chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states she had a localized reaction last year.  An hour or so after her shot today she developed "significant" swelling at the site per another volunteer.  The patient did not come in to my office to show me.  I contacted her by phone and she states has since taken advil and kept a cold pack on the site and the swelling is reducing.  I have advised her to follow up with her PCP.
Information has been received from a physician concerning a patient who on approximately 14-SEP-2007 was vaccinated with a dose of Zostavax (Oka/Merck) instead of Varivax.  It was reported that this was not product confusion but a medical error.  Subsequently, the patient did not experience any symptoms.  It was unspecified if medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
itching; Vesicular papular rash that continues to progress; Arthralgia; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (itching), RASH VESICULAR (Vesicular papular rash that continues to progress) and ARTHRALGIA (Arthralgia) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced ARTHRALGIA (Arthralgia). On 11-Jan-2021, the patient experienced RASH VESICULAR (Vesicular papular rash that continues to progress). On 20-Jan-2021, the patient experienced PRURITUS (itching). The patient was treated with HYDROCORTISONE (topical) on 20-Jan-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, PRURITUS (itching) and ARTHRALGIA (Arthralgia) outcome was unknown and RASH VESICULAR (Vesicular papular rash that continues to progress) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included unspecified birth control pills.  Treatment included and antihistamine medicine. It did not help. The patient had planned to go to Dermatologist on 26-Jan-2021.  It was reported that rash was attributed to keto diet rush.  It was reported that the patient had events due to something else and gone on cessation.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: iNarrative updated with other contributing factor (keto diet rush). On 19-Jun-2021: Clinical course information updated.
Appeared unwell after vaccination. After returning home, sat down in chair and became unresponsive.  Resuscitation unsuccessful. Autopsy performed 2/17/2021 showed severe hypertensive and coronary heart disease with congestive heart failure and no signs of anaphylaxis (postmortem serum tryptase = 9.2 mcg/L; RR <= 10.9).
Shortly after the first dose of my Moderna vaccine on February 27, 2021, I experienced muscle and joint pain in my legs that lasted approximately three weeks. I also developed a large cyst under my right collar bone. I was feeling better in the days before my second shot, so I went ahead with receiving it. On the day of the second dose, March 27, 2021, I began to experience irregular, heavy menstrual bleeding, weakness and extreme thirst that lasted approximately 10 days.  On April 13, 2021, I went to the emergency room, as I had persistent incredible thirst, a pounding heart, and had become so weak that standing was difficult. Blood tests were negative for Lyme and other tickborne illnesses, and an x-ray of my chest and an EKG both came back clear. A CBC showed that my magnesium was low at 1.8, but everything else appeared to be in range, so I was sent home. In the following days I began to experience; shortness of breath and difficulty breathing; heart palpitations and continued pounding; insomnia; anxiety; visual disturbance (difficulty focusing eyes, blurred vision); red petechiae rash on the sides of my neck; exercise intolerance and intense muscle fatigue and soreness; pain and aching in the bones and muscles of my legs that left me unable to stand for more than a few minutes at a time without an increase in pain; joint pain in my knees; muscle twitching; headaches; fatigue; and brain fog. These symptoms have continued ever since.  In June 2021 I experienced a severe ocular migraine that left me with tinnitus and chronic visual disturbance (patch of light in left eye that comes and goes). I also began to experience hair loss and depression around this time. Visits to several doctors and specialists beginning in April 2021 revealed that I was depleted of vitamins and minerals. My ferritin level was dangerously low at 6, my vitamin B12 was 202, my vitamin D was 23ng/mL, and my magnesium was 1.8. Supplementing these things for the past several months has started to improve my symptoms, but I am still struggling with my health. I am unable to do strength training or exercise the way I used to, I struggle with anxiety, and I have several days a month where I cannot focus or sit still for very long due to leg pain. I am still dealing with hair loss as well.
Severe enlarged lymph node, resolved in about a week, large lump in armpit that was super sore and hurt to the touch.  Right arm pit.
