chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The 1st shot only had the red mark on arm with injection that lasted 4 days; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 74-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6203) intramuscularly in left arm on 24Feb2021 09:15 dose 1, single (at the age of 74-years-old) for COVID-19 immunization. Vaccination facility type was reported as workplace clinic. Patient was not pregnant at the time of vaccination. Medical history included blood potassium low, low thyroid, chronic obstructive pulmonary disease (COPD), bladder cancer stage IV (Stage 4 Invasive bladder cancer with metastasis to liver survivor), contrast media allergy (Contrast Dye), allergic transfusion (AB+ platelets), and allergy (rash) to Zoster vaccine. The patient had received other medications within 2 weeks prior to the vaccination. The patient had previously received VARICELLA ZOSTER VACCINE on 19Jul2014 for immunization and experienced allergy (rash). Patient had a similar reaction to Zoster Shingle shot on 19Jul2014 that lasted over 44 days. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19, since the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On unspecified date in Feb2021, the patient reported the first shot only had the red mark on arm with injection that lasted 4 days. The reported seriousness of the report was non-serious. Patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6207) intramuscularly in left arm on 20Mar2021 09:00 as dose 2, single for COVID-19 immunization. Measle like rash primarily on arms and legs from second injection. The outcome of the event was resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
65yo patient presents to clinic for evaluation of a suspected vaccine reaction. The patient received pneumococcal vaccine and two days later developed a fever, and tender red arm. Arthralgias and fatigue were also noted. The patient was given MEDROL dosepak. Patient improved.
Pain between breasts, felt like burp or air, dull sharp, nausea, took two Bayer and water.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: pt alerted pharmacist not feeling well, feeling dizzy/faint,  I ( the pharmacist) instructd pt to stay >15 minutes, lay on floor, elevate feet, provided water.  patient then stated felt like tongue tingling, swelling, hard to swallow/talk, (similar reaction in past to sulfa when presented to er w/ anaphlaxis) administer 1 dose epipen 615 pm,, bp 165/134, 101 hr (620 pm,), paramedics called
Came down with COVID; Arm got swollen; Not been feeling good; Chills; Headache from heck; Arm became sore again; Bones ached; Back hurts; Legs hurt; Arm is throbbing; Skin burns; Skin itches; Sore to the touch initially; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm became sore again), BONE PAIN (Bones ached), BACK PAIN (Back hurts), VACCINATION SITE PAIN (Legs hurt) and LIMB DISCOMFORT (Arm is throbbing) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD and Osteopenia. Concomitant products included UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO), ESTROGENS CONJUGATED (PREMARIN), MULTIVITAMINS [VITAMINS NOS] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore to the touch initially). On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm became sore again), BONE PAIN (Bones ached), BACK PAIN (Back hurts), VACCINATION SITE PAIN (Legs hurt), LIMB DISCOMFORT (Arm is throbbing), SKIN BURNING SENSATION (Skin burns), PRURITUS (Skin itches), CHILLS (Chills) and HEADACHE (Headache from heck). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Came down with COVID), PERIPHERAL SWELLING (Arm got swollen) and FEELING ABNORMAL (Not been feeling good). The patient was treated with PARACETAMOL (TYLENOL) on 10-Feb-2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Arm became sore again), BONE PAIN (Bones ached), BACK PAIN (Back hurts), VACCINATION SITE PAIN (Legs hurt), LIMB DISCOMFORT (Arm is throbbing), SKIN BURNING SENSATION (Skin burns), PRURITUS (Skin itches), PERIPHERAL SWELLING (Arm got swollen), CHILLS (Chills), HEADACHE (Headache from hell) and VACCINATION SITE PAIN (Sore to the touch initially) had resolved and EXPOSURE TO SARS-COV-2 (Came down with COVID) and FEELING ABNORMAL (Not been feeling good) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, SARS-CoV-2 test: positive (Positive) Covid positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 16 Jul 2021 the patient tested positive for COVID-19. The patient claimed to have no symptoms of COVID-19 and was tested only because her husband tested positive.   This case was linked to MOD21-10528 (E2B Linked Report). This case was linked to MOD-2021-012733 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up information received on 29-JUL-2021 contains significant information events and events outcome updated and new lab data added.; Sender's Comments:  MOD21-10528:
Information has been received from a certified medical assistant concerning an unspecified patient (unknown age and gender). Information about concurrent condition, concomitant medication and medical history was not provided. It was reported that on 27-SEP-2016, the patient was administered an improperly stored dose of VARIVAX lot # M025867, expiration date 24-MAY-2018, (dosage was not provided), administered per subcutaneous route, for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Follow-up information has been received on 06-DEC-2016 from the medical assistant referring to the 17 year old female patient. On 22-SEP-2016, a total of 40 doses of VARIVAX (lot # M025867, expiration date 24-MAY-2018) was shipped and delivered to the clinic. The day it was delivered, it was given to the pharmacy. During that time, the shipment remained there for a total of 4 days and/or 96 hours, still in the original shipped packaging. It was never placed in the proper storage setting, the freezer. The vaccine was left out in its original shipped packaging at room temperature estimated at worst case scenario of 70 F for 4 days and/or 96 hours. On the evening/close of the 4th day (18:00), it was placed in the refrigerator rather than the freezer. After speaking to the pharmacy, the reporter learned that the refrigerator was estimated to be at 40 F overnight. Therefore, the VARIVAX vaccine was in the refrigerator for a total of 13 hours at 40 F. On the 5th day, 27-SEP-2016, it was informed by the pharmacy that the shipment of VARIVAX was located there, in the refrigerator. Thereafter, the VARIVAX was immediately counted and stored back in the freezer, its proper location. On 27-SEP-2016 at 8:20 AM, 1 dose of the improperly stored vaccine was actually given to the patient (first dose) in her right arm. Additional information is not expected because all follow ups requested to complete the case were received. Patient, product, AE information and narrative were updated. Sender's Comments: MERCK 1609USA013452:Mfr number.
Left arm axillary lymph node swelling starting 01/18 and still continues; 2nd COVID injection received 02/05 right arm; Large swollen red areas bilateral knees, right ankle started 02/08
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    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 EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 16-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Initial report received from literature on 12 August 2014. It was reported that 21 patients (age and gender not reported), whose medical history was reported as none and concomitant medication were not reported, had received 0.5 ml of INFLUENZA VACCINE (number of dose, batch number, route and site of vaccination not reported) on an unspecified date. On an unspecified date, all 21 patients confirmed influenza positive infection and the case were reported as vaccination failure case. Design/Method: prospective cohort study was conducted over two influenza seasons (2012-2014) in order to assess seasonal variation in influenza infection. Result: During the study conduct 112 patients were enrolled. Median Absolute lymphocyte count at vaccination was reported as 776 cells/mm3. Sixty-eight percent (65/112) were lymphopenic at vaccination. Twenty-three patients had complete serologic data for influenza season one, and 74% had a sero-response to the vaccine. Median ALC at vaccination was not different among sero-responders versus non-responders. Twenty-nine (32/112) reported symptoms consistent with ILI. Median ALC at vaccination in patients with ILI was 646 11s/mm3 versus 836 cells/mm3 in ILI-negative patients. Twenty-one patients had confirmed influenza positive infection. The median ALC at vaccination for influenza positive patients was 530 cells/mm3. There was no statistically significant difference in median ALC between influenza positive and negative patients who received the vaccine. Clinical complications included (1) inpatient hospitalization for influenza symptoms in 29% (6/21), concurrent bacteremia in 20% (4/21), and delayed chemotherapy in 100% (21/21). Conclusion: Influenza infection remains a significant source of morbidity in children undergoing chemotherapy. Lymphopenia at the time of vaccination did not affect immunogenic response. Correlations between immune response and clinical symptoms could not be assessed during influenza season due to limited complete serologic data. An additional sixty-seven patients (145 totals) have been enrolled in influenza season two, and complete serologic data has been obtained on a majority of Patients. Corrective treatment was not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none.
