chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: booster; tiredness; Elevated temperature (100.4); arm soreness; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 31-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2 Unknown Manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 16Dec2021, outcome "unknown", described as "tiredness"; PYREXIA (non-serious) with onset 16Dec2021, outcome "unknown", described as "Elevated temperature (100.4)"; PAIN IN EXTREMITY (non-serious) with onset 16Dec2021, outcome "unknown", described as "arm soreness"; HEADACHE (non-serious) with onset 16Dec2021, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Joint noise, Muscular weakness
Clinical narrative: Weakening of rotator cuffs and cracking of shoulders.  Occurs identically in both shoulders.  This occurred one week after Dose 2 as well, and persisted for several months, including a shoulder injury that occurred during non-strenuous activity (throwing frisbee), but was unreported.  I was unable to do work above my shoulders without tremendous pain for about 2 months.  I could not do pushups or military press without risking injury.  The condition improved after 3 months, and I was back to normal prior to getting boosted.  One day after getting boosted, the same weakness and joint cracking returned and has not abated.  This is not due to the physical administration of the vaccine because the pain/weakening is identical in both shoulders. The pharmacy staff who administered the vaccine did an outstanding job.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: patient woke up saturday morning with rash on left arm , leg and puffy face.   mother gave benadryl for  the allergic reaction.  i suggested if symptoms get worse or difficulty in breathing or swallowing to go  to emergency department for further treatment
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Woke up with pain in right armpit. It is swollen and very sore even just with arm resting normally on side. No treatment as yet. Vaccine was Thursday afternoon, it's Saturday morning. Symptoms immediately following vaccine were soreness and swelling at injection site, next morning for all day, headache, fatigue, muscle aches. Which are normal and occurred after previous 2 shots.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy, Myalgia
Clinical narrative: Woke up with pain in right armpit. It is swollen and very sore even just with arm resting normally on side. No treatment as yet. Vaccine was Thursday afternoon, it's Saturday morning. Symptoms immediately following vaccine were soreness and swelling at injection site, next morning for all day, headache, fatigue, muscle aches. Which are normal and occurred after previous 2 shots.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Lethargy
Clinical narrative: While checking on the patient I noticed she was lathergic and unable to use her words to communicate with me. I proceeded to ask her name and she was unable to give me an answer. During this time she placed her hands on her head several times as if she was thinking of things to say.  Her manners at this time were totally different from our initial conversation. Upon her arrival to the clinic she was able to answer all questions and make small talk before she received her booster. We communicated a several times during her monitoring time and before s/s were presented before discharge from the vaccination clinic.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Condition aggravated, Delivery, Exposure during pregnancy, Fatigue
Clinical narrative: The adverse event is related to early labor and delivery of a baby following the COVID booster shot. At the time of the booster, I was 35 weeks and 1 day pregnant. This was my fourth pregnancy; my first two pregnancies ended with babies delivered vaginally at 39 weeks,  6 days and 40 weeks, 2. days. My third pregnancy ended in miscarriage at 8 weeks. There had been no complications with this pregnancy, and I was measuring to my exact due date of December 5, 2021. The day following the booster,  I felt mild symptoms of fatigue. My water broke at midnight on 11/4,  and a healthy baby boy was delivered vaginally at 10:00 a.m. that morning.  He weighed 5 pounds, 12 ounces. He required no time in the NICU.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Epididymitis, Testicular pain, Testicular swelling
Clinical narrative: Left testicle pain and swelling. I think Epididymitis. Felt similar to after my vasectomy, however this was two years later and started the night I got the vaccine. No impact trauma. It lasted approximately five days and pain/swelling gradually decreased. It was bad enough that I made an appointment with a urologist, however it went away before I was able to attend the appointment.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypomenorrhoea, Intermenstrual bleeding, Pain in extremity
