chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2017US002364, is an initial spontaneous report received from a nurse on 18 Jan 2017. This report refers to a 27 year old patient of unspecified gender. Medical history included prior vaccination and tolerated in past and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619224) intramuscularly in left deltoid at a dose of 0.5 ml on 06 Dec 2016 at 13.46. It was reported that the patient received the second dose of FLUVIRIN (batch number: 168904) intramuscularly in left deltoid at a dose of 0.5 ml on 04 Jan 2017 at 15.05 PM in same season. Nurse reported that a patient received two dose of FLUVIRIN in one season (inappropriate schedule of vaccine administered). No adverse reaction was reported following this administration error. The case was assessed as non-serious by the nurse. Follow up report received from a nurse on 09 Feb 2017: Medical history (prior vaccination and tolerated in past), patient details (weight and height), and dosage regimen anatomical location and time updated. Narrative amended accordingly.
Both hands broke out with raised red oval shaped papules, mostly on palmar surface of fingers and knuckles of right hand about 24 hours after vaccine, then within an hour or so, pt felt very weak, hurt all over, ached from scalp to toes, had chills and fever, no improvement , so saw PMD. 10/13 had X-ray of lungs, UA blood work and blood cultures 30 "apart" all negative. Frontal HA (headache) x 2 weeks, relieve with TYLENOL or ADVIL. No respiratory symptoms. Tired for the next month . Hands began to peel about 3 weeks after immunization, face swelled for about 2 weeks after immunization, "lip looked like had been in a fight, red around eyes". Now 5 weeks after shot his slight fatigue and weakness of legs.
R arm, reddened and some swelling noted. Pt denied pain but c/o itching. Started Benadryl-Tylenol-Motrin. Pediapred 6.7/5ml 1 1/2 tsp x 2 d then 3/4 tsp day 3 and four. 11/14/02 spoke with father-states doing much better-itchy and redness subsided.
cold symptoms; sore throat; headache; lightheadedness; This is a spontaneous report from a Pfizer-sponsored program  from a contactable female consumer (the patient). This female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 , single dose via an unspecified route of administration on 15Feb2021 for COVID-19 vaccination. There was no relevant medical history reported. Concomitant medications were not reported. In Feb2021, the patient experienced lightheadedness for 5 minutes. On 19Feb2021, the patient experienced headache for 24 hours and cold symptoms and sore throat on 22Feb2021. The clinical outcome of lightheadedness, headache, cold symptoms and sore throat was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
After receiving the first course of the Moderna vaccine, patient woke up the next morning with a large red circle on her arm at the site of the injection.  Circle is very tender, slightly raised, and warm to touch.
Attempting to administer PPD intradermal, injected Adult DT by mistake. Pt developed localized pain, red and swelling. Was treated with Cephalexin 500 mg, 1 tablet TID.
This is a spontaneous report from a contactable pharmacist. An 83-year-old male patient of unspecified ethnicity received PREVNAR via an unspecified route of administration on an unspecified date at single dose for immunization. Relevant medical history and concomitant medications were not reported. The patient experienced "on administration he got a big lump that swelled up and it started bleeding right away" on 28Sep2015 with outcome of unknown. The action taken for PREVNAR 7 was not applicable. The pharmacist mentioned that the patient did not have any redness or warmth, no skin reaction, no rash or anything, no fever, no upset stomach. The pharmacist mentioned that the patient was already gone and he was doing fine, but she wanted to know how common that reaction was. Follow-up (27NOV2015): Follow-up attempts are completed. No further information is expected.
Pt expired. Infant found unconscious and unresponsive. Two hours earlier infant was checked on by mother and grandmother and was alive. The infant had well baby check-up and immunizations the previous day. Mother considered infant irritable after immunizations and gave her a dose of non-prescription tylenol. Autopsy states cause of death as SIDS.
