chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: extremely bitter taste in the back of mouth on tongue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220547604 (Janssen).  A 27-year-old male patient received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (booster), single) (Lot number: GA1188) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE, start date: Jul2020; AMLODIPINE BESILATE, start date: Mar2022; ALKA SELTZER PLUS FLU, start date: 18May2022. Vaccination history included: moderna (DOSE 1, Manufacturer : Moderna Covid Vaccine, Lot Number:038A21A, administered on right arm on 11Mar2021 for prophylactic vaccination, dose number in series 1, Past drug history: Spikevax (Elasomeran)), administration date: 11Mar2021, when the patient was 26-year-old, for Covid-19 immunization; moderna (DOSE 2, Manufacturer : Moderna Covid Vaccine, Lot Number:046821A, second dose on 20Apr2021 for prophylactic vaccination, dose number in series 1, Past drug history: Spikevax (Elasomeran).), administration date: 20Apr2021, when the patient was 26-year-old, for COVID-19 immunization; janssen coviD-19 vaccine (Covid-19 vaccine ad26.Cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 20J12-03, and expiry: (Unknown) dose was not reported, 1 total administered on 21Dec2021,Causality as per reporter (Drug/Vaccine): Possible, Causality as per Mfr (Drug/Vaccine): Possible), administration date: 21Dec2021, when the patient was 27-year-old, for COVID-19 immunization, reaction(s): "Extreamly bitter taste in the back of tongue".  The following information was reported: DYSGEUSIA (non-serious) with onset 18May2022, outcome "not recovered", described as "extremely bitter taste in the back of mouth on tongue".  Additional information: It was unknown whether patient had any adverse events following vaccination with first two doses of Moderna (Spikevax) Covid-19 vaccine (Dose number in series 1). It was unknown whether patient had any adverse event following vaccination with first dose of covid-19 vaccine and ad26.Cov2.s (Dose number in series 2). On 18May2022, the patient experienced extremely bitter taste in the back of mouth on tongue, similar to bitter grapefruit. It woke patient up several times throughout the night (Dose number in series 3). This report was non-serious.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: chills; headache; muscle aches; intense fatigue; This is a spontaneous report received from a contactable reporter(s) (Physician).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Aug2021, for COVID-19 immunization, reaction(s): "Chills", "intense fatigue", "Headache", "muscle aches". The following information was reported: CHILLS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021); HEADACHE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021); FATIGUE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "intense fatigue"; MYALGIA (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "muscle aches". It was unknown if therapeutic measures were taken as a result of chills, headache, myalgia, fatigue. Additional information: It was unknown whether the patient had any medical history or known allergies. It was unknown whether the patient had other vaccine in four weeks and other medications in two weeks. The patient had no COVID prior vaccination and had not been COVID tested post vaccination. The patient had experienced similar symptoms 1 day after each of the two doses of Pfizer vaccine that lasted only for 1 day each during her primary vaccination sequence of dosing. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Fatigue, Limb discomfort, Pruritus, Somnolence
Clinical narrative: dead arm; tired and sleepy for about 4-5 days; tired and sleepy for about 4-5 days; The first shot gave me severe itching on the third day; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 46-year-old female patient received BNT162b2 (BNT162B2), on 21Dec2020 at 17:00 as dose 1, single (Lot number: EJ1685) at the age of 45 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: Oct1997 (ongoing); "Migraine", start date: 2000 (ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE] taken for asthma (ongoing); RIZATRIPTAN oral taken for migraine (ongoing). The following information was reported: PRURITUS (non-serious) with onset 24Dec2020, outcome "unknown", described as "The first shot gave me severe itching on the third day"; LIMB DISCOMFORT (non-serious), outcome "recovered", described as "dead arm"; SOMNOLENCE (non-serious), FATIGUE (non-serious), outcome "recovered" and all described as "tired and sleepy for about 4-5 days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received second dose of BNT162b2 (Lot Number: EL1283) on 10Jan2021 at 07:00 in left deltoid. No other vaccinations were given within four weeks prior to the first administration date of the suspect vaccine. It was reported that the second shit almost killed her. She Experienced a blinding headache within the hour of administration. It was so severe she had to leave work. Headache was so bad she passed out at home. Had vomiting and diarrhea for 7 day straight, fever 6 days. she had developed a third boost under her arm pit. The headache is everyday all day, depending on how hectic her day that's how big her headache will be. she had terrible allergies joint pain and a nose drip with clear discharge that will not cease.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to arthropod bite, Chills, Hepatic steatosis, Lymphadenopathy, Pain
