chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Heart rate increased, Hyperhidrosis, Insomnia
Clinical narrative: Fever, chills, sweats, headache, insomnia, rapid heart beat for no reason,   Feeling better mid morning after shower and liquids
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, sweats, headache, insomnia, rapid heart beat for no reason,   Feeling better mid morning after shower and liquids
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Symptoms from Shingles began to dissipate after the first shot.  But after this, the second shot, I began to suffer shingles outbreaks on various places on my body--where I had not had them before. Now, a year later, the symptoms are slowly going.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Employee described the event as swelling, redness, and pain two days after injection given. Stated that is lasted for approximately 2 days.  Employee did not report event until time to complete the second series.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dysstasia, Fatigue, Headache, Muscle spasms
Clinical narrative: Exactly 12 or 13 hours after shot i had chills, high fever, severe muscular cramping (legs, upper back) .   Not naseaus yet.  Medium headache , severe fatigue, i had to crawl to the bathroom cause I couldn't stand up.     I'm writing this about 10:30 am and think I'm feeling a little better.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Exactly 12 or 13 hours after shot i had chills, high fever, severe muscular cramping (legs, upper back) .   Not naseaus yet.  Medium headache , severe fatigue, i had to crawl to the bathroom cause I couldn't stand up.     I'm writing this about 10:30 am and think I'm feeling a little better.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: Flu-like symptoms, pain at injection site and overall achiness, headache, tiredness, nausea, shivering
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Flu-like symptoms, pain at injection site and overall achiness, headache, tiredness, nausea, shivering
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: Nausea, shivery chills, pain at injection site, headache, flu like feeling.  Extreme fatigue.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Nausea, shivery chills, pain at injection site, headache, flu like feeling.  Extreme fatigue.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Ocular discomfort, Ophthalmological examination, Pain of skin
Clinical narrative: Patient  stated on 10/14 she felt her left temple was very sensitive to the touch and she observed the area was also red. She also had sharp pains on her scalp. It was very sensitive it was very difficult to touch her hair. She experienced pressure on her left eye and had to go to her optometrist to get checked out. On 10/19 she saw the NP at her PCP's office who diagnosed her with shingles. Her scalp and forehead are irritated and she is still under treatment with her ophthalmologist. She states her scalp is still sensitive to the touch. It is like ten or more very painful sharp pain needles in her scalp that are hurting very bad and itches a lot.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Sensitive skin, Skin irritation
Clinical narrative: Patient  stated on 10/14 she felt her left temple was very sensitive to the touch and she observed the area was also red. She also had sharp pains on her scalp. It was very sensitive it was very difficult to touch her hair. She experienced pressure on her left eye and had to go to her optometrist to get checked out. On 10/19 she saw the NP at her PCP's office who diagnosed her with shingles. Her scalp and forehead are irritated and she is still under treatment with her ophthalmologist. She states her scalp is still sensitive to the touch. It is like ten or more very painful sharp pain needles in her scalp that are hurting very bad and itches a lot.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased, Sleep disorder
Clinical narrative: Patient described shoulder pain that intiated the day of dose and is still continued 3 months later. Patient reports difficulty moving arm in common activities such as putting on clothes. Pain wakes her up serveral times at night still. She has noticed slow improvement over the 3 months, but the pain is still there.
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no adverse effect reported; INADVERTENT administration to adult female patient; INADVERTENT administration to adult female patient; This spontaneous report was received from a physician and refers to an adult female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 03-NOV-2020, the patient was inadvertently administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route of administration, lot# and expiration date were not reported). No adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 27-NOV-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1637642, expiration date 28-MAY-2022, 0.5 milliliter; route was not reported) for prophylaxis (product storage error). There was previous temperature excursion. Data logger was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637642; expirationdate: 28-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Myalgia
Clinical narrative: had some discomfort; having periodic muscle aches in the arm injected; This is a spontaneous report from a contactable pharmacist. The reporter reported similar events for two patients, this is the first of two reports. A 77-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration in Sep2020 in arm at single dose for immunization. The patient's medical history and concomitant medications were not reported. Pharmacist calling to report administering pneumococcal 13-val conj vac (dipht crm197 protein) to a female patient in Sep2020 who had some discomfort at the time. She still reports having periodic muscle aches in the arm injected. Responds to heat from shower and paracetamol (TYLENOL). No radiating pain down arm, into hands, or in shoulder.  No swelling or bruising at site.  Caller reports no warmness, infection, or cellulitis. Patient has not received PPSV23 vaccine. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020483600 same reporter/drug, similar events, different patient
Sex: M
Vaccine: PNC13
Symptoms: Myalgia
Clinical narrative: Intermittent muscle pain; This is a spontaneous report from a contactable pharmacist. This physician reported similar events for two patients, this is the second of two reports. A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration in 2019 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced intermittent muscle pain a year ago (2019) that resolved after a few months.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020483510 same reporter/drug, similar events, different patient.
