chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a field employee via pharmacist refers to an approximately 68 year old female patient with diabetes. No drug reactions or allergies, no other medical history was provided by the reporter. On an unknown date the patient was vaccinated with ZOSTAVAX (route of administration, anatomical location, lot number not reported). No concomitant medications were reported. On an unknown date the patient experienced shingles after receiving ZOSTAVAX. The patient's husband informed reporter on 27-APR-2014 that the patient experienced a good dose of shingles. Lab diagnostic studies were not provided by the reporter. It was reported that the patient received multiple unspecified prescriptions for treatment of pain and rash, from unspecified healthcare provider. The outcome of shingles/good dose of shingles and pain was not reported. The patient sought medical attention via contacting unspecified healthcare provider. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Right anterior thigh developed an 8x8cm red, raised, sl tender mass 1/2 d after injection at injection site. Resolved without antibiotics.
This spontaneous report as received from a pharmacist refers to a 68 year old female patient with high cholesterol and without any drug reactions or allergies. On 28-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous injection, lot # K009772, expiration date 09-OCT-2015, dose and frequency were not reported). Concomitant therapies included VYTORIN, meloxicam (manufacturer unknown) and zolpidem tartrate (manufacturer unknown). On 29-NOV-2014 the patient experienced redness at the ZOSTAVAX injection site. On 30-NOV-2014 the patient experienced swelling and warmth at the ZOSTAVAX injection site. Patient sought medical attention by calling the pharmacist. No laboratory tests were performed. No treatment was given for the adverse events. The swelling resolved on 02-DEC-2014. The outcome of redness and warmth at the ZOSTAVAX injection site was reported as recovering/resolving. Relatedness between swelling, redness and warmth at the ZOSTAVAX injection site and ZOSTAVAX was not reported. Additional information has been requested.
Rcvd. phone call 5/28/10 that she (pt) was diagnosed with GBS 1 1/2 mo. ago (Definite Dx) by neurologist. Symptom onset was 11-11-09 after CABG x 4. She stated it took so long to confirm Dx of GBS because they thought was due to CABG. Definite date of Sx onset reported by pt.
Approximately 2 hours after vaccination was received, employee stated she had hives on her abdomen. No swelling to face and no difficulty breathing were noted.
January 26, given clean bill of health by cardiologist heart was functioning well; February 5, COVID-19 Shot; Feb 9 -- fell and broke left humerus neck, no real treatment except for sling; Various dates during February and March, passed out when standing up, no treatment; March 22nd, admitted to a Medical Center with Heart failure and Pneumonia, treatment antibiotics, diuretics, released on March 31 with prescriptions for beta blockers, diuretics and potassium; April 4, passed out again, EMT read my BP as 41 systolic, readmitted to hospital, fluids added.  Discharged April 6th.  Advised to use caution when moving around, limit fluids, take beta blocker and potassium.
Started with a rash on his chest, fine without lesion. Maculopapular lesions erupted on 6/19/2016. Diaper dermatitis started 6/23/2016 which became severe with areas of bleeding. Seen in clinic 6/24/2016. Nausea, vomiting and 103 degree fever started overnight of 6/25-6/26. Took to emergency room, stool culture ordered results pending.
moderate chills; body pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHILLS (moderate chills) and MYALGIA (body pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced CHILLS (moderate chills) and MYALGIA (body pain). At the time of the report, CHILLS (moderate chills) and MYALGIA (body pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No relevant concomitant medications were reported.  No treatment was reported.
First dose of series on 30Sep2020, but did not receive second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (might received 1st dose on 30th September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Pharmacist reported that, the patient presented to the pharmacy with a prescription for 2 dose Shingrix series.   Records indicated that, the patient might have received 1st dose of series already on 30th September 2020, but patient did not receive second dose.   Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. Pharmacist stated that, the record was from a clinic and did not include a lot number or expiration date, so she was not completely sure the dose was administered.   She would follow up with the clinic to verify. The reporter consented to follow up.
