chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Has a lump under the arm that got injected.; This is a spontaneous report from a contactable consumer (patient's mother) via medical information team. A male patient (reporter's oldest son) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration, administered in Arm on 21Apr2021 at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced has a lump under the arm that got injected. The reporter stated that her whole family got vaccine on 21Apr2021. They all had a little bit of symptoms here and there but her oldest son has a lump under the arm that got injected. She is wondering if this is common, if it'll go away and if she should consult his doctor. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Received shot on Thursday, December 31. Had no side effects other than sore arm until Monday, January 4 when I had a bout of diarrhea followed by a rapid heart beat, which when checked was 146, then went to 149 and few minutes later was 150.  I became worried and called my cardiologist and the clinic was closed.  The cardiologist on call called me back.  After describing my symptoms and that I had received the Covid 19 shot several days earlier.  He advised me to monitor my heart rate and if it continued to go to the ER.  Shortly after, my heart rate returned to normal, so I did not go to the ER.
Case number PHEH2014US020803, is an initial spontaneous report from a health care professional received on 13 OCT 2014. This report refers to a patient of unknown demographics. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411501) intramuscularly at a dose of 0.5 ml on an unknown date. On an unknown date after vaccination, the patient experienced blurred vision, lightheadedness, headaches and severe abdominal pain. The final outcome of the events was unknown. Seriousness and causality of the events were not reported.
39 YO FEMALE WHO PRESENTED WITH  A C/O OF UNILATERAL PARESTHESIAS . THE TINGLING STARTED IN THE LEFTSIDE OF HER TONGUE AND PROGRESSED TO  HER TOP ORAL PALATE, LEFT LIP, CHEEK, AND UP TOWARDS HER LEFT TEMPORAL LOBE. PT HAS A Hx OF HYPERTRIGLYCERIDEMIA AND ELEVATED BP. BP 184/104 HR 78 SpO2 100% PT APPEARS A/O X 3. PT IS NOT IN PHYSICAL DISTRESS. HER FACE  IS SYMMETRICAL AND NONERYTHEMATOUS. PT ALLERGIC REACTION RESOLVED. PT STABLE ON DISCHARGE.  INSTRUCTED TO  TAKE HER OTC BENADRYL  IF HER SYMPTOMS REOCCUR AND TO F/U WITH HER PCP. PCP WILL CONTINUE TO FOLLOW HER BP.
Moderna COVID?19 Vaccine EUA  Fever of 101.5 for several hours. Severe chills and body aches, throbbing headache, stomach ache, dizzy, general weakness.
Unsure of vaccinator facility or details of vaccine ( Lot # etc) Given at another facility. Circle red rash noted around site of injection. Slight swelling. Some tenderness/discomfort.
Case number PHEH2014US022581, is an initial spontaneous report received from a pharmacist on 10 Nov 2014. This case refers to a 15 years old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 14625P), at a dose of 0.5 ml intramuscularly on 09 Nov 2014, that had been at 34 F to 39.4 F. No adverse event was reported following this administration error (incorrect storage of drug).
After receiving flu vaccine intradermally in (L) deltoid for first time, had adverse moderate reaction with wheezing, tightness in chest, metallic taste in mouth, flushing in face, urticaria.
At 10:06 Pt c/o lips tingling and numb. No airway restriction. Nurses,, RN assessed pt. BP: 118/64, HR: 86. Noted red blotches on neck and face. Adm Benadryl 50mg IM L delt. per protocol. Reasssed pt   at 10:15 and BP: 110/80. HR: 80.
On 11/9/02 at 8PM, patient was unsteady on feet, had no pain or discomfort. On 11/10/02 3AM complained of muscle weakness, unsteady gait. At 10:30AM complained of unable to walk. Seen by MD on 11/10, blood work order. On 11/12 seen by neurologist and was admitted to hospital.
Baby delivered 11/4/21, 9 lbs, diagnosed with tansient tachypnea of the newborn, admitted to NICU and required I believe 13 hrs of CPAP. This is my 5th child and no past history of TTN, although fast delivery in past. Additionally I found interesting in this Healio article they found increased TTN in Covid + mothers. Made me feel it was important to report in case vaccinating the mother resulted in a similar response in the newborn as a history of a covid+ mother.  Of note I was 23 weeks pregnant at time of first vaccination
6/8/22 pt hospitalized with aspiration pneumonia and positive for COVID, dc'd to SNF; 7/3/22 back to hospital with sx of stroke; dx with stroke; and still positive for COVID; family wants no aggressive measures, but does want pt to receive medical management; DNR; eventually changed status to comfort care and pt passed away in the hospital
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided.  It was mentioned that the vial was initially refrigerated  on 18 Nov 2021, the vial did not undergo any temperature excursion and the patient did not experienced any adverse events. Treatment medication was not provided by the reporter
I got sore in the left arm pit and felt my lyphmnodes were abnormal. I got a mammogram and it showed that my lyphmnodes are reactive.