Clinical narrative: Psoriatic Arthritis Flare Up; Fatty Liver; Pain on Right Side; Allergic to Spider Bites; Swollen Lymph Nodes in Left Under Arms; Slight Fever; Chills; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4423021-00 (Agency).  A 36-year-old female patient received BNT162b2 (BNT162B2), on 20Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 13Apr2022 (ongoing) (Batch/Lot number: unknown) subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Route of administration: Intramuscular), administration date: 20Mar2021, when the patient was 34-year-old, for covid-19 immunization; BNT162b2 (Dose 2, Route of administration: Intramuscular), administration date: 20Apr2021, when the patient was 34-year-old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021); PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Slight Fever"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "Swollen Lymph Nodes in Left Under Arms"; PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Psoriatic Arthritis Flare Up"; HEPATIC STEATOSIS (non-serious), outcome "not recovered", described as "Fatty Liver"; PAIN (non-serious), outcome "unknown", described as "Pain on Right Side"; ALLERGY TO ARTHROPOD BITE (non-serious), outcome "not recovered", described as "Allergic to Spider Bites".  The reporter's causality for the event of first booster caused swollen lymph nodes in left under arms, second booster caused sore arm on right side, allergic to spider bites, Pfizer vaccinations caused slight fever and chills for six to eight hours onset in 2021, fatty liver, Pfizer vaccinations caused slight fever and chills for six to right hours onset in 2021 and pain on right side with Humira (Adalimumab) was no reasonable possibility.  Causality for events Swollen lymph nodes, Vaccination site pain, Insect bite allergy, Chills, Fatty liver, Fever, Psoriatic arthritis aggravated and Pain localized with the suspect product(s) BNT162b2 was not provided at the time of this report.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on available information and known profile of the Comirnaty vaccine  ,the reported events of Pyrexia, Chills and Lymphadenopathy   were assessed as related to the  Comirnaty vaccine.  Based on the information provided by the reporter, it appears unlikely that suspect drug contributed to the reported  events Psoriatic arthritis aggravated, Hepatic steatosis , Pain and Allergy to arthropod bite .
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy, Pyrexia
Clinical narrative: Psoriatic Arthritis Flare Up; Fatty Liver; Pain on Right Side; Allergic to Spider Bites; Swollen Lymph Nodes in Left Under Arms; Slight Fever; Chills; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4423021-00 (Agency).  A 36-year-old female patient received BNT162b2 (BNT162B2), on 20Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 13Apr2022 (ongoing) (Batch/Lot number: unknown) subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Route of administration: Intramuscular), administration date: 20Mar2021, when the patient was 34-year-old, for covid-19 immunization; BNT162b2 (Dose 2, Route of administration: Intramuscular), administration date: 20Apr2021, when the patient was 34-year-old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021); PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Slight Fever"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "Swollen Lymph Nodes in Left Under Arms"; PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Psoriatic Arthritis Flare Up"; HEPATIC STEATOSIS (non-serious), outcome "not recovered", described as "Fatty Liver"; PAIN (non-serious), outcome "unknown", described as "Pain on Right Side"; ALLERGY TO ARTHROPOD BITE (non-serious), outcome "not recovered", described as "Allergic to Spider Bites".  The reporter's causality for the event of first booster caused swollen lymph nodes in left under arms, second booster caused sore arm on right side, allergic to spider bites, Pfizer vaccinations caused slight fever and chills for six to eight hours onset in 2021, fatty liver, Pfizer vaccinations caused slight fever and chills for six to right hours onset in 2021 and pain on right side with Humira (Adalimumab) was no reasonable possibility.  Causality for events Swollen lymph nodes, Vaccination site pain, Insect bite allergy, Chills, Fatty liver, Fever, Psoriatic arthritis aggravated and Pain localized with the suspect product(s) BNT162b2 was not provided at the time of this report.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on available information and known profile of the Comirnaty vaccine  ,the reported events of Pyrexia, Chills and Lymphadenopathy   were assessed as related to the  Comirnaty vaccine.  Based on the information provided by the reporter, it appears unlikely that suspect drug contributed to the reported  events Psoriatic arthritis aggravated, Hepatic steatosis , Pain and Allergy to arthropod bite .
