chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Asthma, SARS-CoV-2 test
Clinical narrative: asthma symptoms; Initial information was received on 20-Jan-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional [under reference number: US-SA-SAC20210128000259].  This case involves an adult patient who experienced asthma symptoms (asthma), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It is unknown if the patient had any concomitant disease or risk factor.  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 a non-serious asthma symptoms (asthma) unknown latency following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  Relevant laboratory test results included: On an unknown date SARS-CoV-2 test [Covid test] was done.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information on batch number of this case.
Age: 0.67
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: the 8 month old patient recived 2 doses of Menactra  2 month and 6 days apart, no AE; the patient received first dose of Menactra when she was 8 month and 18 days old, no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00437336) and transmitted to Sanofi on 20-Jan-2021.  This case involved an 8 month and 18 days old female patient who was vaccinated with the first dose (one dosage form) of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on an unknown date of Sep-2019 (product administered to patient of inappropriate age) and the second dose (one dosage form) of same vaccine received at the age of 10 months and 14 days (total duration 2 months and 6 days) (Inappropriate schedule of product administration) on an unknown date of Nov-2019 (batch number and other dosing details were not reported) for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   This was an actual medication error due to drug dose administration interval too short and Inappropriate age at vaccine administration (latency same day).  At the time of reporting, no adverse event reported to the patient.  The reporter wanted to know if this vaccination was enough.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: medication error with Pentacel described as the DTap-IPV portion was given and the Hib powder portion not given with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist and transmitted to Sanofi on 21-Jan-2021.  The case involved an unknown age patient who received Pentacel which was described as the DTap-IPV portion was given and the HIB powder portion was not given (Product preparation issue).  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  It was a case of actual medication error due to inappropriate reconstitution technique (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was 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 Disclaimer: Practices. The classification as a medical error was 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 had contributed to or was to be held liable for the occurrence of this medication error.  There would be no information available on the batch number for this case.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient had received an expired Fluzone HD vaccine/ No AE; Initial information received on 21-Jan-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 57 year old female patient who vaccinated with an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] inadvertently (expired product administered).  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  On 21-Jan-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ249AA and expiry date: 30-Apr-2020) via unknown route in unknown administration site.  It was a case of actual medication error due to expired vaccine used.  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: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Feeling of body temperature change, Migraine, Monoplegia, Sleep disorder
Clinical narrative: 0920 Cleared to leave 0930  Started feeling tired /fatigued  1900 Arms started to become sore, Migraine Headache 2330 Took Tylenol PM 0100 -0300 Restless sleep , body temperature hot & cold but no fever;  arm sore; took ibuprofen   Sun, 31 Jan 21 0900 Woke up with Migraine headache, arms still sore , tired ..stayed in bed all day Mon, 1 Feb 21 Feeling much better; no migraines
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Migraine, Myalgia, Pyrexia, Vomiting
Clinical narrative: Vomiting, Fever >102, diarrhea, arthralgia, myalgia, migraine
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Large swelling of lumphatic system. Lymph nodes are visibility swollen all along arm and immensely painful when moving arm.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Lethargy, Myalgia, Nausea, Pyrexia
Clinical narrative: Chill, lethargy, nausea, slight fever of 98.6F, muscle soreness  lasted about 20 hours  symptoms improved after taking  Advil, a total of 4 pills, each with 4~6 hours apart
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Dyspnoea, Fatigue, Headache, Hot flush
