chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Feel little stinks; Headache; Feel like tired; Chilling; Muscles pain; Cold; This is a spontaneous report from a contactable consumer or other non hcp. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Feb2021 (at the age of 35 years old), 2nd dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got the shots of COVID-19, yesterday (03Feb2021) was her second shot and feels little stinks, she has headache, feel like tired, chilling, muscles pain and cold. And she wants to know if it is, on it paper it is normal but for her but like for like her family. The number 82, so the name of the shot they told her, she has a number, and it is 82, she don't know if it is that one. Therapeutic measures were taken as a result of muscles pain. The outcome of the events was unknown.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Seems like heart rate is increased; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/lot number: EL9264) via unspecified route of administration on 01Feb2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified dose for COVID-19 immunisation. As per reported consumer stated, "I got the second Pfizer COVID-19 Vaccine (later confirmed) on the 01Feb and I, wear a fitbit and it seems like my heart rate is increased. When paraphrased the concern, consumer stated, "Right." Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She has arthritis in her hand and yesterday she hit her in the kitchen and have a lot of pain; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Reporter's Wife). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 29Jan2021 as 1st dose, single for COVID-19 immunization. Medical history included ongoing arthritis in hand. Concomitant medications for patient were not reported. The reporter reported for his wife that she had shot on 29Jan2021, first shot. It was reported that she has arthritis in her hand and yesterday she hit her in the kitchen and have a lot of pain, on an unspecified date. And she wanted to know could she take Tylenol 500mg for that. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body height, Chills, Fatigue, Feeling abnormal
Clinical narrative: Pretty much been in bed most of the time; Body aches; Chills; Headache; Sheer exhaustion; Feels like he got hit by a Truck; This is a spontaneous report from a contactable consumer reporting for father. A 90-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in arm on 28Jan2021 as 1st dose, single (at the age of 90-years-old) for COVID-19 immunization. Vaccination Facility Type was reported as Clinic. Vaccine was not administered at another Facility. Patient medical history and concurrent conditions included: Ongoing prostate cancer with onset at least 15 years ago, extraction of 2 molar teeth which was done last week on an unspecified date in 2021, height shrunk. The concomitant medications included ongoing leuprorelin acetate (LUPRON) injection about every 4 months taken for prostate cancer with last dose administered last week. On 28Jan2021, patient was pretty much been in bed most of the time, had body aches, chills, headache, sheer exhaustion, felt like he got hit by a truck. The patient was administered his first dose of Pfizer COVID-19 Vaccine on 28Jan2021. The patient is normally incredibly active. He does all of his own lawn moving, snow shoveling and he still works. Starting the night of 28Jan2021 he had pretty much been in bed most of the time ever since. Most of the time since then he has had lots of body aches, chills-but no fever, headache and just sheer exhaustion. The patient went into work at the office for a couple hours Monday (01Feb2021), he pretty much slept all day Tuesday (02Feb2021). They called the patient doctor office, and the nurse gave a not real professional response to the events reported to her, that it is really common to have body aches for 2 weeks. They reported to the nurse that this is not normal for the patient. The nurse told them that this happens all the time; but advised them that if they think it is a problem to take him to the urgent care. They have not heard of people with the first Pfizer COVID-19 Vaccine being so knocked out. Some days he was ok, some days the adverse events were incredibly bad. A day before (03Feb2021) he was fine for a couple of hours, on Monday (01Feb2021) he was fine for a couple of hours. His usual statement regarding these adverse events was that he felt like he got hit by a truck. The outcome of the events was unknown.    Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Pretty much been in bed most of the time; Body aches; Chills; Headache; Sheer exhaustion; Feels like he got hit by a Truck; This is a spontaneous report from a contactable consumer reporting for father. A 90-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in arm on 28Jan2021 as 1st dose, single (at the age of 90-years-old) for COVID-19 immunization. Vaccination Facility Type was reported as Clinic. Vaccine was not administered at another Facility. Patient medical history and concurrent conditions included: Ongoing prostate cancer with onset at least 15 years ago, extraction of 2 molar teeth which was done last week on an unspecified date in 2021, height shrunk. The concomitant medications included ongoing leuprorelin acetate (LUPRON) injection about every 4 months taken for prostate cancer with last dose administered last week. On 28Jan2021, patient was pretty much been in bed most of the time, had body aches, chills, headache, sheer exhaustion, felt like he got hit by a truck. The patient was administered his first dose of Pfizer COVID-19 Vaccine on 28Jan2021. The patient is normally incredibly active. He does all of his own lawn moving, snow shoveling and he still works. Starting the night of 28Jan2021 he had pretty much been in bed most of the time ever since. Most of the time since then he has had lots of body aches, chills-but no fever, headache and just sheer exhaustion. The patient went into work at the office for a couple hours Monday (01Feb2021), he pretty much slept all day Tuesday (02Feb2021). They called the patient doctor office, and the nurse gave a not real professional response to the events reported to her, that it is really common to have body aches for 2 weeks. They reported to the nurse that this is not normal for the patient. The nurse told them that this happens all the time; but advised them that if they think it is a problem to take him to the urgent care. They have not heard of people with the first Pfizer COVID-19 Vaccine being so knocked out. Some days he was ok, some days the adverse events were incredibly bad. A day before (03Feb2021) he was fine for a couple of hours, on Monday (01Feb2021) he was fine for a couple of hours. His usual statement regarding these adverse events was that he felt like he got hit by a truck. The outcome of the events was unknown.    Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, X-ray
Clinical narrative: Tiredness; This is a spontaneous report from a contactable consumer (patient's daughter).  A 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8922), via intramuscularly, administered in Arm Left on 27Jan2021 at 08:30 (at the age of 81 year) as, single dose for Covid-19 immunization at Hospital. Medical history included ongoing hypertension diagnosed probably 20 years ago, pericardial effusion from Jul2020 and ongoing, and urinary tract infection from an unknown date and unknown if ongoing. Family Medical History Relevant to AE reported as none and no relevant test was performed. The patient concomitant medications was not reported. History of all previous immunization with the Pfizer vaccine considered as suspect reported as none. The patient was not received any other vaccine prior four weeks of vaccination. The patient experienced tiredness on 27Jan2021. It was reported that, Consumer calling for her mother that got the first shot on 27Jan2021. They read about some of the side effects and one of them was being tired. Caller said that her mother is experiencing the tiredness and it has been about a week and 2 days and she is still experiencing tiredness. She stated that she is calling on behalf of her mother because she can't hear well on the phone. The patient was not visited to Emergency Room/Physician Office for the event. The patient underwent lab tests and procedures which included X-ray: bad UTI on unspecified date. The outcome of the event was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feels terrible after receiving the second dose; This is a spontaneous report received from a contactable consumer (patient herself). A 83-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3302), dose 2 via an unspecified route of administration, administered in arm Left on 03Feb2021 (at the age of 83-year-old) as single dose for covid-19 immunisation in a pharmacy. The vaccine was not administered in a facility. The time the vaccination was given between 13:00 to 14:00. The patient's medical history was reported as none and concomitant medications were not reported. The patient received first dose of bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, on an unspecified date (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive other additional vaccine administered on the same day. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient experienced feels terrible after receiving the second dose on 03Feb2021. The patient did not visit emergency room.  No relevant tests was reported. The outcome of the event was resolving.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Overdose, Product preparation error, Tremor
