chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6 month old infant presented on 3/30 for well-visit and was prescribed to receive DTaP HepB IPV combined vaccine IM (PEDIARIX), HiB PRP-OMP conjugate vaccine 3 dose IM (PedvaxHIB), Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13), and Rotavirus vaccine pentavalent 3 dose oral (ROTATEQ) by MD. CMA prepared vaccines and administered DtaP/HepB/IPV IM in patient's right thigh (LOT# 552F4), Hib (PRP-OMP, PedvaxHIB) IM in patient's left thigh (LOT # U024489), Pneumococcal conjugate 13-valent (Prevnar 13) IM in patient's left thigh (LOT # EX1981) and Rotavirus Pentavalent orally (LOT # U006165). CMA documented "pt tolerated well". On 4/2, parent sent message noting patient had fever (102) day after injections and s On 4/2, parent sent message noting patient had fever (102) day after injections and still in pain. RN responded noting fever post injection indicated muscle administration and immune response triggered. RN did note "we could definitely give vaccines in different part of the leg in the future (upper, lateral thigh would be preferable". RN sent communication to MD noting "Vaccines look like they were given low and more central on the thighs? Maybe an inservice/refresher on giving vaccines for potentially less side effects?" MD agree with RN's recommendation. Follow up on 4/4 noted patient's "leg less redmore like bruises and very swollen if you feel it, it's super hard". MD recommended to continue to monitor, use cool compresses, and contact provider if fever reoccurs, red streak or warmth to skin is noted. System lists the following as adverse reactions for PedvaxHIB include irritability, pain, swelling, tenderness at injection sites, and fever. Patient's symptoms are likely and not unusual reaction for vaccine administration. Possible contributing cause could be if vaccine given in suboptimal location (preferred upper, lateral thigh).
Admitted to hospital 8/24/2021, had fever, cough abdominal cramps, was intubated and pt. expired on 8/27/2021
Product Complaint; neurological symptoms; numb tongue; This case was reported by a pharmacist via call center representative and described the occurrence of neurological symptom in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis. The case was associated with product complaint.  On 25th September 2019, the patient received FluLaval Tetra 2019-2020 season. On 27th September 2019, 2 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced neurological symptom and numbness of tongue. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the neurological symptom, numbness of tongue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the neurological symptom and numbness of tongue to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient reported to the emergency room with neurological symptoms, specifically numb tongue.   The reporter consented to follow up. The case has been linked to the cases US2019176211, US2019176209, reported by same reporter.
Rash on face , ear and neck - Zyrtec and Benadryl
? Chills (from 12 hours after the shot until present?33 hours so far) ? Slight fever (under 100) ? Headache ? Nausea & vomiting ? Dizziness  ? Insomnia
Patient seen 9/21/18, the day after getting vaccines. She complains of adverse reaction to pneumococcal vaccine, which she received yesterday morning. By yesterday evening, she had a swelling "the size of a potato" at the vaccine site, left upper arm. Today the red area is flatter but involves a larger area, most of upper arm, with redness nearly circumferential, and she is feverish and achy. Painful but not at all itchy.
On the 8th day all of a sudden about 4inches below the vaccine shot I started getting hives and they merged together. It was hot to touch, painful and raised up, red, and super itchy. It wasn't right where the needle went in, it was several inches below it. I used Benadryl and hydrocortisone cream , it took about 5 days to go away.    On my second dose the same thing happened on my let arm but was quicker and worse. It happened about 8 hours later.  It took about 7 days to go away. You can still kind of see the outline of it. This one was more painful.
This case was reported by a physician and described the occurrence of injection site pain in a 80-year-old male subject who was vaccinated with influenza virus vaccine (FluLaval) for prophylaxis. Concurrent medications included Atervastin calcium (Lipitor) and Cardiac medication. The subject has unspecified cardiac history. He received the flu injection last year without complaints. On 23 October the subject received 1st dose of FluLaval at 0.5 ml, intramuscularly in the right deltoid. That same day, the subject experienced injection site pain. Four days later, on 27 October 2006, the subject reported increased pain and swelling at the injection site. The subject also reported weakness in his right arm with progressive loss of arm above his shoulder. The physician stated that in order for the subject to lift his arm over his head he had to lift his right arm to fully extend the right arm. The physician considered the events were disabling significant (or requiring intervention) (OMIC). The subject reports significant pain and weakness when he has to lift his arm. At the time of reporting. the events were worse. In the reporter's opinion, the events are probably related to treatment with FluLaval.
