chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an adult patient who received Herpes zoster (Shingle's vaccine).    On an unknown date, the patient received Shingle's vaccine. On an unknown date, unknown after receiving Shingle's vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingle's vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had vaccination but still got the mild case. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, event onset time and laboratory confirmation for shingles were unknown at the time of reporting.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: CHILLS; FEVER; FATIGUE; This spontaneous report received from a consumer concerned a 39 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, and fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: SLUGGISH; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sluggish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sluggish was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: FLU LIKE SYMPTOMS; BODY ACHE; FEVER; This spontaneous report received from a health care professional concerned a patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced flu like symptoms. On 26-MAR-2021, the subject experienced body ache. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, body ache, and fever on 28-MAR-2021. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: ITCHINESS ON BACK, ARM AND FOREHEAD; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 at 09:45 on left arm for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced itchiness on back, arm and forehead. Treatment medications (dates unspecified) included: cetirizine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchiness on back, arm and forehead. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Food interaction, Pain, Pruritus, Stomatitis
Clinical narrative: ITCHINESS ON BACK, ARM AND FOREHEAD; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 at 09:45 on left arm for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced itchiness on back, arm and forehead. Treatment medications (dates unspecified) included: cetirizine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchiness on back, arm and forehead. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: CHILLS AT NIGHT; HEADACHE; TEMPERATURE OF 101.1 F; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced chills at night. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced temperature of 101.1 f. Laboratory data included: Body temperature (NR: not provided) 101.1 F, 100.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, chills at night, and temperature of 101.1 f. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: RASH DOWN THE SIDE OF THE TORSO, ARMS, WRISTS AND CHEST AREA; HEADACHE; FEELING TIRED; SEVERE VOMITING; GENERAL ACHE; FEVER; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination, vaccinated at the left deltoid. No concomitant medications were reported. On 31-MAR-2021, the subject experienced general ache. Laboratory data included: Body temperature (NR: not provided) 99.9 F. On 01-APR-2021, the subject experienced severe vomiting. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced feeling tired. On 03-APR-2021, the subject experienced rash down the side of the torso, arms, wrists and chest area. On an unspecified date, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol, aloe vera, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe vomiting on 02-APR-2021, and headache on 03-APR-2021, was recovering from general ache, had not recovered from rash, and feeling tired, and the outcome of fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Vomiting
Clinical narrative: RASH DOWN THE SIDE OF THE TORSO, ARMS, WRISTS AND CHEST AREA; HEADACHE; FEELING TIRED; SEVERE VOMITING; GENERAL ACHE; FEVER; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination, vaccinated at the left deltoid. No concomitant medications were reported. On 31-MAR-2021, the subject experienced general ache. Laboratory data included: Body temperature (NR: not provided) 99.9 F. On 01-APR-2021, the subject experienced severe vomiting. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced feeling tired. On 03-APR-2021, the subject experienced rash down the side of the torso, arms, wrists and chest area. On an unspecified date, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol, aloe vera, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe vomiting on 02-APR-2021, and headache on 03-APR-2021, was recovering from general ache, had not recovered from rash, and feeling tired, and the outcome of fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Breast pain