Clinical narrative: About 2 hrs after second dose shortness of breath and throat starting to swell for around 15 min then went away on its own. Next morning 1/28 very sore leg muscles, hot flashes, headache. As day went on my limbs were tingling and had some numbness.  Increasingly getting fatigue and wasn't able to keep my head up for more than 30sec with out it falling. By 5p I could not move left arm at all and called PCP office and went to ER. Over 5 hours I got  feeling back in left arm and left ER at 10:30p. CT was done to rule out stroke or other injury. Next day around 2p my right arm started to get more numb and I wasn't able to move it much. SOB and throat tightening came back briefly. Later that day lumbar puncture done to rule out guillain barre syndrome. Numbness is not as severe now 2/3 and each day since 1/28 it gets increasingly less
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Lumbar puncture normal, Mobility decreased, Myalgia, Paraesthesia
Clinical narrative: About 2 hrs after second dose shortness of breath and throat starting to swell for around 15 min then went away on its own. Next morning 1/28 very sore leg muscles, hot flashes, headache. As day went on my limbs were tingling and had some numbness.  Increasingly getting fatigue and wasn't able to keep my head up for more than 30sec with out it falling. By 5p I could not move left arm at all and called PCP office and went to ER. Over 5 hours I got  feeling back in left arm and left ER at 10:30p. CT was done to rule out stroke or other injury. Next day around 2p my right arm started to get more numb and I wasn't able to move it much. SOB and throat tightening came back briefly. Later that day lumbar puncture done to rule out guillain barre syndrome. Numbness is not as severe now 2/3 and each day since 1/28 it gets increasingly less
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Throat tightness
Clinical narrative: About 2 hrs after second dose shortness of breath and throat starting to swell for around 15 min then went away on its own. Next morning 1/28 very sore leg muscles, hot flashes, headache. As day went on my limbs were tingling and had some numbness.  Increasingly getting fatigue and wasn't able to keep my head up for more than 30sec with out it falling. By 5p I could not move left arm at all and called PCP office and went to ER. Over 5 hours I got  feeling back in left arm and left ER at 10:30p. CT was done to rule out stroke or other injury. Next day around 2p my right arm started to get more numb and I wasn't able to move it much. SOB and throat tightening came back briefly. Later that day lumbar puncture done to rule out guillain barre syndrome. Numbness is not as severe now 2/3 and each day since 1/28 it gets increasingly less
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Intentional product use issue, Pneumonia, Pyrexia
Clinical narrative: she got full blown pneumonia after received pneumonia vaccine; Her doctor gave her a 3rd of a test dose of a pneumonia vaccine; This spontaneous report was received from a 54 years old female patient referring to herself via Pfizer, Inc. On an unspecified date in 1976, she got German measles from head to toe (also reported as rubella) after delivering her daughter and receiving with the German measles vaccine. The patient's concomitant medications and drug allergies were not reported.   On an unknown date in 2005, the patient was vaccinated with the 3rd (extra dose administered) of a test dose of pneumonia vaccine (manufacturer unknown) (dose, strength, route, lot # and expiration date were not reported) for prophylaxis.   On an unknown date in May 2005 (also reported as after the shot), she had ended up in the hospital with 103 + Fahrenheit fever with full blown pneumonia. She had a 100.3 (unit not provided) fever for 8 days. She was in the hospital for 2 days and as soon as she was taken off intravenous (IV) therapy and switched to pills, she begged to go home. She promised she would take the pills. She was allowed to go home in May 2005. That Friday morning, her temperature finally broke to 99 (unit not provided). She researched the components of the pneumonia vaccine and saw there was several strains of pneumonia in the vaccine. Her body for some reason, took any bit of it. Ever since then, she has stayed away from vaccine. It could have been deadly if she received the full dose of the pneumonia vaccine considering the way her body reacted to a 3rd of a dose. The outcome of pneumonia was not reported.  The causality between pneumonia and pneumonia vaccine (manufacturer unknown) was not reported.   Upon internal review, pneumonia was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site warmth, Product administered at inappropriate site, Pyrexia
Clinical narrative: chills; fever, described as 99.0; injection site was hot to the touch; injection site was hot to the touch, appeared red; unspecified rash under the neck and upper chest area; Dose 2 was given in the right thigh; This case was reported by a other health professional  and described the occurrence of chills in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 5CB4K, expiry date 23rd August 2023) for prophylaxis.   On 3rd December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd December 2020, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced chills, fever, injection site warmth, injection site erythema and rash. On an unknown date, the outcome of the chills, fever and rash were recovered/resolved and the outcome of the injection site warmth was not recovered/not resolved and the outcome of the injection site erythema and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the chills, fever, injection site warmth, injection site erythema and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix on right thigh and patient experienced chills,fever of 99 degree F. also patient stated injection site was hot to the touch and appeared red. Patient experiened an unspecified rash under the neck and upper chest area. It was reported that patient received the vaccine in right thigh instead of deltoid muscle which led to vaccine administered at inappropriate site. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020248611:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: chills; fever, described as 99.0; injection site was hot to the touch; injection site was hot to the touch, appeared red; unspecified rash under the neck and upper chest area; Dose 2 was given in the right thigh; This case was reported by a other health professional  and described the occurrence of chills in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 5CB4K, expiry date 23rd August 2023) for prophylaxis.   On 3rd December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd December 2020, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced chills, fever, injection site warmth, injection site erythema and rash. On an unknown date, the outcome of the chills, fever and rash were recovered/resolved and the outcome of the injection site warmth was not recovered/not resolved and the outcome of the injection site erythema and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the chills, fever, injection site warmth, injection site erythema and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix on right thigh and patient experienced chills,fever of 99 degree F. also patient stated injection site was hot to the touch and appeared red. Patient experiened an unspecified rash under the neck and upper chest area. It was reported that patient received the vaccine in right thigh instead of deltoid muscle which led to vaccine administered at inappropriate site. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020248611:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Caller looking for information on second dose administration following a positive SARS-Cov-2; Caller looking for information on second dose administration following a positive SARS-Cov-2; This is a spontaneous report from a contactable Nurse. A patient of unspecified age and gender receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller looking for information on second dose administration following a positive SARS-COv-2 on an unspecified date. The outcome of the event was unknown.   Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable healthcare professional. A 43-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EK9231; expiration date not provided), via an unspecified route of administration on 15Jan2021 07:40 at a single dose for COVID-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Concomitant medications were not reported. The patient reported that she was having some side effects from the second dose of the Covid vaccine. On 15Jan2021, within 1 hour, the patient started having a low-grade fever and very nauseous. Also, the patient stated that she "feels awful". She didn't experience this with my first dose. The outcome of the event feels awful was unknown, while the outcome of low-grade fever and very nauseous was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: itching around noon on 16Jan2021 to her right arm/injection site; the area was red, swollen, warm, and measured about 5 inches in diameter; the area was red, swollen, warm, and measured about 5 inches in diameter; the area was red, swollen, warm, and measured about 5 inches in diameter; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140) via an unspecified route of administration on right arm on 07Jan2021 at single dose for COVID-19 immunization. Medical history included Low Thyroid Function, High Blood Pressure, IBS, High cholesterol. Concomitant medication included simvastatin for high cholesterol, metoprolol tartrate (METOPROLOL) for high blood pressure, levothyroxine sodium (SYNTHROID) for thyroid. Patient received the first dose of the bnt162b2 on 07Jan2021 on her right arm. She started to experience itching around noon on 16Jan2021 to her right arm/injection site and reported the area was red, swollen, warm, and measured about 5 inches in diameter. Also reported as starting 16Jan2021 she started to experience in the same injection site area warmth, redness, swelling, itching and she reported that it was measured about 5 inches in diameter around the injection site. She reported taking Benadryl and icing the affected area and stated it felt a little better as of 17Jan2021. The outcome of the events was recovering.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Blindness unilateral, Eye disorder, Headache, Photophobia
