chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US018868 is a combined initial spontaneous report from a pharmacist received on 23 Sep 2015 and on 24 Sep 2015 with a follow up information received from the health care professional on 09 Oct 2015. This report refers to a 49-year-old female patient. Medical history was not reported. Concomitant medications included alprazolam, ASTELIN, XOPENEX and SYNTHROID. She was vaccinated with FLUCELVAX (batch number: 173538, expiry date: 01 Apr 2016) intramuscularly on 11 Sep 2015. On the same day after vaccination, she experienced heart palpitations, internal shaking, throat tightness and lower face paresthesia. She experienced anaphylaxis and anxiety on an unknown date. The patient was currently monitored and was stable at the time of reporting. The final outcome of the events heart palpitations, internal shaking, throat tightness and lower face paresthesia was reported as complete recovery and that of other events were not reported. The reporter reported the events heart palpitations, internal shaking, throat tightness and lower face paresthesia as non-serious. The seriousness of anaphylaxis and anxiety were not reported. The event anaphylaxis was upgraded as medically significant based on the NVS-IME list. The causality of the events heart palpitations, internal shaking, throat tightness and lower face paresthesia was reported as suspected to be related to vaccination with FLUCELVAX. The causality of anaphylaxis and anxiety was not reported. Follow up information received from a health care professional on 09 Oct 2015: Updated patient demographics (initials, date of birth, height and weight), expiry date of vaccination, vaccination date, events (throat tightness, facial paresthesia, shaking), outcome, seriousness and causality.
No ADR Resident was scheduled to receive first dose of the primary series but received the bivalent Pfizer vaccine.
expired dose administered; no adverse events; This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient's pertinent medical history, concomitant medication, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, dose, route and anatomical location was unknown) of lot # R015740 with an expiry date of 02-DEC-2019 for prophylaxis which reconstituted with sterile diluent(MERCK STERILE DILUENT) (strength, dose, route and anatomical location was unknown) of lot# S005087 with an expiry date of 30-SEP-2021. No adverse events were reported. The outcome of expired product administered was unknown. No product quality complaint (PQC) was involved with this report.
Breast feeding; A spontaneous report was received from a 43 year old, female, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) while breastfeeding.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Dec 2020, the patient received her first of two planned doses of mRNA-1272 intramuscularly for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient called to report that she was breastfeeding. She reported no symptoms and consented to follow-up with safety or a health care professional.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, breast feeding, was unknown.; Reporter's Comments: This case concerns a 43-year-old, female patient. The patient's medical history was not provided. The patient reported that she was breastfeeding. The date of birth of the baby was unknown. The patient had an event of exposure during breast feeding after receiving the first dose of mRNA-1273.
VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 21-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513- 2106USA006480: US-009507513- 2106USA006481: US-009507513- 2106USA006482: US-009507513- 2106USA006483: US-009507513- 2106USA006484: US-009507513- 2106USA006485: US-009507513- 2106USA006486: US-009507513- 2106USA006487: US-009507513- 2106USA006488: US-009507513- 2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513- 2106USA006458: US-009507513- 2106USA006459: US-009507513- 2106USA006460: US-009507513- 2106USA006461: US-009507513- 2106USA006462: US-009507513- 2106USA006463: US-009507513- 2106USA006464: US-009507513- 2106USA006465: US-009507513- 2106USA006466: US-009507513- 2106USA006467: US-009507513- 2106USA006468: US-009507513- 2106USA006469: US-009507513- 2106USA006470: US-009507513- 2106USA006471: US-009507513- 2106USA006472: US-009507513- 2106USA006473: US-009507513- 2106USA006474:
This case was reported by a other health professional via call center representative and described the occurrence of nausea in a adult patient who received ENGERIX B (batch number XM59T, expiry date unknown). In May 2017, the patient received ENGERIX B. In May 2017, less than a month after receiving ENGERIX B, the patient experienced nausea, feeling hot and pain arm. On an unknown date, the outcome of the nausea, feeling hot and pain in arm were unknown. It was unknown if the reporter considered the nausea, feeling hot and pain in arm to be related to ENGERIX B. Additional details were reported as follows: This case was reported by medical distributor. The patient was also an employee. The age at vaccination was not provided. Limited information was provided by the reporter. This case was 1 of the 5 cases, reported by the same reporter.
Red, raised area on Rt arm the size of a "golf ball".  Warm to touch with "itching".  Denies pain.
