chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Illness, Oropharyngeal pain, Upper respiratory tract infection
Clinical narrative: discomfort; got sick; throat pain; URT cough; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient received BNT162b2 (BNT162B2 NOS), on 31Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 2022, outcome "recovered", described as "URT cough"; ILLNESS (non-serious) with onset 2022, outcome "recovered", described as "got sick"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "recovered", described as "throat pain"; DISCOMFORT (non-serious), outcome "recovered".  Additional information: Patient got sick before holiday (2022) with URT cough plus throat pain that took over a month to recover from that vaccine on 31Oct2022. Patient had discomfort that did not last long at all.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400320520 Same patient, different vaccine and event;US-PFIZER INC-202500006963 same patient, different product/events;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Discomfort, Oropharyngeal pain, Upper respiratory tract infection
Clinical narrative: discomfort; URT; Cough; Throat Pain; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 3 (booster), single (Lot number: GH9697) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "periodically eczema, left wrist" (ongoing), notes: sporadic mostly dormant. Has Rx to use if needed plus rarely needed to; "allergic dermatitis from chigger bites" (ongoing), notes: in spring plus summer; "allergic dermatitis from chigger bites" (ongoing), notes: in spring plus summer; "orthopaedic problem from multiple body parts" (unspecified if ongoing), notes: knees, left finger middle finger, finger thumb base (both) exostoses bilateral, 1st cuneiform. The patient's concomitant medications were not reported. Past drug history included: Relafen, reaction(s): "did not tolerate NSAIDs plus they generally cause or upper chest rash", notes: NSAID; Relafen, reaction(s): "did not tolerate NSAIDs plus they generally cause or upper chest rash", notes: NSAID. Vaccination history included: Bnt162b2 (dose number unknown, batch lot number unknown), for Covid-19 immunization, reaction(s): "discomfort"; Bnt162b2 (dose number unknown, batch lot number FJ8762), for Covid-19 immunization, reaction(s): "discomfort". The following information was reported: COUGH (non-serious) with onset 2022, outcome "recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "recovered", described as "Throat Pain"; UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 2022, outcome "recovered", described as "URT"; DISCOMFORT (non-serious), outcome "recovered".  Additional information: The patient informed that the others were not painful when the injections were done and the discomfort did not last long at all. The patient informed that she got sick before holiday with URT, cough plus throat pain that took over a month to recover from that vaccine was 31Oct2022, done by pharmacy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400320520 same patient, different product/events;US-PFIZER INC-202500006961 same patient, different product/events;US-PFIZER INC-202500006962 same patient, different product/events;
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: covid; covid; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "osteoporosis" (unspecified if ongoing), notes: unrelated. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, regular vaccinations/boosters, both Pfizer and Moderna), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" (Jan2025) and all described as "covid". Therapeutic measures were taken as a result of vaccination failure, covid-19, treatment was Paxlovid from 02Jan2025 to 06Jan2025. Paxlovid was wonderful, really knocked out the covid by the end of the 5 days of treatment. The patient had regular vaccinations/boosters, both Pfizer and Moderna, and last booster was 3-1/2 months before 12Jan2025.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID after Vaccine/Had COVID after five years of not getting it, after all these vaccines; COVID after Vaccine/Had COVID after five years of not getting it, after all these vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 67-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID after Vaccine/Had COVID after five years of not getting it, after all these vaccines". The patient called and said he felt horrible, and he need this drug bad he was sick as a dog. The caller continues, he just wanted to feel better, this COVID, after five years of not getting it after all these vaccines, and now here he was getting it now. Every time he started to talk, he starts to cough. Therapeutic measures were taken as a result of covid-19, vaccination failure. The patient took Paxlovid.