Clinical narrative: This happened with the first ones also (4/6/2021: EW0151; 5/7/2021: EW0162), with all shots I had spotting for a few days. I was done with having periods. With the booster (1 week after), my  arm started hurting again. I was cold and couldn't get warm. I had spotting to a light period.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache for 1.5 months no treatment finally went away on its own
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Conjunctivitis, Cough, Dyspnoea
Clinical narrative: symptoms started 12-24-2021  and got worse each day forward   Shortness of breath, cough, tiredness, weakness, sore throat, headache, nausea,  muscle aches,  joint aches,  conjunctivitis, nasal congestion, chest congestion,
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Myalgia, Nasal congestion, Nausea
Clinical narrative: symptoms started 12-24-2021  and got worse each day forward   Shortness of breath, cough, tiredness, weakness, sore throat, headache, nausea,  muscle aches,  joint aches,  conjunctivitis, nasal congestion, chest congestion,
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Upper respiratory tract congestion
Clinical narrative: symptoms started 12-24-2021  and got worse each day forward   Shortness of breath, cough, tiredness, weakness, sore throat, headache, nausea,  muscle aches,  joint aches,  conjunctivitis, nasal congestion, chest congestion,
Age: 96.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, COVID-19, Cough, Dyspnoea, Pyrexia
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 03/04/2021.  96 y/o with PMHX of Asthma, COPD, Home O2, HLD, CHF, CVA presents to ER with c/o SOB, cough, abdominal discomfort and fevers x4 days.  Room air sat 96%.    Treated with steroids.
Age: 96.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 03/04/2021.  96 y/o with PMHX of Asthma, COPD, Home O2, HLD, CHF, CVA presents to ER with c/o SOB, cough, abdominal discomfort and fevers x4 days.  Room air sat 96%.    Treated with steroids.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep terror
Clinical narrative: 3 episodes of severe night terrors beginning at 10 PM and continuing approx every 2 hrs
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Swelling
Clinical narrative: One week and 1 day later a (Rash, swelling and left arm pain)
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Immunisation, Lymphadenopathy
Clinical narrative: left underarm swollen to golf ball size assuming it is the lymph node; cold sweats; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 13Dec2021 (Lot number: FD7218, Expiration Date: Feb2022) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (first dose:, LOT-ER8729; EXP JUL 2021, unknown injection site, MANUFACTUERER UNKNOWN), administration date: 08Apr2021, when the patient was 44 years old, for COVID-19 immunization; Covid-19 vaccine (second dose:, LOT-EW0173; Expiration Date- Aug2021, left arm, MANUFACTUERER UNKNOWN), administration date: 29Apr2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset 14Dec2021, outcome "not recovered", described as "left underarm swollen to golf ball size assuming it is the lymph node"; COLD SWEAT (non-serious) with onset 14Dec2021, outcome "not recovered", described as "cold sweats".  Additional information: The patient had no relevant medical history. Patient stated she had got her third dose, the booster, Pfizer Covid shot, Comirnaty on Monday, 13Dec2021. States her underarm is extremely swollen, assuming it is the lymph node, golf ball sized swollen, and she has been having cold sweats, thinks it because of her lymph nodes been. Patient has had no other vaccines within 4 weeks of this vaccine. States she will be calling her doctor for medical advice. It was reported that aware of the golf ball size swelling on Wednesday 15Dec2021.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Lymphadenopathy, Tongue ulceration
Clinical narrative: Ulcers on tongue; Swollen lymphnodes; Armpit pain, left; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 (Lot number: 33130BA/3313OBA) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE , NDC/expiration: Jun2021, Lot: EP6955, Site: left arm), administration date: 27Mar2021, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, NDC/expiration: Jul2021, Lot: EW0153, Site: left arm), administration date: 17Apr2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Swollen lymphnodes"; AXILLARY PAIN (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Armpit pain, left"; TONGUE ULCERATION (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Ulcers on tongue".  Additional information: Patient did not have any additional vaccines administered on same date of the Pfizer suspect. Patient did not require visit to emergency room or physician office. Patient did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Patient did not have AE(s) following prior vaccinations.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia areata
