chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; drowsy; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), SOMNOLENCE (drowsy) and FATIGUE (tired) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Sinus disorder NOS (Reportedly there was none acute illness reported at the time of vaccination and upto one month before), Nasal allergy and Allergy. Concomitant products included DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (CORICIDIN HBP CHEST CONGESTION AND COLD) for Congestion nasal and Drainage, PARACETAMOL (TYLENOL) from 15-May-2021 to an unknown date for Pain and Headache.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 13-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm), SOMNOLENCE (drowsy) and FATIGUE (tired). On 15-May-2021, PAIN IN EXTREMITY (sore arm), SOMNOLENCE (drowsy) and FATIGUE (tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2020, COVID-19: nasal swab nasal swab test done for covid-19.         This case was linked to MOD-2021-078185 (Patient Link).
Flushing, racing pulse, rash (stomach, back), faint, dizzy, nausea, feeling unwell
Initial report received from a health care professional on 15 January 2014. A 53-year-old male whose medical history any had received first dose of FLUZONE ID (lot number: UT4726AA and route of administration was not reported) in the left deltoid on 18 November 2013. The patient had no illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions. Concomitant medications were not reported. The patient had not received any previous dose of FLUZONE ID.  On an unspecified date, the patient developed a hard bump at the injection site; size is smaller than a dime . No redness, no fever, and no other symptoms were seen. The patient's laboratory investigations and corrective medications was not reported. At the time of this report, the patient felt fine but was not recovered. Documents held by sender: none.  Follow-up received on 10 March 2014. No new information received.
Injection site became itchy; Injection site became itchy, red; Injection site became itchy, red and swollen; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Injection Site), VACCINATION SITE PRURITUS (Injection site became itchy), VACCINATION SITE ERYTHEMA (Injection site became itchy, red) and VACCINATION SITE SWELLING (Injection site became itchy, red and swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Seasonal allergy (Seasonal allergy uses Inhalers). Concomitant products included CAFFEINE, EPHEDRINE HYDROCHLORIDE, HERBAL EXTRACT NOS, POTASSIUM IODIDE, SODIUM BENZOATE (ASTHMALGINE) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore Injection Site). On 16-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site became itchy), VACCINATION SITE ERYTHEMA (Injection site became itchy, red) and VACCINATION SITE SWELLING (Injection site became itchy, red and swollen). The patient was treated with CORTISONE at an unspecified dose and frequency. On 17-Apr-2021, VACCINATION SITE PAIN (Sore Injection Site) had resolved. On 20-Apr-2021, VACCINATION SITE PRURITUS (Injection site became itchy) and VACCINATION SITE SWELLING (Injection site became itchy, red and swollen) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Injection site became itchy, red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included use of asthma inhalers.  The patient received treatment with cortisone cream on the injection site.  The patient's second dose was scheduled for May-2021.
pt recv vax 28FEB97 & devel low grade fever 3MAR97 that spiked to 103.7 R on 4MAR97;devel vomiting & diarrhea (gastroenteritis-like) sx 5MAR97;fever resolved 6MAR97;pt also devel cough 6MAR97;amoxicillin started 3MAR97;
Patient came in ...days after receiving multiple vaccines. c/o that she has some swelling on her hands and feet. She also has hives on her neck. C/O of joint pain on her arm and leg. BENADRYL 5ml given by oral children's medications and referred her to Urgent Care facility. Also received TB test when she came in but TB test result on 1/31/10. No signs of dizziness
3d after receiving ROTATEQ and IPV and DTaP vaccines - started with irritability, diarrhea, then fever and dehydration, admitted to hospital 11/9/10 (4d after vaccines) - eventually surgery for necrotic/ischemic jejunum, has TPV, double stoma. Weight loss, started to get fussy 11/6/10.
Patient had a seizure on 2/12/04. He was taken by ambulance to the ER. Temp was 102. Fever, cough, and cold started approximately 7 days after immunizations. No Rx for fever was given prior to ER visit. Patient released from ER that morning.
Developed infection the following week, possible appendicitis.  Currently draining infection to determine whether appendectomy is needed/when to perform surgery.
4 vaccines on Friday, 11/11/2003. On Monday morning (11/17/2003) patient's mother phoned and said that patient was not feeling well on Saturday morning and that he had swollen lymph glands under his left arm and on left side of neck.  Patient did not have a fever.
This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (Lot # M044347; expiration date 04-NOV-2018), (Lot # M047662; expiration date 02-DEC-2018), (Lot # N014366; expiration date 09-MAY-2019) for prophylaxis (dose and route not reported). It was also reported that the vaccine was reconstituted with properly stored diluent (Lot # unknown by reporter). The temperature was -14°C to -10°C for 257 hours and there was no previous temperature excursion. The call was made because of a data logger. Adverse effects reported and there was no PQC involved. This is one of several cases from the same source.; Sender's Comments:  US-009507513-1708USA003628: US-009507513-1708USA003629: US-009507513-1708USA011937: US-009507513-1708USA003631: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA003627: US-009507513-1708USA003630:
Received flu shot Oct 2014 it hurt but by December arm muscles hurt so much I told my doctor, I don't think they believe me now 15 months later I have half of movement back but I'm still limited on what I can do.
