chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 5/29/17 (3 wks after vaccines) infant had apparent febrile seizure, associated with croup. He was seen at ER with stridor and cough noted. Parent concern that his speech is less than older site.
Generalized seizure beginning around 10:15 on 5/4/23, which continued in the ED.  Fever was present to 38.3 C.  Status epilepticus requiring multiple medications to stop seizure.  Admitted to hospital for sepsis evaluation
This spontaneous case was initially received on 19-Oct-2015. the case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 16-Oct-2015 - 16-Oct-2015, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Oct-2015, 8 hours after starting/treatment with AFLURIA the patient experienced Migraine-like headache, Fatigue, Fever 101 Degree F, headache. Event treatment: Ibuprofen. For relevant test results see appropriate report section. Reporter's Assessment:
Received 2nd dose 18 days after 1st dose; A spontaneous report report was received from  pharmacists concerning a male patient  (age unknown) who received the 2nd dose of the vaccine 18 days after 1st dose/inappropriate schedule of product.  The patient's medical history was not provided. No current illness was reported. Concomitant product use was not provided by the reporter.  On 11 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Batch# 007M20A) intramuscularly for prophylaxis of covid-19 infection.  On 29 Jan 2021, 18 days following the first dose, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of covid-19 infection.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, 2nd dose of the vaccine 18 days after 1st dose, was considered resolved on 29 Jan 2021; Reporter's Comments: This report refers to a case of inappropriate schedule of product for mRNA-1273, Batch # 007M20A  with no associated AEs. Causality for the medication error is not applicable.
red and hot to touch; red and hot to touch; pretty large swelling on arm, 9x9 cm; COVID-19; really bad itching on injection site; headache; A spontaneous report was received from a healthcare facility staff member who was a 32-year-old, female patient who received Moderna's COVID-19 Vaccine, and  who experienced a pretty large swelling on arm 9x9 cm (vaccination site swelling), headache, really bad itching on injection site (vaccination site pruritus), redness started to grow and red and hot to the touch (vaccination site warmth and vaccination site erythema).  The patient's medical history included a positive COVID-19 diagnosis on 10-Jan-2021. Concomitant product use was not provided by the reporter.    On 29-Dec-2020, the same day as the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient received her Moderna vaccine on 29-Dec-2020. She reported that approximately 30 minutes after receiving the vaccination, she had a headache that lasted the rest of that day and into the next. The following Wednesday, 06-Jan-2021, she developed itching on the injection site and a few days later, on an undisclosed date, the redness started to grow. She stated that the site was red, hot to the touch and swollen.  The next morning, 07-Jan-2021, she reported that although the site was not as red, it was still swollen 9x9 cm.    Treatment for the event included diphenhydramine.   Action taken with mRNA-1273 in response to the events, a pretty large swelling on arm 9x9 cm, headache, really bad itching on injection site, redness started to grow and red and hot to the touch, was not provided.   The event, headache, was considered recovered/resolved.  The outcome of the events, a pretty large swelling on arm 9x9 cm, really bad itching on injection site, redness started to grow and red and hot to the touch, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However , the mRNA-1273 does not contain a virus capable of causing infection and the occurrence of Covid-19 positive test after vaccination is unlikely related to mRNA-1273.
This spontaneous report as received from a registered nurse refers to a patient of unkonwn age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 20-APR-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reproter. Additional information has been requested.
Persistent shoulder/deltoid pain since the date of the shot, worsening over time and now quite severe with certain movements.
This is an initial spontaneous report from a contactable nurse calling from physician's office who reported for a patient. This is first of the two reports from the same reporter. This 2 month old male patient received PREVNAR 13 (Lot# G75073) on 15OCT2013 at 0.5ml single dose. The patient had no relevant medical history. Relevant concomitant medication included HIB on 15Oct2013 at an unknown dose on left thigh; DTaP on 15Oct2013 at an unknown dose on right thigh, polio on 15Oct2013 at an unknown dose on left arm; rotavirus vaccine on 15Oct2013 at an unknown dose orally. It was reported that on 15Oct2013 the patients leg was red and hard. Therapeutic measures taken in response to the reported events and outcome were unknown at the time of report. Follow-up (11Dec2013): Follow-up attempts completed. No further information expected.
Patient reported a red, tiching, swollen, hot spot the size of a quarter that began the day the vaccine was administered. On 10/26/20 she reported it was the size of a post-it note. She was advised to speak to her doctor.