Clinical narrative: 6 individuals received a 0.3 ml dose of undiluted Pfizer Covid-19 vaccine; 6 individuals received a 0.3 ml dose of undiluted Pfizer Covid-19 vaccine; shakes; chills; This is a spontaneous report from a non-contactable Nurse. This Nurse reported similar events for 6 patients. This report is for 2nd of 6 patient. A patient of unspecified age, male received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route of administration on 05Feb2021 as dose number unknown, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive other vaccines in 4 weeks. Patient did not have COVID prior vaccination. Since the vaccination, patient did not test for COVID-19. No side effects observed/reported 1-hour post-vaccination. No side effects/adverse effects were observed/reported 48 hours post vaccination. On 05Feb2021, the patient experienced 6 individuals received a 0.3ml dose of undiluted Pfizer Covid-19 vaccine, one individual reported a brief period of chills/shakes. No treatment was received for the events. The outcome of the event was recovered, and rest events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130257 same reporter/drug/similar AE with different patient;US-PFIZER INC-2021161829 same reporter/drug/similar AE with different patient
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy
Clinical narrative: Arm & hand numb during night after injection; lymphadenopathy in left armpit (injection given in left arm); This is a spontaneous report from a Non-contactable Nurse (Patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 02Feb2021 (at the age of 60-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included allergic to penicillin and Imipramine, and hypertension. Concomitant medication(s) included Elderberry Syrup, Zicam, HCTZ, lisinopril; all for unknown indications from unknown dates and unknown if ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 12Jan2021 as 1st dose, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021, patient experienced arm and hand numb during night after injection, lymphadenopathy in left armpit. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Disease recurrence, Fatigue, Flank pain
Clinical narrative: flank pain; chest discomfort; night sweat; headache; tired; severe back pain; Slight scratchiness; swelling at the very back of the roof of my mouth and the start of my throat within the 15 min; 1/30 back pain/1/31 tired/back pain,headache 2/1 back pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN5318) via an unspecified route of administration in left arm on 28Jan2021 at 11:00 as unknown single dose for COVID-19 immunization at Clinic. Medical history included inflammatory arthritis, migraine headaches, spinal stenosis, sciatica, tinnitus. Patient previously took trazodone and experienced allergies with trazadone. Concomitant medications included acyclovir [aciclovir], amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), aspirin [acetylsalicylic acid], clarithromycin (CLARITIN [CLARITHROMYCIN]), topiramate (TOPAMAX). Patient did not receive any other vaccine in four weeks. Patient was not pregnant at the time of vaccination. Patient was not diagnosed COVID prior vaccination. On 28Jan2021, patient experienced slight scratchiness, swelling at the very back of the roof of my mouth and the start of my throat within the 15min. of administration. On 29Jan2021 (next day) at 03:00 AM, patient experienced headache, tired, severe back pain. On 30Jan2021, patient experienced back pain, chest discomfort, night sweat, no fever. On 31Jan2021, patient experienced tired, back pain, headache. On 01Feb2021, back pain, flank pain. No treatment was received for the adverse events. Patient had not been COVID tested post vaccination. The outcome of the event flank pain was recovered in Feb2021, outcome of the event disease recurrence was unknown and outcome of the other events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mouth swelling, Night sweats, Scratch
Clinical narrative: flank pain; chest discomfort; night sweat; headache; tired; severe back pain; Slight scratchiness; swelling at the very back of the roof of my mouth and the start of my throat within the 15 min; 1/30 back pain/1/31 tired/back pain,headache 2/1 back pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN5318) via an unspecified route of administration in left arm on 28Jan2021 at 11:00 as unknown single dose for COVID-19 immunization at Clinic. Medical history included inflammatory arthritis, migraine headaches, spinal stenosis, sciatica, tinnitus. Patient previously took trazodone and experienced allergies with trazadone. Concomitant medications included acyclovir [aciclovir], amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), aspirin [acetylsalicylic acid], clarithromycin (CLARITIN [CLARITHROMYCIN]), topiramate (TOPAMAX). Patient did not receive any other vaccine in four weeks. Patient was not pregnant at the time of vaccination. Patient was not diagnosed COVID prior vaccination. On 28Jan2021, patient experienced slight scratchiness, swelling at the very back of the roof of my mouth and the start of my throat within the 15min. of administration. On 29Jan2021 (next day) at 03:00 AM, patient experienced headache, tired, severe back pain. On 30Jan2021, patient experienced back pain, chest discomfort, night sweat, no fever. On 31Jan2021, patient experienced tired, back pain, headache. On 01Feb2021, back pain, flank pain. No treatment was received for the adverse events. Patient had not been COVID tested post vaccination. The outcome of the event flank pain was recovered in Feb2021, outcome of the event disease recurrence was unknown and outcome of the other events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Lymphadenopathy, Tenderness
