chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer / BioNTech: 26Mar2021, 19Apr2021; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: 26Mar2021, 19Apr2021; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 19Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "attention deficit disorder" (unspecified if ongoing); "History of severe bronchitis" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). No known allergies were reported Concomitant medication(s) included: DEXTROAMPHETAMINE [DEXAMFETAMINE], start date: 05Apr2022, stop date: 15May2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Pfizer / BioNTech: 26Mar2021, 19Apr2021; Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound of COVID symptoms and positive COVID-19 test after taking a full course of Paxlovid; Negative, notes: testing negative form several days. Therapeutic measures were taken as a result of vaccination failure, covid-19. The Anti-viral Paxlovid was given to patient and the treatment was started on 16May2022 and stopped on 21May2022 for treatment of COVID-19  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Member was given an un-diluted Pfizer booster vaccine.  Mother of patient was contacted on 10/27.  Parent reported soreness to the injection site but did not report any other adverse reactions.  A telephone appointment was schedule for a follow up with the primary doctor.
Hives/red welts/Location of hive reaction: arms, especially my right arm, stomach and knee joints; itching/Itching is all over body; rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 17:30 as dose 1, single (Lot number: GH9693) at the age of 71 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Sep2022 as dose 1, single (Lot number: GH9693) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "High cholesterol" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 19Sep2022 as dose 1, single. The following information was reported: URTICARIA (non-serious) with onset 02Oct2022 at 04:00, outcome "not recovered", described as "Hives/red welts/Location of hive reaction: arms, especially my right arm, stomach and knee joints"; PRURITUS (non-serious) with onset 02Oct2022 at 04:00, outcome "not recovered", described as "itching/Itching is all over body"; RASH (non-serious) with onset 02Oct2022 at 04:00, outcome "not recovered". Therapeutic measures were not taken as a result of urticaria, pruritus, rash.
Stabbing pain; got scared; Sharp pain under the right breast; Arm hurt; Side headache; Anxiety; Felt like her chest was jumping; Felt weak; This is a spontaneous report from a contactable consumer (patient). A 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 20Feb2021 (at the age of 82-years-old) as dose 1 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 21Feb2021 on sunday the patient developed sharp pain under the right breast and got scared. On an unspecified date in Feb2021, patient arm was hurting, got a side headache, got anxiety because she felt like her chest was jumping and laid down and she felt weak. It was reported that on 22Feb2021 she got another stabbing pain but not like the other one. Patient wanted to know if she should go get checked or if it was a part of it. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
About 20 hours after receiving my 2nd Moderna vaccination for COVID-19, I began to feel lethargic.  Since I had read of others' reactions, I decided to rest.  Early in my rest, I had chills for about 15 minutes, which subsided after I had warmed up under the covers.  I then FELT a bit feverish, but did not take my temperature.  24 hours after these symptoms first appeared, almost all of which were spent in bed, I felt back to normal.
Treatment of COVID-19; Treatment of COVID-19; 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 03Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive any other medications within two weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I was advised to fill out the Adverse Event form.   I do not think my issue is directly related to the vaccine. I developed increased flu like symptoms (before) and after the vaccination. 6 days after the injection, I was advised to take a Covid-19 antigen self test prior to doctors apt. This test on 11=8-2022, and a followup 24hr later on 11-9-2022 both indicated a Positive Covid-19 infection. I was prescribed and (just) finished a 5 day dose of Paxlovid  Flu like symptoms have reduced. Other Covid-19 related symptoms have been mild or not present at this point. My main concern is Long Term Covid and will follow up on reporting as requested by CDC.
This spontaneous report as received from the Nurse practitioner, refers to an unspecified number of patients (reported as children) of unknown age and gender, with no pertinent medical history reported. On unspecified dates the patients were vaccinated with different lots of MMR II (lot number and expiration dates not reported) (dose and route not reported). The Nurse stated that a facility had MMR II that had multiple above temperature excursions with different lots of MMR II. The nurse reported that an unspecified number of children were vaccinated with these vaccines. No adverse effects were reported at that time. Additional information has been requested.
vaccine administration date=16Nov2021; Covid positive; vaccine administration date=16Nov2021; Covid positive; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 61 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: "Hypertension" (unspecified if ongoing); "Known allergy: Tree nut" (unspecified if ongoing); "Known allergy: shellfish" (unspecified if ongoing); "Known allergy: Latex" (unspecified if ongoing); "Known allergy: Sulfa" (unspecified if ongoing); "Known allergy: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; CITALOPRAM; ASPIRIN [ACETYLSALICYLIC ACID]; BIOTIN; CETIRIZINE; VITAMIN D [COLECALCIFEROL]; FISH OIL. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin"; Lidocaine, reaction(s): "Known allergy: Licocaine". The following information was reported: COVID-19 (medically significant) with onset 02May2022 at 14:00, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "vaccine administration date=16Nov2021; Covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Adverse event: Covid positive and started on Paxlovid for 5 days immediately as described above. 3 days after completing paxlovid started with covid symptoms again retested and is positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported event Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Patient was walking down the hall after her vaccine and felt dizzy/lightheaded. Patient stated the thought of needles/blood does this to her and has happened before. Patient was assisted to a chair where she lost consciousness briefly and became very pale and diaphoretic. Patient regained consciousness and was evaluated by EMS prior to returning to work.
