chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's palsy.  The patient's medical history was not provided. Concomitant product use was not provided.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, post vaccination, the reporter who is the patient's son, stated the patient was diagnosed with Bell's palsy.  Treatment for the event included, hydroxypropyl methylcellulose, prednisone and valacyclovir.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, Bell's palsy, was considered unknown.; Reporter's Comments: Very limited information regarding the event of Bell's Palsy has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation, Inappropriate schedule of product administration
Clinical narrative: Hospitalized; Unable to receive second dose of vaccine; Case reference number MOD-2021-014001 is a spontaneous case report sent by a Non-Health Professional on 15-FEB-2021 00:00:00 .  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. After vaccination she was hospitalized and she was unable to receive the second dose of the vaccine.  Action taken with mRNA-1273 was not provided.  Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Non-Health Professional,  Age-  ,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- hospitalized  - unknown; unable to receive the second dose of the vaccine - resolved.; Reporter's Comments: This case concerns a female of unknown age who experienced a serious unexpected event of Hospitalisation and nonserious unexpected event of Inappropriate schedule of product administration, in that she "unable to receive the second dose of the vaccine".  The events occurred with unknown latency after the first dose of mRNA-1273. Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac pacemaker insertion, Inappropriate schedule of product administration
Clinical narrative: Emergency pacemaker; Pain in left shoulder; missed second dose; A spontaneous report was received from a consumer regarding her husband, a 71 year old male, who received first dose of Moderna Covid-19 vaccine and experienced missed the second dose due to hospitalization, emergency pacemaker insertion and pain in shoulder .  The patient's medical history includes high blood pressure, hereditary heart disease, Fuchs Dystrophy and heart attack last year. His concomitant medications were amlodipine 5 mg tablets daily, potassium chloride and indapamide. No information on allergies.   On 15-JAN-2021, prior to the onset of events, the patient received his first of two planned doses of Covid-19 vaccine intramuscularly on his left arm for the prophylaxis of Covid-19 infection(Lot#012LZ0A or 017LZ0A) She is not sure about the Lot number as she couldn't read the handwriting.    On 11-FEB-2021, Patient had Emergency pacemaker insertion done at the hospital, where he stayed for two more days and discharged on 14-FEB-2021. As per his wife, this event is related to his previous heart problems which are ongoing for a long time. His 2nd dose of vaccine is scheduled on 12-FEB-2021, which he missed due to his hospitalization. Doctor said "forget about the shot" after seeing his results in monitor. She thinks, his doctor wouldn't talk about the 2nd dose of vaccine now, so wants to wait till his follow up appointment in March and he may get his second dose in 5-6-week limit. After being discharged from the hospital, wife reports husband is "starting to feel better." Sleeps a few hours and gets up and goes lays back down. Still experiencing pain in shoulder.  Action taken with 2nd dose of Moderna Covid-19 vaccine was postponing of appointment until he is fine.  The outcome of the event emergency pacemaker insertion was recovered and pain in shoulder is not recovered.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273. Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the events of cardiac pacemaker insertion and arthralgia are assessed as unlikely related.  The patient's medical history of high blood pressure, hereditary heart disease and heart attack are risk factors for cardiac pacemaker insertion and confounds causality.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Decreased appetite, Haemorrhage
Clinical narrative: Can't taste or smell food; Can't taste or smell food; No desire to eat; Headache; Severe bleeding; No power; He got tested and the blood became too thick; A spontaneous report was received from a consumer concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe bleeding, he got tested and the blood became too thick, headache, no power, no desire to eat, and can't taste or smell food.     The patient's medical history was not provided. Concomitant product use was provided as anti-depressants and anti-anxiety medication but was unspecified.  On 28JAN2021 prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:030L20A) intramuscularly for prophylaxis of COVID-19 infection.    Patient received the 1st shot of the mRNA-1373 vaccine on 28Jan2021. Patient reported hearing that the vaccine could have messed with his coumadin levels. Patient got tested and reported that the blood became too thick and that after treatment to thin the blood, he had severe bleeding. Patient has a rhino rocket in his nose. About two weeks later after the vaccine, patient reported a headache, having no power, couldn't taste or smell food and had no desire to eat. Patient also reported following up with his Primary Care around about taking more anxiety medication due to this situation. The patient's doctor has provided his approval. Patient wanted to know if the side effects he is experiencing two weeks after the vaccine are normal.   Treatment information was not provided.   The outcome of the events was unknown.; Reporter's Comments: There is not enough detail in the absence of patient's medical history, onset date and list of concomitant medications to assess the events of blood became too thick and severe bleeding and can't taste or smell food. The events of headache, no power, no desire to eat are temporarily associated with the vaccine administration and a causal association cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypercoagulation
Clinical narrative: Can't taste or smell food; Can't taste or smell food; No desire to eat; Headache; Severe bleeding; No power; He got tested and the blood became too thick; A spontaneous report was received from a consumer concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe bleeding, he got tested and the blood became too thick, headache, no power, no desire to eat, and can't taste or smell food.     The patient's medical history was not provided. Concomitant product use was provided as anti-depressants and anti-anxiety medication but was unspecified.  On 28JAN2021 prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:030L20A) intramuscularly for prophylaxis of COVID-19 infection.    Patient received the 1st shot of the mRNA-1373 vaccine on 28Jan2021. Patient reported hearing that the vaccine could have messed with his coumadin levels. Patient got tested and reported that the blood became too thick and that after treatment to thin the blood, he had severe bleeding. Patient has a rhino rocket in his nose. About two weeks later after the vaccine, patient reported a headache, having no power, couldn't taste or smell food and had no desire to eat. Patient also reported following up with his Primary Care around about taking more anxiety medication due to this situation. The patient's doctor has provided his approval. Patient wanted to know if the side effects he is experiencing two weeks after the vaccine are normal.   Treatment information was not provided.   The outcome of the events was unknown.; Reporter's Comments: There is not enough detail in the absence of patient's medical history, onset date and list of concomitant medications to assess the events of blood became too thick and severe bleeding and can't taste or smell food. The events of headache, no power, no desire to eat are temporarily associated with the vaccine administration and a causal association cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Unresponsive; A spontaneous report was received from a Reporter concerning a 25 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 22-DEC-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 01-JAN-2021, The patient became unresponsive and died which is serious.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 01-JAN-2021,  the outcome of the event unresponsive became fatal. patient died.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Diarrhoea, Nausea, Renal failure
Clinical narrative: kindeys started to fail; blood pressure 60/24; red spots around the injection site; nausea; vomiting; diarrhea; cellulitis at the injection site; A spontaneous report was received from a nurse who was also a 61-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24.   Medical history included type 2 diabetes mellitus, lung disease, and high blood pressure.  Concomitant medication included unspecified cholesterol medicines, unspecified heart medicines, levopridsone, and unspecified type 2 diabetes mellitus medicines.    On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot number 057G20A) intramuscularly n the left deltoid for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced cellulitis at the injection site.    On 02 Feb 2021, the patient experienced red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24 (no units or reference range provided).  The patient was hospitalized from 04 Feb 2021 to 07 Feb 2021.    Treatment for the events included hydration, unspecified antibiotics, and levid for blood pressure.  Action taken with the mRNA-1273 was not reported.  The outcome of the events of cellulitis at the injection site, red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24 was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site cellulitis, Vaccination site rash, Vomiting
Clinical narrative: kindeys started to fail; blood pressure 60/24; red spots around the injection site; nausea; vomiting; diarrhea; cellulitis at the injection site; A spontaneous report was received from a nurse who was also a 61-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24.   Medical history included type 2 diabetes mellitus, lung disease, and high blood pressure.  Concomitant medication included unspecified cholesterol medicines, unspecified heart medicines, levopridsone, and unspecified type 2 diabetes mellitus medicines.    On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot number 057G20A) intramuscularly n the left deltoid for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced cellulitis at the injection site.    On 02 Feb 2021, the patient experienced red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24 (no units or reference range provided).  The patient was hospitalized from 04 Feb 2021 to 07 Feb 2021.    Treatment for the events included hydration, unspecified antibiotics, and levid for blood pressure.  Action taken with the mRNA-1273 was not reported.  The outcome of the events of cellulitis at the injection site, red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24 was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema multiforme, Rash, Swelling face