Severe itchiness and hives on body. Prednisone, azithromyisin, Hydroxyzine, and Allegra have all been taken for relief and hives and itchiness are still present.
fever of 101.2 F; Vaccine exposure during pregnancy; and stomach ache; fatigue; headache; itchy arm; tender arm; hot arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), VACCINATION SITE WARMTH (hot arm), VACCINATION SITE PRURITUS (itchy arm) and VACCINATION SITE PAIN (tender arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot arm), VACCINATION SITE PRURITUS (itchy arm) and VACCINATION SITE PAIN (tender arm). On 17-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 28-Jan-2021, VACCINATION SITE WARMTH (hot arm), VACCINATION SITE PRURITUS (itchy arm) and VACCINATION SITE PAIN (tender arm) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Body temperature: 101.2 (High) 101.2 F. On 17-Feb-2021, COVID-19: negative (Negative) She tested negative for COVID.         This case was linked to MOD-2021-016110 (Patient Link).
This case was reported by a consumer via call center representative and described the occurrence of hives in a 23-year-old female patient who received ENGERIX B (batch number 9X4E7, expiry date 26th May 2019). Concomitant products included CLARITIN, ZYRTEC and ALLEGRA. On 15th February 2018 11:30, the patient received ENGERIX B. On 15th February 2018 15:00, 3 hrs 30 min after receiving ENGERIX B, the patient experienced hives, weakness, heart rate increased, tremor, facial swelling, eye swelling, lip swelling and fever. In February 2018, the outcome of the hives, weakness, heart rate increased, tremor, lip swelling and fever were recovered/resolved. On an unknown date, the outcome of the facial swelling and eye swelling were recovering/resolving. The reporter considered the hives, weakness, heart rate increased, tremor, facial swelling, eye swelling, lip swelling and fever to be related to ENGERIX B. Additional details were provided as follows: At 11:30 am, the patient received ENGERIX B on the left arm. The symptoms started to present at 3:00 PM. The patient went to the emergency room at 3:30 PM. Her face, lips and eyes were swollen and she had hives on her face and neck. The fever was 101 to 102 degrees F and she described her heart rate as a high heart rate. Her eye and face were still a little swollen at the reporting time.
Arm swelled, hot to touch, hard lump, increased blood pressure, febrile, increased white blood cell count went to emergency room, and started on cephalexin.
High fever of 105, now 101; lethargy; bitten & scratched by stray dog; vax being given @ hosp ER;
Muscle pain and aches, chills, hives on face, chin and scalp with severe itching, redness and  swelling of chin and ears which began after muscle pain and chills subsided.
SHE GOT IN THE CAR AND FELT CAR SICK SAID SHE HAD NAUSEA, SHE CONTINUED TO HAVE NAUSEA THROUGH THE NEXT DAY.
A drop fall from the syringe, reconstitution technique; Volume administered 0.48ml; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate reconstitution technique in a 49-year-old female patient who received Herpes zoster (Shingrix) (batch number 943GS, expiry date 9th February 2024) for prophylaxis.   Concurrent medical conditions included immunosuppression.   On 5th January 2023, the patient received the 1st dose of Shingrix .48 ml. On 5th January 2023, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and incomplete dose administered. On an unknown date, the outcome of the inappropriate reconstitution technique and incomplete dose administered were unknown.   Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment: The reporter stated that neither skin contact or product quality complaint (PQC) were reported by health care professional (HCP), HCP was referring to reconstitution technique for the drop fall. The reporter consented to follow up via email. Additional Supportive Information: The reporter reported a drop fall from the syringe of Shingrix and the total volume administered was 0.48ml, which led to inappropriate reconstitution technique and incomplete dose administered. Due to limited information, the events were captured conservatively (as reported).