A bubble of clear liquid came up at  the injection site on her right arm; bubble the size of a Q-tip and it is really hot outside; This is a spontaneous report received via Pfizer sponsored program. A contactable consumer (patient) reported a 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 02Jun2021 (at an age of 44-years-old) on arm right as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Jun2021, the patient experienced a bubble of clear liquid came up at  the injection site on her right arm, bubble the size of a q-tip and it is really hot outside. Caller states she got the vaccine, what they did was put the band aid on first the right arm, it was round white circle with clear middle and gave the shot through the band-aid on her arm, the patient saw a big bubble of liquid on her arm and wanted to know if all of this was going to be fine. Patient stated that band-aid started to come up and a bubble of clear liquid came up at the injection site on her right arm 2 hours after the administration. The bubble was the size of a Q-tip and it is really hot outside. Patient also stated that the person who administered did not get her temperature first and asked if this process is correct. Patient also enquired if placing a band aid on prior to administration is appropriate. The clinical outcome of the a bubble of clear liquid came up at the injection site on her right arm, bubble the size of a q-tip and it is really hot outside were not recovered.  Information related to batch/Lot no. was requested.
She got her vaccine, she was not told to wait 15 minutes so she left and had not eaten and thinks her blood sugar bottomed out and felt nauseous like she was going to pass out, but is normal for her.  Did not feel well, and knew she needed to have something to boost it and she did not do that.  She got a candy bar and some water which she was told to drink, and that feeling went away.  She then noticed pain about a day later around her arm and under her arm, and took some Tylenol which the under arm pain went away.  The pain in her arm at vaccine site did not go away and weeks have passed and months and still has the pain in her arm today, feels like she had the vaccine yesterday.  She also has neuropathy which makes her hands go numb, not related to the vaccine.  She has shooting pain in her arm.  She woke up with the pain this morning, has a little dot which she had pain after the 2nd vaccine, but not like this.  The pain is so sore today, no redness, a little dark mark, hurts a little under the arm, but no swelling.  Says it's annoying, and doesn't know what is going on, and states she will not get another one.  She thinks that who injected her hit the muscle itself, and it's crazy.   The pain goes to her neck.  She has notified her doctor of the issue and they told her to come in and see them.    She also hurts in her arm, shoulder and all on the left side and she has tense muscles in her neck, which is making things worse.  She has a herniated disc in her upper neck and lower back, sciatica as well.
My arm was sore, and I was tired after receiving the vaccine. I went to see my primary care doctor for routine exam and blood work. My doctor referred me to a hematologist for additional testing. I was informed that I have high levels of protein antibodies in my system. On 11/24/2022, I had blood work done again and the levels of decreased.
Tinnitus continuous high frequency ringing in both ears... No treatment.... No cessation since inception
meningitis; seizures; almost lost life; Suspected vaccination failure; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant), meningitis (serious criteria hospitalization and GSK medically significant), seizure (serious criteria hospitalization and GSK medically significant) and near death experience (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningitis, seizure and near death experience were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, meningitis, seizure and near death experience to be related to Bexsero.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. It was reported that the patient almost lost her life with meningitis and she was up to date in all her vaccinations. It caused her to have seizures and to be hospitalized for 2 months.  It was reported 10 people that died from the same bacterial infection. The patient was the only one that made it out alive.  The patient was breathing normally. This case was considered as suspected vaccination failure, since the details regarding the time to onset and dose number was not provided.
Diarrhea for 4 days so far; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 15:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 14Apr2021, the patient underwent reverse transcription-polymerase chain reaction (RT-PCR) test for COVID-19 via nasal swab and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications taken within two weeks of vaccination included curcuma longa rhizome (TURMERIC) for unknown indication from an unknown date and unknown if ongoing. On an unknown date in Apr2021, the patient experienced diarrhea, which was there for 4 days till the time of report. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Apr2021, post vaccination the patient underwent test for COVID-19 and the result was not known. The clinical outcome of the event diarrhea for 4 days till the time of report was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient's provider, called today (8/3/20) stating the patient was seen on 7/31/20 and has a left upper back rash. Patient received the first Shingrix dose on 7/29/20.  Provider also states the patient had a cardioversion on 7/7/20 and is currently in A fib.