Pt here for suicidal ideation. Pt needed inpatient psychiatric care, but had to be tested for COVID before placement and was positive. Pt asymptomatic.
It has been just about 7 days since injection and still having itching at the injection site. Day 1 had sever chill's  & pain in arm which subsided at about 28 hours later.  Day 2 headache,  swelling & redness in left arm where injection was. By day 5 redness & swelling in arm started to subside. Today which is almost 1 week from vaccine still have a dime size redness & puffiness at the injection site along with itching still.
diagnose with a granuloma annular; pain on my foot; swollen on my foot; I have had an issue with a gross rash in my foot and leg; soreness; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMA ANNULARE (diagnose with a granuloma annular), PAIN (soreness), PAIN IN EXTREMITY (pain on my foot), PERIPHERAL SWELLING (swollen on my foot) and RASH (I have had an issue with a gross rash in my foot and leg) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN (soreness). On an unknown date, the patient experienced GRANULOMA ANNULARE (diagnose with a granuloma annular), PAIN IN EXTREMITY (pain on my foot), PERIPHERAL SWELLING (swollen on my foot) and RASH (I have had an issue with a gross rash in my foot and leg). At the time of the report, GRANULOMA ANNULARE (diagnose with a granuloma annular) had not resolved and PAIN (soreness), PAIN IN EXTREMITY (pain on my foot), PERIPHERAL SWELLING (swollen on my foot) and RASH (I have had an issue with a gross rash in my foot and leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included unspecified Thyroid medication. Treatment included 2 different unspecified ointment creams.   This case was linked to MOD-2021-370444 (Patient Link).
Pt complained of arthralgia, fever, chills and welt at site on 10/30/00. Told to take fluids and Tylenol. Called on 11/1/00 and requested visit as arthralgia was worsening. Does not have fever or chills. Slight lump at injection site. NAD.
Problems with vision; Problems with hearing; Joint pain; Muscle pain; Rashes; Weakness; Lost the ability to use hands properly; Patient did not receive 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of abnormal vision in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included ZOSTAVAX (received in April 2011) and ZOSTAVAX (received in March 2013).   On 7th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced abnormal vision, hearing impaired, joint pain, muscle pain, rash, weakness, inability to work and incomplete course of vaccination. On an unknown date, the outcome of the abnormal vision, hearing impaired, joint pain, muscle pain, rash, weakness, inability to work and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the abnormal vision, hearing impaired, joint pain, muscle pain, rash, weakness and inability to work to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's comment: The patient's husband reported this case. The patient received first dose of Shingrix vaccine and experienced problems with her vision, hearing, she had joint and muscle pain, rashes and weakness. The patient also had lost the ability to use her hands properly. The reporter did not consented to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose, which led to Incomplete course of vaccination. This case has been linked with case US2022126202, reported by the same reporter. As it was unknown that there was any medical reason due to which patient did not receive the 2nd dose, therefore 2nd dose was coded as suspect and linked with incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022126202:Same reporter
High-frequency, large-volume diarrhea with associated transient fever (Tmax 101F) lasting less than 48 hours; no notable vomiting, no difficulty with oral intake of breastmilk; no treatments needed, symptoms resolved spontaneously
Family called on 11/11/15. Redness and swelling noted on 11/11/15 (L) deltoid region. Mild pain flu shot given 2 days earlier. No problems with post flu shots. Exam: 6 x 9 cm pinkness, induration, mild tenderness (L) upper arm 21 cm circumference (R) upper arm 19.5 cm circumference. No systemic findings.
Information has been received from a pharmacy technician concerning a patient who in March 2010, was vaccinated subcutaneously with a 0.5 mL dose of MMR II (LOT# reported as "1237Z" expiration 29-AUG-2010). The pharmacy technician reported that the patient did not any antibodies for mumps after receiving MMR II. Unspecified medical attention was sought. No further information is available.
Began having suspected ocular migraines approx. 1st or 2nd week of July, 2022. Was seen, received CT and MRI with no abnormalities noted. Received most recent bivalent Moderna vaccine 9/12/2022. Today is 10/18/2022 and I have had 3 migraines with exacerbating symptoms since 10/15/2022. This may have nothing to do with the vaccines, as I have had 3 previous and only experienced minor side effects of body aches, malaise, headache after the previous 3. The vaccine on 9/12/2022 I experienced no side effects afterward.