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: redness and warmth to touch below injection site; redness and warmth to touch below injection site; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A male patient of an unspecified age (reported as 63 without unit) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness and warmth to touch below injection site on an unspecified date with outcome of unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves a female patient age unknown who got the flu for some reason (influenza), when she received INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and expiration date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE years ago .  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment or not.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Fatigue, Headache, Pain
Clinical narrative: headache; Body ache; more tiredness; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case is linked to case 2020SA300039.  This case involved adult patient who experienced headache, body ache (Pain) and more tiredness (Fatigue), while patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced headache, body ache (Pain) and more tiredness (Fatigue), unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  Final diagnosis was more tiredness, body ache and headache.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all the events at the time of reporting.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: symptoms of the flu; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case is linked to cases 2020SA281563 and 2020SA317467 (same reporter).  This case involves a male patient (age unspecified) who had symptoms of flu (Influenza like illness), when he received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had symptoms of flu (influenza like illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  The reporter stated that a person can have a reaction to the flu shot. She did her son did and she spoke to several of her friends that have had the same thing happened to them. They had all the symptoms of the flu.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Bedridden, Malaise
Clinical narrative: patient in bed for 2 weeks; sick; Initial information received on 03-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer (patient) via social media.  This case involves a patient of an unknown demographics who was sick (Illness) and in bed for 2 weeks (bedridden), when received INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed was sick (Illness, non-serious event) (Unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date, the patient was in bed for 2 weeks (bedridden, serious event) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was leading to disability.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Events outcome was unknown, at the time of reporting.  Information on the batch number was requested for this case.; Sender's Comments: This case concerns patient who was presented Illness and was bedridden with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset for both events was unknown. However, patient's medical condition, Laboratory and concomitant medications were ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: The product was exposed to a low temperature of 1.7 degrees Celsius for 2 hours and 15 minutes/no AE; No patient involved, unknown reason of temperature excursion and stability data too not reported.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent to 13 separate patients on different days with no adverse event; Initial information received on 15-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional (pharmacy manager) via call center.  This case is linked to cases 2020SA323787, 2020SA323795, 2020SA323899, 2020SA323872, 2020SA323616 and 2020SA323597 (same reporter).  This case involves a 38 year old female patent for whom it was reported that a pharmacist was supposed to give fluarix, however accidentally grabbed and administered influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] to 13 separate patients on different days (wrong product administered) on 13-Nov-2020 (batch number: UJ552AA and expiration date: 30-Jun-2021) at a dose of 0.7 ml once via intramuscular route in the left arm for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event wrong vaccine administered (latency: 7 days).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good Pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Aphonia, Dysphagia, Immunoglobulin therapy, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: Given that this was one of the last vaccines I had received in 2013 before being diagnosed with Miller Fisher Variant Gullian Barre Syndrome in 2015. During 2014, late July, I started experiencing the lost of my voice. I thought it was sore throat, but after going weeks with no signs of getting better, I started going to different docotrs trying to find out what was wrong with me. I've made repeated trips t the ENT were I was getting a camera down my nose almost every time I went. They found nothing. It wasn't until I was recommended to go see a neurologist who after running a couple of in office test, told me to admit myself in the hospital when I've finally been diagnosed. After more being ran, spinal taps, speech pathologist, and blood transfusions all they could tell me was that what I had closely resembles Miller Fisher Variant Gullian Barre Syndrome. I can no longer speak normally, I speak with a whisper and it is harder for me to swallow food without choking. Swimming has also become more difficult for me since the back of my throat/ vocal chords are  partially paralyzed its harder for me to hold my breathe under water.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Lumbar puncture, Miller Fisher syndrome, Speech disorder, Transfusion, Vocal cord paralysis
Clinical narrative: Given that this was one of the last vaccines I had received in 2013 before being diagnosed with Miller Fisher Variant Gullian Barre Syndrome in 2015. During 2014, late July, I started experiencing the lost of my voice. I thought it was sore throat, but after going weeks with no signs of getting better, I started going to different docotrs trying to find out what was wrong with me. I've made repeated trips t the ENT were I was getting a camera down my nose almost every time I went. They found nothing. It wasn't until I was recommended to go see a neurologist who after running a couple of in office test, told me to admit myself in the hospital when I've finally been diagnosed. After more being ran, spinal taps, speech pathologist, and blood transfusions all they could tell me was that what I had closely resembles Miller Fisher Variant Gullian Barre Syndrome. I can no longer speak normally, I speak with a whisper and it is harder for me to swallow food without choking. Swimming has also become more difficult for me since the back of my throat/ vocal chords are  partially paralyzed its harder for me to hold my breathe under water.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Nausea, Tinnitus
Clinical narrative: Same day, 6pm, started having severe loud ringing in ear/tintis. Then I became nauseated. Ringing began in the left ear, then it moved to right ear. Was more severe in left ear. Still having ringing, but not as bad as day of vaccine. Ringing has not subsided. I have history of tinitus, but it's worse now. Unsure of which flu or Pneum shots were given one month prior to getting the shingrix vax (were given 3 weeks prior to getting the shingrix, one in right, one in left, unsure of which shot in which arm).
