chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Ear pain, Oropharyngeal pain, Pyrexia
Clinical narrative: I got my second shot 01Jun2021 my cough has gotten worser; sore throat; my right ears hurts bad; Fevers; This is a spontaneous report from a contactable consumer.  A 49-years-old female patient bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EW0185 and Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 01Jun2021 (Age at age of 49 years) as second dose single dose for covid-19 immunization. Medical history included type 1 diabetes mellitus and cardiac failure congestive. Concomitant medication included levothyroxine sodium; pantoprazole; solifenacin taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took vasotec (enalapril maleate) and experienced hypersensitivity, thera flu 24 and experienced hypersensitivity. No covid prior vaccination. No covid tested post vaccination. Patient was not pregnant at the time of vaccination. The patient had a bad cough ever since the first covid shot on 11May2021, they said it will go away in a few days it did not, she got her second dose on 01Jun2021 and her cough has gotten worse they keep telling in a few a day it will go away it was not going away. She has a sore throat, her right ears hurt bad, and she was running fevers. The patient underwent lab tests and procedures which included body temperature: unknown results. The outcome of events was unknown whereas the outcome of event cough worsened was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Headache; nose that runs like a faucet; Chills; Sore throat; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown) via an unspecified route of administration on 26Mar2021 as 2ND DOSE, SINGLE DOSE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient took first dose of bnt162b2 (Solution for injection, Batch/Lot number was not reported) on an unspecified date for Covid-19 immunization. It was reported that, She got the second dose of the Pfizer covid vaccine on 26Mar2021. Starting last Saturday she got a headache, a nose that runs like a faucet and chills. She started off with a sore throat in 2021 and that went away. Also reported that, She did not know if it was from the vaccine or if she was sick from something else. Her family thought,  it too long after the vaccine to experience side effects. She was asking if this was normal to experience this long after the second dose. She breezed right through her vaccines. Outcome of the event, 'sore throat' was recovered on 2021 while for other events was unknown.   Information about batch/ lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: He received the covid vaccine. He did not have any complications, other than some joint pain.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced some joint pain. The patient stated he did not have any complications, other than some joint pain. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable consumer. A female patient (daughter) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was unknown and expiration date was unknown), via an unspecified route of administration, administered in Arm Left on 27May2021 as 1st dose, single dose for COVID-19 immunization. Medical history was none provided. The patient's concomitant medications were not reported. The patient did not receive any other vaccines prior to the vaccination (No, she was not there yet, she was going to get next vaccine next week). On May2021, patient experienced hives. Reporter stated, just wanted to know about the reaction that my daughter had with the first dose. Reporter stated, I just want to talk to somebody just to clarify before we get the second dose. Reporter again stated, 5 hours later, I just want to know about the reaction she had was normal, that's all. No, she had a reaction and wanted to know if that was an okay reaction and normal. Reporter stated, No, she did, I mean she was just taking systemic antihistamine does not like, because she has hives. Reporter stated treatment for hives was No. The outcome of event was unknown.  Follow up attempt needed; information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient's husband). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The Patient received the covid vaccine and the Patient did not have any complications, other than some joint pain on an unspecified date. Outcome of the event was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Aphonia, Dizziness, Hypersensitivity, Illness
Clinical narrative: Lost my voice; Abdominal cramps; Vomiting non stop/ still been throwing up; Body aches; They thought I was having an allergic reaction; Sick; Felt dizzy/ lightheaded; Arm was very sore/ arm ached; Couldn't see straight; This is a spontaneous report received from a contactable consumer (the patient reported for herself). A 20-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25May2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included Latex allergy. Concomitant medications included methylprednisolone taken for an unspecified indication, start and stop date were not reported and unspecified nausea medications. No COVID prior vaccination. Post vaccination tested for COVID with negative result. No other vaccine received in four weeks. On 25May2021 10:00, (since the day that the patient got shot) she was sick, felt dizzy, couldn't see straight and arm was very sore. The consumer reported that "The day after I was vomiting non-stop, arm ached, light headed, abdominal cramps, body aches, and overall not doing well. I was transported via ambulance to the ER as they thought I was having an allergic reaction. Since then I haven't really gotten better, I've been having issues and been out of work for over 2 weeks. I lost my voice about a week ago (Jun2021) and still been throwing up and just really over being sick at this point." On 26May2021, the patient underwent lab tests and procedures which included Nasal swab COVID test: negative. The events were assessed as medically significant. Adverse events were treated with steroids and unspecified nausea and abdominal pain medications. The outcome of events was not recovered.  Information about the Lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, SARS-CoV-2 test, Visual impairment, Vomiting
