chrisvoncsefalvay/vaers-outcomes huggingface dataset:
celiac disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), in 2022 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COELIAC DISEASE (medically significant), outcome "unknown", described as "celiac disease". Clinical course: The patient (reporter's son) (20 years old) was supposed to get Trumenba vaccine. He got 1 dose last year, but then shortly after he was diagnosed with celiac disease. Parent asked, "Before we get his 2nd, is the vaccine gluten free? Since he had 1 dose over a year ago, how many more doses should he get and when should he get them?" The reporter's 20 year old son received a dose of Trumenba a year ago, after that he was diagnosed with Celiac disease and he has yet to receive his second dose which should have been given 6 month after the first. He was asking about getting the second dose. His second dose was late, it was supposed to be give in 6 month after the first.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.  Follow-up (14Aug2023): This is a spontaneous follow-up report received from the same contactable consumer (Patient's mother). Updated information: clinical course added.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Throat tightening, 25 mg benadryl, 20 mg pepcid
This spontaneous report was received from a nurse refers to a patient with unspecified age, gender, pertinent medical history or drug reactions / allergies. On an unspecified date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, lot number and route were not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient received a dose of PNEUMOVAX 23 and was hospitalized (Date and reason were not reported). The patient's outcome was unknown. This is a report of several reports from the same source. Additional information has been requested.
Extremely loud tinnitus right ear. Dizziness, vomiting. Been to ER. Diagnosed with heart attack. Had stent in 70% blockage. Been to ENT. Had steroid shot in right ear. Did not help. Had MRI. Completely normal. Been to neurologist. He could not find a reason for tinnitus and dizziness. Ordered ultrasound of my carotid. Supposed to get results next week.
Patient was at first lightheadedness. denied shortness of breath/throat swelling---he was moved to the floor and monitored. He was feeling ok to sit back up in chair. About 5 minutes later he said he was feeling nauseous and wanted to lay down and elevate his legs again. He laid there for about 10 minutes no shortness of breath or nausea. He then wanted to stand up. This made him feel better. He remained in the waiting area for observation. Patient was feeling good to go home. I did follow up with him about an hour later. He did make it home and was feeling better.
Had flu vaccine and pneumococcal vaccine in right arm. Next day arm swelled up and became red down past elbow. Called and was directed to call my own doctor's office. Nurse advised iced compress be applied to stop swelling and redness. I complied for 2 days and swelling and redness left me. Seems OK now.
lower GI track intestinal distress, fatigue, Dose 1 admin in 12/30/2020 - severe GI distress and fatigue the day after vaccination Dose 2 admin on 1/27/20 (Lot 013L20A): severe sinus congestion, lower GI distress two days post vaccination
1 days p/vax pt had mild local rxn @ inj site-erythema, warmth, tenderness & swelling;tx symptomatically rxn restored w/in a few days;
Pt states reaction started 3-4 hrs post getting injection . had itching, redness and swelling started size of orange. Then redness moved down Lt arm warm to touch. Keflex 500mg tid #21, Allegra 180mg. Sxs resolved with 6 days post injection and tx.
WRONG SHOT GIVEN TO 11 YEAR OLD,  INTENDED SHOT WAS FOR PEDIATRIC PFIZER DOSE 0.2ML NOT ADULT PFIZER DOSE 0.3ML.  PT DID NOT HAVE ANY REACTION AT TIME GIVE.
Pt received full dose Moderna instead of Moderna Booster dose.  No adverse effects noted at the time of vaccination or after observation.  Pt stable and released from the vaccination site.
Information has been received from a consumer, a 24 year old Caucasian female patient who on 04/01/99 was vaccinated with one dose of Varicella virus vaccine live. On 04/10/99, the patient learned that she was pregnant. On 12/16/99, at 37 weeks gestation, the patient delivered a baby boy. The infant was placed in the NICU because he had a slight amount of fluid on his lungs. The infant was treated with antibiotics and was discharged from the hospital after 3 days. "He was fine after that". Additional information has been requested. This report is part of the pregnancy registry.
she has not received the 2nd dose and it has been 10 months; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in left arm at a local pharmacy in September 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she has not received the 2nd dose and it has been 10 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-Jul-2023 The patient reported that she has not received the 2nd dose and it had been 10 months since the 1st dose.  Lot and expiry date were not provided.  The customer had been transferred several times during the call and requested information for financial assistance for the 2nd dose of Shingrix and requested the information as soon as possible.  The customer reported that having insurance for her 1st dose of Shingrix but did not have insurance coverage for the 2nd dose.  The consumer did not provided additional information. Not all information was available.  Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient experienced soreness, muscle aching, stomach pain, dizziness, lightheadness, swelling, warmth, fever and headache. Did not seek medical treatment.