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive; did get the flu and Covid vaccine back at the beginning of Oct; tested positive; did get the flu and Covid vaccine back at the beginning of Oct; This is a spontaneous report and received from Consumer or other non HCPs, Program ID.  A 70-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA), in Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: 2 years ago I think, we had tested positive. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 omi xbb.1.5 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive; did get the flu and Covid vaccine back at the beginning of Oct". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 2 years ago; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.    Clinical course: It was reported that the husband and wife (patient) had taken the Paxlovid already, and the caller stated "About 2 years ago I think, we had tested positive and we took it, and then just recently, and we had we were surprised we tested positive we did get the flu and Covid vaccine back at the beginning of Oct. It was indicated that both husband and wife have previously had Covid, previously have taken Paxlovid, previously had a Covid vaccine, and are currently taking Paxlovid now.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick after taking the Pfizer vaccine; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-780965 (Moderna).  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick after taking the Pfizer vaccine".  Additional information: Method of assessment was Global Introspection. It was unknown if the patient experienced any additional symptoms/events.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: SARS-CoV-2 reinfection; SARS-CoV-2 reinfection; This is a literature report for the following literature source(s).  In January 2022, a 45-year-old woman developed symptoms of a COVID-19 infection. Her Long COVID symptoms included fatigue, breathing difficulties, and severe chest pain diagnosed as costochondritis. Over the first eight weeks of her illness, her Long COVID symptoms worsened and she experienced severe weight loss and migraines. Since that time, clinicians diagnosed her with chronic pericarditis, POTS, cardiac fibrosis, ME/CFS, and possible MCAS. Before her illness, she had received two doses of the Comirnaty vaccine (May and July 2021) and a dose of the Spikevax vaccine in January 2022 (immediately prior to her diagnosis). She received an additional dose of the Spikevax vaccine in September 2022. In October 2022, she completed a 5-day course of nirmatrelvir/ritonavir in the setting of a SARS-CoV-2 reinfection. She experienced three days with no fatigue and in which she described "feeling normal." However, these improvements did not persist, and she returned to her pre-reinfection baseline. Because of this temporary improvement, she completed a second, 15-day course of nirmatrelvir/ritonavir in late November 2022 outside of the context of an acute COVID-19 infection. This additional course of nirmatrelvir/ritonavir did not improve her fatigue or her other symptoms in any way.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202500004601 Same patient/drug/event; different dose.;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted COVID; contracted COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 83-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing), notes: medicine get every month. The patient took concomitant medications. Vaccination history included: Covid shot (dose number unknown, manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID". During an inbound call for financial assistance, the patient was calling in regards to Paxlovid. She said that she contracted COVID and her doctor prescribed the medication for her. The patient has never had COVID before, and thought when she travel, she must have picked it up, she got that, and she has it. She spoke with her doctor over the phone, and he wanted her to take it, and he wanted her to start it tonight. The patient also stated, "I actually got the shot, the new shot they had out, and I thought that was really going to protect me because I've gotten every shot they have out there for COVID." The patient stated, "I guess I'm trying to figure out what do I do; I was planning to have my son when he gets off, and he can come check on me, to pick up the medicine so I can start taking it."  Follow-up activities are possible, information on the batch number has been requested.