Clinical narrative: his Alopecia areata got triggered which was very stable for last couple of years within 3 weeks of getting the second dose of vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 14 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: ALOPECIA AREATA (non-serious), outcome "unknown", described as "his Alopecia areata got triggered which was very stable for last couple of years within 3 weeks of getting the second dose of vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Diarrhoea, Immunisation
Clinical narrative: booster dose; uncontrollable diarrhea that has worsened and been going on for 4 months now; uncontrollable diarrhea that has worsened and been going on for 4 months now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 (Lot number: EW0177) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Non-Hodgkin's lymphoma", start date: Aug2016 (unspecified if ongoing); "colonoscopy" (unspecified if ongoing); "fib" (unspecified if ongoing), notes: he reports that he had a fib but he does not have it anymore.; "Non-Hodgkin's lymphoma", start date: Aug2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EL9262), administration date: 28Jan2021, when the patient was 71 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot: EN6200), administration date: 18Feb2021, when the patient was 71 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Aug2021, outcome "unknown", described as "booster dose"; DIARRHOEA (non-serious), CONDITION AGGRAVATED (non-serious) all with onset Aug2021, outcome "not recovered" and all described as "uncontrollable diarrhea that has worsened and been going on for 4 months now".  Additional information: It was reported that he is calling about the Pfizer covid booster. He received the booster on 18Aug2021. He has worsened uncontrollable diarrhea since the booster dose. Describes it as a colonoscopy prep, states if you have ever had one, that is what he has been living with for the most part of 2 months. His uncontrollable diarrhea feels like the prep that has to be done for a colonoscopy. States it has been like that for 6 or 7 weeks. Started out as simple diarrhea back in Aug2021 after the booster dose. It is the most bizarre thing. He is asking if this has been reported by others or does he have something else going on.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Movement disorder, Muscular weakness, Musculoskeletal discomfort
Clinical narrative: General weakness in the arm to the point that you can't even lift 20% of what you could previously lift with ease; left shoulder is more fragile in general; Useless arm syndrome; lifting capacity diminished significantly; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a (RA). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was also reported that, fAfter first and second dose Pfizer Covid 19 Vaccine, the caller had left arm useless syndrome the day after receiving the first dose Pfizer Covid 19 Vaccine for four days. The caller's left arm shut down and the caller couldn't lift anything. He was also enquiring if he got the booster dose, would he experience useless arm syndrome again.  The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "General weakness in the arm to the point that you can't even lift 20% of what you could previously lift with ease"; LIMB DISCOMFORT (non-serious), outcome "recovered", described as "Useless arm syndrome"; MOVEMENT DISORDER (non-serious), outcome "recovered", described as "lifting capacity diminished significantly"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "left shoulder is more fragile in general".  The day after receiving first dose vaccine had useless arm syndrome: The caller clarifies the day after receiving the first dose Pfizer Covid 19 Vaccine the caller had useless arm syndrome. The caller clarifies anywhere from, the average was about 4 days the caller had useless arm syndrome. The caller states it was not that he was not able to lift anything, that would imply the caller was able to lift zero. The caller's lifting capacity diminished significantly. Straight up and down the caller can lift 85% to 80% of half the caller's body weight with the caller's right arm. The caller's left shoulder is more fragile in general and can't do everything.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain
Clinical narrative: He received the booster dose and had pain in the lymph nodes for several days after receiving the vaccines.; He received the booster dose and had pain in the lymph nodes for several days after receiving the vaccines.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. , Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. , Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", LYMPH NODE PAIN (non-serious), outcome "recovered" and all described as "He received the booster dose and had pain in the lymph nodes for several days after receiving the vaccines.". It was unknown if therapeutic measures were taken as a result of lymph node pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Immunisation, Pain, Pyrexia