Clinical narrative: Swollen axillary lymph nodes for 2+ weeks; Low energy; Tender arm; This is a spontaneous report from a contactable Health Care Professional (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route, administered in Arm Left on 22Jan2021 at 13:15 PM (age of 30-year-old at vaccination) as a 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and known allergies were reported as none. The patient's concomitant medications included collagen, ibuprofen and ascorbic acid/biotin/calcium pantothenate/cyanocobalamin/folic acid/nicotinic acid/pyridoxine hydrochloride/riboflavin/thiamine hydrochloride/tocopheryl acetate (MULTIVITAMIN). The patient did not have Covid-19 prior to vaccination. The patient was Vaccinated at  facility. The patient was not on any other vaccine 4 weeks prior to Covid-19 vaccination. On 24Jan2021 at 08:30 AM, the patient experienced swollen axillary lymph nodes for 2 plus weeks, low energy, tender arm. The patient was not tested for Covid-19 post vaccination. The patient had visited physician office. It was unknown if patient received treatment medication for the resulted events. The outcome of the event swollen axillary lymph nodes was recovered on any unknown date in 2021 and outcome of other events was unknown.  This follow-up was being submitted to notify that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Therapeutic response unexpected
Clinical narrative: sore arm; After the vaccine, she noticed an improvement of her Rheumatoid arthritis symptoms. She felt like she didn't have Rheumatoid Arthritis anymore.; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Not Provided), via an unspecified route of administration on an unspecified date as 1st Dose, Single Dose and dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Not Provided), via an unspecified route of administration on an unspecified date as 2nd Dose, Single Dose. The patient's Medical history included ongoing rheumatoid arthritis. She had to suspended all of her biological medications for her Rheumatoid Arthritis to get the vaccines. She has had Rheumatoid arthritis for a couple of years. She does have Rheumatoid arthritis, and after the COVID 19 vaccine , she noticed an improvement of her Rheumatoid arthritis symptoms. Concomitant medications included methotrexate (METHOTREXATE) taken for an unspecified indication, infliximab (REMICADE) taken for an unspecified indication. After both the doses of vaccination, the patient experienced sore arm. After the vaccine, she noticed an improvement of her Rheumatoid arthritis symptoms. She felt like she didn't have Rheumatoid Arthritis anymore.She doesn't know if it stimulated an immuno-regulation of the t suppresser cells or what. She hasn't felt this good even when she has flare ups, and is on steroids. She felt like she didn't have Rheumatoid Arthritis anymore. She had no joint hurting or stiffness. She felt good for about a week. Then her symptoms of Rheumatoid Arthritis came back. It was weird that she saw so much improvement for a week after the vaccine. It happened after both doses. The outcome for the events was Unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Oxygen saturation, Rash, Rash papular
Clinical narrative: little red bumps/ hand over her wrists, you could feel the bumps; Minor rash on back of her hand and wrists; This is a spontaneous report from a contactable consumer (patient, self-reported). A 69-year-old female patient (age at vaccination: 69 year) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9262 and expiry date was not reported), via an unspecified route of administration, in Deltoid Right (upper arm), on 30Jan2021, as a single dose for COVID-19 immunization. The patient's medical history included ongoing lymphoma and leukemia from Jul2018 and fungal lung infection, valley fever, coccidioidomycosis from Sep2020 (Stated she was still taking medicine, it can take over a year for fungus to go away, it is very recalcitrant). Concomitant medications were not reported. The patient reported that she got blood work regularly (unknown result). The patient reported that she got the COVID 19 vaccine, first one on 30Jan2021, at the (Vaccine facility name), afterwards she had a minor rash on wrists, they kept her for an hour to observe, she had no other symptoms, just the rash, it didn't itch, it was slightly on the back of her hand and wrists, and they said if she got the second dose, the reaction could be more severe, she didn't know to get it and take the risk, she was almost 70, and was cautious about being 55% protected with one dose. She talked to her doctor and was told it was up to her. She was calling to ask, it said in the handout, if you have severe allergic reactions you shouldn't, but this wasn't severe, it was mild, a localized rash on both wrists, and she wanted to get the second, she did have other health problems. She went through the clinic, it took a half hour, and she got out to the truck and was going to put on hand sanitizer but didn't, she noticed the rash on her wrists and went back in and told them, they