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Dysphagia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient), program ID: (005570). A female patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the COVID-19 vaccine (primary immunization series complete; manufacturer uknown), for COVID-19 immunization. The patient experienced dysphagia and aphasia, with outcome of unknown. Additional information: She wanted to know if she can have the Paxlovid pill or not. She mentioned on Monday she was not able to talk or swallow. She recently took her Pfizer COVID-19 vaccine shots 2 weeks ago. The symptoms occurred 2 weeks after taking the COVID-19 vaccine booster shot. The medical inquiry was forwarded. Information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A 50-year-old female patient received the 4th dose (second booster) of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 3rd dose (first booster) of the COVID-19 vaccine and the COVID-19 vaccine (primary immunization series complete; manufacturer unknown), for immunization. The patient experienced pyrexia/fever, chills and vaccination site pain/injection site pain, with outcome of unknown. Additional information: Fever, chills and injection site pain occurred after second booster (4th dose). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: feel exhausted; have chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Comirnaty (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "feel exhausted"; CHILLS (non-serious), outcome "unknown", described as "have chills". The events "feel exhausted" and "have chills" required physician office visit.  Additional information: Reporter also mentioned that he and his wife were at the doctor's office all day. He was told by the doctor that people can feel like they have COVID after receiving the vaccine. He stated that after receiving their second Pfizer Covid-19 booster, they have chills and feel exhausted. He is not happy with Pfizer right now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200826818 same reporter, vaccine, event with different patients;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The only thing I have in the arm is that it hurts a little bit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary series immunization, Manufacturer unknown), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The only thing I have in the arm is that it hurts a little bit".  Additional information: Reporter stated, I just had a question. Yesterday I just took the last booster, think number 0524 (Consumer was unsure) at the and live in (Withheld) and a little while ago got bitten by a wasp and was going to put some Benadryl but wasn't sure if should mix Benadryl with my shot and do not know, can you advise me. When paraphrased the concern, reporter stated, No I had booster (Clarified as Pfizer COVID-19 Vaccine) yesterday and today a little while ago about 15 minutes ago a bee or wasp bit me on my back. So my question was can take Benadryl. You know how they say, take Benadryl when a bee bite you. Am I able to take Benadryl or I am going to upset the shot, whatever it is. When again paraphrased the concern, reporter stated, No because got bit my wasp or a bee I am not sure but it just bit me really quick like the bees do in my back. What wanted to do and want to take Benadryl because usually they say when you have a bite and had several bite before, take Benadryl but I didn't want to mix Benadryl with my shot from yesterday and don't know how long the liquid or whatever it is, the shot has. Reporter do not know how long that's going to be in the arm. The only thing had in the arm is that it hurts a little bit, just a little bit but I can handle that. Reporter stated, That's the number I called and they gave me you, The number you gave me is the one I called and I am taking to you. Reporter stated, don't have a computer that's why I am calling you on this phone. What number you want me to call but cannot call tomorrow and had to know today because just got bit today and I do not want to mix it up whatever the shot booster I had yesterday, because received it at noon and now it's just a little bit noon, it's 24 hours. All want to know is can I take this Benadryl.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6201) at the age of 53 years, in left arm and on 15Mar2021 as dose 2, single (Lot number: 7534), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Nov2021 as dose 3 (booster), single (Lot number: 032F21A), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: 056A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "morbid obesity" (unspecified if ongoing); "high blood pressure (mild and under control with medication)" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing). Concomitant medication(s) included: ASACOL, start date: Jan2002; VYVANSE, start date: Jan2016; LISINOPRIL; DESVENLAFAXINE; PRISTIQ; SPIRONOLACTONE; PRILOSEC [OMEPRAZOLE]; VITAMIN D [ERGOCALCIFEROL], vitamin B. Past drug history included: Lovonox, reaction(s): "Allergy"; Heparin, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.The patient received Paxlovid from 31May2022 to 05Jun2022 for the treatment of COVID-19.  