chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The Patient received her second Covid Moderna Vaccine and Waited 15 minutes. She felt well to continue to resume work here at the store. About 30 min later she complained she felt nauseus and dizzy. I immediately sat her down and asked her if she needed me to call 911. I provided a cold compress for her one on her head and one for her neck  and took her Blood pressure two times. I asked if she had any history of high blood pressure or was on any medications. Patient said she has not been to a Dr. but did not have High Blood Pressure. Pts Pressure was 145/95 the first time then after 135/91.  Pt sat with cold compresses and still did not want to go to the hospital. Then 30 -40 min later paramedics were in the store and we asked her if she would allow them to check her. Upon checking her pressure was similar 135/100 and she still felt off balance when she stood up with the paramedics. She said she felt like her right side was imbalanced and leaning to the right.  The paramedics and I said she would be better to get checked by the Dr. and she went to the ER. We will follow up with the patient as well. The store manager was involved and aware of the situation.
12 X 12 cm area of redness, warmth and mild pain and bruising developed over the left thigh where shots given.
Two days after the flu vaccine injection he noticed a slight weakness in his (L) arm. He was able to use his arm in his ADL and regular exercise activities. He has not contacted his PCP. As of 10/18/10 no change 10/19/10 client saw physician's asst. Benign exam.
incident where someone contracted COVID-19 after receiving the Pfizer vaccine; incident where someone contracted COVID-19 after receiving the Pfizer vaccine; His COVID-19 symptom was mild with a cough; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The reporter reported an incident where someone contracted COVID-19 after receiving the Pfizer vaccine. His COVID-19 symptom was mild with a cough. The reporter did not know if the patient had COVID-19 after the 1st or 2nd dose. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
pt recvd vax; aching in back of arm & lateral aspect of lower lt arm 21dec94; some weakness in arm; pt cont to work at dispatch desk; 22dec pt recovered;
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could suppose those conditions mentioned above that the (Oka/Merck) VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse information was available.   Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning (Oka/Merck) VARIVAX temperature excursion and one patient (patient ID#45982) of unspecified age and gender who was vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
developed gastro problems; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (developed gastro problems) and DIARRHOEA (Diarrhea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2020, the patient experienced ABDOMINAL DISCOMFORT (developed gastro problems) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (developed gastro problems) and DIARRHOEA (Diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information not provided. Concomitant medications were not provided.   This case was linked to MOD-2021-215957 (Patient Link).
On 02/24/2021 pt called had reaction to Hep B lip swollen blisters used Epi pen and Benadryl last night.  Advised not to take Hep B in future. take Claritin and Zantac or Pepcid.
10 x 7 1/2 cm erythema with central raised area tender to touch
Patient reported low grade fever (99 degrees) 24 hours after administration. Patient then reported inflammation and possible rash at injection site and went to ER. Patient was given antibiotic course, which was unsuccessful. Patient's symptoms were resolved with short course of steroids starting 12/16/18, prednisone 40mg once daily.
Bad shaking chills, my whole body was shaking started almost exactly 24 hrs after 2nd dose  Shaking lasted about 20 minutes and I continued feeling chilled till bedtime
On the day of the vaccination (2nd dose),  a few hours later, I started to get nauseous, pain in arm, fatigue and chills. I had a fever all night.  I did take Tylenol. The next day, I am still feeling exhaustion, fatigue, nauseous, arm extremely sore and painful to touch. Fever and chills started to improve.  I went to see my doctor and was tested for flu and covid, both came back negative.  I was prescribed an expectorant for the cough Guafenesin/Codeine.  The medication is not really helping to relieve the cough.  I am to follow up at the end of the week if symptoms do not improve.  I am still coughing, feeling fatigue, sore throat, and congestion.
horizontal strip on arm that was hot to the touch and swollen; horizontal strip on arm that was hot to the touch and swollen; red horizontal strip on arm; sore arm causing decreased mobility; Sore arm / soreness when arm is lifted to shoulder level; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 30th August 2020, less than a day after receiving Shingrix, the patient experienced mobility decreased and pain in arm. On an unknown date, the patient experienced swelling, feeling hot and erythema of extremities. On an unknown date, the outcome of the swelling, feeling hot and erythema of extremities were recovered/resolved and the outcome of the mobility decreased and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the swelling, feeling hot, erythema of extremities, mobility decreased and pain in arm to be related to Shingrix.  Additional details were provided as follows: On 30th August 2020, the patient received 1st dose of Shingrix in the left arm, within a day developed a sore arm causing decreased mobility.  Less than 2 months after receiving vaccination, the patient also reported a red horizontal strip on arm that was hot to the touch and swollen that all went away within a week.  The patient still experienced soreness and decreased mobility in arm although it has become better.  Now, patient reported soreness when arm was lifted to shoulder level. When arms were down, the patient reported no pain. This case has been linked to US2020AMR217273, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR217273:same reporter
pt recv vax & 72hr post vax 24AUG96 pt devel low grade fever which inc to 103, malaise & anorexia;3SEP96 steroid therapy was initiated, sx began to resolve;pt was removed from tx & sx persisted;
Diffuse hives and syncope. Hives started 3 hours after vaccines. Syncope occurred morning of 3-9-06. Occurred when pt rising from a seated position.