Burning pain within an hour post vaccination that went all the way down arm into hand; Rapid heart beat; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 05Aug2021 at 13:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. The patient previously received morphine (MANUFACTURER UNKNOWN) and pethidine hydrochloride (DEMEROL) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included hydrocodone (MANUFACTURER UNKNOWN) and leflunomide (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 05Aug2021 at 13:00, the patient experienced burning pain within an hour post vaccination that went all the way down his arm into hand. By night time the patient had a rapid heartbeat, headache and fatigue. This lasted a full week before it started to get better. The events did not result in doctor or other healthcare professional office/clinic visit/emergency visit. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events burning pain within an hour post vaccination that went all the way down arm into hand, rapid heartbeat, headache and fatigue was recovered on an unknown date in Aug2021.  No follow-up attempts are needed. No further information is expected.
Documented Lack of Immunity After Hepatitis B Series; Initial Report Received on 08-Nov-2021. In a case series by patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and with results of post-vaccination tests were collected from existing health records within the military health system.    Patient received an initial hepatitis B series at 57-years-old and a second hepatitis B series at 58-years-old.   A total of 7 doses of the standard hepatitis B vaccine were administered.    At 59-years-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, the hepatitis B surface antibody after the Heplisav-B series was negative.    No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Inflammation in the armpit area, inflammation and pain in the breast area until today January 2022.
pain in shoulder and left side of neck; left arm hurts and is red; pain in shoulder and left side of neck; Dizzy; pain in right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PAIN IN EXTREMITY (pain in right arm), NECK PAIN (pain in shoulder and left side of neck), PAIN IN EXTREMITY (left arm hurts and is red) and ERYTHEMA (left arm hurts and is red) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (Dizzy) and PAIN IN EXTREMITY (pain in right arm). On an unknown date, the patient experienced NECK PAIN (pain in shoulder and left side of neck), PAIN IN EXTREMITY (left arm hurts and is red), ERYTHEMA (left arm hurts and is red) and ARTHRALGIA (pain in shoulder and left side of neck). The patient was treated with PARACETAMOL (TYLENOL) for Dizzy and Pain in arm, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy) and PAIN IN EXTREMITY (pain in right arm) had resolved and NECK PAIN (pain in shoulder and left side of neck), PAIN IN EXTREMITY (left arm hurts and is red), ERYTHEMA (left arm hurts and is red) and ARTHRALGIA (pain in shoulder and left side of neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Case number PHEH2012US015107 is an initial spontaneous report received from a nurse on 01 Aug 2012. This report refers to a 12-year-old female patient. She was vaccinated with MENVEO (batch number: M11075) intramuscularly into her left deltoid muscle on 24 Jul 2012. On the same day she was also vaccinated with TDaP vaccine(other manufacturer, batch number: unknown). The following day she experienced fever up to 104.3 F in addition to headache. She took ibuprofen and TYLENOL for fever and headache. The symptoms lasted for three days. On 28 Jul 2012 she had recovered completely. No other information was available.
22 year old female working, was bitten by a dog and pt received Rabies Immune Globulin (Bayer manuf) and Rabies Vaccine (Aventis) 4 shots IM on gluteal areas. About 20 minutes after receiving the shots, pt became dizzy, hypotensive, bradycardial (high 30's-40's) and diaphoretic. Pt placed on monitor. In bolus fluid x 1 liter, 1 mg Atropine IUP given. Pt's HR elevated to 70's-80's, became normotensive and released from ER about 3-4 hours after tx.
had negative Hep-B titer results; 36 weeks pregnant female had negative Hep-B titer results; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 36-year-old female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Hepatitis B vaccine at an unknown time during the pregnancy. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapy non-responder and vaccine exposure during pregnancy. On an unknown date, the outcome of the therapy non-responder and vaccine exposure during pregnancy were unknown. The pregnancy was ongoing.   It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine.  Additional case details were reported as follows: The age at vaccination was not applicable. The 36 weeks pregnant had negative Hep-B titer results and since plan on vaccination with Engerix-B, which led to therapy non-responder and vaccine exposure during pregnancy. The reporter consent to follow up.