10pm, headache, tired, dizzy, shoulder/upper arms ache 7am next day, headache, body ache, shortness of breath 12pm, fever, chills, headache, shortness of breath, overall body aching, tired
Information has been received from a 73 yr old male with hypertension who otherwise experienced good health and had no allergies who on 26Aug05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included hydrochlorothiazide (+) telmisartan (Micardis HCT) and simvastatin. On 27Aug05 the pt developed red blotches near the injection site. Unspecified medical attention was sought. At the time of the report the pt's red blotches were still present. There was no product quality complaint involved. Additional information has been requested.
The tinnitus, eye aches, nausea and vertigo from the earlier vaccines had simmered down. By the time I got this vaccine I was only suffering the eye pain and the tinnitus (which was getting better). As soon as I got this vaccine the tinnitus began again with an uproar and hasn?t abated much.
Pt received 2 immunizations (Fluzone Quad PF 2023-24-left arm & Shingrix-right arm). She was instructed that it is best to wait a minimum of 15 minutes prior to leaving. Around the 15 minute mark the pt approached the pharmacy saying she was experiencing dizziness, as well as her tongue & lips tingling. She was brought back into the imz room where we offered her Benadryl & offered to call EMS. Pt declined both. I then sat with & monitored the pt for an additional 15 minutes. The patient showed no worsening of condition & chose to leave. We informed her that if her condition worsened it would be best to go straight to the ER, and advised pt to have someone around who could monitor her condition at home. Pt said she would & also informed us she had an EpiPen on hand. Will call and follow-up on the patients status later today. Pt has had Flu vaccines in the past with no issue, so it is believed the reaction was due to the Shingrix vaccine.
TWO DAYS AFTER MY SHOT I GOT VIOLENTLY SICK WITH MASSIVE DIARRHEA, DIZZINESS, HOT/COLD SWEATS AND EXCRUTIATING PAIN AND ENDED UP IN THE ER
A report has been received from a Pharmacist concerning a patient, male subject, who had received nasal FLUMIST Quadrivalent.  FLUMIST Quadrivalent started on an unknown date. It was reported that the patient was inadvertently administered a dose of expired FLUMIST Quadrivalent. The outcome of the event of inadvertently administered a dose of expired FLUMIST Quadrivalent was unknown. The report was considered to be non-serious.
Soreness; Swelling; Redness; Itchiness; Fatigued or exhausted after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness), SWELLING (Swelling), ERYTHEMA (Redness), PRURITUS (Itchiness) and FATIGUE (Fatigued or exhausted after getting the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rash (Rash that has been coming before getting vaccine). Concomitant products included ROPINIROLE and MORPHINE for an unknown indication.    On 19-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 PAIN IN EXTREMITY (Soreness), SWELLING (Swelling), ERYTHEMA (Redness), PRURITUS (Itchiness) and FATIGUE (Fatigued or exhausted after getting the vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CAMPHOR, MENTHOL (SARNA [CAMPHOR;MENTHOL]) at a dose of anti-itch lotion (atopical creams); CORTISONE at an unspecified dose and frequency and COCONUT OIL at a dose of Coconut oil bath. At the time of the report, PAIN IN EXTREMITY (Soreness), SWELLING (Swelling), ERYTHEMA (Redness), PRURITUS (Itchiness) and FATIGUE (Fatigued or exhausted after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter said that she is calling back to provide a fax and email. Prefers to be contacted via email.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received: No new information.
Within first half-hour, began to feel dizzy; symptom remained much of the day. First day: Felt faint often during day vaccine was given; nausea; low-grade (99.4) temp; body aches. Day two: 100F fever (waned with Advil); severe body aches; lethargy; unexplained and brief nasal drip; mild sore throat; nausea and late evening, vomited once. However, was able to go on with day (had to) with Advil. Day three: Lethargy; body ache; chills; 99.3 temp (reduced with tylenol); nausea. NO PAIN AT INJECTION SITE.
Patient received Pfizer COVID vaccine on 3/1/21 and 3/26/21. On 10/5/21, patient was admitted to our facility with acute hypoxic failure due to COVID pneumonia (COVID positive). Patient received tocilizumab (10/9), remdesivir (10/5-10/6), and dexamethasone (10/5-current).  Patient transferred to CCU on 10/9 and intubated today (10/12).
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE DVT, UNSPECIFIED VEIN
Extended tenderness in vaccination site (remains 4 days post). Swollen and tender armpit (most swollen 2 days after, went down slightly on day 4).
