chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; This is spontaneous report from a contactable nurse (patient, an oncology nurse navigator) via a company representative. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient received Pfizer COVID-19 vaccine and got a headache. Patient is a female and. The nurse was excited to share that they received the vaccine. Event took place after use of product. Outcome of the event was unknown.   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
Day of vaccine Urticaria Left arm (at site of injection). Day 2 no symptoms, Day 3 Urticaria on face, Day 4(today, day EE is reporting) tingling of lips
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.
R ARM PNEUMONI VACCINE SQ R ARM 10/11/07; PT STATE S/S BEGAN 10/12/07 WHICH INCLUDED SEVER HEADACHE, FEVER, CHILLS, RIGHT ARM EDEMA, REDENSS, AND WARMTH. ALSO HAD FLU VACCINE R DELTOID @ SAME TIME/DAY. PLANS TO GO TO PMD TODAY
On 3/28, I began experience light-headedness, chills, aches, headache, brain fog, and fatigue.  The symptoms felt just like past instances of the flu I've had.  Given this, I didn't go to work on 3/29, and instead went to get a covid test.  On 3/29, I also started to get consistent pain in emanating from the lymph node in my right arm, the same arm I received the vaccine in on 3/22.  The actual vaccine site no longer has any tenderness, and it was never painful after the shot.  I had no symptoms at all between 3/22 and 3/28.  The lymph node under my right arm is visibly swollen as well.  On 3/30, I was given the results of my covid test from 3/29, which was "covid-19 not present."
pt recv vax 21MAR96 & 25MAR96 pt exp soreness in the vaccinated arm;31MAR96 pt devel edema & redness (25x 14cm area) in the vaccinated arm;pt seen by MD dx w/cellulitis;tx w/ATB
hx of possible sz-1/2 hr p/vax parent states pt's whole body shook for 5-10sec followed by lethargy x 10-15mins;
COVID a week later after 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID a week later after 1st dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced COVID-19 (COVID a week later after 1st dose). At the time of the report, COVID-19 (COVID a week later after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
the administration of Arexvy 4 drops leaked through the needle; drops were in contact with patient´s arm; drops were in contact with patient´s arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 324NX) for prophylaxis.   On 31-OCT-2023, the patient received Arexvy. On 31-OCT-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: the administration of Arexvy 4 drops leaked through the needle), exposure via skin contact (Verbatim: drops were in contact with patient´s arm) and inadvertent exposure to vaccine (Verbatim: drops were in contact with patient´s arm). The outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK receipt date: 31-OCT-2023 The pharmacist called to report during the administration of Arexvy 4 drops leaked through the needle, so the volume of vaccine administered was unknown, which led to incomplete dose administered. The reporter mentioned drops were in contact with patient's arm, which led to exposure via skin contact and inadvertent exposure to vaccine. The reporter did not consent to follow-up.
Case number PHEH2013US026087 is an initial spontaneous report received from a health care professional on 17 DEC 2013. This report refers to an 04 year old male child. His current condition included asthma and concomitant medication was not reported. He was vaccinated with a dose of FLUCELVAX 2013/2014 (batch number: 005021A) intramuscularly on 17 DEC 2013. No adverse reaction occurred following this administration error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 17 DEC 2013. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult product administered to child".