appendicitis; A spontaneous report was received from a consumer (reporting on self) concerning a 52-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced abdominal pain. which was diagnosed as  appendicitis.   The patient's medical history was not provided. Concomitant medications included hydroxychloroquine sulfate.  On 04 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 039K20A) in the left arm for prophylaxis of COVID-19 infection.  On 04 Mar 2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 23M20A) in the right arm  for prophylaxis of COVID-19 infection.  On 07 Mar 2021, the patient had abdominal pain. In the morning of 08 Mar 2021, patient went to urgent care as she thought the pain was due to UTI (urinary tract infection) but urgent care said it was not UTI and they referred  to go to ER (emergency room). The patient went to ER on 08 Mar 2021, where they did CAT scan and found out that she had appendicitis, hence at 7 pm on 08 Mar 2021 they operated the patient and removed appendix.   Action taken with mRNA-1273 in response to the event not applicable   The outcome of the event of appendicitis  was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment information reported
Initial and follow-up information has been received from two Licensed Practical Nurses concerning a 9 weeks male with no known drug allergies and no pertinent medical history who on 21-JUL-2010 was vaccinated with a dose of ROTATEQ (LOT# 665258/0201Z) oral, and the second dose of RECOMBIVAX HB (MSD, LOT# 666187/1484Y). Concomitant vaccination included a dose of PENTACEL (LOT# C3658AA), a dose of PREVNAR 13 (LOT# E61989). There was no other concomitant medication. The nurse reported that the patient developed blood in his stool on two separate occasions after administration of ROTATEQ. He also had mucus in his stool on two separate occasions. The onset date of the experienced events reported as 26-JUL-2010. On 29-JUL-2010, the patient was seen by the physician due to bloody stools. The patient had a stool culture which revealed no stool pathogens reported. The patient did not receive a specific treatment at that time. The patient's parent was advised to follow-up with the physician if the patient's symptoms did not improve. On an unspecified date, the patient recovered and was not back to see the physician for reevaluation. Upon internal review, the experience of blood in stool after vaccination of ROTATEQ was considered to be an other important medical event. Additional information has been requested.
Continued ongoing tinnitus in both ears. Starting the day after the vaccination and continuing as of the date of this submission.
Med ctr employees @ risk for Hep B recvd a series of Engerix-B vax; reporter indicates that 30-40% of those vaxed did not convert; titers checked @ 9 mos;
This case was reported by a healthcare professional and described the occurrence of localized cellulitis left arm in a 2-year-old male subject who was vaccinated with Infanrix for prophylaxis. Co-suspect vaccination administered on 19 April 2007 included Ipol (subcutaneous, left arm). Concurrent vaccination included Recombivax HB (unknown; right arm) given on 19 April 2007. Concurrent medication included Albuterol. On 19 April 2007 the subject received the fourth dose of Infanrix (.5 ml, unknown, left deltoid), and unspecified dose of IPV (subcutaneous, left arm). On 20 April 2007, one day after vaccination with Infanrix and IPV, the subject experienced swelling and redness in his left arm, accompanied by fever. He presented to the emergency room, and was diagnosed with cellulitis. The reaction was characterized by the reporter as localized. This case was assessed as medically serious by manufacturer. The reporter also identified a product quality complaint, questioning whether there was a problem with the Infanrix lot number that was administered to the subject. The subject was treated with Bactrim. At the time of reporting (27 April 2007), the events were resolved. The healthcare professional considered the events were possibly related to vaccination with Infanrix. Comment: the event of "localized cellulitis left arm" was considered to be medically significant by manufacturer.
Rash all over torso within 24 hours, in addition to soreness on arm ?and all over? (the last part was according to the child)
pt recv vax 17APR96&came into office 6MAY96 w/mild&modified case d/t vax;no treatment given recently: close watch&f/u w/office on progress
Tinnitus began about 11pm. Next day feelings of vertigo, dizziness. Flu like symptoms for a couple days.  Dizziness comes and goes, tinnitus has been constant
I received the shot at 14:30, in which medical staff in the jail's medical center watched me for 20 minutes to ensure there were no immediate reactions. I went about my day afterward with no symptoms. At 21:30 when I went to sleep, I got some aches in my joints and took 1 dose of liquid capsule NyQuil to help with the pain and went to sleep. At 00:30, the 7th, I woke up groaning in my sleep to the extreme pain in my joints and feeling hot internally. I decided to get up and take a warm bath to ease the aches. I went and ran the bath and all of a sudden while it was running, I had a severe need to throw up, but could not naturally. Since this was concerning, I got up and walked out of the bathroom and all of a sudden in the hall I got a feeling of impending doom and that something was not right and I fainted. I laid on the floor for what I would approximate to be 5 minutes going in and out of consciousness waiting for the blood to fully return to the brain. After this, I instantly felt like I needed to survive and that I felt like I could be dying so I slowly crawled down the stairs to get to my military ID so I could call the military's nurse advice line. I had to take a break and lay on the concrete in my garage because I felt so dizzy and so hot and began to feel my vision disappear like I was going to faint again. I waited a few minutes before getting back up the stairs crawling to my phone to call. When I called them 00:58, they told me to call 911 because they believed I would be having a severe reaction, though I noted to them I did not have a rash or hives. I then called 911 at 01:08. They sent EMT's to my home which took my vitals. I had normal blood pressure, SPo2, and temp, but an elevated heart rate of just under 100 and a high respiration rate. EMT's made the decision for me to stay home since the hospital did not seem immediate in their opinion. After this I stayed on the couch for a few minutes and then felt very tired so I walked slowly to my room and fell asleep. I woke up at 06:00 for work, and arrived at 07:00. In the hour after waking up I was achy, sweating, and felt light headed. I got to work and my Sergeant told me to go home and sleep. I slept another 5 hours at 08:00 and when I woke up most of my symptoms went away other than aches and getting flush very easily for 5 days.  At this current time all I notice is some random light headedness that quickly resolves and comes a few times a day at random and without cause.
