chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right side about 4" below belly button a dull ache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN LOWER (Right side about 4" below belly button a dull ache) 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 27-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2021, the patient experienced ABDOMINAL PAIN LOWER (Right side about 4" below belly button a dull ache). At the time of the report, ABDOMINAL PAIN LOWER (Right side about 4" below belly button a dull ache) outcome was unknown.              No concomitant medications were reported. Treatment information was unknown.
Pt exp inject site rxn which included redness, & limping w/in 24 hrs p/DTP/HIBTITER immun; Also had a fever of 104; tx APAP & ice packs; Fever resolved on day 3; Local rxn lasted 4-5 days;
about a day after vaccination date, left arm is sore and has been sore since (4 weeks  later) .  it is painful when I lift up my arm , as if a muscle was torn. nothing has changed in daily activity to cause that.
GOING TO LOSE AT LEAST ONE ORGAN QUITE POSSIBLY 4; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age of unknown race and ethnicity. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the reporter stated that "hey your experimental jabbed landed my niece in the hospital no liability for you she will be lucky to survive Just trying to get her to stay alive at this point Going to lose at least one organ, quite possibly 4". The patient was hospitalized (unspecified date and days). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of going to lose at least one organ quite possibly 4 was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211139171 -covid-19 vaccine ad26.cov2.s- "Going to lose at least one organ, quite possibly 4". This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
11/1/21 ED note by Dr.: "Pt is a 36 y.o. male with history as noted below who presents with chest pain. Patient states that last night, after dinner (ate vegan nachos) he developed chest pain while watching TV. He initially thought the pain might be related to "acid reflux" but had no relief with otc pepto-bismal tabs. He states that a little while later, while still sitting watching TV, he developed dizziness (which he described as room-spinning when he closes his eyes), lightheadedness, and nausea, as well as palpitations. Also with slight headache as well. The symptoms were all present while sitting, no worse when standing up. He began concerned and presented to the ED for further evaluation. He denies associated shortness of breath, cough, paraesthesias, vomiting, diarrhea, fevers, or chills. Patient states that about two weeks ago he had "cold-like" symptoms and had a COVID-19 test which was negative. A few days later his wife also developed symptoms and had a positive COVID-19 test (about 11 days ago). He did not retest, but the whole family, including his kids, have been quarantining since her positive test, with their final day supposed to be yesterday. All of his family is now symptom free".
Patient reports having shortness of breath when he woke the morning of Jan 15th. He contacted his physician and had an office visit. He was reportedly advised by the doctor to purchase a pulse ox and if O2 is lower than 90, he is to go to the ER.  Patient experienced SOB for a few days, and has since recovered without further symptoms
fever (up to 100.8) lethargy, generalized aching, some neck stiffness (? mild meningeal irritation); all started w/in 24 hrs of vax & lasted 48 hrs;
left arm Soreness / only hurt when she stretched her left arm; This case was reported by a consumer and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient stated that she also had left arm Soreness for two days after her first Shingrix vaccine. The reporter did not consent to follow-up. All information was not available. For tolerance of 2nd dose refer case US2021042056.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021042056:1st dose, same reporter
pt recvd vax 13AUG93 reports pain & swelling @ inject site, h/a & fever;
Pregnant Female Received HEPLISAV-B in Error; Pregnant Female Received HEPLISAV-B in Error; Initial Report Received on 22-Dec-2021 and 09-Feb-2022  A reporter from a clinic reported that a pregnant female patient (age, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 22-Dec-2021, the pregnant patient came into the clinic and received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) through an unspecified route and site. The clinic reported it as an immunization error to the registry.  The patient did not enroll in the registry and no additional information was reported.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
no adverse event; Medical assistant reported a temperature excursion which was administered to the patient; This spontaneous report was received from a medical assistant concerning, a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.     On 03-APR-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form orally (lot number 1691132 which was verified to be a valid lot number, expiration date reported and upon internal validation established as 30-NOV-2021), as prophylaxis (frequency and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion above 9 degree Celsius (°C) (9.3C) during a time frame of 0 hours 46 minutes and 0 seconds, as recorded by data logger. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001375: US-009507513-2104USA001383: US-009507513-2104USA001384: US-009507513-2104USA001382: US-009507513-2104USA001386:
18 months ago / first Shingrix vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, 18 months ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated that, the patient did not return within the recommended time frame to receive the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist only had the gender of the patient no other information known at the time of call.
Immediately after dose #2 on 9/26/2021,  hot, red, oval shaped rash below injection site. Morning after on 9/27/2021, systemic inflammation. Fatigue, lethargy, dizziness, severe muscle/joint aches. On 9/30, menstrual spotting starting in the am. Resumption of menstrual bleeding starting in the evening.  Last menstrual cycle ended 09/24/2021. No previous issues with irregular cycle or breakthrough bleeding.