During the middle of the night, fever, headache, chest pressure/shortness of breath.  By early morning the following day, severe dizziness and fainting.  Felt like orthostatic hypotension.  Could not even sit up in bed without blacking out.  Lasted for hours until about midday
This case was reported by a nurse via call center representative and described the occurrence of seizure like phenomena in a 20-year-old female patient who received HAVRIX (batch number 9S54N, expiry date 24th July 2017). On 24th July 2017, the patient received HAVRIX. On 24th July 2017, immediately after receiving HAVRIX, the patient experienced seizure like phenomena (serious criteria GSK medically significant), fainting and stiffness. On 24th July 2017, the outcome of the seizure like phenomena, fainting and stiffness were recovered/resolved. It was unknown if the reporter considered the seizure like phenomena, fainting and stiffness to be related to HAVRIX. Additional details were provided as follows: The patient had a seizure like symptoms and was described as, she fainted, her body stiffened and she started to slide off the table. The patient regained consciousness within minutes. The patient was examined by the primary physician in the practice and no hospitalization or medical intervention was required.
Hospital employee given influenza vaccine, then went home. Injection site became red, hot, raised (about 3 inches by 4 inches). Reported to infection control nurse on 12/12/2001. Still red and hot.
Patient called clinic AM on 2/28/07 to report that arm was reddened and tender. Declined office visit on 2/28/07. Was on her way out of town and would apply intermittent ice pack and take Tylenol prn. Will come to clinic 3/1/07 if no better or has questions when she return to town. Will seek treatment out of town 2/28/07, if worse.
Immunized L arm on 2/2/03. Pt states starting having s/s on 2/3/03-reported to MD via phone call on 2/5/03. Reported L field neck swelling with difficulty swallowing and severe pain in L arm, neck and throat. Denied SOB, (+) constant cough with slt fever. Seen at immunization specialist. Dx with mild upper resp. infection incidental to smallpox vaccination. Mild adenopathy. Missed two days of work-non narcotic meds given by ER MD.
5/19/05 DTaP, IPV administered in right arm. Arm began to redden and swell that day. 5/20 developed fever > 100 degrees F. Now arm swollen, red, and tender. Good ROM and pulses right arm and hand. Treated with cool compresses and Benadryl ever 4-6 hours, RIC increase syrup.
11/21 stuffy heald,cold symptoms,11/22 achy joints,low grade fever,11/23 severe dizziness, nausea, vomiting, had to be carried out to car to go to Dr. Dr. came out to car to give phenergan IM and meclizine tabs, went home & slept. 11/24 nausea better, dizziness & headache remain 11/25 some improvement in dizziness until 11/27 could walk but headache continued until 11/28 and felt fine 11/29.
I received my Pfizer booster at 1245 in the afternoon. I felt tired that night with sore left arm. At 0500 on the following day 12/28/2021 I had chills and pain at arm, under left arm and down left arm. I showered and went to work; it was too late to call off. As the day of work progressed, I ran fever 100.8, I took Tylenol. Arm started to have a reddened area below the injection point. I am an ER nurse and a doctor said what's wrong with you. I said I had my booster and felt a bit rough. I then said can you look at my arm. I showed my arm and they said hmmm, we need to keep an eye. I believe this is either cellulitis or a reaction. I put ice pack at arm site and continued to work taking Motrin 400 mg every 4 hours. Upon getting home I showered, went to bed with 102.1 temperature, redness was increasing I marked it with a pen. Went to work the next day after doing a covid test to ensure the experience I was having was vaccine versus covid related. I tested negative for covid every other day. I was experiencing shortness of breath and heart palpitations; I was uncomfortable. I went to work because we are so short staffed, and I told my manager I was unwell. I again had the doctors see my arm and they said its worsening so let's start you on Keflex. I received an RX for Keflex and started to take. The reason we were feeling unlikely cellulitis is that the redness that wrapped around my arm was below injection site. Overall, these were my symptoms after booster: Fever, headache, body aches, chills, redness at injection arm as well as underarm and under left breast, shortness of breath and heart palpitations. I did not feel resolve till 12/31/2021. My arm still is not perfect, but it has very much so resolved.
pt recvd vax & p/3rd dose had tiny red papules lt forearm & rt leg; pt was dx w/scabies; 30DEC92 & 3JAN93; pt recvd 2 prev doses of Engerix-B;
Two days after receiving my 2nd dose, I began noticing a rash on my stomach that initially appeared like hives. The rash then turned into small red bumps all over my back and stomach the next day. It is one week later and the rash is still extensive (now on armpits, neck and mild on legs). It itches slightly but not bad.  I have tried hydrocortisone cream and Benadryl without much benefit.
