chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Ear pain, Influenza like illness, Neck pain
Clinical narrative: CHEST PAIN; FLU LIKE SYMPTOMS; NECK PAIN; EARS HURT; This spontaneous report received from a parent concerned a 19 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, the subject experienced chest pain. On 03-AUG-2021, the subject experienced flu like symptoms. On 03-AUG-2021, the subject experienced neck pain. On 03-AUG-2021, the subject experienced ears hurt. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, flu like symptoms, neck pain, and ears hurt. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: SWOLLEN LYMPH NODES ABOVE CLAVICLE ON LEFT; TIREDNESS FOR A FEW DAYS; MILD FEVER; MILD ACHES; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 21-SEP-2021) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-JUL-2021, the subject experienced mild aches. On 20-JUL-2021, the subject experienced tiredness for a few days. On 20-JUL-2021, the subject experienced mild fever. On 22-JUL-2021, the subject experienced swollen lymph nodes above clavicle on left. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild aches, tiredness for a few days, and mild fever, and had not recovered from swollen lymph nodes above clavicle on left. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Muscular weakness, Peripheral swelling
Clinical narrative: SWELLING ON BOTH LEGS THAT STARTED ON THE LEFT SIDE FROM THE KNEE TOWARDS THE UPPER THIGH; TIGHTNESS OF LEGS; WEAKNESS IN LEGS THAT STARTED ON THE LEFT SIDE FROM THE KNEE TOWARDS THE UPPER THIGH; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high-blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced swelling on both legs that started on the left side from the knee towards the upper thigh. On APR-2021, the subject experienced tightness of legs. On APR-2021, the subject experienced weakness in legs that started on the left side from the knee towards the upper thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling on both legs that started on the left side from the knee towards the upper thigh, weakness in legs that started on the left side from the knee towards the upper thigh, and tightness of legs. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; This spontaneous report received from a patient via a company representative via social media concerned a 36 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: unknown) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-AUG-2021, the subject experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shingles. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SEVERE HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-JUL-2021, the subject experienced severe headaches. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headaches. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Feeling hot, Joint swelling, Limb discomfort
Clinical narrative: did not receive second dose as scheduled; right elbow became swollen; affected area was still swollen; right elbow warm to the touch; opposite arm from injection arm was bothering her; right elbow getting red; after second medication, redness had lessened, but was still sore; diagnosed with cellulitis, took a month to clear up; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (diagnosed with cellulitis, took a month to clear up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Few months before reporting.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced CELLULITIS (diagnosed with cellulitis, took a month to clear up) (seriousness criterion medically significant), LIMB DISCOMFORT (opposite arm from injection arm was bothering her), ERYTHEMA (right elbow getting red) and MYALGIA (after second medication, redness had lessened, but was still sore). On 23-Jan-2021, the patient experienced JOINT SWELLING (right elbow became swollen; affected area was still swollen) and FEELING HOT (right elbow warm to the touch). On 05-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive second dose as scheduled). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) from 26-Jan-2021 to 04-Feb-2021 for Cellulitis, at an unspecified dose and frequency. At the time of the report, CELLULITIS (diagnosed with cellulitis, took a month to clear up) and ERYTHEMA (right elbow getting red) had resolved, PRODUCT DOSE OMISSION ISSUE (did not receive second dose as scheduled), FEELING HOT (right elbow warm to the touch) and LIMB DISCOMFORT (opposite arm from injection arm was bothering her) outcome was unknown and JOINT SWELLING (right elbow became swollen; affected area was still swollen) and MYALGIA (after second medication, redness had lessened, but was still sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was mentioned by reporter  Patient was kept on combination medication consisting of sulfa and antibiotic after putting her on 10 day course of Keflex which did not help her much.  Company comment- Based on the current available information which includes a temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded.  Myalgia is consistent with the known safety profile of mRNA-1273.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded.  Myalgia is consistent with the known safety profile of mRNA-1273.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Product dose omission issue