After about 2 hours I had vertigo and everything began swirling around me and making me feel sick to my stomach. This has improved although it's difficult to watch fast moving objects such as traffic or things on tv. After about 4 days, my left ear started ringing and making weird low humming sounds. I still have this now and it isn't improving and has become very loud. It sometimes wakes me up in the night. In addition, my legs still ache, even after taking Advil and I just feel a bit off.
Patient received second dose of influenza vaccine due to communication error between parent, school, and vaccine registration system.
Patient is an 84 year old woman who presented for evaluation of illness x 2 days. Symptoms included weakness, difficulty breathing, NV, cough, poor appetite and headache. In the ER, she was hypoxic at 79% on RA. She was also febrile. HFNC was started initially but she was later weaned to o2 via NC. COVID-19 PCR was positive and her bnp was over 45K. Although peripherally she did not appear grossly fluid overloaded, her chest xray showed pulmonary edema (along with pneumonia). In the ER, she was given fluids before we later tried to diurese her. An echo was obtained and reviewed with cardiology. Her EF was 20% (lower than most recent) and she had severe valvular disease. I discussed findings with family who did not to pursue any aggressive work up or transfer (cardiology would have discussed timing of possible TAVR amongst other management advise). Based on this conversation, I recommended hospice which family/patient did desire. Consult was obtained and discharge plans were made to get patient home. Symptoms got worse on 1/8; requiring use of NRB mask in addition to 6 L NC. Prior to discharge, she was able to maintain saturations on 6 L.
body aches; Chills/rigors; pain around injection site; headache; This is a spontaneous report from a contactable other hcp (patient). A 21-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6201, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 19Feb2021 17:00 (at the age of 21-years-old) as dose 2, single for covid-19 immunisation.  Medical history included gastrooesophageal reflux disease, covid-19 from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), citalopram (CITALOPRAM), hydroxyzine hydrochloride (HYDROXIZINE) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at time of vaccination. The patient had no known allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: El9262, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 22Jan2021 12:00 as dose 1, single for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. The patient received lo loestrin, nexium, citalopram, hydroxizine other medication in two weeks. On 20Feb2021 04:00, the patient experienced chills, rigors, pain around injection site, headache, body aches. The patient did not receive treatment for the adverse event. Prior vaccination, patient had not been diagnosed with COVID and had not been tested since the vaccination. The outcome of events was recovering.  Follow-up attempts completed. No further information expected.
Approx 3 hours after receiving PNEUMOVAX 23, had sudden onset generalized headache. Since then, as of 5/31/13, has had episodes of "ice pick syndrome" HA's, lasting 10-45 minutes. Debilitating pain. Given Gabapentin 100 mg (1-6 tabs tid prn) TORADOL IM. 6/3/13 OV, 2 ice pick HA's since 5/31/13. Occurred during sleep. Given INDOCIN. Also decrease hearing (L) ear since PNEUMOVAX. 6/13/13 phone consult ice pick episodes yesterday, 3 while sleeping. Neuro eval recommended. Pt. declined.
Pfizer COVID-19 Vaccine EUA  Patient became feeling like her heart was racing. 30 min monitoring bp was 170/88 p 88 oxygen 99 resp 18. Was given juice and monitored for 30 minutes.
