chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a female patient with asthma and graves' disease and no known drug allergies.  who in September 2008 was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX.  Concomitant therapy included LEVOXYL, ADVAIR and NASONEX.  "24 hours after vaccination", the patient developed redness and swelling at the injection site.  It was reported that the patient had a bump at the injection site the size of a golf ball.  She had a fever of 101F.  The symptoms resolved within a couple of days.  The patient reported these adverse events during a different visit. This is one of two cases from the same source.  Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA  First dose caused a sore arm, but not bad. For 2 weeks made me feel a little off, like my brain couldn't multi-task as well but felt fine week 3. After the second does, same thing, except around day 10 I became the sickest I have ever been. Was very sick for 5 days straight, vomited for the first two days, rested for three more days. Then I got itchy scabs around my left eye. Went into an eye doctor. Diagnosed with shingles of the eye. Have been trying to resolve the shingles ever since. Am not able to go completely off steroid drops yet, or the eye pressure/infection comes back. So as of 12/7/21 still taking one drop of Prednisolone daily in left eye, Will try to switch to milder steroid soon. Due to the shingles episode, the eye muscles got thinned, so my left eye pupil is permanently unable to contract (stays dilated). For my entire life, I have always been sensitive to medication. I weigh 115 lbs . I have never needed a full dose of any medication in order to get the desired result. Any type I have tried a full dose, I get sick from side effects. It is not surprising that the second dose of Pfizer Covid-19 vaccine would be too powerful for my body to handle. However, i have seen the vaccine already keep my family and myself safe from Covid, so I'm glad that we had a vaccine to help us. Without the vaccine, Covid-19 would most assuredly have killed me or given me major problems. RECOMMENDATION: for those of us super sensitive to medication, the second dose should have been given in two half doses or moved out a couple of months.
3/28/28 approximately 3PM -> shortness of breath, kept getting worse. Felt pain when inhaling on sternum. No symptoms related to heart. 3/29/18 -took TUMS, thought it was heartburn, but did not work -took COQ10 shortly after shot. Approximately 10/11AM -> pain wore off.
Sharp knife piercing pain in left ear.  Extremely painful tinnitus.  Ringing in ear kept me up all night.  Fever, muscle pain and chills.
Pt began to experience bruise like spots on both hands the Saturday following injection; still apparent at time of reporting on 3/10/2021; no pain/itching or other issues in that area.
According to hospital neurologist on 10/28: He tells me that he received his flu shot 7 days ago yesterday in (actual day determined to be 10/18/22).  He received it from his primary care physician.  3 days ago he was in his normal state was even able to play an 18 hole round of golf.  He went to bed the night before last at 10 PM in his normal state.  He woke up yesterday morning with extreme paresthesias in his feet and eventually in his hands bilaterally as well.  He went to bed at 10 PM last night and woke up at 3 this morning.  When he attempted to stand up to walk to the restroom his legs did not hold him and he fell to the floor.  He currently continues to have severe paresthesias of his feet and hands and he feels as if they have worked proximally as well.  He tells me he feels as if his feet are in concrete blocks.  He was able to lift his cell phone earlier this morning but currently he is unable to even lift his cell phone with his upper extremities. He had cognitive/speech deficits, dysarthria, developed quadriplegia and VII nerve palsy, diplopia,   He was diagnosed with Guillain-Barré syndrome secondary to flu vaccine. Treatments ongoing, but include Gabapentin, IVIG, plasmapheresis. IVIG not effective. Patient has completed 3 of 5 PLEX sessions. Patient is more awake and alert now.