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN6201 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of the complaint history for the reported lot. The final scope included the reported finished goods lot EN6201, fill lot EN5333, and the formulated drug product lot EN5322. A complaint sample was not returned, and photographs were not received. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "breast cancer" (unspecified if ongoing); "Shiitake mushrooms" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical course: Other medication in 2 weeks (Plaquenil). Patient received Anti-viral treatment for COVID-19 with Paxlovid from 06Jun2022 to 10Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 11May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [LEVOCABASTINE HYDROCHLORIDE], start date: 01Jun2010. Past drug history included: Levaquin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID-19"; COVID-19 (medically significant), outcome "unknown", described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL TARTRATE.  Clinical course: The patient stated she got the COVID vaccine (clarified as Pfizer Covid-19 vaccine) earlier today and she was like having chest pain right now. She did not know if it was like relation to it or should she just call emergency room right now or what she should do. Other medical condition: Consumer stated, "heart palpitation (Not appropriately clarified hence tab left unchecked)." Reassurance: Consumer stated, "No, she think that was it for now."   The following information was reported: CHEST PAIN (non-serious), outcome "unknown".  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Drug ineffective, SARS-CoV-2 test, Vomiting
Clinical narrative: took a covid test and the covid test came out positive; had 4 Pfizer shots and I've gotten the 2 regulars and the 2 boosters; took a covid test and the covid test came out positive; had 4 Pfizer shots and I've gotten the 2 regulars and the 2 boosters; I do have the vomiting; the diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Kidney condition" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "took a covid test and the covid test came out positive; had 4 Pfizer shots and I've gotten the 2 regulars and the 2 boosters"; VOMITING (non-serious), outcome "unknown", described as "I do have the vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "the diarrhea". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: took a covid test and the covid test came out positive. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Patient reported as they have received had 2 separate, had 2 different dosages (Unspecified medications), 2 specific medication dosage and she didn't know which one it would be for kidney condition or not. Had symptoms like covid for 3 days, 3 days prior to this, I wouldn't had got a chance till I tested positive for the covid. prescription that they have received they had 2 separate, they had 2 different dosages (name not clarified). Doctor prescribed and apparently somebody got the prescription that he will back in. nurse told her that it's the regime of 5 days and that it would be starting with the Pfizer pill. I guess and so, what the pharmacist told me was that they had 2 specific medication dosage and she didn't know which one it would be, one would be if there's a kidney condition and the other would be if not be kidney condition.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Negative, notes: tested positive again after having tested negative; Positive, notes: tested positive again after having tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medications in 2 weeks. The patient was treated with paxlovid for the events. Treatment start date was 22May2022 and stop date was 27May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  clinical course: The patient was not received other medication in 2weeks. Anti-viral details: treatment of COVID-19 included Paxlovid was started on 04Jun2022 and treatment stopped on 08Jun2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect BNT162B2 cannot be denied for the reported events.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, White blood cell count