Clinical narrative: Lost my voice; Abdominal cramps; Vomiting non stop/ still been throwing up; Body aches; They thought I was having an allergic reaction; Sick; Felt dizzy/ lightheaded; Arm was very sore/ arm ached; Couldn't see straight; This is a spontaneous report received from a contactable consumer (the patient reported for herself). A 20-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25May2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included Latex allergy. Concomitant medications included methylprednisolone taken for an unspecified indication, start and stop date were not reported and unspecified nausea medications. No COVID prior vaccination. Post vaccination tested for COVID with negative result. No other vaccine received in four weeks. On 25May2021 10:00, (since the day that the patient got shot) she was sick, felt dizzy, couldn't see straight and arm was very sore. The consumer reported that "The day after I was vomiting non-stop, arm ached, light headed, abdominal cramps, body aches, and overall not doing well. I was transported via ambulance to the ER as they thought I was having an allergic reaction. Since then I haven't really gotten better, I've been having issues and been out of work for over 2 weeks. I lost my voice about a week ago (Jun2021) and still been throwing up and just really over being sick at this point." On 26May2021, the patient underwent lab tests and procedures which included Nasal swab COVID test: negative. The events were assessed as medically significant. Adverse events were treated with steroids and unspecified nausea and abdominal pain medications. The outcome of events was not recovered.  Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Influenza like illness
Clinical narrative: 2 days of flu-like symptoms post 2nd dose; Post vaccination flare-ups; This is a spontaneous report from a contactable consumer (Patient spouse reported for his wife) via Medical Information Team. A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. It was reported that the patient's spouse queried that had there been COVID-19 vaccine studies looking specifically on Epstein-Barr virus and Herpes II virus, and any related reactions, positive, perhaps lessened viral load, or no reaction. Reporter stated his wife has had post vaccination flare-ups (unspecified condition aggravated), and wondering if there are studies to find and share information. The reporter also stated they both had 2 days of flu-like symptoms post 2nd dose of COVID-19 vaccination on an unspecified date, that cleared. They were grateful and thankful for 'your' work. No product quality complaint was reported. The outcome of the event post vaccination flare-ups was unknown, and outcome of event 2 days of flu-like symptoms post 2nd dose was recovered on an unspecified date.  Information about the Lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle ache; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot/batch no: unspecified) via unspecified route, as a 1st dose, single dose on 23May2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date patient has experienced muscle aches within the past few days. She worked out and was not sure that if that was from working out or the vaccine. The clinical outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable other hcp. A 61-years-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 61-years-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included fish oil (OMEGA-3 FISH OIL) 1000 mg capsule, paracetamol (TYLENOL) 325 mg tablet, nifedipine 10 mg capsule, hydroxychloroquine sulfate, methotrexate 2.5 mg tablet. On an unspecified date, patient stated she had a slight headache after her COVID vaccine last month. Patient held a dose due to vaccination and MD not aware. The outcome of the event was recovered.  No follow up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: After the second dose, her arm has a rash at the site she got the shot.; This is a spontaneous report from a contactable consumer. A contactable reporter reported that a 70-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, lot: EW0179, expiry date: Aug2021) via unspecified route of administered on 02Jun2021 at 11:00 as single dose in left arm for COVID-19 immunization. Medical history and concomitant medication s were not reported. the patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) intramuscularly administered in arm left on 12May2021 11:00 (Batch/Lot Number: EW01735; Expiration Date: unknown date on Aug2021) as single dose for covid-19 immunisation. No Prior Vaccinations (within 4 weeks) was reported. Caller remarked that the only time she had a reaction to a vaccine was in grade school, back in the 50's. She got a rash. Back then they did with not just one needle, they poked her, and she got a scab and rash. Caller reported on the Pfizer Covid 19 shot and who explained she had a reaction to the product. With the first dose she did fine. After the second dose, her arm has a rash at the site she got the shot. It started out the size of a nickel but was now about the size of the top of a soup can. The rash started 07Jun2021 and has gotten worse. Caller confirmed it has increased in size. It was noted she went to emergency care and wasn't given anything for treatment, this was last night 09Jun2021. Outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: A lot of neuropathic pain; Shingles; This is a spontaneous report from a contactable Nurse (patient). A 75-years-old female patient received BNT162B2 (PFIZER-BIOECH COVID-19 VACCINE, solution for Injection, Batch/Lot Number: EN9581), via an unspecified route of administration, administered in Arm Left on 02Feb2021 as second dose, single dose for covid-19 immunization (at the age of 75-year-old). Patient previously received first dose of BNT162B2 (Lot number: ELO142) Anatomical Location: left upper arm on 12Jan2021. The patient medical history and concomitant medications were not reported. She is a very healthy person. It was reported that on 09May2021 the shingles started