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Vomiting
Clinical narrative: vomiting; nauseous; Initial information received on 08-Jan-2025 regarding an unsolicited valid  non-serious case received from a Patient.  This case was linked with US-SA-2025SA012010.  This case involves Adult female patient (59.09 kg) who experienced vomiting and nauseous after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Fluoxetine HCL and Aripiprazole.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, frequency, route, formulation, strength and expiration date: not provided) for immunisation.  On an unknown date the patient developed vomiting and nauseous (nausea) (unknown latency).  Reportedly, patient states she was vomiting and nauseous for 1 week after receiving the flu vaccine, but she is feeling better now.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for both the events.; Sender's Comments:  US-SA-2025SA012010:
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: HIB component of PENTACEL was given to a patient, but it was reconstituted using a sterile diluent and the DTaP-IPV component was not administered with no reported adverse event; Initial information received on 07-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old male patient who received HIB component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel], but it was reconstituted using a sterile diluent and the DTAP-IPV component was not 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 Rotavirus vaccine; and pneumococcal vaccine CONJ 20V (CRM197) [Prevnar 20] both for Immunisation.  On 07-Jan-2025, the patient received 0.5 ml of dose 2  of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection with standard strength (expiry date- 30-Sep-2025 and lot UK112AA) once via intramuscular route in the right thigh as Immunization and HIB component of pentacel was given to a patient, but it was reconstituted using a sterile diluent and the DTAP-IPV component was not administered with no reported adverse event (single component of a two-component 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: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given 3 doses of HPV quadrivalent, competing the series at age 14. On recent visit with PCP on 10/22/2024 patient was given a 4th dose but with HPV9.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Incontinence, Intensive care
Clinical narrative: Patient stated stated feeling symptoms of very tight chest, extreme difficulty breathing at home about an hour after after vaccination. She called the ambulance and  was taking to hospital  and was incontinent at the hospital loosing a sizeable amount  of fluid. Patient stated was in the ICU until 12/10/24.
Age: 82.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: Patient said she had not received a flu vaccine for current season. Batched after vaccine given. Insurance rejected saying already received from another facility in August.
Age: 29.0
Sex: F
Vaccine: FLU3, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Axillary pain, Breast enlargement, Breast pain, Hypoaesthesia, Inflammation
Clinical narrative: pain in left arm Patient reports pain in left arm near deltoid and left axilla post vaccinations on 12/19/24. She states pain started in left deltoid area 2 days after getting immunizations, now radiating from neck down into all 5 fingers with associated numbness and tingling. Also describes pain radiating into left breast and axilla. Patient was seen at emergency room where they provided handout on lymphadenopathy, also recently seen with her PCP. On exam, sensation and strength of upper extremity are intact and symmetrical, there are no signs of infection at any injection sites. Her left upper extremity ROM is slightly decreased due to pain, however she is able to extend, flex, adduct, abduct, internally and externally rotate her left arm. Discussed in depth with patient that soreness, lymph node swelling, and inflammation can happen after immunizations. Patient is likely experiencing some inflammation post immunizations. Also discussed with patient potential for possible brachial neuritis, however she is not experiencing any weakness to left upper extremity. Advised to use ice, rest, continue taking diclofenac prescribed by her PCP. Discussed that pain radiating from neck down into fingers could possibly have to do with her neck and could be separate issue, and if symptoms do not resolve, speak to her PCP about work up. Seek care if unilateral weakness, lower extremity weakness, numbness, severe headaches, fevers, blurred vision or trouble speaking or any worsening symptoms. Patient agrees with this plan. All questions answered, no further concerns today. Patient left in stable condition. pain in axilla (Left) Patient reports left axillary pain and left breast pain after receiving immunizations on 12/19/24. She reports that her left breast has also been enlarged since getting vaccinations. Patient saw her PCP recently for this who ordered breast ultrasound and mammogram. No erythema, edema, signs of infection present on inspection of left breast or axilla. Tenderness to palpation of left axillary area, no tenderness to palpation of lateral aspect of left breast. Patient had mild cervical and left axillary lymphadenopathy. Vital signs stable. Patient was given ice pack for left axillary pain in office. Discussed with patient that lymph nodes can sometimes become enlarged and tender after immunizations and that her axillary pain is likely due to this. Also discussed with patient at length that breast pain can be due to multiple different etiologies and that it is very unlikely this pain is due to her recent immunizations. Encouraged patient to keep appointments for imaging and use diclofenac prescribed by her PCP for pain. All questions answered, no further concerns. Notes from clinic visit 1/9/2025
Age: 29.0
Sex: F
Vaccine: FLU3, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Injected limb mobility decreased, Injection site pain, Lymphadenopathy, Neck pain, Pain