Age: 61.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site bruising, Injection site pain, Pain in extremity
Clinical narrative: Vaccines on 12/4/2020. Called on 12/9/2020 inquiring about side effects. Reports pain to left arm even at rest, but pain traveling from the shoulder to the elbow periodically as well.  ROM not effects. States site is not swollen,  does report small bruise to injection site.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Growth disorder, Haematochezia, Mucous stools, Vomiting
Clinical narrative: Blood in stool. Mucous in stool. Increased vomiting since vaccination. Drop on growth curve despite adequate feeds.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Sore arm
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Developed urticaria on the L side of the forehead, L cheek, abdomen
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Pain and rash at injection site
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Hyperhidrosis, Hypersomnia
Clinical narrative: Shaking from chills, Diarrhea, vomiting, sweats, headache, body aches, slept 36 hours Finally better Thursday noon 11.19.2020
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Vomiting
Clinical narrative: Shaking from chills, Diarrhea, vomiting, sweats, headache, body aches, slept 36 hours Finally better Thursday noon 11.19.2020
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, hot to touch, redness, hard and some pain at injection site
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Migraine, Pain, Pyrexia, Sleep disorder
Clinical narrative: Woke up around 3/3:30am (12/8) with migraine and achy all over (teeth, fingers etc), sweating, couldn't find a comfortable position.  Took 1 Motrin PM at 5:30am. Woke at 8am took 1 Sumatriptan 100mg . Took 1 Excedrin Migraine pill at 12pm because of migraine. Took 2 Sumatriptan at 8pm bc of migraine. Fever was holding around 100-101 all day. This morning (12/9) migraine is gone and fever is 99.8. I'm only reporting this because I've never had a reaction to the flu shot before, so this surprised me. (Also, I don't know the lot#, the NDC# is 33332-0420-10
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Received pediatric dose instead of adult.
Age: 68.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Joint range of motion decreased, Pain, Peripheral swelling, Swelling
Clinical narrative: Pt had flu and PPV23 admin IM to L arm on 11/2/20 and subsequently developed localized Pain and swelling that traveled down to hand, swelling improved but continued to have some Pain in elbow w/reduced ROM, but gradually improving
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Kinrix . This vaccine is for 4-6 year olds.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Feeling hot
Clinical narrative: Fever over 101.00 recording at approximately 2.30AM, patient had taken dose of tylenol at approximately 1:30 after feeling very warm in bed with chills, joint pain and body weakness; symptoms lasted for about 24 hours. Several days after symptoms of body weakness and tiredness
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever over 101.00 recording at approximately 2.30AM, patient had taken dose of tylenol at approximately 1:30 after feeling very warm in bed with chills, joint pain and body weakness; symptoms lasted for about 24 hours. Several days after symptoms of body weakness and tiredness
Age: 74.0
Sex: M
Vaccine: MENB, MNQ, PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: the day after he received the vaccines, he developed swelling, erythema,  warmth and pruritus of his left arm  that lasted several days. No fever. No systemic symptoms.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Haematoma, Pain in extremity, Swelling
Clinical narrative: hematoma, swelling, pain in arm
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Disturbance in attention, Ear pain, Fatigue, Impaired work ability
Clinical narrative: 12/4   vaccine 12/5  woke up with fever 102.6.   Could only take small sips of water or tea.    Threw up what little food eaten.   Throughout the day tried:  3-5 blue berries(AM),   small flakes of Hawaiian roll (late afternoon),  small slice of banana (9pm).    Spent most of day in bed,  could barely watch TV for 30 minutes.    Sinus & ear pain all day.   12/6   woke up, temperature ~100.   Able to drink 2-3 ounces.   Appetite returning and able to take fluids normally.   Normal temperature by evening.   Sinus & ear normal. 12/7   no temperature.    Stay home from work to ensure better.   Light activity & normal appetite.    Very thirsty shortly before bed .   16-20 ounces of water and still thirsty, ~4 ounces OJ seemed to quench thirst. 12/8   no temperature.    Felt slightly off as got ready for work.   Left work after 3 hours at desk ? fatigued and poor concentration.     Felt tired remainder of the day.   12/9   no temperature  seem fine
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Sinus pain, Thirst, Vomiting