Clinical narrative: did not receive second dose as scheduled; right elbow became swollen; affected area was still swollen; right elbow warm to the touch; opposite arm from injection arm was bothering her; right elbow getting red; after second medication, redness had lessened, but was still sore; diagnosed with cellulitis, took a month to clear up; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (diagnosed with cellulitis, took a month to clear up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Few months before reporting.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced CELLULITIS (diagnosed with cellulitis, took a month to clear up) (seriousness criterion medically significant), LIMB DISCOMFORT (opposite arm from injection arm was bothering her), ERYTHEMA (right elbow getting red) and MYALGIA (after second medication, redness had lessened, but was still sore). On 23-Jan-2021, the patient experienced JOINT SWELLING (right elbow became swollen; affected area was still swollen) and FEELING HOT (right elbow warm to the touch). On 05-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive second dose as scheduled). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) from 26-Jan-2021 to 04-Feb-2021 for Cellulitis, at an unspecified dose and frequency. At the time of the report, CELLULITIS (diagnosed with cellulitis, took a month to clear up) and ERYTHEMA (right elbow getting red) had resolved, PRODUCT DOSE OMISSION ISSUE (did not receive second dose as scheduled), FEELING HOT (right elbow warm to the touch) and LIMB DISCOMFORT (opposite arm from injection arm was bothering her) outcome was unknown and JOINT SWELLING (right elbow became swollen; affected area was still swollen) and MYALGIA (after second medication, redness had lessened, but was still sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was mentioned by reporter  Patient was kept on combination medication consisting of sulfa and antibiotic after putting her on 10 day course of Keflex which did not help her much.  Company comment- Based on the current available information which includes a temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded.  Myalgia is consistent with the known safety profile of mRNA-1273.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded.  Myalgia is consistent with the known safety profile of mRNA-1273.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Neck pain
Clinical narrative: Pain in my upper neck and shoulder; Headache; Pain in my upper neck and shoulder; This is a spontaneous report from a contactable consumer. This 39-year-old male consumer reported that:  A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0178; Expiration Date: Aug2021), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain in my upper neck and shoulder, headache, pain in my upper neck and shoulder. When probed for the concern, consumer stated, he had called because he took the first shot of the Pfizer Covid vaccine and have two questions. He had wondered if that was a normal side effect. My second question was, what were the rules about taking Advil, Ibuprofen and Tylenol. Consumer was informed about Pfizer Medical Information Department. Consumer was informed about the Role of Pfizer Drug Safety. When paraphrased the concern, consumer stated, "I have not taken (Advil) since I took the vaccine, I have not taken anything. I am just saying normal in life medication, in general I say from time to time take Advil for Headache." The clinical outcome of events were unknown.  Information on lot/ batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache, Nausea, Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: First dose: her arm hurt a little; First dose: nauseous; First Dose: a headache; sed. rate had gone from 30 before the vaccination to 130 after the vaccination; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EW0196) via an unspecified route of administration in left upper arm on 22Jun2021 15:00 as single dose for COVID-19 immunization. Patient medical history included only has one kidney and fibro from 1992 both are ongoing. Concomitant medications were not reported. Lab testes included patient stated that she had gone to the doctor in the beginning of Jun and got a blood test done with unknow results. Sed. Rate: Caller states the sed. rate of 30 was done before the first vaccination, before 22Jun2021, but unsure of when. sed. rate had gone from 30 before second vaccination to 130 after the vaccination on 14Jul2021. On an unspecified date in 2021 it was reported as patient sed. rate had gone from 30 before the vaccination to 130 after the vaccination and after the first dose her arm hurt a little, she was nauseous for one day and had a headache for a day and a half. Caller confirms began on 22Jun2021 and the arm hurting a little and nausea ended on 23Jun2021 and the headache left another day on 24Jun2021. Caller confirms she has recovered completely. Outcome of event her arm hurt a little and nauseous was recovered on 23Jun2021, headache was recovered on 24Jun2021 and unknown for other event.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: I am not having any complication but it's just under arm, where I had a shot hurting a little; I am not having any complication but it's just under arm, where I had a shot hurting a little; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm on an unspecified date as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  on an unspecified date the patient experienced had not having any complication but it's just under arm, where had a shot hurting a little. Patient wanted to know Is it okay for him to put alcohol on it. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: I had some issue with my arm/ having difficulty with my arm; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FA6780 and expiration date was not reported), second dose via an unspecified route of administration on 17Jul2021 as single for covid-19 immunisation and Prednisone route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included limb deformity from an unknown date and unknown if ongoing (patient stated I had some issue with my arm and not because of the vaccination and it was prior to that and I have spoken to the doctor and she wanted to put me on steroids a prednisone, will that have any effect on the vaccination). The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration on unspecified date as single for covid-19 immunisation. On an unspecified date the patient experienced some issue with arm/ having difficulty with arm. Patient further stated "No it's not concern about vaccination. It's concerning a thought in around about the way. I want to know if it's going to make the vaccination ineffective or last effective by taking the steroids. It was on the steroids sheet that it says somewhere about vaccination, after getting any vaccination or some vaccination with this drug they either raise a chance of infection or make the vaccine not work as well. So, I don't know if there is a possibility of a side effect and if something I don't need to worry about or not need to worry about." The outcome of the event was unknown.  This follow-up is being submitted to notify that 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
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: She feels so tired basically like fatigue; This is a spontaneous report from a contactable consumer. This consumer (parent) reported for a female patient (daughter) of an unknown age received second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: unknown, Expiry Date: unknown), via an unspecified route of administration on an unknown date as dose 2 ,single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: unknown), via an unspecified route of administration on an unknown date as historical vaccine as single dose for Covid-19 immunisation. On an unspecified date, the patient got the second one yesterday, she feels so tired like really fatigue. The outcome of the adverse event was unknown.  Reason for no lot number: Reporter stated, I don't see a LOT# on here. It just looks like healthcare professional clinic site. So, it is EW and I think this is 0196, I think, I don't know if this is 0 or O, I don't know. When paraphrased reporter's name as (Name withheld), reporter stated, "Yes." (complete name not appropriately paraphrased and clarified further, hence only initials for reporter's name captured in tab).Further probing could not be initiated as reporter was unwilling to further answer the questions. Hence, other details were unknown and limited information was available over the call.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: My arm is all swelled up and not extremely by it; Pain; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number EW0182, expiration date was not reported) via an unspecified route of administration on 15Jul2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient stated "I took the COVID 19 the last shot this past Thursday the 15th, now that I am having, my arm is all swelled up and not extremely by it in Jul2021. But is there anything I can do for that, do I need to ice it down or?". The patient stated "Okay I have got swollen my in arm and when I took the shot. Do I need to ice it down or what do I need to do?" In Jul2021 the patient stated "You mean my pain, my pain level?" The outcome of events was unknown.   Follow-up attempts have been completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Muscle soreness; With pull up, it is like a short pain/If he took his elbow to his side, he can feel pain there too; This is a spontaneous report received from a contactable consumer (patient) or other non hcp. A 43-year-old male patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in Arm Left on 01Jun2021, as DOSE 1, SINGLE and then patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in Arm Right on 22Jun2021, as dose 2, single both doses for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced muscle soreness and with pull up, it is like a short pain/If he took his elbow to his side, he can feel pain there too. It was reported as, the caller stated that he received the first dose of the Pfizer BioNTech COVID-19 vaccine last 01Jun2021 where he developed muscle soreness almost at the back of his top left shoulder behind his arm, in the muscle that forms the horseshoe. Caller mentioned he received the first dose on the left arm. Caller mentioned that he can do everything with his left arm. He is doing calisthenics which includes pushups and pull ups. The only time it bothered him or hurt is with pull ups. He has no problem with lifting and pushups. With pull up, it is like a short pain and after he gets done, it throbs for a minute or two. If he took his elbow to his side, he can feel pain there too, only with that time". Caller had the second dose of the vaccine last 22Jun2021 on the right arm since he still feels sore on the left. Caller wanted to know if this had been reported as a side effect with the vaccine and if there is an expected duration. The patient is assuming the anatomical location of the muscle soreness is the rear tricep; there are 3 heads; but when he does pull-ups he can do them but it is not too good, does not feel too great at all. The muscle soreness is ongoing. He was still experiencing the muscle soreness at the time that he was administered the second dose of Pfizer Covid Vaccine so he had them administer the second dose into the opposite arm as the first dose. The muscle soreness is not around the injection site of his arm; it is behind his arm where the triceps tie to his back. He called to ask if this has been reported, and if there is an expected duration for it to last. He never got a fever, never got sick, but the muscle soreness is not going away. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthma exercise induced
