chrisvoncsefalvay/vaers-outcomes huggingface dataset:
for a fewhours she had a really icy feet; Over cold, was really icy cold the whole time; Sore arm; Could not sleep; Next day she was just really tired, has been really tired for a fewdays, she's still tired; Heart rumbling and beating really fast, a fast heart beating; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart rumbling and beating really fast, a fast heart beating), PERIPHERAL COLDNESS (for a fewhours she had a really icy feet), FEELING COLD (Over cold, was really icy cold the whole time), PAIN IN EXTREMITY (Sore arm) and INSOMNIA (Could not sleep) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced TACHYCARDIA (Heart rumbling and beating really fast, a fast heart beating). On an unknown date, the patient experienced PERIPHERAL COLDNESS (for a fewhours she had a really icy feet), FEELING COLD (Over cold, was really icy cold the whole time), PAIN IN EXTREMITY (Sore arm), INSOMNIA (Could not sleep) and FATIGUE (Next day she was just really tired, has been really tired for a fewdays, she's still tired). On 20-Aug-2021, TACHYCARDIA (Heart rumbling and beating really fast, a fast heart beating) had resolved. At the time of the report, PERIPHERAL COLDNESS (for a fewhours she had a really icy feet), FEELING COLD (Over cold, was really icy cold the whole time), PAIN IN EXTREMITY (Sore arm) and INSOMNIA (Could not sleep) outcome was unknown and FATIGUE (Next day she was just really tired, has been really tired for a fewdays, she's still tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) blood pressure was really high and then it lower up a little bit..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included mild hormone. Treatment information was not provided.
After being vaccinated my Psoriatic Arthritis became severe in my hands and my Psoriasis started to flare up. I didn't take anything for my Arthritis, but I used triamcinolone cream for my Psoriasis. I did do Acupuncture for my Arthritis for 6 months and she was able to get it calmed down with that. I am still dealing with this at this time. I am taking a high dose of prednisone right now for my Psoriasis.
Felt a little under the weather; Bit of sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt a little under the weather) and MYALGIA (Bit of sore arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt a little under the weather) and MYALGIA (Bit of sore arm). At the time of the report, FEELING ABNORMAL (Felt a little under the weather) and MYALGIA (Bit of sore arm) outcome was unknown.            No concomitant medications were reported No Treatment medications were reported   This case was linked to MOD-2021-382225 (Patient Link).
Day after vaccine given pt reported pain in the part above where shot was given difficulty moving arm (extremely sore).
Narrative:  Patient with history of cardiac transplant on tacrolimus/mycophenolate. Received Moderna vaccine x 3 (1st dose 02/08/2021 (0.5 mL), 2nd dose: 03/08/2021 (0.5 mL), 3rd dose: 09/13/2021 (0.5 mL)). He was admitted with mild COVID symptoms including muscle aches and fatigue. He was admitted and treated with dexamethasone 6 mg during admission. Remdesivir was deferred due to renal disease. He complete 3 days of dexamethasone before being discharged.
Psychosis - in the 2 week mark on the date I was supposed to get my second dose, I had a ER visit for psychosis and delirium. Delirium caused me to be hospitalized inpatient in the psych hospital for 5 days
Booster; Left leg is really bothering me, it is cramping, it is aching, just all the way from my ankle to my thigh; Left leg is really bothering me, it is cramping, it is aching, just all the way from my ankle to my thigh; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, I had my first 2 Pfizer vaccine doses back in Mar), administration date: Mar2021, for COVID-19 IMMUNIZATION, reaction(s): "Headache"; Bnt162b2 (DOSE 1, SINGLE, I had my first 2 Pfizer vaccine doses back in Mar), administration date: Mar2021, for COVID-19 immunization, reaction(s): "Not feeling well for a day"; Bnt162b2 (DOSE 2, SINGLE, I had my first 2 Pfizer vaccine doses back in Mar), administration date: Mar2021, for COVID-19 immunization, reaction(s): "Headache", "Not feeling well for a day". The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious), MUSCLE SPASMS (non-serious) all with onset Nov2021, outcome "unknown" and all described as "Left leg is really bothering me, it is cramping, it is aching, just all the way from my ankle to my thigh". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Consumer stated, that patient had first 2 Pfizer vaccine doses back in March and patient just got the booster on Friday of last week, so like 5 days ago and patient first 2 (incomplete sentence), patient only reaction was, just headache, you know like mild, not feeling well for a day and then this time, after the booster, patient left leg was really bothering me, it was cramping, it was aching, just all the way from my ankle to my thigh and patient even went on Sunday to get checked, an ultrasound to make sure there was nothing in there but it was okay. Patient don't know what to do. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Noticed swelling of feet and legs (particularly left side) on 08/31/21 with tingling in left arm, which continued through the next day. Also feeling palpitations periodically and general tiredness and fatigue with shortness of breath and chest pressure.
