chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came into office 24 hours after immunization w/complaints of muscle soreness and weakness, plan was to observe and return iF symptoms continued. Patient came back into office 11-27-19 with continued muscle weakness and soreness at injection site. PAIN WAS IN THE ARM THAT BEXSERO WAS ADMINISTERED
drug ineffective; rash on tongue; feeling tired, decreased strength and difficulty walking; feeling tired, decreased strength and difficulty walking; COVID-19; This is a spontaneous report from a contactable consumer based on information received by Pfizer (manufacturer control number US-AMGEN-USASP2021052584). This case was split from master case #2021402787 to capture a female patient taking BNT162B2 and experienced drug ineffective, COVID-19, and tongue disorder. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 on an unspecified date (Batch/Lot number UNKNOWN) as single dose, dose 2 unknown on an unspecified date (Batch/Lot number UNKNOWN) as single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis with rheumatoid factor of right hand without organ or systems involvement. Concomitant medication(s) included etanercept (ENBREL) taken for rheumatoid arthritis,; fluticasone propionate, salmeterol xinafoate (ADVAIR HFA); citalopram hydrobromide (CITALOPRAM HYDROBROMIDE); clotrimazole (CLOTRIMAZOLE); levothyroxine sodium (LEVOTHYROXINE SODIUM); meclizine hcl (MECLIZINE HCL), methotrexate (METHOTREXATE); omeprazole, sodium bicarbonate (OMEPRAZOLE/SODIUM BICARBONATE); clopidogrel (CLOPIDOGREL); clorazepate dipotassium (CLORAZEPATE DIPOTASSIUM); doxycycline hyclate (DOXYCYCLINE HYCLATE).   The patient stated she has had both the COVID vaccines and developed rash on tongue as a result. Since on an unknown date, the patient was feeling tired, decreased strength and difficulty walking. Patient was using walker. Patient stated she was unable to participate in exercise programs as she would like because of health. Recently, on an unknown date in 2021, the patient was diagnosed with COVID. The patient stated, along with recent COVID diagnosis has caused some anxiety. No treatment information was received. The outcome of the event covid-19 was reported as not recovered/not resolved. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the event covid-19. The causal relationship between the event covid-19 and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected.  No follow-up attempts possible. No further information expected.
A nurse reported that a pt received Pnu-Imune 23 and subsequently developed an injection site reaction. No further information was available at the date of this report. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23, lot 470592. See related reports HQ1201422MAY2001 and HQ9390306APR2001.
After getting my second dose I had significant redness and swelling in my arm two weeks later. My first shot was administered slowly but the second one was injected very fast. I did not have any swelling after the first dose. My symptoms started with Sinus congestion, and I thought it was my allergies. The next day I noticed I could not taste anything and I got tested. I tested positive for COVID-19 on 04/08/2021. My congestion persisted and my Oxygen levels were low. I was having trouble breathing and I could barely walk upstairs without being short of breath. I was very tired. The majority of the symptoms lasted almost two weeks. I had chest pain 08/05/2021 and I went to the ER. All tests were negative and I was scheduled for a stress test. It has been 5 months and I still have days where I am very short of breath. I am scheduled for more Cardiology tests.
Chills without fever, Slight Nausea, Dizziness, Lack of concentration. Aches and pains, exhaustion.
