chrisvoncsefalvay/vaers-outcomes huggingface dataset:
still dealing with pain in my arm / pain is awful / been hurting since December 29th,2020; This case was reported by consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1 st dose on an unknown date).   In December 2020, the patient received the 2nd dose of Shingles vaccine. On 29th December 2020, less than a month after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details was reported as follows: The case was reported by patient herself. The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  The patient received 2nd dose and experienced pain in arm. The second shot did not work well for patient. The patient stated that he/she still dealing with pain arm just like he/she got vaccinated day before reporting. The reporter stated that the pain was awful and patient hoped it goes away. The case has been linked with the case US2021AMR073666, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073666:same reporter
Bruise & redness at site of injection. Also red, itchy rash between breasts, which started 3/21/10- c/o pain/pressure at site of rash - no shortness of breath.
HEART ATTACK; COVID-19 PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; ELEVATED CREATININE; This spontaneous report received from a consumer concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included congestive heart failure. He was sick two weeks prior to hospitalization due to congestive heart failure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose, 1 total, administered in the beginning of MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included blood pressure and cholesterol medications. On 07-APR-2021, the patient went to the emergency room (ER) and was admitted to the hospital and was diagnosed with COVID-19 pneumonia and heart attack. He had suspected clinical vaccination failure. She reported of a positive COVID-19 test that was taken in the hospital and lab values showed everything as elevated. The reporter (daughter) also stated that her father had no issues with kidneys before but during hospitalization, he had elevated creatinine. During hospitalization, the patient received remdesevir, dexamethasone and was on heparin drip for first 4 days and was on bilevel positive airway pressure (BiPAP) machine and oxygen. He was stable and was going to be discharged from hospital later this afternoon on 13-APR-2021. He was hospitalized for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart attack, and covid-19 pneumonia, and the outcome of elevated creatinine and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused).; Sender's Comments: 20210424651-covid-19 vaccine ad26.cov2.s-Heart attack. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY  20210424651-covid-19 vaccine ad26.cov2.s- Covid19 Pneumonia. 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).  20210424651-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Incorrect pfizer covid vaccine was administered. Patient received the 10mcg/0.2ml concentration. No adverse events, signs/symptoms, or outcomes have been reported to this day.
Dose administered after manufacturer date of expiry; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 038A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 24-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    Concomitant product use was not provided by the reporter. Patient received vaccine at 01:04 PM . It has been reported that  vaccine had been frozen with no known temperature excursion before being thawed on 24-Feb-2023 for administration. Vial  did not go any temperature excursions. Individual vials or unbroken cartons were 4. Vial size was 5. Date the vial was initially stored in the refrigerator was 24-Feb-2023. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712705 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2023: Live follow up has been appended.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712705:Master case
On day post vax, the pt developed a local reaction of erythema on his left thigh. It was reported that this reaction was from the haemophilus b conjugate vaccine + hepatitis b vaccine recombinant (yeast). Additional information has been requested.
Patient was administered a dose from an expired vial.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported   This case was linked to MOD-2021-366918 (Patient Link).
Pt c/o nausea, vomiting, diarrhea, abdominal pain. x1 day. Treatment is supportive care.
Patient is a 69 Y female who presents to the Emergency Department brought in by ambulance as a transfer, accepted by orthopedics.  Patient reports a trip and mechanical fall resulting in open distal tib-fib fracture.  Ankle was reduced and splinted at outside hospital.  Patient denies any head injury, neck or back pain.  Patient was given Keflex and tetanus was updated at outside hospital.  On-call Ortho has booked OR for tomorrow morning.  Request for CT imaging of the lower extremity.  Of note, patient tested Covid positive at outside hospital.
Patient received 2nd moderna vaccine, patient was seated waiting his 15 min post vaccination. Patient fainted and fell out of chair onto floor. Patient hit his head when he hit the floor.
(L) ankle fracture - pain with standing/walking wears boot, takes meds. Prosthetic shoe on order. Low back pain arthritis. Sleep apnea uses CPAP.
Patient reported having hives and a rash starting this morning. They reported that the rash was itchy and extended down the arm she had the vaccine as well as up onto her shoulder and up to her neck. Patient self-treated rash with diphenhydramine 25mg and reported that it resolved the rash.
Immediate allergic reaction, tingling starting from the top of my head and moving down to my torso. Within 2 hours my whole body turned into one big hive and my asthma flared up. This lasted approximately 30 hours. 3 days after receiving the shot I developed "Covid arm" that lasted 3 days. I took consistent doses of Benadryl and Proair (albuterol) inhaler. I chose not to go to the ER because there was a reported 9 hour wait to be seen.
Information has been received from a registered nurse concerning a female employee who was vaccinated with her second dose of VARIVAX. The patient may have been vaccinated with lot # 61658/1135X. After vaccination, the patient developed swelling, erythema, and fever. The patient sought medical attention at the emergency room. The patient also had a reaction (unspecified) when she received the first dose as well. At the time of reporting (04-DEC-2008) the outcome of the patient was unknown. The nurse requested a lot search of VARIVAX. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. This is one of several cases from the same source. Additional information has been requested.
