chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Palpitations
Clinical narrative: My heart was racing; I was tired, I guess it will make you little tired also; 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 06May2021 14:00 (Lot number: EW0173) 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 Number: 1), administration date: 15Apr2021, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 07May2021 03:00, outcome "recovering", described as "I was tired, I guess it will make you little tired also"; PALPITATIONS (non-serious) with onset 07May2021 05:30, outcome "recovering", described as "My heart was racing". Therapeutic measures were taken as a result of fatigue, palpitations.  Additional information:  Consumer stated, " I had my second Pfizer shot yesterday around 02:00 p.m. I guess, the first one I didn't have much of reaction to I know the second one is said to a little bit stronger, I don't know maybe I, around 05:00 I get home like from work like 02:00 in the morning, I work in a Casino. I have something to eat around 3 or so I was tired, I guess it will make you little tired also I , 05:30 in the morning I woke up and my heart was racing and I was little worried I don't it was maybe something I ate before at work, before I went to work maybe I should have had something strong or yogurt or I had Walnut with some blueberries. I had it woke me up I immediately had the little brochure you have from the Pfizer from where I got the shot and then I took a Ibuprofen 200 mg is that the right thing to do, or kind a calm my heart down?" Name of the Product : Consumer stated, "Yes I had the Pfizer shot (Pfizer COVID 19 Vaccine, confirmed), yes it says, no it says in the brochure that I get I did read out it here that'd have if you have any problems or something you supposed to take Ibuprofen or something. I took the, no I had 200mg of it, without its yesterday, you are supposed to do that if you had some type of side effects or something with the fast heartbeat that would make you better, it seems to be a better after that." Consumer was informed about Pfizer Medical Information Department : Consumer stated, "Oh I thought you are a pharmacist so maybe that you were able to, what's the number?" Consumer was informed about the Pfizer Medical Information and provided with the number. Consumer stated, "Yeah that's good I was, I rather speak to a higher person for." For further probing : Consumer stated, "Well really not to be honest with you I got a I kind of work early today, I am sorry."  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Sore throat; Severe congestion a runny nose; Severe congestion a runny nose; Headache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 08May2021 (Batch/Lot number: unknown) 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, SIngle), for COVID-19 immunisation. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 09May2021, outcome "unknown", described as "Sore throat"; RHINORRHOEA (non-serious), NASAL CONGESTION (non-serious) all with onset 09May2021, outcome "unknown" and all described as "Severe congestion a runny nose"; HEADACHE (non-serious) with onset 09May2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset 09May2021, outcome "unknown", described as "Fatigue".  Additional Information: The reporter stated that their daughter who is 30 which was not clarified had her second Pfizer vaccine shot yesterday and this morning she woke up with sore throat, severe congestion a runny nose, headache and fatigue.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Nausea, Vomiting
Clinical narrative: fogginess; tiredness; nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 06May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization.  The following information was reported: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "fogginess"; FATIGUE (non-serious), outcome "not recovered", described as "tiredness"; NAUSEA (non-serious), outcome "not recovered", described as "nausea"; VOMITING (non-serious), outcome "not recovered", described as "vomiting".  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling, Vaccination site swelling
Clinical narrative: lump under arm size of small orange, paper work said, could be lymph nodes swollen; left arm swollen where she received vaccine; left arm swollen/ whole arm was swollen down to her fingertips; 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 64 year-old female patient received bnt162b2 (BNT162B2), administration date 03May2021 (Batch/Lot number: unknown) at the age of 64 years as 1st dose, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: She was a person that in November she almost died from the coronavirus and she doesn't know if that has anything to do with it. The patient's concomitant medications were not reported.  The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 03May2021, outcome "unknown", described as "left arm swollen/ whole arm was swollen down to her fingertips"; LYMPHADENOPATHY (non-serious) with onset 04May2021, outcome "unknown", described as "lump under arm size of small orange, paper work said, could be lymph nodes swollen"; VACCINATION SITE SWELLING (non-serious) with onset 03May2021, outcome "unknown", described as "left arm swollen where she received vaccine".  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: With the first shot I had a sever headache, and very fatigued; With the first shot I had a sever headache, and very fatigued; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 08:00 (Lot number: ER8730) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "pencycline" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; PROZAC; CLARITIN ALLERGIC; BIOTIN. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Sulfur, reaction(s): "Known allergies: sulfur".  The following information was reported: FATIGUE (non-serious), HEADACHE (non-serious) all with onset 2021, outcome "recovering" and all described as "With the first shot I had a sever headache, and very fatigued". Therapeutic measures were not taken as a result of fatigue, headache.  Additional information: It was reported that with the first shot patient had a sever headache, and very fatigued. Other medications in two weeks included symbicort, prozac, claritin, biotin. There were no other vaccine in four weeks. The patient did not had covid prior vaccination. The patient did not tested covid post vaccination. Known allergies included penicillin, codeine, sulfur  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Nasal discomfort, Oral discomfort