Very sore arm starting about 4 ours post injection.  Couldn't raise it above shoulder level.  Felt very thick and heavy.  Throbbing.  Pulsating, as though I could feel my heartbeat in my arm when I went to bed.  Took to Tylenol or sleep would have been impossible.  Woke up to a less painful arm and it improved throughout day feeling almost normal by bedtime 24 hours later.  Took 2 Tylenol to ensure sleep.  Woke up Tuesday morning and arm felt almost 2100% normal.  I thought, wow, that wasn't so bad.  BUT I WAS WRONG.  Tuesday mid morning, I began to feel what I would describe as jittery.  Around 11:00 am a wave of nausea washed over me and subsided.  I thought maybe I needed to eat as I hadn't yet so I had lunch.  After lunch I began to feel nauseous again and like diarrhea was coming.  After going to the bathroom, the nausea started building again,  and the diarrhea recurred, and the nausea heightened.  By mid afternoon I was on the floor hugging the toilet bowl wanting to vomit, waiting to vomit, groaning.  It's been years since I've had nausea or vomiting and the whole experience was unexpected from what I read about possible reactions.  I wondered if it was food poisoning but my husband and I had eaten the same thing and he was fine.  Finally about 3:30-4:00, 48 ours post vaccine, I threw up multiple times, perhaps 5 times.    After about 4:30 pm it was over.  I was worried that if I ate again I'd be sick so I only drank decaf tea.  I felt exhausted from the ordeal but very wired and jittery too.  I crawled into bed hoping for sleep.  No luck.  At 3:00 am I was still watching the clock and shocked that I couldn't sleep.  I had to get up at 6:30 in the morning due to some construction at our home.  I was legit exhausted Wednesday.  I no recurrence of the nausea or diarrhea after the bout on Tuesday afternoon.  I ate modestly but normally on Wednesday and slept normally Wednesday night.    Nothing more to report, although I read that up to a week later some people experienced a reaction so I wanted to give it a week to see if anything else would happen.  Nothing else to report.
Moderate pain (4 on 1-10 scale) upper R. deltoid, persisted for approx. 36 hours.  Not tender to touch.  Pain was sensitive to movement and somewhat restricted movement of R. shoulder for a while. Not considered serious by patient. Pain was fully gone 48 hours post injection.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. No medical history was reported. on 13-JUN-2013, the patient was vaccinated with an expired dose of GARDASIL (lot # 668670/0476AA, expiry: 03-JUN-2013) 0.5 ml, intramuscularly. No concomitant medications were reported. No adverse effect reported. This is one of 2 reports received from the same reporter. Additional information has been requested.
noted local erythema (blotchy) area of 3-4inch area of inj site lt leg 24hrs p/inj of DTAP;No other sxs; stie also itched slightly
Injection site bruised, red, swollen, painful, flu symptoms, fatigue, pain all over.
Right thigh red, swollen, hot. Treated with Orapred and Keflex and signs and symptoms resolved.
Tinnitus, vertigo and pressure in ears on multiple occasion after 2nd dose. Requiring me to stop and wait for symptoms to lessen to be able to continue with my day. I have seen my primary care doctor and an Audiologist. Symptoms still remain but less frequently occurring about 4 times a month.
Found out later that the person who received the vaccine was a minor (17 years, 4 months old).  Our physician advisor approved the administration of the follow up (2nd) dose.
The day after the vaccine all day I had a weird scary feeling in my chest which was the same feeling I got right when a nurse in 2017 pushed Ancef into my IV and then seconds later I had an anaphylactic reaction.  That day after the vaccine I was very lethargic, lightheaded and nauseous that whole day, but then felt fine the following day.  13 days after my 2nd dose of the vaccine I woke up with urticaria all over my body.  Every day since then I have urticaria that gets worse at night and early morning.  Last night I developed angioedema of my upper lip along with severe urticaria covering my whole body.  I took 50 mg of Benadryl and a Zyrtec and when woke up this morning, the urticaria was mostly gone, but I still have the angioedema, which has lasted all day today.  I have no other symptoms currently.
As per the patient, her lips were swollen the night and the morning after the vaccine.  I as the vaccinator did not witness this reaction when patient was asked to stay 15mins for monitoring post vaccine
Breakthrough COVID infection. Patient was fully vaccinated on Feb 13, 2021. Positive covid test on Sep 1 2021.
About 1-2 days after the vaccine, I had flu like symptoms- achy, soreness, fatigue, my arm was sore. I started having intermittent episodes of exhaustion and nausea and I noticed I could not stand. I check my blood pressure and it was low around 90/48 and 90/41. I made sure I was hydrated. I went to see my doctor and did blood work. My blood work show low RBC, hematocrit and hemoglobin was low. Also my theragen iron levels were also low. I was prescribed oral iron supplements (ferrous sulfate). I am to follow up with specialists- PCP, cardiologist with hematologist/oncologist, and GI.
