chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 01/17/2022- I have been having headaches, they don't go away, They are there 24/7. I have been having a runny nose. On 01/19/2022, I went to an urgent care and was given a COVID-19 rapid test, the results were negative. The doctor noticed that my heart rate was racing and asked if that is normal. And I said no that is not normal. My heartrate tends to race more when I lay down. I still have the racing heart, it comes and goes, but mostly in the night and the headaches continue. The doctors at the urgent care recommended me to make an appointment with my primary doctor. I take Tylenol for the headaches, but it doesn't do much.
After 1st dose, she had body aches started within 24 hours; She slept a lot for about 4 days.; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (She slept a lot for about 4 days.) and PAIN (After 1st dose, she had body aches started within 24 hours) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, METOPROLOL, LOSARTAN, FLUOXETINE and ATORVASTATIN for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced HYPERSOMNIA (She slept a lot for about 4 days.). On 01-Apr-2021, the patient experienced PAIN (After 1st dose, she had body aches started within 24 hours). On 03-Apr-2021, HYPERSOMNIA (She slept a lot for about 4 days.) outcome was unknown. At the time of the report, PAIN (After 1st dose, she had body aches started within 24 hours) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medications were not reported.   This case was linked to MOD-2021-286585 (Patient Link).
Moderately painful raised circular swollen area surrounded by red rash. Started one day after vaccination.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 11-AUG-2015, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # K025006; expiration date 22-JUL-2017) dose and route of administration were not reported. Concomitant therapy was not reported. No adverse events have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
haven't taken 2nd dose yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2020).   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 reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to  incomplete course of vaccination. The patient asked could took the 2nd shot even though it was been.
Patient is pregnant - no reaction reported as of yesterday still but patient was made aware by the doctor of the risks.
23MAY92 17 days p/recvd MMR sudden swelling of lymph glands @ base of skull w/ c/o dizziness & stiff neck; no fever; glands were approx 1 cm & brownish in color; given Amoxicillin;
Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2008 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles at a physician's network. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016 the patient was treated at an urgent care for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Patient admitted for acute hypoxic respiratory failure. Started with symptoms on 12/30 and tested positive on 1/2. Was exposed to COVID positive wife and had MAB in November.
Approx. 8 hrs after getting vaccine pt said she felt severe bone/joint pain coupled with a fever of 103F, vomiting, and hallucinations. Resolved after 24 hours.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient came in to pharmacy and had concerns about swelling and redness on injection site. Patient saw her provider after leaving the pharmacy. Per patient, the provider was not concerned about the reaction and was advised to apply a cool cloth over the injection site to reduce swelling.
Myalgias, first day. Worst headache of life on d. 3, less than 48 hours after w/vomiting, continued myalgias fasciculations left arm - on first day, few minutes.
24hr p/vax this pt devel a 4inch by 2inch area of redness @ the inj site;
Patient had an in-home close contact (daughter) who had symptomatic COVID-19.  As a result, patient went to be tested and received a positive test result on 4/7/2021.  Subsequently (around the next day), he developed symptoms of diarrhea which lasted for two days and resolved at home without treatment, and he  remained in isolation for 11 days.
PT STATED THAT SHE HAD A SORE AND SWOLLEN ARM, NAUSEA, CHILLS, SHE DID TAKE TYLENOL
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-NOV-2009, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-AUG-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster and herpes zoster Keratitis. On or about 11-SEP-2015, the patient received subsequent treatment for ongoing and worsening symptoms of shingles, and was further diagnosed with post-herpetic neuralgia, a chronic condition of nerve pain and damage secondary to zoster infections. On or about 15-JAN-2014, the patient was treated for new and worsening outbreaks of shingles and uncontrolled pain. On or about 31-JAN-2014, the patient sought additional treatment for persistent shingles and escalating pain, and was referred by his physicians to seek pain management evaluation. On or about 30-AUG-2016, the patient was treated for severe neuropathic pain secondary to post-herpetic neuralgia. The patient was subsequently treated on or about 28-FEB-2017 for uncontrolled and persistent outbreaks of shingles and severe neuropathic pain. The patient has been prescribed NEURONTIN, lidocaine, LIDODERM patches, hydrocodone, tramadol and gabapentin in escalating dosages in attempts to manage his painful symptoms. The patient has also undergone cryogenic therapy for treatment of his shingles-related injuries. As a direct and proximate result of these malfunctions, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, the events of Herpes zoster Keratitis was determined to be medically significant. Additional information has been requested.