Sore thraot, cough, chills, loss of taste and smell, and nasal congestion.  COVID (+), Vaccinated
Bell's palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02AA21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's palsy) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company Comment : This case concerns a 70 year old male with no relevant medical history who experienced serious expected event of Bell's palsy on unknown date. Patient received second of the Moderna Covid 19 vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns a 70 year old male with no relevant medical history who experienced serious expected event of Bell's palsy on unknown date. Patient received second of the Moderna Covid 19 vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.
Insidious development of cough and shortness of breath. This waxed and waned over time. He first reported at 4/14/21 visit, at which time he said it had started 2 mo prior. Initially treated as post-nasal drip w no improvement. Chest x-ray nl. No benefit from trial of bronchodilator. Referred for cardiol eval in Sep - new dx aortic ectasia.  Admitted to hospital 3/19-20/2023 adm obs for acute hypoxic respir failure - initially thought to be interstitial lung disease, but BNP quite elevated and symptoms resolved with diuresis.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants were provided. No treatment was provided.
This spontaneous report as received from a 69 year old female consumer with no pertinent medical history or drug reactions/allergies refers to herself. On 26-DEC-2012 the patient was vaccinated with a dose of ZOSTAVAX (dose and lot number unspecified). Concomitant therapies included ADALAT. The consumer reported an AE after getting ZOSTAVAX. One day after getting the shot, on 27-DEC-2012, the injection site was swollen and itchy. That reaction recovered two days after shots, on 28-DEC-2012. No treatment was given for the events. No lab diagnostics studies performed. The patient did not seek any medical attention. The relatedness for the events to ZOSTAVAX was unknown. Additional information is not expected.
This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a physician concerning a 12 year old female with candidal vaginitis at the time of vaccination who on 26-APR-2007 was vaccinated intramuscularly in the left arm with a first dose of Gardasil (lot # 656050/0245U). On 15-MAY-2007 the patient noted weakness on right side of face and was diagnosed with Bell's palsy after receiving the first dose. The patient was treated expectantly, and no medications were given. There were no laboratory or diagnostic tests performed. Medical attention was sought. At the time of reporting the patient has recovered. On 29-MAY-2007 the patient recovered fully. Additional information has been requested.
initially I had generalized body aches, sweats and fatigue.  Last week it progressed to muscle spasms in my feet, legs, hands and arms with some facial dropping.  Over the past weekend I started having muscle spasms in my back in addition to the other things already mentioned
Pt went limp and was unresponsive 1030pm 10/7/14 and about 1030 am and 11am on 10/8/14. Perioral cyanosis with 1 episode. No fever. Has had diarrhea for about 6 days pre vaccine.
PAIN AT SITE, REDNESS AT SITE, HOT TO TOUCH AT SITE, SLIGHT SWELLING AT SITE
Left deltoid redness, swelling, pain at injection site, inflamed yellow filled pustule at injection site, fatigue. Pustule, fatigue approx. 5 days present.