Evening of the day ZOSTAVAX was given pt. noted itching, redness about silver dollar size and area firm. Felt tired next day no fever. No respiratory problems. 3-16-11 at 12:30pm took BENADRYL came to office. Redness 35-40mm. firmness slightly smaller. Warm to touch. Pt. said area felt hotter earlier. Called 3-17 AM pt. stated decrease in redness and swelling. BENADRYL & ice have helped.
On Fri 3/5 one of the RPhs on duty administered the vaccine around 2:45 PM. RPh advised patient to wait in the waiting room for 15 minutes to make sure she felt fine. Around 3 PM patient told another patient sitting in the waiting room that she was feeling light headed and told her to call the pharmacy staff, which she did. One of the RPhs went out of the pharmacy into the waiting room to check up on her while the other pharmacist called 911. RPh who went to check up on her found her on the floor slouching. RPh tried to shake her awake and she appeared nodding off and on. Finally after a minute of two, she became more coherent and conscious. Team member grabbed orange juice to give to her. Other patient who grabbed our attention stated she was slowly sliding off her chair. RPh stayed by her side until paramedics arrived. Although she marked "No" on Section B #5 on the VAR form, she stated that she gets light headed and dizzy whenever she gets blood drawn or at the dentist. Paramedics checked on her vitals, was within normal range. Patient opted not to be taken to the hospital. RPh advised patient to call a  family member to pick her up because although she felt ok to drive, she stated she felt a little nauseous and her head kind of hurts. Mother picked her up about an hour after the incident occurred.
Severe fatigue for about a week and a half - ( I do have periods of fatigue because I'm disabled) - but this was unbelievable fatigue. One day, I was in bed the whole day - maybe the 25th. On 22nd and 23rd, I wash having hopeless and crying - which is unusually for me. On 24th, I started feeling better. I talked to my psychiatrist - I had my thyroid meds changed on 13th  (Levythroxine) and dr thought it was the meds and he wanted me to see Dr. - who was my primary care at the time. I saw Dr on the 26th of May. When I saw the doctor, on 26th,  I had been  starting to limp and my joints were swollen. I do have problems with my joints but this has been more than usual. Now after the vaccine, anything I do, I do have to ice my knees when I come home. And when I sit Indian style my knees are going to hurt really bad. And occasionally my kneecap comes out of joint. It usually has to do with if I twist too much. It  usually only happens a few times a year but now it is happening really regularly. Even when I sleep at night. Range of motion with my knee - there will be a moment when it comes out of joint and floats. A couple of years ago when I had  severe reaction  - immunosuppressant - I'm not on this now and haven't been for the time during the pandemic. But when I took that - a couple of years ago, within 10 minutes my joints were stiff and it was hard to walk. And so these symptoms I'm experiencing now is a bit similar to that as far as muscles and joints. I've had more pain. One of the other symptoms I've had with the vaccine, is a more intense allergy reactions when have exposure to one of the things I'm sensitive too. Dr said I was having the symptoms of hypo-thyroid and hyper-thyroid. Thyroid tests completed. Will see dr on the 10th to get the results. I think this is an auto-immune flare. I do have a pain log that I've been that I've been keeping if that would be helpful. I can send that to you.
Initial unsolicited report received from Health care professional on 29-May-2018. This case involves female patient (age also reported as less than 1 year as 2m, 4m) who was vaccinated with an 0.5 ml once expired dose of MENACTRA (batch number- U54642AA, expiration date, dose, dose in series, route of administration was not reported) in right deltoid on an unknown date. Medical history were not reported. No other vaccines used. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event occurred. 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 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. Documents held by sender: none.
After the vaccination my airway was tightening and chest tightness and coughing. When i coughed it was really bad i still have th ecoughing the doctor prescribed the medicine and steroids it is a little better but i still have the symptoms.
Significant throbbing pain in right shoulder joint (not muscle) for 2 days.  Difficult to sleep.  Has since stopped throbbing or hurting when sleeping, but right shoulder remains very weak and there is discomfort in reaching for items across my body (e.g. fastening seat belt), over my head, and out in front of me.  Some days there is more pain and weakness than others.  Almost every day stiff and painful when waking in the morning.  Only treatment to date has been rest and ibuprofen.  Have not yet gone to the doctor, although did e-mail the doctor first 2 days in light of the significant joint pain.
Patient came in for his first pfizer shot, but the pt stated that he received his J&J vaccine on 4/6/21. Patient stated that it's his first covid vaccine but he changed his words after getting the pfizer vaccine.