after the second dose. patient believes it seems to be a latent effect. The shingles show up a couple months later. Also reported A lot of neuropathic pain. Patient reported that she is calling about the Vaccine and is suspicious of the side effects with regard to Shingles. She is trying to follow it as she is a health care worker as well and find out how many people have gotten shingles after receiving the vaccine. she has shingles and has received the shingles vaccine. She is curious to know how many other people have had this happen after the vaccine. She is just relating if her shingles are related to the Pfizer COVID vaccine. She has been kind of trying to google it as she has been feeling suspicious. She has had shingles for about 5 weeks. She said after talking with multiple people she knows they have been noting the increase of shingles cases as well this year, seems it may hit the immune system in a way that brings these things back up more easily, even though they had received the shingles vaccine. She sent a picture to the hospice doctor she works with to show him her shingles. she also adds shingles aggravating. She has seen it, that is has been related to someone having had an active COVID case, that has shown shingles, She doesn't believe she has had an active case of COVID, but she guesses it could always have been subclinical, but there is relevance between people with active COVID and getting shingles after getting the COVID shot. Patient visited physician office for events. ER visit: no. the outcome for the event shingles was reported as not resolved and for A lot of neuropathic pain outcome was unknown.   Information on Lot/Batch number was available. Additional information has been requested ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021685057 Same reporter/ AE, different drug/ patient
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Chest pain, Fatigue, Feeling abnormal
Clinical narrative: getting good sleep, but he's absolutely exhausted all day; feeling absolutely terrible; under his left armpit, there's a bump and it's super sore; his whole armpit and chest area has been sore out of no where for a few days; his whole armpit and chest area has been sore out of no where for a few days; This is a spontaneous report from a contactable consumer (Patient). A 25-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on 07Jun2021 (at the age of 25-years-old) as, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The details about patient history and other products were not provided. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported) on an unspecified date as single dose for COVID-19 Immunization and experienced the left arm was so sore after the first one but the soreness went away after a few days. On unspecified date, patient was getting good sleep, but he is absolutely exhausted all day. Patient stated that under his left armpit, there was a bump and its super sore and his whole armpit and chest area has been sore out of nowhere and its been for a few days. It was reported that the patient got his second dose of the Pfizer vaccine this Monday, it's now Thursday morning and he is honestly just feeling absolutely terrible and he just wants to make sure this was normal. Patient stated that he has other symptoms he is getting concerned about at this point, it's been a few days since he started having them. Patient stated that he honestly feels terrible, he cannot physically do anything. Patient stated that he was actually going to a doctor's appointment in 15 minutes and stated he will call back at a later time, he just wanted to know if what he was feeling was normal or if he needs to seek further medical advice and confirms it was the Pfizer Covid vaccine that he was speaking of and received. The outcome of the events was reported as unknown  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oral infection
Clinical narrative: Mouth infection; This is a spontaneous report received from Pfizer sponsored program received via contactable consumer or other non- health care professional (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration on 22May2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she got the first COVID 19 vaccine on 22May2021 and she will be getting the second dose on 12Jun2021 upon checking it is 21days apart but she mentioned inside three weeks she developed a mouth infection. The patient wanted to know if it will cause a complication if she has the mouth infection and is taking a disinfection. Therapeutic measures were taken as a result of mouth infection but the infection is not gone yet. The clinical outcome of the event was reported as unknown.  Information on Lot/Batch number was available. Additional information has been requested
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise
Clinical narrative: had a little bit of weakness; feeling a little icky; This is a spontaneous report from a contactable consumer or other non hcp via medical information team. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 15:00 (Batch/Lot Number: EW0185) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient not had any prior vaccination. The patient experienced had a little bit of weakness and feeling a little icky on an unspecified date in 2021. It was reported that 19May2021 was patients first dose and patient only had a little bit of weakness and feeling a little icky but then it went away. Patient was taking Pfizer BioNTech Covid-19 Vaccine because lots of people died without it. She figured she needed to get it. Caller stated that she took the Pfizer first shot. She took it and had no serious reaction right after the needle was taken out of her arm. Later she felt weak. It went away. She knew this was common. Caller stated that she hadn't weighed herself in awhile. She thought she was about 230 pounds. Caller mentioned she was expecting that to feel weak. She later went on to explain about feeling a little weak. It stated that she felt weak a day or two after the shot. It lasted for a week. It went away to her feeling normal. The outcome of event was recovered on an unspecified date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021684035 same patient/drug, different dose/event