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2021 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Low WBC" (unspecified if ongoing); "Idiopathic" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative; (09Jun2022) positive, notes: tested positive; White blood cell count: (unspecified date) Low. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was used for the treatment of covid-19 from 01Jun2022 to 05Jun2022, lot number: FX2741. Did not experience any known allergies. The patient did not received other medication in 2weeks. The patient has no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: 2 days later while rinsing my hair, a clump of hairs came out in my hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE), administration date: 31Mar2021, for COVID-19 immunization, reaction(s): "hair started to fall out at an alarming rate"; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "2 days later while rinsing my hair, a clump of hairs came out in my hand".  Additional information: Patient got 2nd dose of the Pfizer on 31Mar2021. Starting in Apr2021 patient noticed hair started to fall out at an alarming rate. Patient had since lost 50 % of my hair mass. patient got my 2nd booster on 27May. On Sunday 2 days later while rinsing my hair, a clump of hairs came out in my hand. Was there a treatment to counteract the effects of the vaccine that causes hair loss.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: (I have 3 shot of your vaccine). /I get Covid 19 and my primary doctor prescribe me Paxlovid; (I have 3 shot of your vaccine). /I get Covid 19 and my primary doctor prescribe me Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and legal division. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "(I have 3 shot of your vaccine). /I get Covid 19 and my primary doctor prescribe me Paxlovid". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: I get Covid 19 and my primary doctor prescribe me Paxlovid 2x150mg 100mg (EUA) QTY: 30 (LOT:FX4465) EXP 31Jan2023. On 3rd day I have to stop take the pills because I fell like poison on my body, I felt intoxicated), and my eyes like fire l and too much bitter on my mouth and vomiting. I call your facilities on (withheld) and talk with Nurse of Medical Department and explain the situation. I try to make a claim  but I can't communicate with that Department. (I have 3 shot of your vaccine).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid; covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 at 09:00 as dose 1, single (Lot number: EN6200), in left arm, on 12Apr2021 at 09:15 as dose 2, single (Lot number: EP7588), in left arm and on 11Nov2021 at 09:15 as dose 3 (booster), single (Lot number: 8020) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Meniere's" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim"; Levaquin, reaction(s): "known allergies: Levaquin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative, notes: Took paxlovid 29May2022 for covid.and tested negative one week later; (12Jun2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: No other medication in 2 weeks. Took paxlovid 29May2022 for covid. She took paxlovid on 31May2022 till 04Jun2022 and tested negative one week later. 12Jun2022 tested positive again.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My wife and I both had all the vaccinations Pfizer offered and all the boosters from Pfizer offered./Pfizer however they were positive with Covid19, he and his wife; My wife and I both had all the vaccinations Pfizer offered and all the boosters from Pfizer offered./Pfizer however they were positive with Covid19, he and his wife; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "My wife and I both had all the vaccinations Pfizer offered and all the boosters from Pfizer offered./Pfizer however they were positive with Covid19, he and his wife". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  Clinical course: The was fully vaccinated with Pfizer (COVID-19 Vaccine); still got positive with Covid. This report is related to a study or program. The patient was also the reporter. He was a patient and he was calling to ask if there was a correlation between Paxlovid and all of the vaccination they received. He mentioned that he was fully vaccinated with Pfizer however they were positive with Covid19, he and his wife. What was the correlation between Pfizer vaccinations and boosters My wife and I both had all the vaccinations Pfizer offered and all the boosters from Pfizer offered? What is the correlation between Paxlovid and all the vaccinations we had from Pfizer." The Correlation between Paxlovid and all the other vaccination that he received that was his exact question. All the vaccination he has received, he mentioned that he is fully vaccinated with Pfizer (Later clarified as COVID-19 Vaccine hence captured as suspect and manufacturer checked Yes for Pfizer) and they still got positive with Covid.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200836871 Same reporter/drug/AE, different patient;
