chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Believes that the syringe was not filled with any solution at the time of administration; A Spontaneous report was received from a consumer concerning a female patient (age not provided) who received Moderna (mRNA-1273) vaccine and believed that the syringe was not filled with any solution at the time of administration (vaccine underdose)  The patient's medical history was not provided. No relevant concomitant medications was known.   On 26-Jan-2020, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route, for prophylaxis of Covid-19 infection.   The reporter stated that both of them have received the second dose and believed that his wife did not receive the full second dose ( believed that the syringe was not filled with any solution at the time of administration).  Lab data was not provided.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event was unknown.; Reporter's Comments: This report refers to a case of underdose for mRNA-1273 with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Vaccine was shaken up before vaccine was given; A spontaneous report was received from a consumer concerning a 78 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) vaccine was shaken up before vaccine was given (product administration error).  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly] for prophylaxis of COVID-19 infection.   On an unspecified date the vaccine was shaken before vaccine was given (product administration error).   Action taken with mRNA-1273 in response to the event was not provided.  The event product administration error was unknown.; Reporter's Comments: This case concerns a 78-year-old male who experienced nonserious unexpected event of Product administration error for mRNA-1273, lot # unknown, with no associated adverse events. Event outcome not reported.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: Vaccine spilled on patient's arm; I dont think patient received any dose; crack in syringe and vaccine spill; A spontaneous report was received from a healthcare professional concerning a patient on an unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and there was a crack in the syringe and the  vaccine spilled on patient's arm and don't think the patient received any dose.   The patient's medical history was not reported. No relevant concomitant medications were reported.     On 08-feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 08-feb-2021, pharmacy intern called to ask for some guidance for an incident that happened in the pharmacy. When they were vaccinating one of the patients, there was a crack in the syringe and the vaccine spilled on patient's arm. They did not think the patient received any dose. They wanted to know regarding the 2nd dose of vaccine and should they wait 4 weeks for it, and can patient absorb any vaccine topically.   Pharmacy intern didn't have any information about the patient because she wasn't the one who administered the vaccine. She said she will tell other people to report it. No treatment information was provided.    Consent for follow up was not given.   Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events and there was a crack in the syringe and the vaccine spilled on patient's arm and don't think the patient received any dose were considered resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender who experienced NS unexpected events of Device connection issue, exposure via skin contact, and underdose with mRNA-1272 (lot # unknown) with no associated adverse events.  Events considered resolved.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: I think they administered a vaccine that had expired the day before; A spontaneous report was received from a 77-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and thought that she was administered a vaccine that had expired the day before (PT: expired product used).     The patient's medical history was not provided. No relevant concomitant medications were reported.    On 05-FEB-2021, the patient received her first of two planned doses of mRNA-1273 (batch number# 13M20A, expiration date: 04-FEB-2021) through an unknown route in an unknown arm, for prophylaxis of COVID-19 infection.   The patient believed that she was administered a vaccine that had expired.  Treatment information was not provided.  The outcome of the event was considered  recovered on 05-FEB-2021.; Reporter's Comments: This refers to a case of 77-year-old female patient, who had an "expired product administered" of  Moderna's COVID-19 vaccine (mRNA-1273)(Lot#13M20A ) with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product administered at inappropriate site