Clinical narrative: pain in left arm Patient reports pain in left arm near deltoid and left axilla post vaccinations on 12/19/24. She states pain started in left deltoid area 2 days after getting immunizations, now radiating from neck down into all 5 fingers with associated numbness and tingling. Also describes pain radiating into left breast and axilla. Patient was seen at emergency room where they provided handout on lymphadenopathy, also recently seen with her PCP. On exam, sensation and strength of upper extremity are intact and symmetrical, there are no signs of infection at any injection sites. Her left upper extremity ROM is slightly decreased due to pain, however she is able to extend, flex, adduct, abduct, internally and externally rotate her left arm. Discussed in depth with patient that soreness, lymph node swelling, and inflammation can happen after immunizations. Patient is likely experiencing some inflammation post immunizations. Also discussed with patient potential for possible brachial neuritis, however she is not experiencing any weakness to left upper extremity. Advised to use ice, rest, continue taking diclofenac prescribed by her PCP. Discussed that pain radiating from neck down into fingers could possibly have to do with her neck and could be separate issue, and if symptoms do not resolve, speak to her PCP about work up. Seek care if unilateral weakness, lower extremity weakness, numbness, severe headaches, fevers, blurred vision or trouble speaking or any worsening symptoms. Patient agrees with this plan. All questions answered, no further concerns today. Patient left in stable condition. pain in axilla (Left) Patient reports left axillary pain and left breast pain after receiving immunizations on 12/19/24. She reports that her left breast has also been enlarged since getting vaccinations. Patient saw her PCP recently for this who ordered breast ultrasound and mammogram. No erythema, edema, signs of infection present on inspection of left breast or axilla. Tenderness to palpation of left axillary area, no tenderness to palpation of lateral aspect of left breast. Patient had mild cervical and left axillary lymphadenopathy. Vital signs stable. Patient was given ice pack for left axillary pain in office. Discussed with patient that lymph nodes can sometimes become enlarged and tender after immunizations and that her axillary pain is likely due to this. Also discussed with patient at length that breast pain can be due to multiple different etiologies and that it is very unlikely this pain is due to her recent immunizations. Encouraged patient to keep appointments for imaging and use diclofenac prescribed by her PCP for pain. All questions answered, no further concerns. Notes from clinic visit 1/9/2025
Age: 29.0
Sex: F
Vaccine: FLU3, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: pain in left arm Patient reports pain in left arm near deltoid and left axilla post vaccinations on 12/19/24. She states pain started in left deltoid area 2 days after getting immunizations, now radiating from neck down into all 5 fingers with associated numbness and tingling. Also describes pain radiating into left breast and axilla. Patient was seen at emergency room where they provided handout on lymphadenopathy, also recently seen with her PCP. On exam, sensation and strength of upper extremity are intact and symmetrical, there are no signs of infection at any injection sites. Her left upper extremity ROM is slightly decreased due to pain, however she is able to extend, flex, adduct, abduct, internally and externally rotate her left arm. Discussed in depth with patient that soreness, lymph node swelling, and inflammation can happen after immunizations. Patient is likely experiencing some inflammation post immunizations. Also discussed with patient potential for possible brachial neuritis, however she is not experiencing any weakness to left upper extremity. Advised to use ice, rest, continue taking diclofenac prescribed by her PCP. Discussed that pain radiating from neck down into fingers could possibly have to do with her neck and could be separate issue, and if symptoms do not resolve, speak to her PCP about work up. Seek care if unilateral weakness, lower extremity weakness, numbness, severe headaches, fevers, blurred vision or trouble speaking or any worsening symptoms. Patient agrees with this plan. All questions answered, no further concerns today. Patient left in stable condition. pain in axilla (Left) Patient reports left axillary pain and left breast pain after receiving immunizations on 12/19/24. She reports that her left breast has also been enlarged since getting vaccinations. Patient saw her PCP recently for this who ordered breast ultrasound and mammogram. No erythema, edema, signs of infection present on inspection of left breast or axilla. Tenderness to palpation of left axillary area, no tenderness to palpation of lateral aspect of left breast. Patient had mild cervical and left axillary lymphadenopathy. Vital signs stable. Patient was given ice pack for left axillary pain in office. Discussed with patient that lymph nodes can sometimes become enlarged and tender after immunizations and that her axillary pain is likely due to this. Also discussed with patient at length that breast pain can be due to multiple different etiologies and that it is very unlikely this pain is due to her recent immunizations. Encouraged patient to keep appointments for imaging and use diclofenac prescribed by her PCP for pain. All questions answered, no further concerns. Notes from clinic visit 1/9/2025
Age: 65.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Injection site pain, Joint stiffness, Pain, Pain in extremity
Clinical narrative: On 11/23/2024 Patient reported, by phone, pain with motion in the right arm, joint stiffness, and pain to the touch of the injection area.  We advised she see a medical provider to assess the issue.