09/21/22 presents to EC ED for "chest pain". PMHx of "crohn's disease, chronic pancreatitis and chronic iron deficiency anemia"
Pt recvd MMR vax 19JUL90; On 01AUG90 pt exp rt knee joint pain; exp arthritic pain in lt great toe, lt wrists, digits two & three on lt hand, rt middle finger, rt metatarsal area; Also devel lymphadenopathy; Tx Advil & ASA;
Seizures; bumps on her right arm; red big spots on her right arm; Fever; A spontaneous report was received from a caregiver concerning a 55-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced seizures, fever, and red spots and bumps on her arm.  The patient's medical history, as provided by the reporter, included being non-verbal, unable to walk, and seizures that last 1-2 seconds.  No relevant concomitant medications were reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 041L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   The reporter was a consumer who holds a foster care for older patients. This patient was under her care at the time of the report. The patient received the Moderna Covid-19 vaccine on 13 Jan 2021 at 10 A.M. at the foster care location. She did not notice any reaction after administration. That evening, she saw two big red spots and bumps on her right arm. She iced the patient's arm, but the redness was still visible and bumps were present. That night, the patient started a fever of 102 degrees Fahrenheit. The reporter iced her body down and gave her paracetamol, which helped. She reported that there was no vomiting.   On 14 Jan 2021, in the morning the patient had a seizure that lasted 30 mins. The reporter stated that she usually does not call 911 because she is familiar with the patient's seizures that last between 1-2 seconds, but this led her to call emergency services. The seizure was gone when they arrived, and she continued to care for the patient at the home.   On 16 Jan 2021, the seizure returned.   She had another seizure on 18 Jan 2021, which was concerning, per the reporter because of their frequency. She contacted the patient's health care provider who did not advise anything. She scheduled an appointment with a neurologist.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, seizures, fever, and red spots and bumps on her arm, was not reported.; Reporter's Comments: This case concerns a 55-year-old female patient with a significant medical history of seizures who experienced a medically significant and unexpected event of Seizure and non-serious unexpected event of Injection site papule along with non-serious expected events of Injection site erythema and Pyrexia. The event of Seizure occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (041L20A), which returned on day 3 and 5 after vaccination. The events of Injection site erythema, Injection site papule and Pyrexia occurred on the same day after receiving their first of two planned doses of mRNA-1273 (041L20A). Treatment for pyrexia included iced her body down and Tylenol. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. Of note, patient's prior history of seizures is considered a confounding factor for the event of seizure.
12/17/ (L) arm swelling, wrist to elbow, red/tender to touch, warm, injection site at intermittent/nontender. Tx CLARITHROMYCIN 500 bid x 7d R-O All PCN
Information has been received from a medical assistant concerning a 65 year old male who is the husband of an employee of the office with no known drug allergies and no pertinent medical history reported who on 14-OCT-2008 was vaccinated with a dose of ZOSTER (Oka/Merck), intramuscularly in the left deltoid.  There was no concomitant medication.  On 14-OCT-2008, a few hours after receiving ZOSTER (Oka/Merck) the patient developed pain at the injection site.  The patient sought medical attention calling to the office.  At time of the reporting the patient had not recovered.  Additional information has been requested.
muscles aches;CPK-1400;EMG myopathy;muscle biopsy pending;rx w/steroids;
I start to get headaches because of the light sensitivity; exacerbation in photophobia/the photophobia increased a little after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (exacerbation in photophobia/the photophobia increased a little after the 1st dose) and HEADACHE (I start to get headaches because of the light sensitivity) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 006C21A) for COVID-19 vaccination.     The patient's past medical history included Trauma. Concurrent medical conditions included Photophobia. Concomitant products included METFORMIN, GLIMEPIRIDE and ALOGLIPTIN for Diabetes, CELECOXIB and CETIRIZINE for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced PHOTOPHOBIA (exacerbation in photophobia/the photophobia increased a little after the 1st dose). On an unknown date, the patient experienced HEADACHE (I start to get headaches because of the light sensitivity). At the time of the report, PHOTOPHOBIA (exacerbation in photophobia/the photophobia increased a little after the 1st dose) and HEADACHE (I start to get headaches because of the light sensitivity) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant include OTC multivitamins and minerals.  Treatment medicines were not reported.   This case was linked to MOD-2021-261761 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow-up received, event outcome changed from unknown to not recovered for exacerbation in photophobia and headache.
Tingling in tongue, tightness in jaw. Oral liquid Benadryl self-administered at 10:00 AM, Personal EPI pen self-administered at 10:10 AM.
Persistent diarrhea- lasted over 3 weeks. Extreme fussiness due to stomach pain, and developed transient lactose intolerance. On 05/02/2014 started a pro-biotic and eliminated dairy from mother's diet, as baby is breast fed. It took 3 weeks from the start of treatment before dairy could be tolerated again. Dairy is still limited in Mother's diet because it upsets his stomach if there is too much. He never had any problems or reactions to dairy before he received the Rota Teq vaccine.