Clinical narrative: sore arm; Caller reported a vaccine recipient thought the first dose of the covid 19 vaccine was too high up on the arm so the vaccine administrator gave a second dose within 15 minutes.; Caller reported a vaccine recipient thought the first dose of the covid 19 vaccine was too high up on the arm so the vaccine administrator gave a second dose within 15 minutes.; This is a spontaneous report from a contactable Pharmacist. A female patient in her 20s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 27Jan2021,14:30 (lot number: unknown) and second dose on 27Jan2021, 14:40- 14:45 both via an unspecified route of administration in the arm at 0.3mL single dose for COVID-19 immunization in the clinic. The patient's medical history and concomitant products were unknown. The reporter, was a pharmacist, was a Depo leader with the pharmacy COVID-19 vaccine clinic. They had a clinic in one of the facilities. One of the patient who could have been a Nurse, or at least had medical background was the patient. The pharmacist at a pharmacy gave the patient 0.3mL of the Pfizer COVID vaccine. The patient claimed the Pharmacist gave it too high up, near her shoulder. The patient then went to a different Pharmacist because she felt like she didn't get her dose and got a second dose of 0.3mL within 15 minutes. The reporter doesn't know which arms they were given in. The reporter stated the patient had experienced sore arm. The pharmacist assessed the events as non-serious. The outcome of the event as unknown.  Information on the lot/batch number has been requested.  Follow-up (02Feb2021): New information reported from a contactable Pharmacist includes: new event (sore arm).   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: After 1st dose tested positive for Covid-19; After 1st dose tested positive for Covid-19; This is a spontaneous report from a Pfizer-sponsored program.  A contactable consumer (patient) reported that a 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient had first vaccine almost 21 days ago, after 1st dose tested positive for covid-19 on an unspecified date. The patient wanted to know if she should have 2nd dose. She stated she has finished her 10-day quarantine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Nausea, Vomiting
Clinical narrative: nausea; vomiting; diarrhea; not feeling too good; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number ang expiry date unknown), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she was not feeling too good since an unspecified date in 2021. She reported that on 31Jan2021, since she received the first dose she has woken up every morning with nausea, vomiting and diarrhea. She asked if this was normal and how long it will last. She was asking what is the efficacy of one dose of the vaccine and if should get the second dose. The outcome of the events was unknown. The events were reported as non-serious.   Information about Lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Musculoskeletal discomfort, Musculoskeletal stiffness, Myalgia
Clinical narrative: sore muscle around my neck; when in bed last night, she could not turn her head without it been so painful; had discomfort in her shoulder and stiffness; had discomfort in her shoulder and stiffness/neck was so stiff that it hurt to turn her/can hardly turn her neck; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264), via an unspecified route of administration on 30Jan2021 at 16:10 (4:10 pm) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Jan2021, the same night of vaccination, the patient had discomfort in her shoulder and stiffness. On Monday, 01Feb2021, patient reported that her "neck was so stiff that it hurt to turn her head". She can hardly turn her neck. She added when in an "upright" position "it is ok" but "when in bed last night, she could not turn her head without it been so painful" to the point where she felt like she "would cry out". On an unspecified date it was reported that patient had sore muscle around my neck. The patient mentioned she alleviates her pain with "Tylenol, hot compresses, took a towel and put hot water on it and then put it around my neck, and a cream for soreness". The patient took a Tylenol last night and put hot compress on it. And rubbed it with a muscle something for a sore muscle. But it still very painful. The patient doesn't know whether it's related to the vaccine or not. The outcome of the event sore muscle was not recovered while for the rest of the events was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: sore muscle around my neck; when in bed last night, she could not turn her head without it been so painful; had discomfort in her shoulder and stiffness; had discomfort in her shoulder and stiffness/neck was so stiff that it hurt to turn her/can hardly turn her neck; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264), via an unspecified route of administration on 30Jan2021 at 16:10 (4:10 pm) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Jan2021, the same night of vaccination, the patient had discomfort in her shoulder and stiffness. On Monday, 01Feb2021, patient reported that her "neck was so stiff that it hurt to turn her head". She can hardly turn her neck. She added when in an "upright" position "it is ok" but "when in bed last night, she could not turn her head without it been so painful" to the point where she felt like she "would cry out". On an unspecified date it was reported that patient had sore muscle around my neck. The patient mentioned she alleviates her pain with "Tylenol, hot compresses, took a towel and put hot water on it and then put it around my neck, and a cream for soreness". The patient took a Tylenol last night and put hot compress on it. And rubbed it with a muscle something for a sore muscle. But it still very painful. The patient doesn't know whether it's related to the vaccine or not. The outcome of the event sore muscle was not recovered while for the rest of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site induration