Clinical narrative: My mouth and sinuses felt mentholated. It wasn't so much a flavor thing as it was the sensation. It felt like I was carry around a mentol diffuser everywhere for about 3 weeks; My mouth and sinuses felt mentholated. It wasn't so much a flavor thing as it was the sensation. It felt like I was carry around a mentol diffuser everywhere for about 3 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 09:30 (Lot number: Ew0169) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hbp" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "poor kidney/liver function" (unspecified if ongoing); "Known allergies: All nuts" (unspecified if ongoing); "Known allergies: can eat legumes" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: ORAL DISCOMFORT (non-serious), NASAL DISCOMFORT (non-serious) all with onset 16Apr2021 10:45, outcome "recovered" (2021) and all described as "My mouth and sinuses felt mentholated. It wasn't so much a flavor thing as it was the sensation. It felt like I was carry around a mentol diffuser everywhere for about 3 weeks". Therapeutic measures were not taken as a result of oral discomfort, nasal discomfort.  Additional information included: The patient age group was Adult (18-64 Years). The patient did not receive other vaccine in four weeks. The patient had no covid prior vaccination. The patient had not tested covid post vaccination. Not so much adverse, but while receiving my second dose my pharmacist was surprised that I mentioned that about an hour after my first dose my mouth and sinuses felt mentholated. It wasn't so much a flavor thing as it was the sensation. It felt like I was carry around a mentol diffuser everywhere for about 3 weeks. She said she had heard other pharmacists and doctors mention it in others, but had never encountered anyone that mentioned it until me.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Weight abnormal
Clinical narrative: earache; if adverse events are related to weight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 42 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EAR PAIN (non-serious), outcome "unknown", described as "earache"; WEIGHT ABNORMAL (non-serious), outcome "unknown", described as "if adverse events are related to weight".  Additional information: Reporter asked on behalf of her son, 42 years of age. She was asking if adverse events are related to weight. The patient yet to receive his second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching, Vaccination site pain
Clinical narrative: arm pain at the injection site; muscle spasms and twitching in his calf muscles that doesn't seem to stop at rest; Muscle spasms or twitching primarily in my legs in calves region; 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 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Apr2021 (Lot number: EW0171) at the age of 32 years as dose 2, single and administration date 03Apr2021 (Lot number: EW0151) as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "arm pain at the injection site"; MUSCLE SPASMS (non-serious) with onset 2021, outcome "not recovered", described as "muscle spasms and twitching in his calf muscles that doesn't seem to stop at rest"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "not recovered", described as "Muscle spasms or twitching primarily in my legs in calves region". Therapeutic measures were not taken as a result of vaccination site pain, muscle spasms, muscle twitching.  Additional Information: The patient reported that little bit after receiving the first dose he felt nothing more than arm pain at the injection site and later the other events. He even stated, after the second dose the events have gotten worse and seemed to be 24/7 and he cannot think of anything else different in life that could have caused these side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: no signs of allergy since receiving Pfizer Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "wheat allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "no signs of allergy since receiving Pfizer Covid".  Additional information: Consumer stated that your vaccine may be remediate that wheat allergy for me; I got your vaccine, this has happened. Is there a correlation between the vaccine and maybe mean that feeling my wheat allergy no more. He got the two doses of your vaccine (Further clarification was unknown hence captured as unspecified vaccine), last dose 3 weeks ago. He had a wheat allergy. Since he got your vaccine, he pushed himself to wheat and he had not got a reaction. So no more, he eat wheat. Its only when he got your vaccine that this has happened. Consumer also stated, It was not a concern. It was a good thing. The only difference was he was not feeling allergy himself.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: dizziness; headache; 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 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 13:15 (Lot number: ER8727) at the age of 74 years as dose 2, single and administration date 05Mar2021 (Lot number: EN6204) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (ongoing), notes: Taking PROZAC for depression. Concomitant medication(s) included: PROZAC taken for depression (ongoing). The following information was reported: DIZZINESS (non-serious) with onset Apr2021, outcome "not recovered", described as "dizziness"; HEADACHE (non-serious) with onset Apr2021, outcome "not recovered", described as "headache". Therapeutic measures were taken as a result of headache.  