Age: 0.42
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness around vaccine spot, warm to touch
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Laboratory test normal, Syncope
Clinical narrative: Patient told me that she got dizzy and fainted two days after her Arexy vaccine. She was taken to the hospital and tests were run but nothing was found to be wrong with her. The doctors felt it was from the vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: erythema and tenderness to left deltoid
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Quote from the facility staff "had to have her arm looked at because it is bruised from her shoulder down to her elbow on the side she got her shot done.  We recommend that she go to her doctor to get it checked out and they said that the shot must have nicked a vein which would of caused that to happen."
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site rash, Pruritus
Clinical narrative: patient experienced large rash around injection site. The prescriber suggested to do cold compress and gave her a cream for rash for itching.
Age: 67.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Patient received both vaccines in left arm because she told the administrating technician that she does not have lymph nodes in her right arm.  The administration went smooth and I asked patient  to stay around afterwards for 30 minutes because she has a history of   an allergic reaction to Boostrix in 2016.  when she received anaphylaxis.  She felt good after 30 minutes and left.  She went shopping and while shopping she passed out and fell and hit a shelf with her head. She does not remember anything but waking up with glass around her from the shelf. She did not go the ER or to the DR office. She did  leave a message with her neurologist and is waiting for a return call.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after receiving  meningitis shot
Age: 74.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse reaction pt got a second pneumonia shot within 2 years of last one.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient has received 2 doses of Shingrix in one day due to duplicate eRx being sent to our pharmacy. Patient received the dose in the clinic but provider also sent over an eRx to the pharmacy.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lymphadenopathy, Tinnitus
Clinical narrative: Tinnitus (whooshing in ears)     Went to Urgent Care Clinic on December 16, 2024, and prescribed prednisone 20 mg tablets for 5 days and taken off work for 2 days   Tinnitus is still in ears Fatigue dizziness swollen lymph nodes
Age: 68.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Extra dose administered
Clinical narrative: Patient presented to pharmacy requesting RSV vaccination, patient received second dose of RSV vaccination despite previously receiving an initial dose, contradictory to manufacturer and CDC guidelines. Patient did not present any complaints at time of vaccination regarding side effects that would result in need for treatment or any symptoms or signs in need of addressing.
Age: 87.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: pt inappropriately received a second RSV vaccine, first dose was administered 1/4/24. has not reported any rxn thus far.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: He claims that RPH may hit the needle to near neve. He took ibuprofen and aspirin and got no relief. He did stretching, ice pack and heat pack as per MD advise and no relief too. HIs main CX is difficulty raising his arm to not more than 30-40% and feels like stabbing pain. Symptoms started after couple days and subsided and came back. HIs pain went from his fingers to shoulder.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt inappropriately received an additional RSV dose. initial dose received 12/4/23. no reaction reported from pt thus far.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face, Urticaria
Clinical narrative: Woke up with swollen lips a couple days after vaccine which continued over the course of several months (now 4 months later, I will have swelling of the lips and face periodically). Hives presented a few days later and became progressively worse. I take one Zyrtec 10 mg every other day as the drug wears off. As soon as it wears off, my body will quickly develop hives. They are usually on my trunk, thighs, bikini line, low back, arms and neck. I?ve never had a reaction to any vaccine before.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient had already received a seasonal influenza vaccine on 9/30/24. She intended to get a Covid vaccine at our facility, but was administered a dose of adjuvanted seasonal flu vaccine. So, she received two influenza vaccines in the same season.