kept her another hour, took her blood pressure, oxygen and what not, and she was fine, had no symptoms, and they said the county may not give her another vaccine, if she got the second she could have a more severe allergic reaction. She was trying to weigh the risk of being about 50% protected versus a severe reaction. There was a hospital about 3 blocks away from the clinic. The rash went away, she was fine now, she had it Saturday, Sunday, into Monday, it went away Tuesday, it was slightly up the back of her hand and both wrists, little red bumps, she didn't itch or anything, but if you ran your hand over her wrists, you could feel the bumps. Vaccine card said to get second dose by 20Feb2021, 3 weeks later. Outcome of the event minor rash on back of her hand and wrists was recovered on 02Feb2021 and for another event, it was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: The lymph nodes along my neck are swollen; This is a spontaneous report from a contactable pharmacist (patient). A 35-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3246) on 11Jan2021 15:00 (at the age of 35-year-old) via an unspecified route of administration, administered in arm left as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included none. Patient had no allergies. Patient had COVID prior vaccination. Patient's concomitant medications were not reported. Patient has not received any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL0140) on 21Dec2020 15:00 (at the age of 35-year-old) via an unspecified route of administration, administered in arm left as 1ST DOSE, SINGLE for COVID-19 immunization. On 18Jan2021 12:00, the patient's lymph nodes along the neck were swollen. Patient did not receive any treatment for the adverse event. The patient underwent lab tests and procedures which included Nasal swab (PCR): negative on 23Jan2021. Outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Eye irritation, Eye swelling, Insomnia, Investigation
Clinical narrative: Eye was being irritated to blink or rub it; Is still able to see, but is very blurry; Felt like someone was scratching her eye with sandpaper; It woke her out of her sleep; Eye swelled up; White of her eye was red as if she had pink eye; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 27Jan2021 as SINGLE DOSE for covid-19 immunisation. Medical history included allergies, sinus drain through her nose and eyes will dry out (no, allergies and sinus drain through her nose and her eyes will dry out. Dr. said that was not the cause.). There was no corneal abrasion. She has no pink eye. It was very irritated and swollen.  Historical vaccine included BNT162B2 for COVID-19 immunisation (Received both doses in her right arm).  There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for COVID-19 Since the vaccination. On 28Jan2021, 1 Day after vaccination the patient experienced eye swelled up and white of her eye was red as if she had pink eye. On an unspecified the patient experienced eye was being irritated to blink or rub it and was still able to see, but was very blurry, felt like someone was scratching her eye with sandpaper, it woke her out of her sleep. Only blurry when the light would hit it. She put hot towels on it. White of her eye was almost puffing out and white of her eye was red as if she had pink eye. On an unknown date, the patient underwent lab tests and procedures which included eye pressure (eye pressure was checked and was good) and eye stain with unknown results (eye stain to make sure it wasn't scratched). The patient went to eye doctor on Tuesday. Eye pressure was checked and was good. The patient took Prednisolone Acetate 1% (NDC: 60758-119-05, Lot: 91118PY, E89581 and Exp: May2023), one drop 4 times a day for ten and left eye. The patient had to get a steroid eye drop from the doctor on Tuesday. The outcome of events was unknown.  No follow-up attempts possible. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Vision blurred
Clinical narrative: Eye was being irritated to blink or rub it; Is still able to see, but is very blurry; Felt like someone was scratching her eye with sandpaper; It woke her out of her sleep; Eye swelled up; White of her eye was red as if she had pink eye; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 27Jan2021 as SINGLE DOSE for covid-19 immunisation. Medical history included allergies, sinus drain through her nose and eyes will dry out (no, allergies and sinus drain through her nose and her eyes will dry out. Dr. said that was not the cause.). There was no corneal abrasion. She has no pink eye. It was very irritated and swollen.  Historical vaccine included BNT162B2 for COVID-19 immunisation (Received both doses in her right arm).  