Additional Information: It was reported that, the patient did not receive any prior vaccinations within 4 weeks. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the Pfizer Suspect were none. No Family History and relevant test. After getting the Pfizer COVID019 vaccine (Apr2021), he had been experiencing headache, dizziness, and steady head pain. The head pain varies thorough out the days it can sometimes be more intense than other days. It helped a bit with TYLENOL and ALEVE. The patient just didn't understand because headaches were not usually normal for him and had been experiencing this for a month. Headache was reported as worsened. He received the second dose of the Pfizer COVID 19 vaccine 30MAR2021 at 13:15 in the left arm (lot ER8727) at Hospital, he had a headache and at times dizziness. Adds he got the first dose 05Mar2021, but he does not remember the time or which part of his body he received the vaccination. He thought he had headache and dizziness for the whole month of Apr2021. Adds, it could be from the first dose, he was unsure. Stated, he had to get a hold on things like when he is taking a shower, he had to hold on due to the dizziness, but it is okay when he was sitting down. Mentions a couple of times he thought about going to the emergency room or calling his doctor, but he didn't. Additionally, he was going to call his doctor at the facility next because this was not normal for him.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain in the am". Additional information: PQC not present. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Also have had neck pain since the first vaccine that will not go away; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 13:00 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: METHYLPHENIDATE. The following information was reported: NECK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Also have had neck pain since the first vaccine that will not go away". The event "also have had neck pain since the first vaccine that will not go away" was evaluated at the physician office visit. Therapeutic measures were taken as a result of neck pain. Additional information: Patient was not administered with other vaccine in four weeks. 3 weeks after the final vaccination, despite being active and healthy - I experienced suddenly extreme pain in my left leg and was unable to walk on it. doctors found a superficial blood clot. Also have had neck pain since the first vaccine that will not go away. Patient was not tested covid prior vaccination and post vaccination. No known allergies:  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021523842 same patient/drug, different dose/event
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Fatigue
Clinical narrative: she had diarrhea that lasted for weeks; seemed confused all the time; her confusion was from the exhaustion caused by the weeks of diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 10:00 (Lot number: EN6204) at the age of 71 years as dose 1, single for covid-19 immunisation. Family history included: "High blood pressure" (unspecified if ongoing), notes: she had high blood pressure for 10 years or more. high blood pressure was an issue in her family. The patient's concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 10-MAR-2021 15:00, outcome "unknown", described as "she had diarrhea that lasted for weeks"; CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "seemed confused all the time"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "her confusion was from the exhaustion caused by the weeks of diarrhea". The events "she had diarrhea that lasted for weeks", "seemed confused all the time" and "her confusion was from the exhaustion caused by the weeks of diarrhea" were evaluated at the physician office visit.  Additional Information: Reported 5 hours after she had her first COVID-19 Vaccine, she had diarrhea that lasted for weeks. She clarified she had already called Pfizer after her first inoculation because she had enough of the stomach issues (diarrhea). She said she seemed confused all the time, and she thought her confusion was from the exhaustion caused by the weeks of diarrhea. She said she was a healthy eater and was making sure she kept her diet well after having the diarrhea for so long. She said her diarrhea was so bad at times, she almost did not make it to the bathroom. She said it was just draining to go through having diarrhea for that long. She said being older, too, probably didn't help with her recovering as quickly.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Vaccination site joint pain
Clinical narrative: continues to experience arm pain or really bad soreness to her arm that has been ongoing for well over 10 weeks.; She also reports that the patient is now experiencing High blood pressure.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Batch/Lot number: unknown) 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), administration date: 27Jan2021, for COVID-19 immunization. The following information was reported: VACCINATION SITE JOINT PAIN (non-serious), outcome "not recovered", described as "continues to experience arm pain or really bad soreness to her arm that has been ongoing for well over 10 weeks."; HYPERTENSION (non-serious), outcome "not recovered", described as "She also reports that the patient is now experiencing High blood pressure.".  Additional information: The patient experienced a side effect following administration of the covid vaccine. The patient went to her doctor who prescribed Physical therapy, but the pain has not been resolved. High blood pressure a side effect of the covid vaccine and are there any treatment recommendations that Pfizer provides to treat the arm pain this patient is experiencing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: Was in bed for two days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BEDRIDDEN (non-serious), outcome "unknown", described as "Was in bed for two days".  Additional information: Reporter together with his wife got their first dose of the vaccine 3 weeks ago (13Apr2021). Their second dose of the vaccine is due tomorrow 04May2021. However, they were told that they will be receiving the second dose on a different facility and have to re-schedule. They did not receive a call yet regarding where to go for their second dose of the vaccine. It was stated that he is 62-year-old and wife is 65-year-old. They both received their second Pfizer Covid vaccines on 05May2021 and on 06May2021 he reports they have low grade fevers. He has no questions at this time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Rhinorrhoea