Sunday, 12/26, rather acute onset shortness of breath, O2 saturation in low 90s/high 80s, low grade fever (102.8 was highest), malaise, fatigue.  Productive cough, wheezing.  Symptoms progressed over the next 48 hours and have very slowly now begun to taper. Nasal PCR swab was negative for COVID-19.  I was unable to find a clinic for oral swab
the arm I had received the vaccine in was generally sore from elbow to shoulder; cold; headache; Muscle soreness; Fever; I had the chills; I had an elevated Temp 99.2F; unusual fatigue; This is a spontaneous report from a contactable consumer. This 70yearsold male consumer reported for himself that:  A 70-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on 09Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none. There were no concomitant medications. On 26Feb2021, the patient experienced i had the chills, i had an elevated temp 99.2f, unusual fatigue, fever. On 27Feb2021, headache, muscle soreness. On an unspecified date, the arm i had received the vaccine in was generally sore from elbow to shoulder, cold.  At the time had minor soreness. But then 2 1/2 weeks later he had a delayed reaction to the shot. He had an elevated Temp 99.2F, on Saturday morning (27Feb2021), the arm he had received the vaccine in was generally sore from elbow to shoulder and also he had the chills. Should he still got his second dose. On 26Feb2021, pretty bad reaction. The is supposed to get the second dose tomorrow. Is there any concern about getting the second shot tomorrow. This past weekend, he had a delayed reaction to the first shot. After the first shot he had a minor sore arm, then this weekend all of the sudden Friday the caller got really tired, his temperature was somewhat elevated from normal base. Saturday morning his temperature was 99.2, his normal base is 96.5, this was a fever for him. The caller had a headache, the muscle in the same arm from the shot was really bothering him, it was generic muscle pain, not very site directed. The caller also got chills, was very cold and could not warm up and has been quarantining and stying within his family bubble. The caller wanted to know if this was a very delayed reaction, 2.5 weeks later, was a known thing. The patient underwent lab tests and procedures which included temp: 99.2 fahrenheit on 27Feb2021, covid test: negative on 27Feb2021. The clinical outcome of events chills, i had an elevated temp 99.2f, unusual fatigue, fever were recovering and other events were unknown.  No follow-up attempts are possible; No further information are expected.
Patient states she developed respiratory symptoms 09/03/2005 2 days after injection. And by Monday 09/05/2005 she had cellulitis in inner aspect of left arm just above the elbow. HCP diagnosed cellulitis and RX'D Avelox.
Around 3PM on 4/16 I started to get sick to my stomach.  Around 5PM I started to get light headed and then around 6:30 PM I started to get the chills really bad.  I took Dual Action Advil with Acetaminophen, 500 mg & 250 mg respectively, at 7:00 PM.  The chills went away around 9:30-10:00 PM.  I woke up feeling ok but rested for the morning.  At 12:30 PM I went and hooked up my camper and moved it to a different location and that is when the symptoms started again.  Specifically being light headed, loss of all energy along with an upset stomach  and slight headache.
5/27/11 Pt. in office recently & mentioned sore arm where received injection. In today and requests vaccine reporting event. States 1-2 days post injection in (L) upper arm - deltoid noted soreness which progressively continued and still has soreness at same place first noticed. Has movement - no Hx. paralysis - says the area is still sore and somewhat limits how high he raises his arm. Saw Dr. 1-6-11 & took cortisone shot that did not relieve nor improvement without some discomfort. Also saw Dr. 5/24/11 - no treatment but did x-ray.
