chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: experiencing joint and muscle pain; experiencing joint and muscle pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old patient of an unspecified gender received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 01Mar2021 at 12:45 (lot number was not reported) as dose 1, single for COVID-19 immunization.  Medical history included Guillain Barre and allergies to sulfa on unknown dates. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient did not receive other vaccines in four weeks and other medication in two weeks. About four to five days after the vaccine, on 05Mar2021 (as reported), the patient started experiencing joint and muscle pain. These have not improved and have actually gotten worse. Pain killers do not help. The 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Extreme fatigue; Injection site soreness; Injection site itch; Minor headache; Exacerbated pain in arthritic SI joints; This is a spontaneous report from a contactable consumer (patient).   A 50-year-old non-pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 01Mar2021 14:00, at the age of 50-years-old, (Lot Number: 59267-1000-01) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included Depression, Anxiety, Asthma, SI joint arthritis, obesity, migraines, and environmental allergies. The patient did not have COVID-10 prior the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN); sertraline hydrochloride (ZOLOFT); modafinil; folic acid; and ibuprofen, all were taken for unspecified indication, start and stop date were not reported.  On 01Mar2021 20:30, the patient experienced extreme fatigue, injection site soreness, injection site itch, minor headache, and exacerbated pain in arthritic SI joints. The patient was not tested for COVID-19 post vaccination.  The outcome of the events was not recovered. No treatment was received for the events.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This is a spontaneous report from a contactable health care professional (patient). A 64-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 07Mar2021 at 15:00 (lot number was not reported) as dose number unknown, single for COVID-19 immunization.  The patient's medical history was not reported. The patient did not have COVID prior to vaccination. The patient did not receive other vaccines in four weeks. The patient received other unspecified medications in two weeks. The patient has not been tested for COVID post vaccination. The patient previously received Benadryl and experienced allergies. The patient reported that since she had the shot, she has been having shortness of breath that started on 10Mar2021. The patient did not receive treatment for the event. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever (99.6F); Sore Arm; body aches; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Mar2021 12:00 (Batch/Lot Number: EN6204) (at the age of 49 years) as dose 1, single for covid-19 immunisation. Medical history was none. There were no concomitant medications. There were no known allergies. There was no other vaccine in four weeks. The patient experienced fever (99.6f), sore arm, body aches, all on 14Mar2021 04:00 with outcome of not recovered. There was no treatment received for the events. Patient has no COVID prior vaccination and had not been tested for COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: 99.6 Fahrenheit on 14Mar2021.    No follow up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: fatigue; chills; joint pain; low fever; nausea; loose stool; swollen lymph nodes; insomnia; head ache; scratchy throat; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 04Mar2021 11:00 (Batch/Lot Number: EN6199) (at the age of 67-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. It was unknown if patient had covid prior vaccination. The patient has not been tested for covid post vaccination. Medical history included high blood pressure, hypothyroidism, gout, and known allergies to medications with bromine salts. There were no concomitant medications. On 06Mar2021 16:00, the patient experienced fatigue, chills, joint pain, low fever, nausea, loose stool, swollen lymph nodes, scratchy throat, insomnia, and head ache. No treatment was received for the events. The patient had not yet recovered from the events.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lymphadenopathy, Nausea, Pyrexia, Throat irritation
Clinical narrative: fatigue; chills; joint pain; low fever; nausea; loose stool; swollen lymph nodes; insomnia; head ache; scratchy throat; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 04Mar2021 11:00 (Batch/Lot Number: EN6199) (at the age of 67-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. It was unknown if patient had covid prior vaccination. The patient has not been tested for covid post vaccination. Medical history included high blood pressure, hypothyroidism, gout, and known allergies to medications with bromine salts. There were no concomitant medications. On 06Mar2021 16:00, the patient experienced fatigue, chills, joint pain, low fever, nausea, loose stool, swollen lymph nodes, scratchy throat, insomnia, and head ache. No treatment was received for the events. The patient had not yet recovered from the events.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling underneath the armpit; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 09Mar2021 (Batch/Lot Number: EN6202) (at the age of 56 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included sinus disorder from an unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for sinus disorder, start and stop date were not reported. The patient was getting like a little side effect and experienced swelling underneath the armpit on an unspecified date in Mar2021 with outcome of unknown. Therapeutic measures were taken as a result of event (Ibuprofen).   