Started with headache, by 10PM went to bed with severe headache and all over achie, 2 degree temp started around 12 PM. Laid in bed all day 17th, started feeling better but still ached and weak on the 18th each day a little better today 09/21/2015 just fell a little weak.
significant fatigue, intermittant , ongoing 1 week out signifcant muscle pain on days 4-6 ongoing pain at injections site now runny nose no fever
Patient received a COVID-19 vaccine on 06MAR21 @ 1030.  Approximately 2 hours later, she began developing a reddened area on her arm at the injection site which was hot to touch and became itchy.  She reached out to our onsite nurse on 08MAR21.  She iced the area and took Benadryl.  She was told to follow-up with our onsite nurse if her condition didn't improve.  On 10MAR21, she reported she has been taking Benadryl HS and the area is "almost completely cleared up."
Within 4 hours developed "hives on the hands and arms, which is still visible 3 weeks later.; "This is a spontaneous report from a contactable pharmacist. A 30-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient reported, within 4 hours developed ""hives on the hands and arms, which is still visible 3 weeks later on an unspecified date. Patient mentioned they declined to give the second dose, and would like to confirm this with Pfizer. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Continued pain since vaccination in left deltoid when moving arm back and/or up - pt states pain will go away after 2 or 3 minutes.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: after previous bout with COVID, now has asthma; " COVID" (unspecified if ongoing), notes: after previous bout with COVID, now has asthma. The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "known allergies: Demerol", notes: known allergies: Demerol; Cedar, reaction(s): "known allergies: Cedar", notes: known allergies: Cedar. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective with Paxlovid from 27Feb2023 to 28Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The association between the event lack of effect (COVID-19) with BNT162b2 can not be fully excluded.
After receiving the vaccine he developed lightheadedness, and blurred vision. He also felt as if he was going to faint. He denies chest pain or shortness of breath. Denied loss of vision. He did not have a weakness. Blood pressure 106 / 68, 78, oxygen saturation 98% on room air on April 6th 2021 at 2:25 p.m.  In general patient is without distress oh, but he does look anxious  Heart: rate and Rhythm, as one has to, no Gallup or murmurs or rubs Lungs: CTA bilaterally  neuro: 5 / 5 bilateral upper and lower extremity strength, cranial nerves 2-12 intact No gait dysfunction
This spontaneous report was received from a certified medical assistant, and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported. In November 2017, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (lot # and expiration date were unspecified). On 21-SEP-2018, the patient went to the reporter's office to receive the second dose of GARDASIL 9, which was a late dose (inappropriate schedule of vaccine administration). No adverse effects reported.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in an adult male patient who received Influenza vaccine Quadrivalent for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent, the patient experienced general body pain, fever and heavy sweating. On an unknown date, the outcome of the general body pain, fever and heavy sweating were unknown. It was unknown if the reporter considered the general body pain, fever and heavy sweating to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not provided. The patient reported that he received the Flu vaccine (unknown manufacturer) at his place of employment around in 1958. He got Flu shot at office, and then had to drive somewhere, so he left. Sometime during the night he pulled over to sleep, when he woke up he and the interior of the truck was dripping with water, and he felt like someone had beat him up with a baseball bat. He was achy all over. He thought he must have had a fever, and that is why everything was wet. He saw his physician afterwards and was told to never get the Flu shot again. The patient said a nurse called and spoke with someone for a long time about his experience with the Flu vaccine. When the nurse came back, she provided him with GlaxoSmithKline number and said someone with the company wanted to talk with him, so he called GlaxoSmithKline.
10 days following my vaccine injection I experienced severe vertigo requiring ambulance to hospital and 2 days in hospital treatment.  Diagnosis was Vestibular neuritis.
Pt vaccinated with DTP/OPV developed flail, blue pallor, did not respond - at end of nap, failed to respond to stimulus, rushed to ER. See WORM for more details.
This is a spontaneous report from a contactable consumer (Patient's mother) via a sales representative. A male patient of an unspecified age (age: 16; unit: Unknown) and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation, MENACTRA, via an unspecified route of administration on unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received meningococcal group b rlp2086 and meningococcal vaccine a/c/y/w conj (dip tox) at same visit in same arm. The next day patient had fever over 102, abdominal pain, headache worse than a migraine, muscle weakness so bad that the mom had to help him walk. Urgent care sent him to the ER where he got IV fluids and blood work. They said it was either viral or from the vaccines. He felt better the next day. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
5:30am woke up nauseated  ... started throwing up.   lasted until 1:00pm     had headache      very weak and tired    temp went up to 103.4   had muscle pain and joint pain.     Temperature was back to normal the next morning.    still had headache, weakness, and tired.    If I got up and walked around, my headache would get worse  so day 2, I had to mostly stay laying down.      Day 3, was good, all side effects were gone.
