chrisvoncsefalvay/vaers-outcomes huggingface dataset:
74-year-old female presents emergency department by EMS from home.  She will history of CVA couple years ago.  She lives at home with her husband and has a caregiver come in to help out as well.  She was awake tonight and had a controlled fall.  She states she has been increasingly weak over the past year.  She does not want nursing home treatment and the husband states he will take her home.  EMS initially was going to go to refusal however she could not stand and pivot to get to the bathroom and she was brought in for evaluation.  No chest pain or difficulty breathing.  No injuries. Associated Symptoms: fall, fatigue, weakness
I caught Covid 19, positive; I have a fever with horrible headache as well as much muscle aches and join aches; I saw my doctor and he gave me antibiotics to keep me from getting an infection.
Pt recvd 2 doses of Engerix-B & on 1JUL92 a rash appeared; had sl wheezing p/ a hot flash; 20JUL92 seen by dermatologist; itching was eased w/Medrol but came back on taper down of regimen;
Head cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Head cold) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication. No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NASOPHARYNGITIS (Head cold). At the time of the report, NASOPHARYNGITIS (Head cold) was resolving. No concomitant medication was reported. On an unknown date, the patient experienced HEAD COLD. COVID-19 VACCINE MODERNA (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for SKYRIZI (RISANKIZUMAB): The reporter's causality for the event(s) of HEAD COLD was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
headache; redness at the injection site; first dose of the Shingrix vaccine about a year ago; This case was reported by a consumer via call center representative and described the occurrence of headache in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 28th January 2020, the patient received the 2nd dose of Shingrix. On 28th January 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced headache and injection site erythema. On an unknown date, the outcome of the headache, injection site erythema and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the headache and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the first dose of the Shingrix vaccine about a year ago and did not receive the second dose yet. The patient was planning to get the second dose of Shingrix on the reporting date, which led to lengthening of the vaccination schedule.  She states he did experience headache and redness at the injection site with the first dose.  Customer did not want to provide her address.  No additional information provided. The reporter consented to follow up.  This case has been linked with US2020015819, reported by same reporter.
Increased notability in tinnitus. This was noticed after the initial vaccination (both shots) but did not correlate with them. After receiving the booster shot the same increase returned.
The next day, I had lymph nodes that were swollen and it went on for five days.
She thought she had a reaction to the vaccine, but it was actually poison ivy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE TO TOXIC AGENT (non-serious), outcome "unknown", described as "She thought she had a reaction to the vaccine, but it was actually poison ivy".  Additional information: She got prescribed prednisone. Her doctor told her she shouldn't get a vaccine while taking that medication. She thought she had a reaction to the vaccine, but it was actually poison ivy. she wants to reschedule her second dose for another time. She didn't have info for vaccination site  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shopped in store for approx.-15 minutes, the muscles in my back felt like they couldn't work. I wasn't able to stand upright for approx. 2 min. I got the chills and a headache. This lasted for 48 hours.
Approximately 5" x 2" reddened, blanchable area with injection site as well as under (R) arm. Had mild pain (R) arm pit. Also, itching at injection site. Almost completely resolved by 9/24/07
Systemic: Body Aches Generalized-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Joint Pain-Medium
fever (101), chills, temporary shortness of breath, and numbness of the fingers of the left hand Pain at the injection site (left arm)
Soreness beginning 4 hours after vaccination - then fever beginning 12 hours later. Next morning red, swollen, hot vaccination site. Patient presented to urgent care and was diagnosed with cellulitis - prescribed keflex 500mg every 6 hours for 10 days  to treat redness. Fever broke on 10/16/18. Redness has reduced as of 10/17/18.