Husband called stating pt was experiencing "Significant chest pain." Instructed him to seek immediate emergency medical care  for her as that could be a sign of a blood clot.
Dizziness upon getting out of bed. Came in waves during tiredness during day, very unsteady when walking. Used a cane for steadiness. Lasted for 4 days.
Flushing of skin, dizziness, feeling weak. After 30 minutes of observation stiffness of the neck.
Getting COVID After the Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Getting COVID After the Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Getting COVID After the Vaccine). At the time of the report, COVID-19 (Getting COVID After the Vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. No treatment was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up is added. No new information was reported. On 29-May-2021: No new information was reported.
First dose / on 2007 and went to the facility to have his second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 40-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix with an associated reaction of no adverse event (1st dose received in 2007).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. The twinrix second dose was not given as the health care professional did not want to administer the patient because the information he read in the Twinrix PI The reporter consented to follow up. Pharmacist asked information for this case.
felt like I was hit by a bus; ache started in my mouth; ache started in my mouth, then face; ache started in my mouth, then face, head; ache started in my mouth, then face, head, and the rest of my body.; pain starting in my lower right jaw is extremely painful; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th February 2020, the patient received Shingrix. On 11th February 2020, 1 days after receiving Shingrix, the patient experienced feeling abnormal, oral pain, facial pain, headache, general body pain and jaw pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the feeling abnormal, oral pain, facial pain, headache, general body pain and jaw pain were unknown.   It was unknown if the reporter considered the feeling abnormal, oral pain, facial pain, headache, general body pain and jaw pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for self. The age at vaccination was not reported. The patient received shingrix vaccine and next day felt like hit by a bus. The patient also experienced ache which was started in mouth, then face, head and rest of the body. The patient took lots of Tylenol and woke up during the night needing more tylenol. The patient stated that pain was started in mouth first where it hurts the worse. The patient stated that sudden pain that started in lower right jaw was extremely painful. At the time of reporting patient felt better but worried about the time when tylenol wore off. The patient's last dentel exam was less than 2 months ago from reporting date and there were no issues. The patient wanted to know whether pain in jaw was one of the side effect of vaccine.
This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EN6208) via an unspecified route of administration on 16Mar2021 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date, prior to vaccination and known allergies were reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021, the patient experienced severe leg cramps which was worse at night. No treatment was received for the reported events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of severe leg cramps was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Seven days post vax, the pt started running a fever of 102. The next day, she had a fever of 104. She also developed a rash on her forehead. The fever continued for the next two days. Her rash progressed to her neck and back.
improperly stored administered doses of  GARDASIL 9; No reported adverse affected; Information has been received from a health care worker referring to a patient of an unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies.   On 20-MAY-2019, the patient was administered improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) with lot number N020353 and expiration date on 28-APR-2020 (strength, dose, dose number, anatomical injection site and route of administration were not reported) for prophylaxis.   It was reported that on an unknown date, the vaccine was exposed to a temperature excursion above 47 degrees Fahrenheit (F) (49 degrees F) for 171 (units not reported). There was a previous temperature excursion reported. The call was not placed because of a Digital Data logger report. No reported adverse affected.; Sender's Comments:  US-009507513-1905USA012025:
I am experiencing facial paresthesia symptoms: tingling, burning, pricking sensation in my teeth, gums, tongue, and lips. Primarily in the lower part of my mouth, but also present in the upper part.
