chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was supposed to be giving regular scheduled 15 mos immunizations but I gave the patient the 2nd dose of the MMR which is usually given at 4-6 years. along with the varicella vaccine which both doses are usually given at 4-6 years of age, this was the patients second doses of the vaccines. I talked with the provider over seeing the patient and provider stated no harm would come to patient. She stated they got there second dose earlier than at the normal scheduled time.
Fever 101+ for two days, severe aches in hips and pelvis, loss of appetite, loss of energy which is continuing.  Intestinal upset  which is continuing.
Dose of Dtap-Polio not infant formula as of this report, chills has experienced some fever, o other reported symptoms
shaking; sweating; numbness in legs; Liver enzymes high; shortness of breath; Headache; vomiting; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 13:30 (at the age of 51years) as dose 1, single for Covid-19 immunization. Medical history included high blood pressure, CRPS (complex regional pain syndrome), fibromyalgia, migraines, osteoarthritis, and known allergies: most antidepressants, arthritis meds. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included lisinopril (LISINOPRIL) and pantoprazole (PANTOPRAZOLE); both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 (15:30), the patient experienced headache, vomiting, shaking, sweating, numbness in legs, shortness of breath, liver enzymes high. The patient had 2 trips to ER (Emergency room) and numerous tests. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was treated with IV's (intravenous-as reported) and vomiting medications so far. The patient had a Covid test post vaccination. Covid test type post vaccination: Nasal Swab on 20Mar2021. Covid test result: Negative; Covid test date:03Apr2021; Covid test type post vaccination: Nasal Swab; Covid test result: Negative. The outcome of events was not recovered.
Case received from a healthcare professional in the USA on 22/Nov/2005 via the MIS/VIS under the reference number 05-0699. This case is included in a cluster of 5 cases and is linked with an 08 year old male patient with no medical history noted had received on 05/Nov/2005 an intramuscular dose of influenza vaccine (Fluzone), batch number U1819AA in the deltoid and 2 days later, i.e. on 07/Nov/2005 he experienced redness and swelling from deltoid to back beyond shoulder and down to elbow with injection site warmth to touch per he mummy. The patient was recovered on unspecified date.
2 episodes "limpness" questionable apnea occurring w/in 15 minutes of each other & assoc w/fever 104;
Rash (macular patch approximately 5 x 6 cm over (R) and 5 x 5 cm over (L)) over extensor aspects of upper arms.
With 2 minutes following MMR vaccine client develops 3 hives 1/4 inch lateral of MMR site on right mid anterior thigh above knee. Hives converge to 1/2 centimeter hive. Client remains alert active, good color, no respiratory distress or signs of hives elsewhere. Mom remains with at clinic for 20 minutes hive recedes, spot is mildly red. Instructed to call or have seen emergency if symptoms return.
Patient felt tired and body felt sore several hours after vaccines. Her left arm hurt and she couldn't lift it easily. The next day her left arm became red and swollen starting at injection site. The swelling moved down her arm and onto the inside of her arm, while the swelling and redness on shoulder stopped.
I am very healthy, exercise, eat properly. I developed Bell's Palsy, which is now Facial Paralysis, high blood pressure, nose bleeds.
After 18 days of vaccine I feel itchy body and cramp legs at night. Also I still feel soar throat and stuffy nose.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 02-MAR-2018 the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
She started her menstruations and they was extremely heavy she was dignosed with Endometriosis and had to have her appendix removed because they have ruptured.
This spontaneous report was received from a certified medical assistant, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored GARDASIL 9 (lot # M009378, expiration date: 23-APR-2018; lot # M009378;  expiration date: 07-APR-2019). The vaccines were exposed to 32 degrees F to 35 degrees F for 8 hours. No previous excursions. A data logger was used. No adverse effects were reported.  This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA007389: US-009507513-1703USA007409: US-009507513-1703USA007408:
FAINTED AND FELT LIGHT ENDED POST VACCINE, ALSO FELT NAUSOUS
Narrative: Pt presented with tachycardia with n/v upon receiving his second dose of the COVID19 vaccine. Physician assessment upon presentation to ED states "77 yr old male who presents in atrial flutter/atrial fibrillation after receiving COVID-19 vaccine". Pt was found to have Aflutter with 2:1 AV block from ECG and physician's plan states that "while symptoms started after receiving a second dose of COVID-19 vaccine patient has no evidence of anaphylaxis including respiratory symptoms, difficulty breathing, no rash or hives or other cutaneous symptoms". Pt was admitted for cardiology and monitoring.
2 weeks after 2nd injection  6/2/2021 I presented in the ED with a red rash on my legs and blood lesions in my mouth with nose bleed. I was admitted to hospital with ITP blood platelet count 4000. After 3 infusions of platelets with no improvement they did a steroid and IVIG. My platelets went up to 51000. After 5 days in hospital they sent me home. Two days later on 6/8/2021 I started having the mouth blood blisters lesions again went back to ED where I was admitted again.  They gave iv steroids in ED.  On 6/9/2021 gave 65mgs of oral steroids and did a IVIG treatment platelets went up to 26000.  On 6/10/2021 continued 65mgs of oral steroids another treatment of IVIG and platelets are at 36000. Not what I or the doctors were expecting we were expecting a higher number. So now 6/11/2021 still in hospital with no answers.