Clinical narrative: Booster; chills (shaking uncontrollably); chills; body aches all night; 104 fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44 year-old male patient received bnt162b2 (BNT162B2), administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: Note: Takes Lipitor. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "Booster"; TREMOR (non-serious) with onset 17Dec2021, outcome "unknown", described as "chills (shaking uncontrollably)"; CHILLS (non-serious) with onset 17Dec2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset 17Dec2021, outcome "unknown", described as "body aches all night"; PYREXIA (non-serious) with onset 17Dec2021, outcome "unknown", described as "104 fever". Relevant laboratory tests and procedures are available in the appropriate section included body temperature: 104 fever.   Additional Information; The patient got Pfizer booster shot Friday 17Dec2021. Friday night had chills (shaking uncontrollably) and body aches all night with 104 fever. Optional Information: Patient has high cholesterol and takes Lipitor. Tylenol was received as treatment drug.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Booster; chills (shaking uncontrollably); chills; body aches all night; 104 fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44 year-old male patient received bnt162b2 (BNT162B2), administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: Note: Takes Lipitor. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "Booster"; TREMOR (non-serious) with onset 17Dec2021, outcome "unknown", described as "chills (shaking uncontrollably)"; CHILLS (non-serious) with onset 17Dec2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset 17Dec2021, outcome "unknown", described as "body aches all night"; PYREXIA (non-serious) with onset 17Dec2021, outcome "unknown", described as "104 fever". Relevant laboratory tests and procedures are available in the appropriate section included body temperature: 104 fever.   Additional Information; The patient got Pfizer booster shot Friday 17Dec2021. Friday night had chills (shaking uncontrollably) and body aches all night with 104 fever. Optional Information: Patient has high cholesterol and takes Lipitor. Tylenol was received as treatment drug.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Axillary pain, Blister, Chills, Immunisation
Clinical narrative: itchy blisters on skin; under armpit pain; extremely weakness; fever; right arm pain and soreness; chills; skin rashes developing 24 hours after; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN ), for COVID-19 immunization; Bnt162b2 (Dose:2), for Covid-19 immunization, reaction(s): "extremely weakness", "under armpit pain at same arm site", "itchy blisters on skin", "chills", "developed right arm pain and soreness ", "fever ", "skin rashes ". The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "booster dose"; BLISTER (non-serious) with onset 17Dec2021, outcome "unknown", described as "itchy blisters on skin"; AXILLARY PAIN (non-serious) with onset 17Dec2021, outcome "unknown", described as "under armpit pain"; ASTHENIA (non-serious) with onset 17Dec2021, outcome "unknown", described as "extremely weakness"; PYREXIA (non-serious) with onset 17Dec2021, outcome "unknown", described as "fever"; VACCINATION SITE PAIN (non-serious) with onset 17Dec2021, outcome "unknown", described as "right arm pain and soreness"; CHILLS (non-serious) with onset 17Dec2021, outcome "unknown", described as "chills"; RASH (non-serious) with onset 17Dec2021, outcome "unknown", described as "skin rashes developing 24 hours after".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021381656 same reporter/patient/product, different dose/event.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash, Vaccination site pain
Clinical narrative: itchy blisters on skin; under armpit pain; extremely weakness; fever; right arm pain and soreness; chills; skin rashes developing 24 hours after; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN ), for COVID-19 immunization; Bnt162b2 (Dose:2), for Covid-19 immunization, reaction(s): "extremely weakness", "under armpit pain at same arm site", "itchy blisters on skin", "chills", "developed right arm pain and soreness ", "fever ", "skin rashes ". The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "booster dose"; BLISTER (non-serious) with onset 17Dec2021, outcome "unknown", described as "itchy blisters on skin"; AXILLARY PAIN (non-serious) with onset 17Dec2021, outcome "unknown", described as "under armpit pain"; ASTHENIA (non-serious) with onset 17Dec2021, outcome "unknown", described as "extremely weakness"; PYREXIA (non-serious) with onset 17Dec2021, outcome "unknown", described as "fever"; VACCINATION SITE PAIN (non-serious) with onset 17Dec2021, outcome "unknown", described as "right arm pain and soreness"; CHILLS (non-serious) with onset 17Dec2021, outcome "unknown", described as "chills"; RASH (non-serious) with onset 17Dec2021, outcome "unknown", described as "skin rashes developing 24 hours after".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021381656 same reporter/patient/product, different dose/event.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pruritus, Pyrexia, Rash