Clinical narrative: patient received the Covid vaccine below the deltoid muscle, possibly in the subcutaneous tissue.; patient had an injection induration at administration site.; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on the arm (also reported as below the deltoid muscle), on an unspecified date at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the COVID vaccine below the deltoid muscle, possibly in the subcutaneous tissue. It was asked if there is a need for revaccination. Patient also had an injection induration at administration site. The outcome was unknown.   Information about lot/batch number has been requested.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Neck pain
Clinical narrative: back and neck pain/ back was hurting and went up into his neck; back and neck pain/ back was hurting and went up into his neck; feeling "woozy/dizzy"/ lightheaded; This is a spontaneous report from a contactable consumer (patient's daughter). A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter said that her father received his 1st dose of vaccine on 25Jan2021. Yesterday on 01Feb2021, patient started experiencing back and neck pain and feeling "woozy/dizzy". She also reported that patient's back was hurting and went up into his neck.  Reporter said that he is really dizzy, that's what he's concerned about. And today on 02Feb2021, he was feeling lightheaded and dizzy. Reporter asking if these could be side effects from the vaccine since its a week later. She also would like to know if he should get the second shot. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: lump in her left arm, where she received the injection; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 01Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing arthritis. Concomitant medication included diphenhydramine hydrochloride, paracetamol (TYLENOL PM) for arthritis to help her sleep. The patient reported a "lump in her left arm, where she received the injection" on 01Feb2021. She asked if she could take diphenhydramine hydrochloride, paracetamol after her first and/or her second dose of the vaccine, how long to wait after the injection to take it and she mentioned she sometimes takes it at night to sleep better because she has arthritis. The patient further stated she was holding for drug safety and got disconnected. Stated she took diphenhydramine hydrochloride, paracetamol right after her first shot. She stated she got the Covid vaccine yesterday, stated everyone was telling her that she cannot take diphenhydramine hydrochloride, paracetamol. She clarified that she takes diphenhydramine hydrochloride, paracetamol once and a while for arthritis to help her sleep, wanted to know if this was true or not. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: first thought it was a rash, and after he went to the Dr., she confirmed that what he had was actually the shingles; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL1283), via an unspecified route of administration on 15Jan2021 17:00 (at 72-year-old) at single dose (Left Arm) for COVID-19 immunization.  Medical history included type 2 diabetes (he uses insulin for this), bladder cancer (he was a former bladder cancer patient). Concomitant medication included insulin for Type 2 diabetes. Patient had the first dose of the Pfizer BioNTech COVID-19 vaccine. A week later, he had developed a rash and it turned into shingles. It is currently clearing up and he is taking medications for it. He is due for his second shot of the vaccine on 05Feb2021 and was wondering if there are any recommendations for him not to take it. It was clarified that on 22Jan2021 a rash developed on his face which was found to be shingles. He saw a personal doctor, the doctor even put him on medication. All has gone well, once he started taking the medication the shingles didn't progress and dried up and is now in the late stage of drying up. He asked if he should be reporting this, he also would like to know if he should get the second covid vaccine. The Rash started on 22Jan2021 and was on the face, hair scalp region. He specified further that the rash was located in the upper right quadrant on his face, also being on the eye lid and hairline. He added that he actually had a second doctor check this as well, because the rash was on the eyelid. His Primary Care doctor had him see a ophthalmologist. Patient clarified that he first thought it was a rash, and after he went to the Dr., she confirmed that what he had was actually the shingles. Outcome described as still with a little bit of redness, but it is healing and it is dried up. Dr prescribed him Valtrex for the shingles. The patient underwent lab tests and procedures which included that he has had no positive covid tests. In Dec2020, he had the regular covid test and that was negative. In early Jan2021, he had the regular covid test as well as a covid-19 antibody test, and both were negative. Patient mentioned serology test, he then confirmed that he used the word serology inadvertently, and meant antibody. He has had no issues with vaccines in the past. The outcome of the event was recovering.