Pt cried & held ears for almost a wk following both the 1st & 2nd dose of HIBTITER;
Inconsolable crying x 2 nights would only quiet x 5 mins-high pitched crying per mom; PE-nl on 17APR92;
Awakened by fever at 2:00 AM, took Tylenol, returned to bed.  Temp at 07:30AM was 101.5, c/o sore injection site and chills/achiness.  Took a nap, returned to urgent care at 4:34 PM, temp was 102.4. given Tylenol 650mg. Lab work done, WBC 6.7.  (She is on Augmentin for the dog scratch.)
14:55 Called to pt lying on ground sleeping, c/o DIB with back pain and sharp pains in my body, unable to stand, denies any LOC, face and chest erythematous, no hives. 15:50 no DIB at this time and pain pain cont'd. Benadryl 50mg IM left GM, fluids and rest for 2 days.
Pt. states received 2nd Moderna 04/16/2021 vaccine, and 06/03/2021 waiting with menstrual period symptoms (includes bleeding), lasting 3 days, experiencing another 07/06/2021 3 day period of discharge and discomfort. 06/13/2021 Primary visit and ordered monthly check-in/ 07/13/2021 appt. with physical exam (Ultrasound- Internal) no results noted. A1C down 6.5  Recommendation for an appt. with OBGYN (date unknown).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 04-JAN-2014, the patient was inoculated with the ZOSTAVAX vaccine at a local health department as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 03-FEB-2014, the patient was treated by a physician for a vesicular outbreak which was diagnosed as shingles. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of 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. The outcome of the events was unknown. Additional information has been requested.
Bad Diarrhea; His stomach feels a little queasy; This spontaneous case was reported by an other caregiver and describes the occurrence of DIARRHOEA (Bad Diarrhea) and NAUSEA (His stomach feels a little queasy) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced DIARRHOEA (Bad Diarrhea) and NAUSEA (His stomach feels a little queasy). At the time of the report, DIARRHOEA (Bad Diarrhea) and NAUSEA (His stomach feels a little queasy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Patient received a 4th dose of COVID vaccine on12/16. Previous doses were on 2/23/21, 4/26/21, and 11/17/21. No adverse events reported by patient or caregivers.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient might have received one of the improperly stored vaccines: either ROTATEQ oral liquid, lot number: M019691, expiration date: 02-NOV-2017 (dose was not reported) or PNEUMOVAX23 injection, lot number: M022085, expiration date: 09-OCT-2017 (dosage and route of administration were not reported). The reporter was not sure which of the vaccines the patient could have received. No adverse effects were reported. The vaccines experienced temperature excursion of 32-35 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous excursions reported. Digital data logger was used to record the excursion. There was no product quality complaint involved in this case. Additional information has been requested.
Feelings of Nausea, headache, restlessness, unable to concentrate, skin rash, swelling down arm, itchiness.
Seizure (pt has hx of seizures but have been well-controlled for years until this occurrence).
Emp states received Flu vaccine approx 1045 and slowly noticed she was itchy. At 2:30 emp was itchy to face, neck, arms and head. Neck and upper arms became reddened and blotchy. No respiratory symptoms. Benadryl 25 mg po given at 3:40 pm rechecked emp at 4:46 symptoms resolving itch was almost gone and redened areas disipated to pink.
Hot, red, area from top of shoulder to just before elbow - localized swelling (left arm only).
One week after vaccination, blister and hives on both legs were yellow outlined in red, some scabbed, fever of 103 rectally, was advised to put hydrocortisone cream on sores. Fever 4 days blisters 5 weeks to heal completely with scarring. No tests done-doctor unsure of diagnosis.
Arm turned hard, red, slight rash and itching.  Upper arm and neck hurt.  Getting better after a few days.
Fever@12am 1/14/21 thru 1/15/21 took tylenol  Body aches started @8pm 1/13/21 Chills started @12am 1/14/21 Headache @8pm 1/13/21 thru 1/15/21
p/vax pt rpt urticaria on arms; legs & trunk w/severe itching; self-medicated c/ OTC benadryl; then sought MD attention;
Narrative:  66yo female died inpatient at hospital MICU on 12/23/2021. Death was caused by: Pneumonia, Acute hypoxic respiratory failure, septic shock (COVID NEGATIVE). Patient was terminally extubated per family's wishes..Pt had received covid vaccines on 3/15/21, 4/12/21, & 11/8/21. Death is not related to covid vaccines.
It is now day six and I have dizziness and vertigo.   Today is day six and this morning my ears feel clogged as well. The symptoms are not getting better. I did have the flu shot at the same time in the same arm.   I had no symptoms with my first 4 shots accept slight arm pain for a day.
Patient was 18 days prior to 18th birthday, ineligible for Janssen as per EUA