chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We administered the Pfizer Adult Vaccine to the 11-year-old patient, but only 0.1ML. At the time the patient came in, parents were requesting the vaccine and it was just approved and we thought we could use the Pfizer Adult vaccine but just administer half the dose. After we realize that Pfizer had a different vaccine for adults and pediatrics.   We called patient to check if patient had any reaction to vaccine, but patient was feeling good and didn't have any reaction or other symptoms.
My tongue started feeling itchy, I have a metal taste in my mouth. It has been this way since about an hour after I got the shot. Itchy has turned into like a tingling but also the feeling it you "burn" your tongue. It is not uncomfortable but a symptom that was not listed on the affects
CHILLS; LOW OXYGEN LEVEL; CHEST DISCOMFORT; This spontaneous report received from a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-APR-2021, the patient experienced chills. On an unspecified date in APR-2021 the patient experienced low oxygen levels and chest discomfort in the evenings for the next few days. On 09-APR-2021, after advising with doctor of oxygen levels in the low 80s, the patient was admitted to hospital for nearly a week where the patient was given oxygen and albuterol treatments. They were unable to find a reason for her symptoms. The patient's oxygen levels returned to normal . On an unspecified date in APR-2021, the patient was released. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low oxygen level on APR-2021, and the outcome of chills and chest discomfort was not reported.  This report was serious (Hospitalization Caused / Prolonged). This spontaneous report received from a patient concerned a patient of unspecified age and sex.; Sender's Comments: V0: 20210537756-Covid-19 vaccine ad26.cov2.s-Low oxygen level, Chest discomfort. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  V0: 20210537756-Covid-19 vaccine ad26.cov2.s-Chills. This event(s) is labeled per RSI and is therefore considered potentially related.
Vaccine administered on 12/5/22 from a vial that expired 12/4/22
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The initial case was missing the following minimum criteria: Other-Info not qualifying for AE reporting. Upon receipt of follow-up information on 06Apr2021, this case now contains all required information to be considered valid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
5/5/09 Administration of L arm erythema & firmness 2-3 cm, Local reaction. Noted 5/7/09.
White blood cells were below 1 on Monday, repeat labs Wednesday they were above 1; Worsening lymphedema since Jan2021 or Feb2021; Joints hurt; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on 02Jun2021 (age at vaccination: 57-year-old) as dose number unknown, single for COVID-19 immunization. Medical history of the patient included adhesive tape allergy, iodine tincture allergy, lymphedema (worsening lymphedema since Jan2021 or Feb2021). Concomitant medications included Tocopherol (Vitamin E), naproxen sodium (Aleve), fulvestrant (Faslodex), Levothyroxine, Multivitamin capsule, Vitamin D for unspecified indication, started and stopped on an unspecified date. Patient previously took Macrobid on an unspecified date for an unspecified indication and experienced allergy. On an unspecified date in Jun2021, patient white blood cells were below 1 on Monday and her white blood cells were above 1 on Wednesday, worsening lymphedema since Jan2021 or Feb2021, joints hurt. MD is aware. Outcome of the events were unknown.  Information about lot/batch number has been requested.; Sender's Comments: Limited information of white blood cell count prior to vaccine preclude a comprehensive causality assessment, underlying medical conditons of lymphedema and allergy may be contributory to events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
On the morning of 07/17/2022, I woke up feeling like I had the flu. I had the chills and achiness in all of my joints. My throat was also sore and scratchy. I did not have a fever though and I felt a bit nauseous but never threw up. Monday morning, I felt a bit better and tried to go to work, but it got worse, so I went home and took a COVID-19 test which was positive. I called my doctor who prescribed PAXLOVID, zinc, vitamin D, MUCINEX, and an acid reflux medication. I took all of those as prescribed and beginning the next day, I felt almost completely better. On 07/22/2022, I was negative for COVID-19. The Monday following that, I took an additional COVID-19 test and was positive again. I felt fine but was testing positive until 08/10/2022. The only symptom I experienced during my second round of COVID-19 was a scratchy throat, which still occasionally returns to this day.
HIGH FEVER OF OVER 103-104.7 FOR 3 DAYS SO FAR. STARTED 4 DAYS AFTER THE SHOT. FEVER IS STILL ONGOING.