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID as well/started to feel real sick; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN9581), via an unspecified route of administration (injection) into left arm on 27Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD), he has chronic bronchitis and was diagnosed with COPD probably over a year ago and stated that he takes inhalers, but no further details were provided by the caller, ongoing prediabetes diagnosed about two to three years ago, ongoing high blood pressure from 2008 and he stated that he takes 95 mg of three different types of blood pressure medications; but no further details on medication names or exact dosing of each were provided by the caller, and ongoing high cholesterol from 2008. Concomitant medication included metformin for prediabetes, started the product about two to three years ago and ongoing. The patient would like to know if he may take the second dose of the COVID vaccine after testing positive for COVID. He stated that he received the 1st dose of the COVID vaccine on 27Jan2021, started to feel real sick on 31Jan2021 and tested positive for COVID. It was further reported that he got his first shot of the COVID vaccine on Wednesday last week. On Friday, he stated that his wife tested positive for COVID, and then the caller got real sick on Sunday, and he then tested positive for COVID as well. He was wondering if that will affect the second dose or if there were recommendations about the second dose for people who got COVID in between doses. He stated that he has breathing problems anyway. He was planning to call yesterday but he still was not feeling up to it yesterday. He was starting to come over the hill today though. He reported that he just went online and scheduled the appointment himself for the vaccine because he has COPD, and they were allowing people with underlying issues to get the vaccine. He provided his primary care information as they were the ones who tested him for COVID on Sunday. He reported that he got his COVID vaccine on 27Jan2021, and he was tested for COVID on Sunday 31Jan2021. He stated that the clinic told him that the test takes about 15 minutes but they came back in about 10 minutes and told him that he was positive for COVID. The outcome of the events was unknown.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received first dose of BNT162B2, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient asked if she can get the second dose of the Pfizer covid-19 vaccine while taking tofacitinib citrate (XELJANZ). She forgot to ask for the first dose and she already got it. She received the first dose of the Pfizer covid-19 vaccine and experiencing a sore arm that lasted a couple of days. The patient recovered from sore arm on an unspecified date.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lacrimation increased, Nasopharyngitis, Rhinorrhoea, Swelling of eyelid
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the right arm, on 23Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient felt exhausted and like catching a cold and had fluid pouring out of his nose. His eyes was tearing and eye lid blew up on 2021. Everything happened on his right side and it lasted 4 days. He was told to take allergic medication. Outcome of the events was unknown  Information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Feeling abnormal, Headache, Pain
Clinical narrative: low grade fever (99.4F); really bad headache with aches all over/aching all over; feeling like she had been run over by a truck; really bad headache with aches all over/head has been hurting really bad; cough; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received her first dose bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262; expiration date: unknown) at vaccination age of 67-year-old via an unspecified route of administration in the left arm on 29Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included blood pressure (blood pressure abnormal), cholesterol (blood cholesterol) and several bypass surgeries. She mentioned that she was pretty healthy for her age. Family history included father died of heart disease and her sister has heart disease. Concomitant medication included unspecified blood pressure and cholesterol medication. The patient has no previous vaccination within 4 weeks and did have other vaccines given on the same day. The patient reported that she did not feel bad on the first day, but she started getting a cough on Saturday night (30Jan2021) and on Sunday (31Jan2021), she started getting a really bad headache with aches all over. This morning (02Feb2021), she is running a low-grade fever (99.4F). She added that now she was sick, she has a low-grade fever, chills, is hurting all over, all the things on the list. She inquired if these are common side effects of the vaccine and was asking if she should get tested to see if she's diagnosed with COVID-19. She inquired will her getting the shot effect the results of the COVID test, would she test positive for COVID now that she's had the shot. It is confirmed she has not tested positive for COVID. She did have 2 tests previously in Dec2020 before and after traveling. She further explained that she didn't feel bad until Saturday night and that is when she started with nagging cough. The aching all over started on Sunday (31Jan2021), feeling like she had been run over by a truck. She hadn't had a fever until this morning (02Feb2021), she woke up with a low-grade temperature of 99.4. She has been taking acetaminophen (TYLENOL) that helps. The call also notes later in the call that her head has been hurting really bad and this started yesterday (01Feb2021 [also reported as 31Jan2021]). It is remarked that she will probably be tested if the vaccine doesn't affect the results. The adverse events did not require emergency room or physician office. The outcome of the events was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: low grade fever (99.4F); really bad headache with aches all over/aching all over; feeling like she had been run over