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Musculoskeletal stiffness, Pain
Clinical narrative: pain; tired; his arm started feeling stiff and heavy in the area where he had the injection and back towards his shoulder; his arm started feeling stiff and heavy in the area where he had the injection and back towards his shoulder; This is a spontaneous report from a contactable consumer (Patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on 21May2021 as 1st dose single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tired the next day of vaccination (on 22May2021) and his arm was stiff, but then he felt fine. A 6-7 days later (in May2021), his arm started feeling stiff and heavy in the area where he had the injection and back towards his shoulder. The pain and stiffness were light but continued. He wanted to know if this was normal and if he should get his second vaccination in a few days. As a response he was suggested to discuss with his vaccinator. The outcome of the event tired and heaviness in arm was unknown, stiffness and pain was not resolved.  Information about lot/batch number is requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Malaise, Peripheral swelling, Pyrexia
Clinical narrative: had fever; couldn't get out of bed; arm swelled up; bright red then turned black and didn't feel good; bright red then turned black and didn't feel good; bright red then turned black and didn't feel good; This is a spontaneous report from a non-contactable consumer (patient himself). A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single dose and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 2nd dose single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient got Pfizer's first shot and had fever for 1and 1/2 days. The patient could not get out of bed. On the 3rd day arm swelled up, bright red then turned black and did not feel good. The patient got second shot and had fever again, arm did the same thing, it was a month before that the patient felt like old self. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: had fever; couldn't get out of bed; arm swelled up; bright red then turned black and didn't feel good; bright red then turned black and didn't feel good; bright red then turned black and didn't feel good; This is a spontaneous report from a non-contactable consumer (patient himself). A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single dose and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 2nd dose single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient got Pfizer's first shot and had fever for 1and 1/2 days. The patient could not get out of bed. On the 3rd day arm swelled up, bright red then turned black and did not feel good. The patient got second shot and had fever again, arm did the same thing, it was a month before that the patient felt like old self. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feeling unwell; This is a spontaneous report from a contactable consumer (patient).   A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date at single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient has received both doses of the Pfizer COvid-19 Vaccine. Patient was asking what "feeling unwell" on the fact sheet means. Caller reported to DSU 16 Adverse Events. The outcome of event feeling unwell was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: achy arm; This is a spontaneous report from a Pfizer- sponsored program. A contactable  female consumer reported for herself via telephonic activity that includes: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration on 04Mar2021 as 1ST DOSE, SINGLE DOSE, dose 2 via an unspecified route of administration on 23Mar2021 (Batch/Lot Number: ER8730) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient had both doses of the Pfizer vaccine 3 months ago and got a (Name) email and she don't know why she got it. It was reported that she had a side effect of a little ache here and there, nothing major and that she has not called us. It was reported that Caller states the real reason she called is 1, she worked for 50 years in IT and the Pfizer logo is different and she though it was a phishing email kind of thing and she don't know if this is a legal email. It was reported that she didn't complain about her Pfizer shot. She had concerned about that email. It was reported that she had an achy arm like you would with a flu shot. It was reported that Caller is asking if making a report about her achy arm is important, she states it was no big deal and she was expecting that at the least. Caller declines to make a report. The outcome of event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeding disorder, Malaise, Nausea
Clinical narrative: He was throwing up and he was not eating; He was throwing up and he was not eating; Nauseous all day; Chills; Tiredness; Feeling sick; This is a spontaneous report from a contactable consumer (patient's father). A 14-years-old male patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 09Jun2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.On 10Jun2021, the patient experienced feeling sick, he was throwing up and he was not eating, nauseous all day, chills and tiredness. The reporter wanted to know if those are normal adverse events with the Pfizer COVID-19 vaccine. Thee patient wanted to know if there was any recommendation for what he was feeling. The patient was referred to consult his doctor or health care provider for further guidance, as his doctor/healthcare provider was the most familiar with your medical condition.They wanted to know if those are normal adverse events with the vaccine.The case was assessed as non serious.The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: He was throwing up and he was not eating; He was throwing up and he was not eating; Nauseous all day; Chills; Tiredness; Feeling sick; This is a spontaneous report from a contactable consumer (patient's father). A 14-years-old male patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 09Jun2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.On 