chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Electrolyte imbalance, Hypersomnia, Muscular weakness
Clinical narrative: weakness/ little weak; legs were shaky; legs suddenly gave out in the kitchen and she could not get up or pull herself up/ severe leg weakness; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 06Feb2021 at 16:30 as a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on 15Jan2021 for COVID-19 immunization and she was mostly in bed, sleeping for 2 days and felt extremely tired but was ok after resting. On 07Feb2021 at 14:00 the patient reported that her legs suddenly gave out in the kitchen and she could not get up or pull herself up and she had severe leg weakness. Because of her weakness, she stayed on the floor from 14:00 to 21:00. She asked a friend to come over and pull her up and she had to scoot to the backdoor to let her friend in. Her friend was unable to pull her up. About 15-20 minutes after her friend had arrived, her legs were still shaky, but she was able to pull herself up. she could not get up or sit up for 6 hrs and She did not lose consciousness, she tried to reach the fridge handle to pull herself up, could not do it from 2 pm to 9 pm. After that, she drank Gatorade (electrolyte) and ate food because she did not eat anything the whole time she was on the floor. She mentioned that she was weak for 2 days. After a couple of days, she was ok again. She reported that the AEs she experienced for the 2 doses were similar. However, she did not felt weakness since she was sleeping excessively. She said her AEs were so severe that she had to report it. She wanted to know if she could get the Pfizer vaccine if there may come a time that additional doses are needed to be covered for the new strains of the virus. She heard on the news about third shot of Pfizer's vaccine and was wondering if she could receive a third booster shot once it is studied. She also wanted to know if she could switch to another kind of COVID-19 vaccine (like Moderna) after completing the Pfizer COVID-19 vaccine vaccination series. Patient took Gatorade as a treatment for the events. The outcome of all events was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Suspected COVID-19
Clinical narrative: my niece was diagnosed with Covid and I had a lot of contact with her in the week before she was tested; feel bad; This is a spontaneous report from a Pfizer-Sponsored program Pfizer.com. A contactable consumer of unspecified age and gender reported that he/she received  second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he/she got second shot  3 weeks ago. His/her niece was diagnosed with Covid and patient had a lot of contact with her in the week before she was tested (she had no symptoms). On an unknown date patient felt bad, but it could have been from the weather. Also patient's mother started having chest pains and asked patient to take her to the hospital and it was Covid. The patient wanted to ask if he/she should get tested again for records sake or not. The outcome of all events was unknown.  No follow-up attempts were possible, Information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Tooth fracture
Clinical narrative: She reports having broken a tooth.; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an (Age: 71, Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported Pfizer), via an unspecified route of administration on 02Feb2021 as 1st dose, single and received second via an unspecified route of administration on 23Feb2021 dose as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported having broken a tooth on Mar2021. Reporter would like to know if it is okay to go to the dentist appointment after received both doses of the Pfizer covid vaccine. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: arm pain on the side of the injection; tiredness; headache; muscle pain; chills; joint pain; fever; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 24Feb2021 (35-yeras age at the time of vaccination) as SECOND DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 on an unknown date for COVID-19 immunisation. The patient experienced arm pain on the side of the injection, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell on an unspecified date in Jun2021. He asked if it was a severe risk if someone was afflicted by regular pain on the body after the second dose. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: arm pain on the side of the injection; tiredness; headache; muscle pain; chills; joint pain; fever; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 24Feb2021 (35-yeras age at the time of vaccination) as SECOND DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 on an unknown date for COVID-19 immunisation. The patient experienced arm pain on the side of the injection, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell on an unspecified date in Jun2021. He asked if it was a severe risk if someone was afflicted by regular pain on the body after the second dose. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Erythema, Investigation, Skin discolouration