by a truck; really bad headache with aches all over/head has been hurting really bad; cough; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received her first dose bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262; expiration date: unknown) at vaccination age of 67-year-old via an unspecified route of administration in the left arm on 29Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included blood pressure (blood pressure abnormal), cholesterol (blood cholesterol) and several bypass surgeries. She mentioned that she was pretty healthy for her age. Family history included father died of heart disease and her sister has heart disease. Concomitant medication included unspecified blood pressure and cholesterol medication. The patient has no previous vaccination within 4 weeks and did have other vaccines given on the same day. The patient reported that she did not feel bad on the first day, but she started getting a cough on Saturday night (30Jan2021) and on Sunday (31Jan2021), she started getting a really bad headache with aches all over. This morning (02Feb2021), she is running a low-grade fever (99.4F). She added that now she was sick, she has a low-grade fever, chills, is hurting all over, all the things on the list. She inquired if these are common side effects of the vaccine and was asking if she should get tested to see if she's diagnosed with COVID-19. She inquired will her getting the shot effect the results of the COVID test, would she test positive for COVID now that she's had the shot. It is confirmed she has not tested positive for COVID. She did have 2 tests previously in Dec2020 before and after traveling. She further explained that she didn't feel bad until Saturday night and that is when she started with nagging cough. The aching all over started on Sunday (31Jan2021), feeling like she had been run over by a truck. She hadn't had a fever until this morning (02Feb2021), she woke up with a low-grade temperature of 99.4. She has been taking acetaminophen (TYLENOL) that helps. The call also notes later in the call that her head has been hurting really bad and this started yesterday (01Feb2021 [also reported as 31Jan2021]). It is remarked that she will probably be tested if the vaccine doesn't affect the results. The adverse events did not require emergency room or physician office. The outcome of the events was not recovered.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives; itching throughout her body; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982), intramuscular on the left arm at the age of 77 years, on 27Jan2021 11:30 at a SINGLE DOSE for covid-19 immunization and cefuroxime axetil (CEFUROXIME AXETIL), oral from 25Jan2021 to Jan2021 at 250 mg, 2x/day (250mg tablet, one tablet twice a day by mouth ) for urinary tract infection. Medical history included ongoing diabetes mellitus diagnosed many years ago, ongoing rash because she was still having a problem in her pubic area with a rash that is going on, states this is from the urinary tract infection and urinary tract infection from an unknown date and unknown if ongoing. When she got the vaccine she was on an antibiotic for a urinary tract infection (UTI), she is asking if there would be any correlation or any interaction between the antibiotic and the vaccine. The antibiotic was something she has taken quite often and has taken it before called cefuroxime axetil. Concomitant medication included insulin (INSULIN) for diabetes. The patient developed itching throughout her body, like hives that started late Friday (29Jan2021) and she will get areas on her hands and arms. This morning it was on her legs where it was red and warm. She reported it goes away and comes back. This morning the hives were fairly heavy and now that she has gotten up and cooled her body down, the hives were subsiding. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with covid 19; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient got on 22Jan2021 the first dose of the vaccine and she was scheduled to get the second on 12Feb2021 but she got diagnosed with Covid 19 on 2021. She would like to know if she should receive the second dose.  Outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Pruritus, Rash, Swelling face
Clinical narrative: swelling of the face and itching all over her body; swelling of her face and eyes; itching all over her body; it is worse with swelling of her face and eyes and itching and rashes; This is a spontaneous report from a non-contactable consumer.  A female patient of an unspecified age (reported as "Age:70; Unit: Unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: not provided), 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. The reporter stated that his wife had no problem after the first dose of the vaccine on an unspecified date. After the second dose, patient had swelling of the face and itching all over her body. Reporter stated the first two days were okay, but the third day patient went to emergency room and got Cortisol. On "Sunday", patient was better and now it was worse with swelling of her face and eyes and itching and rashes. Outcome of the events was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EN5318), via an unspecified route of administration at the left arm on 29Jan2021 at single dose for covid-19 immunization. She doesn't really have any other health problems or take many medications. On 31Jan2021, the patient experienced headache. They are not just little small headaches. She has taken Tylenol/ Acetaminophen for it. She will get more. The outcome of the event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache
Clinical narrative: tiredness/tired; weakness/weak; headache; This is a spontaneous report from a contactable consumer.  A male patient (husband) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: not provided), 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 is due to receive his second dose of Pfizer-BioNTech Covid19 vaccine this Friday, 05Feb2021. After the first dose on an unspecified date, the patient experienced, tiredness/tired, weakness/weak, and a headache. The reporter wanted to know if they should push back the interval to 4 weeks, to alleviate adverse events after the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: face turned puffy; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) solution for injection, 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. The reporter was asking if the second dose of the vaccine should be taken if you experienced a reaction after the first dose. It was reported that the patient's face turned puffy on an unspecified date. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles rash; pain; This is a spontaneous report from a contactable healthcare professional via a Pfizer-sponsored program. A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on an unspecified date. The patient developed shingles after the second dose of the Pfizer covid 19 vaccine. He received the vaccine on 29Jan2021 and developed a shingles rash on Sunday (31Jan2021). The healthcare professional wanted to know if he can take antivirals, if it is safe for him to get antivirals, and what he could take for pain on an unspecified date in 2021.   Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Insomnia, Pain
Clinical narrative: diarrhea; whole body aches; He can't sleep; feels like crap; This is a spontaneous report from a contactable consumer. A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EL9264 expiry date not reported) via an unspecified route of administration from 31Jan2021 at single dose for covid-19 immunization. The patient's medical history includes ongoing nausea and Not able to eat/ he can't drink or eat. Just thinking about eating makes him nauseated and threw up. Concomitant medications were not reported. The patient experienced whole body aches, he can't sleep and feels like crap on 31Jan2021. The patient also experienced diarrhea on 02Feb2021. The patient mentioned that on the morning of the vaccine, Sunday, he woke up, and tried to drink coffee and threw up. The Sunday morning he was nauseous before the shot. When he drank his coffee that morning. In the mornings, he can't drink or eat. Just thinking about eating makes him nauseated. His body aches started a little while after the shot. It was still Sunday when they started though. He can't sleep the body aches are so bad. Sunday evening is when he started to feel like crap. He has also had diarrhea. The outcome of the events whole body aches, feels like crap and diarrhea was not recovered. Outcome of the event He can't sleep was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little sore arm; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported for similar events. This is the first of the two reports.   A female patient of an unspecified age received the first dose bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 22Dec2020 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a little sore arm on an unspecified date. The outcome of event was unknown.  The information on the lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021149307 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pyrexia, Rash
Clinical narrative: Felt bad with a headcahe which kept getting worse; Fever that never got over 102F; Rash; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On a unspecified date, it was reported that the first 2-3 days the patient felt bad with a headache which kept getting worse, fever that never got over 102F. The headache was the worst which lasted 10 days or longer. This continued for about a week. The patient also had a rash which eventually disappeared, nausea & vomiting. The patient's doctor is not sure whether or not to continue with the second dose. Seeking guidance given the side effects experienced. The patient was tested for COVID-19 and the results were negative on an unspecified date. The outcome of the event rash was recovered while for the rest of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: Felt bad with a headcahe which kept getting worse; Fever that never got over 102F; Rash; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On a unspecified date, it was reported that the first 2-3 days the patient felt bad with a headache which kept getting worse, fever that never got over 102F. The headache was the worst which lasted 10 days or longer. This continued for about a week. The patient also had a rash which eventually disappeared, nausea & vomiting. The patient's doctor is not sure whether or not to continue with the second dose. Seeking guidance given the side effects experienced. The patient was tested for COVID-19 and the results were negative on an unspecified date. The outcome of the event rash was recovered while for the rest of the events was unknown.   Information about lot/batch number has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Poor quality sleep