I have an extreme fear of needles and we thought that the dizziness came from that and the nauseous came from that as well, that night I had a tough time sleep because my arm was so painful and over the next several days my arm had became inflamed and red we noticed that my sugar had started climbing. So I was kinda okay Monday still kinda sick and nauseous at 6:00 am that morning I started to throw up and I threw up at 6 times my mother had to call 911 and I was taken to hospital in the squad  my sugar was 501 I was dka, I had to go without food and water for over a day. I had complications with the insulin and the shot was causing my sugar to rise and there were complication. I was not able to lay on my left for a week longer maybe a little longer. I think my shot was infected it started to leak white goop as well. I was on an insulin drip for a while, my pump was not working so I had to stay longer until a new pump came. I went into the er Tuesday morning and came out Thursday morning
Neutropenia; sounds like a cold; Voice change; Throat issues; gotten worse; Sinusitis; cough; Nasal issues; burning sensation in throat; Severely congested and inflamed; Swollen cheeks; Severely congested and inflamed; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization.  Medical history and concomitant medications were not reported.  Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 54 years), as dose 1, single for COVID-19 immunization. On 14Oct2021 the patient experienced sounds like a cold, voice change, throat issues. on 2021 gotten worse, sinusitis, cough, nasal issues, burning sensation in throat, severely congested and inflamed, swollen cheeks, severely congested and inflamed, Neutropenia. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Oct2021. The patient was diagnosed with Sinusitis. The outcome of the events was sounds like a cold, Voice change, Throat issues, gotten worse was not recovered. All the other events was unknown.  Lot/batch number is not available despite the follow up attempts made. Follow-up attempts are completed. No further information is expected.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 11-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 12-SEP-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Immediate itching Rash developed on day 3 on injection arm and down back Intense joint pain in fingers and wrist is ongoing
Abnormal weight loss, generalized weakness, trouble walking, fatigue, insomnia, failure to thrive (child), dizziness, chronic pain, depression. TREATMENTS medications: SNRI, scopolamine, promethazine, melatonin, Feeding tube placed. REFERRALS Occupational Therapy, Neurology, Pain Medicine, Dietician, Behavioral Medicine.
PER PATIENT STATEMENT: I noticed the itching around 3pm and redness associated, very inflamed feel. I had some upper back burning and prickly sensation last night and my arm is still itching today with a tight rubber band feeling around the area. Occasionally get a cool sensation down the arm with light tingling. I took Benadryl last night with hydrocortisone on the site. It seems less itchy today but still there.
mild puffiness under eyes and on lip, mild sore throat, beginning about an hour after the shot and continuing to this writing
patient states she received injection on 1/27/21 with no issues at time of injection. On 2/8/21 she noticed tenderness at site of injection, fine rash with redness, red streaks down the arm and heat noticed to area. States she has been putting ice packs and Benadryl cream to area. 2/12/21 PCP Dr  notified of signs & symptoms per patient and also via me.
Day following vaccine administration (11/01/07), mother contacted our office stating patient woke up with hives on his face and torso. Patient was referred to either report to the ER or call their physician to be scheduled for an appointment. Mother called physician on 11/01/07 they suggested he take Benadryl and call them if child worsened or no better. Mother stated child was doing ok and on Friday morning (11/09/07) the child's eyes were swollen. Mother stated she called the physician and they saw the child. Child was placed on medication. The physician indicated that the child's hives could have been a result of the administered Meningococcal vaccine. Mother also kept an appointment with the physician for the child to be seen on 11/14/07.  11/16/07 Spoke with mother. Mother stated that the child is doing better. Advised mother to keep in touch with the physician for follow up care. Informed mother that event would be reported to the VAERS today.
Fever, chills, achy, tired, slight headache all over a period of 30 hours
Lack of mobility unable to lift arm over head 7-10 days post vaccine. Mom reported 8/29/16.