Patient admitted to Medical Center for a principle and pre-operative diagnosis of closed displaced fracture of lateral condyle of right tibia.  Patient underwent open reduction internal fixation and was hospitalized post-op. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Approximately, 14 hours after Immunizations: Child had acute onset of prolonged seizures activity was transported to hospital ER (in ambulance) then Life Lifted to "another" hospital. Approximately 24 hours of coma - no vent support.
20 year old patient that received a pediatric dose of ENGERIX-B vaccine; 20 year old patient that received a pediatric dose of ENGERIX-B vaccine; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of adult use of a child product in a 20-year-old patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: 20 year old patient that received a pediatric dose of ENGERIX-B vaccine) and underdose (Verbatim: 20 year old patient that received a pediatric dose of ENGERIX-B vaccine).  The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 31-AUG-2023 The physician on behalf of patient reported that he/she administered the pediatric dose of  Engirix-B vaccine (manufactured by Glaxosmithkline). The patients' demographics were unknown. No additional information was provided. The 20 year old patient administered pediatric ENGERIX-B which led to Adult use of a child product and underdoes. Consent to contact reporter was unspecified.
Information has been received from an office manager concerning a 79 year old female with hypertension, cholesterol high, asthma, rhinitis allergic and osteoarthritis and a history of diverticular disease, goiter nodular, carpal tunnel syndrome, lumbar spinal stenosis, lumbar radiculopathy, restless legs syndrome and vertigo who on 27-OCT-2005 was vaccinated with the first dose of PNEUMOVAX.  Concomitant therapy included TYLENOL, NASONEX, gabapentin, ergocalciferol, MIRAPEX, CARDIZEM, DIAZIDE, simvastatin (manufacturer unknown), FLOVENT and albuterol sulfate.  On 26-AUG-2009 the patient received the second dose of PNEUMOVAX (lot # 663936/0508Y).  Subsequently, the patient developed pain and swelling in the left arm, and "could not lift her arm".  The patient was seen in the emergency room and was hospitalized.  No lab diagnostics studies were performed.  The patient was given a sling and discharged home.  The patient was seen in the office on 27-AUG-2009 for follow up, no changes noted.  At the time of the report, the patient was recovering.  Follow-up information has been received from an office manager stated that on 26-AUG-2009, the patient did not receive any concomitant vaccinations when the PNEUMOVAX (lot # 663936/0508Y) was administered.  It was unknown if the patient was admitted to the hospital.  On 27-AUG-2009, the patient was seen by the physician.  The patient complained of left arm pain.  The physician documented that the patient's left deltoid muscle was tender to the touch with edema.  The patient had reduced range of motion on inspection.  The patient was treated with TYLENOL No3 with CODEINE.  On 31-AUG-2009, the patient was seen by the physician with complaints of pain in the deltoid muscle for 5 days.  The patient stated that the TYLENOL No3 with CODEINE did not control the pain.  The patient's treatment was switched to hydrocodone (unspecified) with TYLENOL, one table, every 4 hours.  The patient was recovering and had a scheduled follow-up visit with the physician in October 2009.  Follow-up information has been received from a physician concerning a patient with no illness at the time of vaccination who on 26-AUG-2009 at 2:05 PM was vaccinated with the first dose (previously reported as the second dose) of PNEUMOVAX (lot # 663936/0508Y) IM in the left deltoid.  On 26-AUG-2009 at 4:00 PM. the patient developed pain and swelling which affected the left upper extremity.  On approximately 01-SEP-2009, the patient recovered.  This is one of two reports from the same source.  Additional information is not expected.