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: pain in both shoulders and neck area; pain in both shoulders and neck area/ constantly sore in my neck; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 17Feb2021 13:00 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported; no known allergies. Concomitant medication included hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient did not have COVID and did not receive any other vaccine in four weeks. On an unspecified date, the patient was having pain in both shoulders and neck area for last two to three weeks. His shoulders ached down to the sockets and constantly sore in his neck. No treatment was received for the events. Post-vaccination, the patient has not been tested for COVID. 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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Movement disorder, Pain in extremity, Pyrexia
Clinical narrative: motion was more difficult; experiencing 100.9 Temperature; arm was sore; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 60-year-old, via an unspecified route of administration, administered in left arm on 04Mar2021 12:45 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included asthma. Concomitant medication included other medications (unspecified) in two weeks. No other vaccine in four weeks. The patient has known allergies to morphine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVOD-19 post vaccination. The patient experienced arm was sore on 05Mar2021 14:00. The motion was more difficult and experiencing 100.9 temperature on 05Mar2021 16:45 (reported as after 28 hours). The patient did not received treatment for the events. The patient recovered from the events on an unspecified date. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: Low fever; mild headache; fatigue; This is a spontaneous report from a non-contactable consumer (reported for herself). A 20-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in right arm on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history was not reported.  The patient was not pregnant at the time of the report. The patient had no Covid prior vaccination. There were no concomitant medications. The patient no other vaccine in four weeks. The most recent vaccine was administered in a public health. On an unspecified date, the patient experienced low fever (body temperature), mild headache, and fatigue. No treatments received in response to the events reported. The patient was not tested for Covid post vaccination. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: low grade fever; Felt aches the next day after shot 2 low grade fever; This spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11Mar2021 (Batch/Lot Number: En6206) (at the age of 55 years) as dose 2, single for covid-19 immunisation. Medical history included rheumatoid arthritis and known allergies: Sulfa from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 administered in Arm Left on 18Feb2021 08:00 AM (Batch/Lot Number: El9266) (at the age of 55 years) for covid-19 immunisation. There was no other vaccine in four weeks. The patient felt aches the next day after shot 2, and low grade fever, both on 12Mar2021 06:45 with outcome of recovered.  There was no treatment received for the events. Patient has no COVID prior vaccination and had not been tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: fatigue; low grade fever; chills; This is a spontaneous report from a non-contactable consumer (patient herself). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 06Mar2021 (Batch/Lot Number: EN6205) at the age of 50 years as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 prior to vaccination. The patient had no known allergies. There were no concomitant medications, no other vaccine in four weeks, and no other medications in two weeks. On 07Mar2021 06:00, the patient experienced fatigue, low grade fever, and chills. No treatment was required for the events. Outcome of the events was recovered on an unspecified date. The patient was not tested for COVID post vaccination. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: it caused an allergic reactions; This is a spontaneous report from a non-contactable consumer (patient reported for herself) from the Pfizer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took palbociclib in tablets and experienced allergic reactions (capsule did not cause reactions). On an unspecified date, the patient stated that it caused allergic reactions. Patient was inquiring why it causes different reactions. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: chills; fever; headache; she became nauseous; This is a spontaneous report from a contactable consumer (patient) received from a regulatory authority. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 on 02Feb2021 for Covid-19 immunisation. The patient experienced chills, fever, headache and she became nauseous on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: swollen lower lip; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 11Mar2021 at 09:00 (at the age of 67-years-old) as dose 2, single for COVID-19 immunisation. Medical history included fillers in lips about 6 months ago. There were no concomitant medications. The patient previously received the first dose of BNT162B2 administered in arm left on 15Feb2021 at 09:00 AM (at the age of 67-years-old) for COVID-19 immunisation. The patient experienced swollen lower lip on 13Mar2021 at 05:00. There was no treatment received for the event. The outcome of the event was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: slight nausea; Fever; arm soreness; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 13Mar2021 13:15 (lot number and expiry date: unknown) at the age of 36-years-old, as dose 1, single for Covid-19 immunisation. Medical history included known allergies to sulfa. Concomitant medications included ganoderma lucidum (REISHI MUSHROOM); astragalus mongholicus (ASTRAGALUS); sambucus nigra fruit (ELDERBERRY [SAMBUCUS NIGRA FRUIT]); and clarithromycin (CLARITIN) all taken for unspecified indications, start and stop dates were not reported. The vaccine was administered in a pharmacy or drug store. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with Covid-19 before vaccination. On 13Mar2021, at 22:00, the patient experienced fever, arm soreness, and slight nausea. The patient did not receive treatment for the events. Outcome of the events was recovering. The patient has not been tested for Covid-19 after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; fever; headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot number was not reported), dose 2 via an unspecified route of administration, administered in right arm on 12Mar2021 17:30 (at the age of 48-year-old) as dose 2, single for COVID-19 immunization in the Hospital. Medical history included hypothyroidism and allergy to shrimp. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) and levothyroxine sodium (SYNTHROID).  The patient previously took naproxen and experienced allergies. The patient previously received the first dose of bnt162b2 administered in left arm on 20Feb2021 18:00 (at the age of 48-year-old) as single dose for COVID-19 immunization. No other vaccine in four weeks. No Covid prior vaccination nor tested with Covid post vaccination. On 13Mar2021 17:00, the patient experienced chills, fever and headache. The patient received no treatment for the events. The outcome of the events recovered on unspecified date in 2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Depressed mood, Fatigue, Malaise
Clinical narrative: Tiredness; Muscle pain/muscles are so sore from her neck to her feet; Joint pain; Feeling unwell/not feeling well; doesn't have any energy; she has been down; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tiredness, muscle pain, joint pain, feeling unwell, doesn't have any energy and she has been down. Course of events: The patient had the first dose of the Pfizer Covid 19 vaccine. The patient was feeling tired and has gone downhill, she usually walks and goes to the gym and then she started not feeling well, she just doesn't have any energy. The caller has been going downhill a little bit each day, her muscles are so sore from her neck to her feet. The patient has been unable to do anything, it has been brewing since she had the shot. When the caller woke up this morning every muscle in her body is killing her. The patient wanted to know how does she get some kind of relief? The patient was looking at the side effects of the vaccine and checked off tiredness, muscle pain, joint pain, feeling unwell. Feeling unwell and tiredness started first, the caller can't go to the gym and it's not like her to say she can't do something. She knows that why she has been down is because of the shot because it is all new. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Tiredness; Muscle pain/muscles are so sore from her neck to her feet; Joint pain; Feeling unwell/not feeling well; doesn't have any energy; she has been down; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tiredness, muscle pain, joint pain, feeling unwell, doesn't have any energy and she has been down. Course of events: The patient had the first dose of the Pfizer Covid 19 vaccine. The patient was feeling tired and has gone downhill, she usually walks and goes to the gym and then she started not feeling well, she just doesn't have any energy. The caller has been going downhill a little bit each day, her muscles are so sore from her neck to her feet. The patient has been unable to do anything, it has been brewing since she had the shot. When the caller woke up this morning every muscle in her body is killing her. The patient wanted to know how does she get some kind of relief? The patient was looking at the side effects of the vaccine and checked off tiredness, muscle pain, joint pain, feeling unwell. Feeling unwell and tiredness started first, the caller can't go to the gym and it's not like her to say she can't do something. She knows that why she has been down is because of the shot because it is all new. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: she developed rashes all over the face and neck; This is a spontaneous report from a Regulatory Authority. From a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that after a few hours when she left the facility (after 1st shot), she developed rashes all over the face and neck on an unspecified date in Mar2021 with outcome of unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: upset stomach; vomiting; diarrhea; high temp; This is a spontaneous report from a Pfizer . A contactable consumer reported that a 19-year-old male patient (reporter's son) received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 13Mar2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient started experiencing upset stomach, vomiting, has diarrhea and a high temp on 14Mar2021, 24 hours from receiving the first dose of the vaccine. The patient took Tylenol for event high temp. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Callers dad had a fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The caller's dad had a fever for the past day and a half after getting vaccine on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: arthritis; This is a spontaneous report from a contactable consumer (patient) via Regulatory Authority.. A female patient of an unspecified age received bnt162b2, via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient previously took acetaminophen (TYLENOL) for arthritis. The patient experienced arthritis on an unspecified date with outcome of unknown. The clinical course was reported as follows: Patient got the first dose of the vaccine today (12Mar2021). She said she has arthritis and wants to know if she can resume taking Tylenol for her arthritis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Nausea, Pain, Vomiting
Clinical narrative: chills; body aches; nausea; Vomiting; coughing; This is a Spontaneous report from a contactable Pharmacist. A contactable Pharmacist reported on behalf of her husband that:  A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8737), via an unspecified route of administration on 06Apr2021 as dose 2, single. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills, body aches, nausea, vomiting, coughing on an unspecified date. caller asked if this was normal. Pharmacist (patient wife) also stated her husband experienced fever and then clarified to state he did not had a fever. She stated that was the patient's 2nd dose of the Pfizer Vaccine and the 1st dose was fine and this 2nd dose was horrible. The outcome of events was unknown.   No Follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Drug ineffective, Rhinorrhoea, Suspected COVID-19
Clinical narrative: I start having a dry cough which is until now I still suffering; I start having running nose; I just like I feel like I have covid on my situation right now; drug ineffective; This is a spontaneous report from a contactable consumer(patient).A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on 26Mar2021 (Lot Number: EP6955) as dose 2, single and first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age 62-years-old) as dose 1, single for COVID-19 immunization. Medical history included hypertension and blood cholesterol. Concomitant medications included telmisartan (TELMISARTAN) 40 mg, once a day taken for hypertension and atorvastatin (LIPITOR [ATORVASTATIN]) 40 mg, once a day taken for blood cholesterol. Patient does not have any lab tests. On 27Mar2021, the patient experienced Runny nose and on 28Mar2021, the patient had dry cough. In Mar2021, the patient had suspected Covid-19. It was reported that 2nd vaccine patient received last 26Mar2021 and 2nd day after vaccination, the Saturday 27Mar2021 she started having running nose and then the 2nd day Sunday the 28Mar2021 she started having a dry cough which was until now and she was still suffering as It's been like a week (one week after her vaccine) and she still has it. The patient wanted to know if she was going to be okay. Nothing was going to happen to her, that's what she was concerned. She just wanted to know if she was going to be okay. The first day she tried the because she thought it was an allergy so the first day she tried to take the allergy medicine but it doesn't work and even the 2nd day she tried to do it, it doesn't work so she just like she feel like had Covid on her situation right now but the vaccine she may have, it may be the side effect at last it was already a week, almost a week. Tomorrow was going to be a week that she had this or experiencing this. That's why she was concerned. Therapeutic medication taken as a result of event runny nose and cough included Allertec 10 mg. The outcome for event suspected Covid-19 was unknown and patient had not yet recovered from other events  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Diarrhoea, Headache, Hypoaesthesia
Clinical narrative: Diarrhea came two days after for four days.; Sore arm.; Head felt numb-ish; tingly on right side and sore shoulder/arm; tingly on right side and sore shoulder/arm; small bumps on head and headache/Bumps moving and forming in different areas side of vaccine; headache; Then, five days or later large bumps formed on head. Top of head, then moved to right side of head, lymph nodes and right side of neck swelling; Then, five days or later large bumps formed on head. Top of head, then moved to right side of head, lymph nodes and right side of neck swelling; Then, five days or later large bumps formed on head. Top of head, then moved to right side of head, lymph nodes and right side of neck swelling; Face swelling; Throat swelling; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8734), via an unspecified route of administration, administered in Arm Right on 10Apr2021 14:00 (at the age of 46-year-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications. Patient did not have any known allergies. Patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. Patient did not have covid prior vaccination and covid was not tested post vaccination. Patient reported that Diarrhea came two days after (on 12Apr2021) for four days. Sore arm, Head felt numb-ish, tingly on right side and sore shoulder/arm. Then, small bumps on head and headache. Then, five days or later large bumps formed on head, top of head, then moved to right side of head, lymph nodes and right side of neck swelling. Very severe headache 7 days later. Emergency call was made to doctor and doctor was visited. Bumps moving and forming in different areas side of vaccine. Also experienced face swelling, throat swelling all on right side. Adverse events started on 10Apr2021 18:00. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment as Benadryl, Tylenol and Advil so far. The outcome of diarrhea was recovered on 16Ap2021 and for all other events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Paraesthesia, Pharyngeal swelling, Skin lesion