Clinical narrative: 12/4   vaccine 12/5  woke up with fever 102.6.   Could only take small sips of water or tea.    Threw up what little food eaten.   Throughout the day tried:  3-5 blue berries(AM),   small flakes of Hawaiian roll (late afternoon),  small slice of banana (9pm).    Spent most of day in bed,  could barely watch TV for 30 minutes.    Sinus & ear pain all day.   12/6   woke up, temperature ~100.   Able to drink 2-3 ounces.   Appetite returning and able to take fluids normally.   Normal temperature by evening.   Sinus & ear normal. 12/7   no temperature.    Stay home from work to ensure better.   Light activity & normal appetite.    Very thirsty shortly before bed .   16-20 ounces of water and still thirsty, ~4 ounces OJ seemed to quench thirst. 12/8   no temperature.    Felt slightly off as got ready for work.   Left work after 3 hours at desk ? fatigued and poor concentration.     Felt tired remainder of the day.   12/9   no temperature  seem fine
Sex: U
Vaccine: FLUX
Symptoms: Adverse drug reaction
Clinical narrative: after flu shots, patient got bad reactions; Initial information regarding an unsolicited valid non-serious case received from a consumer(patient) via social media on 15-Dec-2020.  This case involves a patient of unknown demographics who was reported to have after flu shots, patient got bad reactions (Adverse drug reaction), while he/she received vaccine Influenza Vaccine.   The patient's medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiration date unknown) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date (latency unknown) after the administration of suspect the patient was reported to have after flu shots, patient got bad reactions (Adverse drug reaction).   It was not reported if the patient received a corrective treatment.  The outcome was unknown for adverse drug reaction.  There will be no information available on the batch number for this case.       The reporter assessed the causal relationship with suspect vaccine as related.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: 6 days after patient received influenza vaccine patient was sick; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via social media and transmitted to Sanofi on 22-Oct-2020.  This case is linked to case 2020SA300039.  This case involves a patient of an unknown age for whom it was reported that six days after the patient received influenza vaccine, the patient was sick (illness).  Medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, six days after the patient received influenza vaccine, the patient was sick (illness).  Final diagnosis was illness.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for illness.  There will be no information regarding the batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: patient made patient sick two years ago; Initial information regarding an unsolicited valid non-serious case received from a consumer (Patient) social media and transmitted to Sanofi on 23-Oct-2020.  This case involves patient with unknown age who INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via unknown route in unknown administration site for prophylactic vaccination made patient sick two years ago (Illness).  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   Final diagnosis was Illness.  No relevant laboratory tests were reported.   It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for Illness.  There will be no information regarding batch number for the case.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: 51 year old female patient administered expired dose of Tenivac, no AE; Initial information received on 16-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 51 year old female patient who was vaccinated with an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  Patient did not received other vaccines.  On 06-Oct-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6101AA and expiry date: 23-Oct-2020) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gait inability, Headache, Hot flush, Impaired work ability
Clinical narrative: This is to report reaction to the second series shot of the Shingrix vaccine.  The first was given on 2/5/19 with no side effect.   The second shot was administered in the morning on 4/7/19, by the  evening I developed a moderate headache and nausea.  At approx 2:00 in the morning I woke with severe alternating chills and hot spells, my legs were shaking, headache was increased and nausea was increased.  I tried to get out of bed as I was going to vomit and couldn't stand due my legs shaking and loss of lower muscle strength.  I crawled to the backroom where I did vomit and had vertigo with extreme cold chills.  My husband assisted me back to bed where the above side effects continued until mid morning (9 am).  I was then able to sit up with continuation of a headache, nausea, profound weakness and vertigo.  This continued throughout the day until the following morning.  I was not able to go to work the day of the reaction.   I have never had a reaction to any vaccine and I have had annual influenza and required pneumococcal vaccines in the past.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Nausea, Tremor, Vertigo, Vomiting