Clinical narrative: Erythema multiforme; Swelling on the face; Full body rash; Joint pain; A spontaneous report  was received from a HCP concerning a 47 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events - Swelling on the face, Joint pain, Full body rash, and Erythema multiforme (medically significant event).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 07-Feb-2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  Four days after receiving the vaccine the oatient started experiencing swelling on the face, joint pain, full body rash and erythema multiforme.  Laboratory details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events, swelling on the face, Joint pain, Full body rash, and Erythema multiforme were unknown.; Reporter's Comments: Based on the information provide which includes a strong temporal association and excluding other etiologies, a causal association between the reported events and the administration of the mRNA-1273 cannot be excluded. Joint pain, rash and facial swelling are consistent with the known safety profile of the product.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, COVID-19 pneumonia, Decreased appetite, Diarrhoea
Clinical narrative: covid pneumonia; diarrhea, stomach issues; weakness; no appetite; Covid; A spontaneous report was received from a consumer concerning an 88-year-old, female patient who experienced diarrhea, got sick with COVID, stomach issues, weakness, no appetite, and covid pneumonia.    The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included Eliquis, Omeprazole, and Metoprolol.   On 07JAN2021, approximately 7days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   Caller stated that her mother in law who is 88 years old received the Moderna vaccine on 07Jan2021 and within 7 days, she got sick. Patient had had diarrhea, stomach issues, weakness, no appetite and ended up with covid pneumonia. Treatment for the events included Regeneron antibody therapy. Caller would like to know if the therapy negated the benefits of the vaccine.    Action taken with mRNA-1273 in response to the event was not provided/unknown.  The events, diarrhea, got sick with COVID, stomach issues, weakness, no appetite, and covid pneumonia were considered recovered/resolved.; Reporter's Comments: This case concerns an 88-year-old female who experienced a serious unexpected event of COVID-19 pneumonia along with unexpected COVID-19, decreased appetite, and asthenia.  The events occurred 8 days after first dose of mRNA-1273. Treatment included Regeneron antibody. Further information has been requested.  Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; A spontaneous report was received from a physician concerning a 56-year-old, male patient, who received their first of two planned doses of mRNA-1273, and who developed anaphylactic reaction.    The patient's medical history included blindness and severe allergies to shellfish.  Products known to have been used by the patient, within two weeks prior to the event, included Losartan and Melatonin.    On 28 JAN 2021, approximately 15  minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient's wife called to indicate that her husband had an anaphylactic reaction to the mRNA-1273 vaccine. Patient received the vaccine on 28 JAN 2021 in his left arm. Patient's wife indicated that her husband texted her at 3.21 pm to let her know that he has gotten the shot, indicating that he must have received it around 3.19 pm. Patient's wife indicated that around 3.34 pm, patient said he'd had an anaphylactic reaction, that he had administered a shot of epinephrine and that an ambulance was on its way. The patient's wife noted that the reaction happened within 15 minutes or so. Once in the hospital, the patient was administered Pepcid and Steroid orally. Additional treatment medication for the event included the previously epinephrine and a shot of Benadryl.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. Patient's significant medical history included severe allergies to shellfish.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: Diverticulitis; This spontaneous report  was received from consumer on 18-FEB-2021, concerning a 76 year old female patient who was administered Moderna COVID-19 vaccine9( mRNA-1273). The patient experienced diverticulitis.  The patient's medical history was not provided.  Concomitant medications included was blood thinners.  The patient received suspect product  mRNA-1273 on 23 JAN 2021 prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:030L20A) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection.   On 4 FEB 2021, approximately within 24 hours of receiving shot, the patient experienced diverticulitis. Treatment history was not reported.  Action taken with the  dose of mRNA-1273  in response to the event was unknown.  The outcome of the event, diverticulitis was considered as unknown.; Reporter's Comments: This case concerns a 76-year-old female who experienced Serious unexpected event of Diverticulitis.  The events occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown.  Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Mild nausea; light headache; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, expiry date unknown), intramuscular at the left arm on 29Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced mild nausea and light headache on 30Jan2021 08:00. Events were non-serious. No treatment was received for the adverse events. Facility where the most recent COVID-19 vaccine administered was workplace clinic. The outcome of the events was recovering. Events were non-serious.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: has been in contact with his family (wife and child) who tested positive for the coronavirus; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown dates (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient had been in contact with his family (wife and child) who tested positive for the coronavirus and would like to know if he should get his second dose of the Covid vaccine. The outcome of the event exposure to COVID-19 was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Vaccination site pain