Clinical narrative: his arm was a little red the first day; his is like a black purple bruise; he has seen how peoples' arms turn red, and his is purple and black after getting the shot/ it wasn't red or swollen, more like blood turning purple like when blood gets dry; This is a Spontaneous report from a contactable male consumer reported for himself. A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN9587, Expiration date: unknown), via unspecified route, administered in right arm on 27Feb2021 (at the age of 57-year-old) as single dose for COVID-19 immunization. The patient medical history includes sleep apnoea from 2006 and unknown ongoing, and have not had any other recent vaccinations or started any new medications.. On 27Feb2021, after the vaccination, the patient experienced redness initially and later on unspecified date in 2021, it turned to purple and black colour and it has been 4 days. He explained that he took the shot from his doctor. He says it could be just the colour of his arm, but while he was looking online most images, he had seen were red and swollen, and his is like a black, purple bruise. his arm was a little red the first day he said, but it wasn't like the pictures, it wasn't red or swollen, more like blood turning purple like when blood gets dry. The patient underwent with lab test and procedures which include unspecified tests on unspecified date with no abnormal results (reported as All good). The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Illness, Pain, Pyrexia
Clinical narrative: She stated she got so sick after the 2nd shot; Felt like a truck ran her over; Headache; Fever; Achy; This is a spontaneous report from a contactable consumer (reporting on herself). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and Expiration date was not reported), via an unspecified route of administration on 03Feb2021  as 2nd dose, single dose for COVID-19 immunization. Medical history included allergic to sulfa. The patient is not diabetic, overweight or have any heart disease. The patient concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FL0140 or EL0140and Expiration date was not reported), via an unspecified route of administration on 06Jan2021, as 1st dose, single dose for COVID-19 immunization. It was reported that the patient had first dose COVID-19 vaccine 06Jan2021 and second dose on 03Feb2021. She was really sick after the second COVID-19 vaccine and was in bed for two and a half days. She had a headache, fever, and was achy and felt like a truck ran her over on 04Feb2021. Symptoms began on Thursday morning at 03:00. She reported that she was in bed all Thursday, Friday, and half of Saturday. She didn't work out or do anything strenuous until Monday. At the appointment for her second COVID-19 vaccine, the nurse looked at it and stated that is not enough. It was confirmed that she did not receive that COVID-19 Vaccine and the nurse went and gathered another COVID-19 Vaccine that was the appropriate dose. Also stated that it looked like the nurse knew what she was doing and everything was very organized. She went to doctor last week on 04Mar2021, because she wanted to make sure that she had the antibodies and her doctor just called and stated that she does not have antibodies for COVID-19 Virus and Antibody test taken on 04Mar2021. Her doctor is going to talk with an infectious disease doctor. She was concerned because she was a dental hygienist, and her husband was a Periodontist, and both are in patient's mouths and also babysitting her granddaughter. Laboratory tests included antibodies test for COVID-19 Virus and result was negative. Outcome of the events headache, fever, achy, she got so sick after the 2nd shot, felt like truck ran her over and does not have antibodies for covid-19 virus was reported as unknown.  No follow up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: She stated she got so sick after the 2nd shot; Felt like a truck ran her over; Headache; Fever; Achy; This is a spontaneous report from a contactable consumer (reporting on herself). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and Expiration date was not reported), via an unspecified route of administration on 03Feb2021  as 2nd dose, single dose for COVID-19 immunization. Medical history included allergic to sulfa. The patient is not diabetic, overweight or have any heart disease. The patient concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FL0140 or EL0140and Expiration date was not reported), via an unspecified route of administration on 06Jan2021, as 1st dose, single dose for COVID-19 immunization. It was reported that the patient had first dose COVID-19 vaccine 06Jan2021 and second dose on 03Feb2021. She was really sick after the second COVID-19 vaccine and was in bed for two and a half days. She had a headache, fever, and was achy and felt like a truck ran her over on 04Feb2021. Symptoms began on Thursday morning at 03:00. She reported that she was in bed all Thursday, Friday, and half of Saturday. She didn't work out or do anything strenuous until Monday. At the appointment for her second COVID-19 vaccine, the nurse looked at it and stated that is not enough. It was confirmed that she did not receive that COVID-19 Vaccine and the nurse went and gathered another COVID-19 Vaccine that was the appropriate dose. Also stated that it looked like the nurse knew what she was doing and everything was very organized. She went to doctor last week on 04Mar2021, because she wanted to make sure that she had the antibodies and her doctor just called and stated that she does not have antibodies for COVID-19 Virus and Antibody test taken on 04Mar2021. Her doctor is going to talk with an infectious disease doctor. She was concerned because she was a dental hygienist, and her husband was a Periodontist, and both are