Clinical narrative: This is to report reaction to the second series shot of the Shingrix vaccine.  The first was given on 2/5/19 with no side effect.   The second shot was administered in the morning on 4/7/19, by the  evening I developed a moderate headache and nausea.  At approx 2:00 in the morning I woke with severe alternating chills and hot spells, my legs were shaking, headache was increased and nausea was increased.  I tried to get out of bed as I was going to vomit and couldn't stand due my legs shaking and loss of lower muscle strength.  I crawled to the backroom where I did vomit and had vertigo with extreme cold chills.  My husband assisted me back to bed where the above side effects continued until mid morning (9 am).  I was then able to sit up with continuation of a headache, nausea, profound weakness and vertigo.  This continued throughout the day until the following morning.  I was not able to go to work the day of the reaction.   I have never had a reaction to any vaccine and I have had annual influenza and required pneumococcal vaccines in the past.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased
Clinical narrative: High heart rate
Age: 54.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Cellulitis, Fatigue, Injection site erythema, Pain, Skin warm
Clinical narrative: PATIENT NOTICED IMPROPER TECHNIQUE WHEN GIVING VACCINE, SAID NEEDLE HIT TABLE BEFORE GIVING INTO HER ARM. A DAY OR TWO LATER SHE NOTICED REDNESS AROUND INJECTION, MARKED IT WITH A MARKER TO TRACK. CAME IN TO CLINIC TODAY TO GET TREATED FOR CELLULITIS, OBSERVED REDNESS EXPANDED INTO UPPER ARM, WARM TO TOUCH. PATIENT STATED SHE FELT TIRED AND SORE. NO FEVER REPORTED
Age: 50.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Nausea
Clinical narrative: This was second of two shots for the shingles vaccine. The first time I got chills and body aches and was tired. That was it. This time, I have chills no body aches and very strong nausea. I am having to exert control to keep anything down (bananas, oatmeal).
Age: 32.0
Sex: F
Vaccine: FLUR4, TDAP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: PT WAS ADMINISTERED BEFORE DISCOVERY CURRENT PREGNANCY AT ESTIMATED 9 WEEKS.
Age: 41.0
Sex: M
Vaccine: HPV9
Symptoms: Underdose
Clinical narrative: No additional AE reported; patient received his first dose of GARDASIL 9 in February 2020. He has not received his second dose yet; This spontaneous report was received from a physician referring to a 41 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     In February 2020, 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) 0.5 milliliter, for prophylaxis (strength, route of administration, anatomical location, lot # and expiration date were unknown).         In December 2020, the patient had not received his second dose yet which had to be received approximately in April 2020. Patient had been placed on hold due to the pandemic. No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Ischaemic stroke, Tinnitus
Clinical narrative: Sudden ringing in his right ear, numbness to the right of his face, arm and leg; This spontaneous report as received from a lawyer and refers to a patient of unknown age and gender concerning a case in litigation. The patient's medical history, concurrent conditions, historical drugs and concomitant therapies were not reported.  On 02-DEC-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for prevention of shingles (herpes zoster) (dose, route, lot number and expiration date were not reported).         On an unknown date, the patient sudden suffered ringing in his right ear, numbness to the right of his face, arm and leg. The patient was hospitalized and diagnosed with an acute ischaemic stroke. the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries.The patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The outcome of ischaemic stroke was reported as unknown. The reporter considered ischaemic stroke to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, the event was considered medically significant.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: was sick; Initial information was received on 07-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) who was sick (illness), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious was sick (illness) (24 hours) following the administration of INFLUENZA VACCINE. It was reported that the patient was remained sick for 5 more days.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: was turned up sick; Initial information was received on 08-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves patient (unknown demography) who was turned up sick (illness), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious was turned up sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Illness, Influenza, Malaise
Clinical narrative: flu; very sick; Initial information was received on 09-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) who had flu (influenza) and very sick (illness), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had flu (influenza) and very sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Near death experience