Clinical narrative: PAINFUL RIGHT BREAST; RIGHT BREAST FEELS HEAVY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-APR-2021, the subject experienced painful right breast. On 02-APR-2021, the subject experienced right breast feels heavy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the painful right breast and right breast feels heavy was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: It feels a little tender when she touches it; swollen lymph nodes; This is a follow up spontaneous report from a Contactable consumer. A 73 year old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration in the left arm on 29Jan2021 10:00AM and 10:15AM at single dose for COVID-19 immunization. Medical history included swollen lymph nodes and bone density abnormal. Concomitant medications included Strontium and Algae Cal Plus. On 01Feb2021 patient developed swollen lymph nodes. Upon follow up 03Feb2021, It feels a little tender when she touches it. The outcome of events was unknown.  Follow up (03Feb2021): This is a follow up spontaneous report from a Contactable consumer included: medical history, concomitant medications, and event information.  Information on the Lot/Batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: But yesterday, caller hurt her back, although this is a condition that comes up every now and then; This is a spontaneous report from a contactable Consumer (Patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date were not Provided) via unspecified route of administration on 06Feb2021 at single dose for covid-19 vaccination. Medical history included back condition the flares up when she picks up heavy items, that she treats with Oxycodone. concomitant medications were not reported.   The reporter (the patient) stated that she had the COVID shot on Saturday, and she was told at the time to take Tylenol if needed, instead of other pain killers and not to take Advil. had no adverse effects. On 08Feb2021, the patient hurt her back, although this is a condition that comes up every now and then, and the patient usually just takes one Oxycodone and the pain goes away, was afraid to take the Oxycodone without knowing if it will effect the vaccine. The patient queried about use of antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine, whether oxycodone will affect her vaccine. The patient confirms that her issues with her back have occurred many times prior to getting the COVID shot, many times over the years. The patient was picking up cartons yesterday and caused it. Investigation Assessment was not Provided. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Dyskinesia, Hepatic enzyme increased, Influenza virus test
Clinical narrative: Severe joint pain; Fever; Bone and joint pain; She can barely walk around or can't move; Her jaw hurts from the pain; She had been sore; Bone and joint pain; She can barely walk around or can't move; liver enzyme was slightly elevated; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received bnt162b2 (Solution for injection), via an unspecified route of administration on 29Jan2021 (Lot Number: Q13247) as single dose for covid-19 immunisation. Medical history included follicular lymphoma. The patient concomitatnt medication was not reported. Reporter stated, "they were good, fairly normal. One liver enzyme was slightly elevated and oncologist was not concerned as blood work was done at his office and was fine from their perspective. Reporter stated, "First of all, she had a fever last night in 2021. Yesterday afternoon, it started around dinner time, our dinner time 5-6 o'clock in the evening, no 3 or 4 in the afternoon. They did a flu test, they did a Covid test and they just said that it didn't have anything to do with flu or COVID. It came down with Tylenol and Ibuprofen (treatment). Last night, during the night she complained of bone and joint pain on an unknown date in 2021. And today, up until about 3 hours ago she was fine but the last three hours have been what I would call severe pain where she can barely walk around or can't move. Her jaw hurts from the pain in 2021. Reporter stated, "She took Tylenol earlier and then she just took four Ibuprofen and she had been taking it for various things around the clock. She had been sore and fever obviously from the yesterday's episode. The outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Liver function test, Pain, Pain in jaw, Pyrexia
Clinical narrative: Severe joint pain; Fever; Bone and joint pain; She can barely walk around or can't move; Her jaw hurts from the pain; She had been sore; Bone and joint pain; She can barely walk around or can't move; liver enzyme was slightly elevated; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received bnt162b2 (Solution for injection), via an unspecified route of administration on 29Jan2021 (Lot Number: Q13247) as single dose for covid-19 immunisation. Medical history included follicular lymphoma. The patient concomitatnt medication was not reported. Reporter stated, "they were good, fairly normal. One liver enzyme was slightly elevated and oncologist was not concerned as blood work was done at his office and was fine from their perspective. Reporter stated, "First of all, she had a fever last night in 2021. Yesterday afternoon, it started around dinner time, our dinner time 5-6 o'clock in the evening, no 3 or 4 in the afternoon. They did a flu test, they did a Covid test and they just said that it didn't have anything to do with flu or COVID. It came down with Tylenol and Ibuprofen (treatment). Last night, during the night she complained of bone and joint pain on an unknown date in 2021. And today, up until about 3 hours ago she was fine but the last three hours have been what I would call severe pain where she can barely walk around or can't move. Her jaw hurts