Delayed reaction such as redness, rash, and itchiness after 1week post vaccination.
got the shot, and had them even worse/ Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient friend. The age at vaccination was not reported. The patient had shingles, received Shingles vaccine and had them even worse. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR188607:Same reporter
Stiff neck, chills, rash and lethargy and myalgia. Started 24 hours after vaccine: resolving with 7 days.
Numbness and tingling sensation on the left hand.  Hard to extend the pinky finger on the left hand,  feels like a nerve is pinched.
PATIENT RECEIVED THE PNEUMOVAX 23 INTRAMUSCULAR VACCINE. AFTER GOING HOME PATIENT HAS CONTACTED THE PHARMACY STATING THAT SHE FEELS ARM PAIN. AFTER 2 WEEKS PATIENT STILL REPORTS ARM PAIN AND INABILITY TO HAVE FULL FUNCTIONALITY OF LEFT ARM. PATIENT STATES THAT SHE IS TAKING STEROIDS AND HAS AN MRI SCHEDULED TO ADDRESS THE PAIN.
Multiple pulmonary embolism 100 degree fever Chills incontinence Gout  Blood Uric Acid Increase Shortness of breath
At approx. 11:42, pt. reported "burning on inside." Pt. was taken to first aid area of clinic. Pt. denies any rash, puritis, difficulty breathing, or throat irritation. V/S @ 1148: 97.9, 80, 180/95. Pt. started to report worsening of symptoms ("burning on the inside.") Benadryl 25mg PO administered per standing order at 11:52. Additional Benadryl 25mg PO given per standard order @ 1202. Nursing staff continued to monitor patient and @ approx. 1207, pt. developed shortness of breath and throat tightening. Epi 0.3mg IM administered per MD order at 1208. Pt. started to show improvement of symptoms at approx. 1210. Pt. reported that throat tightening was subsiding. EMS contacted. BP: 193/107 @ 1213, 181/95 @ 1219. Paramedics arrived at 1223 and patient transported. Daughter followed.
In the evening of the day I had the Janssen vaccine shot, at around 7:00pm (4/5/2021) I experienced strong chills that immediately became a fever. I took some ibuprofen and went to sleep. When I woke up in the morning the fever was gone and I felt fine.
Patient report that next day after getting the shot he had flu like symptoms... His left wrist has sharp pains ...
Red lump, hot to the touch 3-4cms. Give Tylenol, use ice on area.
Telephone call from pt states hives developed that evening of 4/28/06 after receiving the hep B.  States previous Hep B 1st dose 3/28/06 same thing happened but did not report, wasn't sure it was related to vaccine then. Hives in her back, a few in her abdomen and legs. None upper body. Taking Benadryl, symptoms relieved some.
Information has been received from a health professional concerning a 5 year old female with no allergies and no medical history reported, who on 08-JAN-2002 was vaccinated with the first dose of VARIVAX (Oka/Merck) (Lot# 640468/0796L) and on 07-FEB-2008 was vaccinated with the second dose of VARIVAX  (Lot # 651177/0428R). There was no concomitant medication. In September 2006, the patient developed a "full blown case of chickenpox" after administration of two doses of VARIVAX (Oka/Merck). On an unknown date, the patient recovered from "full blown case of chickenpox". The patient sought medical attention at the office. Additional information has been requested.
Patient presented to facility today for her appointment and noted that she received her booster shot at location on Monday. She presented today with significant swelling, redness, and heat at the site of injection. She denies pain in the area and can palpate it without discomfort. She did note that it occasionally feels itchy.
On August 18th I became very weak and I started feeling sick. I was so weak I didn't use the bathroom. At 12:00 am I tried to use the bathroom and noticed I couldn't. I proceeded to head to the ER because I knew something was off. A few hours later I lost feeling in everything below my neck. Thats when I realized I couldn't walk anymore, I couldn't hold anything in my hands and I could no longer use the bathroom on my own. I've been like this ever since.
This spontaneous case was reported by a consumer and describes the occurrence of LIP BLISTER (Fever blisters,they are inside and outside the bottom lip) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A.) for COVID-19 vaccination. Concurrent medical conditions included Asthma. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced LIP BLISTER (Fever blisters,they are inside and outside the bottom lip). At the time of the report, LIP BLISTER (Fever blisters,they are inside and outside the bottom lip) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant Medications were not provided by the reporter. For the treatment of lip blisters lip gel abreva, mouth wash peroxyl were given.