in patient's mouths and also babysitting her granddaughter. Laboratory tests included antibodies test for COVID-19 Virus and result was negative. Outcome of the events headache, fever, achy, she got so sick after the 2nd shot, felt like truck ran her over and does not have antibodies for covid-19 virus was reported as unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: fever blisters on her lip; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: Not re-ported), via an unspecified route of administration on 26Feb2021 as 2nd dose, single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: unknown) on an unspecified date for COVID-19 immunization. On 04Mar2021, after second dose the patient experienced fever blisters. Consumer stated that she had her second Pfizer vaccine last Friday (26Feb2021), and this morning she woke and had a couple of fever blisters on her lip. She took her fever blister medicine. She took an antiviral medication. She asked that did she negate her second dose. She was wondering if it will affect the vaccine. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID Positive after vaccine; This is a spontaneous report from a contactable consumer (reporting on himself). A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 07Jan2021 (at the age of 39 years old) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that patient had the first dose of the pfizer covid vaccine on 7Jan2021 and about one week later he tested positive for the Covid virus on 17Jan2021. The patient wants to know what are the Pfizer recommendations for the second vaccine after testing covid positive. The patient states he was due for his second dose on 28Jan2021, but he missed it because he had been recovering from being sick with covid. The patient underwent lab tests and procedures which included covid test positive on 17Jan2021. Outcome of the event was recovered on 21Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: trouble taking a deep breath (not exactly short of breath--just feel need to try to get deep breath frequently).  Best best describe it as; sore right arm; This is a spontaneous report from a contactable consumer (Patient herself). A 66-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration, administered in Arm Right on 09Mar2021 11:15 as single dose for COVID-19 immunization. Medical history included autoimmune thyroiditis, coagulopathy, osteoporosis from an unknown date and unknown if ongoing. Patient had not any known allergies. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included apixaban (ELIQUIS) and thyroid (ARMOUR THYROID) taken for an unspecified indication. It was reported that, on 09Mar2021 she had expected sore right arm; however, since last evening, she was having trouble in taking a deep breath (not exactly short of breath-just felt need to try to get deep breath frequently). Best described it as need to take deep yawn. The patient had not received any treatment for adverse event. The patient was not diagnosed prior and since the vaccination with COVID-19. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: aches; sore throat; congestion; cough; Mild arm pain; some fatigue; This is a spontaneous report from a contactable consumer (Patient). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 09:00 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation (Age at the time of vaccination 67 year). The patient medical history was not reported. Concomitant medication included oxcarbazepine (TRILEPTAL); losartan; dulaglutide (TRULICITY). Patient did not receive any other vaccine in four weeks. The patient experienced mild arm pain, some fatigue on 04Mar2021 and patient experience aches, sore throat, congestion, and cough on an unspecified date. It was reported patient experienced Mild arm pain and some fatigue for two days following injection. On 4th day following injection, aches, fatigue, sore throat, congestion, and cough all for 2.5 days. Patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 09Mar2021 Nasal swab. The outcome of event were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: aches; sore throat; congestion; cough; Mild arm pain; some fatigue; This is a spontaneous report from a contactable consumer (Patient). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 09:00 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation (Age at the time of vaccination 67 year). The patient medical history was not reported. Concomitant medication included oxcarbazepine (TRILEPTAL); losartan; dulaglutide (TRULICITY). Patient did not receive any other vaccine in four weeks. The patient experienced mild arm pain, some fatigue on 04Mar2021 and patient experience aches, sore throat, congestion, and cough on an unspecified date. It was reported patient experienced Mild arm pain and some fatigue for two days following injection. On 4th day following injection, aches, fatigue, sore throat, congestion, and cough all for 2.5 days. Patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 09Mar2021 Nasal swab. The outcome of event were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Blood pressure systolic increased, Dizziness
