chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; 2 vaccines in 1 season; Sore arm; This is a spontaneous case from, initially received from other health professional (nurse) on 09-Jan-2019, concerning a female patient of an unspecified age.  The patient had no medical history and was not taking any concomitant medications.  On 01-Nov-2018, the patient was administered the first dose of Afluria Quadrivalent [influenza vaccine, dose, route of administration, anatomical location, batch number and expiry date: not reported] for an unknown indication.  On the same day after vaccination, the patient experienced sore arm which was recovered on 02-Nov-2018. The patient did not receive any treatment medications for the event.  On 09-Jan-2019, the patient was administered the second dose of Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: YF40608 and expiry date: 30-Jun-2019] for influenza prophylaxis (explicitly coded as extra dose administered).  On the same day after vaccination, the patient experienced sore arm which was recovered on 10-Jan-2019. The patient did not receive any treatment medications for the event.  The reporter assessed this case as non-serious.  Follow up received from other health professional (nurse) on 06-Feb-2019: The classification special case with no AE' was deleted from the general tab. The reporter's details (address, department and email address) were added in the general tab. The patient's details (name, address, state, county, postal code and email address) were added in the patient tab. It was reported that the patient had sore arm for 24 hours after each influenza vaccination. Hence, added the event pain in arm' twice in the event tab with different start dates and stop dates in the event tab. The narrative and case comment were amended accordingly.  Case re-opened for completion of full data entry: 06-Feb-2019; Reporter's Comments: A female patient of an unspecified age was administered two doses of Afluria Quadrivalent vaccine in same season (extra dose administered). The patient experienced sore arm, on the same day after each vaccination. The company assessed the causality of the events pain in arm as related to the suspect vaccine due to plausible temporal relationship between events and suspect vaccine. The company assessed the causality of the event 'extra dose administered' as not related to the suspect vaccine due to accidental nature of the event.
Immediate severe pain in left shoulder, pain became increasingly worse. Unable to lift arm, bend shoulder, unable to groom properly not able to use left arm at it's full capacity due to significant pain.
Severe swelling and redness in the upper left arm, radiating out from the injection site.  Three weeks later, he has developed angioedema with an episode of swelling in the left lip/face and and episode of severe swelling of the left hand.
COVID 19 VACCINE SYRINGE WAS PLACED IN A COOLER WITH LOWEST TEMPERATURE 20.6 F AND HIGHEST 40.8 F FOR APPROXIMATELY 1 HOUR AND 15 MINUTES; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 1808980 expiry: 20-JUN-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUN-2021, the subject experienced covid 19 vaccine syringe was placed in a cooler with lowest temperature 20.6 f and highest 40.8 f for approximately 1 hour and 15 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid 19 vaccine syringe was placed in a cooler with lowest temperature 20.6 f and highest 40.8 f for approximately 1 hour and 15 minutes was not reported. This report was non-serious. This case, from the same reporter is linked to 20210605045, 20210603408 and 20210602705.
Headache, low grade fever (<100 F), body aches, chills, sweats, fatigue.
cont crying from pain x 6 hrs, t102, neg UA, spinal tap, CBc; observed in hosp overnoc, OK in AM;
Information has been received from a physician concerning a female who on unspecified date, was vaccinated with the second 0.5 ml dose of GARDASIL. Subsequently the patient experienced fever and body aches for a week. The patient didn't experience an AE after the first dose. On unspecified date, the patient recovered from fever and body aches. Additional information has been requested.
lymph node swelling; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph node swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph node swelling). At the time of the report, LYMPHADENOPATHY (lymph node swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided. No Treatment History was provided. Action taken with mRNA-1273 in response to the event was unknown
Pfizer-BioNlech COVID-19 Vaccine EUA The day after the second shot on 10/04/2021 I had a red rash across my chest and stomach and was itchy for two or three days.  The rash went away.   Since the second shot my forehead has been moist no matter what temperature I am.  It is rare that it is not.  It is not outright sweat, but it is not normal and it is annoying.