PAINFULL TO THE TOUCH SWELLING ON RIGHT ARM ABOVE ELBOW.  RED RASH.
This case was reported by a consumer via other manufacturer and described the occurrence of injection site erythema in a male patient who received SHINGRIX for prophylaxis. On 4th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIOX, the patient experienced injection site erythema, injection site swelling, injection site itching and nocturnal awakening. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site itching and nocturnal awakening were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site itching and nocturnal awakening to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The batch number and expiry date was unknown by the reporter. The patient experienced red swollen and itchy arm after being vaccinated with SHINGRIX. The patient also reported that this had been waking him up at night and was not able to clarify further. No further information was provided.
No adverse effect; patient received improperly stored VARIVAX; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 20-AUG-2019, the patient was vaccinated with vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # r019237 with expiration date on 04-JUL-2020, or S005078 with expiration date on 19-FEB-2021 (dose and route of administration were not reported) for prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) was mixed with properly stored sterile diluent.    The vaccine underwent a temperature excursion of -14 (-9.74 C) to -10 degrees Centigrade. The timeframe was unspecified. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.
shingles; This is a spontaneous report from a contactable other healthcare professional (patient).  This other healthcare professional reported same events for two patients (patient himself and his mom). This is the first of two reports.  A 47-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 01Apr2021 09:30, at the age of 47-years-old, (Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation.  Medical history included testicular cancer - currently in remission, and penicillin allergy.     The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2, lot number: EN6202, on 11Mar2021 08:30 AM on Left arm. Prior vaccination, the patient was not diagnosed with COVID-19. On 04Apr2021 02:00 AM, the patient experienced extremely painful headache (just on the left side) and congested ear ache on the left side, red bumpy rash on scalp and forehead extremely sensitive to touch and painful on scalp. Then on a follow-up call, the patient reported he was calling because he had to go to the ER. He was diagnosed with shingles after his COVID dose which was whole a new adverse events and his mother also went in for her second dose on Tuesday she also got shingles. Patient also added, Is there anything in regards to compensating for ER visits or kind of stuff or no and he has to go to the ER due to being diagnosed with shingles, is there anything monetarily Pfizer can do to compensate for having go to the ER. Is there any way applying for the reimbursing of money to put out that he has to go to the ER? Since the vaccination, patient has not been tested for COVID-19. The outcome of the event was not recovered. Treatment includes acyclovir.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021443896 same reporter/drugs/events; different patients
Rash: popular. Lesions on belly, chin, none on hands or feet, single one on lower back
Vaccine may have been compromised due to temperature excursion event. Report has been filed with Pfizer and we are waiting for a response. No reaction reported from patient.
Mom States child started becoming grouchy. Appetite decreased. Few days later noticed left side of face/jaw swollen. Went to Doctor-who was sure was mumps from vaccine. Has had no fever-swelling now almost gone-states patient feels fine now.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Nausea-Mild, Additional Details: Upon pt reported tachycardia/"pounding heart," RPh went out to vaccine waiting area and checked pt's vitals. BP came out 128/87 and pulse was at 86. Offered pt some water and advised to relax. Closely monitored pt every 3 minutes for initial 15 minutes and had a conversation. Pt requested to recheck her vital, and it came out 125/81 and pulse was at 75. Monitored 15 more minutes and got confirmation from Pt directly that she's ok to walk/leave.
Case previously recorded as MA2009-4220. Initial case report received from a Nurse via MedComon 11 NOV 2009. Patient below 4-year-old was vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102046P1) i.m. on 10 NOV 2009. MedCom reference no.: NA09-008010.
No adverse effects COVID 19 vaccine given >12 hours from drawing. Vaccine was drawn, stored in refridgerator overnight. given to patient the following afternoon. Manufacturer notified. Awaiting guidance re. patient.
Lot numbers not available for vaccines. Pt died on 9/12/2021 of aspiration pneumonia and respiratory failure. This is not a covid related death
Two weeks after booster, experienced weakness, extreme fatigue and cognitive difficulties/brain fog.  Passed out on 11/11 and taken by ambulance while non responsive, to hospital where I stayed 8 days.  Transferred by ambulance to hospital where I remained for 11 days and was diagnosed with MIS-A.  I was treated with antibiotics and steroids for organ involvement/infection.  High fever, breathing difficulty, immobile due to weakness.
The pt experienced hive like rash over trunk, legs and arm that was itchy. Both ears were red and swollen for 48 hours. Treated with Benadryl. Pt took 6 doses.
The pt was presented to the ER on 10/9/00 in cardiopulmonary arrest. This occurred 6 days post vax. A full autopsy was performed and cause of death is SIDS.