Clinical narrative: itchy blisters on skin; under armpit pain; extremely weakness; fever; right arm pain and soreness; chills; skin rashes developing 24 hours after; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN ), for COVID-19 immunization; Bnt162b2 (Dose:2), for Covid-19 immunization, reaction(s): "extremely weakness", "under armpit pain at same arm site", "itchy blisters on skin", "chills", "developed right arm pain and soreness ", "fever ", "skin rashes ". The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "booster dose"; BLISTER (non-serious) with onset 17Dec2021, outcome "unknown", described as "itchy blisters on skin"; AXILLARY PAIN (non-serious) with onset 17Dec2021, outcome "unknown", described as "under armpit pain"; ASTHENIA (non-serious) with onset 17Dec2021, outcome "unknown", described as "extremely weakness"; PYREXIA (non-serious) with onset 17Dec2021, outcome "unknown", described as "fever"; VACCINATION SITE PAIN (non-serious) with onset 17Dec2021, outcome "unknown", described as "right arm pain and soreness"; CHILLS (non-serious) with onset 17Dec2021, outcome "unknown", described as "chills"; RASH (non-serious) with onset 17Dec2021, outcome "unknown", described as "skin rashes developing 24 hours after".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021381656 same reporter/patient/product, different dose/event.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Gait disturbance, Immunisation, Magnetic resonance imaging, Muscle spasms
Clinical narrative: Booster; Lot of leg pain; Joint pain in my knee; Leg cramps; Weakness in both of my legs; Difficulty walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old patient received bnt162b2 (BNT162B2), administration date 11Nov2021 (Lot number: FG3527) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm left (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 11Nov2021, outcome "unknown", described as "Lot of leg pain"; ARTHRALGIA (non-serious) with onset 11Nov2021, outcome "unknown", described as "Joint pain in my knee"; MUSCLE SPASMS (non-serious) with onset 11Nov2021, outcome "unknown", described as "Leg cramps"; MUSCULAR WEAKNESS (non-serious) with onset 11Nov2021, outcome "unknown", described as "Weakness in both of my legs"; GAIT DISTURBANCE (non-serious) with onset 11Nov2021, outcome "unknown", described as "Difficulty walking". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for influenza vaccine was unknown. Therapeutic measures were not taken as a result of immunisation, pain in extremity, arthralgia, muscle spasms, muscular weakness, gait disturbance.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Booster; Lot of leg pain; Joint pain in my knee; Leg cramps; Weakness in both of my legs; Difficulty walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old patient received bnt162b2 (BNT162B2), administration date 11Nov2021 (Lot number: FG3527) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm left (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 11Nov2021, outcome "unknown", described as "Lot of leg pain"; ARTHRALGIA (non-serious) with onset 11Nov2021, outcome "unknown", described as "Joint pain in my knee"; MUSCLE SPASMS (non-serious) with onset 11Nov2021, outcome "unknown", described as "Leg cramps"; MUSCULAR WEAKNESS (non-serious) with onset 11Nov2021, outcome "unknown", described as "Weakness in both of my legs"; GAIT DISTURBANCE (non-serious) with onset 11Nov2021, outcome "unknown", described as "Difficulty walking". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for influenza vaccine was unknown. Therapeutic measures were not taken as a result of immunisation, pain in extremity, arthralgia, muscle spasms, muscular weakness, gait disturbance.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Immunisation
Clinical narrative: her blood pressure was elevated. She took her BP again on 20Dec2021 and reports it was still up.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer), for Covid-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021, outcome "unknown", described as "booster"; BLOOD PRESSURE INCREASED (non-serious) with onset 19Dec2021, outcome "not recovered", described as "her blood pressure was elevated. She took her BP again on 20Dec2021 and reports it was still up.". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Thermal burn