About 30 minutes after receiving the Moderna vaccine my whole face went numb.  It felt like a had been given a dose of novocaine. It lasted about 24 hours then went away.  I also had severe pain in my left arm and was unable to lift my arm for about 24 hours.  Two days later I developed sinus symptoms and 6 days later I lost my sense of taste and smell and tested positive for COVID
Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Shakiness-Medium
Fever 101.2 axillary, crying out in sleep, thrashing and twitching for rest of the night.  Gave 5 ml. of childrens advil, lowered fever but thrashing disturbed sleep continued.  Fever returned next day at school.  Afebrile by bedtime.  104.5 axillary temperature the following night, with lethargy and loss of appetite
This prospective pregnancy case was reported by a consumer (husband of subject) and described the occurrence of arm soreness at injection site in a 26-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. Concurrent medical conditions included uterine fibroid. The subject had no previous pregnancies. The mother was not using contraception and they type of conception was normal. There was no evidence of a defect from prenatal testing. There was no paternal history which may have an impact on the outcome of this pregnancy. On 23 December 2013 at 19:30 the subject received a dose of BOOSTRIX (.5 ml, unknown details, left deltoid) and experienced vaccine exposure during the 3rd trimester of pregnancy. The gestational age at the time of vaccination was 33 weeks per the reporter. The date of last menstrual period was unknown. The estimated date of delivery was reported as 13 February 2014 per the reporter. On 23 December 2013, less than one day after vaccination with BOOSTRIX, the subject experienced arm soreness at injection site. There was no evidence of defect from prenatal testing. At the time of reporting, the pregnancy was ongoing. At the time of reporting the events were unresolved. Follow up was received from the subject on 22 January 2014. The subject provided the lot number of BOOSTRIX that was administered. The date of last menstrual period was reported as May 2013. Follow-up information was received on 13 May 2014 via healthcare professional who reported that the outcome of the pregnancy was unknown. The healthcare professional stated they did not "provide this service" (vaccination) and to contact the physician who treated the patient with BOOSTRIX. No other information was provided. The case was closed as lost to follow-up.
Information has been received from a nurse concerning a 4 year old patient who on 01-AUG-2008 was vaccinated with a dose of VARIVAX (Merck) (lot#659606/1905U). The nurse mentioned that on 06-JUN-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient status was unknown. A lot check has been initiated. Follow up information has been received from a registered nurse concerning a male child patient with no illness at the time of vaccination and no pre-existing allergies, birth defects or medical conditions who received the first dose of VARIVAX (Merck) subcutaneously on 01-AUG-2008 at 11:30 pm. The patient received the second dose of VARIVAX (Merck) at the age of 4 years (in 2011). The patient went to the clinic on 06-JUN-2012 with a rash described as "vesicular, papular, erythematic non confluent, non symmetrical, with no scaling", diagnosed with varicella. No tests were done. This was one of the several reports from the same source. Additional information has been requested.
Cellulitis at injection site. Induration pt was seen at PCP office 2 days post injection stated on AUGMENTIN. Vomited AUGMENTIN and Rx changed to BACTRIN on 7/23/16.
Fatigue, Nausea, Fever, Chills, Sever lethargy, Severe headache, Bodyache, Muscle pain, Sever pain on the site of the injection, Swelling of Left arm
It started a couple weeks after first shot and it was a gradual itching like I had dry skin and small red bumps. I used aveeno on it and it didn't help and kept getting worse and it spread over all of my body and raised whelps and itched unbelievably. I saw my dermatologist early part of March and she did a biopsy and it came back that they suspected an allergic reaction so I stopped all my medications and over counter medications except Eliquis and beta blockers and we switched from Toprol xl to carvedilol to make sure it wasn't causing the itching and nothing helped. They put me on steroid creams which lessened the rash somewhat but it was still pretty itchy. We ran through a regimen triamcinolone for 3 weeks to a month and stopped and the rash came back and it was very bad so Dr put me on prednisone 60 mg for 5 days and I tapered off and within a couple of days the itching stopped and rash receded and prednisone took it right away. Within a couple of days it came back after taking prednisone, so I used the cream for a few weeks and it's keeping it under control a little bit. Prednisone seemed to knock it right out the way and when I stopped it would come right back. This is still ongoing. They want to do a patch test to see what I might be allergic to but I haven't heard back. It's generally when I get up in the morning that it's very itchy and during the day when I'm doing stuff it's not too bad, and at night time it's very itchy.