Age: 0.25
Sex: M
Vaccine: PNC20, UNK, UNK
Symptoms: Electroencephalogram, Magnetic resonance imaging, Seizure
Clinical narrative: More than one seizures , neurologist  prescribes keppra , still continuing seizures
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Raised rash that is red, warm to the touch, itchy, and aching .  Fatigue,
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm
Clinical narrative: Raised rash that is red, warm to the touch, itchy, and aching .  Fatigue,
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Pyrexia, Respiratory disorder
Clinical narrative: Patient experienced breathing issues & chills 30-60 min after shot. In about 90-120 minutes after shot, breathing fine, no chills, but got fever with 101.9 Took ibuprofen and tylenol to decrease fever. Waiting for fever to break after Tylenol.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain
Clinical narrative: Had soreness and pain immediately after vaccine administration described as atypical from past vaccination. Pain was persistent and progressive and eventually associated with decreasing range of motion and reduced function due to pain.
Sex: M
Vaccine: RSV
Symptoms: Atrial fibrillation
Clinical narrative: Atrial Fibrillation; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from Regulatory Authority. Regulatory number: 2679669-1 (VAERS ID).  A 72-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 02Sep2023 as dose number unknown, single (Lot number: HF7708) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "heart condition" (ongoing), notes: heart condition. The allergies history was none. The patient's concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 03Sep2023, outcome "recovered" (Sep2023). The event "atrial fibrillation" required physician office visit and emergency room visit. Clinical course: patient received RSV (Abrysvo) vaccine on 02Sep2023 at Pharmacy. Next day after receiving the vaccine, patient called to report of potential Atrial fibrillation the patient experienced based on the A Fib sensor device reader the patient wears. Pharmacist advised patient should follow up with his doctor or go to the emergency room. Patients doctor advised patient to go to the emergency room, where the A fib event the patient experienced was confirmed. Patient was treated at the emergency room and sent home. Patient was still concerned if he will have a repeat of the A Fib event. Pharmacy was reporting this event.   No follow-up attempts are possible. No further information is expected.  Follow-up (13Jan2025): This is a spontaneous follow-up report received from a contactable reporter (Consumer or other non HCP).  Updated Information: patient's age added.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired drug used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 30-year-old male patient who received HAV (Havrix) (batch number 55M72, expiry date 13-DEC-2024) for prophylaxis.   On 06-JAN-2025, the patient received Havrix (right arm). On 06-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Drug Used). The outcome of the expired vaccine used 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: 06-JAN-2025. The medical assistant stated that a patient received an expire dose Havrix on the day of reporting in right arm, which led to expired vaccine used. No reactions to report but reporter had questions on how to proceed.  The medical information, phone number and transfer was provided.
Age: 50.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Bursitis, Electromyogram, Eye irritation, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Tingling all limbs, mostly RUE. especially digits 1-3 volar   Temp sensitivity now. Numbness developing. Stinging burning. Tx GABA mg b complex diclofenac oral. Methocarb. Tenosynovitis. Mass. Bursitis.
Age: 50.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Pain, Paraesthesia, Scan with contrast, Temperature intolerance, Tenosynovitis
Clinical narrative: Tingling all limbs, mostly RUE. especially digits 1-3 volar   Temp sensitivity now. Numbness developing. Stinging burning. Tx GABA mg b complex diclofenac oral. Methocarb. Tenosynovitis. Mass. Bursitis.