Pt recvd DTP/OPV/HBOC 19DEC91 mom states began having shaking & vomiting & temp of 101 starting 20DEC @ 8AM was seen by MD; 20DEC @ 230; MD felt was not an immun reactions, pt had OM;
Rash on (R) arm where DTaP, IPV; H1N1 given red, warm mildly raised -Tx - cool compress - KEFLEX -  BENADRYL - Suspect H1N1 - prior DTaP, IPV without problem.
Rash underneath the injection site; Rash go down to the elbow; Very Itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash underneath the injection site), RASH (Rash go down to the elbow) and PRURITUS (Very Itchy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Hypersensitivity to medications. Develop rash for any medication.).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash underneath the injection site), RASH (Rash go down to the elbow) and PRURITUS (Very Itchy). The patient was treated with HYDROCORTISONE on 15-Feb-2021 at an unspecified dose and frequency. On 19-Feb-2021, PRURITUS (Very Itchy) had resolved. At the time of the report, VACCINATION SITE RASH (Rash underneath the injection site) and RASH (Rash go down to the elbow) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26-apr-2021. The outcome of the event updated to resolved.
didn't really noticed until the next dayor so when got a red rash, it don't hurt, it don't hurt according to the patient. The rash is about 6 to 7 inches long; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (didn't really noticed until the next dayor so when got a red rash, it don't hurt, it don't hurt according to the patient. The rash is about 6 to 7 inches long) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RALOXIFENE, LOSARTAN and AMLODIPINE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (didn't really noticed until the next day or so when got a red rash, it don't hurt, it don't hurt according to the patient. The rash is about 6 to 7 inches long). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (didn't really noticed until the next day or so when got a red rash, it don't hurt, it don't hurt according to the patient. The rash is about 6 to 7 inches long) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications Blood pressure medicine, Relaoxafine, Losartine, Amlopadine. Treatment details Benadryl on topic and Benadryl pill
my body shutdown I had to sleep out of no where after about an hour I started to have uncontrollable shivers/shakes I was over heating but under a blanket to see if that would help with the shaking but it didn't once it did stoped I was knocked out sleeping again until 3am. I took my temp for the first time that night around 3pm also and it was at 100.5°f. I haven't had a fever over 99.9 since elementary school
This is a spontaneous report from a contactable consumer via Medical information team. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reports a person in the bakery knows someone who had heart palpitations after the vaccine on an unspecified date. The governor is deciding it would be better to give everyone just one shot and then wait longer for the second dose. The outcome of the event was unknown. Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Watery, green diarrhea 6-8 times per day for 3 weeks with abrupt onset and offset. Diaper rash associated with diarrhea frequency. No fever. No vomiting. No change in appetite. Diarrhea led to weight loss from 13.48 pounds on the day of vaccination to 13.38 pounds 17 days later dropping a full percentile group (from 75th percentile to 50th percentile) on the growth charts. Weight gain after resolution of diarrhea, but still not back to 75th percentile as of 1/4/18.
The pt experienced a 4x5 cm area of erythema at the vax site. Elbow and shoulder joint pain with localized pruritus.
Within a few days of receiving vaccine up until present time, I have experienced intermittent, burning pain in left shoulder with movement away from body. It has been over a month, and finally improving somewhat.
Patient received flu shot when shingrix was requested. Patient has already received flu shot previously. Notified patient that vaccine is inactivated, but may experience flu-like symptoms.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: 7 minutes after receiving 1st dose of Moderna covid vaccine 0.5ml in the left deltoid muscle via IM route, patient felt light head and fainted.  He stated this has only happened after giving blood.  He regained consciousness immediately, BP check- given orange juice, paramedics were called and on site they evaluated patient and took over care.  Upon review, the patient was able to leave and did not need to go to the hospital.
When waking up I had a rash on my neck coming down to my chest, it wasn?t itchy but very red.
Information has been received from a registered pharmacist concerning a 67 year old female with concomitant medications, drug allergies and pertinent medical history not specified, who on 10-MAY-2008 was vaccinated with a dose of PNEUMOVAX 23, IM, (Lot# not specified), while hospitalised for an unspecified condition.  Subsequently in MAY-2008 the patient developed a severe localised reaction and the injection site was red and hot.  The patient also developed edema.  At the time of reporting, the outcome of the events was that the patient was "home and stable."  It was noted by the reporter that the patient's experiences caused a prolonged hospitalization.  No product quality complaint was involved.  Additional information has been requested.