My most severe side effect was abdominal bloating, including swelling of the liver.  I also had fever, intense fatigue, body aches, headache, and chills.
Feels like dripping in back of throat; Running a fever of 103; sore arm; dry, intermittent cough; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), COUGH (dry, intermittent cough), THROAT TIGHTNESS (Feels like dripping in back of throat) and PYREXIA (Running a fever of 103) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and COUGH (dry, intermittent cough). On 02-Mar-2021, the patient experienced THROAT TIGHTNESS (Feels like dripping in back of throat) and PYREXIA (Running a fever of 103). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), COUGH (dry, intermittent cough), THROAT TIGHTNESS (Feels like dripping in back of throat) and PYREXIA (Running a fever of 103) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Pyrexia: 103 (High) Running a fever of 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Anaphylaxis, SkinRash, Tachypnea & Rash Narrative:  Developed erythematous rash and worsening severe shortness of breath. 911 called, epipen used once followed by diphenhydramine IM. Shortness  of breath improved with epinephrine. Paramedics arrived, sent to local ER where he said he was treated with steroids and observed for several hours.   Other Relevant History:
Within 2 minutes of receiving the COVID19 vaccine I became moderately mentally foggy with mild dizziness and headache.  I then experienced tightness in the center of my chest and a generally mild shakiness.  After waiting my 20 minute observation time, I recovered enough to drive home.  However, mild mental fogginess, headache, tightness in chest and generally feeling unwell remain for 24 hours.
Joint pains, especially in both knees started 2 days after the vaccine. This is documented in the VSafe portal from day 1 to 6 months after vaccination.   I saw a rheumatologist in July 2021.  Blood tests revealed higher than normal inflammatory markers.  The blook tests were repeated in December 2021;  they are normal-low positive.  I continue to have nerve pain in both knees at the same intensity, painful and swollen hands and feet,  shooting pain that last a few seconds in both arms and legs.
Bilateral hand swelling, tingling, weakness, pain:  R > L.  Today, 11/01/2010 still with weakness in hands, grasps 3/5 bilaterally.
4 hours after the vaccination I had fatigue, nausea and then it moved to joint pain and flu like symptoms the next day and that lasted 48 hours and I also had a huge headache and that was all than I felt better by Tuesday I felt good for one week than I got sick with diarrhea hurting stomach and now I have Diverticulitis and I'm on antibiotics for the next ten day (Amoxicillin-clavulanate).
The Moderna monovalent vaccine was given instead of the Moderna bivalent vaccine. Client was advised of the error and told that she could get the bivalent vaccine in 2 months if she wanted.
This is a spontaneous report from a non-clinical study program, from a contactable pharmacist. A 75-year-old female patient received the first dose of PREVNAR 13 (lot J23867, expiration date Jan2016, NDC 00005197102) intramuscular in the right arm 03Nov2014 at 0.5 ml single for pneumonia prevention. The patient medical history was not reported. Concomitant medication included the first dose of influenza vaccine administered for immunization intramuscularly in the left arm at 1 dosage form single on the same day. On 03Nov2014 the patient experienced bruising at injection site that then went away on an unspecified date, there was also a welt and it still itched at the injection site and these conditions had been persisting for 2 months after the injection. Follow up (26Jan2015): New information from the same contactable pharmacist includes: events duration detail.
Influenza vaccine administered 9/17/09. Rash on medial thigh/proximal leg and antecubital areas noted 9/30/09. Patient received methylprednisolone dosepak 9/30/09, resulting in marked improvement with rash resolving 10/7/09. Triamcinolone ointment was then prescribed to enhance healing.
Symptoms: Numbness, difficulty breathing, paralysis, slurred speech, Treatment: 15 courses of Immunoglobulin and Plasmapheresis.
An hour after the second shot, she vomited and had nausea; An hour after the second shot, she vomited and had nausea; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (An hour after the second shot, she vomited and had nausea) and VOMITING (An hour after the second shot, she vomited and had nausea) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NAUSEA (An hour after the second shot, she vomited and had nausea). 2021, the patient experienced VOMITING (An hour after the second shot, she vomited and had nausea). In 2021, NAUSEA (An hour after the second shot, she vomited and had nausea) and VOMITING (An hour after the second shot, she vomited and had nausea) had resolved.            No concomitant medications were reported.  It was either March or April of last year, patient had her initial shots. Patient reported that an hour after the second shot, she vomited and had nausea and it  lasted for probably 24 hours.  No treatment medications were reported.   This case was linked to MOD-2022-662398, MOD-2022-662392 (Patient Link).