from the pain in 2021. Reporter stated, "She took Tylenol earlier and then she just took four Ibuprofen and she had been taking it for various things around the clock. She had been sore and fever obviously from the yesterday's episode. The outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Severe joint pain; Fever; Bone and joint pain; She can barely walk around or can't move; Her jaw hurts from the pain; She had been sore; Bone and joint pain; She can barely walk around or can't move; liver enzyme was slightly elevated; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received bnt162b2 (Solution for injection), via an unspecified route of administration on 29Jan2021 (Lot Number: Q13247) as single dose for covid-19 immunisation. Medical history included follicular lymphoma. The patient concomitatnt medication was not reported. Reporter stated, "they were good, fairly normal. One liver enzyme was slightly elevated and oncologist was not concerned as blood work was done at his office and was fine from their perspective. Reporter stated, "First of all, she had a fever last night in 2021. Yesterday afternoon, it started around dinner time, our dinner time 5-6 o'clock in the evening, no 3 or 4 in the afternoon. They did a flu test, they did a Covid test and they just said that it didn't have anything to do with flu or COVID. It came down with Tylenol and Ibuprofen (treatment). Last night, during the night she complained of bone and joint pain on an unknown date in 2021. And today, up until about 3 hours ago she was fine but the last three hours have been what I would call severe pain where she can barely walk around or can't move. Her jaw hurts from the pain in 2021. Reporter stated, "She took Tylenol earlier and then she just took four Ibuprofen and she had been taking it for various things around the clock. She had been sore and fever obviously from the yesterday's episode. The outcome of the events was unknown.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: his shoulder got a little sore; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL9263), via an unspecified route of administration, in the Left arm on 08Feb2021 15:00, as single dose for covid-19 immunization. The patient's medical history included skin cancer, predating treatment with the Pfizer COVID 19 vaccine. Concomitant medications were not reported. On 08Feb2021, the patient's shoulder got a little sore some hours later after the vaccination but it is about back to normal now; he has to raise his arm straight up to even feel it. Caller stated that he received the first dose of the Pfizer covid 19 vaccine on 08Feb2021 and will not be back in the state for the 21-day dosing schedule. Caller wants to know how long he can go and how long can he wait between shots as he will not be back until 04Mar2021 which is longer than 21 days from his first dose. They advised him he could wait 6 weeks maximum and no more. On or after 08Mar2021, the patient was planning to get the second dose. The outcome of event was recovering.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Influenza like illness
Clinical narrative: Stated that she felt like she had flu; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EM9810), dose 1 via an unspecified route of administration on 03Feb2021 as single dose for COVID-19 immunisation. Medical history included blocked subclavian artery and arteriosclerosis, both were diagnosed seven years ago and are ongoing. The concomitants medication was not provided. About 36 hours after vaccination, the patient experienced all side effects except fever and nausea, felt like she had flu and severe allergic reaction. The patient ended up going to bed and taking fluids for two days. The patient had flu for a few days and slept for a few days. She was back to normal. She is scheduled for a second shot in couple of weeks. She wanted to know the likelihood is great for this to happen again so that she can mentally prepare. The patient stated that the majority of the side effects in her age group did increase after the second dose. She stated one should not get the Pfizer-BioNTech COVID-19 Vaccine if had a severe allergic reaction after a previous dose of this vaccine. The reporter assessed the event as non-serious. The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pruritus, Pruritus
Clinical narrative: Body itch; internal mouth itch; This is a spontaneous report from a contactable other hcp (patient). A 58-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right in Jan2021 at the age of 58 years old (Batch/Lot Number: EL9262) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma , breast cancer, Allergy to all seafood including shellfish and codeine. Prior to and since the vaccination the patient has not been diagnosed with COVID-19. Concomitant medications included exemestane (EXEMESTANE), omeprazole magnesium (PRILOSEC), cetirizine hydrochloride (ZYRTEC). On The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 18:00 the patient experienced body itch and internal mouth itch, the patient took Benadryl and Tagamet as treatment for the events. Outcome of the events was recovered on an unspecified date 2021.   Follow-up (29Mar2021): No new information.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Malaise, Pain