Patient came in to the clinic for her annual influenza vaccine. Patient's name and date of birth were verified along with allergies, recent vaccinations, and what she was being seen for her today. Patient confirmed she was being seen for her influenza vaccine and wanted the vaccine in the right deltoid. Consent was filled out prior to administering vaccine. Provider wrote patient was recieving FLUBLOCK which is the appropriate vaccination for this patients age. The vaccine admittedly was not checked prior to writing flublock and the patient was given high dose fluzone,0.7mL in the right deltoid. The patient was notified of this error and made aware that she was given the high dose and not the standard dose for her age.
itchy, swollen, slightly sore left arm at injection site and arthritis pain in left hand
Pt got J and J in March, moderna twice in october and november, and pfizer in december
LMT-HBCV leg became swollen red & warm to touch that evening p/receiving inject; child did not run fever or have any sz; 3cm purple colored area on LMT @ inject site hard to touch;
C/O LEFT ARM NUMBNESS/TINGLING POST VAC. SHOT.  EMS ON SITE. 1035:  VS: 02 SAT R.A.:  98%, P:  95, BP:  147/82; T:  98.1 DEG. F. 1050:  LEFT FACILITY, NO COMPLAINTS.
Increased blood pressure after first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Increased blood pressure after first 2 doses) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for Blood pressure management.   On 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced BLOOD PRESSURE INCREASED (Increased blood pressure after first 2 doses). At the time of the report, BLOOD PRESSURE INCREASED (Increased blood pressure after first 2 doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: increased (High) Increased.         No treatment information was provided.   This case was linked to MOD-2021-420137, MOD-2021-420124 (Patient Link).
no adverse event; The patient was vaccinated with a first dose ofGARDASIL 9 on 10/4/2016. He received the second dose of GARDASIL 9 on 7/17/2019.; This spontaneous report was received from a nurse concerning a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 04-OCT-2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   On 17-JUL-2019, the patient was administered the second dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported) (inappropriate schedule of product administration). No adverse symptoms reported.
Pt recvd vax on 5AUG92 & 24 hrs later devel grapefruit size swelling  inject site w/itching & a local rash;
Mother in clinic (without child) reporting, red bumps to (L) arm, extending from shoulder to hand, that "look like mosquito bites", 1 bump on (R) shoulder blade. Fever of 104 deg. Fever responding to OTC ibuprofen but returns within 6 hrs of giving it. Started approx. 8pm on 8-1-12.
receiving doses from vials affected by a temperature excursion; receiving doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2022 at 11:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2022 at 11:35 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received half dose of Moderna vaccine.  No concomitant medications were reported.  20 patients received doses from the lot number affected by a temperature excursion as the freezer went out of range. It was reported that no adverse event occurred at time of administration or were reported thereafter.  No treatment medications were reported.
temperature excursion that was intermittent beginning 28-JUL-2020 / there have been administered doses; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  Since 28-JUL-2020 (conflicting information also reported as 30-JUL-2020), varicella virus vaccine live (Oka/Merck) (VARIVAX) had intermittent temperature excursion, the vaccine was stored at a temperature of -14 degrees Celsius (C) to -10 C (max -9.5C), during a time frame total of 38 hours and 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion.  On an unspecified date, the patient was vaccinated with an improper stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 milliliter (ml) (lot number S032357 which has been verified to be valid, expiration date reported and validated as 14-OCT-2021) (it was also reported that the lot number: T002843; expiration date: 23-JAN-2022 was involved, however, information of administration was not provided) (vaccination scheme, frequency, route of administration and anatomical site of injection were not reported), as prophylaxis (product storage error).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014689: US-009507513-2008USA014711: US-009507513-2008USA014749: US-009507513-2008USA014777: US-009507513-2008USA014790: US-009507513-2008USA014797:
BODY ACHES; CHILLS; ARM SORENESS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced arm soreness. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, chills, headache, fever and arm soreness was not reported. This report was non-serious.
Fever up to 101.0F, body aches, general malaise, shivering, headache, nausea, pain at injection site.  Symptoms began in the afternoon after morning administration and lasted for 3 days. Fever subsided on morning of day 3. This resulted in my missing 2 days of work due to the above symptoms.