Clinical narrative: She wore sunglasses in her house because the light bothered her eyes; Eyes felt dry; Loss of vision in right eye; Hole in her retina; Bad headache for 3 days; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported similar events for 2 patients. This is 1st of 2 report.   A 61-year-old female consumer (patient) received 2nd dose of BNT162B2 (Covid Vaccine, lot number: EL1248) on 06Jan2021 at single dose in the right arm for COVID-19 immunisation. Medical history was not reported. Concomitant drug included Multivitamin, Vitamin C, Vitamin D Zinc all from Mar2020 and ongoing. Historical Vaccine was 1st dose of BNT162B2 (Batch/lot number: EK5730) on 18Dec2020 in the right arm. Patient got COVID vaccine and a few hours later or the next day she started getting a hole in her retina and started losing her site in right eye. she went to the doctor as she has a hole in her retina. Again, this may be totally unrelated but she wanted to call and get this reported. She is going to see a retinal specialist this afternoon. After she had her COVID vaccine she had a bad headache for 3 days. She wore sunglasses in her house because the light bothered her eyes. She noticed this on 16Jan2021 because she was looking at paperwork and her eyes felt dry. She blinked a few times and had opened one eye alone, and she noticed that her left eye was fine but the vision in her right was not. This could have been going on longer. She just never closes only one eye. When both are open, her vision is normal. She saw the eye doctor yesterday, and that is when they said she had a hole in her retina. They said she will have to have surgery to close the hole. She knows she is at the right age for this to spontaneously happen, but just in case it is related, she wanted to report it. Outcome of the event Loss of vision in right eye was Not Recovered, for headache was recovered, for other events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046804 same reporter, AE and drug, different patient
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Retinal tear
Clinical narrative: She wore sunglasses in her house because the light bothered her eyes; Eyes felt dry; Loss of vision in right eye; Hole in her retina; Bad headache for 3 days; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported similar events for 2 patients. This is 1st of 2 report.   A 61-year-old female consumer (patient) received 2nd dose of BNT162B2 (Covid Vaccine, lot number: EL1248) on 06Jan2021 at single dose in the right arm for COVID-19 immunisation. Medical history was not reported. Concomitant drug included Multivitamin, Vitamin C, Vitamin D Zinc all from Mar2020 and ongoing. Historical Vaccine was 1st dose of BNT162B2 (Batch/lot number: EK5730) on 18Dec2020 in the right arm. Patient got COVID vaccine and a few hours later or the next day she started getting a hole in her retina and started losing her site in right eye. she went to the doctor as she has a hole in her retina. Again, this may be totally unrelated but she wanted to call and get this reported. She is going to see a retinal specialist this afternoon. After she had her COVID vaccine she had a bad headache for 3 days. She wore sunglasses in her house because the light bothered her eyes. She noticed this on 16Jan2021 because she was looking at paperwork and her eyes felt dry. She blinked a few times and had opened one eye alone, and she noticed that her left eye was fine but the vision in her right was not. This could have been going on longer. She just never closes only one eye. When both are open, her vision is normal. She saw the eye doctor yesterday, and that is when they said she had a hole in her retina. They said she will have to have surgery to close the hole. She knows she is at the right age for this to spontaneously happen, but just in case it is related, she wanted to report it. Outcome of the event Loss of vision in right eye was Not Recovered, for headache was recovered, for other events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046804 same reporter, AE and drug, different patient
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches, chills, fever.  Started 14 hours after vaccine, and lasted 36 hours.  Used tylenol for symptoms.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscle tightness, Nausea, Palpitations
Clinical narrative: patient with complaint of feeling tightness in jaw and throat, nausea, dizziness, and heart palpitations immediately following the vaccine. resolved after 30 minutes of observation.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: May have received a higher dose of vaccine due to insufficient diluent being inserted into the vial. A total of two doses were able to be drawn from the vial instead of five. The individual was notified by phone that day and a report was made in our city immunization information system. No side effects were identified during the time in clinic or reported by the patient during the call.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: May have received a higher dose of vaccine due to insufficient diluent being inserted into the vial. A total of two doses were able to be drawn from the vial instead of five. The individual was notified by phone that day and a report was made in our city immunization information system. No side effects were identified during the time in clinic or reported by the patient during the call.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Injection site abscess
Clinical narrative: Light headedness, weakness, injection site tenderness
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: May have received a higher dose of vaccine due to insufficient diluent. The individual was unable to be reached by phone. A report was made in the city immunization information system. No side effects were identified during the observation period.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initially day two there was swelling and pain at injection site which subsided in two days.  On day 10, after a workout, arm swelled - hard knot at site, unable to determine redness as there is dark tatoo in the area.  Burning and very hot - applied ice packs and this lasted two days.  Extremely uncomfortable.  Still has small not but bearable.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Mobility decreased, Muscle spasms, Pain in extremity