Clinical narrative: dizzy; stomach seems a little upset; didn't sleep very well; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient started received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264 and expiry date: unknown), via an unspecified route of administration on the right arm, on 01Feb2021 at a single dose for COVID-19 immunization. The first dose was received on 11Jan2021 (lot number: EL0142) Medical history included GERD. Concomitant medication included pantoprazole and other unspecified product. Patient got the first shot of the COVID vaccine three weeks ago, and she didn't know anything had happened to her. She got the second dose of the vaccine yesterday at noon, and she was fine, although she didn't sleep very well on 01Feb2021. But the morning of 02Feb2020, she went in the kitchen and dropped some blueberries because the plastic boxes don't close easily, and she bent over to pick the blueberries up and she got dizzy. She did not know why she should get suddenly dizzy, and her stomach seemed a little upset, but she has no fever on 02Feb2021. Patient was just wondering if the dizziness is a side effect of the vaccine. Patient had no other vaccines on the same day as the COVID vaccine and stated when she had the incident where she bent over and was dizzy, it felt just really terrible, but she was feeling fine now, but the incident did shake her up a bit. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness
Clinical narrative: stiff neck; crampy on both sides of her neck; This is a spontaneous report from a contactable consumer (patient's husband) via Medical Information Team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 29Jan2021 at SINGLE DOSE for COVID-19 Immunisation. The patient's medical history and concomitant medications were not reported. The patient got the vaccine on Friday (29Jan2021) and then on Sunday (31Jan2021) she started having a stiff neck. She can barely move her head side to side. The reporter further stated that the patient has stiff neck type things, and was crampy on both sides of her neck and can hardly turn it sideways, up or down. He would like to know if this may be caused by the vaccine. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Back disorder, Computerised tomogram, X-ray
Clinical narrative: he has back problems; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included colon cancer and melanomas taken out of his neck and ear, but he didn't receive chemotherapy. Concomitant medications were not reported. The patient had back problems on an unspecified date. On an unspecified date, the patient underwent lab tests and procedures which included computerised tomogram and x-ray, both with unknown results. Clinical outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hypoaesthesia, Malaise, Nausea
Clinical narrative: Had the runs (diarrhea); Felt numbness in my cheek; Getting nauseous; Not feeling good. Cant do too much of anything, just sit/ sick; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient (also age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9269), intramuscular from 30Jan2021 17:00 (5pm) in the left arm at SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a Pharmacy (Pharmacy/drug store). Medical history included ongoing thyroid condition diagnosed at least 10 years ago. Concomitant medication included levothyroxine (LEVOTHYROXINE) at 50mcg tablet once a day by mouth (Taking it for years) for Thyroid/ thyroid condition. For prior vaccinations: The higher dose, senior dose of the flu shot (for immunization), she stopped taking it when the lower dose came out. She gets very sick with the senior dose. She does not know the name and does not have lot number of the senior dose of the flu shot to provide. It was stated to the patient that there may be too much protein in it. The patient is asking if she should get 2nd dose after having negative experience post vaccination of 1st dose. The patient received first dose of vaccine on sat (30Jan2021) evening. It was reported that as soon as she got to her car,  "I thought I felt numbness in my cheek. It didn't stay, went right away.  My husband thought i was just nervous. It was also stated that she then started "getting nauseous" about 30min after vaccine. The patient has "been sick since I had it.. not sure if its normal?  It was also reported that she "had the runs" (diarrhea) for one day, that has now resulted. It was also said that "I'm not feeling good. cant do too much of anything, just sit". The patient asked if this is normal and "when will I feel better"?  It was also reported as she had the first dose of the Pfizer covid vaccine late Saturday afternoon at 5pm. She has been feeling nausea and sick since then. She asks if this is normal and how long it will stay. The treatment used was taking Tylenol. It was noted that if she does not do anything and lays down it will go away but if she starts doing too much she will get real nauseous again. It was added that the patient and her husband went to get the vaccine on the same day. It was noted that she felt a little numbness on her face, in her right cheek and then it went away after 20 to 30 seconds. Her husband said she may have been nervous and may have caused that herself. She is a hyper type. The outcome of the event Felt numbness in my cheek recovered on 30Jan2021; for all other events was unknown. There was no additional vaccines administered on same date. No events requires visit to emergency room or physician office. No prior vaccinations (within 4 weeks) reported.