A consumer report has been received. The report concerned a four year-old female patient. No medical history, concomitant medications were provided. The patient had leukemia. The reporter stated that after on an unknown date, her daughter's first nasal FLUMIST administration, the patient had flu like symptoms for the following 10 days. Five of those days she had a fever over 104 F. The reporter added that, they unknowingly put their neighbor at risk who had leukemia. The reporter stated, her daughter did not have direct contact with the patient. Action taken with FLUMIST was unknown. The outcome of the event was unknown. The report was considered to be non-serious by company physician. Summary to follow-up information received AstraZeneca/MedImmune 25-Sep-2012 from the reporter: The event of flu like symptoms was deleted. The patient's initials and age added. Narrative updated. Corrected report 05-Sep-2012: relationship to patient field was corrected to other. Summary paragraph updated.
Not even 20 hrs after she received the vaccine she couldn?t breathe, she?s been fine nothing wrong at all. 7am she was awake sitting up in bed doing crosswords told her great granddaughter to have a good day at work and would see her shortly . 739 I walked out the room to take my kid to work was gone till 751 not even 12 minutes and I came in and my gram couldn?t breathe was yelling for me saying she couldn?t breathe. It sounded like my gram had come over with upper respiratory problems in a matter of 10 minutes she was gasping for air called 911 spoke to operator my gram was talking saying she couldn?t breathe she was trying to breathe, my grams last words were if they don?t hury I?m going to die I?m 100% sure my gram was dead in my arms before EMS arrived. Yes she was 95 but she is a healthy lady have had no issues of health problems lately. We?ve done everything to keep her save from the virus and then she gets her 2nd moderna shot and she?s dead 20 hrs later there?s a huge problem old age or not
12/21/21 presents to ED "as a transfer from ER with a chief complaint of elevated blood pressure". PMHx of "uncontrolled hypertension asthma, sciatica, restless leg syndrome and depression"
100.1 fever after 2 ibuprofen, chills for several hours, body aches (felt more like bone aches  - even my teeth hurt), didn't sleep at all due to body aches
severe headache and nausea that came on about 4 hours after the vaccination; severe headache and nausea that came on about 4 hours after the vaccination; This is a spontaneous report from a contactable Other Hcp. This 47-Year-old Other Hcp (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: 3247) via an unspecified route of administration on 05Mar2021 at 09:00 AM on left arm at 1st dose, single for COVID-19 immunization (at the age of 47-year-old). The patient's medical history included hypertension, hypothyroidism and migraine, all from an unknown date and it was unknown if ongoing. The patient's concomitant medications included amlodipine, levothyroxine and naproxen sodium (Anaprox), all taken for an unspecified indication and start and stop date were not reported. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination and since the vaccination, she was not tested for COVID-19. The patient had no allergies to medications, food, or other products. Four hours after the vaccination on 05Mar2021 at 01:00 PM the patient experienced severe headache and nausea. No treatment was received for the events. On an unknown date in Mar2021 the events recovered.  No follow-up attempts were needed. No further information was expected.
pt recvd vax 15NOV95;1wk later arm swollen, soreness, itching & redness 5" x 4";also had node enlargement;saw MD in ER who dx allergy to tetanus was given DPh & aTB on 24NOV95;
PFIZER/BIONTECH 0.3ML FOR IM LOT ER8730 EPX:07/31/2021 No known adverse events.  Vaccinated under FDA approved age.
A report was received from a health care professional on 12/23/03 concerning a 1 year old male vaccinee who was inadvertently administered Fluvirin on 12/8/03. On 12/8/03, the vaccinee was inadvertently administered Fluvirin. No adverse events have occurred, as a result at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Pt. got shingles 8 days after receiving vaccine, on 6/20/18.
Patient is experiencing left shoulder pain which she feels is in result of her flu vaccine adminsitered on 10/27/08. She stated 2 hours after the injection she started noticing a burning type pain and a low grade fever. She was also unable to reach behind her head. No swelling or redness was present. She had been seen by Dr. on 11/10/08. A left shoulder xray was obtained. Agreed upon recommendation - physical therapy for the shoulder per Dr. dictation.
Anxiety, Vertigo, Chest Pain, Ataxia, paresthesia.  Developed several hours after the shot 12/30/21 but did not seek care immediately.  Seen in my office on 01/03/22 and evaluated with appropriate blood and image testing.  Seen in follow up on 01/14/21.  Mild vertigo but otherwise resolved symptoms with normal tests results.