10Jun2021, the patient experienced feeling sick, he was throwing up and he was not eating, nauseous all day, chills and tiredness. The reporter wanted to know if those are normal adverse events with the Pfizer COVID-19 vaccine. Thee patient wanted to know if there was any recommendation for what he was feeling. The patient was referred to consult his doctor or health care provider for further guidance, as his doctor/healthcare provider was the most familiar with your medical condition.They wanted to know if those are normal adverse events with the vaccine.The case was assessed as non serious.The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) received via Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER CVOID-19 VACCINE), via an unspecified route of administration on 10Jun2021 07:15 (Lot Number: EW0175) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced soreness arm on 10Jun2021 and enquired if she could take acetaminophen (TYLENOL). The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Sore arm; Her arm is feeling numb; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on 10Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Jun2021, after vaccination in the evening the patient experienced sore arm and her arm was feeling numb after vaccination. Reporter asking for treatment recommendations for her daughter's sore arm. Caller reports that she filed a report (no reference number for that encounter) and asked that agent for recommendations of what she should do and he gave her the number for medical information. Reporter reports that she asked the pharmacist who said its probably her nerve and advised to place an ice pack on the area and take Tylenol but she calls now to ask what else her daughter should do. The outcome of event was Unknown.  DSU - E-transmitting for AE data capture. Caller reports that she already filed a report with some-one else but was sent over to medical information to assist with her question about treatment and management of her daughters sore arm. No reference number for that encounter.  Response: Confirmed Pfizer Covid vaccine. Spoke from attached documentation and referred to HCP for evaluation and treatment recommendations. E-transmitting for AE data capture.  Follow up attempts are needed; information about lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: She also has herpes and never has experienced an outbreak since getting the Pfizer-BioNTech COVID-19 vaccine; This is a spontaneous report from a contactable consumer or other non hcp (Patient). This consumer (patient) reported for herself.  A 50-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. Medical history of patient included herpes. The patient's concomitant medications were not reported. On an unknown date, the patient experienced she also has herpes and never has experienced an outbreak since getting the pfizer-biontech covid-19 vaccine. It was reported that she explained this group includes people with STD that have experienced positive reaction to the COVID-19 vaccine. She explained this individual called Pfizer earlier and reported never having an outbreak of her herpes since being vaccinated and encouraged Pfizer to make a study on such population. Caller explained she doesn't had the individual's gender since they are using false usernames. She added she also had herpes and never has experienced an outbreak since getting the Pfizer-BioNTech COVID-19 vaccine. She specified not having any medical inquiries. The outcome of event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021687833 same reporter/drug/AE, different patient;US-PFIZER INC-2021694629 Same reporter/ drug/ AE, different patient
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Sore throat; Runny nose; Fatigue; This is a spontaneous report from a contactable consumer (patient's parent). A 12-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as second dose, single dose for covid-19 immunization. Medical history included ongoing obsessive-compulsive disorder (reported as His mother noticed some OCD symptoms yesterday which is common when his PANDAS is active). The patient's concomitant medications were not reported. On an unspecified date the patient experienced sore throat, runny nose, fatigue. The outcome of events was unknown.  Information on Lot/Batch number can be requested.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Pyrexia
Clinical narrative: patient developed a fever which lasted for a day; 1st dose:23May2021/2nd dose:06Jun2021; 1st dose:23May2021/2nd dose:06Jun2021; This is a spontaneous report from a contactable consumer.   An adult female patient of unknown age received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 06Jun2021 as, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: unknown) dose 1 via an unspecified route of administration on 23May2021 as, single for covid-19 immunisation. On 07Jun2021 (One day after the second dose of vaccination), the patient had fever which lasted for a day. The outcome of the event was resolved on 08Jun2021.  Information about lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: 3 days PV shingles flare up on mid-chest and R arm; This is a spontaneous report from a contactable Physician. A 74-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as single dose for covid-19 immunisation. The patient medical history included HX of kidney failure, anemia, HTN (hypertension), gout, heart failure, A-fib. Treated with valacyclovir and mupirocin, clinically diagnosed. Concomitant medications were not reported. On unspecified date, the patient experienced 3 days PV shingles flare up on mid-chest and R arm. Event took place after use of product. The patient received treatment for the event. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Peripheral swelling