headache, bone ache, fatigue; took tylenol; resolved in 4 days
pt exp temp 104 w/in 24 hr; tx w/ tylenol; persist for 4 day
Hearing loss in left ear; A spontaneous report was received from a 77-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hearing loss in the left ear.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 23 Jan 2021, the patient started to experience hearing loss in the left ear. Tinny sound in left ear. Treatment for the events was not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event, hearing loss in the left ear, was unknown.; Reporter's Comments: This case concerns a 77 year-old, male patient, who experienced event of hearing loss in the left ear . The event occurred 2 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Mild arm soreness after dose #1 for several days.  DOSE #2:  General malaise started approximately 18 hours post-vaccination #2. Moderate arm soreness started several hours after dose #2 and continues through day 3.  Day 3 arm site is swollen, red and warm.  Day 2 started with 100.2 fever.  Day 3 low grade fever persists (99.4) and headache and slight malaise persists.
Patient presented to emergency department and was admitted to the hospital for a submassive pulmonary embolism
c/o pain in groin area noc of 10SEP90;crying, unable to sleep, very diff to walk next AM;intermittent pain over next several months;dx JRA 26JAN91;exp arthritic pain & sx in almost all joint of body;
I experienced redness on my arms, chills, nausea, fever and muscle aches.
Had first 2 periods of her life on 7/6/09 and 8/3/09 and then on 9/04 missed period.  Period returned on 10/4/09.  This is happening all of the internet and also to  a close friend's daughter.  She missed 2 periods.  This needs to be reported as a side effect of Gardasil.
Approx 5 minutes after receiving the vaccine, patient fainted briefly and leaned onto the patient next to them. We administered aid by laying him down with feet elevated. Approx 10 minutes later, the patient was comfortable enough to sit upright in the chair and another 15 minutes later was comfortable enough to leave.
I had a scratchy throat, and a little congested. After I spoke with my doctor's office, I was prescribed PAXLOVID and took it for five days. I felt I had a very mild case. My wife never got it, as I isolated away from her. My fever got up to 100. My case only lasted about 5 days.
Have a rash on my fingers , top of hand, up my arm to shoulder and under my arm onto my shoulder blade that began 3/14/21 with no other symptoms. Very painful and burns constantly
Swelling & soreness under armpit; fever 102.0*; welts & swelling on upper arm.
A report from VAERS concerns a 10 year old female. No concomitant medication or relevant history was provided. The patient received nasal FLUMIST on 28-Oct-2009. She developed hepatitis, thrombocytopenia, and her liver function test was abnormal. The outcomes of the hepatitis, liver function test abnormal, and thrombocytopenia were unknown. The following lab data were provided: On 16-Nov-2009 AST 435, ALT 1331, Alk phos 237, T bili 11.7, Hepatitis A, B and ANA (Antinuclear antibody) were negative, WBC (White blood cell count) 1.3. ANC (Absolute neutrophil count) 0.0, AST (Aspartate aminotransferase) 198, ALT (Alanine aminotransferase) 207, GGT (Gamma-glutamyltransferase) 483, T bili (Total bilirubin) 5.8 on 18-Nov-2009. Assessment of the serious criteria for the events was as follows by the reporter: hospitalised.
Headache(4days), nausea(2days), body ache(3days), fatigue(3days), bruising of the arm injected(5days),  hive at injection site for 5days. All symptoms started 24 hours after vaccine was given.
Axillary pain on right side (shot side) Delayed reaction of red, hot, painful, itchy welts at shot site