Sex: U
Vaccine: PNC15
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported.; HCP stated that the VAXNUEVANCE vaccine expired on 01/10/2025 and was administered to a patient on 01/14/2025.; This spontaneous report was received from a nurse and refers to a patient with 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 14-JAN-2025, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X011735, expiration date: 10-JAN-2025, administered for prophylaxis (strength, dose and route of administration were not provided) (Expired product administered). It was stated that the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) vaccine did not have any previous temperature excursions. No additional adverse event (AE) reported (No adverse event).  Lot# is being requested and will be submitted if received.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix third dose; late second dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number 445TK, expiry date 09-AUG-2026) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in NOV-2023). Concurrent medical conditions included stem cell transplant and immunosuppression.   On 20-DEC-2024, the patient received the 3rd dose of Shingrix. In OCT-2024, the patient received the 2nd dose of Shingrix. In OCT-2024, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: late second dose of Shingrix). On 20-DEC-2024, the patient experienced extra dose administered (Verbatim: Shingrix third dose). The outcome of the drug dose administration interval too long and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 20-DEC-2024 and 23-DEC-2024 The pharmacist reported that a patient received third dose of Shingrix, which led to extra dose administered. At the moment of call patient was fine and no reactions. The vaccine administration facility was the same as primary reporter. The patient received an initial dose in November 2023 that facility was unaware of that as it was administered at different facility, after that they administered a second dose in October 2024, which led to drug dose administration interval too long. Health care professional mentioned during the conversation that patient was taking immunosuppressive medication for hematopoietic stem cell transplantation.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient called in January and stated since one week after receiving flu vaccine right arm she has problems with movement in that arm. She is visitng doctor for followup and treatment.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt. was given vaccines to early. No adverse reactions. (Vaccine administration error)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Apathy, Arthralgia, Fatigue, Immediate post-injection reaction, Injection site discomfort
Clinical narrative: Patient received the vaccine on 12/9 and immediately started feeling some discomfort as the medication was entering her arm. Patient did not think anything of it because she has had vaccines before, and she has some mild discomfort from it but this 1 did feel little different on the administration of the shingles vaccine. As the day progressed, she started feeling tiredness and nausea and had a little bit of reduced motivation to do her day-to-day tasks because of how she felt. She started experiencing left shoulder tenderness at the site of injection by the time she got home about 30 minutes later.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Patient received the vaccine on 12/9 and immediately started feeling some discomfort as the medication was entering her arm. Patient did not think anything of it because she has had vaccines before, and she has some mild discomfort from it but this 1 did feel little different on the administration of the shingles vaccine. As the day progressed, she started feeling tiredness and nausea and had a little bit of reduced motivation to do her day-to-day tasks because of how she felt. She started experiencing left shoulder tenderness at the site of injection by the time she got home about 30 minutes later.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Bradycardia, COVID-19, Dizziness, Electrocardiogram abnormal
Clinical narrative: Experienced Bradycardia following the administration of Paxlovid for treatment of Covid-19. Began taking Paxlovid within 1 day of symptoms and testing positive for Covid-19. I am NOT current on Covid-19 vaccine because I had severe allergic reaction to the booster (3rd dose) and mild reaction after 1st and second doses). The booster caused swelling and hives and blood test results showed elevated levels of iron saturation, and ferritin levels indicating possible hemochromatosis. So, its advised by a healthcare professional that I avoid receiving the Covid-19 vaccine, On day 4 of taking Paxlovid, HR dropped below 39 bpm and experienced dizziness, headache, and lightheadedness, which are still occurring after medication administered was completed on 5. Made an appointment with primary care provider and was given an EKG and it was determined that Bradycardia is present. Blood present was in the hypertension range (150/96) and was told to monitor at home for the next few days as BP is typically in the normal range. If symptoms do not improve within 48 hours, will need ton return to PCP for follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate decreased, SARS-CoV-2 test positive, Serum ferritin increased, Transferrin saturation increased