Patient came into office at 1130 for his second dose of Hep A and third dose of Hep B. He was given demographic sheet and health questionnaire to complete. Once it was turned in the health questionnaire was checked for any allergies or health issues. All questions were answered "no."  Employee called the patient back to the exam room at around 1135 where his health questionnaire was once again checked and she asked him if he had any issues with his previous doses of Hep A and Hep B. Patient stated that he did not have any issues before and that he had done fine. Employee proceeded to administer both injections. Employee and the patient had continuous conversation during this time in the exam room. He requested a copy of his shot record and was told to have a seat in the waiting room while the record was prepared. Once employee updated his shot record and printed a copy, she called the patient?s name. He did not acknowledge that his name had been called. He was sitting in the waiting room chair with his elbows resting on his knees and his head in his hands. Employee called his name again and he looked up so she told him she had his shot record ready. As he stood up, she asked him if he was feeling okay. As he was walking toward her, he said that he felt a little ?funny? and his ears were ringing. Employee could tell he was about to pass out so she reached through the window and grabbed him by his shirt and around his neck to keep him from falling and hitting his head on the floor. His chin hit the ledge out by the front window. Employees saw that the patient getting ready to fall and they ran around out into the waiting room to help lower him onto the floor. While employees were lowering the patient to the floor and calling his name, another employee ran to grab to grab alcohol swabs for him to breathe and cool packs. He was sweating profusely so ice packs were placed on his neck, front and back. The patient then stated that he was very nervous before his shots due to not liking needles and that he had not eaten yet. Employee then gave him a sprite to drink. After several minutes, he said he was feeling much better so it was suggested that he try sitting up in a chair for a little while before standing up. A chair was then brought to him and employees helped him into it. He stated talking to us then passed out again. He came to almost immediately but then quickly passed out again. This time his color was gray and he would not respond. Employee asked if she should go call EMS and was told yes. As employee was walking to call EMS the patient began to convulse. Employees immediately began lowering him to the floor. He began sweating more profusely so more cold packs were placed on him (on front and back of neck, under both arms, and on both sides of him). Once he was able to speak coherently, he informed staff that he had an ?artificial heart valve but he didn?t have heart disease because his doctor told him that.? Employee asked him why he had the heart valve replaced and he said that he had an infection in his blood that damaged his heart valve but it did not cause heart disease. EMS arrived and took over from there.
large, swollen, erythematous area w/chills, fever, h/a, myalgia
I had very slight nausea about an hour after the vaccine and slight fatigue, both of which went away quickly. What has concerned me is that I have had chest constriction/pressure/tightness which started about 45 hours after second shot was administered along with asthma related feeling of airway inflammation and cough. I also did a very light low impact cycling workout the morning that these symptoms occurred if that is of any importance. It has now been 3.5 days after the vaccination and I still have all of the chest/airway related symptoms.
This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown age and gender. On an unknown dates since 16-FEB-2015, the patients were vaccinated with an unspecified number of improperly stored doses of RECOMBIVAX HB intramuscularly (dose and lot number were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
4 days after the second Vaccination, at night just before I fall asleep I hear a pulse/buzz sound in my head.  Some nights it happens once and other nights it happens multiple times.  This has been happening every single night since the vaccination.  I am also sensitive to sharp sounding noises.  My right hand also has some some strange sensation in that it, at times, feels like I have something around my wrist even though nothing is around my wrist.  My right hand also cannot at times feel my left arm-weird!  All of this started happening within days of the second Maderna vaccination.
Pt. states that after receiving the 1st dose of J&J 10/06/2021, started experiencing symptoms 2 hrs later of blurred vision and headaches. No noted Primary visit, still continuing to experience symptoms.
presented with n/v, diarrhea; + Covid in ED; Admit 9/24 medical with Covid infection; tx 9/24  steroids, merrem, Vit C, Vit D3, LMWH, zinc, started; 9/25 remdesivir started; O2 @ 2 LPM with admit; weaned to RA by d/c
No other adverse events reported; Caller reports that improperly stored vaccines were administered.; This spontaneous report has been received from an administrator and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 30-MAR-2023, the patient was vaccinated with the first dose of an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product storage error) injection (lot number U031056 has been determined to be valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Expiration date has been established as 16-JUN-2024), administered for prophylaxis (strength, and route of administration were not provided). No other adverse events were reported.
Second shot was late because he could not get it from being sick from his gastroparesis; Second shot was late because he could not get it from being sick from his gastroparesis; legs feel weak/His arms also feel weak; blurred eyes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 21May2021 (Lot number: EW0165) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Raynaud's Disease" (unspecified if ongoing); "Gastroparesis", start date: Jan2010 (unspecified if ongoing); "Cdiff" (unspecified if ongoing); "Hospitalization" (unspecified if ongoing), notes: He had prior hospitalizations on 23 Feb 2021, and 24 Feb 2021; "Helicobacter pylori", start date: Aug2020 (unspecified if ongoing); "Implant (stomach)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown" and all described as "Second shot was late because he could not get it from being sick from his gastroparesis"; MUSCULAR WEAKNESS (non-serious) with onset 24May2021, outcome "unknown", described as "legs feel weak/His arms also feel weak"; VISION BLURRED (non-serious) with onset 22May2021, outcome "unknown", described as "blurred eyes".  No follow-up attempts are possible. No further information is expected.
Patient experienced rash, fever, vomiting, diarrhea, headache and a bruise the day after vaccination. Her physician stated if a rash occurred to see a doctor. So, she went to urgent care where she was diagnosed with cellulitis.