Expired on 15SEP2022, initially stored in the refrigerator on 12OCT2022, administration of vaccine on 12OCT2022; no adverse events; patient received an expired Monovalent First Primary (Presumed repeat) dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired Monovalent First Primary (Presumed repeat) dose), PRODUCT STORAGE ERROR (Expired on 15SEP2022, initially stored in the refrigerator on 12OCT2022, administration of vaccine on 12OCT2022) and NO ADVERSE EVENT (no adverse events) in a 26-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Dose 1, Unknown Brand and On unknown date in another country). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine.    On 12-Oct-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired Monovalent First Primary (Presumed repeat) dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired on 15SEP2022, initially stored in the refrigerator on 12OCT2022, administration of vaccine on 12OCT2022) and NO ADVERSE EVENT (no adverse events). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired Monovalent First Primary (Presumed repeat) dose), PRODUCT STORAGE ERROR (Expired on 15SEP2022, initially stored in the refrigerator on 12OCT2022, administration of vaccine on 12OCT2022) and NO ADVERSE EVENT (no adverse events) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse events) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received an expired Monovalent First Primary (Presumed repeat) dose) and PRODUCT STORAGE ERROR (Expired on 15SEP2022, initially stored in the refrigerator on 12OCT2022, administration of vaccine on 12OCT2022).    Concomitant medications were not reported.  They were not sure of spacing between first and second primary shot. The vial size was 5.5 ml. The vial did not undergo any temperature excursions Treatment medications were not reported.
Pt collapsed while in the arms of his mother. Pt was laid down on the ground gently (protecting the head). Was given cold compresses and fanned down. When he felt better we assisted him to a seat to rest. Was given vitamin H2O to drink. Recovered after approximately 30 minutes.
24 hours after administering DTaP and IPV he had edema at the site of injection with erythema and warmth; approx 10cm x 8cm. Afebrile.
75 hours after vaccine , lower part of upper arm very swollen and red (blanchable through and non tender, also itchy); phone call 11/7/04, recovering well per day (mom not home)
Redness around left eye developed into severe rash spread all over body. Intense itching and discomfort. All  started to occur 3/16 and  progressively got worse and continued to spread. 1st dx was shingles (2nd time having it?2018) treated with prednisone and then dx contact dermatitis steroid shot and antihistamines then  diflucan and went to Derm gave another steroid shot and antibiotic?all since 3/16 still progressing
Redness and sore right arm. Chills, shakes, woozy, nerve syncope. Right arm swelled, spackled; episodes of diaphoresis.
Starting at 6 pm on 09/18/23, pain began in my left arm, headache, muscle pain in my back and a feeling of tiredness. On 09/19/23 the symptoms were more intense. After a light lunch at around 3 pm I tried to take a nap and when I lay down in bed I felt intense dizziness that I have never had before, I got up and as I walked the dizziness went away. After an hour I tried to take a nap and the intense dizziness occurred again, when I got up it was difficult for me to walk due to the intensity of the dizziness. At 6 pm I felt nauseous and after a few minutes I vomited, a situation that was repeated between 8 pm and 9 pm. Today, 09/20/23, I had mild dizziness, a mild headache, and an upset stomach that prevented me from eating.
Red swollen area, warm to touch 1" x 1 1/4" in size, Tylenol for comfort
On August 27, 2021,  was he found deceased in his bed.  An autopsy was performed by the medical examiner's office.   Patients' sister reported that the night before he went to bed and was behaving normally. On Saturday, August 28th, the medical examiner called and informed us that his heart was enlarged. No previous history of enlarged heart had ever been reported and no heart issues had ever been considered in his past.
Fever 36 hours, very sore stiff left arm, bicep, Elbow, head and neck area. Overall weakness for 2+ days, sweating at night, could not get comfortable to fall asleep (no sleep 36 hours post injection). Arm and Elbow pain persists today. Headache.
20OCT pain in upper arm;21OCT cont pain in arm (p/a sleepless noc), swelling above & below area of shot;22OCt heat, redness, cont swelling spreading over larger area, visit to family MD, antihistamine & steroids prescribed;
8cm induration, non-tender with erythema, no itching on left thigh.
