chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial pain, swelling, induration, erythema at injection site, progressively worse after 24 hours of vaccine. Later in the day, (about 30 hours after vaccine): chills, arthralgias, myalgias, asthenia, fatigue, and low grade fever (99.7 F to 100.2 F).
screaming cry & very irritable for 2 1/2 hrs. Very irritable infant /w hyper-active reflexes.
Information has been received from a physician concerning a 4-month-old male with no pertinent medical history and no drug reactions/allergies who in February 2007, was vaccinated PO with a 2mL dose of Rotateq. There was no concomitant medication. Subsequently the patient experienced bloody stool Subsequently, the patient recovered. There were no lab diagnostic studies performed. Unspecified medical attention was sought. There was no product quality complaint. Upon internal review, the event was considered to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
expired dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment medication were provided.
The patient had aphasia the following morning prompting him to go to the ER.   He was diagnosed with TIA and acute kidney injury.  Smptoms have resolved.  He is back at baseline.
Pt received inactivated Influenza vaccine, 0.5ml IM in the left deltoid at 1410 on 16 Jan 2007.  At approximately 1508, the pt came to the front clinic desk c/o wheezing/coughing.  I quickly notified Dr who came out and brought her to the back treatment room.  He listened to her lungs, thten requested us to perform a PFT on the patient.  After the PFT's were accomplished, she was administered a nebulizer treatment of Albuterol 5mg and Atrovent 0.05mg.  Following completion of the neb tx, Dr listened to her lungs again, and requested us to repeat the PFT.  After those results came up, the patient was still complaining of cough. Dr asked her several times if she had any other symptoms other than a cough, and this time she said she was having some chest tightness.  Dr ordered me to administer 0.3mg of Epinephrine IM.  I administered the Epi at 1542.  Following the dose of Epi we obtained vital signs.  After the second set of vital signs, the patient was given 40mg of Prednisone to decrease the chances of a latent phase reoccurrence of the reaction.  We observed the patient for an hour, she continued to improve, then when Dr felt confident enough about her condition, she was released to her husband who drove her home.
J18.9 - Pneumonia I21.4 - NSTEMI (non-ST elevated myocardial infarction)
enroll in pregnancy registry; This spontaneous prospective pregnancy case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (enroll in pregnancy registry) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion on 13-Apr-2021.    On 12-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 26-Aug-2020 and the estimated date of delivery was 15-Jun-2021. On 12-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (enroll in pregnancy registry). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  On 12-Jan-2021, EXPOSURE DURING PREGNANCY (enroll in pregnancy registry) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2021: Pregnancy update - Added FU AI; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
HYPOXEMIA 10/18/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
On 10/13, patient started feeling achy around legs.  On 10/14, patient developed fever of 102 for 3 days. Covered with rash, raised, around chest, breast, back and stomach. Went to see allergist and internist on 10/16 - was given Benadryl every 6 hours.  Physisicians stated that it looks like an adverse reaction.
30Oct89 pt vax w/ hepta B; 14Nov89 exp right flank + abdo pain tx unsucc. w/ heat + Motrin, devel cystitis + low grade fever.  CBC + urinalysis revealed urinary tract infection.  Urine culture was positive for yeast. Tx w/ Cipro. See worm..
Information has been received from a physician concerning an 8 year old female patient who on 23-JAN-2006 was vaccinated with the first dose of MMR II.  On 12-NOV-2006, the patient was vaccinated with the second dose of MMR II.  On 22-NOV-2009, the patient experienced mumps (diagnosed on 24-NOV-2009) the patient had fever 103 F and had left parotitis.  On 24-NOV-2009, laboratories performed showed serum immunoglobulin M test (IgM) less than 1.10 (normal range less than 1:10), serum immunoglobulin G test (IgG) 6.25 (normal range greater than 1.10) and serum amylase test 126.  The patient's outcome was unknown.  No further information is available.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other= Moderna/vaccine administration date=02Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 as dose 4 (booster), single (Lot number: Gn9703) at the age of 78 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 25Feb2021 as dose 2, single (Lot number: 013a21a), in right arm and on 02Nov2021 as dose 3 (booster), single (Lot number: 014f21a), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AVASTATIN; LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other= Moderna/vaccine administration date=02Nov2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: negative rapid test; (01Jan2023) Positive, notes: Symptoms resumed and rapid test positive about 10 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: The patient received other medication in 2 weeks. Patient received Paxlovid for COVID 19 treatment from 18Dec2022 to 22Dec2022. No known allergies reported.
This happened a few months after getting my vaccine. I had a sore throat that then progressed to cold like symptoms. It was so bad that I did go see my primary care doctor. Not strep, cold or flu it was just a cold I guess I'm not contribute this to the vaccine.
