-2023, an unknown time after receiving Shingrix and between 4 and 6 months after receiving Shingrix, the patient experienced localized erythema (Verbatim: red spot on her hip with the case of shingles). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: red spot on her hip with the case of shingles) and blister (Verbatim: Blister). The patient was treated with valaciclovir hydrochloride (Valacyclovir Hcl). The outcome of the vaccination failure, localized erythema and blister were unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, localized erythema and blister to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, localized erythema and blister to be related to Shingrix and Shingrix.   Additional Information: RA Receipt date: 01-DEC-2023 The patient was self-reported.  She had 2 Shingrix shots and reported that she had shingles 4 or 5 times in the last year, about every other month, and that all the cases of shingles were after receiving both doses of Shingrix. The patient was unable to provide dates for all the cases of shingles, except the last case was 9-NOV-2023, and she started symptoms again last night 30-NOV-2023.  On 9-NOV-2023 the patient reported that she had red spot on her hip with the case of shingles. Patient reported if she did not get to the red spot it turns to blisters.  Patient takes Valacyclovir HCL 1 GM three times a day for 7 days as treatment when she had shingles. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: developed a rash all over my body, red patches every where even on my face; every joint in my body hurt; This spontaneous case was reported by a patient and describes the occurrence of PAIN (every joint in my body hurt) and RASH (developed a rash all over my body, red patches every where even on my face) in a 56-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3833D) for COVID-19 prophylaxis.     No Medical History information was reported.   On 31-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 06-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced RASH (developed a rash all over my body, red patches every where even on my face). In November 2023, the patient experienced PAIN (every joint in my body hurt). At the time of the report, PAIN (every joint in my body hurt) had not resolved and RASH (developed a rash all over my body, red patches every where even on my face) was resolving.      For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Reported that every joint in body hurt and continues to hurt as of 10-Dec-23 and has not gotten any better.
Age: 23.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: I had received the flu shot on 10/18/2023. I had become very ill after receiving the shot and went to an urgent care. I had come in on 12/10/2023 to the pharmacy for a COVID-19 vaccine to meet my job's requirement. I had explicitly stated COVID-19 vaccine and checked off COVID-19 vaccine on my form. The provider did not confirm the vaccine before administration of the shot to me. After asking the provider for the necessary paperwork to provide to my work, they would find out that they accidentally administered the flu shot to me instead of the COVID-19 shot I had requested. I left the pharmacy and would receive the COVID-19 vaccine the following day.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dysarthria, Extremity contracture, Eyelid function disorder, Gait disturbance
Clinical narrative: Couldn't hold eyes open, stumbling getting up to use the bathroom, slurring trying to talk, left arm/hand drawing up . Couldn't sign my name. Left leg foot not responding to brain to move. 24hours til hospitalized.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Musculoskeletal disorder
Clinical narrative: Couldn't hold eyes open, stumbling getting up to use the bathroom, slurring trying to talk, left arm/hand drawing up . Couldn't sign my name. Left leg foot not responding to brain to move. 24hours til hospitalized.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) in a 64-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) had not resolved.            No concomitant medication was reported. Patient had a headache basically since two hours after the shot. Not horrible, but it has been there most of the time. Tylenol and Advil don't really help a lot.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Hypoaesthesia, Neck pain, Pain in extremity
Clinical narrative: Dizziness, left sided wrist and hand numbness, left sided headache, left sided leg pain, left sided neck pain,
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Agitation, Angiogram cerebral normal, CSF protein increased, CSF white blood cell count increased, Computerised tomogram head normal