shingles; This is a spontaneous report from a non-contactable consumer (Pfizer employee). A female patient of an 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) at 2nd dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. After the patient got her 2nd Pfizer vaccine for Covid, she got shingles, and she thought they were related. Outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant medication were not provided. Nurse practitioner reported that the patient received their first two doses of GARDASIL on unspecified dates and received their final dose in the series 7 years later on an unspecified date. The final dose give to complete the series was GARDASIL 9 (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Patient began having chills, patient's mother noticed she was burning up. Patient went non  responsive for approximately 1 minute during which her eyes rolled back. Epinephrine was not administered due to patient becoming responsive with no difficulties breathing. EMS was called and patient left under her own power. Patient declined EMS transport to hospital.
Get the shot shingles/suspected vaccination failure; shingles; most painful thing ever; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a adult 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got Shingles, the most painful thing ever after vaccination . This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Unknown amount of time with a minimum temperature of 24.9°F with no adverse event; vaccines were administered post-excursion with no adverse event; Initial information received on 27-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom vaccines was administered post-excursion with no adverse event and Pneumovax,  meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] was kept at unknown amount of time with a minimum temperature of 24.9°f with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date it was reported that vaccines was kept at unknown amount of time with a minimum temperature of 24.9°f with no adverse event (product storage error).  On an unknown date, the patient received a  dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine, Solution for injection, (lot U7483AA, Expiry date; 20-Oct-2023) via unknown route in unknown administration site and patient received a  dose of suspect PNEUMOVAX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for Prophylactic vaccination was administered post-excursion with no adverse event (poor quality product administered) (unknown latency)   Action taken : not applicable.  Outcome : Unknown.  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 the guidelines. 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.; Sender's Comments:  01164014: 01164336:
pain at injection site; Chills; Headache; Fatigue; body aches; woke with a clogged ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization, reaction(s): "pain at the injection site". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at injection site"; CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; PAIN (non-serious), outcome "unknown", described as "body aches"; EAR DISCOMFORT (non-serious), outcome "unknown", described as "woke with a clogged ear".  Additional Information: Is Pfizer Covid-19 vaccine a Pfizer product: Unspecified. Pfizer Covid-19 vaccine manufacturer was unspecified. Dates for Pfizer Covid-19 vaccine were Unspecified. NDC number and Expiry Date of Pfizer Covid-19 vaccine was not Provided. Reason for no lot number: of Pfizer Covid-19 vaccine: Caller unwilling to complete the report. Other Products were not Provided. Investigation Assessment was not Provided. Dates for pain at injection site, Chills, Headache, Fatigue, body aches, woke with a clogged ear was provided as unspecified. Additional Context: Caller is reporting that she experienced a reaction after getting the Pfizer Covid-19 vaccine. Declines to provide email address. She reports that on Monday morning, she received the second dose. Like the first time she had pain at the injection site. The pain did go away. She also had chills, headache, fatigue and body aches. She went to bed on Tuesday and yesterday she woke with a clogged ear on the side that she received the shot. She didn't make a big deal out of it or relate it to the vaccine. She researched and realized her ear clogging could be a side effect of the vaccine. She read that others had this. She is asking if we have heard this? What needs to be done? Does she need to see an ENT? Does anyone at Pfizer have an explanation or suggestion? Reporter seriousness for pain at injection site, Chills, Headache, Fatigue, body aches, woke with a clogged ear was provided as unspecified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On Dec 4 at 6pm severe myalgia and lethargic.  9pm fever 102.7., 1:30am   Debilitating  headache requiring ice and pain meds. Unable to get out of bed without help for 14 hours. All symptoms subsided at 8pm on December 5th.
This case was reported by a pharmacist via sales rep and described the occurrence of asthma in a adult female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT. In December 2015, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced asthma (serious criteria hospitalization) and laryngospasm (serious criteria hospitalization). On an unknown date, the outcome of the asthma and laryngospasm were recovering/resolving. It was unknown if the reporter considered the asthma and laryngospasm to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: The reporter stated that, apparently the event occurred in the month of December 2015.