Clinical narrative: after his second COIVD vaccine he has been experiencing stuffiness in only his left nostril; runny nose in just one nostril after receiving the 2nd dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,single.), for COVID-19 Immunization. The following information was reported: NASAL CONGESTION (non-serious), outcome "unknown", described as "after his second COIVD vaccine he has been experiencing stuffiness in only his left nostril"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose in just one nostril after receiving the 2nd dose.". Therapeutic measures were not taken as a result of nasal congestion, rhinorrhoea.  Additional information: It was reported that on an unspecified date after his second COIVD vaccine the patient experienced stuffiness in only his left nostril. The patient reported that he had both shots of the Pfizer COVID vaccine. He reported that he saw on the news, that he could possibly be contacted for a booster shot. His wife told him he would be a good candidate for the booster shot. He wanted to know how he can get signed up for one. The patient reported that after his second COIVD vaccine he has been experiencing stuffiness in only his left nostril. The patient wanted to know more information about the booster shot of the covid-19 vaccine. He mentioned that he already took both doses of the vaccine but can't remember the exact date anymore. He also wanted to know if he already heard of someone who had a runny nose in just one nostril after receiving the 2nd dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Tooth disorder, Toothache
Clinical narrative: tooth issue (flare up) in between the 2 shots; he got a bad tooth ache; 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 (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 17Apr2021 (Lot number: EW0161) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing); "Restless legs and cramps" (unspecified if ongoing); "Severe headache and migraine" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM HYDROBROMIDE taken for depression (ongoing); METFORMIN HCL PFIZER taken for type 2 diabetes mellitus (ongoing); GABAPENTIN "PCD" taken for muscle spasms (ongoing); NORTRIPTYLINE HYDROCHLORIDE taken for migraine (ongoing); METOPROLOL TARTRATE (ongoing). The following information was reported: TOOTH DISORDER (non-serious), outcome "unknown", described as "tooth issue (flare up) in between the 2 shots"; TOOTHACHE (non-serious), outcome "unknown", described as "he got a bad tooth ache". Therapeutic measures were taken as a result of tooth disorder, toothache.  Additional information: However though in between dosage, prior to the second dose he got a bad tooth ache.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Circumstance or information capable of leading to medication error, Fatigue, Feeling abnormal, Influenza
Clinical narrative: what he has experienced just gives a pause to whether or not he wants to continue with the vaccination; experienced flu, body hurt, fatigue and felt foggy/flu like symptoms; experienced flu, body hurt, fatigue and felt foggy/flu like symptoms; experienced flu, body hurt, fatigue and felt foggy; experienced flu, body hurt, fatigue and felt foggy; 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).  A male patient in his 60's received bnt162b2 (BNT162B2), administration date 23Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), PAIN (non-serious) all with onset 03May2021, outcome "unknown" and all described as "experienced flu, body hurt, fatigue and felt foggy/flu like symptoms"; FATIGUE (non-serious), FEELING ABNORMAL (non-serious) all with onset 03May2021, outcome "unknown" and all described as "experienced flu, body hurt, fatigue and felt foggy"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "what he has experienced just gives a pause to whether or not he wants to continue with the vaccination". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated her husband on 23Apr2021, a Friday, got his fist dose of the Pfizer COVID vaccine. He had no reactions or symptoms, everything was fine and he was feeling fine. Then oddly enough, they didn't think about it at first but a little over a week later on 03May2021, Monday, he started getting flu like symptoms. They have been pretty diligent for the last year with social distancing, they have taken care of themselves, they wear their masks, they have been very vigilant and have been very healthy and they continued to practice these same things even though they had their first dose of the COVID vaccine. They are never sick from work but when her husband had flu like symptoms he had stayed out of work because he felt like he had the flu. But to make a long story short her husband went to the doctor and he got a COVID test and the doctor said that her husband didn't have COVID. Reporter stated the 2nd dose will be on 14May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: what he has experienced just gives a pause to whether or not he wants to continue with the vaccination; experienced flu, body hurt, fatigue and felt foggy/flu like symptoms; experienced flu, body hurt, fatigue and felt foggy/flu like symptoms; experienced flu, body hurt, fatigue and felt foggy; experienced flu, body hurt, fatigue and felt foggy; 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).  