Clinical narrative: night cramps in both right and lleft calf muscle; very painful; Mobility decreased; ringing of ears; sore arm; fever; chills; fatigue; This case was reported by a consumer  and described the occurrence of ringing in ears in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2020, the patient received the 1st dose of Shingrix. On 1st December 2020, 1 days after receiving Shingrix, the patient experienced ringing in ears, pain in arm, fever, chills and fatigue. On 2nd December 2020, the patient experienced muscle cramp, pain and mobility decreased. On an unknown date, the outcome of the ringing in ears, pain in arm, fever, chills, fatigue, pain and mobility decreased were unknown and the outcome of the muscle cramp was not recovered/not resolved.   It was unknown if the reporter considered the ringing in ears, pain in arm, fever, chills, fatigue, muscle cramp, pain and mobility decreased to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. On 30th November 2020, the patient received 1st dose of Shingrix on left arm. The patient experienced ringing of ears, sore arm, fever, chills, fatigue, night cramps in both right and lleft calf muscle at same time and behind knees at same time. The cramps were very painful and the patient could not move for 15 minuteswhen he got cramps.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tinnitus
Clinical narrative: night cramps in both right and lleft calf muscle; very painful; Mobility decreased; ringing of ears; sore arm; fever; chills; fatigue; This case was reported by a consumer  and described the occurrence of ringing in ears in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2020, the patient received the 1st dose of Shingrix. On 1st December 2020, 1 days after receiving Shingrix, the patient experienced ringing in ears, pain in arm, fever, chills and fatigue. On 2nd December 2020, the patient experienced muscle cramp, pain and mobility decreased. On an unknown date, the outcome of the ringing in ears, pain in arm, fever, chills, fatigue, pain and mobility decreased were unknown and the outcome of the muscle cramp was not recovered/not resolved.   It was unknown if the reporter considered the ringing in ears, pain in arm, fever, chills, fatigue, muscle cramp, pain and mobility decreased to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. On 30th November 2020, the patient received 1st dose of Shingrix on left arm. The patient experienced ringing of ears, sore arm, fever, chills, fatigue, night cramps in both right and lleft calf muscle at same time and behind knees at same time. The cramps were very painful and the patient could not move for 15 minuteswhen he got cramps.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Facial paralysis, Headache, Lipids increased, Rash
Clinical narrative: bell palsy; Headache; rash; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 44-years-old male patient received the first dose of BNT162B2 via an unspecified route of administration on 15Jan2021 15:30 at single dose in deltoid left for COVID-19 immunisation. Medical history included ongoing hypertension, Lactose intolerance, and lipids were a bit elevated on 14Jan2021. Family history included mother has diabetes and hypertension. The patient was allergic to Olives. There was no other vaccine in four weeks. Concomitant medication included ongoing lisinopril daily for blood pressure, ongoing colecalciferol (VITAMIN D) weekly, ongoing duloxetine to help with the blood pressure control, and ongoing Multivitamins daily. On Friday 15Jan2021 night around 11:00 PM he started experiencing headaches and rash. On Sunday night (17Jan2021) he experienced the bell palsy/Facial Paralysis and went to the ER. For bell palsy, the patient first had a shot of steroid, then was given oral Methylprednisonole and oral Famcyclovir. Treatment also received for headache and rash. He is still taking Still taking Methyl-prednisolone and the Famcyclovir and he will end these medications tomorrow. The patient had blood work on 14Jan2021 with normal result, lipids were a bit elevated. Events outcome was not recovered.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Nausea, Pain
Clinical narrative: Body aches, joint pain, dizziness,nausea and headache
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Nausea, Night sweats, Pyrexia
Clinical narrative: Started ~10:00 PM - Current: Fever (101 F), Chills, Severe night sweats, Nausea and vomiting all night, Abdominal pain
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Started ~10:00 PM - Current: Fever (101 F), Chills, Severe night sweats, Nausea and vomiting all night, Abdominal pain
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Oral discomfort
Clinical narrative: Client reported numbness and burning sensation to lips 10 minutes after vaccination.  Evaluated by EMS on site.  No medical intervention initiated.  Client observed for 40 minutes.  Client reported decreased numbness and burning.  Awake, alert, verbally responsive.  Client released by EMS.  No distress noted.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Current fever of 101.0F, headache, sweat/chills.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis
Clinical narrative: Very fatigued. Slept all day after vaccine. Broke out in drenching sweats and then chills.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Resident with c/o nausea and vomiting.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Pyrexia
Clinical narrative: Mild headache, mild chills and slight fever, queasy stomach
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: 103 degree fever, chills, fatigue, and muscle aches
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia, Rash
Clinical narrative: Burning sensation raised rash all over back appeared 1/31/2021 around 8:30pm.  I took one 200mg ibuprofen tablet.  The rash was gone the next day but the sensation of pins and needles was still present on 2/1/2021.  I then took benedryl and the sensation went away.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Shingles vaccine Headache Chills Muscle aches Nausea
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Aches, general malaise, fever, lasting 30 hrs
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: 20 hours after my first injection my entire body broke out into a rash. My skin was warm to the touch and itched. The rash lasted about 8 hours
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Exposure during pregnancy, Fatigue
Clinical narrative: 15 weeks pregnant, expected date of delivery is July 24, 2021. Dizziness to the point of almost fainting, sudden chills, low grade temperature of 99, muscle aches, no appetite, severe tiredness. Lasting from noon 02/02/2021 until time of form submission. Have been resting, drinking liquids, and taking Tylenol every 4-6 hours since symptom onset.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Presyncope, Pyrexia
Clinical narrative: 15 weeks pregnant, expected date of delivery is July 24, 2021. Dizziness to the point of almost fainting, sudden chills, low grade temperature of 99, muscle aches, no appetite, severe tiredness. Lasting from noon 02/02/2021 until time of form submission. Have been resting, drinking liquids, and taking Tylenol every 4-6 hours since symptom onset.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dizziness, Headache, Heart rate increased, Hypertension
Clinical narrative: Blurry Vision, headache,dizziness, armpit pain, increased heartrate ( 165) , high blood pressure ( 195/110 ) leg pain, muscle aches
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vision blurred
Clinical narrative: Blurry Vision, headache,dizziness, armpit pain, increased heartrate ( 165) , high blood pressure ( 195/110 ) leg pain, muscle aches
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itchy and redness, one week later, on arm where vaccine given. First-dose shot received 2021.01.25. Adverse event noticed 2021.02.02. Am writing this on 2021.02.03, so not sure how long event will last. Not taking any medication regarding the event, no antihistamine for example.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Human papilloma virus immunisation, Product storage error, Product temperature excursion issue
Clinical narrative: No other AE; Incorrect product storage; This spontaneous report was received from an office manager referring to unknown number patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On unknown dates, the patients were vaccinated with improperly stored of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1637651, expiration date 09-JUN-2022; dose and route were not reported) for prophylaxis (product storage error).    The administered doses of the vaccines experienced a temperature excursion of above 47 Fahrenheit (F) (48.98 F) for 3 hours 30 minutes (also reported as 49 F). There was no previous temperature excursion. The digital data logger was involved. No other AE was reported. Device was not available for evaluation (obtain was false).  This case was non-valid due to no patient identifiers.  Follow-up information has been received from the office manager on 21-JAN-2021.  The patient was 11-year-old male. He was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 18-NOV-2020 at a private doctor's office/ hospital. The vaccine was purchased with public funds. There was a power outage and the temperature was out of range for 3.5 hours. 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: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient was administered expired VAQTA on 26-JAN-2021; This spontaneous report was received from a nurse regarding a 55-year-old female patient. The patient's pertinent medical, medical history, drug reactions, allergies, and concomitant therapies were not provided.   On 26-JAN-2021, the patient was inadvertent vaccinated with  an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose, route of administration, anatomical location and vaccine scheme were not provided) lot number S037821 has been verified to be a valid lot number, expiration date was on 07-JAN-2021, as prophylaxis (expired product administered).There was no prior temperature excursions reported. No additional adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis atopic, Rash erythematous, Rash macular