On 3-10-21 at 1pm PST I entered a room at PCP office. Pt already prepared the Hep. B vaccine.  I thought this was strange.  With all the people in the nation dying from Covid-19 vaccinations, the nurse should of waited until I was in the room to see her prepare the vaccination for my safety.  Instead she tried to administer the shot without my verification of the contents.  Before administering the shot I stood to verify the empty bottle which state Hep. B vaccine.  When the nurse administered the shot I immediately got a metallic taste in my mouth.  After I left the doctors office and around 2pm  my throat became sore  to the point it felt as if I could not breathe and had a hard time swallowing.  I felt dizzy as well.  Under my chin is very sore as well.
This case was reported by a pharmacist and described the occurrence of hard lump at injection site in an unspecified number of subjects of unspecified age and gender who were vaccinated with FLUARIX (GlaxoSmithKline). On unspecified date(s) the subject(s) received a dose of FLUARIX (unknown details) and experienced hard lump at injection site. The reporter stated "multiple patients who have received FLUARIX complained about a hard lump at the injection site." At the time of reporting the outcome of the event was unspecified.
Fever in ear of 102.9, rigors, body weakness, body pain, fatigue. Took Tylenol 1000mg, hydrating with water.
THE PATIENT IS ONLY 50 YEARS OLD BUT WAS MISTAKENLY GIVEN THE FLUAD FORMULATION INSTEAD OF THE FLUCELVAX THAT WE WOULD HAVE NORMALLY HAVE GIVEN A PATIENT HER AGE. PHARMACIST GIVING THE VACCINE, NOTIFIED THIS WRITER OF THE ERROR IMMEDIATELY AFTER IT OCCURRED, PATIENT WAS EDUCATED REGARDING THE ERROR AND INFORMED THAT THE VACCINE SHOULD STILL BE EFFECTIVE (ARGUABLY, MORE EFFECTIVE), AND APOLOGIZED FOR THE MISTAKE.
Throat swelling Syncopal episode Fever Shaking chills Wheezing Muscle cramps Skin red/hot Joint pain
I administered the AFLURIA vaccine on 10-23-15. Patient's wife called 11-18-15 stating that her arm and her husband's arm was having pain in their shoulder joint, in the arm where the shot was given. She said patient could not lay on his arm at night to sleep. She said it was not the injection site but the shoulder joint.
Last November it  began with the weakness in my legs and my collapse on my walk.  I took a shower and then went to Urgent Care.  Since I had not broken any bones they sent me home.  A few days later the tingling began in my legs and it would radiate up into my body.  I was never provided medication.  It began to get better towards the end of January.  By the time I got around to having my MRI the symptoms went away.  Since February 2022 the symptoms have not appeared again but my legs are weaker than they used to be.  I have not been walking as much as I used to.
24 hrs p/ admin, devel rt cervical lymph node swelling & rt submandibular gland tenderness & swelling. No fever, no other nodes & no ear s/s.
NO ADVERSE REACTION NOTED; CLIENT WAS 17 YEARS OLD AT TIME OF VACCINATION.
pt was given rabies vax 30SEP97 came into ER on 3OCT97 w/c/o vomiting, cough rash;also had acute suicide ideation;
Pain, redness, and swelling at vaccination site, along with mild generalized malaise. Area of erythema and induration reached approximately 6 x 10 cm at its maximal extent on 2/08/2014.
pt recvd vax & devel throbotic thrombocytopenic purpura
This spontaneous report was received from an office manager and refers to a 13 month-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 25-OCT-2016, the patient was vaccinated with the first improperly stored dose of  VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 70-year-old female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site warmth, injection site pain, injection site rash and injection site itching. On an unknown date, the outcome of the injection site warmth, injection site pain, injection site rash and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site warmth, injection site pain, injection site rash and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient had heat, pain, bumps and itching at the injection site. The patient initially reported to her physician that these symptoms lasted for 21 days. When the pharmacist spoke with the patient she said it was might be a couple weeks. The dose of SHINGRIX was not given at the reporter's pharmacy.
pt recvd vax 1530 11DEC92; At home devel shaking chills (not tonic clonic sz), cyanosis, & apnea; called ambulance, responded to 02 in ambulance; In ER t102.9, rt ear sl red, acting tired, in a daze, turned blue; poss pseudoseizure; URI pos
sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact
Tinnitus became much worse 6 days after vaccination. (I have had tinnitus for about 20 years. It has been stable for the last 10 years.)