This spontaneous report as received from a registered nurse refers to unknown patients of unknown age and gender. Current conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of PROQUAD (Lot # M018638, expiration date 11-OCT2-017; M021731, expiration date 17-OCT-2017; M015695 26-SEP-2017) (Dose and route were not provided). Concomitant medications were not reported. The temperature excursion details were -11.2C for 1 hour 18 minutes. A second freezer containing different lots for Lots M011663, expiration date 08-SEP-2017; M015698, 26-SEP-2017; M029595, 31-DEC-2017, with a temperature excursion of -12.9C for 48 minutes. The lot# M015695, expiration date 26-SEP-2017) had an additional excursion of -9 C for 2 hours. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Many project vomits 21 a day to 8 a day for 5 day other are possible reaction due Dtap and prior Grand mal seizure 6/11/00 Hib possible for immediate reaction after talk with CDC in 2007.  05/08/2008 MR received for several ER visits dated 6/13/2000 and 2 visits 6/17/2000 with DX: Vomiting (6/13 and 6/17 #1) and Status Epilepticus, Probable cerebral insult, respiratory failure. Initially seen 6/13/00 with c/o spitting up every feed. D/C home on Pedialyte.  Returned 6/17/00 with c/o vomiting x 1 week.  PE WNL except somewhat pale. To f/u with PMD. Returned later that day with c/o pallor, weakness and poor intake. Pt noted to be in critical condition upon admission.  PE (+) for pallor, shallow respirations, posturing, roaming eye movements, decreased breath sounds and only responsive to painful stim. Small contusion noted on forehead. Pt given O2 then intubated.  Pupils initially equal, then developed anisocoria, then equal following intubation. Transported to higher level of care.  5/12/08 PCP records received for DOS 6/12/00 with Impression:  Suspicious hx of neonatal seizures. In for WCC with report of "abnormal movements"-upward rolling of the eyes and jerking of upper limbs 1 day prior to exam. PE WNL. Child was active and smiling. Poor weight gain noted (5th percentile).  6/12/2008 MR received from transfer hospital for DOS 6/17-7/28/2000 with sx c/w Shaken Baby Syndrome.  Infant received from local hospital with altered mental status, h/o vomiting/diarrhea, now with bulging fontanelle.  On mechanical ventilation and on Fosphenetoin.  PE (+) for lethargy, 2x2 cm ecchymosis on R frontal area, bulging fontanelle, coarse BS and decreased air entry at L lung base, heart sounds with intermittant gallop with inspiration, bradycardia and posturing. GCS 4 on admission. R pupil 4mm and fixed. Admitted to ICU. Ophth exam (+) for retinal hemorrhages. No surgical intervention required for intracranial trauma.
Extensive Papular Urticaria reaction.  Rash covering next, chest, face and both forearms and hands.  Cleared in about 4 days
Patient was given Meningococcal B vaccine. Patient is 11 years old and should have received the Meningococcal conjugate Menveo but was given Bexsero.
24 to 48 hrs after vaccine sore throat, then felt like a cold (runny nose, congestion)
Diagnose with vertigo; Not able to walk; Fatigue; Really-really dizzy and dizziness; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Diagnose with vertigo), GAIT INABILITY (Not able to walk), DIZZINESS (Really-really dizzy and dizziness), NAUSEA (Nausea) and VOMITING (Vomiting) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE and AMLODIPINE BESILATE (PROVASC) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced DIZZINESS (Really-really dizzy and dizziness), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced VERTIGO (Diagnose with vertigo), GAIT INABILITY (Not able to walk) and FATIGUE (Fatigue). At the time of the report, VERTIGO (Diagnose with vertigo), GAIT INABILITY (Not able to walk), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown and DIZZINESS (Really-really dizzy and dizziness) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 17-Mar-2021, the patient received their first dose of vaccine. On day 1, the patient was really-really dizzy, nausea and vomiting. Following the day, the patient felt better, and dizziness. After 5 days the patient again experienced dizziness.  Reportedly, the patient was not able to walk, and it lasted for a week.   The patient was also diagnosed with vertigo and still felt dizziness, fatigue.   Treatment information provided by the reporter included physical therapy and home exercises.
Patient's arm very sore since 4/12 - called Dr and patient has been taking Ibuprofen - I told her to call Dr. and follow up. Can't move arm very well.
Rash developed 2-3 days after 2nd dose.  Patient seen in clinic on 5-28-21 and rash is getting worse.  Rash started on arms and stomach  and is spreading to legs.  Some pain was noted with scratches.  Hydrocortisone 2.5% lotion prescribed twice daily as needed for 14 days, Calamine lotion 2-3 times per day as needed for 14 days and Benadryl 50 mg twice daily for 10 days as needed.
a little bit of joint pain; This spontaneous case was reported by a non-health professional and describes the occurrence of ARTHRALGIA (a little bit of joint pain) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (a little bit of joint pain). At the time of the report, ARTHRALGIA (a little bit of joint pain) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication was reported. It was stated that patient had no issues, only a little bit of joint pain No treatment medication was reported.
After 2nd Pfizer vaccine on 3-2-21, patient noticed insomnia and weight loss. Then after booster received on 12-17-21 noted swelling in legs and erratic heart rate.  Arranged to get lab tests at hospital and passed out while at hospital.  Patient did get lab tests done and was told by Dr. that it was the lowest TSH result that he had ever seen.  Reports that heart tests were done, and left atrium was enlarged, there was atrial fibrillation and signs of Congestive Heart Failure.  Was diagnosed with hyperthyroidism.  Reports 50-pound weight loss from approx. 275 to 225.