Clinical narrative: flu like symptoms; Body aches; headache; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EM9810, Expiration Date: Jun2021) via unspecified route on 11Feb2021 at 11:30 AM in the left arm as single dose for covid-19 immunisation at hospital. Patient's medical history included GERD, take 20 mg Nexium and allergic for clyndamycin antibiotics. Concomitant medications not included. The patient did not receive any other vaccines in 4 weeks. The patient was not diagnosed with COVID-19 prior or since the vaccination. On 12Feb2021, at 02:00 AM the patient experienced body aches, flu like symptoms, feeling unwell and headache for about 2 days. After a day 2 days of headache still lingers. Events were treated with Tylenol twice a day and once on next day. Outcome of events was recovered with lasting effects.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021363289 Same reporter/ drug, different patients/ events;US-PFIZER INC-2021363288 Same reporter/ drug, different patients/ events.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: she was sick; Caller got the 1st dose of Vaccine on the 19Jan2021, 2weeks later She tested positive with covid-19 with minor symptoms.; She tested positive with covid-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown,) via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. It was unspecified covid vaccine a Pfizer product and covid vaccine manufacturer was also unspecified. There was no lot number because caller was unwilling to complete the report. The patient's medical history and concomitant medications were not reported. The patient experienced caller got the 1st dose of vaccine on the 19Jan2021, 2 weeks later she tested positive with covid-19 with minor symptoms and she tested positive with covid-19 in 2021 and she was sick. There was product complaint. She is calling about the covid vaccine. Patient stated she got the 1st dose of vaccine on the 19Jan2021, 2 weeks later she tested positive with covid-19 with minor symptoms. She is fine now, but she missed the second dose. She tried to get with the agency since she missed the 2nd dose which supposedly is on the 09Feb2021. She is stuck in (state) trying to get the 2nd dose. Now she is having a hard time, in getting the second dose. She needs to find a facility that has a second dose of Pfizer. Some facilities say that they are not giving the Pfizer anymore. She did call the agency, because some people told her she can't get second dose, the agency told her that is incorrect, she absolutely cannot get the second dose only if she had treatment. She states that she had mild symptoms and got no treatment, she is 10 days over and free to get second dose. Caller states that she has been searching for a second dose. She called the local health department and told them that she missed her second dose, because she was sick. She needs a second dose of Pfizer. She was told not to get (another brand vaccine name) since she had a first dose of Pfizer. When queried for a safety report, she states that the first lady she spoke to was really nice. She's the one who hooked her up on this line, she didn't call the line for herself, her purpose of calling was absolutely not to go through a safety report. She wanted her question addressed.  She wants to know where in (state name) or in general vicinity can she get a second dose. She declined the safety report. The patient underwent lab tests and procedures which included sars-cov-2 test positive in 2021. The outcome event was recovered.   Information regarding Lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: received the 1st dose of the Pfizer covid vaccine on 29Jan2021/ A week later, she was diagnosed with covid; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:00 (Batch/Lot Number: EN5318) as single dose for covid-19 immunisation. Medical history included none. No known allergies. The Concomitant medications in two weeks were not reported. The patient reported, if she can take her 2nd dose of the Pfizer covid vaccine this Friday, with a covid positive history. She received the 1st dose of the Pfizer covid vaccine on 29Jan2021. A week later, she was diagnosed with covid. It will be 14 days since her 1st symptom. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 antibody test positive on 09Feb2021. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with Covid; diagnosed with Covid; This is a spontaneous report from a contactable consumer or other non health professional. A contactable female patient of an unspecified age received bnt162b2 (BNT162B2; Batch/Lot number: unknown, Expiry date: Not provided), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient information about other products were not reported. On 20Dec2020, the patient was diagnosed with covid (covid-19). The outcome of the events were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I was diagnosed with Covid; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: E0249), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Feb2021, the patient was diagnosed with Covid. The patient went to the emergency room and she had one of those infusion for seizures. The outcome of the event was unknown.   Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Cough, Headache
