chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No event; temperature excursion - vaccine not viable according to the manufacturer; ROTATEQ: basic series: 13-APR-2023/23-JUN-2023; This spontaneous report was received from a physician and refers to a 5-month-old male patient.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included hepatitis b vaccine (recombinant) (manufacturer unknown), diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13).   On 13-APR-2023, the patient received the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally (exact dose, lot #, expiration date were not provided) for prophylaxis. On 23-JUN-2023, the patient received the second dose (Inappropriate schedule of product administration) of improperly stored (Product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot # reported and upon internal validation confirmed as: 1968385, expiration date was reported and confirmed as: 22-MAY-2024, administered orally (exact dose was not provided) for prophylaxis, at private doctor's office/hospital, by the physician. On the same day, the patient additionally received second doses of diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13). No prescription drug treatment was required. Alarm believed to be due to sensory issues, monitoring temperatures with back up logger. Temperature in range, new data logger currently in use. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA013096:
experienced nerve pain in her arms, chest, and ribs; weakness in her arms; arms numb; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number X2XJ7, expiry date 8th August 2021) for prophylaxis.   On 4th November 2020, the patient received Boostrix. On an unknown date, less than 6 months after receiving Boostrix, the patient experienced nerve pain, weakness of arms and numbness of upper extremities. On an unknown date, the outcome of the nerve pain, weakness of arms and numbness of upper extremities were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain, weakness of arms and numbness of upper extremities to be related to Boostrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient stated, ever since she received vaccine, she experienced nerve pain in her arms, chest and ribs. She also had weakness in her arms. All above events were unresolved. The patient had been to multiple doctors who could not diagnose what was wrong and due to this she was a bit uncooperative, was very upset that no one did give her answers on why she felt this way. She did ask for legal, so this case might be legally significant The patient reported that, her pharmacist called GlaxoSmithKline to report this event, but could not locate in any data base. It was also reported on VAERS. The patient did not consent to follow-up. Note:The events were reported as Nerve pain in arms, ribs and chest but in event section these are provided separately. These are coded as nerve pain according to narrative.
For a long time I had a pimple on my chest. It swelled up to the size of a ping pong ball, and it has fluid in it. I went to see my doctor. They referred me to see a dermatologist. The dermatologist was concerned with the size of it, and its also located on my breast.  I haven't had a mammogram since the beginning of the pandemic. Tomorrow I am scheduled for a mammogram, sonogram, and another pap smear.
under the recommended age to receive vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the recommended age to receive vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 19-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the recommended age to receive vaccine). On 19-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the recommended age to receive vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided, treatment medication not provided   This case was linked to MOD-2021-078863 (Patient Link).
Information has been received from a physician concerning a female pt who was vaccinated with a dose of varicella zoster virus vaccine live. Subsequently the pt experienced a varicella like rash at the injection site. The phsyciain did not want to make a report because he felt it was part of the normal AE's. No further information was available.
I had an allergic reaction, with  hives all over my body. I  had to take OTC Allegra for several weeks.
S.Q. injection (R) deltoid. Very large area of redness, warmth, edema & hardness. Mom states child ran a fever although did not take temperature, 4/5/13 temp checked by county nurse = 97.7 oral. Child given TYLENOL, BENADRYL & cool cloths. Mom states was worried.
shingles; This case was reported by a nurse via other manufacturer and described the occurrence of shingles in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DUPILUMAB (DUPIXENT) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 1st dose of DUPIXENT. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comment: This case involved few adult patients who experienced shingles while being treated with Dupilumab (Dupixent) and Varicella Zoster vaccine (Shingrix). The patient's past medical history , medical treatment, vaccination and family history were not provided. On an unknown date, the patient started taking Dupixent (Dupilumab) of unknown formulation, strength, dosage, frequency , route batch number expiry date for unknown indication via unknown device and Shingrix ( Varicella Zoster vaccine) of unknown formulation , dosage and batch number. On an unknown date , the patient developed a non-serious event shingles ( herpes zoster) (unknown latency following the first dose intake of Dupilumab and Varicella Zoster vaccine. It was reported that, a few patients that had started on Dupixent who had developed Shingles later. The reporter enquired, with the Shingles vaccine (now been not live) when it should be administered. The medical information agent confirmed the spelling of demographic with the caller for accuracy. The reporter stated that, the patients were waiting, she did not have time to answer any questions over the phone but sated that, if paperwork were sent to her, she could provide information then. It was not reported if the patient received the corrective treatment for the event. At the time of reporting, the outcome was unknown for the event shingles. It was unknown if the reporter considered the shingles to be related to Dupixent .
Patient was walking in parking lot. Patient uses a cane to help walk. Patient stated that his leg cramped up and collapsed in parking lot. He never lost consciousness. Patient was alert and aware. 911 was called and he was shortly treated by paramedics and taken away in ambulance.
COVID-19 after receiving Moderna booster shot /  he got sick / Cough and cold; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 after receiving Moderna booster shot /  he got sick / Cough and cold) in an 87-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 after receiving Moderna booster shot /  he got sick / Cough and cold). At the time of the report, COVID-19 (COVID-19 after receiving Moderna booster shot /  he got sick / Cough and cold) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Mar-2023: Live followup contains no new information.