Clinical narrative: Experienced Bradycardia following the administration of Paxlovid for treatment of Covid-19. Began taking Paxlovid within 1 day of symptoms and testing positive for Covid-19. I am NOT current on Covid-19 vaccine because I had severe allergic reaction to the booster (3rd dose) and mild reaction after 1st and second doses). The booster caused swelling and hives and blood test results showed elevated levels of iron saturation, and ferritin levels indicating possible hemochromatosis. So, its advised by a healthcare professional that I avoid receiving the Covid-19 vaccine, On day 4 of taking Paxlovid, HR dropped below 39 bpm and experienced dizziness, headache, and lightheadedness, which are still occurring after medication administered was completed on 5. Made an appointment with primary care provider and was given an EKG and it was determined that Bradycardia is present. Blood present was in the hypertension range (150/96) and was told to monitor at home for the next few days as BP is typically in the normal range. If symptoms do not improve within 48 hours, will need ton return to PCP for follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Generalised tonic-clonic seizure
Clinical narrative: Patient received 2nd Shingrix vaccine in the afternoon. Patient is on seizure medications but a clonic-tonic seizure had been triggered by the afternoon. Patient knows that this was caused by the vaccine as she experienced a more serious clonic-tonic seizure after receiving the Moderna's COVID-19 vaccine 03/22/2021.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Employee (patient) states later that evening noticed increased swelling of left upper arm (smaller than the size of a golf ball. Pain and red streaks near injectin site and radiating down to left lower arm. Employee applied ice that evening, took ibuprofen, Benadryl and Zyrtec. Employee reported reaction on 1/16/25 to Nursing supervisor when she returned to work. Employee was sent to Employee Health (per her request for further examination). She does report her Left arm is improving, swelling has decreased and decreased pain. No red streaks noticed going down her left arm, states improved.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Axillary pain, Mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Pain in arm, shoulder, armpit and elblow. Unable to lift  arm above head or straighten elblow out. SIRVA
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Mobility decreased, Nervous system disorder
Clinical narrative: Pain in arm, shoulder, armpit and elblow. Unable to lift  arm above head or straighten elblow out. SIRVA
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardioversion, Resuscitation, Sudden death, Syncope
Clinical narrative: Sudden death of male likely 67 to 68 at time of his initial inoculations. On 10/29/23 victim collapsed while dancing. Ambulance arrived at the scene. He worked in music. I believe he met the criteria of "fully vaccinated" because state mandated these inoculations by August 2021 to attend music events. IMO he was inoculated at clinic. Can't obtain dates, lot, maunfacturer et website DOB-address obtained via online website There is also another report that states different as his DOB.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Respiratory disorder, Sudden death
Clinical narrative: Online report of sudden death in female EUA recipient that was weeks away from her birthday. At that time of inoculations victim was 49-years-old. DOSE#1 Date 03/11/2021 LOT# ? DOSE#2 Date 04/08/2021 Lot# ?. Victim on 04/21/21 made a social media post-that described post Inoculation (of dose#2) adverse events taking place after day 5 fasting until day 13. She stated her adverse events as chills, temp, weakness and breathing. Despite being active on social medica her last post was on 10/11/21. Victim died in her residence according to obituary. There is conflicting data on city-ounty of victim at time of death, social media profile states as home. Online obituary states another location as place of residence. Estimated DOSE#2 date arrived by subtracting 13 days from 04/21/21 as per victims social media post.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Condition aggravated, Haemoglobin decreased, Heavy menstrual bleeding, Hysterectomy
Clinical narrative: ANEMIA / LOW HGB / LONG PERIODS WITH LOT OF BLOOD / LOST OF VISION PARTIALLY / HEMORRATIAL VITRIUS
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Transfusion, Visual impairment, Vitreous haemorrhage
Clinical narrative: ANEMIA / LOW HGB / LONG PERIODS WITH LOT OF BLOOD / LOST OF VISION PARTIALLY / HEMORRATIAL VITRIUS
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became red, hot, sore, itchy, and swollen. A large rash lasted for over a week. I used an ice pack to help with pain; I also took Tylenol.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Injection site became red, hot, sore, itchy, and swollen. A large rash lasted for over a week. I used an ice pack to help with pain; I also took Tylenol.