Clinical narrative: lightheadedness; Vaccine-Related Anxiety (include misc mental health); Pt encouraged to monitor bp at home and follow up with pcp if noted to be 140/90 consistently.; This is a spontaneous report from a non-contactable other hcp reported that. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration on an unspecified date as 1st DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced lightheadedness, vaccine-related anxiety, patient encouraged to monitor bp at home and follow up with pcp if noted to be 140/90 consistently. The patient underwent lab tests and procedures which included blood pressure measurement: 140/90. Therapeutic measures were taken as a result of lightheadedness. Outcome of the event lightheadedness is recovering, anxiety is unknown, and pt encouraged to monitor bp at home and follow up with pcp if noted to be 140/90 consistently is reported as unknown (at this point of time).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: a little pain and redness in the injection site that felt warmer than the rest of the arm; a little pain and redness in the injection site that felt warmer than the rest of the arm; a little pain and redness in the injection site that felt warmer than the rest of the arm; This is a spontaneous report from a contactable consumer or other non hcp (From patients daughter). A 84-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a little pain and redness in the injection site that felt warmer than the rest of the arm on an unspecified date. The reporter stated she was looking for this information since she mentions that her mother got recently the vaccine and had a mild reaction to it: she got a little pain and redness in the injection site that felt warmer than the rest of the arm. The patient wanted to know if the pain and redness in the injection site along with the warmness has been reported for Prevnar 13. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Nasopharyngitis, Pain in extremity, Rhinorrhoea
Clinical narrative: soreness in her arm; she has "light cold" symptoms that include runny nose and watery eyes; she has "light cold" symptoms that include runny nose and watery eyes; she has "light cold" symptoms that include runny nose and watery eyes; This is a spontaneous report from a contactable consumer and concerns a female patient of unknown age who reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 06Mar2021, as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date the patient reported soreness in her arm, she has light cold symptoms that included runny nose and watery eyes. No fever was reported. She wanted to know if she could safely return. The outcome of events were unknown. The patient wanted to know if the vaccine could cause a positive Covid test (nasal swab).  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Fever; chills; total body joint pain; This is a spontaneous report from a contactable Nurse, the patient. A 59-years-old non-pregnant female patient received the first dose of bnt162b2 (BNT162B2, Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 26Feb2021 10:00 (at the age of 59-years-old) as a single dose for covid-19 immunization. Medical history included ESRD hypothyroidism, hyperparathyroidism. The patient previously took and had allergies with latex, gaseoflatex plus, stadol, trimethoprim, noroxin and progesterones. The patient was not pregnant at the time of vaccination. The patient had no other vaccine within four 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. On 10Mar2021 07:15, the patient experienced fever, chills, total body joint pain and treated with Tylenol, pain medication. Outcome of the events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction/she is having a reaction to vaccine; This is a spontaneous report from a contactable consumer or other non hcp.  A 26-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6206) as UNKNOWN, SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient experienced allergic reaction/she is having a reaction to vaccine on an unspecified date. she had allergies to it she believed. She wanted to let them know symptoms and ask if there was anything to do for them. Caller does not clarify this statement other than to say she was doing many things at one time. Caller says she was panicking because she was having a reaction to vaccine and wants to ask what should she do. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Product storage error
Clinical narrative: excursion max: 11.6 C for one hour; excursion max: 11.6 C for one hour; This is a spontaneous report received from a contactable nurse. A pediatric patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe) via an unspecified route of administration on an unspecified date as single dose for immunization. Patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that, seeks stability; excursion max: 11.6 C (degree Celsius) for one hour, non single excursion. Outcome of events was unknown.  No follow-up attempts are needed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021268716 same reporter/drug/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Product storage error
Clinical narrative: excursion max: 11.6 C for one hour; excursion max: 11.6 C for one hour; This is a spontaneous report. A contactable nurse reported for a consumer (patient) via Medical information team.This case was created for the 10th patient. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that seeks stability; excursion max: 11.6 C for one hour. non single excursion. Patients involved: 10 Paediatrics (Prevnar only). For product TRUMENBA no patient was involved. The outcome of the events was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021268716 same reporter/drug/event, different patient.