Patient given Rotarix vaccine IM instead of oral. Induration at sight, no redness.  Given Rotarix orally after error realized.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 09-MAR-2016, the patient was vaccinated orally with a dose of ROTATEQ lot # L026740, expiry date 16-APR-2017 (dose was not specified). The administered dose of ROTATEQ underwent temperature excursion at 11 Celsius degrees for 15.5 hours. No previous temperature excursions were reported. No adverse events were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Facial rash that spread to upper extremities bi lateral, along with nausea.  Client transfer to ER via EMS for further evaluation
DEVELOPED SYSTEMIC HIVES ABOUT 12 HOURS AFTER VACCINE. SEEN AT ED ON 10/7/23 AND 10/8/23. STARTED ON ANTIBIOTICS, PREDNISONE, AND BENADRYL
No adverse event; The patient received first dose on 14-Aug-2021 and second dose on 10-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 14-Aug-2021 and second dose on 10-Apr-2022) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. FC3181 and FP9894) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-Apr-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 14-Aug-2021 and second dose on 10-Apr-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 14-Aug-2021 and second dose on 10-Apr-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 14-Aug-2021 and second dose on 10-Apr-2022).    Concomitant medication information was not provided.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721275 (E2B Linked Report). This case was linked to MOD-2023-722079 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721275:master case
Janssen COVID-19 Vaccine EUA   Fatigue and chills, but no fever. These symptoms started about 6 hours post-vaccine and lastest for about 36 hours on and off.    Arm at injection site is still sore to the touch, but manageable.   Around 3 PM on Sunday, April 11th a small rash/hives broke out on the inside of my left arm opposite of my elbow. My vaccine was given in the right arm, but the right arm did not have any reaction. This rash lasted for about 12-24 hours and then was gone. It was never itchy.
Lactose intolerance; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of LACTOSE INTOLERANCE (Lactose intolerance) and DIARRHOEA (Diarrhea) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK Citrate free. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate free. In 2021, the patient experienced LACTOSE INTOLERANCE (Lactose intolerance) and DIARRHOEA (Diarrhea). At the time of the report, LACTOSE INTOLERANCE (Lactose intolerance) outcome was unknown and DIARRHOEA (Diarrhea) had not resolved.            No concomitant products were reported.  In 2021, the patient experienced lactose intolerance and diarrhea. Covid-19 vaccine moderna (covid-19 vaccine mrna (mrna 1273)) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 27-Feb-2021, patient received 1st dose covid-19 vaccine manufactured by moderna. On 27-Mar-2021, patient received 2nd dose covid-19 vaccine manufactured by moderna.  Causality for humira (adalimumab) The reporter's causality for the event(s) of lactose intolerance and diarrhea was not provided.   No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Meningococcal MCV4 Lot# U3433AA - Exp. 08/02/11 vaccine administered 08/10/11, 8 days after expiration date. Dose not re-administered.
Within one half hour of receiving the vaccine. Patient became puritic all over and developed a rash to her back. Patient took Benadryl and symptoms were relieved by 1630 of the same day.
Pain in joints, toes, fingers, wrist, knee.  Symptoms began about 5 weeks after second dose on Feb. 5, 2021.  April 15, 2021 bloodwork confirmed Rheumatoid Arthritis
Bell's palsy. Initial pain behind the ear started 2 days after vaccine. Full facial nerve palsy started 4 days after vaccine
Shortness of breath had a terrible asthma attack very congested in my lungs weezing
The patient is a 61-year-old female who presents to the emergency department due to diffuse abdominal pain, bilateral flank pain, as well as nausea, vomiting, and diarrhea.  The patient received her second dose of the Covid vaccine and noted that her symptoms started ~24 hours after that.  She complained of pain that was a 6 out of 10, but has been as bad as a 10 out of 10.  She described this pain as burning, achy, and throbbing.  She said the pain is worse in her flanks, bilaterally but also has diffuse abdominal pain.  She had fevers and chills with a temperature of 102 degrees the prior night.  She had nausea and vomiting, and notes that she had not vomited since she was a child so this is very unusual for her.  Patient had also had some diarrhea today.  She says that prior to today her last bowel movement was 2 days ago, and then before that it was a week ago.
On the left arm a red spot about the size of a quarter.  A line going down the arm about 2 inches long and about as wide as an index finger.  Starting to fade now.  Pt. took 1 Benadryl on Saturday and 1 Benadryl on Sunday.  Rubbed site with rubbing alcohol each day.