A male patient in his 60's received bnt162b2 (BNT162B2), administration date 23Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), PAIN (non-serious) all with onset 03May2021, outcome "unknown" and all described as "experienced flu, body hurt, fatigue and felt foggy/flu like symptoms"; FATIGUE (non-serious), FEELING ABNORMAL (non-serious) all with onset 03May2021, outcome "unknown" and all described as "experienced flu, body hurt, fatigue and felt foggy"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "what he has experienced just gives a pause to whether or not he wants to continue with the vaccination". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated her husband on 23Apr2021, a Friday, got his fist dose of the Pfizer COVID vaccine. He had no reactions or symptoms, everything was fine and he was feeling fine. Then oddly enough, they didn't think about it at first but a little over a week later on 03May2021, Monday, he started getting flu like symptoms. They have been pretty diligent for the last year with social distancing, they have taken care of themselves, they wear their masks, they have been very vigilant and have been very healthy and they continued to practice these same things even though they had their first dose of the COVID vaccine. They are never sick from work but when her husband had flu like symptoms he had stayed out of work because he felt like he had the flu. But to make a long story short her husband went to the doctor and he got a COVID test and the doctor said that her husband didn't have COVID. Reporter stated the 2nd dose will be on 14May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is hurting very bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 15May2021 (Batch/Lot number: unknown) as dose 2, 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, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Arm is hurting very bad".  Additional information: Caller's friend had his second shot and he feels alright but his arm is hurting very bad is it safe to put an ice pack on his arm? Caller did what her friend said to do to her male friend her friend put an ice pack on her arm since that friend was told to put an ice pack on the arm and her male friend said his arm was feeling some better.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: little soreness in his left arm and upper back/neck; little soreness in his left arm and upper back/neck; 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 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 (Lot number: EN6206, Expiration Date: Jun2021) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Surgery" (not ongoing), notes: Heart Surgery 1.75 years ago, valve repair open heart surgery to repair 2 valves. There were no concomitant medications. The following information was reported: NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "little soreness in his left arm and upper back/neck".  Additional Information: It was reported that, the patient did not have anything at first, a week later the pain was in the arm and the back of the head/neck area on the left side. It lasted for another week to 10 days and then it was done. The reporter stated that he had heart surgery a year and a half ago, and the pain in the left arm was giving mixed signals as to whether it was from the vaccine or from heart, so he decided to take the second shot on the other side. The patient was pretty good with the pain and didn't take any Tylenol with the first shot and then it went away. The patient  did not take any additional vaccine on the same date of pfizer suspect. Patient received both doses of pfizer suspect vaccine. Adverse events did not result in emergency room visit or physician office visit. Prior vaccination information in 4 weeks was that the patient received only both the doses of pfizer vaccine. Family medical history related to adverse event was none. Relevant tests were none.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sore arm for 2 days".  Additional Information: The report was not related to a study or programme. NDC number and expiry date was not reported. He got his first dose a week ago and it went very well. Stated he only had a sore arm for like 2 days. He was looking forward to his second shot. He thinks that the reporting coming out is wrong.  He says he believes that with the two dose vaccines, the majority of people are only getting one dose; but it is being counted and reported as they got the complete dose. They sent him the appointment for his second dose first, and the appointment for his first dose second. He thinks that a lot of people may have gotten these emails, which look the same but with 2 different dates; and only looked at the most recent one they received.  Therefore, only going to one appointment. States he keeps seeing different television and radio reports for different age groups.  Says he gets the reporting PDF file and some of it is correct; but he thinks some is getting lost in too much data.  He thinks that Pfizer's numbers for the vaccine are being misreported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Oligomenorrhoea, SARS-CoV-2 test