muscle aches; joint aches; fever; headache; stuffiness in her head; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2019, the patient received the 1st dose of Shingrix. On 10th October 2019, 1 days after receiving Shingrix, the patient experienced muscle pain, joint pain, fever, headache and head discomfort. On an unknown date, the outcome of the muscle pain, joint pain and fever were resolved with sequelae and the outcome of the headache was unknown and the outcome of the head discomfort was recovering/resolving.   It was unknown if the reporter considered the muscle pain, joint pain, fever, headache and head discomfort to be related to Shingrix.  Additional details were provided as follows: The patient experienced muscle and joint aches, fever and headache and some stuffiness in her head. The patient consented to follow up.
pt collapsed p/leaving immun room w/father catching pt; pt unresponsive until on floor then pt asked dad what happened?; pt's vital signs obtained  every 15 mins w/pt remaining stable; pt graduated from lying position to ambulatory state;
I was feeling a bit of a sore thorat and was fatigued. Within about 12 hours I had a fever and chills with body aches and a head ache. On the 20th I took a home COVID-19 test and it was positive. I then reached out to my Doctor with my positive results. The worst says were at the beginning I was having a hard time sleeping and it was the worst part. After that point I was just really tired and had some lingering congestion.
A report was received from a health care professional on 10/30/03, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/01/03: Follow up information received from a health care professional indicated that a 9 month old female vaccinee inadvertently received Fluvirin on 10/23/03 and had not experienced any adverse event at the time of report. No follow up pending, all information received. Cross reference with: PJP2003000957, PJP200400013, PJP200400014, PJP200400015, PJP200400016, PJP200400018, PJP200400019, PJP200400021, PJP200400022, PJP200400023, PJP200400024.
(L) upper arm red and swollen AM after vaccine administration. Apply cold compresses Will put a Note in chart to monitor for reactions for future vaccines.
Patient received her 3rd Moderna vaccine on 1/3/21. The next day, 1/4/21, she developed a "deep, achy pain" in her right upper thigh. After a few days, she was concerned, and was evaluated at an Urgent Care on 1/7/21. Due to her personal concern for blood clot, d-dimer was sent, and result was normal (<0.270 ugFEU/mL). Pain continued, and a few days later she developed a blistering rash in the area of pain, on approximately 1/10/21 or 1/11/21. She was then evaluated by this provider in clinic on 1/14/21, and diagnosed with herpes zoster.
Pt received COVID 19 injection on 1/16/21 and on 1/21/21 broke out with shingles He did have a shingles vaccine 10/22/12
About 30 minutes after having the vaccine my face got tingly and I had a bad ear ache. It took 40 minutes to get back to my work at which time my face on the right side was starting to swell and look funny (drooping) I continued to have tingling and later noticed hives that were larger than most hives I get. Only about 50-60 hives on my entire body but my numbness of my face was the entire right side starting by my lips moving to my cheek and eye area as well as on my head by the back of my ear.  My ear ache came and went for the last week.  Today only 1 ear ache.  Facial swelling went down with in hours and my facial drooping was gone in 2 days.  Numbness in face gone in 2 days as well.
Anaphylaxis & Palpitations Narrative:  Pt received Moderna COVID vaccine at facility and reported a tightness in her throat, dizziness and heart palpitations 10 min following vaccine receipt. Pt taken to ED for evaluation, received benadryl IVP and monitored closely; pt's sx resolved within an hour. She was discharged home with an EpiPen for future potential anaphylaxis situations.  Other Relevant History:
Arm pain post injection Severe pain in shoulder joint, down arm, pain elbow, pain firearm and hand on left side. Diagnosed as reactive arthritis due to vaccine
This spontaneous report as received from other health professional via company representative refers to a 31 year old patient of unknown gender. On 28-FEB-2014 the patient was accidentally vaccinated with VARIVAX injection 0.5 milliliter (ML)/one shot with lot # 1408AA that has expired on 16-SEP-2013. No adverse experiences were reported. The outcome of administered an expired VARIVAX and no adverse experiences was unknown. No further adverse event (AE) information was reported. Additional information has been requested.
Caller had no further AE to report.; Caller stated the first dose of the vaccine was administered to a patient who was 7 months 26 days.; This spontaneous report has been received from other reporter, concerning a 7-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 19-JAN-2023, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliters (ml) (vaccination scheme, frequency, lot number, and expiration date were not provided) for prophylaxis, who was 7 months and 26 days (product administered to patient of inappropriate age ).  No additional adverse events (AE) were reported.