Clinical narrative: Booster; Accidentally burned her hands with a microwave bowl; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558) and received in response to mail trail sent regarding the confirmation of below mentioned query. The reporter is the patient. A 74-year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, Single), for COVID-19 Immunisation; Comirnaty (Dose 2, Single), for COVID-19 Immunisation. The following information was reported: THERMAL BURN (non-serious) with onset Dec2021, outcome "unknown", described as "Accidentally burned her hands with a microwave bowl"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster".  Additional information: Female consumer accidentally burned her hands with a microwave bowl. Caller wanted to know if she still had the immunity of the vaccine if she had received 2 doses and the booster dose of the Pfizer COVID vaccine and has underlying conditions. Caller withheld called in and stated that she had her two doses and a booster shot already and she was reporting that she had an accident two weeks ago in her kitchen. Her arms were burned by a microwave bowl. She wants to know if she still has the immunity of the Booster vaccine. She wanted to know if there was a loss of immunity in her body. Caller asking how long does it take to get full immunity from the booster. Caller also asking was there any test or blood work to test for immunity from the booster dose? Caller asking if she could get another booster dose (4th dose) after she had received the primary series and a booster dose already. Response: Provided disclaimer that Pfizer cannot recommend the use of the vaccine outside of what is approved, which was the primary series and a booster dose. Told caller we do not have information regarding a 4th dose or an additional booster dose and referred caller to the HCP. Seriousness was no.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Product administered at inappropriate site, Vaccination site pain
Clinical narrative: received a booster dose of Pfizer Covid vaccine on 04Nov2021 but he received it subcutaneously; received a booster dose of Pfizer Covid vaccine on 04Nov2021 but he received it subcutaneously; The only side effect was he had was tenderness at the shot but not deep pain like with the other shots.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 41-year-old male patient received bnt162b2 (BNT162B2), subcutaneous, administered in deltoid left, administration date 04Nov2021 (Lot number: FE3590) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, start date: 2021, stop date: 2021. Vaccination history included: Covid-19 vaccine (First dose, Given at an unknown time in the left shoulder, Lot: EW0150.), administration date: 08Apr2021, for COVID-19 immunization, reaction(s): "he had was tenderness at the shot but not deep pain like with the other shots"; Covid-19 vaccine (Second dose, Given at an unknown time in the left shoulder, Lot: EW1067.), administration date: 29Apr2021, for COVID-19 immunization, reaction(s): "the first 2 shots he declines saying it was the normal pain after a shot". The following information was reported: IMMUNISATION (non-serious), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) all with onset 04Nov2021, outcome "unknown" and all described as "received a booster dose of Pfizer Covid vaccine on 04Nov2021 but he received it subcutaneously"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "The only side effect was he had was tenderness at the shot but not deep pain like with the other shots."  Additional information: The patient received booster dose on 04Nov2021 and it was later determined he received it subcutaneously. Prior Vaccinations (within 4 weeks):  The patient stated that he got Flu shot before the booster, probably a few weeks the booster shot but the date was unknown. The patient does not know the flu shot name. It was stated the patient had no negative reaction to the shot it was just administered incorrectly. The only side effect he had was tenderness at the shot but not deep pain like with the other shots. He wanted to know if it was possible to get another shot. The patient observed when the dose was administered, that it was given more under the skin and wondered if he should get another shot, if it would be effective.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Immunisation, Pain, Thrombosis