About 10 hours after receiving the vaccine (3:30AM), I spiked a fever initially and took some Tylenol. I then spiked another fever around 9:45AM, which prompted me to take more Tylenol. I was fatigued, had body aches, chills, etc. throughout the morning. However, my fever started to climb around 1:00PM, and at that time I realized I hadn't felt the baby move any if at all since the morning. I tried to drink some water, shift positions, and eat a light snack to try and promote movement, to no avail. Typically, the baby is very active all throughout the day, so this was unusual. I called my OB/midwife team and they brought me in at 3:30PM for a non-stress test to check and make sure baby was doing good. They determined he was good, and told me to drink plenty of fluids and take Tylenol when I could again to manage the fever. Overall, I spiked two more fevers >101 degrees F that day/night but besides body aches that ended on 11/4/2021. I did not have another period of time where I did not feel baby move post the NST.  Overall, my pregnancy has been fairly normal, I believe. I had a sub chorionic hemorrhage in April which resolved by 8-9 weeks gestation, and a fibroid of about 5 cm was found at that time as well. Then, I was diagnosed with slight anemia at 27 weeks. I received my TDAP vaccine booster at that time as well, and my flu vaccine at 29 weeks. I am due December 19, 2021.
Information has been received from a physician referring to her son, a 24 year old male patient with no pertinent medical history or drug reactions/allergies. The patient received an initial dose of VARIVAX (Merck) at age of 5 years old (approximately in 1996). The reporter stated that she was under the impression that the patient was going to receive a second (booster) dose of VARIVAX (Merck) at age 24 years old when he visited his own physician on 16-FEB-2016, however, he was instead vaccinated with a dose of ZOSTAVAX (subcutaneous; lot# and expiration date were not reported at that visit. There was no concomitant medication. The reporter was uncertain whether the ZOSTAVAX was inadvertently administered instead of VARIVAX (Merck), or whether the patient's physician had decided to intentionally administer ZOSTAVAX to the patient for an unspecified reason. In February 2016, the patient developed redness at the injection site after receiving ZOSTAVAX. He consulted the reporter to seek medical attention and no treatment was given for the events. No lab diagnostic studies were performed. At the time of the report, the patient had not recovered from the event injection site erythema. Causality between injection site erythema and ZOSTAVAX was not reported. Additional information has been requested.
Severe pain in left arm, 1 hour, post vax. Conditioned worsened until arm was unusable. Could not raise arm. Arm throbbed with pain. Blood vessel burst on inside of elbow. Went to ER, 2 days before Thanksgiving. Had to wear a sling on arm for 10 days. Arm is better but soreness not completely gone.
She is complaining of pain along nerve where she had shingles disease 13 years ago.
Incident details: Per Drs. (Medical director) email sent out on 9/1/22-"the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand." The patient was seen in office on 9/2/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (Pfizer) by RN in error as patients are now only supposed to receive the bivalent booster per Drs. email. Patient was due for booster at the time they received it, however the bivalent booster was not yet stocked. Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation of monovalent Covid boosters until Private receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also 'monovalent' and 'bivalent' are new terms that have not previously been used when discussing booster vaccines.  Corrective Action: Corrective action included notifying staff and providers of the recent change regarding COVID vaccines and were notified to stop giving COVID booster doses until the Clinic receives the bivalent vaccines. Staff and providers were notified via email, digital media, and verbally. Incident reported to VAERS
arm is warm at the site of injection; fever; chills; arm is swollen at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm is warm at the site of injection), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE SWELLING (arm is swollen at the site of injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE WARMTH (arm is warm at the site of injection), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE SWELLING (arm is swollen at the site of injection). At the time of the report, VACCINATION SITE WARMTH (arm is warm at the site of injection), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE SWELLING (arm is swollen at the site of injection) outcome was unknown.            Treatment product- Tylenol
Fever of 102.3 began.  Tylenol administered, checked with pediatrician, said it was shot related.  MMR and Chicken pox given at 12month checkup.  Fever continued for three days.  Spots appeared on back of neck on third day.  Diarrhea on third day, as well.  Fever has not returned, but rash spread to face, behind ears, scalp then spread to torso, arms and legs.  Dr. said to give Benadryl and Tylenol.  Rash resembled images of measels, not quite as dense.
Patient's left arm was swollen from the bottom of the deltoid down to the middle of the forearm, with a red rash that was spreading from the day before. Patient described pain in the arm, with mild pain in the deltoid where administered.