Acute Hives all over body.  Started out very slowly on left arm where I got both shots.  Couldn't get into dermatologist before going on vacation on 5/8.  They were getting worse leading up to vacation but then exploded there.  Was prescribed Hydroxyzine 10g 3x a day, that was after using xyzel and allegra over the counter.  Didn't make a difference and then hives went to eyes, ears and face so that's when I went to an urgent care iand got a prednisone shot and prescription prednisone, 20mg 2x day and famatodine 20mg 2x day.  This seems to have done the trick but I still have prednesone in my system.
BREAKTHROUGH COVID: FULLY VACCINATED  69-year-old female who was admitted to the hospital for COVID-19 and respiratory failure.  Patient was started on Decadron, remdesivir, and oxygen supplementation. Patient did very well during her stay.  She was quickly weaned off oxygen.  She did remain over the weekend for further monitoring due to her suspected COPD.  Patient was discharged in stable condition on June 13, 2022.  She will continue with a 5 day course of Decadron.
Chills; Nasty taste in her mouth/ She described this to be a metallic taste; She described this to be a metallic taste later on and stated she could smell it as well which was making her nauseous.; She described this to be a metallic taste later on and stated she could smell it as well which was making her nauseous.; Belching; This is a spontaneous report from a non-contactable healthcare professional. A 36-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration on an unknown date (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, during 15minutes waiting period after the injection the patient experienced chills and a nasty taste in the mouth. The patient described this to be a metallic taste later on and stated the patient could smell it as well which was making her nauseous. The patient also mentioned belching started after her vaccine. The patient denied difficulty breathing, difficulty swallowing, throat tightness, facial swelling, lip swelling and tongue swelling. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the events which included water and pepcid (MANUFACTURER UNKNOWN) and two lozenges to help with bad taste. Follow up response to treatment was good. The patient had complete resolution of symptoms within a few minutes of taking the pepcid 20mg solution. The patient was observed for another 10 minutes and the taste did not return. The patient was discharged, was stable to go home and advised to follow up with primary care physician (PCP). The clinical outcome of the events chills, nasty taste in the mouth, described this to be a metallic taste later on and stated the patient could smell it as well which was making her nauseous and belching was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Started taking Nyquil just so he could sleep; Feet and lower body started to get numb; Penis and anus doesn't work, can't control how much he urinates or defecates; Penis and anus doesn't work, can't control how much he urinates or defecates; Hasn't been able to get an erection at all; Had the sweats; Chills; Fever; Cough; Aches and pains; It was just like the flu; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: FC3182), via an unspecified route of administration, administered in the left deltoid on 20Sep2021 13:00 (at the age of 66-years-old) as dose 1, single for COVID-19 immunization. Medical history included allergy to shellfish (he swells up and his throat closes). The patient has no concomitant medications. The patient did not receive any other vaccines prior to the COVID-19 vaccine. he has never gotten the flu shot. He always makes sure to wash his hands and is pretty clean. He doesn't drink and he doesn't smoke. On 20Sep2021 13:00, the patient was off work so he got the COVID-19 vaccine. The patient reported that due to peer pressure, he got the COVID shot and thought it was not a problem. On 21Sep2021, he went back to work and he started feeling bad, had the sweats, chills, fever, cough, and aches and pains. It was just like the flu and he hasn't had that for 20 years. He has never gotten the flu shot. The patient was feverish and it was terrible according to him, he was having to go to be at 19:00. In Oct2021 (3 weeks after the vaccination), the patient's feet and lower body started to get numb. Also, his penis doesn't work and his anus doesn't work (as reported). He hasn't been able to get an erection at all. He never had problems with that before. The patient clarified that these symptoms (sweats, chills, fever, cough, aches and pains) all occurred on 21Sep2021 and that it all lasted for 3 weeks. He has completely recovered completely from all of these symptoms except for the cough. He still has the numbness and it has stayed the same. Then, the urine just drops out and he can't control it at all, he can't control how much he urinates or defecates, that started 3 weeks prior to the report (Oct2021). The patient thought that it would only last maybe a week. That is why he went to the pharmacy and he was told to report these events to Pfizer. The patient started taking Nyquil just so he could sleep. The patient did not visit the emergency room or physician's office since he didn't think the doctor could do anything about a reaction (what was he going to give him). The patient reported that he had gone for a physical and everything was fine and really good for his age. He is a pretty healthy guy. The outcome of events Sweating, Chills, Fever, Pain, Flu-like illness was recovered in Oct2021 (3 weeks after the vaccination) while the outcome of events cough and numbness of lower extremities was not recovered. The outcome of the remaining events was unknown.