Information has been received from a physician concerning a male patient who on 28-FEB-2011 or 06-MAR-2011 was vaccinated with a dose of PNEUMOVAX 23 ("intramuscular or subcutaneous injection", 0.5 ML, Lot # 667995/1150Z and expiration date: 04-Mar-2012). The physician reported that the patient experienced swollenness and redness at the injection-site in the arm. The physician had not seen this type of reaction in this type of consistency. Patient sought unspecified medical attention. At the time of reporting the patient was recovering. This is one of several reports received from the same source. Additional information has been requested.
Nose bleed; Anemic; her husband's hemoglobin and hematocrit were low; her husband's hemoglobin and hematocrit were low; low on iron; This is a spontaneous report from a contactable consumer (wife of patient).  An 87-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 at 16:00 at single dose in right arm for COVID-19 immunisation at the age of 87-year-old. Lot number was EL3249. Medical history included atrial fibrillation, by-pass surgery in 1999 then high blood pressure in 1999, gout (diagnosed before 1999, it was an on and off thing, he had flare ups, the last one was at Christmas time), High cholesterol (diagnosed in 2000 or 2001), diabetes, anemia. Concomitant medications included rivaroxaban (XARELTO) in 2014 for atrial fibrillation. Historical vaccine included flu vaccine in Sep2020 for immunization. On 20Jan2021, the patient was anemic. On 21Jan2021 at 02:30, nose bled. The patient just kept wiping his nose for thirty minutes before it stopped. On 20Jan2021, hemoglobin resulted 12.6, hematocrit was 3.9. The patient went to the hematologist the day before the report who said the patient was low on iron, hemoglobin and hematocrit were low, so he had to get an iron infusion the day of report for that (the patient went every three months and if his iron was low he got an infusion). The patient recovered from nose bled on 21Jan2021, the outcome of other events was unknown.
Initial report received from a healthcare professional on 31 Mar 2010: This patient was vaccinated with two doses S-OIV FLUVIRIN (batch number: 102045P1), intramuscular, on 31 Mar 2010. On 31 Mar 2010 (on same day), the patient inadvertently received two doses of FLUVIRIN vaccine. No adverse reaction occurred. The outcome of the event was not reported. Follow up report received from a healthcare professional on 10 Jun 2010: It was reported that the patient did not experience any adverse events and the patient is doing fine. No other information was reported.
Caller reporting that doses of PROQUAD were administered to a patient who is older than 12 years old (14 years and 8 months). Their vaccination status prior to this recent vaccination was unknown by parents and patient as they are from another unspec; This spontaneous report was received from a nurse practitioner, referring to a 14-year-old (reported as 14 years and 8 months old) of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-SEP-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  The reporter stated that the patient who was older than 12 years old (inappropriate age at vaccine administration). It was also confirmed that their vaccination status prior to this recent vaccination was unknown by parents and patient as they were from another unspecified country and there were no records.
Ran 100.4 fever and developed red rash over front of neck, around 3-4" wide and high
4 days after 2nd dose experienced post menopausal bleeding, bloating, abdominal pain, muscle aches, sharp pains throughout body, lighthead, diarrhea and headaches.
Sudden onset nausea, profuse sweating, pale, tingling hands and felt like would lose consciousness approx 1.25-1.5 hours after injection. around 12:10 pm or so.    Removed excess clothing, put head between legs and turned on fan.  Symptoms improved within 15 minutes.  Headache later Saturday evening.  Face hot and flushed and bad headache around 6pm Sunday evening.  Face hot and flushed still Monday 1/25 in am but is getting a little better (I think) at the time of report.
acid reflux; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) and MYALGIA (sore arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001c21a and 016C21a) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, 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 experienced GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) and MYALGIA (sore arm). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) and MYALGIA (sore arm) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
The patient experienced itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (The patient experienced itchy rash) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (The patient experienced itchy rash). At the time of the report, RASH PRURITIC (The patient experienced itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.