Information has been received from a nurse concerning a 9 year old female who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced injection site reaction of swelling and itching that lasted for more than three days. Medical attention was sought. The patient has been recovering. No product quality complaint was involved. This one of two reports from the same source (WAES0708USA05334). Further information has been requested.
Baby was found to have no heart beat on 28 week check up 4/7/21. Was found to have blood clot in placenta. All work up for possible disorders that can cause blood clots have been negative. No prior hx of blood clots.
On the 8th day after the 1st dose of the vaccine, I became dizzy when laying down on my back and upon sitting up. This has continued for a week whether laying on my back with a spinning fewling in my head with or without my eyes closed as well as when going to pick something up on the ground whether in a standing or sitting position.  This has occurred approximately 2 to 3 times daily that I have noticed.
Myalgia, Fever, NauseaVomiting, fatigue, chills Narrative:
Shots given 10/21/02-returned to office 10/24/02 with swollen right leg. No redness, 2 days fever. CT scan of abdomen negative. Improved over 7-10 days.
Patient complaining of continuous pain at injection site, progressive weakness and tremors in Left arm (vaccination site). Patient had not sought evaluation from her primary medical provider.  Advised to follow up with PMD for clinical evaluation.
The night after the shot I became ill with mild flulike symptoms: headache, fever of 101, aches, chills. This seemed fully within what I had expected and been told might happen, but as these symptoms eased up over the next 48 hours, I experienced, and continue to experience, a weird neurological paresthesia-type symptom where it feels as though my skin is covered in some kind of cold minty lotion. (Not the same as chills, though it sounds like it, I realize.) Mostly on my upper back, but also at the injection site, and sometimes other places too. Not painful, just distracting and  kind of worrying. Not anything I have ever experienced before, and not related to any sort of external variable. I consulted with both a doctor and my brother and his wife (both doctors) by telephone. Everyone has advised a wait and see approach, but my brother (an epidemiologist) recommended that I report this as an adverse event.
Patient refers with numbness in the left arm then it manifested to the right arm it continues after the first dose since day 17/08/21. Patient with 5 months of pregnancy is recommended to visit her medical doctor to tell him a her symptoms.
4 hours after vaccination:  foreign body sensation in throat, dry cough 6 hours after vaccination:  fatigue, low-grade fever (temperature not taken), uncontrollable chills/rigors, muscle aches (entire body), injected eyes ("bloodshot") 7 hours after vaccination:  Treatment with Advil 400 mg 2 hours after Advil:  improvement in symptoms 8 hours after Advil:  further improvement except for tiredness
Ocular hyperemia, eye discharge, stomatitis, wheezing, face red, pharyngolaryngeal pain, vomiting, pain. This non serious case was received on 11 march 2009 from VAERS (reference number 265980) via a search of the QSCAN database. A 43 year old female patient received FLUZONE SV 2006-2007 (lot number U2717AA, which is invalid) intramuscularly on 02 November 2006. Approximately two hours after receiving flu vaccine the in side of the patient's mouth began burning and stinging. Her throat hurt and felt "like something was in it". Her face became red, eyes became bloodshot with a mucousy discharge. She began wheezing, vomiting, and became achy. She went to the urgent care facility and was given an anti-histamine. The patient reported a similar reaction to a flu vaccine which happened the prior year (manufacturer not provided). The patient was reported as recovered.
See narrative Narrative:  An individual who is both an employee and a Veteran received a first dose on 3/9, which was documented in system under the employee heading. The individual was then confused and scheduled an appointment as a Veteran on 3/18. The error was not discovered until after the 3/18 dose was given.  Other Relevant History:
TEMPERATURE EXCURSION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021, the subject experienced temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of temperature excursion was not reported. This report was non-serious.