Clinical narrative: 8 days after she received the injection (12/7) she developed confusion which progressed to agitation, paranoia and then a seizure. Following the seizure she became obtunded and then required intubation and mechanical ventilation.   She was empirically started on antibiotics and given a dose of high dose steroids (1 gram solumedrol) due to deterioration .  A lumbar puncture was done which did not show any organisms but was consistent with albuminocytological dissociation (CSF WBC 10 Protein 125) .  Her mental status slowly improved.   She was extubated on 12/9 and her mental status continues to improve.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Confusional state, Depressed level of consciousness, Diffusion-weighted brain MRI abnormal, Endotracheal intubation, General physical health deterioration
Clinical narrative: 8 days after she received the injection (12/7) she developed confusion which progressed to agitation, paranoia and then a seizure. Following the seizure she became obtunded and then required intubation and mechanical ventilation.   She was empirically started on antibiotics and given a dose of high dose steroids (1 gram solumedrol) due to deterioration .  A lumbar puncture was done which did not show any organisms but was consistent with albuminocytological dissociation (CSF WBC 10 Protein 125) .  Her mental status slowly improved.   She was extubated on 12/9 and her mental status continues to improve.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Mechanical ventilation, Mental status changes, Paranoia, Seizure
Clinical narrative: 8 days after she received the injection (12/7) she developed confusion which progressed to agitation, paranoia and then a seizure. Following the seizure she became obtunded and then required intubation and mechanical ventilation.   She was empirically started on antibiotics and given a dose of high dose steroids (1 gram solumedrol) due to deterioration .  A lumbar puncture was done which did not show any organisms but was consistent with albuminocytological dissociation (CSF WBC 10 Protein 125) .  Her mental status slowly improved.   She was extubated on 12/9 and her mental status continues to improve.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID vaccine breakthrough case
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gait disturbance, Gait inability, Malaise, Vertigo, Vertigo positional
Clinical narrative: I woke up the next morning with the world spinning. I went to the bathroom and couldn't walk back to the room. I lay on the floor for an entire day and night. Someone helped me to get to bed where I stayed for 2 more days. At first the room was spinning even if I was lying down. The last day, if I stay still, the world didn't spin, but if I moved spinning continued. I couldn't even go to the bathroom. I used bedpans. This is the first time in my life I had vertigo and it lasted 3 days. Since I was too sick to go to the doctor, my doctor arranged for an EMT to come to my house. I had one more episode of vertigo a bit later, but it lasted only a day
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: This was a historical report patient informed PCP at clinic at first visit when initiating care. No other information was provided other than rash with flu shot. PCP flagged pt's
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Red spots after injection of Influenza vaccine
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Muscle spasms, Pyrexia
Clinical narrative: Had first dose of Shingle vaccine. The side effects was fast within 2 hours, felt like having fever, fatigue, headache and cramps. The first 3 days were really bad but eased off afterwards. Today is 12/10, I am still have fatigue on and off as well as headaches.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Cerebral haemorrhage, Confusional state, Death, Headache
Clinical narrative: My father received the booster for covid on October 24th 2023 at his local pharmacy. He started developing symptoms 48 hours later that included aphasia, headache, & confusion. He was taken to the hospital on the 27th and was admitted. He was scanned and identified to have a brain hemorrhage. A second brain hemorrhage happened 36 hours later that was catastrophic. He did not recover and was put on life support and died on October 29th.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Life support, Magnetic resonance imaging head abnormal
Clinical narrative: My father received the booster for covid on October 24th 2023 at his local pharmacy. He started developing symptoms 48 hours later that included aphasia, headache, & confusion. He was taken to the hospital on the 27th and was admitted. He was scanned and identified to have a brain hemorrhage. A second brain hemorrhage happened 36 hours later that was catastrophic. He did not recover and was put on life support and died on October 29th.