The employee called the center on 5/25/22 at approximately 1000 reporting current s/s of headache and upset stomach. Employee stated the onset was about 30 minutes after the vaccine was administered to him on 5/24/22 at approximately 1500. Employee states the s/s did not resolve at home and that the severity of s/s are about the same. Employee denies seeking outside medical care. Employee was educated to seek outside medical care if symptoms persist or worsen and to call the center with any further questions or concerns.
PT EXPERIENCED FLU LIKE SYMPTOMS THE NIGHT OF THE VACCINATION (WEDNESDAY). HE FELT OK UNTIL SUNDAY THE 13TH WHEN HAD A HIGH FEVER AND WAS DELIRIOUS. AMBULANCE WAS CALLED AND PATIENT WAS ADMITTED ON MONDAY 9/14/20 WITH SEPSIS. CULTURED KLEBSIELLA. AT THIS POINT HOSPITAL CAN NOT FIND SOURCE OF INFECTION.
Itching at trunk of body and around ankles; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching at trunk of body and around ankles) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018m20a) for COVID-19 vaccination.     The patient's past medical history included Blood pressure management (Blood pressure medications) since an unknown date. Concurrent medical conditions included Rheumatoid arthritis (Rheumatoid arthritis medications). Concomitant products included VITAMINS NOS and PROBIOTICS NOS for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PRURITUS (Itching at trunk of body and around ankles). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching at trunk of body and around ankles) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included BLOOD PRESSURE MEDICATIONS, CHOLESTEROL MEDICATIONS and RHEUMATOID ARTHRITIS MEDICATIONS.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant Follow-up received on 14-Jul-2021 contains additional information - Event outcome was updated, other relevant history updated
COVID Vaccine Adverse Event Documentation  After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM.    Signs/Symptoms:  Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments)      Reaction Comments:  Skin blotchiness, dizziness, shaky, responsive but limp  Treatment Administered:  Cold Compress and Sips of Water      Treatment Comments:  Crackers, put in supine position  Disposition:  Home      Disposition Comments:  Next vaccine should be supine when receiving it.  Additional Documentation:   Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75           Supervising Provider Notified of Reaction: MD
eczematous rash to dorsum of right foot 4 days after 2nd vaccine dose spreading caudally to mid-shin
I had fever and body aches , and I was tired. I expected those symptoms, but I didn?t anticipate having chest pain and more pain on inhalation deep to my chest.
2 red dots for both shots in the upper arm; Sore arm; Injection site hurts; Has 2 red dots for both shots in upper arm; can feel them at touch; fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MACULE (2 red dots for both shots in the upper arm), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), INJECTION SITE PAIN (Injection site hurts) and INJECTION SITE SWELLING (Has 2 red dots for both shots in upper arm; can feel them at touch) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On 23-Mar-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced INJECTION SITE MACULE (2 red dots for both shots in the upper arm), PAIN IN EXTREMITY (Sore arm), INJECTION SITE PAIN (Injection site hurts) and INJECTION SITE SWELLING (Has 2 red dots for both shots in upper arm; can feel them at touch). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, INJECTION SITE MACULE (2 red dots for both shots in the upper arm), INJECTION SITE PAIN (Injection site hurts) and INJECTION SITE SWELLING (Has 2 red dots for both shots in upper arm; can feel them at touch) had not resolved and PAIN IN EXTREMITY (Sore arm) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use also included supplements (not specified).  Consent was given for Safety follow up.   This case was linked to MOD-2021-263790 (Patient Link).
Had shingles innoculation June 07 developed CMV virus - August 07. Fever 3 weeks pain, very ill, took 7-8 weeks to recover shingles and CMV both herpes types of virus.
Shortness of breath 5 minutes after, fainting, and severe migraine with aura 1.5 hours after.  Muscle pain and aches for 24 hours after. low-grade fever.
Information has been received from a physician concerning a 14 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL in another office. Concomitant therapy included YAZ and SOLODYN. It was reported that 5-7 minutes later "her throat closed, she hyperventilated and had nausea and vomiting". The physician stated that the patient became anxious during this whole process. It was reported that this lasted 20 minutes after which the patient resolved. Additional information has been requested.
Individual fully vaccinated with COVID-19 Pfizer vaccines on 1/29/21 and 2/22/21 and tested positive for SARS-CoV-2 on 4/16/21.
2 day hx of diffuse papular, blanching, erythematous rash, beginning on face and spreading to entire body. Sparing of palms, and soles of feet. No fever associated, no itchiness.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases: A0756483A - A0756517A, A0756519A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers:  AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received from batches reviewed (AFLUA350BA) : AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.