There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for COVID-19 Since the vaccination. On 28Jan2021, 1 Day after vaccination the patient experienced eye swelled up and white of her eye was red as if she had pink eye. On an unspecified the patient experienced eye was being irritated to blink or rub it and was still able to see, but was very blurry, felt like someone was scratching her eye with sandpaper, it woke her out of her sleep. Only blurry when the light would hit it. She put hot towels on it. White of her eye was almost puffing out and white of her eye was red as if she had pink eye. On an unknown date, the patient underwent lab tests and procedures which included eye pressure (eye pressure was checked and was good) and eye stain with unknown results (eye stain to make sure it wasn't scratched). The patient went to eye doctor on Tuesday. Eye pressure was checked and was good. The patient took Prednisolone Acetate 1% (NDC: 60758-119-05, Lot: 91118PY, E89581 and Exp: May2023), one drop 4 times a day for ten and left eye. The patient had to get a steroid eye drop from the doctor on Tuesday. The outcome of events was unknown.  No follow-up attempts possible. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Sinus disorder, Vital signs measurement
Clinical narrative: had site injection soreness like last time; issues with her sinuses; headache; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982), via an unspecified route of administration on 13Jan2021, (at the age of 48-year-old) as single dose for COVID-19 immunization. The patient's medical history included type 2 diabetes mellitus which was diagnosed probably more than 10 years, hypertension for which she was taking high blood pressure medication for 5-6 years and sleep apnoea syndrome. Consumer says they have had no other recent vaccinations or new medications. After the first dose of vaccine patient had injection site soreness. Patient had a headache prior to getting her second dose of the vaccine, as she had issues with her sinuses, so she took medicine before getting the second dose of vaccine because she assumed it was sinuses. There was no further details provided about medication she took for her sinuses. The patient underwent lab tests and procedures which included blood cholesterol was normal, blood glucose abnormal was normal, blood pressure measurement was normal. The patient received unspecified medication for the headache and sinus. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Vaccination site pain
Clinical narrative: doesn't feel anything and is unsure if the  medication was injected in his body; has a little pain at injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 13Feb2021 16:30 (age at vaccination was 63 years) (Batch/Lot Number: EL9269) as 2nd dose, single at hospital for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. On an unspecified date after the vaccination the patient did not felt anything, he did not feel the needle, and was unsure if the medication was injected in his body and he also had a little pain at injection site. Patient did not receive any treatment to events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the reporter stated that, patient was allergic to the vaccine and has been advised to not take the second dose. The reporter asked that If a person doesn't take the second dose of the Covid vaccine, is it harm to the body. The reporter stated that was watching the show, Expert, which is a Christian program, and they were stating that the vaccine takes away the ability of the placenta. The reporter heard that 99% of people get over the Covid virus.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: Extra runny nose causing sore throat; Extra runny nose causing sore throat; Muscle aches all over; Slightly upset stomach; Chills; tiredness; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Feb2021 at 08:45 as single dose for Covid-19 immunization. The patients medical history included ongoing Diabetes type 2, prostate cancer from 2004 to an unknown date and treated with radiation (since, undetected) and allergies to sulfa from an unknown date and unknown if ongoing. The patient did not have Covid prior vaccination and did not take any other vaccine in four weeks. The patient's concomitant medications were not reported. On 03Feb2021 at 15:00, the patient had extra runny nose causing sore throat, muscle aches all over, slightly upset stomach, chills, and tiredness. The patient was not covid tested post vaccination. No treatment received for the reported adverse events. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Extra runny nose causing sore throat; Extra runny nose causing sore throat; Muscle aches all over; Slightly upset stomach; Chills; tiredness; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Feb2021 at 08:45 as single dose for Covid-19 immunization. The patients medical history included ongoing Diabetes type 2, prostate cancer from 2004 to an unknown date and treated with radiation (since, undetected) and allergies to sulfa from an unknown date and unknown if ongoing. The patient did not have Covid prior vaccination and did not take any other vaccine in four weeks. The patient's concomitant medications were not reported. On 03Feb2021 at 15:00, the patient had extra runny nose causing sore throat, muscle aches all over, slightly upset stomach, chills, and tiredness. The patient was not covid tested post vaccination. No treatment received for the reported adverse events. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Lymphadenopathy, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Left foot tingling; Tongue and nose numb; Tongue and nose numb; Lymph node was very swollen; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 33-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in right arm on 28Jan2021 at 12:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. No known allergies. Concomitant medications included escitalopram, birth control; Both received within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. No COVID prior vaccination. The patient has been tested for COVID post vaccination. On 28Jan2021 at 12:00, the patient experienced left foot tingling, tongue, and nose numb, lymph node was very swollen. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test and procedure which included rapid nasal swab: Negative on 02Feb2021. No treatment medications was received for the adverse events. The outcome of the events was not recovered.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This was 1st of two reports. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter was reporting that he had a delayed reaction to the COVID vaccine. He saw his allergist and primary care provider. The primary care informed him that she had 2 other patients who this has happened with and they had rashes. Unable to provide any further details about the 2 other patients. The outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162064 Same reporter/ product/ event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This was 2nd of two reports. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter was reporting he had a delayed reaction to the COVID vaccine. He saw his allergist and primary care provider. The primary care informed him that she had 2 other patients who this has happened with and they had rashes. Unable to provide any further details about the 2 other patients. The outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : Same reporter/ product/ event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Joint range of motion decreased, Limb discomfort, Salivary hypersecretion
Clinical narrative: 45 min after the vaccine, she started salivating/mouth was just watering; 1.5 hours after the vaccine, she did actually vomit/pretty violent vomiting episode; Felt like her body was extremely heavy; Limbs feel heavy; She doesn't feel normal; Arm was hurting her quite a bit at the injection site; Hard to lift up her arm without pain. Which was limiting her full range of motion; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Patient has been experiencing some symptoms. She was wondering if it was a part of the vaccine or something else. She also had an episode after getting the vaccine, probably 45 min after the vaccine, she started salivating. She wasn't really nauseated, but her mouth was just watering. She felt like she was going to vomit but didn't vomit in that incidence. Then, 1.5 hours after the vaccine, she did actually vomit. She had a pretty violent vomiting episode. She was now having, not body pains, but it felt like her body was extremely heavy. Her limbs feel heavy. She doesn't feel normal. She was curious if this was a side effect from it. Her arm was hurting her quite a bit at the injection site. It was hard to lift up her arm without pain. Which was limiting her full range of motion. She was kind of wondering if this was common side effects of the vaccine. Or was this something that was brewing. Was something immediately supposed to happen, and to be happening 14 hours after the vaccination. The outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: 45 min after the vaccine, she started salivating/mouth was just watering; 1.5 hours after the vaccine, she did actually vomit/pretty violent vomiting episode; Felt like her body was extremely heavy; Limbs feel heavy; She doesn't feel normal; Arm was hurting her quite a bit at the injection site; Hard to lift up her arm without pain. Which was limiting her full range of motion; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Patient has been experiencing some symptoms. She was wondering if it was a part of the vaccine or something else. She also had an episode after getting the vaccine, probably 45 min after the vaccine, she started salivating. She wasn't really nauseated, but her mouth was just watering. She felt like she was going to vomit but didn't vomit in that incidence. Then, 1.5 hours after the vaccine, she did actually vomit. She had a pretty violent vomiting episode. She was now having, not body pains, but it felt like her body was extremely heavy. Her limbs feel heavy. She doesn't feel normal. She was curious if this was a side effect from it. Her arm was hurting her quite a bit at the injection site. It was hard to lift up her arm without pain. Which was limiting her full range of motion. She was kind of wondering if this was common side effects of the vaccine. Or was this something that was brewing. Was something immediately supposed to happen, and to be happening 14 hours after the vaccination. The outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.