Age: 80.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Body temperature abnormal, Chills, Erythema, Injected limb mobility decreased, Injection site erythema
Clinical narrative: swelling in her left arm. It was red/swollen down to elbow and hand; It was red, hot; body rash all over/rash on her hand; itchy; swollen down to elbow and hand; effected her movement of her hand; temperature abnormal; chills; hot swollen arm down to elbow; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM197 Protein) (PREVNAR 13, Solution for injection in pre-filled syringe, lot number: PAA135492), via an unspecified route of administration, in arm left, on an unknown date in Oct2020, as a single dose for immunization and influenza a(h1n1) pdm09 vaccine (INFLUENZA) via an unspecified route of administration, on an unknown date in Oct2020, as a single dose for Immunization. Patient's medical history and concomitant medications were not reported. It was stated that she did have a pneumonia vaccine, Pfizer in October of last year and didn't have any breathing problems but she did have severe swelling in her left arm. It was red, hot, swollen down to elbow and hand and effected her movement of her hand. Stated that 30 days later, she had terrible body rash all over that was so itchy it was like poison ivy. Stated that she didn't know if that was related to the shot or something in it and she did have that last fall with the shot not breathing problems, but temperature abnormal, chills, red, hot swollen arm down to elbow and severe rash on her hand and all over her body 30 days later; all events were occurred to the patient on an unknown date in 2020. Confirmed that events occurred on left arm. She added, on the same day she also got the Influenza vaccine. No additional details provided. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site swelling, Injection site warmth, Peripheral swelling, Rash, Rash pruritic
Clinical narrative: swelling in her left arm. It was red/swollen down to elbow and hand; It was red, hot; body rash all over/rash on her hand; itchy; swollen down to elbow and hand; effected her movement of her hand; temperature abnormal; chills; hot swollen arm down to elbow; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM197 Protein) (PREVNAR 13, Solution for injection in pre-filled syringe, lot number: PAA135492), via an unspecified route of administration, in arm left, on an unknown date in Oct2020, as a single dose for immunization and influenza a(h1n1) pdm09 vaccine (INFLUENZA) via an unspecified route of administration, on an unknown date in Oct2020, as a single dose for Immunization. Patient's medical history and concomitant medications were not reported. It was stated that she did have a pneumonia vaccine, Pfizer in October of last year and didn't have any breathing problems but she did have severe swelling in her left arm. It was red, hot, swollen down to elbow and hand and effected her movement of her hand. Stated that 30 days later, she had terrible body rash all over that was so itchy it was like poison ivy. Stated that she didn't know if that was related to the shot or something in it and she did have that last fall with the shot not breathing problems, but temperature abnormal, chills, red, hot swollen arm down to elbow and severe rash on her hand and all over her body 30 days later; all events were occurred to the patient on an unknown date in 2020. Confirmed that events occurred on left arm. She added, on the same day she also got the Influenza vaccine. No additional details provided. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Skin warm
Clinical narrative: swelling in her left arm. It was red/swollen down to elbow and hand; It was red, hot; body rash all over/rash on her hand; itchy; swollen down to elbow and hand; effected her movement of her hand; temperature abnormal; chills; hot swollen arm down to elbow; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM197 Protein) (PREVNAR 13, Solution for injection in pre-filled syringe, lot number: PAA135492), via an unspecified route of administration, in arm left, on an unknown date in Oct2020, as a single dose for immunization and influenza a(h1n1) pdm09 vaccine (INFLUENZA) via an unspecified route of administration, on an unknown date in Oct2020, as a single dose for Immunization. Patient's medical history and concomitant medications were not reported. It was stated that she did have a pneumonia vaccine, Pfizer in October of last year and didn't have any breathing problems but she did have severe swelling in her left arm. It was red, hot, swollen down to elbow and hand and effected her movement of her hand. Stated that 30 days later, she had terrible body rash all over that was so itchy it was like poison ivy. Stated that she didn't know if that was related to the shot or something in it and she did have that last fall with the shot not breathing problems, but temperature abnormal, chills, red, hot swollen arm down to elbow and severe rash on her hand and all over her body 30 days later; all events were occurred to the patient on an unknown date in 2020. Confirmed that events occurred on left arm. She added, on the same day she also got the Influenza vaccine. No additional details provided. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (the patient herself). An 84-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 07Mar2021 (at the age of 84-year-old) at single dose for COVID-19 immunisation. Relevant medical history included diabetes and high blood pressure. Concomitant medications included metoprolol, isosorbide mononitrate and telmisartan. On 07Mar2021 the patient had terrible headache day all day into night. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: very sick; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported she has been feeling very sick since the first vaccine dose. The patient wanted to know if she needs to take the second dose of the vaccine since she is having reaction from the first. The event outcome was unknown at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Swollen lymph nodes in bilateral arm pits; pain in bilateral armpits that radiates to breasts, upper arms, and down both sides; pain in bilateral armpits that radiates to breasts, upper arms, and down both sides; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231), via an unspecified route of administration, administered in left arm on 05Jan2021 at 05:00 PM (at the age of 45 years old), at second dose, single dose for COVID-19 immunisation. The patient was not pregnant upon vaccination. Medical history included autoimmune disorder. The patient didn't have COVID-19 prior to vaccination and was not tested for COVID post vaccination. The patient was tested for autoimmune more than 10 years ago, but never received a firm diagnosis. Concomitant medications included famotidine (PEPCID AC) and calcium carbonate (TUMS ANTACID). Past drug events included allergy in etodolac (LODINE). The patient was previously administered the first dose of BNT162B2 (Lot number: EH9899) in right arm, on 15Dec2020 (at the age of 45 years) for COVID-19 immunisation. On 06Jan2021, 05:00 PM, the patient experienced swollen lymph nodes in bilateral arm pits 24 hours after the second vaccination. She also had severe pain and tenderness in bilateral armpits radiating into breasts and down sides for one week. Still continuing to have daily pain in bilateral armpits that radiates to breasts, upper arms, and down both sides often requiring ibuprofen. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: Sore throat; runny nose; sneezing; This is a spontaneous report from a contactable pharmacist (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6208), via an unspecified route of administration, administered in the right arm on 10Mar2021, 16:45 (at the age of 36 years old) as first dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no other vaccines four weeks prior vaccination and was not pregnant by the time of vaccination. Concomitant medications included cetirizine and multiple vitamin. The patient experienced sore throat, runny nose, and sneezing on 11Mar2021. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Therapeutic measures were taken as a result of sore throat, runny nose, and sneezing and included treatment with benzonatate and cough/cold syrup. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: sore arm; tired; headache; nausea; This is a spontaneous report from a contactable consumer (patient).   A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 12:45 at the age of 51-years-old (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation. The patient was not pregnant.  No Covid prior vaccination. The patient had not tested for Covid post vaccination. Medical history included bicuspid aortic valve, thyroidectomy, seasonal allergy. The patient concomitant medications were not reported. The patient experienced sore arm, tired, headache, nausea all on 10Mar2021 14:00 with outcome of recovering. The patient did not receive any treatment for the events.  The events were assessed as non-serious.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nail discolouration, Nausea, Pain in extremity