Shortly after flu vaccine was administered, pt turned pale white and passed out. Recovered but stated she was dizzy and labored breathing as well could answer basic question somewhat. After 3-4 min, condition worsened and BP was checked and found to be 53/37. Epinephrine 0.3 mg was administered and pt recovered quickly. EMS arrived 10 min later and took to hospital.
I experience a lot of pain, and then my shoulder and neck hurt a lot, I also experience Sharp stabbing pain.  experience some pain on my breast like sharp pain starting then the next Wednesday I noticed that my neck continue hurting and Thursday I called my doctor. He and give me directions on what to do.  He also said that if the symptoms don?t get better go away that I need to Get further evaluation.
This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 13Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced has a spot the size of a lemon and is angry red on an unspecified date. Outcome of the event was not recovered.  Follow-up (15Feb2021): This is a follow-up spontaneous report from a contactable consumer.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
11:45pm woke with severe chills teeth chattering.then began severe body aches and severe?bone? pain of all my bones. Shivers lasted about 4 hours. Pain was deep in bones(all bones)@ intensity 7-10 for 4 days. Unable to sit or stand d/t pain. For 1st 2 days bone pain accompanied by shooting pulsations. Day 5 is today and most bone aches improved except for sacral bones and iliac crests. This pain is still 4-5 and increase to 7 with wrong movement or sitting. I am a nurse so if this sounds too medical that is why. Have a call to my FNP for possible appointment waiting to hear back.
GARDASIL 9 being administered in the glute instead of the anterolateral thigh; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.     On 12-OCT-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml; lot #, expiration date and route were unknown) for prophylaxis. The vaccine was administered in the glute instead of the anterolateral thigh (product administered at inappropriate site).
Started Sunday evening.   Fever of 103, severe headache, body aches, chills, sweats, blotchy skin.  Episode lasted for 8 days straight.
The pt developed rash with crusted lesions on back, one small vesicle, red throat and tongue.
About 3 weeks after the 1st dose, on Friday 2/26/2021, I noticed a red, 3-inch circular lump that was sore to the touch on my left calf. I called the doctor that following Monday and went the same day to see the doctor. I was referred to a specialist and did an ultrasound of my left leg and was diagnosed with a blood clot. I was given a prescription for compression stockings to wear and advised to take a low dose aspirin daily. I went ahead to proceed to get my 2nd vaccine the following week. Around 5/1/2021, I was shopping at the store and felt like I was going to fall or faint. I stopped by the customer service and asked them to call 911. I sat down on the floor and waited for the ambulance to arrive, took deep breaths and drink water and started to feel better. I did go to the ER, and they did a bunch of tests, blood work, ultrasound of my leg and EKG and everything came back normal. I was not diagnosed with anything since they did not find anything. They also did not find any blood clot in my leg, which has resolved.
This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear pain while laying down), VACCINATION SITE PAIN (Injection site pain) and EAR INFECTION (ear hurts believing it might be has ear infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (Ear pain while laying down), VACCINATION SITE PAIN (Injection site pain) and EAR INFECTION (ear hurts believing it might be has ear infection). At the time of the report, EAR PAIN (Ear pain while laying down), VACCINATION SITE PAIN (Injection site pain) and EAR INFECTION (ear hurts believing it might be has ear infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26-APR-2021 updated contact information.
Felt foggy and couldn't think clear; Sore arm; Racing heart; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Racing heart), FEELING ABNORMAL (Felt foggy and couldn't think clear) and PAIN IN EXTREMITY (Sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PALPITATIONS (Racing heart). On an unknown date, the patient experienced FEELING ABNORMAL (Felt foggy and couldn't think clear) and PAIN IN EXTREMITY (Sore arm). At the time of the report, PALPITATIONS (Racing heart), FEELING ABNORMAL (Felt foggy and couldn't think clear) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
Patient reported localized swelling, redness, tenderness, and heat in her right shoulder which started almost immediately following immunization and has gotten progressively worse over the last three days.  It has extended down to the right elbow and over to the right underarm and breast.  Patient using ice and acetaminophen to manage the symptoms, and she is planning on seeking further medical attention if the condition worsens significantly or does not improve within 24 hours.