The patient was complaining  about filling light headed having chills and anxiety. Patient declined to have his vitals checked, the patient was moved to an observation area and monitored by qualified staff. No further actions were taken.
Pain in back, shoulders, neck, loss of balance, vertigo, weak, plugged ears, congestion in head, bronchitis, tired, tight band around head;
headaches that stopped her in her tracks; she felt like she had the flu; weakness in her muscles; She is tired; feels like she needs to lay her head down by lunch time; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7533 and Expiration date was not reported), via an unspecified route of administration in left arm on 08Apr2021 (at the age of 68-year-old), as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Prior Vaccinations (within 4 weeks) and any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. The patient medical history included joint pain and arthritis. The patient historical vaccine she reports maybe a sore arm with the flu vaccine. She's had her shingles and pneumonia vaccines and never had any problems. NDC/Lot/Expiry for the flu vaccine not known. The sore arm is not even anything she would have been concerned about, there's no issue with a sore arm. The concomitant medications included levothyroxine sodium (SYNTHROID) and celecoxib (CELEBREX). The pharmacist told her to call Pfizer and report her symptoms and side effects. She and her husband both had their first Covid 19 vaccine on 08Apr2021 and she was fine for a few days. Then she noticed that she was getting headaches that stopped her in her tracks. The headaches would last a while then ease up. Then, in her muscles, she felt like she had the flu. She kept thinking her symptoms will work their way out of her system, but it's been constant. She hasn't received her second Covid 19 vaccine because honestly, she's afraid. She's still having headaches every day and weakness in her muscles. She's tired. She's usually energetic, she's a grandmother and she has many duties as a grandmother but now she feels like she needs to lay her head down by lunch time. She would like it known that her symptoms aren't debilitating or keeping her down or at home all the time. Sometimes she just has to stop in her tracks and rub her head a little bit. The napping and tiredness are not how she usually is but none of this is debilitating. Her symptoms haven't gotten worse or better, it's staying about the same. She has not taken anything different that would have affected the vaccine. She hasn't reported her symptoms to her primary healthcare provider. She thought her symptoms would go away. She hasn't been to the emergency room or any medical care facility. The outcome of the event was reported as not recovered.
I26.92 SADDLE PULMONARY EMBOLISM 4/2/2022 URINARY RETENTION I95.9 HYPOTENSION 2/9/2022 URINARY RETENTION I26.92 SADDLE PULMONARY EMBOLISM 4/2/2022 ACUTE PULMONARY EMBOLISM I95.9 HYPOTENSION 2/9/2022 ACUTE PULMONARY EMBOLISM I26.92 SADDLE PULMONARY EMBOLISM 4/2/2022 ANEMIA I95.9 HYPOTENSION 2/9/2022 ANEMIA I26.92 SADDLE PULMONARY EMBOLISM 4/2/2022 DM 2 CONTROLLED BY DIET I95.9 HYPOTENSION 2/9/2022 DM 2 CONTROLLED BY DIET I26.92 SADDLE PULMONARY EMBOLISM 4/2/2022 FAILURE TO THRIVE SYNDROME, ADULT I95.9 HYPOTENSION 2/9/2022 FAILURE TO THRIVE SYNDROME, ADULT I26.92 SADDLE PULMONARY EMBOLISM 4/2/2022 ABDOMINAL PAIN I95.9 HYPOTENSION 2/9/2022 ABDOMINAL PAIN I26.92 SADDLE PULMONARY EMBOLISM 4/2/2022 UTI (URINARY TRACT INFECTION) I95.9 HYPOTENSION 2/9/2022 UTI (URINARY TRACT INFECTION) I26.92 SADDLE PULMONARY EMBOLISM 4/2/2022 ANEMIA I95.9 HYPOTENSION 2/9/2022 ANEMIA
Client recieved Flumist which is contraindicated for a client with Asthma Client did not have reaction at time of vaccination. Called CDC for possible reactions.