Clinical narrative: High fever, chills, headache, cough; High fever, chills, headache, cough; The caller received the first vaccine on 28Jan2021 and tested positive for Covid on 02Feb2021.; High fever, chills, headache, cough; High fever, chills, headache, cough; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL8982; Expiration Date: 31May2021) via an unspecified route of administration in the left arm on 28Jan2021(at the age of 66-years-age) as a SINGLE DOSE for covid-19 vaccination. Patient medical history included hypertension, diabetes, cholesterol and patient reported that, he does take medications for hypertension, diabetes, cholesterol.   The patient stated that back on 28Jan2021, he had first dose of Pfizer Covid vaccine, he got a terrible reaction, had fever and chills and eventually they sent him to get tested and found out that he tested positive for coronavirus, had just contracted the coronavirus before he got the vaccine. When probed for the adverse reactions, the consumer stated, "High fever, chills, headache, cough". Second dose was scheduled for tomorrow morning he said, should he get that or put it off, he still had cough and headache from coronavirus. Caller, the patient clarified he was tested on 01Feb2021 and got positive results on 02Feb2021. Treatment received by the Consumer (patient) was reported as, "Just a little over the counter, Acetaminophen, Aspirin, cough syrup". The outcome for the events covid-19, headache, cough were not recovered and the outcome for fever, chills were recovered on 12Feb2021.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: High fever, chills, headache, cough; High fever, chills, headache, cough; The caller received the first vaccine on 28Jan2021 and tested positive for Covid on 02Feb2021.; High fever, chills, headache, cough; High fever, chills, headache, cough; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL8982; Expiration Date: 31May2021) via an unspecified route of administration in the left arm on 28Jan2021(at the age of 66-years-age) as a SINGLE DOSE for covid-19 vaccination. Patient medical history included hypertension, diabetes, cholesterol and patient reported that, he does take medications for hypertension, diabetes, cholesterol.   The patient stated that back on 28Jan2021, he had first dose of Pfizer Covid vaccine, he got a terrible reaction, had fever and chills and eventually they sent him to get tested and found out that he tested positive for coronavirus, had just contracted the coronavirus before he got the vaccine. When probed for the adverse reactions, the consumer stated, "High fever, chills, headache, cough". Second dose was scheduled for tomorrow morning he said, should he get that or put it off, he still had cough and headache from coronavirus. Caller, the patient clarified he was tested on 01Feb2021 and got positive results on 02Feb2021. Treatment received by the Consumer (patient) was reported as, "Just a little over the counter, Acetaminophen, Aspirin, cough syrup". The outcome for the events covid-19, headache, cough were not recovered and the outcome for fever, chills were recovered on 12Feb2021.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Dizziness, Erythema, Facial pain
Clinical narrative: headache; Face blood red and hot to touch; Face blood red and hot to touch; Face blood red and hot to touch, really hurt; Dizzy; Vomiting; nausea; weakness; Face blood red and hot to touch; This is a spontaneous report from a contactable consumer herself (patient). A 70-years-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 10Feb2021 13:15 (lot Number: EM9809) as single dose for covid-19 immunisation. Medical history included Pennicyllian, low thyroid, high blood pressure and diabetes II. Concomitant medication included propranolol 80 mg, levothyroxine sodium at 100 mg; nortriptyline. The patient had, terrible headache 2 days, Face blood red and hot to touch, really hurt - 2 ½, days, Dizzy, still slightly, vomiting 2 days could not keep anything down, nausea, weakness on 12Feb2021 02:30 PM. The patient underwent lab tests and procedures which included blood pressure: high, covid-19: positive on if covid prior vaccination: Yes, Low thyroid all are prior to start of thereapy. The outcome of the event was recovered with sequels.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Hot flush, Nausea, SARS-CoV-2 test
Clinical narrative: headache; Face blood red and hot to touch; Face blood red and hot to touch; Face blood red and hot to touch, really hurt; Dizzy; Vomiting; nausea; weakness; Face blood red and hot to touch; This is a spontaneous report from a contactable consumer herself (patient). A 70-years-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 10Feb2021 13:15 (lot Number: EM9809) as single dose for covid-19 immunisation. Medical history included Pennicyllian, low thyroid, high blood pressure and diabetes II. Concomitant medication included propranolol 80 mg, levothyroxine sodium at 100 mg; nortriptyline. The patient had, terrible headache 2 days, Face blood red and hot to touch, really hurt - 2 ½, days, Dizzy, still slightly, vomiting 2 days could not keep anything down, nausea, weakness on 12Feb2021 02:30 PM. The patient underwent lab tests and procedures which included blood pressure: high, covid-19: positive on if covid prior vaccination: Yes, Low thyroid all are prior to start of thereapy. The outcome of the event was recovered with sequels.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test, Vomiting