Clinical narrative: Diarrhea came two days after for four days.; Sore arm.; Head felt numb-ish; tingly on right side and sore shoulder/arm; tingly on right side and sore shoulder/arm; small bumps on head and headache/Bumps moving and forming in different areas side of vaccine; headache; Then, five days or later large bumps formed on head. Top of head, then moved to right side of head, lymph nodes and right side of neck swelling; Then, five days or later large bumps formed on head. Top of head, then moved to right side of head, lymph nodes and right side of neck swelling; Then, five days or later large bumps formed on head. Top of head, then moved to right side of head, lymph nodes and right side of neck swelling; Face swelling; Throat swelling; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8734), via an unspecified route of administration, administered in Arm Right on 10Apr2021 14:00 (at the age of 46-year-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications. Patient did not have any known allergies. Patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. Patient did not have covid prior vaccination and covid was not tested post vaccination. Patient reported that Diarrhea came two days after (on 12Apr2021) for four days. Sore arm, Head felt numb-ish, tingly on right side and sore shoulder/arm. Then, small bumps on head and headache. Then, five days or later large bumps formed on head, top of head, then moved to right side of head, lymph nodes and right side of neck swelling. Very severe headache 7 days later. Emergency call was made to doctor and doctor was visited. Bumps moving and forming in different areas side of vaccine. Also experienced face swelling, throat swelling all on right side. Adverse events started on 10Apr2021 18:00. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment as Benadryl, Tylenol and Advil so far. The outcome of diarrhea was recovered on 16Ap2021 and for all other events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: Diarrhea came two days after for four days.; Sore arm.; Head felt numb-ish; tingly on right side and sore shoulder/arm; tingly on right side and sore shoulder/arm; small bumps on head and headache/Bumps moving and forming in different areas side of vaccine; headache; Then, five days or later large bumps formed on head. Top of head, then moved to right side of head, lymph nodes and right side of neck swelling; Then, five days or later large bumps formed on head. Top of head, then moved to right side of head, lymph nodes and right side of neck swelling; Then, five days or later large bumps formed on head. Top of head, then moved to right side of head, lymph nodes and right side of neck swelling; Face swelling; Throat swelling; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8734), via an unspecified route of administration, administered in Arm Right on 10Apr2021 14:00 (at the age of 46-year-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications. Patient did not have any known allergies. Patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. Patient did not have covid prior vaccination and covid was not tested post vaccination. Patient reported that Diarrhea came two days after (on 12Apr2021) for four days. Sore arm, Head felt numb-ish, tingly on right side and sore shoulder/arm. Then, small bumps on head and headache. Then, five days or later large bumps formed on head, top of head, then moved to right side of head, lymph nodes and right side of neck swelling. Very severe headache 7 days later. Emergency call was made to doctor and doctor was visited. Bumps moving and forming in different areas side of vaccine. Also experienced face swelling, throat swelling all on right side. Adverse events started on 10Apr2021 18:00. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment as Benadryl, Tylenol and Advil so far. The outcome of diarrhea was recovered on 16Ap2021 and for all other events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain, Pain in extremity
Clinical narrative: my right shoulder was sore; fatigued; random pains; For three days the bottom of my left foot was moderately painful; This is spontaneous report from a contactable other HCP. This 40-year-old female non-pregnant other HCP reported for herself she received bnt162b2 (BNT162B2) formulation: Solution for injection, dose 2 (Lot Number: EL3302 expiry date was unknown) via an unspecified route of administered in arm left on 26Jan2021 as a single dose for covid-19 immunisation. Medical history included sjogren's syndrome, raynaud's phenomenon, epilepsy from an unknown date and unknown if ongoing. Concomitant medication(s) included lamotrigine taken for an unspecified indication, start and stop date were not reported. Historical vaccine dose 1 product=COVID 19, pfizer/biontech, (lot number=EL 1284 expiry date was unknown) via Intramuscular route of administration at left arm on 05Jan2021 05:45 PM. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient had lamotrigine medications in two weeks. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Patient had Known allergies with salicylates. She had sjogrens syndrome and over the course of 14 days post 2nd vaccination she developed random pains. For three days the bottom of her left foot was moderately painful; for 3 days her right shoulder was sore even though it was the opposite arm of the vaccination site. She was also very fatigued for 12-24 hours after each dose. Outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Vaccination site hypoaesthesia, Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: Pain at injection for 4 days; Numbness/tingling at injection for 3 hours; Numbness/tingling at injection for 3 hours; Flushing for 4 days; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection and lot number: EJ1685) via an unspecified route of administration in left arm on 05Jan2021 10:35 (at the age of 30 years). as dose 1, single dose for COVID -19 immunization (Hospital, Workplace clinic). The patient medical history and concomitant medications were none. Vaccine Administered at Military Facility was no. The patient did not have a history of any previous allergies to specific products or any conditions indicative of an allergy. Patient was not taking any medication prior to the event being reported. The patient did not receive any recent vaccines for other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-Biontech COVID-19 vaccine prior to the event being reported. The patient did not receive any other vaccines around the time of Pfizer biotech COVID -19 vaccine vaccination. In Jan2021 the patient experienced pain at injection for 4 days, flushing 4 days. Numbness/ tingling at injection for 3 hours. It was reported that there was no multiorgan involvement, respiratory, difficulty breathing, sensation of throat closure, sneezing, rhinorrhea, cardiovascular, measured hypotension, shock, tachycardia, capillary refill time>3sec, reduced central pulse volume, decreased level of consciousness, loss of consciousness, dermatological/mucosal, generalised urticaria, generalised erythema, angioedema, generalized pruritus with skin rash, generalized pruritus without skin rash, generalised prickle sensation, localised injection site urticaria, red and itchy eyes, gastrointestinal, diarrhea, abdominal pain, nausea, vomiting, any other sign/symptoms. Patient did not receive any new medication or treatment or procedure for the events. AE does not require a visit to Emergency room or physician room. The patient was bot admitted to hospital. The patient did not provide the information regarding the reported adverse events with the use of the product. The outcome of the events was unknown.  No follow-up attempts are possible. No further information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Rash
Clinical narrative: Rash all over my stomach and groin plus diarrhea; Rash all over my stomach and groin plus diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 39-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 29Jun2021 17:45 (Vaccination at the age of 39 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 (covid prior vaccination: Yes) from an unknown date and Known allergies: No. No other vaccine in four weeks. Had covid prior vaccination and covid not tested post vaccination. The patient experienced rash all over my stomach and groin plus diarrhea on 01Jul2021 10:00. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: now a week late in receiving the second dose with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from pharmacist and consumer/non-health care professional. This case involved an unknown (age and gender) patient receiving a week late second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (inappropriate schedule of product administration)   The patient's past vaccination(s) included imovax on 31-Aug-2021 with first dose.  Relevant medical history, medical treatment(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a week late second dose of suspect RABIES (HDC) VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination (inappropriate schedule of product administration) and would like to know how to proceed with administration  It was reported "She states that the patient is receiving dose two today for pre-exposure prophylaxis. She would like to know when they need to come in for their third dose".  This case was an actual medication error due to inappropriate schedule of vaccine administered (latency same day).  At the time of reporting, no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 70.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient received DAPTACEL instead of ADACEL/no adverse event; DAPTACEL was given to 70 years elderly male patient/no adverse event; Initial information was received on 16-Sep-2021 regarding an unsolicited valid non-serious case from other health professional and physician via call center via Medical Information (Reference number- 00773106).  This case is linked to case 2021SA309592(CLUSTER).  This case involves a 70 years old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.    On 10-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5687AA and expiry date: 09-DEC-2021) via an intramuscular route in the deltoid nos for prophylactic vaccination.  It was of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency: same day)  At the time of reporting, no adverse event reported.  It was reported "caller asks if the patient's should be injected with Adacel now, or if the Daptacel was sufficient."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.