Vertigo,  Chills,  Fatigue,  Body Aches,  Tinnitus
Pt here for HPV vaccine, inadvertently gave Prevnar 20 in error, boxes look similar
Red, swollen and sore upper left arm for 5 days. Shivering and Fever for approximately 30 hours, followed by 2 days of upset stomach and 4 days of Headache, Fatigue, Weakness, and general Achiness.
This was first doze administered 4/7/21.  None after first dose other than soreness at injection site.  After 2nd dose on 5/4/21, started having intermittent heart fluttering, shortness of breath at times, cheat pains, afib-like symptoms.  Occasionally at first, now so frequent (as of 1/23/2023) I have scheduled a cardiologist visit to schedule a full workup.   I had a previous history of Afib that was in 100% remission for 5 years prior to vaccination.  I'm part of an at-risk group that should have been precluded from receiving this vaccine.
New onset rash predominantly on face but occasional lesions, elsewhere. Red raised  lesions noted, some vesicles, some crusted. Pt has no appetite. Pt was fussy. Treated with calamine lotion and Tylenol Elixir and Pedialyte. Pt is recovering from the reaction.
Patient was diagnosed with Acute Guillain-Barre Syndrome.  She had a weak ankle on Tuesday, 10/12/2021 and saw a physical therapist who referred her to another PT the next day.  On 10/13/2021, she collapsed getting out of bed with weakness in her legs.  She saw PT, who referred her to a neurologist, who then sent her to the ER for an MRI, who then sent her to Hospital for that MRI.  The MRI happened early morning of 10/14/2021.  It showed inflammation consistent with GBS so they put her under to install a central line and do a spinal tap.  By hen, she was only able to move her head a couple inches.  No movement in her arms and legs, but there was pain everywhere.  The tests came back verifying GBS and the Neurologist said it was Acute Motor Axonal Neuropathy. Plasmapheresis began the evening of 10/14/2021 (7 bottles) and IVIG right after.  Patient had a total of 5 treatments of plasmapheresis over 10 days, every other day (Thursday, Saturday, Monday, Wednesday and Friday).  IVIG then followed on Saturday and another Sunday. Patient worked with PT and OT every day after movement started again.  She worked on standing the Friday of the last plasmapheresis, worked on walking with a walker on Saturday and Sunday and could walk on her own a little Monday.   She will be working on walking more each day and start outpatient PT at hospital TIRR on November 8, 2021. Please note, patient is 15 and the youngest Studio Company  This is really effecting her and her future job opportunities that she has been training for since she was 2 years old!
Pt reported redness, hot to touch the following day, swelling and aches, lasted 1 1/2 weeks, redness still present 11-8-2018, not hot and not painful, appears like a local reaction.
vivid dreams with each dose of vaccine; This spontaneous case was reported by a physician and describes the occurrence of ABNORMAL DREAMS (vivid dreams with each dose of vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 and Vivid dreams (developed extremely vivid dreams during COVID, but it was resolved and again came back with each dose of vaccine).    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABNORMAL DREAMS (vivid dreams with each dose of vaccine). At the time of the report, ABNORMAL DREAMS (vivid dreams with each dose of vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The patient was an entomologist. The vivid dreams which were developed by the patient during COVID was resolved, but comeback briefly with each dose of vaccine.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-708066 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708066:Bivalent booster
body ache; chills; fever; bad Headache; This is a spontaneous report from a contactable reporter (patient's husband). A 41-year-old female patient (wife) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration on 15Apr2021, as single dose for COVID-19 immunisation. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, on an unknown date, as single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. On 15Apr2021, the patient experienced body ache, chills, fever, a bad headache. Caller stated that his wife received the second dose of the Pfizer Covid-19 vaccine yesterday morning and by noon until now she has felt like she was run over with a truck, she has a strong body ache, chills, fever, a bad headache and it has been going back and forth. Would like to consult when will these side effects will pass. Outcome of the events were unknown.  No follow up activities required as no further information can be expected.
pt walked from the exam room, sat in waiting room then became pale, dizzy then fainted;RN used ammonia salts & cool cloth & laid down, quickly regained consciousness but fainted a second time;responded to ammonia;became alert & oriented
I experienced some brief chest pain in the center of my chest in the evening and afternoons.  This lasted for a few months ending about 4/2/2023.  I consulted my PCP who recommended taking an acid reflux pill.  Had annual Cardiologist appointment and he performed an Echo and a stress test, all results normal.