Headache, Arthralgia, Fever, weakness; injection site pain, chills Narrative:
Birth weight: 7 lb 9 oz No issues during pregnancy. Baby was delivered via csection. Birth complications: Chorioamnionitis Vaccine adverse reaction was eczema that started within a week of vaccination. Eczema is on hands of mother and thought to be gone after delivery of baby, but it has instead become permanent. Eczema is triggered by stress and contact with soaps and antibacterial lotions.
Patient was administered a vaccine that had expired on 11/30/2022. No symptoms present at time of the vaccine
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative, notes: Rebound COVID after testing negative for 3 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
lips swollen 3 time nl size welts on arm; 4OCT92 to ER treated w/Pred & DPH;
Information has been received from a physician concerning a female (age not reported) who on 02-MAR-2007 was vaccinated with Pneumovax 23 (lot # 655152/0889F) IM.  The patient sought medical attention.  On 02-MAR-2007, the patient developed cellulitis of the arm at the injection site after immunization with Pneumovax 23.  No lab diagnostic studies were performed.  The patient was being treated with oral antibiotics.  At the time of reporting, the outcome of the cellulitis was unspecified.  The physician requested a lot check.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released by the regulatory agency.  Additional information has been requested.
After first dose of HPV vaccine, fainted in reception area, but no one witnessed it. Got half way thru second dose in January of 2014 and passed out, postured, red face and seizure like symptoms.  Witnessed by the nurse giving the vaccine.  So she should have reported this.  She suggested not getting another dose, due to her extreme concern.
After injecting Patient complained about not able to here everything what I was saying to her because of too much pressure in her ear, few seconds later she said having light headache and pressure in her chest or difficulty breathing that is when we called 911. I made Patient to lie down on the floor gave ice pack to put it on her head and started checking blood pressure every 5 minutes. Patient was coherent and conscious all the time and was talking to me she was feeling better every minute after she lied down. Her Bp was 215/118 with pulse rate of 93 for the 1 st time and went down every time since and last one was 120/86 when EMS took her BP. EMS arrived at 12:50 AND SAID EVERYTHING WAS OK AND SHE PROBABLY TOO WORKED UP BECAUSE OF FEAR OF NEEDLES. SUGAR WAS 75. AFTER FEW MINUTES WITH EMS PT. WAS RELEASED TO GO AND GET SOMETHING TO EAT.
pt recvd vax 25SEP95 315PM & next day 10:30 lt arm inj site became numb, tingling sensation really hurt;2 episode of the numbness & then pain in arm;swelling in both arms, small bruise @ inj site, sl swelling, pain inj site;breathing troubl
Unknown number of patient dosed with vaccine from a syringe >12 hrs; The vaccine was stored in syringes in the refrigerator and administered for up to 24 hours from the time of puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Unknown number of patient dosed with vaccine from a syringe >12 hrs) and EXPIRED PRODUCT ADMINISTERED (The vaccine was stored in syringes in the refrigerator and administered for up to 24 hours from the time of puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Unknown number of patient dosed with vaccine from a syringe >12 hrs) and EXPIRED PRODUCT ADMINISTERED (The vaccine was stored in syringes in the refrigerator and administered for up to 24 hours from the time of puncture). At the time of the report, PRODUCT STORAGE ERROR (Unknown number of patient dosed with vaccine from a syringe >12 hrs) and EXPIRED PRODUCT ADMINISTERED (The vaccine was stored in syringes in the refrigerator and administered for up to 24 hours from the time of puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported. No adverse event reported.  It was reported that provider has had lot numbers 051F21A, 025C21A, and 040B21A.
Post COVID vaccination, the patient started to seem sweaty; increased HR (117), elevated BP (174/93). The patient declined Benadryl and continued to have her feet up on the recliner. Around 02:45 pm, the patient walked out of the clinic without dizziness.
makes my head feel really high; shaking; kinda feel weak; makes my stomach nauseous; shot site was itchy and a little painful; shot site is itchy, was a little painful; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (makes my head feel really high), TREMOR (shaking), ASTHENIA (kinda feel weak), VACCINATION SITE PRURITUS (shot site is itchy, was a little painful) and NAUSEA (makes my stomach nauseous) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Erythromycin) and Drug allergy (Halidol.). Concomitant products included AMITRIPTYLINE, CITALOPRAM, FOLIC ACID, ADALIMUMAB (HUMIRA), HYDROXYCHLOROQUINE, CALCIUM FOLINATE (LEUCOVORINE), LEVOTHYROXINE, LOSARTAN and METHOTREXATE for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (shot site is itchy, was a little painful) and VACCINATION SITE PAIN (shot site was itchy and a little painful). On 09-Aug-2021, the patient experienced HEAD DISCOMFORT (makes my head feel really high), TREMOR (shaking), ASTHENIA (kinda feel weak) and NAUSEA (makes my stomach nauseous). At the time of the report, HEAD DISCOMFORT (makes my head feel really high), TREMOR (shaking), ASTHENIA (kinda feel weak), VACCINATION SITE PRURITUS (shot site is itchy, was a little painful), NAUSEA (makes my stomach nauseous) and VACCINATION SITE PAIN (shot site was itchy and a little painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reported that the patient was having the same as the effects when she took Erythromycin.  No treatment information was provided.