Clinical narrative: He is experiencing swelling in the left arm; first dose 18May2021 and second dose 01Jun2021; This is a spontaneous report from a Pfizer sponsored program via contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer COVID-19 Vaccine, Formulation: Solution for injection) via an unspecified route of administration on 01Jun2021 (Lot number and Expiry date was not reported) as 2nd dose, single dose for COVID-19 immunisation and first dose on 18May2021 (Lot number and Expiry date was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Jun2021, the patient had 1st shot was given 18May2021 and 2nd dose was given 01Jun2021, on an unspecified date, the patient experienced swelling in the left arm. The patient wanted to check how many days he can get the pneumococcal vaccine after getting the 2nd dose of the COVID-19 vaccine. The outcome of the event swelling in the left arm was not recovered and had 1st shot was given 18May2021 and 2nd dose was given 01Jun2021 was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: mild sore throat; This is a spontaneous report from a contactable consumer(patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0177), via an unspecified route of administration on an unspecified date, as unknown, single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced mild sore throat. The consumer stated, the patient experienced some mild sore throat not too bad but just a little mild since I have received the vaccine. The outcome of the mild sore throat was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. An unspecified age male patient received the first dose of BNT162B2 via an unspecified route of administration on 13May2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, the patient experienced pain. The patient scheduled to take the 2nd dose on 10Jun2021. The patient had the confirmation of their schedule on current date but would like to confirmed if they can rescheduled it due to Medical Appointment for his pain management. The patient stated he didn't experience any reactions after the shot and pain right now. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021687666 same reporter/drug/event and different patient.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This is a spontaneous report from a contactable consumer or other non hcp received from a Pfizer sponsored program. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on 13May2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient experienced pain on an unspecified date. It was reported that patient had their first dose on 13May2021 and scheduled to take the 2nd dose 10Jun2021. Reporter confirmed that patient had schedule today but would like to confirm if the date can be rescheduled due to Medical Appointment for his pain management. Reporter stated that patient did not experience any reactions after the first dose and pain right now. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021687630 same reporter/drug/event and different patient.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia, Pain, Pain in extremity
Clinical narrative: Some of her friends reported feeling tired; feel discomfort at the injection site; sore arm; muscle soreness, like an ache "on and off"; had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group; having a tingling feeling off and on; some weakness to her hand on the side of her injection; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported), via an unspecified route of administration on 18April2021 as Second dose ,single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose BNT162b2  for Covid-19 immunisation. The reporter stated that she has friends who have experienced similar symptoms such as feeling tired, feel discomfort at the injection site, sore arm ,muscle soreness, like an ache "on and off" , had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group , having a tingling feeling off and on but that went away , some weakness to her hand on the side of her injection and picking things up and dropping things .The outcome of all events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021684418 same patient/drug/similar event, different patient;US-PFIZER INC-2021687674 same patient/drug/similar event, different patient;US-PFIZER INC-2021687677 same patient/drug/similar event, different patient;US-PFIZER INC-2021687676 same patient/drug/similar event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site discomfort
Clinical narrative: Some of her friends reported feeling tired; feel discomfort at the injection site; sore arm; muscle soreness, like an ache "on and off"; had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group; having a tingling feeling off and on; some weakness to her hand on the side of her injection; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported), via an unspecified route of administration on 18April2021 as Second dose ,single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose BNT162b2  for Covid-19 immunisation. The reporter stated that she has friends who have experienced similar symptoms such as feeling tired, feel discomfort at the injection site, sore arm ,muscle soreness, like an ache "on and off" , had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group , having a tingling feeling off and on but that went away , some weakness to her hand on the side of her injection and picking things up and dropping things .The outcome of all events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021684418 same patient/drug/similar event, different patient;US-PFIZER INC-2021687674 same patient/drug/similar event, different patient;US-PFIZER INC-2021687677 same patient/drug/similar event, different patient;US-PFIZER INC-2021687676 same patient/drug/similar event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: he feel sick; This is a spontaneous report from a contactable consumer (patient's Mother). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number  EW0178 and expiration date: not reported), via an unspecified route of administration, on Right arm, on 09Jun2021 18:37 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number EW0175 and expiration date: not reported) via unspecified route of administration, on 19May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The patient felt sick on Jun2021. The reporter would like to know whether any medication can be given to the patient for sick. No treatment was received for the adverse event. The outcome of event is unknown.