First acute schizophrenic episode (disorentation and hallucinations)occurred 3 days after HPV vaccination.  Required hospitalization and continues to need ongoing treatment.  Unable to return to school and usual activites. 11/2/09:  Hospital Records and Discharge Summary received for dates of service 4/16/09 to 5/4/09.  Dx:  Schizoaffective disorder, bipolar type, attention deficit hyperactivity disorder, cannabis abuse, alcohol abuse.   Assessment:  Pt. brought to hospital ED by local police on a certificate of hold after being missing for 1 day and being found wandering, distracted and responding to internal stimuli.  She was anxious, irritable and easily agitated.  She had stopped taking her psychiatric medications several weeks before.  She displayed prominent thought blocking with loose associations and was having visual and auditory hallucinations.  With the help of psychiatric medications, by discharge her affect became broader, mood brighter there was no further thought blocking, thought process was more organized, and she was A&O x 3.     11/2/09:  Hospital Records and Discharge Summary received for dates of service 6/18/09 to 6/23/09.  DX:  Schizoaffective disorder, bipolar type, attention deficit hyperactivity disorder. Assessment:  Brought to the Hospital ED by police after threatening to shoot herself, though she had no access to a gun.  She had stopped taking psychiatric medications 3 days prior.  She was intrusive and tried to escape from the ED, so was medicated with good effect.  On assessment she was paranoid and guarded, however she denied suicidal or homicidal ideations. Appeared to be responding to auditory hallucinations and other internal stimuli.  While hospitalized, her medications were re-started, her thought processes became logical and coherent.  She did not appear to be guarded anymore.  Her insight, judgment and impulse control were improved and fair at time of discharge.
During administration of the vaccine, the RN noted that the vanishpoint syringe (automatic retractable needle syringe) began retracting too early before the RN had fully depressed the plunger and before all of the vaccine was in the patient's muscle. In addition, the RN noted that vaccine was leaking out of the syringe and down the patient's arm.  The RN was unable to determine the exact amount that entered the patient and how much leaked out of the syringe.  The RN spoke with Health Deparment's physician who was on-site. The RN and the physician looked at the syringe and discussed the incident. It was determined since some of the vaccine went into the patient, the dose should not be repeated for concerns of overdosing the patient.  The patient was informed that a VAERS report would be filed and that we would attempt to contact moderna. The patient was advised to come for the second dose as scheduled on their card and that the patient could speak with their healthcare provider about whether or not a titer/antibody test should be run after the second dose to ensure the patient had adequate immunity.
Fever of approximately 100.5, shaking, chills, muscle aches, restless legs.
No fever. Vesicles on erythematous covering face, trunk, extremities. Pruritic. Supportive.
Returned to clinic two days after receiving vaccines to have TB test read.  Right upper arm with 5 cm round erythemic area.  No swelling noted.
Suspected SIRVA -Patient presented to me November 29, 2017 complaining of inability to move her left shoulder in full range of motion as well as severe shoulder pain since the vaccine October 17, 2017. She reports she thought it was just the "normal soreness" she would get after a vaccine but the pain only worsened and the limitation in range of motion became more apparent. She began taking 800 mg ibuprofen which did not help. She reports the pain felt like something was tearing inside her shoulder any time she moved her shoulder. She has had difficulty sleeping due to the pain. On exam yesterday her left shoulder had a normal appearance without erythema, warmth or swelling. Her active range of motion of teh left shoulder was greatly decreased with minimal ability to internally rotate, moderately decreased external rotation, abduction to 90°, and forward flexion to approximately 100°  and all with pain. Passive range of motion with slightly better than this but because of severe pain this testing was abandoned. Her left shoulder was tender to palpation shoulder anteriorly and laterally. Her right shoulder was normal with full range of motion and no tenderness to palpation. Range of motion of her cervical spine was intact as well. There was no muscle atrophy noted. Abduction strength was decreased due to pain but otherwise motor strength was intact in both upper extremities. Her arms were neurovascularly intact. No rashes were noted. I sent her for an x-ray and started her on a Medrol Dosepak. I advised her to stop the ibuprofen while on the Medrol Dosepak and provided her with tramadol to help with the pain. I asked her to call me if the tramadol was not  enough to control her pain and advised her I would start on her on hydrocodone if needed. I also provided her with a referral for physical therapy.
It started with shaking and feeling cold. it lasted about an hour. I could not stop shaking. my temperature was 103.5. I had trouble walking, I had fatigue and tiredness. My arm hurt up to the base of my neck. I had pain urinating. my fever lasted about 12 hours. It did go away by 2/21.
Initial unsolicited report received from a nurse on 03 November 2016. This case involves a 21-years-old female patient who was vaccinated with a first dose of FLUZONE ID (batch number- UT5572BA, expiratory date-30 June 2017) (dose in series and dose was not reported) via intradermal route in right forearm on 01 November 2016. The patient had allergy to sulfa and illness at time of vaccination was reported as none. Concomitant medications were not reported. On 02 November 2016, (It was reported as within 24 hours) following the vaccination, the patient had developed an irregular reddened area at site of vaccination, measuring 7cm x 7cm and was warm to touch and after 24-48 hours increased in size to 8cm x 13 cm and it's warm to touch and tender. Patient was required doctor visit. Relevant laboratory data was reported as none. The patient received Zyrtec, ibuprofen (using cool and warm compresses to area) as corrective treatment. The outcome of the event was reported as unknown. List of documents held by sender: none.