Moderna arm   painful red hot itchy large area on arm 2 inches below jab. Also very painful joint pain especially in hands  wrists and arms  much worse with this second shot  the Moderna arm did not appear with first shot  but joint pain started a few days after  first  shot  now worse pain a few days after second  shot  used  and using cold packs on Moderna arm did  not use anything for joint pain
Message from patietn:  Due to other vaccine reactions I had to wait for 30 minutes after my shot.  All was okay, until I got in the car to drive home.  My tongue began to tingle and headaches began.  I immediately took an antihistamine as a tingly tongue for me is a sign of an allergic reaction.  I then had a band like pain across my upper back, and then the chills, tiredness, nausea, sore throat, sore arm which are all normal reactions from the printed information - well except for the tingly tongue and a red rash across my nose, cheeks and chin.  Tingling and rash subsided about an hour after taking the antihistamine, but all of the other symptoms remained.  My shot was at 1:50 PM and just before 11 PM I had instant onset of pain in my chest wall with breathing.  It went across the top of both breasts in the center where my ribs meet my sternum.  This has lessoned with laying down, but when I am up and about it increases although not as bad as last night.  I am also experiencing bursts of itchy spots all over.  As I have an EpiPen I did not  go to hospital but am wondering about what to do for the 2nd shot.  I think it will be best if I take an antihistamine prior to the shot and I will continue taking them for this one until my symptoms go away.
According to the pt covid vaccine card, pt received orange cap 5-11yr covid dose. Per pt recieved age appropriate dose. Clinic notified of their error. No side effects. Ok to give age appropriate dose today.
A week after my vaccine, I started getting headaches and flashes of light in my peripheral vision. My blood pressure also elevated so I went to see the doctor. The headache lasted for 3 days and the symptoms subsided with rest and OTC medication.
Fever; body aches; chills; weakness; nausea; This is a spontaneous report received from a contactable other hcp (Patient). A 46-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6206), Solution for injection, via an unspecified route of administration, administered in Arm Left on 06Mar2021 14:00 (at the age of 46-year-old) as single dose for covid-19 immunisation. Medical history included fibromyalgia, diabetes mellitus and hypertension. Concomitant medications included chlorthalidone (CHLORTHALIDONE), lisinopril (LISINOPRIL), methylphenidate hydrochloride (RITALIN), bupropion hydrochloride (WELLBUTRIN) and ascorbic acid (C [ASCORBIC ACID]). Patient had no known allergies. Patient did not receive other vaccine within four weeks of Pfizer vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since vaccination. On 07Mar2021 02:00, the patient experienced fever, body aches, chills, weakness and nausea. No treatment was received to treat adverse events. The outcome of events was recovering.   No follow up attempts are possible. No further information is expected.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were provided. Vaccine was administered 8 days after first puncture of vial. No treatment was provided.  This is a case of expired product administered for this 81 year-old, male patient with no relevant medical history, with no associated adverse events. The expired product administered occurred on the same day after the dose of mRNA-1273 vaccine. It is not clear from the source document whether this was a first or second dose. The rechallenge was unknown since only one dose has been given and no information about the second dose is available. The benefit-risk relationship of Spikevax in not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received and it contains no significant information. Sender's Comments: This is a case of expired product administered for this 81 year-old, male patient with no relevant medical history, with no associated adverse events. The expired product administered occurred on the same day after the dose of mRNA-1273 vaccine. It is not clear from the source document whether this was a first or second dose. The rechallenge was unknown since only one dose has been given and no information about the second dose is available. The benefit-risk relationship of Spikevax in not affected by this report.
Ill; This case was reported by a consumer via interactive digital media and described the occurrence of illness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included swine flu vaccine with an associated reaction of illness.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced illness. On an unknown date, the outcome of the illness was unknown.   It was unknown if the reporter considered the illness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received H1N1 swine flu shot about 10 years ago and got very sick and was out of work for two weeks with bad flu like symptoms.  No more vaccines were received by the patient. The patient stated that she/he might have hypersensitive to vaccines. The patient received flu shot one year before the time of reporting and got very ill.  The patient was not planning on strike 3.
NOSE BLEED; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (NOSE BLEED) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (NOSE BLEED). At the time of the report, EPISTAXIS (NOSE BLEED) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Reportedly, nose bleed stopped after about 10 minutes.  Treatment information was not provided.
I began heart palpitations 2 days after the vaccine and I get weird irregular patterns it also makes a humming sound. It doesn't happen everyday but when it does it get bad to where it wakes me up out of my sleep.
Itching at site and redness progressing over 3 days. At time of doctor visit, area was about 2X3 inches in size. Extremely itchy and red