Lost my vision; Got shingles in the left eye - Valtite - anti-viral and prednisone eye drops - so far improved but not all the way better. (Ophthalmologist) January 7 tested positive for COVID and was very sick. Those symptoms began Jan 5 2021. Fever; chills; sinus; congestion; and shortness of breath and cough. Fatigue was the worse. They let me go back to work on 19th.  Not due to get the second dose until Feb 3.
Location: Mobile Vaccine Unit (MVU)    Incident date/ time: 5/20/22 1530pm  12 year old female accompanied by grandmother arrived at MVU site. (Patient's guardian.)   Grandmother registered the patient with the electronic registration system.   The vaccine was prepared and administered to the patient prior to verifying the patients current vaccine status.  Grandmother had the vaccine card and provided it to the team after the vaccine was given.   At this time it was realized that the patient had received a booster vaccine of Pfizer prior.  The patient had received a booster of Pfizer on 1/15/22.  Patient was held in observation for 15 minutes.  No reactions/ adverse effects noted while in observation at the MVU.  Patient ambulated home with grandmother without incident.  Phone call made to patient and family with region lead for Nurse as witness.   5-20-22  1852  great grandmother (legal guardian)  Situation was explained.  Informed 2nd booster was given in error.  No more vaccines at this time explained.   Calm and collected demeanor.  Patient without any current complaints.  Er precautions given.  Regional Lead for Nurse contact information was given.  1858 end of conversation
Patient's father returned to the pharmacy to report that patient was having soreness in her arm with sudden movements and that he thought it should have gone away at this point.  I agreed and told him that he may advise her to see a doctor if the pain continues.  Denies that it may be "in her head" as a result of her fear of needles.  Says it is causing her trouble when playing volleyball.  Despite her being an adult, he reported the adverse event to me because he was "going to be in pharmacy" so he told her he would ask for her.
Within 15 minutes developed throat swelling and chest tightness. Over the next few days developed paresthesias, cold sensations in extremities.
patient had a FLUZONE HD (0.5 ml pfs) from 2019-2020 season, and it was accidentally given to a patient with no adverse event; Initial information regarding this unsolicited valid non-serious case via The Agency (reference number: 00317517) received from pharmacist and transmitted to Sanofi 15-Oct-2020.  This case involved a male patient of unknown age who received a 0.5 mL dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (lot number and expiry date not reported) with pre-filled syringes accidentally via unknown route in unknown administration site, from 2019-2020 season, for prophylactic vaccination (accidental exposure to product).  Relevant medical history, past medical treatment, vaccination details and family history were not provided.  It was a case of actual medication error due to accidental exposure to product.  At the time of report, no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 03-SEP-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 for prophylaxis (strength, exact dose, route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions reported. Digital Data Logger was involved. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Starting 04/10/2022, I developed sinus infection symptoms: headache, sore throat, fatigue and sinus pressure. I tested positive on 04/11/2022 and I called my doctor on that monday 04/12/2022. She prescribed me Paxlovid. After taking the Paxlovid, my symptoms got a little milder but it took about a week for the major symptoms to resolve and only minor symptoms remained for another week or so (scratchy throat and post nasal drip). It basically felt like a sinus infection to me.
chills, severe body aches, weakness, headache, fever, nasal congestion X 24 hours some symptom improvement with Tylenol sore left upper arm and axillary area
Upset stomach, chills, body aches, drowsy, followed by vomiting and lose stool.
23 yo female c/o intermittent left sided chest pain -- in the evening after getting the second Pfizer earlier in the day. Chest pain was positional when she stands or turns from side to side. Had some relief with lying down. Was awakened with chest pain the day after the vaccine, felt chest pain and fatigue with walking. Has hx of Steven's Johnson syndrome from Tylenol. Denies shortness of breath. Chest pain 6-7/10. This patient was referred to the emergency room.
Pt presented to ER with vomiting and fever (100.8), lethargic per mother.  Pt received Motrin and Tigan supp.  Pt return to ER later with focal seizure activity per mother.  MD to rule out febrile seizures vs MMR reaction.
Information has been received from an investigator concerning a 17 month old male child who received Prevnar on 12/8/00. The next day, post vax, the child was taken to a local clinic with urticaria and angioedema. The child has since recovered. Angioedema was considered a "Medically Important Event". Both the investigator and the medical monitor agree that this event was 'possibly' related to vaccine administration. Follow up information was received on 03/09/2001 that clarified that the patient did not experience angioedema as originally reported. the patient experienced hives/urticaria only. Therefore, this report has been downgraded to non-serious.