swelling under my left arm; throbbing pain in my jaw and my ears for about 3 days; throbbing pain in my jaw and my ears for about 3 days; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15May2021 13:00 (Lot number: EW0167) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (ongoing). Concomitant medication(s) included: ALLEGRA-D 24 HOUR taken for hypersensitivity (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: ER8731, Anatomical site: Left upper arm, Route of administration: Intramuscular, Time of administration: 13:00), administration date: 22Apr2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 16May2021, outcome "recovered", described as " swelling under my left arm"; PAIN IN JAW (non-serious), EAR PAIN (non-serious) all with onset 16May2021, outcome "recovered" and all described as "throbbing pain in my jaw and my ears for about 3 days"; ARTHRALGIA (non-serious) with onset 16May2021, outcome "recovered", described as "joint pain".  Additional information: Patient received the second dose in left upper arm. Prior Vaccinations (within 4 weeks) were reported as None. Patient's Medical History (including any illness at time of vaccination), Relevant Tests and Specific relevant test for thromboembolic events with thrombocytopenia reported as None. For the 2nd and 3rd doses I experienced swelling under my left arm. The swelling was approx. the size of a softball. I also had joint pain and a throbbing pain in my jaw and my ears for about 3 days. Patient received Dose 3 (Lot no FH8030 Expiry date not provided) on 21Nov2021 at 17:00 via intramuscular route of administration in left upper arm. For the 3rd booster only, I also had in my going area for about 2 days after my vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101649158 same reporter/patient/product, different dose and similar events
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases : A0756483A - A0756504A, A0756506A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers:  AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA) : AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
This spontaneous report as received from a consumer refers to her 89 year old father with asthma, diabetes and emphysema and no drug/reactions and allergies. On 23-MAY-2013 the patient was vaccinated with second dose of ZOSTAVAX dose, lot # and route of administration not reported. Date of first dose was unspecified. Concomitant therapies included EFFEXOR, KLONOPIN, olanzapine, PLAVIX, aspirin, NORVASC, metoprolol tartrate and pantoprazole. On 23-MAY-2013 the patient saw a decline in his blood sugar levels after receiving a second dose of ZOSTAVAX. There were no lab diagnostics studies performed. As a treatment patient ate candy to raise his blood sugar levels. The patient did not seek medical attention. The outcome of decline in his blood sugar levels after receiving a second dose of ZOSTAVAX was unknown. The relatedness between adverse event and ZOSTAVAX was unknown. Additional information is not expected.
Can't raise his hand for a day or 2; Coughing; Sinus strain; Sick for 18 hours; Sore arm; Aching all over; Head hurt bad; Fever for 101 degree; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Can't raise his hand for a day or 2), COUGH (Coughing), SINUS DISORDER (Sinus strain), ILLNESS (Sick for 18 hours) and PAIN IN EXTREMITY (Sore arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (Can't raise his hand for a day or 2), COUGH (Coughing), SINUS DISORDER (Sinus strain), ILLNESS (Sick for 18 hours), PAIN IN EXTREMITY (Sore arm), MYALGIA (Aching all over), HEADACHE (Head hurt bad), PYREXIA (Fever for 101 degree) and FATIGUE (Fatigue). At the time of the report, MOBILITY DECREASED (Can't raise his hand for a day or 2), COUGH (Coughing), SINUS DISORDER (Sinus strain), ILLNESS (Sick for 18 hours), PAIN IN EXTREMITY (Sore arm), MYALGIA (Aching all over), HEADACHE (Head hurt bad), PYREXIA (Fever for 101 degree) and FATIGUE (Fatigue) was resolving. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concurrent medication not provided.   Treatment medication not provided.   This case was linked to MOD-2021-074036 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up information received on 14-MAY-2021 contains significant information: The outcome of the events changed from unknown to resolving.
Two weeks after first dose, started menstrual bleed that lasted for a month. During the time of bleeding began feeling off balanced and dizzy. This worsened and began having chest tightness and nausea. Then started having insomnia due to body feeling wired and continue to struggle with dizzy bouts and chest tightness and insomnia
severe n/v (10-12x) post vax;no fevers, rash, or other sx;occurred 5/20/99;
This case was reported by a physician and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with Twinrix for prophylaxis.  On an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of Twinrix (unknown).  At an unspecified time after vaccination with Twinrix, the subject experienced not responding to therapy.  The Twinrix series of vaccinations had been repeated two additional times and the titers were negative.  At the time of reporting the outcome of the event was unspecified.  Follow-up information was received from the reporting physician on 12 July 2007.  There was no additional information regarding the event included in the follow-up information.
A HCP called and reported an AE where doses of improperly stored products were possibly administered to patient(s) on unknown dates.; No additional AE reported.; This spontaneous report was received from a medical assistant regarding an unknown number of patients of unspecified age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates, the patients were vaccinated with improper storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U038854, expiration date: 20-APR-2023, taken orally (dosage regimen and strength were not provided) as prophylaxis; measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot #T039671, expiration date: 24-NOV-2022, lot #U017524, expiration date: 03-JUN-2023, (dosage regimen, strength, anatomical location, and route of administration were not provided) as prophylaxis; hepatitis a vaccine, inactivated (VAQTA) lot #W002889, expiration date: 06-MAR-2023, lot #U024504, expiration date: 15-OCT-2022, (dosage regimen, strength, anatomical location, and route of administration were not provided) as prophylaxis (Product storage error). No additional adverse events were reported.  The improperly stored vaccines of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #T039671 and lot #U017524), and hepatitis a vaccine, inactivated (VAQTA) lot #W002889 underwent a temperature excursion of 48 degrees Fahrenheit (F) for 10 minutes without previous excursions. The improperly stored vaccines of hepatitis a vaccine, inactivated (VAQTA) lot #U024504 underwent a temperature excursion of 49 degrees Fahrenheit (F) for 10 minutes without previous excursions (This lot was stored in a second refrigerator).  This is a non-valid report due to lack of patients' identifiers.