Clinical narrative: he received his booster dose of Pfizer BioNtech covid 19 vaccine; shooting pains in his left foot occuring every 15 minutes; he tries to walk his foot goes out on him and ankle won't work; he feels like he "shot his foot"; if it could be a blood clot; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A 59 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Dec2021 (Batch/Lot number: unknown) at the age of 59 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Unknown manufacturer, unknow dose number), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Dec2021, outcome "unknown", described as "he received his booster dose of Pfizer BioNtech covid 19 vaccine"; THROMBOSIS (medically significant) with onset Dec2021, outcome "unknown", described as "if it could be a blood clot"; PAIN (non-serious) with onset 19Dec2021, outcome "unknown", described as "shooting pains in his left foot occuring every 15 minutes"; GAIT DISTURBANCE (non-serious) with onset 19Dec2021, outcome "unknown", described as "he tries to walk his foot goes out on him and ankle won't work"; FEELING ABNORMAL (non-serious) with onset 19Dec2021, outcome "unknown", described as "he feels like he "shot his foot"".  The clinical course was reported as follows: he received his booster dose of Pfizer BioNtech covid 19 vaccine yesterday and last night he left to go home before 22:00, he went home and tried to go to bed. He laid down and he started feeling shooting pains in his left foot occuring every 15 minutes,he feels like he "shot his foot" and when he tries to walk his foot goes out on him and ankle would not work. They are wondering if it could be a blood clot. Caller says she told him to take aspirin. No Emergency Room,No Physician Office.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site bruising, Vaccination site discolouration
Clinical narrative: I developed like a bruise and the slight skin discoloring at the spot of the, at the spot of the vaccine, where the injection was injected; I developed like a bruise and the slight skin discoloring at the spot of the, at the spot of the vaccine, where the injection was injected; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 13Dec2021 (Lot number: 33130BA) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "booster"; VACCINATION SITE BRUISING (non-serious), VACCINATION SITE DISCOLOURATION (non-serious), outcome "unknown" and all described as "I developed like a bruise and the slight skin discoloring at the spot of the, at the spot of the vaccine, where the injection was injected".  Additional information: Consumer stated, "I am Calling, regarding, So, I got a booster shot a week ago and I developed like a bruise and the slight skin discoloring at the spot of the, at the spot of the vaccine, where the injection was injected and I mean, I would think that it would go but it sort of become bit more prominent now so, I was wondering what my options are, How do I consult someone for this". Product conformed-COVID 19 Vaccine(Booster).  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Emotional distress, Feeling abnormal, Immunisation, Nail disorder
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 (Lot number: FG3527) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Lot: EN5318, Site: right arm), administration date: 02Feb2021, when the patient was 74 years old, for COVID-19 immunization; Bnt162b2 (Second Dose, Lot: EN6200, Site: right arm), administration date: 01Mar2021, when the patient was 74 years old, for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "Booster"; PSORIASIS (non-serious) with onset Nov2021, outcome "not recovered", described as "Body was covered from head to my feet with psoriasis and it is bad; Whole body was covered from top of my head I even got it on the bottom of my feet"; FEELING ABNORMAL (non-serious) with onset 20Nov2021, outcome "unknown", described as "Have been through hell and back since the 20Nov and it is caused from your stupid booster shot"; EMOTIONAL DISTRESS (non-serious) with onset Nov2021, outcome "unknown", described as "Pain and suffering"; NAIL DISORDER (non-serious) with onset Nov2021, outcome "unknown", described as "I got my booster shot on the 18Nov and 2 days later I noticed these 'things' on my finger nails"; RASH (non-serious) with onset Nov2021, outcome "not recovered", described as "she got the booster vaccine and 2 days later developed an ugly rash around her fingernails of her right hand, and then progressed to her whole body from head to toe"; SCAB (non-serious), ULCER (non-serious) all with onset Nov2021, outcome "unknown" and all described as "crusty sores"; RASH ERYTHEMATOUS (non-serious) with onset Nov2021, outcome "unknown", described as "Rash as bloody". The event "she got the booster vaccine and 2 days later developed an ugly rash around her fingernails of her right hand, and then progressed to her whole body from head to toe" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash. Additional information: The patient had not received any other vaccine within 4 weeks of covid-19 vaccine. After two days of booster dose, the patient developed an ugly rash around her fingernails of her right hand, and then progressed to her whole body from head to toe. The reporter described the rash as bloody, and crusty sores. The reporter stated that her doctor sent photos to the dermatologist confirmed it was psoriasis. The reporter stated that she had taken Prednisone as treatment since that Friday and that had dried up some of the rash. The reporter stated that she would see a dermatologist in Feb2022.