Two days after getting the second dose of Pfizer, she woke with a migraine, possible low grade fever, body aches, and chills.  Symptoms still continue on day 4 post vaccine.
Initial report received from a nurse on 10 Feb 2011: This patient was vaccinated with only the MenCWY liquid conjugate component of MENVEO (batch number 100003) intramuscularly without being reconstituted with the MenA conjugate component on 03 Feb 2011. No adverse events were noted following this administration.
This spontaneous case reported by an other healthcare professional, describes the occurrence of urticaria (systemic hives and welts) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced urticaria (systemic hives and welts). At the time of the report, urticaria (systemic hives and welts) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-325440 (patient link).
Patient was given DTAP-IPV combo vaccine and it is for children 4-6 years old.  This patient was almost 15 months old at the time of vaccination.  No adverse symptoms were reported.
< 50 crusted lesion Pt. had fever for 2 days of 101 F.
Friday:  Very sore arm.  Saturday: arm was better but had aching body, chills, & headache.  Chills lasted about 2 hours, headache and aching body lasted until next morning.  Slept all day, very little appetite.  Sunday:  no more aching body or headache but little appetite continued and arm at the injection area was swollen and warm to touch.  That evening the arm started to itch.  Monday morning  (today):  arm still swollen, warm, and itchy.  Took 8 total tylenol capsules, 2 at a time, from Friday night until Saturday night.
Unfortunately also got COVID-19 despite 4 doses of vaccination as well as Evusheld, while on a cruise       vaccine given at facility, no lot number
This is a spontaneous report from a contactable consumer, who reported for herself and who was enrolled in a Pfizer-sponsored program; this report regards events part of the clinical course of the patient. A 76-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (unspecified manufacturer) in Aug2017 (as reported, however patient couldn't really remember) at single dose for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date she experienced flu and starting of pneumonia in one of her lungs, due to which was admitted to hospital from 05Jan2018 and released on 08Jan2018. The pneumonia was starting in her left lung. She went to the regular doctor first, she had a temperature of 105.9F. The doctor told her that she had to go to the hospital. It was checked her for flu which she had and X-rays of her lungs was done on an unknown date. Patient explained "she couldn't have the flu because she had the flu shot and the pneumonia shot, but she did have the flu". Patient was getting a little better every day but it was slow; events improved but were ongoing. Final outcome of the event was recovering. Information on the batch number has been requested. Pfizer is a Marketing Authorization Holder of Pneumococcal 13-Val Conj Vaccine (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in cases where another Marketing Authorization Holder of Pneumococcal 13-Val Conj Vaccine (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.
Itches at the left arm; Swelling at the left arm; Redness at the left arm; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PRURITUS (Itches at the left arm), VACCINATION SITE SWELLING (Swelling at the left arm) and VACCINATION SITE ERYTHEMA (Redness at the left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 VACCINATION SITE PRURITUS (Itches at the left arm), VACCINATION SITE SWELLING (Swelling at the left arm) and VACCINATION SITE ERYTHEMA (Redness at the left arm). At the time of the report, VACCINATION SITE PRURITUS (Itches at the left arm), VACCINATION SITE SWELLING (Swelling at the left arm) and VACCINATION SITE ERYTHEMA (Redness at the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     Patient was not tested positive for COVID-19  Patient did not have acute illness at the time of vaccination and up to month before. It was reported that there were no known drug allergies and no known chronic or long-standing health conditions.     On 30-Mar-2022 at 6:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported It was unknown whether the patient took any prescriptions, over-the-counter medications, dietary supplements or herbal medicines at the time of vaccination or at the time of adverse event. No adverse events were reported by the patient. The vial was initially stored in the refrigerator on 01-Mar-2022. The vial did not undergo any temperature excursions. No treatment medications were reported. This case was linked to MOD-2022-532165 (Patient Link).
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-JUL-2016, the patient was treated at a hospital for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient's guardian reports no adverse reaction or symptoms; child was 16 years old at the time of vaccination.
Employee reports receiving vaccination on 10/2/07. She reported local rash at site of injection to Occupational Health Services about 2-3 days later. Rash then developed on trunk and "top of legs" at about 7-10 days. Employee's PMD diagnosed rash as measles.  Rash was macular papular in presentation resulting in "red splotches" that resolved in about 3 days without treatment.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2022 as dose 4 (booster), single (Lot number: FP4544) at the age of 64 years, in left arm 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 included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Covid Rebound. then positive again starting 15Jul2022; (unspecified date) Negative, notes: Tested negative for 5-6 days; (15Jul2022) Positive, notes: then positive again starting 15Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Therapeutic measures included anti-viral treatment with Paxlovid with start date 06Jul2022 and stop date 10Jul2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.