Clinical narrative: exercise induced asthma; This is a spontaneous report from a contactable consumer. This female consumer reported that.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE; dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that Caller had both Pfizer Covid vaccines in January. She is over 65, and (on an unspecified date) she has exercise induced asthma, which she controls with a low dose steroid inhaler. She would like to be a part of a booster trial. Patient received treatment for adverse event. The outcome of event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Paraesthesia, Vaccination site swelling
Clinical narrative: numbness and tingling in the fingertips; swelling in the lymph nodes on the whole left side and under the armpit; numbness and tingling in the fingertips; swelling in the lymph nodes on the whole left side and under the armpit where she got the vaccine; This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 25Jun2021 for COVID-19 immunization. On 16Jul2021, the patient experienced numbness and tingling in the fingertips, swelling in the lymph nodes on the whole left side and under the armpit. Reporter stated they have a patient who received the second dose of the Pfizer Covid-19 vaccine on 16Jul2021, 3 days ago and experienced swelling in the lymph nodes on the whole left side and under the armpit where she got the vaccine and has had numbness and tingling in the fingertips. They did noticed this in the paperwork they hand out, the information sheet that this has been reported with the swelling of the lymph nodes at the injection site as a reaction. Wondering what the next step is or if they should refer her to the physician or is there a waiting period for resolving. Was calling to see what the recommendations are from Pfizer. This was her second dose. She had the first dose on 25Jun and had no issues. Outcome of the events was unknown.  Information about the Lot/batch number has been requested.  Follow-up (PRD/SRD 03Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Erythema, Nodule, Pain in extremity
Clinical narrative: Palpitations; very short of breath; chest pain; sore arm; knot on the arm; redness and itching to the arm; redness and itching to the arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: E0181), via an unspecified route of administration in arm right on an unspecified date as dose 1, single for COVID-19 immunisation. The medical history of the patient included asthma, heart disease, HTN and covid-19. The patient had no known allergies. The concomitant medications of the patient were not reported. The other medications in two weeks were reported as yes. No other vaccine in four weeks. The patient was not pregnant at the time of vaccination. The covid prior vaccination was reported as yes. The patient had not been covid tested post vaccination. On 16Jul2021 at 05:45, the patient experienced palpitations, very short of breath, chest pain, sore arm, knot on the arm, redness and itching to the arm. Therapeutic measures were taken as a result of events that included breathing treatments. The outcome of all the events was reported as resolving.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pruritus
Clinical narrative: Palpitations; very short of breath; chest pain; sore arm; knot on the arm; redness and itching to the arm; redness and itching to the arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: E0181), via an unspecified route of administration in arm right on an unspecified date as dose 1, single for COVID-19 immunisation. The medical history of the patient included asthma, heart disease, HTN and covid-19. The patient had no known allergies. The concomitant medications of the patient were not reported. The other medications in two weeks were reported as yes. No other vaccine in four weeks. The patient was not pregnant at the time of vaccination. The covid prior vaccination was reported as yes. The patient had not been covid tested post vaccination. On 16Jul2021 at 05:45, the patient experienced palpitations, very short of breath, chest pain, sore arm, knot on the arm, redness and itching to the arm. Therapeutic measures were taken as a result of events that included breathing treatments. The outcome of all the events was reported as resolving.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Extra dose administered
Clinical narrative: she had received an extra injection; I did find out that I am allergic to the Covid vaccine; This is a spontaneous report from a Non-Contactable consumer. This 42-year-old female consumer (patient) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she had no changes to her health. She did find out that she was allergic to the Covid vaccine on unknown date in 2021. She reported that she had received an extra injection (took 3 in one month) cleared the breakout due to the vaccination. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Event "she had received an extra injection" recoded to "extra dose administered".
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Nasal congestion, Respiratory tract congestion
Clinical narrative: Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; This is a spontaneous report from a non-contactable consumer. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 16Jul2021 10:45 (at the age of 42 years old) as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has no history of COVID-19 prior vaccination. On 17Jul2021 17:00, the patient started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus. No treatment was received for the events. The patient was covid tested post vaccination via nasal swab on 21Jul2021 with negative results. The outcome of the events was recovering.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Secretion discharge, Sinus headache