Patient bled after the vaccine and a bruise was visible right away within a minute, Pt stayed for 15 min after the vaccine and reported brief pain down the elbow after the shot, pain did not reoccur. The injection site was elevated, patient was advised to ice the injection site, and went home. Pt reported the swelling went down within an hour after icing. Injection site was still bruised on 11/20/2023. Patient denied limited range of motion, or pain.
4 month old child was given kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th February 2022, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 9th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 provided as follows: The reporter stated that a 4 months patient was administered the kinrix vaccine in left thigh, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
FINGERS AND TOES FREEZING; CHILLS; SORE ARM; FEVER; SUPER FATIGUE; SICK TO STOMACH; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced fingers and toes freezing. On 2021, the subject experienced chills. On 2021, the subject experienced sore arm. On 2021, the subject experienced fever. On 2021, the subject experienced super fatigue. On 2021, the subject experienced sick to my stomach. Laboratory data included: Body temperature (NR: not provided) 100.0 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, fever, chills, super fatigue, fingers and toes freezing and sick to stomach was not reported. This report was non-serious.
In August 2022 I had an allergic reaction to a dog that I had never had before.  Later that month, I developed a respiratory infection with fever and anemia.  That infection turned into a tight jaw and then to my neck and my knees.  In January I had a frozen shoulder.  I had 7 major nose bleeds between February and March 2023.  The ENT did a procedure to help with this.  In March 2023 I saw a rheumatologist for some testing.  I was diagnosed with giant cell arteritis.  Later in March I also had chest pain and I was diagnosed in the emergency department with mild myopericarditis.
Arm soreness - more than "typical", low-grade fever onset 10/8/05 temperature ranging from 99.4 to 101.6. Swelling and rash appeared on 11/10/05 covering inside portion of left arm, below injection site and around the arm. Swelling dissipated overnight, but rash remains. Began 3 ibuprofen every 6 hours on 11/10/05.
The child became rigid, stared into space and did not respond to verbal stimuli for about 2-3 seconds. Child responded as soon as placed in supine position.
Pt complained of uticaria within 10 mins of vaccination, rash on trunk and arms
she has a friend who tested positive for COVID-19 virus infection 2 days after receiving Pfizer's COVID-19 vaccine; This is a spontaneous report from a non-contactable consumer (reporter's friend). A 69-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter called requesting information about whether she can be administered with the first dose of Pfizer's COVID-19 vaccine after being with somebody 15 days ago who was now sick with COVID-19. During the call the consumer reported she has a friend who tested positive for COVID-19 virus infection 2 days after receiving Pfizer's COVID. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse refers to a patient of unknown demographics. On 24-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 injection, multi-dose vial (dose, route and frequency unspecified). No concomitant medications were reported. On 24-SEP-2014, the patient was injected with the entire contents of a PNEUMOVAX 23 multi-dose vial. No adverse symptoms reported. The outcome of patient was injected with the entire contents of a PNEUMOVAX 23 multi-dose vial and no adverse symptoms reported is unknown. There was no product quality complaint involved. Additional information has been requested.
admitted to hospital 1/11/2020 with Acute respiratory failure with hypoxemia; Iron deficiency; SOB (shortness of breath); Symptomatic anemia; still admitted
Patient received Shingrix Dose#1 on 5/26/21 @ 7:40pm. Next morning on 5/27/21, patient had swelling and pain on the left arm at injection site. He also had symptoms of fever, felt hot and cold, and body aches. These side effects subsided after 3 days, except a non painful lump at the injection site remained. Patient reported on 6/12/21 at the pharmacy to see if it is normal to have the lump remained. The lump is about 1 inch in diameter, and does not appear to be red/swelling. Patient did not report any pain from the lump. Patient was advised to consult with a physician about this lump, and consult for professional opinion if we should proceed with Shingrix dose 2 when the time comes.
Headache, Myalgia, Fever, NauseaVomiting, chills, sweats, sore arm Narrative: On 2/4/2021 and 02/05/2021 - severe muscle aches, chills, sweats, fever, nausea, headache, sore arm  Other Relevant History: