chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients; No adverse event; vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and NO ADVERSE EVENT (No adverse event) in a 46-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022 at 3:57 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 dosage form. On 21-Sep-2022 at 3:57 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients).    Concomitant medication information was not provided. The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients. On 07 Sep 2022 vials moved from freezer to refrigerator The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle. The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle. No treatment information was provided.
This spontaneous case was initially received on 29-Sep-2015. Follow up information received on 30-Sep-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on unknown dates, Batch no: 11449211A, Route of administration: intramuscular, Dose: 0.5 ml. AFLURIA was stored at 41 degrees Fahrenheit and was not exposed to any temperature excursions. It was monitored with a digital thermometer between 38-44 degrees Fahrenheit and the alarm sounds if the temperature exceeded this range. No additional drugs suspected. On an unspecified date, the patient received an intramuscular dose of AFLURIA that may have contained a black particle floating in the vaccine (small protein-like particles), The particle was 1 mm T-shaped suspended in the solution (did not dissolve when shaken for a few seconds), described as looking like a 'piece of pepper'. The AFLURIA vial with PharmaJet device was punctured once with the adaptor cap. The particulate/foreign matter did not appear to be a piece of rubber stopper. After the pharmacist saw the black particle, he started to inspect the other vials. He could see 'white matter suspended in the solution, they look like proteins'. They appear as red shapes but some looked like 'flakes'. Some appeared big and some are small, but they did not float. It was very hard to see and only visible when a piece of paper was held up to the vial. It was noticed after removal from carton. No adverse reaction since receiving the vaccine. The pharmacist had quarantined  the vaccine. No additional information was available. The outcome was not reported. Reporter's assessment: non-serious. Reported the terms 'Medication error' and 'Quality defect'. As part of the investigation undertaken for this complaint, description testing was performed for the returned sample. The description testing confirmed the reported complaint. Further analysis by FTIR and SEM (scanning Election Microscopy) and EDS (Energy-Dispersive X-Ray Spectroscopy) was performed and determined the composition of the particle to bot be similar to the vial stopper. The bulk reference sample were inspected and found to be of normal appearance for the vaccine and the retention sample inspection also met the standard description of AFLURIA vaccine. The analysis of the particle shows the dimensions as approximately 665 x 610 microns. Given these dimensions, it would not have been possible for the particle to have passed through any of the filtration steps listed above. There have been no other complaints reported for this batch. Also, to date, there have been no reported complaints for particles in the sister batch (dispensed from the same bulk). In conclusion, the investigation demonstrates that the particle was most likely introduced into the vial from an unidentified external source after the stopper had been pierced. Case correction (31-Mar-2016): AE 1 and 2 re-coded to better terms and AE 3 was deleted.
I experienced occasional ringing in the ears after receiving the vaccine, but no other noticeable side effects during the first 48+ hours. However, soon after the 2-day mark had passed, I developed tinnitus (ringing in the ears) that has now been continuous for 24 hours.
"Pfizer-BioNTech COVID-19 Vaccine EUA"  About 2 minutes after receiving my first dose, I had several common symptoms such as tiredness and soreness. However, I started feeling very lightheaded and felt like my hearing wasn't as good for up to ten minutes after the onset of symptoms. About 15 minutes later and having a piece of candy along with some water, I felt much better and was able to drive home and go about the rest of my day.
Initial solicited report received from a consumer (online market research respondent) in the study on 09 September 2015. The subject (gender and age were not reported) experienced an adverse event on an unspecified date, after receiving a dose of influenza vaccine (manufacturer unknown) (date of vaccination, site and route of administration and batch number were not reported). Medical history and concomitant therapy details were not reported. The subject experienced an adverse reaction to Flu shot which was received in the past. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
High fever (102 F) for 3 days and febrile seizure on day 2.
Localized swelling, pain, redness, fever. Swollen lymph node over left clavicle (vaccine in left arm). Pain, achiness, swollen lymph node persisting for 3 weeks.
Sore arm initially,  mild headache and slight runny nose. Three days later I still had a dull headache  and noticed itching at the injection site.  Four days later I noticed a large rash on my arm that was hot and itchy . I contacted my Doctor and was,advised to take an antihistamine like Claritin .
Red, slight swelling and warm to touch. Arm was sore throughout day and pt felt tired and achy all over. Noticed redness Wednesday evening.
"white" as a ghost, hard to arouse, high pitched screaming evening of immun;
Headache, fever (100.1), muscle pain in legs and arms, chills, and hoarseness.    Took 1 ibuprofen every four hours.   All conditions gradually improved over next two days.  Back to normal on third day
Patient received vaccination within 3 days began to have low grade fever was assessed by personal physician.  Reported to have low grade fever, achiness and fatigue.  Dr. was concerned that patient may have been having a reaction to Yellow Fever immunization.  1 day later fever appeared to be waning, productive cough developed.  Writer encouraged Primary care MD to perform Influenza culture.  Unsure if that was done.
Immediately could taste the vaccine. Sore, Tired, pain at injection site.  No big deal .  My brain was foggy - impaired - felt dizzy - or unbalanced  - next day missed work .  My head felt like in a vice.  Terrible. pain.  This was really scary - I did not know if I was so tired - it was effecting me this way - but honestly I was worried about having a stroke or something similar.  I had the shot on Tuesday morning - felt impaired somewhat on Tuesday day - really unwell - but Wednesday - was afraid to drive - as felt mentally impaired.  Friday today - I  am taking 4000 milligrams of Tylenol per day and it is helping.  I am much better today.   I hope I will be all better tomorrow.
This spontaneous report has been received from the medical assistant refers to a 12 months old male patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to the patient included sterile diluent (MRK INJ) used to reconstitute the VARIVAX was properly stored. On 05-JUN-2018, the patient was vaccinated with improperly stored doses of VARIVAX (dose, units and frequency not reported) (lot# N031001 and expiration date 03-NOV-2019), subcutaneously. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (degree F) to 14 degree F (also reported as "9F") for a time frame of 10 minutes; and of 15 degree F to 46 degree F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1806USA001756.
pt recvd vax; exp approximately 300 chicken pox lesions;md reported 2 patients who devel chicken pox p/ vax;
Patient received an undiluted 0.2ml dose of this vaccine. No adverse reactions, events or symptoms observed 15 minutes post vaccination on 11/30/2022 or reported by mother on follow up 12/01/2022.
Symptoms began late evening on day vaccine was administered and included chills, aches, shortness of breath, nausea, tachycardia and cough.  Symptoms lasted until the next morning then subsided. No treatment was required.
-Redness, round, swollen, warm, 3-4 inches diameter on RA.
approx 26 hr p/vax pt devel significant pallor, hypotonia & lethargy; adm overnoc for observation; resolved @ 40 hr p/vax given;
severe Running nose, severe watery eyes, running eyes, red eyes, inflamed eyes, itchy eyes, sandpaper effect on touching eyes, pain on both eyes. blurry eye sight from 5am Thursday morning 5/3 Treated with  Muro 128,  Tobramycin and Dexamethasone Ophthalmic Suspension
Now I'm sick; This is a spontaneous report received from a non-contactable consumer or other non hcp via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date as 1st dose, single and received second dose via an unspecified route of administration on an unknown date as 2nd dose, single both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient got sick. Patient wanted to know that what could he do about it. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
has had swollen arm for more than 48 hours/it is red, hot and hard; has had swollen arm for more than 48 hours/it is red, hot and hard; has had swollen arm for more than 48 hours/it is red, hot and hard; has had swollen arm for more than 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (has had swollen arm for more than 48 hours/it is red, hot and hard), VACCINATION SITE INDURATION (has had swollen arm for more than 48 hours/it is red, hot and hard), VACCINATION SITE ERYTHEMA (has had swollen arm for more than 48 hours/it is red, hot and hard) and VACCINATION SITE SWELLING (has had swollen arm for more than 48 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (has had swollen arm for more than 48 hours/it is red, hot and hard), VACCINATION SITE INDURATION (has had swollen arm for more than 48 hours/it is red, hot and hard), VACCINATION SITE ERYTHEMA (has had swollen arm for more than 48 hours/it is red, hot and hard) and VACCINATION SITE SWELLING (has had swollen arm for more than 48 hours). At the time of the report, VACCINATION SITE WARMTH (has had swollen arm for more than 48 hours/it is red, hot and hard), VACCINATION SITE INDURATION (has had swollen arm for more than 48 hours/it is red, hot and hard), VACCINATION SITE ERYTHEMA (has had swollen arm for more than 48 hours/it is red, hot and hard) and VACCINATION SITE SWELLING (has had swollen arm for more than 48 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or concomitant medications was provided. On an unknown dates, unspecified number of unspecified patients received improperly stored doses of (Merck) PROQUAD injection, lot # K009891, expiration date 11-JAN-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of the several report received from the same reporter. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, the patient was in his late 60's. The patient experienced very sore arm which was rated as 7 on the scale of 1 to 10, for approximately 3 days. The reporter did not agree for follow up.
Patient ran a low grade fever right after his Hep B vaccination, He was taken to emergency room for seizures, he was treated and released, Patient is seeing a neurologist and is being treated for epilepsy and Tourettes Syndrome, and is currently taking Trileptal for control of his seizures and tics, tics started occuring same time as his seizures, which consist of clearing of throat, uncontrollable body movement, cursing, out of control behavior, rolling of eyes, repetitive movement of muscles. Started noticing changes in patient's behavior, and physical well being less than two weeks after his Hep B vaccination.
Patient presented with sever pain over on 3rd branch of trigeminal distribution. Patient had recently been to dentist without revealing in dental issue causing pain. Patient described triggers of pain which included chewing or light touching of the face. Patient stated symptoms began after 2nd dose of the Pfizer vaccine. Denies any febrile illness or other complaints
Patient states that developed redness and warmth at the site of the injection on 10/25/11.  Patients reported by 10/28/11 warth has resolved and redness is fading.
Chest pain.   Hurts to inhale as well as bend over. Could not sleep.     Leg and shoulder pain as well.
Injection site swelling; Injection site hardening; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site swelling and injection site induration. On an unknown date, the outcome of the injection site swelling and injection site induration were recovered/resolved.   It was unknown if the reporter considered the injection site swelling and injection site induration to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced swelling and hardness at the injection site for five days after the administration of Bexsero.
pain in right arm redness swelling; pain in right arm redness swelling; pain in right arm redness swelling; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9261), via an unspecified route of administration in the right arm, on 22Jan2021 at 17:00 (at the age of 55-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atorvastatin calcium (LIPITOR). The patient experienced pain in right arm redness swelling on 23Jan2021. The events were reported as non-serious. The patient did not receive any treatment for the events. The clinical outcome of pain in right arm redness swelling was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Mom noted bruising and purple dots from knee down to foot. No swelling No fevers. Received 2 injections (L) thigh (where reaction noted) Hep B and PENTACEL.
Patient rec'd 3rd dose to early.  Rec'd 3rd dose 5 weeks after 2nd dose.  No treatment needed, no adverse reaction.
p/vax pt devel a palm sized area of rash @ the inj site which was resolving @ the time of this report 5/12/99;
URINARY TRACT INFECTION SYMPTOMS (URGENCY TO URINATE AND BURNING)/ ELEVATED WBC AND NITRATES; UPSET STOMACH; INCREASED FREQUENCY OF BOWEL MOVEMENTS/NUMBER 2 MORE OFTEN; STIFF NECK; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 235 pounds, and height was 64 inches. The patient's past medical history included hysterectomy, gall bladder removal, lost voice, urinary tract infections, factor v leiden, and biceps tenodesis, and concurrent conditions included high blood pressure, seasonal allergies, and environmental allergies ( cannot use cleaners wheeze and headache with bleach, perfume).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included salbutamol for allergies, amlodipine for high blood pressure, lisinopril for high blood pressure, and epinephrine for stings. On 09-APR-2021, the subject experienced stiff neck. On JUN-2021, the subject experienced upset stomach. On JUN-2021, the subject experienced increased frequency of bowel movements/number 2 more often. On 16-JUN-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Enlarged liver, but her bladder was emptying properly, and Urine analysis (NR: not provided) Not reported. On an unspecified date, the subject experienced urinary tract infection symptoms (urgency to urinate and burning) / elevated wbc and nitrates. Laboratory data (dates unspecified) included: Urinalysis (NR: not provided) positive for increased WBC, nitrates and negative for infection, positive urinary tract infections. Treatment medications (dates unspecified) included: ibuprofen, nitrofurantoin, azithromycin, phenazopyridine, and phenazopyridine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from urinary tract infection symptoms (urgency to urinate and burning)/ elevated wbc and nitrates, and increased frequency of bowel movements/number 2 more often, and had not recovered from stiff neck, and upset stomach. This report was non-serious.
I had a lot of soreness  in my arm on the day of the shot. The following day I got very sick which lasted for about a week. I lost my voice and had a lot of congestion. I think I had a fever at one point and had some body aches.