Clinical narrative: headache; Face blood red and hot to touch; Face blood red and hot to touch; Face blood red and hot to touch, really hurt; Dizzy; Vomiting; nausea; weakness; Face blood red and hot to touch; This is a spontaneous report from a contactable consumer herself (patient). A 70-years-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 10Feb2021 13:15 (lot Number: EM9809) as single dose for covid-19 immunisation. Medical history included Pennicyllian, low thyroid, high blood pressure and diabetes II. Concomitant medication included propranolol 80 mg, levothyroxine sodium at 100 mg; nortriptyline. The patient had, terrible headache 2 days, Face blood red and hot to touch, really hurt - 2 ½, days, Dizzy, still slightly, vomiting 2 days could not keep anything down, nausea, weakness on 12Feb2021 02:30 PM. The patient underwent lab tests and procedures which included blood pressure: high, covid-19: positive on if covid prior vaccination: Yes, Low thyroid all are prior to start of thereapy. The outcome of the event was recovered with sequels.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 12:00 (Batch/Lot Number: EL3246) as single dose for covid-19 immunisation. Medical history included High BP. Concomitant medication(s) included metoprolol 50mg; valsartan 325mg. No Known allergies reported. The patient had diarrhea several times each day beginning the evening after the shot. It's worse at night but it's been 10 straight days of continuous going. Patient had not experienced any other side effects. No fever, pain, swelling, fatigue or anything. The patient experienced diarrhea on 09Feb2021 20:00. No COVID prior vaccination and no COVID tested post vaccination were reported. No treatment was received. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity
Clinical narrative: Rash all over face and arms appeared 3 days later. It is now the 5th day and the rash has spread to my legs and stomach/very itchy and irritating; fatigue; This is a spontaneous report received from a contactable consumer (Reporting for herself). A 17-years-old female patient received Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9810, Expiration date: not reported) via an unspecified route of administration in Arm Left on 13Feb2021 12:45 (At the age of 17 years-old) as single dose for COVID-19 vaccination. The patient medical history was not reported and no known allergies. The historical vaccine included first dose of BNT162B2 received via an unspecified route of administration in Arm Left on 23Jan2021 12:30 for COVID-19 vaccination. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. No COVID tested post vaccination. It was reported that patient had no symptoms after the 1st dose.   On 16Feb2021 she had fatigue (the first 1-2 days after getting the 2nd dose of Pfizer) that got better. Rash all over face and arms appeared 3 days later. It is now the 5th day and the rash has spread to legs and stomach. It was beginning to get very itchy and irritating. Patient was treated with hydrocortisone 3-4 times a day and it was not of much help. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: fever; nausea; aches; This is a spontaneous report from a contactable consumer (Patient) received from a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received the second dose of Covid-19 vaccine today (date not specified). According to her, she had a reaction fever, nausea, aches with the first Covid shot so her Doctor told her to take Ibuprofen after receiving the second dose. She doesn't have Ibuprofen at the moment, but she has Aleve and Bayer Aspirin. Patient was asking if it is okay to take these medications instead of Ibuprofen. The outcome of the events was unknown.  Information on lot/ batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Hyperhidrosis
Clinical narrative: diarrhea; muscle aches; sweating and shaking from fever; shaking; sweating; Severe 5 day headache; severe joint pain in hands and elbow; severe chills; This is a spontaneous report from a contactable 51-years-old non-pregnant female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL0739), via an unspecified route of administration on 17Feb2021 at 14:00 as single dose in left arm for covid-19 immunization. The patient's medical history was not reported. Historical vaccine included bnt162b2 on 27Jan2021 for covid-19 immunization (administration time=04:00 PM, vaccine location=Left arm, dose number=1). Concomitant medications included levothyroxine sodium and amlodipine besilate. The patient took Codeine in the past and had allergies. On 18Feb2021 at 16:00, the patient had severe 5-day headache, severe joint pain in hands and elbow, severe chills, sweating and shaking from fever, diarrhea, and muscle aches. The patient's laboratory details included covid-19 virus test with negative results on 17Feb2021. The patient did not take any treatment for the events. The outcome of the event was not recovered.  Information on the lot batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test, Tremor