Patient is a 70 yr/o female with a history of dementia, hyperlipidemia, hypertension and GERD, who presents to the emergency department complaining of head pain status post fall she reports that this morning she was getting up to let her daughter into her house and she lost her balance and fell back and hit her head.  She report that when she stood up "everything felt dark"  Denies any LOC or anticoagulation.  She denies any chest pain shortness of air dizziness palpitations or passing out prior to fall.  Denies any blurry vision, nausea or vomiting.  Patient is a nontobacco user.  She denies any illicit drug use and occasional alcohol use.
2 days after administration, lumps becoming pink and tender about injection site. Now has gradually developed new papules which become hard and tender on arms. 2 areas of purpura on hand and right arm weakness.
pt. reported hx of anxiety and forgot to take medication. BP 152/84.  HR-WNL.  pt. now wants her BP checked.    No interventions other than reassurance.   pt. verbalized understanding to call 911 for any assistance after leaving clinic.
omg, these pages are so difficult to fill out.  Everytime I ender a date, it autocorrects it to the same date, I'm about to give up.    I'll try one more page.    I started having chest palpitations about 8 months ago, I didn't pay attention to it too well so I don't know the exact date.   I didn't connect it to the vaccine and still not sure if it is.  But EVERYDAY, my heart is beating out of my chest, even if I'm laying down sleeping.    I'm concerned about it, so I went to a heart doctor and did a stress test and echo, he said everything was ok, but the pounding in my chest is still there.   I don't have lot numbers on my card to fill out the above, but it was Pfizer all the way
Had a low-grade fever 99. Sore in my left arm.  I also had body ache.  On the second day, I wake up with both shoulder pain and had a fever.  I felt very weak.  My whole body ached.  I also had a running nose and was sneezing a lot.  I felt litharge and really tired.  I had a doctor phone appointment.  Then I feel asleep.
had two shots and now have them/ suspected vaccination failure; have them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient had two shots of Shingles vaccine and till the time of reporting, the patient had shingles for the fifth time. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding time to onset and laboratory confirmation for shingles were unknown.
Client states he was experiencing dizziness and headache after receiving the vaccine.  Client states that he did not take his medication prior to vaccination.  He was cleared by EMT to go home and take prescribed medication.
31OCT91 fever cutting teeth; 2-3NOV cold sx chest congest loose cough productive of green sputum, loose stools, nasal drainage; 8NOV91 t103F called MD given meds; 9NOV91 t105F, soreness legs, cranky, whiny, lethargic, poor appetite;
At VARIVAX injection site left posterior arm - red raised area at 2inch long. Warm and tender to touch.
swelling, pain, warmth, redness to injection site x 6 days. this started 8 days after injection
No second dose since 6Apr2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (No second dose since 6Apr2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (No second dose since 6Apr2021). In 2021, PRODUCT DOSE OMISSION ISSUE (No second dose since 6Apr2021) had resolved.            Concomitant medication were not reported. Treatment medication were not reported.
Information has been received from a 74 year old female consumer with no pertinent medical history and allergic reaction to codeine who in October 2008 and in October 2009, was vaccinated with the first and second doses of PNEUMOVAX 23. Secondary suspect vaccination included a dose of influenza virus split virion 3v vaccine inactivated (MSD) a week before receiving the second dose of PNEUMOVAX 23 (duration and dose not reported). Other concomitant therapies included XANAX and LEXAPRO. The patient had no adverse reaction after the first dose of PNEUMOVAX 23. In October 2009, after receiving the second dose of PNEUMOVAX 23, the patient experienced redness, pain and swelling of her arm "as big as a tennis ball" at the injection site. It was noted that the patient received both of the PNEUMOVAX 23 doses in another country. The patient was evaluated in an unspecified emergency room, and was not admitted to the hospital. No lab diagnostic studies were performed.  The patient stated that she recovered within a few days of receiving the second dose of PNEUMOVAX 23 in October 2009. No further information is available.
2 days following injection work up with severe hearing loss in left ear.  Hearing has not returned.  Tinnitus in left ear persists.