Aches, Fever 103, and Headache for 6 hours Nausea (next day)
I experienced an electric shock feeling and blood pressure was high, Cardiologist had to increase BP meds. 120mg Diltiazem 3x, 40mg Lisinopril 40x2, 25mg Hydrochlorothiazide, somewhat under control. I was under 150 BP and heart rate was fine. I went for ultrasounds for carotid, echocardiogram and nuclear stress test. Carotid was blocked and cholesterol was good. I was sent to a Thoracic Surgeon and had surgery which helped issues and lowered BP meds. Symptoms have abated. Mental state was altered, hard to focus. Lasted a few months. Stopped Antidepressants. Now I take vitamin D3 & Beta-carotene.
low grade temp 26JUL98 followed by red lesions 27JUL98, a few lesions devel into vesicular lesions like varicella 28JUL98;new lesions 27JUL97 & 28JUL98;total of 10 lesion;
flu like symptoms; FEVER; WEAKNESS; HEADACHE; NAUSEA; MUSCLE PAIN; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 3HX44, expiry date 15th November 2021) for prophylaxis.   On 23rd September 2019 04:00, the patient received the 2nd dose of Shingrix .5 ml. On 23rd September 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, weakness, headache, nausea and muscle pain. On an unknown date, the outcome of the influenza-like symptoms, fever, weakness, headache, nausea and muscle pain were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, fever, weakness, headache, nausea and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at 4:00 pm and few hours later she began to experience flu like symptoms including, fever, weakness, headache, nausea and muscle pain. The symptoms are resolving but not entirely resolved. There is discrepancy between the outcome reported in the structured field of system recovering while in source document it is reported as fatal.
Muscle weakness, pain, numbness and tingling hands, feet, legs and arms.  10/7/2008 Office records received from PCP for 7/21/08. Pt presented with c/o arm and leg pain, extreme muscle fatigue and diarrhea since 7/18/08. PE (+) for wide based gait, decreased muscle strength in lower (3/5) & upper 4/5) extremities as well as decreased sensation to sharp and dull. Normal reflexes. Sent to ER (above) with concern for GBS. 10/06/2008 ER record received for DOS 7/21/2008 with DX: Hyperglycemia. Pt presented to ER from PCP's office with c/o new onset weakness, aching and paresthesias of the extremities. PE WNL. D/C home.  10/10/08 Spoke with reporter who recently saw patient. Still having some muscle tingling and weakness as well as easy fatigability. No definite dx.
Developed joint pain in both hands 5-7 days after second dose. Pain is worse in the left hand.  Pain still ongoing since receiving vaccine. 1st dose got me into the Emergecy room due to sever headaches that lasted all day and night for several months.
This spontaneous report as received from a Registered Nurse regarding a 6 year old Child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 30-JAN-2019, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA001085.
Fever; Injection site was aching; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) and VACCINATION SITE PAIN (Injection site was aching) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stent placement on 29-Jan-2021.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and VACCINATION SITE PAIN (Injection site was aching). At the time of the report, PYREXIA (Fever) and VACCINATION SITE PAIN (Injection site was aching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Electrocardiogram: abnormal. On 28-Jan-2021, Myocardial necrosis marker: 9, likely had a heart attack in the past 24 hours.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was reported. It was reported that patient had fever and injection site was aching after first and second Monovalent booster. No treatment information was reported.   This case was linked to MOD-2022-670601, MOD-2021-039119 (Patient Link).
While writer was observing patients in obs area, noticed pt. anxious, fidgety, upon checking on  she c/o itching and feeling anxious, no throat problems or swelling, or hives noticed, no resp complaints. pt was walked over to EMS  Upon EMS eval patient had itchiness and redness in the face. Patient then complained that the itchiness had progressed down the back of her neck and into her elbows. Patient started to have hives on inside elbows. 25mg oral Benadryl administered. Patients hives started to dissipate 20 minutes later. Patient signed EMS RMA and left vaccination pod.  Patient had no signs of anaphylaxis and no further complaints when she left.
Patient presented to Family Medicine on 07/10/18 for an office visit and it was noted in NP's note that patient presented for questionable reaction to PNA vaccine, stating that hours after the vaccine was placed on 07/09/18, she "Began having low grade fevers of 100, Warmth and Tenderness at site of injection, Myalgia, Headaches and Chills. It does appear she had a local reaction".
9SEP94 1210AM eye (rt) swelled up for no apparent reason; visited emergency room given ATB;next 12-18hrs vomiting & diarrhea;refused to eat;fever escalated;returned to emergency room;spinal mengitis dx'd-hospitalized