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose number unknown , single (Batch/Lot number: unknown), in left arm, on 25Mar2021 as dose number unknown , single (Batch/Lot number: unknown), in left arm, on 28Sep2021 as dose number unknown , single (Batch/Lot number: unknown), in left arm and on 17Mar2022 as dose number unknown , single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SIMVASTATIN; PANTOPRAZOLE (other medication in 2weeks). There was no known allergies.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 30Mar2022, outcome "unknown", COVID-19 (medically significant) with onset 30Mar2022, outcome "not recovered" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Mar2022) Positive; (07Apr2022) Negative; (13Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient was Tested positive for Covid 30Mar2022, and immediately began treatment with Paxlovid. Tested negative 8 days later. Symptoms returned 12Jun and tested positive morning of 13Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound case of COVID.  Symptoms and positive tests ended on day 7.  New symptoms and positive tests began on day 12.; Rebound case of COVID.  Symptoms and positive tests ended on day 7.  New symptoms and positive tests began on day 12.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Lisinopril for high blood pressure, notes: high blood pressure treated with Lisinopril. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jun2022, outcome "not recovered" and all described as "Rebound case of COVID.  Symptoms and positive tests ended on day 7.  New symptoms and positive tests began on day 12.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (13Jun2022) Positive, notes: Rebound case of COVID. Symptoms and positive tests ended on day 7. New symptoms and positive tests began on day 12; (Jun2022) Positive, notes: Rebound case of COVID. Symptoms and positive tests ended on day 7. New symptoms and positive tests began on day 12. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Peripheral numbness feet, legs; tingling in hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EN6200), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pancreatic cancer" (unspecified if ongoing); "Shellfish" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VIT D3; ASPIRIN [ACETYLSALICYLIC ACID]; PANTOPRAZOLE. Vaccination history included: Bnt162b2 (lot number=EL9261, Other vaccine same date vaccine date=20May2022, dose 1, single, location=Right arm.), for Covid-19 Immunization, reaction(s): "Peripheral numbness feet, legs", "tingling in hands". The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Peripheral numbness feet, legs"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling in hands".  Additional information: Peripheral numbness feet, legs and tingling in hands. Started after first dose but didn't equate it with vaccine until after the most recent booster. Initially in left foot/leg only about two three weeks after shot. A week after the 4th booster my right foot/leg and fingers were affected and right leg worse. Then connected the dots from beginning.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia, Vomiting
Clinical narrative: low grade fever; muscle aches; vomiting all night; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jun2022 at 10:15 as dose 4 (booster), single (Lot number: Fp7135) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ms" (unspecified if ongoing); "chronic kidney disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "hasimotos thyroid" (unspecified if ongoing); "known allergies: Erythromycin" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LOSARTIN; LEVOTHYROXINE; B12 [CYANOCOBALAMIN]; D3; PRILOSEC [OMEPRAZOLE], 83 (as reported). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: En6202, Location of administration: Right arm), administration date: 28Feb2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: En6204, Location of administration: Right arm), administration date: 21Mar2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE , Lot number: 30130aa, Location of administration: Right arm), administration date: 04Oct2021, when the patient was 68-year-old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 11Jun2022 at 12:00, outcome "recovered" (Jun2022); PYREXIA (non-serious) with onset 11Jun2022 at 12:00, outcome "recovered" (Jun2022), described as "low grade fever"; MYALGIA (non-serious) with onset 11Jun2022 at 12:00, outcome "recovered" (Jun2022), described as "muscle aches"; VOMITING (non-serious) with onset 11Jun2022 at 12:00, outcome "recovered" (Jun2022), described as "vomiting all night". Therapeutic measures were not taken as a result of pyrexia, myalgia, vomiting, fatigue.  Additional information: The facility type vaccine was Pharmacy or Drug Store. The patient had not received any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19.