Sore arm; Fatigue; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Feb2021 at 13:00 (at the age of 40-years old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had known allergies to adhesive and imitrex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) and estradiol (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Jan2021 at 13:00 (at the age of 40-years old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Feb2021 at 14:30, the patient experienced sore arm and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm and fatigue was recovered on an unknown date in 2021.   No follow-up attempts are possible. Information about lot number cannot be obtained. No further information is expected
April 1-2/Fever, Chills. severe body aches April 3-6/ Hives, red inflamed itchy  on torso, legs,& arms.  Diarrhea,  severe Migraines
woke up between MN & 1AM-hives from neck downward-profuse itching-tightness in chest & throat;top of mouth felt numb-skin tingled & was itching-given DPH;hives resolved about 3PM-lt deltoid sore but not red & swollen
Headache, Myalgia & NauseaVomiting Narrative:  TOOK HALF A DAY OFF OF WORK. SYMPTOMS RESOLVED BY 1/26/2021.   Other Relevant History:
ACUTE PULMONARY EMBOLISM 4/21/2023 ACUTE PULMONARY EMBOLISM CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/24/2023 ACUTE PULMONARY EMBOLISM HYPOXIA 4/21/2023 ACUTE PULMONARY EMBOLISM ACUTE PULMONARY EMBOLISM 4/21/2023 HYPOXIA CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/24/2023 HYPOXIA HYPOXIA 4/21/2023 HYPOXIA
Patient received flu vaccine on 10/20/03. On 11/11/04 symptoms of head tingling, numbness in extremities. Diagnosed with GBS on 11/14/03 at hospital. Currently is wheelchair bound and receiving water therapy. The discharge summary received on 3/23/04 states spinal tap headache and hypertension. The medical record received on 3/23/04 states gait unsteady and weakness.
Severe rash, redness and inflammation on the injection site and all over her body Skin infection near the injection site Severe itchiness on the affected areas No sleep for 4-6 days after vaccination was given, constant crying and discomfort for consecutive days  This happened in the past will all previous doses, but this last one was the worst.
approx 8mos p/vax pt exp herpes zoster & seen by dermatologist. on 22dec98 pt exp chickenpox w/12 lesions & persisted 2-3 days. seen by MD
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were inadvertently vaccinated with improperly stored doses of ROTATEQ (dose and route were not reported, lot # K020182, expiry date 25-JUN-2016; lot # L008053, expiry date 30-NOV-2016). concomitant medications were not reported. No adverse reactions were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I received both Shingrix vaccinations within the recommended time frame but 5 months later came down with Shingles anyway. No testing. Diagnoses was based on symptoms.
Cough, loss of taste; then chills, diarrhea, mild nausea
DIZZY; THROW UP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced dizzy. On 06-APR-2021, the subject experienced throw up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy and throw up was not reported. This report was non-serious. This case, from the same reporter is linked to 20210420279.
Patient had an exposure and when checking to verify hep b  series completed and immune it was noted she had not received dose #3. That was give on date of exposure 12/22/19. At 6weeks it showed she was not immune so# 2nd series started with the new heplisav. The morning the vaccine was given the employee said within 1-2  hours after shot she severe deep joint pain and pain all over her body and a mixture of itching with pins a needles all over my body. It progressively became worse requiring her to go to bed and taking Benadryl and another antihistamine. She then felt still to bad to work  the next evening and called and stayed in bed with more Benadryl. Felt better the next day.
The first dose was due on 7mar2023 and it has been 16 days out with no reportd adverse event; Initial information received on 23-Mar-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and gender patient whose first dose of rabies (HDC) vaccine [Imovax Rabies]  was due on 7mar2023 and it has been 16 days out with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitants(s) and family history were not provided.  On an unknown date, patient received an unknown dose of suspect rabies (HDC) vaccine, powder and solvent for suspension for injection (With unknown strength, route, lot number, expiration and at unknown administration site) for prophylactic vaccination (immunization).  On an unknown date, reporter reported that patient whose first dose was due on 7mar2023 and it has been 16 days out with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for an event.  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 the Directive 2001/83/EC 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.