Clinical narrative: Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; This is a spontaneous report from a non-contactable consumer. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 16Jul2021 10:45 (at the age of 42 years old) as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has no history of COVID-19 prior vaccination. On 17Jul2021 17:00, the patient started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus. No treatment was received for the events. The patient was covid tested post vaccination via nasal swab on 21Jul2021 with negative results. The outcome of the events was recovering.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Feeling abnormal, Headache, Malaise
Clinical narrative: coughing; where I got the injection, it is hot and swollen; where I got the injection, it is hot and swollen; her arm is sore; feel really really sick; Nausea / I have Ondansetron that I take for nausea and that's helping a little bit; Stiff neck; feeling worse; severe headache / (Advil migraine) it is not doing a thing for the headache/(Tramadol) That has not even helped the headache; pain that goes across her shoulders/painful joints and muscles; whole body was in pain; painful joints and muscles; fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, strength: 0.3 ml, #lot: FA7484) via an unspecified route of administration, administered in Arm Right on 21Jul2021 (at the age of 67-years-old) as single dose for covid-19 immunization, ibuprofen (ADVIL MIGRAINE, #lot: ER4082), tramadol (#lot: AN627) and ondansetron (ONDANSETRON). The patient's medical history included high cholesterol, acute intermittent porphyria, fibromyalgia and allergic to bees. The patient's concomitant medications included topiramate at 150 mg, atorvastatin at 10 mg, lorazepam at 1 mg, tizanidine, loratadine at 1 mg for allergy, hydroxyzine hydrochloride at 25 mg for itching and hives, albuterol sulfate and epinephrine (EPIPEN). On 21Jul2021, the patient woke up with a severe headache last night and pain that goes across her shoulders. When she woke up this morning, her whole body was in pain, she has painful joints and muscles, and she is running a fever on 21Jul2021. She has taken Advil Migraine and Tramadol 50 mg and now is coughing too on an unknown date. She was feeling worse and her daughter brought over her granddaughter today. When probe for concern, patient stated she got the second COVID shot yesterday and last night she woke up with, well she started getting stiff neck and pain across her shoulders and she woke up with worst headache. She has had and she cannot even say when and today her whole body and her joints hurt so bad, it literally hurts to walk almost and she have been taking Advil migraine and it is not doing a thing for the headache and she has ondansetron that she takes for nausea and that's helping a little bit. The patient stated she have Tramadol 50 mg and she can take one tablet twice daily for chronic pain that has not even helped the headache. When probed the vaccine name as Pfizer COVID shot, patient stated she got the injection, it is hot and swollen and her arm is sore all the way down. She feels really sick. The outcome of the events was unknown.  Information on batch/lot number is requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: coughing; where I got the injection, it is hot and swollen; where I got the injection, it is hot and swollen; her arm is sore; feel really really sick; Nausea / I have Ondansetron that I take for nausea and that's helping a little bit; Stiff neck; feeling worse; severe headache / (Advil migraine) it is not doing a thing for the headache/(Tramadol) That has not even helped the headache; pain that goes across her shoulders/painful joints and muscles; whole body was in pain; painful joints and muscles; fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, strength: 0.3 ml, #lot: FA7484) via an unspecified route of administration, administered in Arm Right on 21Jul2021 (at the age of 67-years-old) as single dose for covid-19 immunization, ibuprofen (ADVIL MIGRAINE, #lot: ER4082), tramadol (#lot: AN627) and ondansetron (ONDANSETRON). The patient's medical history included high cholesterol, acute intermittent porphyria, fibromyalgia and allergic to bees. The patient's concomitant medications included topiramate at 150 mg, atorvastatin at 10 mg, lorazepam at 1 mg, tizanidine, loratadine at 1 mg for allergy, hydroxyzine hydrochloride at 25 mg for itching and hives, albuterol sulfate and epinephrine (EPIPEN). On 21Jul2021, the patient woke up with a severe headache last night and pain that goes across her shoulders. When she woke up this morning, her whole body was in pain, she has painful joints and muscles, and she is running a fever on 21Jul2021. She has taken Advil Migraine and Tramadol 50 mg and now is coughing too on an unknown date. She was feeling worse and her daughter brought over her granddaughter today. When probe for concern, patient stated she got the second COVID shot yesterday and last night she woke up with, well she started getting stiff neck and pain across her shoulders and she woke up with worst headache. She has had and she cannot even say when and today her whole body and her joints hurt so bad, it literally hurts to walk almost and she have been taking Advil migraine and it is not doing a thing for the headache and she has ondansetron that she takes for nausea and that's helping a little bit. The patient stated she have Tramadol 50 mg and she can take one tablet twice daily for chronic pain that has not even helped the headache. When probed the vaccine name as Pfizer COVID shot, patient stated she got the injection, it is hot and swollen and her arm is sore all the way down. She feels really sick. The outcome of the events was unknown.  