BODY ACHES X 2 DAYS, BACK PAIN X 2 DAYS, , FEVER 100.6  X 2 DAYS SEVERE DIARRHEA  > 10 X DAILY FOR 4 DAYS AT THIS TIME CONTINUES WITH LOSE STOOLS 4 TIMES DAILY WITH ABD CRAMPING
NO ADVERSE EFFECT The MODERNA BIVALENT PINK TOP was given s the first dose vs the BLUE TOP BIVALENT
This is a spontaneous report from a contactable pharmacist received via a sales representative. A 70-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced right arm was like he had a big bicep, like the bicep was bulged and swollen up on an unspecified date with outcome of unknown.
From initial information received on 01/APR/2003 from physician regarding an adverse event occurring in the USA, it was reported that a 58 year old female pt received TD ADS ADULT, given intra muscular in the left arm on 26/MAR/2003. The following day, the patient devloped petechiae on her left ankle and right thigh. PTT and CBC labs were taken, results not provided. The patient had hay fever at the time of vaccination. Reportedly, it is unknown if the pt recovered from this event.
Patient reports her tongue felt like it was large and lips felt swollen, tingling in arm on where she received the vaccine, had trouble swallowing and dry throat
Information has been received from a pharmacist concerning a female who on 16-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot no., route and site of injection were not reported). On an unspecified date following the vaccination the patient developed redness at injection site. The patient sought unspecified medical attention.  Additional information has been requested.
mom states had persistent, high pitched crying for hrs & ran very high fever p/2nd vax & was carried to MD; mom says pt did same thing p/1st vax;
Wheezing and hives about 3 hours after the injection Took Benadryl immediately and subsided my wheezing and hives
Patient received vaccination at 1:45 PM on 3/16/21.  Woke up at 3:00 AM on 3/17/21 with difficulty breathing.  Went to ER where he was diagnosed and treated for angioedema secondary to a vaccination.  Given IV steroids and benadryl.  Discharged home with oral prednisone, hydroxyzine and epi pen.  ECG, cardiac enzymes, CT neck negative for any acute process.  Patient has a history of stephens johnsons syndrome secondary to taking Bactrim.  Followed up with PCP on 3/25/21.  All symptoms had fully resolved.
At 11 AM patient began having a miserable sinus reaction to the shot. He was having the usual allergy symptoms of sneezing, runny nose, and extreme nasal congestion. This lasted about 24 hours. At 7:00 PM patient began having diarrhea that lasted about 8 hours also. Although both of these are not life threatening we wanted to report them because these are not commonly listed and patient would have missed school for these effects.
Concentration problems and reduced mental performance ("foggy head") on the next day (20 hours after injection), now slowly subsiding and replaced by headache (26 hours after injection).; Concentration problems and reduced mental performance ("foggy head") on the next day (20 hours after injection), now slowly subsiding and replaced by headache (26 hours after injection).; Pain in injection site 4 hours after injection, stronger than after first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 23Mar2021 14:30 (Lot number: EP6955) at the age of 34 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot no: EP3247, Anatomical location: Arm left, Time of administration: 10:00), administration date: 01Mar2021, when the patient was 34 years old, for COVID 19 Immunisation, reaction(s): "mild pain at the injection site". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Mar2021 18:30, outcome "recovering", described as "Pain in injection site 4 hours after injection, stronger than after first dose"; FEELING ABNORMAL (non-serious) with onset 24Mar2021 10:30, outcome "recovering", HEADACHE (non-serious) with onset 24Mar2021 16:30, outcome "recovering" and all described as "Concentration problems and reduced mental performance ("foggy head") on the next day (20 hours after injection), now slowly subsiding and replaced by headache (26 hours after injection).". Therapeutic measures were not taken as a result of vaccination site pain, feeling abnormal, headache. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination.  No follow-up attempts are possible. No further information is expected.
Anaphylactic reaction, started approx 25mins after administration.  Rash, swelling, airway concerns. Emergency telephoned by facility; transfer to ED.  Multiple epinephrine injections, steroids, Benadryl, breathing treatments, approx 6 days in ICU and further hospitalization.  Continued issues with shortness of breath, voice and swallowing problems.
Reaction started the night patient received the Shingrix shot, 10/03/19 and lasted until Monday, Oct 7th.  She had a real high fever, arm swollen to the size of grapefruit where she received shot and was red and painful.  Swelling and pain have gone down.
rash on chest/rash on neck; headache; swollen glands; This is a spontaneous report from a Pfizer- sponsored program.   A contactable consumer (patient) reported that a female consumer of unknown age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history includes- allergic to penicillin and has only ever had the polio vaccine.  Concomitant medications were not reported. It was reported that the patient got second Covid dose Wed and now has a rash on neck and chest, headache, swollen glands. There is no information whether the patient did a test Covid post vaccination or if the patient received any treatment. Outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Two bumps at right ear.Swollen lymph node on right side right next to bumps.
pt recv vax & immed fainted was assisted to floor demonstrated stiffening muscles, rolling eyes, growling lasting not longer than 10sec;consciousness returned w/no further problems;