Localized lymphadenopathy to left supraclavicle node and left cervical node.
ACUTE RESPIRATORY FAILURE 4/3/2022 BRAIN MASS  ACUTE RESPIRATORY FAILURE 4/3/2022 HEADACHE         ACUTE RESPIRATORY FAILURE 4/3/2022 CHRONIC MYELOID LEUKEMIA  ACUTE RESPIRATORY FAILURE 4/3/2022 CHEMOTHERAPY  ACUTE RESPIRATORY FAILURE 4/3/2022 CHEMOTHERAPY  ACUTE RESPIRATORY FAILURE 4/3/2022 LEUKEMIC MENINGITIS, UNSPECIFIED         ACUTE RESPIRATORY FAILURE 4/3/2022 CHRONIC MYELOID LEUKEMIA  ACUTE RESPIRATORY FAILURE 4/3/2022 COGNITIVE DEFICIT IN ATTENTION OR CONCENTRATION  ACUTE RESPIRATORY FAILURE 4/3/2022 FACTOR V DEFICIENCY  ACUTE RESPIRATORY FAILURE 4/3/2022 RIGHT LEG CELLULITIS  ACUTE RESPIRATORY FAILURE 4/3/2022 CMV INFECTION  ACUTE RESPIRATORY FAILURE 4/3/2022 PANCYTOPENIA  ACUTE RESPIRATORY FAILURE 4/3/2022 ACUTE PYELONEPHRITIS  ACUTE RESPIRATORY FAILURE 4/3/2022 VISUAL DISTURBANCE
pt recv vax;found to be pregnant;premature labor at 33.5 wk of gestation; f/u showed pt & baby had not had any further problems;
pt exp burning @ inject site following administration of 2nd dose of vax in deltoid on 19JAN93; burning was reported to not be associated w/the insertion of the needle; the nurse reported that she shook the vial well a/drawing;
Initial unsolicited report received from a physician on 21 October 2015. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (batch number,route, dose, cycle in series and site of administration were not reported) on an unspecified date in 2014. Patient medical history and concomitant medications were not reported. On an unspecified date in 2014, following the vaccination, the patient experienced malaise, leg cramps, and elevated muscle enzymes. Lab data and corrective treatments were not reported. The patient recovered from the events. List of documents held by sender: none.
all over; Hives; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION ( all over), URTICARIA (Hives) and HEADACHE (Headaches) in an 89-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION ( all over), URTICARIA (Hives) and HEADACHE (Headaches). At the time of the report, CONTUSION (all over), URTICARIA (Hives) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: abnormal (abnormal) Platelet drop.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment medicines were reported.
Pt received varicella on 1/6/00. Pt was presented to medical facility with 6 lesions appearing on neck and trunk (papular vesicular).
Full body hives within 30 min of vaccine administration. Treatment - BENADRYL 12.5 mg IV x1, hydrocortisone 100 mg IV x 1.
Pt received Influenza vaccine on 10/28/2020. Noticed urticaria & swelling at site. No fever. RX: Benadryl + Clindamycin.
Headache, Diarrhea, Increased fatigue, muscle aches, chills/swets,  Narrative:
I developed a fever of 102, queasiness (unable to eat), body aches, headache, and fatigue. On day three after the vaccine, the previously mentioned symptoms ceased but I developed a series of sores in my left nostril, sinus/headache, constant runny nose...almost like a sinus infection but with sores the entire canal, and a twitch in my left eye. It's day 4 now and it's painful and uncomfortable.
on the 9th day (4/9/2021), I developed a large red circle reaction at the vaccine site in my left arm; it was itchy for a few days prior; it's  warm/hot to the touch and sometimes itchy; I have tried claritin but doesn't do much today is the 4th day and redness is still present (started claritin on 3rd day)
Inject site dent, in lt thigh;dent is deep & different than skin color;
24APR92 AM 2-3 hives on face; 145PM hives on face gone-hives on feet/ankles-bad-feet swollen-feels warm (temp not taken) APAP given 1030A; has little wheeze; hx of asthma;
Left axillary pain beginning 1/19/2021. Red itchy oval rash at site of injection on left upper arm beginning 1/20/2021.