Patient turned pale. felt nauseous, and broke out in a sweat for approximately 5 minutes. Patient almost passed out. *As her mother, I believe the long-term benefits of this drug far outweigh the risks.
Initial unsolicited report received from a pharmacist on 20-May-2017. This case involves 18-year-old female patient who was vaccinated with a dose of YF-VAX (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 18-May-2017. The patient's medical history including illness at time of vaccination and the pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. The concomitant medications were reported as vaccination with a dose of Vivotif (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was also reported that Vivotif have not lot number since was not administered at reporter's facility. On 18-May-2017, same day following the vaccination, the patient had experienced red, itchy and hard area at injection site. On 20-May-2017, two days following the vaccination, the patient had experienced fever and dizziness. The lab data and corrective treatment were not reported. The outcome of all the events were unknown. List of documents held by sender: none.
Sour/Salty/Bitter taste and/or drainage in right side of mouth. It is constant over 24 hours never leaves. Note received Flu shot on same day at same location but they were approx. 1 hour apart.
Palpitations (had to start taking a medication to control)  Also, left breast tenderness & leaking from nipple. Saw specialist & had ultrasound down.  I still am having issues.
10AM vax given APAP given-slept 30mins-45mins; @ 1PM-2-4PM crying doesn't want to walk on leg; crying inconsolably; 420PM phoned mom pt walking & eating now; 2APR95 mom states pt fine;
They came to the house in the morning, gave my mother the second jab, later that day she had to go to hospital shortness of breath, died in hospital two days later.
Received mandatory vaccine noticed redness and itching that haven't resolved; placed warm compress without relief.
I administered the Janssen COVID-19 vaccine to Client in the deltoid muscle of the left arm. She was seated in our observation chair when the friend she was with asked for a trash can because she was feeling nauseous. He stated that she has a phobia on needles, and nausea was common. I went back into the pharmacy after giving her a trash can. I then looked over at the observation chair and her friend stated she was going to pass out. She became stiff and arched back in her chair for a few seconds before slumping forward.  We called EMS while placing an ice pack on the back of her neck. Once the ice pack was in place she became more alert and oriented. She vomited. We placed her laying down on her side until EMS arrived. She was alert and oriented at this time.
This case was reported by a physician via sales representative and described the occurrence of serum sickness like symptoms in a 7-day-old subject of unspecified gender who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). On an unspecified date the subjects received 1st dose of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced serum sickness like symptoms and hive. The sales representative stated the physician reported a 7-day old subject received Hepatitis B vaccine (unknown manufacturer) and developed hives and serum like sickness after the dose. The subject has also seen an allergist regarding these issues. At the time of the report no additional information was available. At the time of reporting the serum sickness like symptoms and hive were resolved.
Patient came in for 2nd dose in a 2 dose series 31 days after the first dose was given. The dose was given and the error was realized by me a few minutes after giving. Called patient back to pharmacy to explain the dose was to be given 2-6 months after the first dose. Explained it had only been 31 days. Told pt I would document error, explained this is not in the guidelines to give this early. Asked patient and his wife to monitor for any adverse reactions, such as fever, body aches, headaches, if any reaction may occur to call pharmacy immediately or seek appropriate help.
This spontaneous report as received from a Licensed Practitioner Nurse refers to a patient (age and gender not reported) who on 27-JAN-2015, was vaccinated with an expired ZOSTAVAX (Lot No. J013451, exp. 24-JAN-2015), 0.65 ml, subcutaneous in the left arm. No adverse effect has been reported. Additional information has been requested.
Warmness; Severe itchiness; Soreness of the injection arm; Swelling; Redness of one to one and half inches in size; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmness), VACCINATION SITE PRURITUS (Severe itchiness), VACCINATION SITE PAIN (Soreness of the injection arm), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness of one to one and half inches in size) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmness), VACCINATION SITE PRURITUS (Severe itchiness), VACCINATION SITE PAIN (Soreness of the injection arm), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness of one to one and half inches in size). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. On 18-Feb-2021, VACCINATION SITE WARMTH (Warmness), VACCINATION SITE PRURITUS (Severe itchiness), VACCINATION SITE PAIN (Soreness of the injection arm) and VACCINATION SITE SWELLING (Swelling) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness of one to one and half inches in size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-036518 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.  Vaccination site pain, vaccination site erythema, vaccination site pruritus and vaccination site swelling are consistent with the product safety profile.
suspected vaccination failure; shingles, Dr said it was the worse case he'd ever seen; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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 unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got shingles vaccine and got shingles. Doctor said that it was the worst case he had ever seen. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Case number PHEH2014US024290, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 15 years old female patient. Her medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 05 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration. No further information was provided. Follow up received from nurse on 21 Jan 2015: updated site of vaccination and reporter comment.
Severe throbbing headache, which lased until visit with doctor on 4/6/2021.  Received Toradol injection, Thigh.  Headache tapered off, then resumed one week later.  Doctor ordered a prednisone taper, which ended the headache.  Also, had a two week abdominal rash, beginning  2/27/2021 which was treated with Clobetasol Propionate .05% to resolve severe itching.