Bilateral  pain in both wrists developed out of the blue which progressively worsened with both hurting.; This is a spontaneous report from a contactable pharmacist, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 17Aug2021 at 11:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no chronic diseases, no significant medical history and had no history of wrist problems or arthritis. . The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin d nos (VITAMIN D) and zinc (MANUFACTURER UNKNOWN); both taken for unknown indications from unknown dates and unknown if ongoing. On 24Aug2021 at 08:00, the patient experienced bilateral pain in both wrists that developed out of the blue which was followed by the vaccine shot. It had progressively worsened with both wrists hurting. On 04Sep2021, the patient wrapped right wrist with bandage and then bought wrist brace at store on 07Sep2021 for right wrist since the patient was right-handed and complete rest for that wrist was not possible. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures taken as a result of the event included treatment with wrapping of ace type bandage on the right wrist from 04Sep2021 and wrist braces which was used from 07Sep2021. The clinical outcome of the event bilateral pain in both wrists was not resolved at the time of this report.
Episode of vomiting within 4 hours , headache , dizzy , sore throat , general not feeling well followed by urticaria at approximately 30 hrs , fever of 101.5 with Tylenol, Benadryl. Called PCP , within an hour seen at the local ED due to the allergic reaction, given IBU and Prendnisone at ED @ 10 pm , prescribed prendnisone for the following days.
pain where the vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain where the vaccine was given) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Cholesterol.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain where the vaccine was given). At the time of the report, VACCINATION SITE PAIN (pain where the vaccine was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified drugs for high blood pressure and cholesterol.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-081697 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081697:for 2nd dose
Patient had shoulder pain (5/10) starting the day after second dose of vaccination.  Some ROM limitation.
Pt first began to notice left leg "stiffness" after receiving his first COVID vaccine (Phizer) several weeks ago. Pt states that after receiving his 2nd dose on 05/06, he noticed his leg stiffness got significantly worse. He tells me that he tried to "push through the pain" and mow his lawn but had to stop d/t severe cramping of the LLE and pelvis. He states he rested his leg and went to bed, and when he woke up he noticed that his left leg was severely swollen. Pt decided to take 3 days off work to continue to rest the leg, but ultimately came in for evaluation at the suggestion of his coworkers. Pt denies fever, chills, chest pain, or SOB. He denies history of smoking, prior clotting, long car travel, air travel, leg injury, or recent surgery.    On exam, the left lower extremity is significantly swollen, erythematous, and hot to the touch. Physical exam otherwise unremarkable. Will admit to the hospitalist service for further medical management.   ED Course: Hypertensive with BP 170/93. Initial workup significant for WBC 13, K 3.3, glucose 159. CT chest/a/p with findings suggestive of multiple PE's of the left and right lower lobes as well as extensive LLE DVT extending slightly into the IVC. Trop <0.03. BNP 66. ECG shows sinus tachycardia.
After my booster shot in Oct, I developed two patches on my face; After my booster shot in Oct, I developed two patches on my face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 21Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), administration date: 27Feb2021, for COVID-19 Immunization, reaction(s): "Psoriasis", "I had flaking and build up of skin around my ears"; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), administration date: 20Mar2021, for COVID-19 Immunization, reaction(s): "Psoriasis", "I had flaking and build up of skin around my ears".  The following information was reported: IMMUNISATION (non-serious) with onset 21Oct2021, outcome "unknown", SKIN DISCOLOURATION (non-serious) with onset Oct2021, outcome "unknown" and all described as "After my booster shot in Oct, I developed two patches on my face".  The lot number for bnt162b2 was not provided and will be requested during follow up.
05/07/2021 The night after I received your vaccination I began having a burning sensation all over my back. It never came down off of it. In July, I had a very bad flare up. I went to the ER. The pain became intense. They had to give me some morphine to calm me down and put on lidocaine patches and prescribed some ibuprofen. This pain went on for months and months and would not stop. I had issues with my back 4 years ago, but this was really different, I have never hurt like this before. I am not experiencing the pain too much. I will still get tingles in my feet, which are normal from a previous condition.
With the 1st dose, my lips were swollen and cracked; With the 1st dose, my lips were swollen and cracked; This is a spontaneous report from a contactable consumer(patient).   This 74-year old female patient (Not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EL9262) dose 1 via an unspecified route of administration at right arm on 10Feb2021 at 01:15 am as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No Known allergies. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 12Feb2021, her lips were swollen and cracked. No treatment received. The event assessed as non-serious with outcome not recovered.