Anaphylactic Reation.  everything swelled and rash appeared, couldn't swallow, throat constricting. Epinephrine injection, Racepinephrine, diphenhydramine methlprednisolone, famotidine  Day after feel like run over by a truck and nausea, feel sick, headache, joint pain not sure how long everything will last or if more will appear
child less active & not eating well since noc before 7/21/99; worse AM of 7/22/99;advised go to MD;upon arrival presented in resp distress/apnea, pale, poor perfusion & dusky;started 02 w/mask & pos pressure vent; paramedics called; remains
One week post injection (1/19)  red rash appeared slightly below the injection site.  Rash was warm and sensitive to the touch, tight, was slightly risen but not hard, covered top quarter of arm.   1/21 severe, splitting headache, feels like brain being squeezed at temples, fatigue and disoriented.  Took advil and that did not help.  Rash beginning to diminish.
Site: Redness at Injection Site-Mild, Systemic: TENDER BREAST, SWALLON LYMPH NODE-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: TENDER BREAST, SWALLON LYMPH NODE
Tightness in Chest; Tightness in throat; Difficulty in Breathing; Redness on face and chest; difficulty in swallowing; Throat irritation; Urticaria; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in Chest), OROPHARYNGEAL DISCOMFORT (Tightness in throat), DYSPNOEA (Difficulty in Breathing), ERYTHEMA (Redness on face and chest) and DYSPHAGIA (difficulty in swallowing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to antibiotics.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST DISCOMFORT (Tightness in Chest), OROPHARYNGEAL DISCOMFORT (Tightness in throat), DYSPNOEA (Difficulty in Breathing), ERYTHEMA (Redness on face and chest) and DYSPHAGIA (difficulty in swallowing). 08-Mar-2021, the patient experienced THROAT IRRITATION (Throat irritation) and URTICARIA (Urticaria). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) 08-Mar-2021 for Adverse event, at a dose of 25 mg twice a day. At the time of the report, CHEST DISCOMFORT (Tightness in Chest), OROPHARYNGEAL DISCOMFORT (Tightness in throat), DYSPNOEA (Difficulty in Breathing), ERYTHEMA (Redness on face and chest), DYSPHAGIA (difficulty in swallowing), THROAT IRRITATION (Throat irritation) and URTICARIA (Urticaria) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up was received from regulatory authority on 18-MAY-2021. Accepted VAERS ICSR as FU.  Dose of treatment medication- 'Benadryl' was updated. Additional events- throat irritation and Urticaria. were added.
I have had reaction and I am feeling pretty ill after the shot; This is a spontaneous report received from a contactable reporter The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EW0176) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I have had reaction and I am feeling pretty ill after the shot".  No follow-up attempts are possible. No further information is expected.
Immediately after injection, felt itching. I had taken 400 mg ibuprofen prior to my injection.  12hrs later, stiffness in right upper trapezius and shoulder, took 440 mg naproxen and felt great! 24 hours after 2nd dose, redness. Itching and swelling at injection site. Tired, cold, temp 100.4. Applied ice 20 min on/off throughout day, took ibuprofen 1/16/21. Today 1/17/21, still red, warm to touch and itchy. I took a photo because I couldn?t tell if red area bigger. temp  99.4, slight headache
Patient received the first Moderna covid vaccination on 12.28.2020 (lot 025J20-2A, expiration date 01.21.2021) and the second covid vaccination on 01.25.2021 (lot 025J20-2A, expiration date 02.25.2021). During routine PCR testing on 02.11.2021 she tested positive for covid, results returned on 02.13.2021. Runny nose began after the testing on 02.11.2021 and resolved by 02.15.2021.
09/28/201:30 pm vaccines. 5:30 pm 101.3 fever. Tylenol administered. Vomiting. 12am vomiting 102.7 fever. Lethargic. 1am 103 fever. Tylenol. Vomiting. Motrin 5:50 am febrile seizure lasting approximately 4 minutes. Followed by vomit. Taken to ER. Monitored and given Tylenol. Tylenol and Motrin were administered recommended by pediatrician and tepid bath and pushed fluids. Nothing would bring the fever down.  10/05/20: refusing to walk. Regressed to crawling. Fumbling and falling when trying to walk. Muscle weakness. Excessively tired. No appetite. Diarrhea
I have been experiencing muscle twitches in my left arm everyday since April 12th. The neurologist did not provide any treatment for it, since they claimed there is nothing that I could do about it and that they will continue to keep an eye on it for now.
Hives on trunk, Benadryl 25-50 q 4-6h. Prednisone 40mg T QD x 5 days.
Patient experienced light-headedness and syncope 5-10 minutes following administration. Patient began feeling normal again shortly after. Vitals checked normal by EMS personel and patient was released.
This spontaneous report as received from a physician refers to a 13 month old patient (unknown gender). Who on approximately 27-MAR-2013 "about three weeks ago" was inadvertently vaccinated with PNEUMOVAX 23 injection 25/0.5 Y, 5 ml, intramuscular (lot# reported as H010917 exp date: 17-FEB-2014). No adverse event was reported. Additional information has been requested.
This happened with the second dose. It started with itching and became worse. There are redness, swelling and rash at the site of injection. Patient said it started with small spots and spread.