The day after the injection I experienced heart palpitations, fast heart rate, tired legs, and back pain. It worsened over the day over the next day. I went to urgent care a few days after the injection. I received a COVID test, EKG, and was sent to the emergency room to rule out blood clot. I also experienced pain over my sternum. I went to the local hospital and was told to follow up with a cardiologist. I was prescribed a "cardiac cocktail" and beta blockers to lower my heart rate. I started to experience neuropathy in my left leg. I saw my cardiologist May 2021. I was diagnosed with vaccine induced Lupus due to all of the symptoms and joint pain.
Had seizure 2-3 days after vaccine. No temp. Was taking Tylenol every 6 hours and Trileptal 2ml tid. Tries to give meds 9-10:00 AM, 1:30-2:00 PM and 7-8:00 PM but sometimes is late. He acts exhausted all time. Local physician recommended he return to pediatric neurologist for medicine evaluation. 11/25/03: no more seizures per mother. Has not seen PMD or pediatric neurologist.
The middle of her right forearm started turning white with white welts. The Welts looked like mosquito bites with fluid in them; Her forearm looked like it was frosted white/her right forearm started turning white; Her right arm itched like her skin was going to come off; She had a fever; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (The middle of her right forearm started turning white with white welts. The Welts looked like mosquito bites with fluid in them), SKIN DISCOLOURATION (Her forearm looked like it was frosted white/her right forearm started turning white), PRURITUS (Her right arm itched like her skin was going to come off) and PYREXIA (She had a fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046CZ11A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced URTICARIA (The middle of her right forearm started turning white with white welts. The Welts looked like mosquito bites with fluid in them), SKIN DISCOLOURATION (Her forearm looked like it was frosted white/her right forearm started turning white), PRURITUS (Her right arm itched like her skin was going to come off) and PYREXIA (She had a fever). On 01-Oct-2021, URTICARIA (The middle of her right forearm started turning white with white welts. The Welts looked like mosquito bites with fluid in them), SKIN DISCOLOURATION (Her forearm looked like it was frosted white/her right forearm started turning white), PRURITUS (Her right arm itched like her skin was going to come off) and PYREXIA (She had a fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Everything lasted for about an hour and a half and then her arm went back to normal again.  No concomitant medication was provided.  No treatment medication was provided.
3-17-21 3:43PM PT STATES SHE FEELS'LIGHTHEADED'. PALE, DIAPHORETIC, A/O , RESP SHALLOW. HEAVY COAT REMOVED, CRACKERS AND WATER GIVEN.  STATES SHE IS FEELING 'BETTER NOW'.  PINK, W/D, RESP WITH EASE. 3:50PM PT STATES SHE FEELS '100% BETTER NOW'. A/O, PINK, W/D; AMBULATORY TO EXIT, GAIT BRISK AND STEADY. NO ACUTE DISTRESS NOTED. 3-22-21 9:30AM: PT STATES SHE 'FEELS FINE NOW'.
No additional AE; 41 year old patient was accidently administered two doses of PROQUAD; patient was accidently administered two doses of PROQUAD instead of two doses of MMR II; 41 year old patient was accidently administered two doses of PROQUAD; patient was accidently administered two doses of PROQUAD instead of two doses of MMR II; This spontaneous report was received from a medical assistant and refers to a 41-year-old patient of unknown gender. There was no information about the patient's pertinent medical history, concomitant medications or drug reactions and allergies provided.   On 27-JAN-2023, the patient was accidently vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) lot# W01273, expiration date 16-OCT-2023 (exact dose and route of administration were not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (product administered to patient of inappropriate age, wrong product administered). On 27-FEB-2023, the patient was vaccinated with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis lot# W012731 and expiration date 16-OCT-2023  (dose and route of administration were not provided)  (inappropriate schedule of product administration, wrong product administered). Both doses were supposed to be measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), but instead the patient was accidently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) both times. No additional adverse events were reported.
Red, itchy rash on chest, bilateral arms, and small rash on right leg. I took 50mg BENADRYL PO due to symptoms. Symptoms lasted approx 3 hrs.