Information on batch/lot number is requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: coughing; where I got the injection, it is hot and swollen; where I got the injection, it is hot and swollen; her arm is sore; feel really really sick; Nausea / I have Ondansetron that I take for nausea and that's helping a little bit; Stiff neck; feeling worse; severe headache / (Advil migraine) it is not doing a thing for the headache/(Tramadol) That has not even helped the headache; pain that goes across her shoulders/painful joints and muscles; whole body was in pain; painful joints and muscles; fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, strength: 0.3 ml, #lot: FA7484) via an unspecified route of administration, administered in Arm Right on 21Jul2021 (at the age of 67-years-old) as single dose for covid-19 immunization, ibuprofen (ADVIL MIGRAINE, #lot: ER4082), tramadol (#lot: AN627) and ondansetron (ONDANSETRON). The patient's medical history included high cholesterol, acute intermittent porphyria, fibromyalgia and allergic to bees. The patient's concomitant medications included topiramate at 150 mg, atorvastatin at 10 mg, lorazepam at 1 mg, tizanidine, loratadine at 1 mg for allergy, hydroxyzine hydrochloride at 25 mg for itching and hives, albuterol sulfate and epinephrine (EPIPEN). On 21Jul2021, the patient woke up with a severe headache last night and pain that goes across her shoulders. When she woke up this morning, her whole body was in pain, she has painful joints and muscles, and she is running a fever on 21Jul2021. She has taken Advil Migraine and Tramadol 50 mg and now is coughing too on an unknown date. She was feeling worse and her daughter brought over her granddaughter today. When probe for concern, patient stated she got the second COVID shot yesterday and last night she woke up with, well she started getting stiff neck and pain across her shoulders and she woke up with worst headache. She has had and she cannot even say when and today her whole body and her joints hurt so bad, it literally hurts to walk almost and she have been taking Advil migraine and it is not doing a thing for the headache and she has ondansetron that she takes for nausea and that's helping a little bit. The patient stated she have Tramadol 50 mg and she can take one tablet twice daily for chronic pain that has not even helped the headache. When probed the vaccine name as Pfizer COVID shot, patient stated she got the injection, it is hot and swollen and her arm is sore all the way down. She feels really sick. The outcome of the events was unknown.  Information on batch/lot number is requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Fatigue, Pain in extremity, Paraesthesia
Clinical narrative: chronic and persistent joint pain in knees and legs; Excruciating pain in both hands (mostly right hand)/This pain at times radiates to my upper arm; Tingling; Burning Sensation; Preventing a restful sleep at Night; chronic fatigue; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm (at the age of 52-year-old) on 16Jul2021 15:00 (Batch/Lot Number: FA6780) as dose 1, single for covid-19 immunisation. Medical history included penicillin allergy and sulfonamide allergy. Concomitant medications were not reported. On 18Jul2021, the patient experienced chronic and persistent joint pain in knees and legs; excruciating pain in both hands (mostly right hand), tingling, burning sensations, indescribably painful to the point of tears preventing a restful sleep at night this pain at times radiates to my upper arm; chronic fatigue. The patient had clinic visit on 23Jul2021 and received treatment for the events. The outcome of the events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: chronic and persistent joint pain in knees and legs; Excruciating pain in both hands (mostly right hand)/This pain at times radiates to my upper arm; Tingling; Burning Sensation; Preventing a restful sleep at Night; chronic fatigue; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm (at the age of 52-year-old) on 16Jul2021 15:00 (Batch/Lot Number: FA6780) as dose 1, single for covid-19 immunisation. Medical history included penicillin allergy and sulfonamide allergy. Concomitant medications were not reported. On 18Jul2021, the patient experienced chronic and persistent joint pain in knees and legs; excruciating pain in both hands (mostly right hand), tingling, burning sensations, indescribably painful to the point of tears preventing a restful sleep at night this pain at times radiates to my upper arm; chronic fatigue. The patient had clinic visit on 23Jul2021 and received treatment for the events. The outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: My menstrual cycle was longer and heavier/bleeding was more than normal; My lower abdomen was also more swollen with my cycle; My menstrual cycle was longer and heavier/ The cycle lasted for almost 2 weeks; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 01Apr2021 15:30 (Batch/Lot Number: ER8734) (at the age of 49-year-old) as dose 2, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was school or student health clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included Polycystic ovarian syndrome (PCOS), and known allergies to wheat, soy, peanuts, eggs, berries, trees. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in the left arm on 11Mar2021 at 03:30 PM (Batch/Lot Number: EN6207) (at the age of 49-year-old) for COVID-19 immunization. The patient previously took Azithromycin and Ceftin and experienced allergy with both drugs. The patient reported that her menstrual cycle was longer and heavier. The cycle lasted for almost 2 weeks and bleeding was more than normal (for the patient). Her lower abdomen was also more swollen with her cycle. The onset of events was on 13Apr2021. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive treatment for the events. The outcome of the events was recovered on an unspecified date.   Follow-up attempts are completed. No further information is expected.