Clinical narrative: atopic dermatitis at the site the size that it expanded; becomes more reddened after shower and exercise; macular type rash; This case was reported by a nurse and described the occurrence of atopic dermatitis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriasis and alopecia totalis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced atopic dermatitis, macular rash and red rash. The patient was treated with triamcinolone and emollients and protectives (Moisturizing Lotion (Nos)). On an unknown date, the outcome of the atopic dermatitis, macular rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the atopic dermatitis, macular rash and red rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced atopic dermatitis at the site and macular type rash that became more reddened after shower and exercise. The patient had been using triamcinolone and moisturizing lotion as a treatment. The patient was fearful regarding the 2nd dose of vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: experienced a rash over his body; This case was reported by a other health professional and described the occurrence of generalized rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2020, the patient received the 1st dose of Shingrix. On 29th September 2020, 1 days after receiving Shingrix, the patient experienced generalized rash. On 5th October 2020, the outcome of the generalized rash was recovered/resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced a rash over his body the next day.  The patient recovered a week later. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: experienced a painful arm; This case was reported by a pharmacist and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a painful arm since 2nd dose of Shingrix was administered. The pharmacist notes that the patient reported using over the counter treatments with no success.  Over the counter treatment names were not provided. Lot number and expiration date were not provided.  The patient's date of birth and initials were not provided.  The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Giant cell arteritis, Haemorrhage, Vein rupture
Clinical narrative: Bleeding of the veins, temples; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bleeding of the veins, temples.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On Unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, the patient experienced bleeding of the veins, temples. Treatment for the event was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the event, bleeding of the veins, temples was unknown.; Reporter's Comments: This case concerns a female patient of unknown age, who experienced a serious unexpected event of Haemorrhage. The event occurred on unknown date after first dose of mRNA-1273, lot # unknown. Treatment information is not provided. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 7-8 drops of vaccine fell down arm when vaccine was given; A spontaneous report was received from a consumer concerning her 75-year old, mother who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, 7-8 drops of vaccine fell down the arm when the vaccine was given.  The patient's medical history was not provided. Concomitant medications were Levothyroxine sodium, Atorvastatin calcium and Acetylsalicylic acid.  On 20 Jan 2021, the patient received their first dose of two planned doses of mRNA-1273 (Lot Number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient received the mRNA-1273 vaccine and 7-8 drops of vaccine fell down the arm when the vaccine was given. As per the reporter, the vaccinating nurse stated that she believed that less than half of the dose was actually given.  No treatment for the event was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, 7-8 drops of vaccine fell down the arm when the vaccine was given was considered Resolved on 20 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Myalgia, Vaccination site movement impairment
Clinical narrative: believed vaccine was administered subcutaneosly; It hurt to raise her arm; muscle soreness in arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced believed vaccine was delivered subcutaneously, vaccination site movement impairment and muscle soreness.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 20 Jan 2021, approximately 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient believed she was administered the vaccine subcutaneously as she thought the needle was small and noted the vaccinator pinched her arm prior to administration. Following vaccination, she experienced some muscle soreness and it hurt to raise her arm. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event  believed vaccine was delivered subcutaneously, was considered resolved on 20 Jan 2021. The outcomes of the events vaccination site movement impairment and muscle soreness were unknown.; Reporter's Comments: This case concerns a female patient,  who experienced an incorrect route of product administration, non-serious unexpected event of vaccination site movement impairment and non-serious expected event of myalgia. There were no AEs associated with incorrect route of product administration. The events of vaccination site movement impairment and myalgia occurred 1 day (same day) after first dose of mRNA-1273, lot # 012L20A.  Based on the current available information and temporal association between the use of the product and onset of the events, vaccination site movement impairment and myalgia,  a causal relationship cannot be excluded.