Clinical narrative: diarrhea; muscle aches; sweating and shaking from fever; shaking; sweating; Severe 5 day headache; severe joint pain in hands and elbow; severe chills; This is a spontaneous report from a contactable 51-years-old non-pregnant female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL0739), via an unspecified route of administration on 17Feb2021 at 14:00 as single dose in left arm for covid-19 immunization. The patient's medical history was not reported. Historical vaccine included bnt162b2 on 27Jan2021 for covid-19 immunization (administration time=04:00 PM, vaccine location=Left arm, dose number=1). Concomitant medications included levothyroxine sodium and amlodipine besilate. The patient took Codeine in the past and had allergies. On 18Feb2021 at 16:00, the patient had severe 5-day headache, severe joint pain in hands and elbow, severe chills, sweating and shaking from fever, diarrhea, and muscle aches. The patient's laboratory details included covid-19 virus test with negative results on 17Feb2021. The patient did not take any treatment for the events. The outcome of the event was not recovered.  Information on the lot batch number has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Body rash spotty on both arms, but more extensive on midriff and groin; This is a spontaneous report from a contactable consumer. A 81-years-old male patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection) via an unspecified route of administration in Arm Left on 17Feb2021 at 14:00 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received other vaccine (first dose) in four weeks on 27Jan2021. On an unspecified date, the patient had experienced Body rash spotty on both arms, but more extensive on midriff and groin. Patient did not received any treatment. Patient did not tested covid post vaccination. The outcome of the event was not resolved.  Information of lot and batch number has been provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Malaise, Pain, Pain in extremity
Clinical narrative: Feeling unwell; lower back is killing her; left leg pain; left thigh swollen/left calf swollen; feeling really bad and may go to emergency room; in lots of pain/had some pain Sunday; This is a spontaneous report from a contactable consumer. A 81-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine, Solution for injection), via an unspecified route of administration, at dose 1 administered in Arm Right (Arm Right Upper) on 04Feb2021 15:30 to 04Feb2021 15:30 (at the time of 81-years-old) as single dose for covid-19 immunisation (due to age 81). The patient's medical history was not reported. There were no concomitant medications. She was in a lot of pain this morning. Yesterday she was fine and on Sunday she had some pain on Feb2021. Today she feels unwell and her lower back is killing her, has left leg pain, the left thigh is swollen and the calf of the left leg is swollen on 10Feb2021. Mentions she had her first Pfizer BioNTech Covid-19 vaccine last Thursday. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. Later mentions she feels really bad and might go to the emergency room. No further details provided. The outcome of events was not recovered.  No follow-up attempts (needed or possible). No further information expected. Information about lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Feeling unwell; lower back is killing her; left leg pain; left thigh swollen/left calf swollen; feeling really bad and may go to emergency room; in lots of pain/had some pain Sunday; This is a spontaneous report from a contactable consumer. A 81-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine, Solution for injection), via an unspecified route of administration, at dose 1 administered in Arm Right (Arm Right Upper) on 04Feb2021 15:30 to 04Feb2021 15:30 (at the time of 81-years-old) as single dose for covid-19 immunisation (due to age 81). The patient's medical history was not reported. There were no concomitant medications. She was in a lot of pain this morning. Yesterday she was fine and on Sunday she had some pain on Feb2021. Today she feels unwell and her lower back is killing her, has left leg pain, the left thigh is swollen and the calf of the left leg is swollen on 10Feb2021. Mentions she had her first Pfizer BioNTech Covid-19 vaccine last Thursday. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. Later mentions she feels really bad and might go to the emergency room. No further details provided. The outcome of events was not recovered.  No follow-up attempts (needed or possible). No further information expected. Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got the COVID infection after getting the first dose of the COVID Vaccine; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), via an unspecified route of administration on 31Dec2020 as SINGLE DOSE for COVID-19 immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported. One week later after the first dose of the vaccine he reported COVID infection. The outcome of the event was unknown.     Information on the Lot/Batch number has been requested.