Clinical narrative: My finger tips under my nails turned blue on my left hand (same side as my injection).; Nausea; Headache; My arm is sore; Fatigue; This is a spontaneous report from a contactable consumer reported for herself A 27-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 10:30 (Batch/Lot number was not reported) at the age of 27 years as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]); collagen (COLLAGEN); lepidium meyenii root (MACA ROOT). The patient reported that "my finger tips under my nails turned blue on my left hand on 12Mar2021 17:00 with outcome of not recovered, nausea on 12Mar2021 17:00 with outcome of recovered, headache on 12Mar2021 17:00 with outcome of recovered, " my arm is sore" on 12Mar2021 17:00 with outcome of not recovered and fatigue on 12Mar2021 17:00 with outcome of recovered.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the spot of the injection; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, in left arm on 10Mar2021 at 09:45AM (at the age of 38-years-old) (Lot Number: Et 3247) as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. The patient was not pregnant. The patient did not have COVID prior to vaccination. The patient did not receive other vaccines in four weeks. On 10Mar2021 at 16:00 (also reported as about 6 hours after the injection), the patient experienced pain at the spot of the injection and lasted for about 16 hours. No treatment was received for the events. The patient was not tested for COVID post vaccination. The outcome of the event was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Pain in extremity, Peripheral coldness
Clinical narrative: my arm was very cold an stiff even after moving it around.; my arm was very cold an stiff even after moving it around.; it was very painful compared to the "sore" others had experienced.; She was not able to move it for about 3 days; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration, administered in left arm on 06Mar2021 at 02:45 PM (at the age of 28 years old), at first dose, single dose for COVID-19 immunisation. The patient was not pregnant upon vaccination. The patient has no relevant medical history. The patient has no COVID-19 prior to vaccination and has no known allergies. There were no concomitant medications. The patient reported that after receiving the first dose of BNT162B2 on 06Mar2021 (Saturday), her arm was very cold and stiff even after moving it around. She was not able to move it for about 3 days, it was very painful compared to the "sore" others had experienced. The patient took acetaminophen (TYLENOL STRENGTH) and it did not help the pain. A week later, the pain went away, and on 13Mar2021, the patient woke up and her arm was in the same pain. She was unable to raise it without it feeling restricted. The patient was not COVID tested post vaccination. The outcome of events was recovered with sequel on Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, C-reactive protein, C-reactive protein abnormal, Groin pain, Hyperhidrosis
Clinical narrative: fever up to 37.8 with sweating; fever up to 37.8 with sweating; CRP 90; Sedimentation rate 70; pain in left groin; This is a spontaneous report from a contactable physician.    A 88-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Right on 03Feb2021 09:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation  .  Age at vaccination :88 years.Medical history included Bilateral inguinal hernia Repair. Facility type vaccine: Unknown;No  other vaccine in four weeks; No Other medications in two weeks.  The patient experienced fever up to 37.8 with sweating (non-serious) on 03Feb2021 11:00 with outcome of not recovered ,  crp 90 (c-reactive protein abnormal) (non-serious) on 03Feb2021 11:00 with outcome of not recovered , sedimentation rate 70 (non-serious) on 03Feb2021 11:00 with outcome of not recovered , pain in left groin (non-serious) on 03Feb2021 11:00 with outcome of not recovered.  The patient underwent lab tests and procedures which included body temperature: 37.8   on Feb2021   , c-reactive protein: 90   on 03 Feb2021   , red blood cell sedimentation rate: 70   on 03Feb2021  .  The action taken in response to the event(s) for bnt162b2 was not applicable.  The patient received treatments for all events: Acetaminophen and Celecoxib.The adverse events resulted in: Doctor or other healthcare Professional office or clinic visit.Addiitonal information :No covid prior vaccination. No covid tested post vaccination. The patient received dose 2 of bnt162b2 (Brand Pfizer) intramuscular, administered in Arm Left on 24Feb2021 11:00 (Batch/Lot number was not reported) as DOSE, SINGLE,  No follow up attempts are possible. Information about lot/batch number cannot be obtained.