12/22 annual H&P completed by APRN, no new issues or concerns. Ongoing  12/23/2021 06:43 found to be unresponsive, skin pale cool and dry. agonal respiration, increased oral secretions, resp labored. pupils fixed pin point not reactive to light. sp02 72% ra, o2 applied 2l via n/c. t 96.6 59 irregular, 24 labored. 122/77 . 02 sat 70 % 2l. cALL PLACED TO ADPOA, no answer. son contacted.no answer. retry cell phone and home number of Adpoa. updated on her mothers declining condition. Adpoa wants mom kept comfortable here at hcnh. no want labs, abt. no aggressive treatments. Dr. update on res decline status. new order do not hospitalize, hospice eval., levsin 0.125mg tab sl q 2 hours prn secretions. family at bedside. res noted increased labored respiration, grimace. new order obtained from Dr. morphine sulfate 20 mg/ml give 5mg ( 0.25ml) sl q2 hours prn pain /dyspnea. Adpoa in agreement plan care. provided levsin 0645 and prn ms04 0720. Family request Priest for last rights. Father returned call, will be here shortly. Family appreciative, sitting at bedside. Passed away peacefully with family at bedside 12/23/2021 at 0920
patient who has received Moderna and J&J in one week; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who has received Moderna and J&J in one week) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Tramadol).    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who has received Moderna and J&J in one week). On 16-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who has received Moderna and J&J in one week) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
3/13/08 - Local swelling and tenderness. Aching within hours of the injection. - Advised rest, ice. Advil 400g qid. 3/14/08 - Expanding area of erythema 10cm x 24cm, slightly warm, margins well demarcated. Skin is sensitive. No fever; Rx - Keflex 500 qid x 7 days
Patient developed Redness & Swelling of Left arm Chills, Headache, myalgia and fatigue after Shingrix vaccine then developed fever of 103 F. Last 3 days.
Headache, body aches, ear ache, fatigue, nausea, sore left arm near injection site
Bright red rash; large welts covering across butt; purple in spots; Chills; fatigue; Loss appetite; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, batch/lot number and expiration date not reported), via an unspecified route of administration (vaccine location: left arm) on 27Jan2021 10:00 for COVID-19 immunization. Facility type Vaccine: Pharmacy/Drug Store. Medical history included high blood pressure and heart surgery in past. The patient was not pregnant at the time of vaccination and at the time of reporting. The patient had no known allergies. The patient had no Covid prior vaccination. Concomitant medications/ other medications included metoprolol, rosuvastatin, and OTC anti acid. There was no other vaccine given withiin four weeks. On 27Jan2021 23:00, the patient experienced chills, fatigue and loss appetite; bright red rash and large welts covering across butt - needed to seek treatment at urgent care. It was now 4 days later and still present and purple in spots. Prescription cream (unspecified) was given. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Started with numbness in left arm the evening of 11/06/2016.  Numbness then went to face and then went down entire left side.  Numbness comes and goes in these areas.  She slept all night and then woke up next day in a.m. with left handed numbness. Received VARIVAX, ADACEL, and FLUZONE on 11/03/2016.  Went to Urgent Care and had EKG done which was normal. Reported that they are suspecting Gullaine Barres.  CBC, CMP, CRP, and ESR done and results are pending.
Started feeling achy all over on 4/24/06 until 04/27/06, when rash appeared took Tylenol for aches.
Started feeling fatigue; Chills; Overall body malaise the next morning (March 11th); This is a spontaneous report from a contactable pharmacist, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an intramuscular route of administration in the left arm on 10Mar2021 at 15:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) and doxycycline (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 17Feb2021 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 11Mar2021 at 09:00, the patient started feeling fatigue, chills and overall body malaise the next morning (11Mar2021) and had continued throughout the day. No actual fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events started feeling fatigue, chills and overall body malaise the next morning (March 11th) was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient had first primary pfizer dose, was given bivalent pfizer as a second dose. No s/s at this time.
No additional AE reported; Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to patients before calling; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 16-DEC-2022, the patient was vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) subcutaneous injection, lot #W019628, expiration date: 19-DEC-2023, administered intramuscularly into right thigh (exact dose was not provided) for prophylaxis. On 10-DEC-2023, the vaccine experienced the temperature excursion between negative 14 and negative 10 Celsius degrees for 1 hour (product storage error). No additional adverse event (AE) details were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA007822: US-009507513-2304USA007836: US-009507513-2304USA007931:
Pt received one J&J vaccine at a different location and then came to us for the pfizer series. No issues, shots were just given outside of guidelines.
Throbbing pain down the right arm to the wrist beginning a few hours after the injection and lasting to the onset of shingles 3 days later.