Approximately 10 hours after the vaccine, I awoke with pain in all the joints in my body. I took Ibuprofen and went back to sleep. When I woke up later I felt better but was tired and achy for the next 24 hours. I continued taking Ibuprofen    So adverse event lasted approximately 48 hours
Angio edema 3 hours post injection of IM high dose quadrivalent FLUZONE. I have received standard dose dose annually for at least 30 years with no problems.
On Saturday, noticed a red band at injection site, lip and tongue tingling. Called doctor, advised to take Tylenol and apply ice pack. Went to walkin clinic., was told to take Benadryl. Told it was COVID arm.
choking and spitting up liquid, it was a clear liquid; he drinks a lot of water and thinks that is what he was spitting up.; pain on right side of tongue; from the stomach up there was pain at his stomach on the right side and if he took too big of a breath it would be all across his whole stomach; Muscle pain; Joint pain; Headache; Nausea; Fever; Fatigue; This is a spontaneous report from a contactable consumer (patient).  A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 3 via an unspecified route of administration, administered in Arm Right on 19Oct2021 13:00 (Batch/Lot Number: FH8020; Expiration Date: 30Apr2022) age at vaccination of 69-years-old, as single dose (booster dose),for covid-19 immunisation.  Medical history was none. The patient received BNT162B2, dose 1 via an unspecified route of administration, administered in Arm Right on 07Mar2021 (Lot Number: I or E followed by N6205) age at vaccination of 68-years-old, as single dose, for covid-19 immunisation and no adverse event occurred (he was completely fine). The patient received  BNT162B2, dose 2 via an unspecified route of administration, administered in Arm Right on 28Mar2021 (Lot Number: ER8727) age at vaccination of 68-years-old, as single dose, for covid-19 immunisation and no adverse event occurred (he was completely fine). The patient received flu shot vaccine, never had a reaction to a vaccine in the past, he gets the flu shot every year. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the booster when driving home he started having muscle pain in his shoulder on 19Oct2021; when he got home he had joint pain, headache, nausea, fever, and fatigue, all on 19Oct2021. The patient felt like he had every side effect a person could have. The patient wasn't throwing up but was choking and spitting up liquid, it was a clear liquid, not bile or phlegm (he drank a lot of water and thought that is what he was spitting up) on an unspecified date. The patient took medication daily but has had no changes (as reported). It was also noted he had pain on right side of tongue on an unspecified date, from the stomach up there was pain at his stomach on the right side and if he took too big of a breath it would be all across his whole stomach. No emergency room nor physician office visit required. was confirmed all events have resolved on 22Oct2021 except the fatigue that was resolving (as of this morning it is a little bit better).
Back aching, taking Tylenol, r/arm f/u, no redness, felt like real bad bruise, but no discolor, feels warm to touch, very slight swelling, no pain @ time of inject, weak and dizziness.
3/28/21 Patient presented to the ED with peakness, poor po intake and diarrhea. In ED, RA pulse ox wa 88%. Pt was placed on O2 and admitted for COVID pneumonia. He was outside window for Remdesivir. Was started on IV Decadron. He gradually worsened ind required higher O2 concentration. He was proned. Imaging showed worsening infiltrates. ID was consulted and recommended adding Tocilizumab.-administered 4/1. He had significant improvement and was discharged to home on oxygen 2L per NC on 4/2.
I had swelling and fluid retention that started in my stomach and then lower legs then thighs arms and face. The edema is worse when I am active. It has gotten so significant that it effects the way I walk. I also then feel extreme fatigue after exertion. For example after working three 12s I will sleep for 24 hours straight which is not at all normal. I also have muscle pain when the edema starts to subside. And shooting pain in joints especially.
Chills, sweating, throbbing headache, terrible body aches, fatigue, malaise, sore left arm
At 2:30 pm on 7/22/2008, fever started 99 degrees, in 1/2 hour went up to 101 degrees. Seizure started went to ER in Ambulance, seizure lasted 45 minutes given VALIUM and seizure medication, admitted to PICU given antibiotics. 1 week later fever up to 103 degrees with rash all over body. The next two months constant fevers, rashes and hives. Also his lymph nodes in groin were swelled. 3/18/09-records received for DOS 7/22-7/25/08- DC DX: new onset seizure. Admitted in status epilepticus reuiring sedation and mechanical ventilation, subsequently extubated.  DC Summary received for DOS 8/4-8/7/08-DC DX: fever, rash, lymphadenopathy resolving possibly viral. Neutropenia getting better. Seizure disorder. Admitted with fever for 4 days with diffuse rash for 3 days and mild edema  of lower extremities and bilateral inguinal lymphadenopathy of 3 months duration. Rash fine lacy erythematous.
expired Moderna vaccine administered to patients; Vaccine was expired on 01 Apr 2022 and stored in refrigerator on 05 Apr 2022 and administered between 06-Apr-2022 to 09-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01 Apr 2022 and stored in refrigerator on 05 Apr 2022 and administered between 06-Apr-2022 to 09-Apr-2022) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01 Apr 2022 and stored in refrigerator on 05 Apr 2022 and administered between 06-Apr-2022 to 09-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01 Apr 2022 and stored in refrigerator on 05 Apr 2022 and administered between 06-Apr-2022 to 09-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The administration occurred from 06-Apr-2022 to 09-Apr-2022.  The vial did not undergo any temperature excursion. Patients did not reported any adverse reactions.  No treatment medications were reported.   This case was linked to MOD-2022-538692 (Patient Link).
gasping, not self, fever up to 103 @ home; 99.4 in office PE on 27MAY neg;
A little tenderness/tender to touch; Radiating leg pain; Shooting pain; Like nerve pain (not muscle pain); A little pain at injection site, only if she touches it; Super slight headache; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (A little tenderness/tender to touch), PAIN IN EXTREMITY (Radiating leg pain), PAIN (Shooting pain), NEURALGIA (Like nerve pain (not muscle pain)) and VACCINATION SITE PAIN (A little pain at injection site, only if she touches it) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 immunisation: J&J (Batch Number-1805022) on 11-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J.  On 03-Nov-2021 at 4:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (A little tenderness/tender to touch), PAIN IN EXTREMITY (Radiating leg pain), PAIN (Shooting pain), NEURALGIA (Like nerve pain (not muscle pain)), VACCINATION SITE PAIN (A little pain at injection site, only if she touches it) and HEADACHE (Super slight headache). At the time of the report, TENDERNESS (A little tenderness/tender to touch), PAIN IN EXTREMITY (Radiating leg pain), PAIN (Shooting pain), NEURALGIA (Like nerve pain (not muscle pain)), VACCINATION SITE PAIN (A little pain at injection site, only if she touches it) and HEADACHE (Super slight headache) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.
Pt recvd 1st dose of Engerix-B FEB91 & some day later felt paresthesias in one foot & "bad pain to walk" 3 wks p/vax pt hospitalized; dx multiple sclerosis was made; MD stated that this event is unlikely related to the vax;
Received shot in right arm on 9/11/21.  On 9/12/21, my left eyelid and underneath my eye began swelling.  I took Benadryl by capsule, and rested all day.  The swelling was decreased somewhat by Monday, 9/13/21, but still present.  Swelling abated by Tuesday, 9/14.  However, I woke up with swelling in both eyelids on Monday, 9/20/21.  The right eye began to itch (inside) at about 3 p.m., and a large bump appeared on the inside of the right eyelid.  I took Benadryl again, and the bump went away several hours later.  I am still somewhat swollen in both eye areas as of Tuesday, 9/21/21.  I also have had a headache for the past two days, which may or may not be related to the vaccine reaction.
Admitted to hospital 4/5/21 with DX pneumonia & anemia ( Hgb 6.7). Visit to PCP 4/3/21, chest X ray done, showing developing pneumonia. Abx prescribed but not filled by pt. Pt remains inpatient.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: patient was given shot by immuizing tech. patient and vaccine were both double verified with patient. A man with patient states she isnt feeling too well. immunizing tech lets pharmacist know. pharmacist sees patient, she states she is lighteheaded and feels warm. Patients presentation was inline with syncope reaction. cold water was offered and gotten for the patient. pharmacist stayed with patient 15M until patient stated she was feeling better. told patient to ask if anything else was needed
Nausea, followed by several episodes of vomiting, diarrhea and chills.
Patient was fine all day then complained at about 9:00 p.m. that his arm was hurting he had no fever and didn't want to take Tylenol. I took him up to bed with me to try to get him to sleep after some fussing he fell asleep after about 10 minutes I heard him making a strange noise he was stiff as a board and convulsing we immediately called 911 and he was taken to the ER at hospital.
Around 6 pm after receiving the vaccine, I had a massive headache (felt like my head was being compressed severely), chills and body aches all over, pain and swelling at the injection site, nausea, a fever of 100 F, and my bones feeling brittle/weak.  I had blankets piled on me, an ice pack on my head, and two ibuprofen.   The fever broke over night and the headache reduced over night as well. The oter symptoms became less severe over the course of the 28th and are only remnant on the 29th. The arm pain and swelling are still present and I have muscle tension and pain pulsing up the left upper back/ neck area.
high fever day of vax & for 2 days following vax (104-105); sl irritability responded to APAP;
Shortly after the 2nd dose of Pfizer, my son started getting headaches, nausea and fever. About 1 week after the 2nd dose, my son started getting rapid heartbeats and trouble breathing. Waiting to see a cardiologist March 7th. I wish we could see one tomorrow. This is very upsetting.
Round rash on left shoulder and swelling lips 1 week after they wont  stop swelling
Severe headache on right side of the head, pain irradiates to neck and right side of the face, nauseous
No adverse event; Received first dose more than 35 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose more than 35 days ago) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    In January 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In January 2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose more than 35 days ago). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose more than 35 days ago) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), 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 (Received first dose more than 35 days ago).    No concomitant medications were reported. No treatment details were reported.   This case was linked to MODERNATX, INC. (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.Patient-2 case