Delayed skin reaction; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (Delayed skin reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (Delayed skin reaction). At the time of the report, SKIN REACTION (Delayed skin reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.     This case was linked to MOD-2021-213382 (Patient Link).
gave an MCV4 instead of a Hep A; no Tx, no signs or symptoms of distress
Pt reacted by 11PM got real hot & was given advil temp check during night was 105.7 did dec w/advil over next 24 hrs but had to alternate w/APAP to keep temp down; called MD but did not take pt to MD;
23 hours after administration, pt contacted office C/O fever localized swelling, nausea and headache - patient treated with TYLENOL and REGLAN.
Patient received Pfizer COVID vaccine on 4/19/21 and 5/19/21. On 11/11/21, patient tested positive for COVID and patient admitted to our facility on 11/19/21 for acute respiratory failure due to COVID-19 pneumonia. She was placed in CCU from 11/19/21 to 11/25/21, and she's currently in med/surg unit from 11/25/21 until today (11/29/21).
From initial information received on 30OCT2003 from an MD regarding an adverse event occurring in the USA, it was reported that a 78 year old female patient received a dose of FLUZONE on 18OCT2003. The route and site of administration were not reported. Three days later , on 21OCT2004. the patient developed a bitemporal, persistent , severe headache. She also had throbbing in her inner ears. A CAT scan was within normal limits. The pt's recovery status is unk.
Pt. here to report rec'd Tdap vaccine on 7/27/11 & now has a big knot where she rec'd the shot. Pt. sts had a fever of 102 degrees.
SORENESS IN ARM; DIARRHEA; FULL BODY ACHES; LOW GRADE FEVER; LETHARGY; ERYTHEMA ACROSS UPPER ARM -- ALL X 48 HOURS MAX.
Information has been received from a physician concerning to a 38 year old male patient with no pertinent medical history nor drug allergies. On 02-DEC-2016, was vaccinated with a dose of M-M-R II (Lot number not reported), subcutaneous for prophylaxis. No concomitant medications reported. On 19-DEC-2016, the patient was diagnosed with mumps, at an emergency room, but he was not admitted. The mumps titer was elevated. The patient did not receive treatment for the mumps. There was no intervention to prevent serious criteria, no disability, cancer, life threatening, overdose nor death were reported. On an unknown date the patient recovered from mumps. No product quality complaint was reported. The relationship between mumps and vaccination with M-M-R II was not reported. Additional information has been requested.
SAME DAY PT EXP STIFFNESS, BACK AND SHOULDER PAIN, SORENESS IN BACK AREA FOR APPROX-48 HRS. TREATMENT :  HEAT, ADVIL.  SYMPTOMS SUBSIDED WITHIN 2 DAYS.
No additional AE reported; PEDVAX HIB was administered after temperature excursion/Temperature 32.79F for 15 minutes; 34.22F for 15 min; This spontaneous report was received from a licensed visiting nurse (L.V.N), concerning a patient of unspecified age, gender and race. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-APR-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), 0.5 mL (lot # U024089 has been verified to be a valid lot # for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), expiration date: 27-OCT-2023) (strength, route of administration, and anatomical location were not provided) as prophylaxis. It was reported that the vaccine underwent a temperature excursion of 32.79 F degrees and 34.22 F degrees, each for a duration of 15 minutes (Product storage error). It was also reported that no previous excursions had presented. There were no further adverse events or additional information available.
Four to five  children who are below 18 year and received the first dose of Moderna covid-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Four to five children who are below 18 year and received the first dose of Moderna covid-19 vaccine) in a patient of an unknown age and gender 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Four to five children who are below 18 year and received the first dose of Moderna covid-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Four to five  children who are below 18 year and received the first dose of Moderna covid-19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information reported. only 2 children got vaccine for both the doses . the children took vaccine under the age   This case was linked to MOD-2021-244154 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received on 01-Jul-2021: It was reported that 2 children received got vaccine and they got second dose also.
At about 20 hrs complained of abdominal pain, unmeasured fever.  At about 44 hours had vesicles at deltoid injection site.  At 53 hours vesicles crusted, erythema 22cm long from elbow to medial end of clavicle.  Arm circumfrence increased 3cm.  Clearly vesicles at upper site of DTaP, not lower site of IPV.