Clinical narrative: 2nd vaccine : I am still waiting to start my period. I am over 2 weeks late , bad cramping for over 2 weeks; 2nd vaccine : I am still waiting to start my period. I am over 2 weeks late , bad cramping for over 2 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Mar2021 12:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "latex" (unspecified if ongoing), notes: Known allergies: Latex. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), when the patient was 49 years old, for Covid-19 immunisation, reaction(s): "first vaccine- my period came more a week early". The following information was reported: MUSCLE SPASMS (non-serious), OLIGOMENORRHOEA (non-serious) all with onset 23Apr2021, outcome "not recovered" and all described as "2nd vaccine : I am still waiting to start my period. I am over 2 weeks late , bad cramping for over 2 weeks". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle spasms, oligomenorrhoea.  Additional Information: She was not able to locate or read the details. The patient did not receive any other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient did not have covid prior vaccination. The patient was tested for covid post vaccination. Known allergies: Latex  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph Nodes Swollen/swelling of his lymph nodes near his armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04May2021 19:48 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Verbatim: Asthma. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1: Covid vaccine, Anatomical Location: right arm), administration date: 13Apr2021, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 06May2021, outcome "unknown", described as "Lymph Nodes Swollen/swelling of his lymph nodes near his armpit". Additional information: Other Conditions has been a life-long condition; but is well controlled. Patient is curious because it looks like he had a side effect on his lymph nodes near his armpit. Patient does not have his vaccination card available. He also does not have any other information containing the Lot Number for his vaccinations. Relevant Tests none. Vaccination Facility Type is Pharmacy. Adverse event does not require a visit to Emergency Room or Physician Office. The patient had not received prior vaccinations within 4 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Nasal discomfort, Oral discomfort, Throat irritation, Tongue discomfort
Clinical narrative: Burning in lip; burning the tongue, rest of the mouth and then down to the throat all the way even the eyes and the nose; Burning in lip; burning the tongue, rest of the mouth and then down to the throat all the way even the eyes and the nose; Burning in lip; burning the tongue, rest of the mouth and then down to the throat all the way even the eyes and the nose; Burning in lip; burning the tongue, rest of the mouth and then down to the throat all the way even the eyes and the nose; Burning in lip; burning the tongue, rest of the mouth and then down to the throat all the way even the eyes and the nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 63-year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Lot number: EW0161) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization. The following information was reported: ORAL DISCOMFORT (non-serious), TONGUE DISCOMFORT (non-serious), THROAT IRRITATION (non-serious), EYE IRRITATION (non-serious), NASAL DISCOMFORT (non-serious) all with onset 15Apr2021, outcome "recovering", and all described as "Burning in lip; burning the tongue, rest of the mouth and then down to the throat all the way even the eyes and the nose". The event "burning in lip; burning the tongue, rest of the mouth and then down to the throat all the way even the eyes and the nose", "burning in lip; burning the tongue, rest of the mouth and then down to the throat all the way even the eyes and the nose", "burning in lip; burning the tongue, rest of the mouth and then down to the throat all the way even the eyes and the nose", "burning in lip; burning the tongue, rest of the mouth and then down to the throat all the way even the eyes and the nose" and "burning in lip; burning the tongue, rest of the mouth and then down to the throat all the way even the eyes and the nose" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of oral discomfort, tongue discomfort, throat irritation, eye irritation, nasal discomfort.  Additional information: Patient had the Pfizer vaccine on 4/16 and within less than an hour had kind of burning in lip and then it stayed that way for about 48 hours and then it kind of started burning the tongue, rest of the mouth and then down to the throat all the way even the eyes and the nose. So patient ended up to the doctor office they send her to the ER and they try to treat her with some Benadryl and steroids, they treated her with but patient was still having kind of the same symptoms but not as severe and had been on Zyrtec and Prilosec (treatment).   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dyskinesia
Clinical narrative: Back pain/painful to stand up and move around; It is painful to stand up and move around.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic lower back pain" (unspecified if ongoing), notes: back pain isn't associated with the first shot, the caller just has chronic lower back pain. The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "Back pain/painful to stand up and move around"; DYSKINESIA (non-serious), outcome "unknown", described as "It is painful to stand up and move around.".  Additional information: The caller was concerned because he had back pain right now and was scheduled for second shot today at 13:30. The caller wasn't sure if he should be getting the shot today because of the back pain. The back pain wasn't associated with the first shot, the caller just has chronic lower back pain and his back went out 4 days ago. It was painful to stand up and move around. The caller knows the second dose was a little worse and wants to know if this will effect the lower back. The caller declines to file a safety report as he does not believe that this event is related to the first dose of the vaccine, no further information or details were captured at this time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypersensitivity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0171, expiration date: Aug 31, 2021), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for immunisation. The patient experienced dizziness and hypersensitivity (severe allergic reaction), with outcome of unknown. Additional information: The patient got the 2nd dose of the Pfizer COVID-19 vaccine, and had dizziness. The patient read this was one of the severe allergic reactions. No follow-up attempts possible. No further information expected.