Clinical narrative: she nearly died from the flu after the shot; Initial information was received on 02-Dec-2020 regarding an unsolicited non-valid serious case from a consumer or non-health care professional via social media.  This case involves a female patient (age unspecified) who nearly died from the flu (influenza), while she received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [batch number and expiry date not reported] via an unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient nearly died from the flu after the shot (influenza, non-serious) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for influenza.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: seriously ill; Initial information was received on 03-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient's son/ daughter) via social media.  This case involves female patient (age not specified) who had seriously ill (illness), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious (severe) seriously ill (illness) (Unknown latency) after the administration of INFLUENZA VACCINE.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: red swollen arm warm to touch no streaking
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Joint range of motion decreased, Pain in extremity, Vaccination site pain
Clinical narrative: Pt described an extended time of vaccination site pain. Pt receive the vaccine in october and still experiencing pain in december. Symptoms include limited ROM with pain at the injection site. no redness or fever. Pt describes pain and numbness from shoulder down to fingertips. Current treatment with NSAIDS and Neurontin. Pt referred to physical therapy.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Flushing, Headache, Nausea, Pain
Clinical narrative: PAIN BEGAN IN RIGHT ARM AND CREPT DOWN RIGHT SIDE INTO HIP. BY AM WHOLE BODY ACHED AND COULD HARDLY GET OUT OF BED. ALL JOINTS WERE PAINFUL.NAUSEA. HEADACHE. FEVER 104. FLUSHING OVER ENTIRE BODY. BARELY STAND
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: PAIN BEGAN IN RIGHT ARM AND CREPT DOWN RIGHT SIDE INTO HIP. BY AM WHOLE BODY ACHED AND COULD HARDLY GET OUT OF BED. ALL JOINTS WERE PAINFUL.NAUSEA. HEADACHE. FEVER 104. FLUSHING OVER ENTIRE BODY. BARELY STAND
Age: 17.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Facial paralysis, Headache
Clinical narrative: headaches for 3 days Starting on 11/30/2020, and Facial drooping on 12/2/2020.  GLYCERIN-HYPROMELLOSE-PEG 400 (ARTIFICIAL TEARS) 0.2-0.2-1 % SOLN    Administer 1 drop into the right eye 4 times daily as needed for Dry Eyes for up to 7 days. Order Dose: 1 drop PREDNISONE (DELTASONE) 20 MG TABLET    Take 3 tablets by mouth daily for 7 days. Order Dose: 60 m VALACYCLOVIR (VALTREX) 500 MG TABLET    Take 2 tablets by mouth 3 (three) times daily for 7 days. Order Dose: 1,000 mg.    Is being sent to Physical Therapy
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Foetal disorder, Foetal heart rate abnormal, Human chorionic gonadotropin, Ultrasound antenatal screen abnormal
Clinical narrative: Fetus stopped developing right after getting the INFLUENZA VIRUS VACC QUAD 3 YRS & OLDER . At 6 weeks.  Patient had a partial molar pregnancy the year before.  No complication before getting the vaccine.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: NO ADVERSE REACTION, WRONG VACCINATION GIVEN
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Lethargy, Rash
Clinical narrative: Mom called on 12/9/20 stating that her daughter was lethargic, a rash had started on her right cheek and around the right eye and is now on her chest and back. Mom describes rash as little bumps. Also states that around the site it is read and raised, about a dime-sized. This writer encouraged mom to take her to a walk-in clinic to be seen, mom was worried that she would be told it is just a regular reaction and abut the cost of the office visit. Strongly encouraged mom to have her checked out, it could be a reaction, but hard to tell over the phone.
Age: 79.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient noticed significant swelling and pain on her left arm and side after vaccinations.  By the time she presented to the pharmacy after vaccination, it had been 5 days and the swelling was going down.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Abortion spontaneous, Exposure during pregnancy, Pyrexia, Subchorionic haemorrhage
Clinical narrative: 14 and 6 weeks pregnant with identical twins. Complications of sub chorionic hemorrhages. Due date May 15, 2021. Following the flu vaccine, I developed a low grade fever at home. Stomach pain was increased. I carried the low grade fever the next three days and miscarried the twins.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash pruritic, Skin warm
Clinical narrative: Patient broke out in rash around and below injection site, claimed rash was itchy and warm to the touch. doctor prescribed triamcinolone cream
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Per patient: numbness to entire left arm at vaccine administration that lasted less than 30 min. 2-3 days later severe pain in shoulder and shooting down arm. pain in arm has persisted for 2 weeks without improvement. numbness/tingling/weakness to arm also.   On exam: weakness and altered sensation present to left hand. Pain reported.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Per patient: numbness to entire left arm at vaccine administration that lasted less than 30 min. 2-3 days later severe pain in shoulder and shooting down arm. pain in arm has persisted for 2 weeks without improvement. numbness/tingling/weakness to arm also.   On exam: weakness and altered sensation present to left hand. Pain reported.