Clinical narrative: very sore arm at the injection site after both doses; Dr. told me that Aspirin was not stopped in the trials; This is a spontaneous report from a contactable physician, the patient. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown for first and second doses) solution for injection intramuscular on an unknown dates (at the age of 67-years-old) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medications included acetylsalicylic acid (ASPIRIN) low dose and ongoing atorvastatin. The patient got a very sore arm at the injection site after both doses but no other side effects. The patient took low dose aspirin and atorvastatin and was concerned that the reason for the lack of side effects was that the medications may have blunted the vaccine immune response. A doctor told the me (patient) that aspirin was not stopped in the trials. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report from a contactable healthcare professional, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced felt really tired. The outcome of the event felt really tired was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021145089 same drug/patient, second dose/different AE
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arms a little sore; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. Medical history included blood pressure (abnormal). Concomitant medication included verapamil for blood pressure. It was reported that the patient got to receive the first one on the 8th. She did not have any symptoms than her arms a little sore. She got her second dose of Pfizer shot on the 28th and then she guessed the first. Outcome of the event was unknown.   Information on lot/batch has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: she experienced a metallic taste; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiration date: May2021), via an unspecified route of administration on the left arm on 30Jan2021 09:00 at a single dose for Covid-19 immunization. The vaccine was administered at the hospital. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jan2021 for Covid-19 immunization. On 30Jan2021 09:30, she experienced a metallic taste for about 30 minutes after the injection that lasted about an hour with outcome of recovered on 30Jan2021 10:30.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Urticaria
Clinical narrative: 2nd dose was more tired and itchy; 2nd dose was more tired and itchy; Hives; This is a spontaneous report from a contactable consumer (the patient) received from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of   BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on an  unspecified date as a SINGLE DOSE for covid-19 vaccination. Historical data includes patient received Dose 1 (got tired and was itchy).   The patient medical history and concomitant medications were not reported.  On an unspecified date , The patient experienced  2nd dose was more tired and itchy and had  hives. Consumer wants to know if she should go the Emergency Room 'waited 3 min and cold transferred to D&S Pfizer CEP 2191'. The clinical outcome of the events fatigue, itchy and hives was unknown.   Information about Batch/Lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site pain
Clinical narrative: Injection site pain; arm pain; headache; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the second dose of BNT162B2 (UNSPECIFIED TRADE NAME; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On unspecified dates the patient experienced injection site pain, arm pain and headache. The clinical outcomes of injection site pain, arm pain and headache were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 12Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the Pfizer COVID-19 vaccine on 12Jan2021 (reported as 21 days ago). Tomorrow (02Feb2021) is her second shot. On 16Jan2021 (16 days before the reporting), the patient got COVID-19. The patient was inquiring for the timeline of second dosage. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: fatigue; arm soreness; This is a spontaneous report received from a contactable consumer (patient). A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247, expiry date was unknown), via an unspecified route of administration on right arm on 03Feb2021 11:30 AM at single dose for COVID-19 immunization, at workplace clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 03Feb2021, 18:00, the patient experienced fatigue, arm soreness. Patient was not given treatment for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (husband) reported for a female patient (wife) with unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 at 1:30pm at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced headache from unspecified date, and the consumer was asking if patient can take Excedrin for pain killer. The outcome of event was unknown.   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain
Clinical narrative: Chill; Body aches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL8982), via an unspecified route of administration, on 21Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was inquiring if she can take paracetamol (TYLENOL) after the first COVID-19 vaccine because she was having body aches after the first injection on 21Jan2021. As of 03Feb2021, the patient was due for her second done on 11Feb2021. The patient had been hearing a myth that she wanted to know if it is true. After the patient's first shot she only had a small side effect which was the body aches. The patient got these about 12 hours after the shot, it happened through the night while she was sleeping. The following morning (22Jan2021), the patient also had what might have been a slight chill but just a slight one, but it was the body aches mostly. The patient took paracetamol (TYLENOL) extended release for the events. Then the patient was told that she shouldn't have taken the paracetamol and that people weren't supposed to take anything after getting the vaccine. The patient asked confirmation if this can't be true and asked what a person would take if they had a fever. The patient confirmed that she did not have a fever. The events subsided immediately, and it was like she never had them; they didn't last long at all. The patient recovered from the events in Jan2021.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Chill; Body aches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL8982), via an unspecified route of administration, on 21Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was inquiring if she can take paracetamol (TYLENOL) after the first COVID-19 vaccine because she was having body aches after the first injection on 21Jan2021. As of 03Feb2021, the patient was due for her second done on 11Feb2021. The patient had been hearing a myth that she wanted to know if it is true. After the patient's first shot she only had a small side effect which was the body aches. The patient got these about 12 hours after the shot, it happened through the night while she was sleeping. The following morning (22Jan2021), the patient also had what might have been a slight chill but just a slight one, but it was the body aches mostly. The patient took paracetamol (TYLENOL) extended release for the events. Then the patient was told that she shouldn't have taken the paracetamol and that people weren't supposed to take anything after getting the vaccine. The patient asked confirmation if this can't be true and asked what a person would take if they had a fever. The patient confirmed that she did not have a fever. The events subsided immediately, and it was like she never had them; they didn't last long at all. The patient recovered from the events in Jan2021.
Sex: M
Vaccine: COVID19
Symptoms: Immunoglobulins, Immunoglobulins decreased, Investigation
Clinical narrative: got the 2nd Covid dose on 12Jan2021 and he stated his IMG was extremely low; This is a spontaneous report from a Pfizer Sponsored Program. A contactable other healthcare professional (patient) reported that a male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 12Jan2021, at a single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) on an unspecified date, for COVID-19 immunisation. On an unspecified date, the patient's immunoglobulins (IMG) were extremely low. He then took a surge test and the report came back negative. He was surprised by this and wanted to know if that is normal. Outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Pain of skin, Pruritus, Rash
Clinical narrative: Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; edge is now scaly and dry; edge is now scaly and dry; This is a spontaneous report from a contactable Other Health Professional (patient). A 36-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) on 21Jan2021 (Lot number: El3249) via an unspecified route of administration in the right arm at single doe for COVID-19 immunization. The patient had no medical condition. The patient had no allergies to medications, food, or other products. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 08:00 AM (Lot number: EJ1685) via an unspecified route of administration in the left arm for COVID-19 immunization and at 31Dec2020 12:00 PM experienced small rash on left side of chest. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient concomitant medication included Levothyroxine sodium (Euthyrox, Strength: 150ug) and Drospirenone/ethinylestradiol (Nikki, Strength: 3mg/0.02mg). After first shot developed small rash on left side of chest. Persisted for three weeks and was starting to fade when she got second dose. Grew 4-5 times larger, raised, painful, red itched and tender. Now reaches my neck and breasts and shoulders. White normal skin in center, edge was now scaly and dry, itches very badly. Dr won't prescribe steroid fears it will dampen immune response. Taking Allegra, Benadryl and hydrocortisone cream. Does not help. Never had a reaction to a vaccine before. The patient was underwent COVID-19 (Nasal Swab) and PCR at pharmacy (nasal swab) test (test twice weekly for work) both on 29Jan2021 which were negative. The events were assessed as non-serious by the reporter. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Skin exfoliation, Skin reaction
Clinical narrative: Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; edge is now scaly and dry; edge is now scaly and dry; This is a spontaneous report from a contactable Other Health Professional (patient). A 36-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) on 21Jan2021 (Lot number: El3249) via an unspecified route of administration in the right arm at single doe for COVID-19 immunization. The patient had no medical condition. The patient had no allergies to medications, food, or other products. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 08:00 AM (Lot number: EJ1685) via an unspecified route of administration in the left arm for COVID-19 immunization and at 31Dec2020 12:00 PM experienced small rash on left side of chest. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient concomitant medication included Levothyroxine sodium (Euthyrox, Strength: 150ug) and Drospirenone/ethinylestradiol (Nikki, Strength: 3mg/0.02mg). After first shot developed small rash on left side of chest. Persisted for three weeks and was starting to fade when she got second dose. Grew 4-5 times larger, raised, painful, red itched and tender. Now reaches my neck and breasts and shoulders. White normal skin in center, edge was now scaly and dry, itches very badly. Dr won't prescribe steroid fears it will dampen immune response. Taking Allegra, Benadryl and hydrocortisone cream. Does not help. Never had a reaction to a vaccine before. The patient was underwent COVID-19 (Nasal Swab) and PCR at pharmacy (nasal swab) test (test twice weekly for work) both on 29Jan2021 which were negative. The events were assessed as non-serious by the reporter. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for the Covid virus on 2ndFeb; tested positive for the Covid virus on 2ndFeb; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 3 patients. This is 1st of 3 reports. A 62-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Pharmacy technician, calling on behalf of three patients who tested positive after receiving the first dose of the Covid vaccine, asked when they can get the second dose of the Covid vaccine. They received their first dose on 16Jan2021 and tested positive for the Covid virus on 02Feb2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021140772 same drug/event, different patients;US-PFIZER INC-2021140773 same drug/event, different patients
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, SARS-CoV-2 test positive
Clinical narrative: feeling really bad; pain; tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient).  A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  the first dose,via an unspecified route of administration on 28Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She started "feeling really bad, having pain, and felt like something ran over her" after the vaccine was given. She went to her MD and tested positive for Covid-19. She asks, "Can I take the second dose on 24Feb2021?'The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive. Outcome of event was unknown. Case was assessed as non-serious (Serious: No).  Information about lot/batch number has been requested.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Glassy eyes, Headache, Malaise, Nausea, Ocular hyperaemia
Clinical narrative: Headache; Nausea; Eyes are bloodshot red and kind of glaze over; Eyes are bloodshot red and kind of glaze over; He just can't feel real good; This is a spontaneous report from a contactable consumer. A 96-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Jan2021 as a SINGLE DOSE for COVID-19 vaccination.   Medical history included heart problems from an unknown date and unknown if ongoing, he has gone over for a battery replacement, pacemaker, and he has eye problems so, he is taking eye drops for those. Concomitant medications included unspecified eye drops. On unspecified date, the patient experienced headache, nausea and his eyes are bloodshot red and kind of glaze over. He just can't feel real good. His eyes are real red and like glaze over. No treatment was received for the events. Outcome of the events headache, nausea, eyes are bloodshot red and kind of glaze over and he just can't feel real good were unknown.  Information on the lot/ batch number has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Dental discomfort, Gingival swelling, Swelling face
Clinical narrative: Facial swelling; I have got Vitallium Partial, there was a pinching, it was very uncomfortable; Gum swelling; This is a spontaneous report from a contactable consumer (patient). This 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number E79262) via an unspecified route on an unspecified date (at the age of 85-years-old) as a single dose in the right upper arm for COVID-19 immunization. Medical history included unspecified health issues. Concomitant medications included unspecified regular medications he took several in the morning and at night. The patient also took vitamins "and different things like that" from unspecified dates for unspecified indications. The patient experienced facial swelling and gum swelling on an unspecified date. The patient had a Vitallium partial. The metal and the partial denture were pinching him; it was very uncomfortable. The patient stated it was not a life or death situation but he was ready to go to the dentist for an adjustment in the partials so it didn't hurt. The patient did not undergo any lab tests. The patient did not receive treatment for the events. The outcome of facial swelling and gum swelling was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: mild fever; body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on an unknown date (at the age of 24-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included anxiety and depression. Concomitant medication included escitalopram oxalate (LEXAPRO). Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination in Jan2021 and experienced body chills. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date, the patient experienced mild fever and body aches. The outcome of the events mild fever and body aches was unknown. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021144818 same reporter/patient/vaccine, different dose/event
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in her arm; This is a spontaneous report from a contactable healthcare professional, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on an unknown date (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on an unknown date and experienced she felt really tired. On an unknown date, the patient experienced pain in her arm. The outcome of the event pain in her arm was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093322 same drug/patient, different dose/AE