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Pruritus, Swelling, Urticaria
Clinical narrative: Received COVID-19 vaccine, had multiple episodes of angioedema, swelling, urticaria, and pruritus 1-2 weeks afterwards.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue
Clinical narrative: Attempt made to administer flu vaccine, upon applying pressure on syringe vaccine unable to move through needle. Can't fully depress/push plunger to administer vaccine. Had to obtain second vaccine and needle which then was successful. Fluzone Quadrivalent Lot UT8109NA Exp 2024/06
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: C19 Pfizer 5-12y vaccine given to 13 y old.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Pyrexia, Vomiting
Clinical narrative: Patient was given 12+ vaccine instead of correct dosing for her age. Pt had fever of 102.5 the night of the vaccine as well as vomiting. Vomiting resolved as well as fever.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt felt fine at the time of leaving the office. No reaction to report. Reporting incorrect dose was given at today's visit.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Wrong product administered
Clinical narrative: Administered Meningococcal B instead of the ordered Meningococcal (Menveo A-C-Y-W).  Patient will return to office for Menveo vaccine.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: Patient should have received Tdap (Boostix) vaccine not Td Absorbed (Tenivac). No treatment. Outcome: Patient will receive Tdap vaccine.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Product packaging confusion, Wrong product administered
Clinical narrative: Nurse carelessly pulled a box off the pharmacy color that matches the color of the RSV Vaccine which I was supposed to receive. I walked into the Pharmacy the next day and was pulled aside and told a mistake had been made by the nurse and I was actually given an injection of Shingrex.  I've already had 2 doses of that vaccine in 2019.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product packaging confusion, Wrong product administered
Clinical narrative: Nurse carelessly pulled a box off the pharmacy color that matches the color of the RSV Vaccine which I was supposed to receive. I walked into the Pharmacy the next day and was pulled aside and told a mistake had been made by the nurse and I was actually given an injection of Shingrex.  I've already had 2 doses of that vaccine in 2019.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Joint range of motion decreased, Mobility decreased
Clinical narrative: I have no range of motion. Unable to lift my arm.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired at time of vaccination expiration date 10/10/2023 NO adverse reactions were had. Parent was notified and has no complaints or complications to report.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Electric shock sensation, Hypoaesthesia, Injection site pain, Pain
Clinical narrative: Member here with left hand pain and numbness. Member received Flu vaccination on 12/11/23 at 1030 am.  Seen by PCP , with orders for medication, Per Dr.'s orders Tylenol 500 mg PO given at 1: 27 pm. Member complains of radiating pain from left elbow to up neck, pain is sharp. Below elbow pain in on and off like electricity passing. member is in tears.  Seen by PCP.  Member declines Toradol IM.  Complains her left hand is shaking. Notified PCP. 2:28 PM- Member feels sleepy for Tylenol, pain scale 4/10, below left elbow is still numb.  Seen by PCP, advised discharge home, if condition worsens to go to any AUC. 2:50 pm- Member declines Ibuprofen. Notified PCP. Seen by PCP, AVS and VOT given.  D/C home ambulating.Plenty of hydration Use warm compresses to the left arm injection site  Take ibuprofen 600 mg p.o. Q 8 hours with food as needed for pain and swelling Keep arm elevated on a pillow while  sleeping   Dr. If the pain swelling numbness give was return to urgent care
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Somnolence, Tearfulness, Tremor
Clinical narrative: Member here with left hand pain and numbness. Member received Flu vaccination on 12/11/23 at 1030 am.  Seen by PCP , with orders for medication, Per Dr.'s orders Tylenol 500 mg PO given at 1: 27 pm. Member complains of radiating pain from left elbow to up neck, pain is sharp. Below elbow pain in on and off like electricity passing. member is in tears.  Seen by PCP.  Member declines Toradol IM.  Complains her left hand is shaking. Notified PCP. 2:28 PM- Member feels sleepy for Tylenol, pain scale 4/10, below left elbow is still numb.  Seen by PCP, advised discharge home, if condition worsens to go to any AUC. 2:50 pm- Member declines Ibuprofen. Notified PCP. Seen by PCP, AVS and VOT given.  D/C home ambulating.Plenty of hydration Use warm compresses to the left arm injection site  Take ibuprofen 600 mg p.o. Q 8 hours with food as needed for pain and swelling Keep arm elevated on a pillow while  sleeping   Dr. If the pain swelling numbness give was return to urgent care
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, IPV, MMR, PNC20, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given 2 doses of polio at her office visit 12/08/23 at about 9 am. She received a combination vaccine that included polio and then just a regular polio by itself I hadn't realized the combination vaccine included polio. Pt did not have any reaction in office.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site erythema, Vaccination site oedema, Vaccination site pain
Clinical narrative: Patient received Tdap vaccine at Pharmacy and experienced erythema, edema, and tenderness to the vaccination site (left deltoid) post vaccine. 8.5 cm diameter.