Per father, HE believes that ever since the patient received the HPV vaccine, she has not been herself. He reports that her sleeping pattern changed first and she complained that she was not feeling quite like herself. Two weeks after the vaccine was given she started with vomiting and mild diarrhea. Those symptoms resolved but again at the time he expressed his concern that this was due to the vaccine despite discussions of viral illnesses that could be present. Three days later she started complaining about a sore throat, she was seen at ER and diagnosed with Mononucleosis and Strep Throat. Despite treatment for strep throat, her sleep pattern and behavior continued to worsen, so she was seen again in ER. At that time she was admitted for altered mental status for two days, while tests were performed. She had been referred to psychologist in October when she reported not feeling quite like herself, and has continued in counseling. At the hospital, she was referred to a neurologist for continued care as well. While I do not believe the vaccine was the cause of the events that transpired, her dad is extremely concerned that it could have contributed to her symptoms.
Pt received Covid vaccine BUD. Vaccine expired on 7/7/22 and was given on 7/19/22
It has bruising on the injection site; Muscle spasm; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER2613, Expiration date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 at 14:00 (at the age of 42-years-old) as Dose 1, Single for Covid-19 immunization. Vaccination facility type was reported as sports facility. The patient's medical history included ongoing migraine headache. The patient's concomitant medication included brivaracetam (BRIVIACT) taken for migraine headache, start and stop date were not reported. On 22Mar2021 at 22:00, the patient experienced bruising on the injection site, it had bruise. Next day, she stated that yes bruise was lesser than yesterday. On an unspecified date in 2021, the patient had muscle spasm. It was reported that, patient had her cholesterol, blood test and calcium test 2 months ago, so nothing in the last month. Patient was taking medication of other vaccine (unspecified vaccine) and cyclobenzaprine (medication) for muscle spasm. She was concerned about her bruise and queried if she should check with her nurse or her doctor. Due date of second vaccination was reported as 12Apr2021 at 10:39 PM. Outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PAIN IN LEFT LEG AND KNEE...COULD NOT WALK FOR TWO DAYS  STILL HAVING PROBLEMS....
arm is still sore/would hurt/it is worse now with the hurting; arm is still sore, at first it was just red and swollen a bit; arm is still sore, at first it was just red and swollen a bit; brain tumor; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on May2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) on Apr2021 for COVID-19 immunization. On an unspecified date, patient experienced arm is still sore, at first it was just red and swollen a bit, but would hurt and it is worse now with the hurting. On Jun2021 patient had brain tumor and would be undergoing surgery. Outcome of event "arm is still sore/would hurt/it is worse now with the hurting" was not recovered while outcome of all other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypertension-Medium, Additional Details: lost conciousness for about 5 seconds. RN did assessment including bp, pulse ox, and nero exam. 911 was called due to sustained elevated BP
Fever 100.9 , chills, body aches, nausea,  vomiting started around 3pm and when I went to bed around 9:30 I had shortness of breath. Then when I woke the next morning to just body aches and nausea.
This spontaneous report was received from a nurse refers to 2 patients of unknown demographics. On 04-NOV-2013, the patients were vaccinated with a dose of PNEUMOVAX23 (lot# J004080, expiry date 22-AUG-2014). On 04-NOV-2013 the patients developed a rash, warmth and knot at the injection site. No treatment was provided for the events, however, the patients sought medical attention (spoke with the nurse). The events were reported to be recovered on 05-NOV-2013. There was no product quality complaint involved. Additional information has been requested.
HPI patient is a 43-year-old female who presents for evaluation.  Patient is having mild upper respiratory tract type symptoms with cough nonproductive she has lost her taste and smell.  Patient been going on for last 3 to 4 days.  As noted her husband is quite sick with regard to GI complaints associated possibly with COVID-19 as well.  Patient denies any other significant problems at this point.  GI or GU complaints no other cardiac or pulmonary complaints medications were reviewed with the patient as were her drug allergies