Approx 30 minutes after the vaccine was administered, I started to feel  very nauseous. It got worse for the next 24 hours.  About an hour after the shot, I began to have a serious headache which lasted for approx  12 hours.  I also had chills  for 24 hours and significant joint aches  with the feeling of fatigue for the next 24 to 48 hours.   I stayed in bed much of the first 24 hours
Severe sharp pain under right scapula, radiating up through neck and down to right elbow. Went to Urgent Care because it was hard to get through work, prescribed flexeril, meloxicam, and Voltaren cream. Still painful one month after it started. Seeing chiropractor and Physical Therapy. Also much difficulty sleeping due to pain.
Received Moderna vaccines on 3/10, 4/7, 12/30/21 COVID-19 positive by PCR on  1/6/22 admitted to hospital on 1/8-1/10 d/t falls.
I had been exposed to COVID from a patient. I developed fever, chills, and a sore throat after about 3 days. I was tested about 5 days later and was positive. I was not given anything was just advised to monitor it. I had an increase in my blood pressure since finding out I was positive for COVID. I was prescribed amlodipine. My blood pressure continues to be elevated to date.
Pt received an expired DTAP. The vaccine expired on 2/9/2021 and was given on 2/25/21.  Mother and baby stayed in clinic room for 20 minutes while she breast fed her baby and monitored for reaction.  Once 20 minutes was up and no reaction occurred mother and pt left.  The DTAP was given about 9:30am on 9/24/21 and mother and baby left clinic around 9:55am on 9/24/21 am
AFTER THE VACCINE PATIENT REQUESTED TO STAY SEATED, SHE WAS DIZZY AND PASSED OUT AND FEL FOR A BRIEF MOMENT.
Initial information received on 12-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case is linked with: 2018SA203963 (same reporter, same suspect). This case involves a female patient (gender and age not reported) who experienced vaccine underdose and syringe broke while the vaccine was being given, while she received vaccine ADACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history and concomitant medication were not provided. On 06-Jul-2018, the patient received a partial dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5875AA, expiry date-14 Feb 2020. It was a case of actual medication error due to vaccine underdose (underdose). It was also a case of (syringe issue). It was unclear whether the flange was cracked before. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
red inflammed arm; red inflammed arm; fever; could not use my arm; awful pain in my back; This case was reported by a consumer via interactive digital media and described the occurrence of inflammation in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included shingles (under the left breast and around the back) and neuropathic pain (around the heart).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced inflammation, erythema of extremities, fever, mobility decreased and back pain. Shingles vaccine was discontinued. On an unknown date, the outcome of the inflammation, erythema of extremities, fever and mobility decreased were recovered/resolved and the outcome of the back pain was not recovered/not resolved.   It was unknown if the reporter considered the inflammation, erythema of extremities, fever, mobility decreased and back pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient stated that he/she took 1st dose for the shingles vaccine and had bad reaction so could not take the 2nd dose and it was awful. The patient's arm started out with a coin size red inflamed arm and then fever set in, and he/she could not use arm, lasted a couple weeks so the physician said no for the 2nd dose. At the time of reporting, the patient had awful pain in back. The follow-up would not possible as no contact details were available.
Pt reported tachycardia post receiving vaccination.  Pt reported PMHX of anxiety.  Symptoms response within 5 minutes.  No Treatment or Transport.
Approximately 72 hours after receiving vaccine shot, I developed a spontaneous subconjunctival hemorrhage in my right eye. I have never had this event happen before, and there was nothing  else that would have caused it (i.e. normal causes did not apply or happen). I am now on day 6 and it is not yet healing.
7cm erythematous raised lesion warm to touch on day two on day three the lesion is still erythematous and warm to touch and covered in fluid filled (clear) vesicles of various sizes.
SOB, lips swollen and peeled, felt like I had swallowed acid.  My heart rate has been in the 50?s for days (have photo on my pulse ox), fever and chills first 3 days with muscle aches fatigue and feeling like I want to pass out.
On 12/28/00, at about 7 or 8 PM, pt complained of a headache. Awoke early AM on 12/29/00 and "felt weird"; got up and took a shower. Then around 8 AM, had a fever of 104F (ear); 103.6F (ear); pulse 104. Had a runny nose "all week".